liraglutide profile

ID Source	ID
PubMed CID	16134956
CHEMBL ID	4084119
CHEBI ID	71193
MeSH ID	M0405743

Synonym
gtpl1133
204656-20-2
liraglutide ,
saxenda
nn2211
nn-2211
nn 2211
liraglutida [inn-spanish]
nnc 90-1170
liraglutide [usan:inn:ban:jan]
n26-(hexadecanoyl-gamma-glutamyle)-(34-arginine)glucagon-like-peptide-1-(7-37)-peptide
hsdb 8205
839i73s42a ,
arg34lys26-(n-epsilon-(gamma-glu(n-alpha-hexadecanoyl)))-glp-1(7-37)
liraglutidum [inn-latin]
n(sup 26)-(hexadecanoyl-gamma-glutamyle)-(34-arginine)glp-1-(7-37)-peptide
n26-(hexadecanoyl-gamma-glutamyle)-(34-arginine)glp-1-(7-37)-peptide
unii-839i73s42a
CHEBI:71193 ,
liraglutide recombinant
nnc-90-1170
nn9924
nn-9924
liraglutide component of xultophy 100/3.6
xultophy 100/3.6 component liraglutide
liraglutide (rdna origin)
EX-A2418
AKOS037435224
bdbm50240819
CHEMBL4084119 ,
DTXSID60174433 ,
AS-56276
n26-(n-hexadecanoyl-l-gamma-glutamyl)-(34-l-arginine)glucagon-like peptide 1-(7-37)-peptide
n(sup epsilon26)-(n-hexadecanoyl-l-gamma-glutamyl)-(34-l-arginine)glucagon-like peptide 1-(7-37)-peptide
liraglutidum (inn-latin)
arg(sup 34)lys(sup 26)-(n-epsilon-(gamma-glu(n-alpha-hexadecanoyl)))-glp-1(7-37)
a10bj02
liraglutida (inn-spanish)
liraglutide (mart.)
liraglutidum (latin)
dtxcid6096924

Excerpt	Reference	Relevance
"Liraglutide is an acylated glucagon-like peptide-1 (GLP-1) analogue that binds to serum albumin in vivo and is approved for once-daily treatment of diabetes as well as obesity. "	( Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide. Bloch, P; Gram, DX; Knudsen, LB; Knudsen, SM; Kofoed, J; Kruse, T; Lau, J; Madsen, K; McGuire, J; Nielsen, FS; Pettersson, I; Reedtz-Runge, S; Schäffer, L; Spetzler, J; Steensgaard, DB; Strauss, HM; Thygesen, P, 2015)	1.86
"Liraglutide (LIR) is a potent anti-diabetic drug and also has antioxidant and anti-inflammatory properties."	( Assessment of the cardioprotective effect of liraglutide on methotrexate induced cardiac dysfunction through suppression of inflammation and enhancement of angiogenesis in rats. Abdel All, MO; Abdelaleem, OO; Abdelmeguid, EA; Eldosoki, DE; Elsayed, RM; Mahmoud, RH; Mohammed, MA; Morsi, EM; Said, ES, 2021)	1.6
"Liraglutide 3 mg is a once daily injectable GLP-1 receptor agonist that is licensed for the treatment of obesity in the general population and has the potential to be used in people with severe mental illness."	( Liraglutide and the management of overweight and obesity in people with severe mental illness: qualitative sub-study. Asher, C; Barnard-Kelly, K; Holt, RIG; Peveler, RC; Phiri, P; Price, HC; Rathod, S; Whicher, CA, 2022)	2.89
"Liraglutide appears to be an acceptable therapy for obesity in this population with limited side effects. "	( Liraglutide and the management of overweight and obesity in people with severe mental illness: qualitative sub-study. Asher, C; Barnard-Kelly, K; Holt, RIG; Peveler, RC; Phiri, P; Price, HC; Rathod, S; Whicher, CA, 2022)	3.61
"Liraglutide is a long-acting glucagon-like peptide 1 (GLP-1) receptor agonist used as an anti-hyperglycemic agent in type 2 diabetes treatment and recently approved for obesity management. "	( Liraglutide Activates Type 2 Deiodinase and Enhances β3-Adrenergic-Induced Thermogenesis in Mouse Adipose Tissue. Amato, AA; Bauer, EJ; Beserra, BTS; Coelho, MS; Maia, AL; Neves, FAR; Oliveira, FCB; Pereira, SA; Ribeiro, CM; Wajner, SM, 2021)	3.51
"Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor that is widely used in the clinic and is approved to treat obesity and diabetes."	( Liraglutide attenuates hepatic iron levels and ferroptosis in db/db mice. An, JR; Chen, Q; Ji, ES; Jia, CL; Song, JX; Xu, S; Yang, XY; Zhao, YS, 2022)	2.89
"Liraglutide (Lg) is a novel long-acting analog of glucagon-like peptide-1 that has potential protective effects against stroke."	( Liraglutide Ameliorates Cerebral Ischemia in Mice via Antipyroptotic Pathways. Chen, L; Chen, R; Cheng, J; Du, Y; Qiao, H; Shi, G; Yang, L; Zhang, C; Zhang, X, 2022)	2.89
"Liraglutide is an effective treatment for the management of type 2 diabetes mellitus (T2DM). "	( A pilot clinical study to Evaluate Liraglutide-mediated Anti-platelet activity in patients with type-2 Diabetes (ELAID study). Chronopoulos, A; Cohen, AC; Dauer, R; Dear, AE; Gilfillan, C; Green, S; Hamilton, J; Harris, C; James, V; Kaloupis, GM; Loganathan, J; Morgan, S; Wallis, A, 2022)	2.44
"Liraglutide is a long-acting analogue of a glucagon-like peptide 1 (GLP-1) receptor agonist used for lowering blood glucose in patients with DM, and is believed to possess cardiovascular protective effects."	( Liraglutide Attenuates Restenosis After Vascular Injury in Rabbits With Diabetes Via the TGF-β/Smad3 Signaling Pathway. Ding, HX; Dong, NX; Hou, L; Ma, HF; Wang, FJ; Xing, N; Zhou, CX, 2022)	2.89
"Liraglutide is a glucagon-like peptide-1 (GLP-1) analogue that is used to treat type-2 diabetes mellitus."	( The Anti-Seizure Effect of Liraglutide on Ptz-Induced Convulsions Through its Anti-Oxidant and Anti-Inflammatory Properties. Erbas, O; Erdogan, A; Erdogan, MA, 2023)	1.93
"Liraglutide is an effective option for the treatment of type 2 diabetes and has recently been reported to exert cardioprotective effects on MI/RI."	( Liraglutide Attenuates Myocardial Ischemia/Reperfusion Injury Through the Inhibition of Necroptosis by Activating GLP-1R/PI3K/Akt Pathway. Li, Y; Liu, D; Liu, Y; Wu, H; Yang, J; Yang, Q; Ye, M; Zhang, D; Zhang, J; Zhou, G, 2023)	3.07
"Liraglutide is a long-acting GLP-1RA that can reduce blood pressure, blood lipids, and inflammation."	( GLP-1 receptor agonist, liraglutide, protects podocytes from apoptosis in diabetic nephropathy by promoting white fat browning. Liu, F; Long, D; Wang, J; Wu, Y; Zhou, Y, 2023)	1.94
"Liraglutide is a drug, widely used for DKD treatment globally."	( Effects of liraglutide on extraglycemic inflammatory markers and renal hemodynamic parameters in diabetic kidney disease (DKD). Rao, X; Song, W; Sun, X; Xu, M, 2023)	2.02
"Liraglutide is a glucagon-like peptide-1 receptor agonist and a potential treatment for TBI-induced memory deficits."	( Mitigation of Hearing Damage With Liraglutide Treatment in Chinchillas After Repeated Blast Exposures at Mild-TBI. Gan, RZ; Jiang, S; Sanders, S, 2023)	1.91
"Liraglutide (LIR) is a novel long-lasting glucagon-like peptide-1 (GLP-1) analogue that facilitates insulin signalling and shows also neuroprotective properties in different brain disease models. "	( Evaluation of the effects of liraglutide on the development of epilepsy and behavioural alterations in two animal models of epileptogenesis. Abdalla, K; Arturi, F; Citraro, R; Constanti, A; De Caro, C; De Sarro, G; Iannone, M; Leo, A; Nesci, V; Palma, E; Russo, E; Tallarico, M, 2019)	2.25
"Liraglutide (LG) is a new kind of long-acting analogue of glucagon-like peptide-1 (GLP-1) and has potential protective effects in stroke."	( Role of liraglutide in brain repair promotion through Sirt1-mediated mitochondrial improvement in stroke. He, W; Li, L; Tian, X; Wang, H; Zhao, C, 2020)	1.71
"Liraglutide is a novel, long-acting glucagon-like peptide-1 (GLP-1) analogue used to treat type 2 diabetes mellitus. "	( Cardiovascular outcomes of liraglutide in patients with type 2 diabetes: A systematic review and meta-analysis. Duan, CM; Wan, TF; Wang, Y; Yang, QW, 2019)	2.25
"Liraglutide is a glucagon-like peptide-1 receptor (GLP-1R) agonist and incretin mimetic used for the treatment of Type 2 diabetes mellitus. "	( Liraglutide promotes the angiogenic ability of human umbilical vein endothelial cells through the JAK2/STAT3 signaling pathway. Di, Y; Du, X; He, J; Li, H; Liu, X; Liu, Y; Ma, P; Niu, C; Shen, N; Tian, F, 2020)	3.44
"Liraglutide is a new therapy used in diabetes and its effect on diabetic complications particularly cardiovascular ones is still under investigated. "	( Impact of liraglutide on microcirculation in experimental diabetic cardiomyopathy. Abdel-Hamid, AAM; Abdelrazik Soliman, NG; El-Hawwary, AA; Ellakkany, A, 2020)	2.4
"Liraglutide is a new hypoglycemic drug. "	( Liraglutide attenuates renal tubular ectopic lipid deposition in rats with diabetic nephropathy by inhibiting lipid synthesis and promoting lipolysis. Chen, C; Su, K; Xia, T; Yang, YF; Yao, BQ; Yi, B; Zhang, ZH, 2020)	3.44
"Liraglutide is an activator of glucagon-like peptide-1 receptor (GLP-1R) that activates anti-apoptotic pathways and exerts anti-inflammatory effects."	( Mesenchymal stem cells combined with liraglutide relieve acute lung injury through apoptotic signaling restrained by PKA/β-catenin. Chen, X; Don, O; Feng, Y; Liu, J; Ma, X; Qu, J; Song, Y; Yang, X, 2020)	1.55
"Liraglutide is an analog of glucagon-like peptide-1, a drug used in patients with type 2 diabetes."	( Repurposed Analog of GLP-1 Ameliorates Hyperglycemia in Type 1 Diabetic Mice Through Pancreatic Cell Reprogramming. Aguilera, E; Ampudia, RM; Cano-Sarabia, M; Coma, M; Gomez-Muñoz, L; Perna-Barrull, D; Pujol-Autonell, I; Rodriguez-Fernandez, S; Vázquez, F; Verdaguer, J; Villalba, A; Vives-Pi, M, 2020)	1.28
"Liraglutide is a glucagon-like peptide-1 receptor agonist that promotes sustained weight loss, as well as abdominal fat reduction, in individuals with obesity, prediabetes, and type 2 diabetes mellitus."	( Liraglutide: New Perspectives for the Treatment of Polycystic Ovary Syndrome. Constantinidou, KG; Filippou, PK; Papaetis, GS; Stylianou, CS, 2020)	2.72
"Liraglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist that shares 97% homology to native GLP-1 with effects on the limbic system."	( New-generation anti-obesity drugs: naltrexone/bupropion and liraglutide. An update for endocrinologists and nutritionists. Barrea, L; Colao, A; Laudisio, D; Muscogiuri, G; Pugliese, G; Savastano, S, 2020)	1.52
"Liraglutide is a commonly used long-acting agonist that shows promising cardioprotective benefits."	( GLP-1 receptor agonist liraglutide protects cardiomyocytes from IL-1β-induced metabolic disturbance and mitochondrial dysfunction. Chang, D; Diao, S; Tian, J; Xiao, M; Zhang, G; Zhang, L, 2020)	1.59
"Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that prevents metabolic side effects of the antipsychotic drugs (APDs) olanzapine and clozapine through unknown mechanisms."	( Effect of liraglutide on neural and peripheral markers of metabolic function during antipsychotic treatment in rats. Babic, I; Else, PL; Nealon, J; Osborne, AL; Pai, N; Sellers, D; Weston-Green, K, 2021)	2.47
"Liraglutide is an analog of human glucagon-like peptide-1 which play essential roles in regulation of glycolipid metabolism. "	( Enhancing bile tolerance of Lactobacilli is involved in the hypolipidemic effects of liraglutide. Dong, QQ; Hu, HJ; Huang, R; Li, ZY; Luo, XG; Song, YJ; Wang, C; Wang, N; Zhang, TC; Zhao, W, 2021)	2.29
"Liraglutide is a glucagon-like peptide-1 receptor agonist used for management of diabetes and obesity."	( Liraglutide modulates olfactory ensheathing cell migration with activation of ERK and alteration of the extracellular matrix. Anoopkumar-Dukie, S; Chen, M; Ekberg, J; Lai, R; Oieni, F; Smyth, G; St John, J; Tseng, YT, 2021)	2.79
"Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for the treatment of patients with type 2 diabetes."	( The effect of liraglutide on insulin allergy in a patient with glucocorticoid-induced diabetes and multiple sclerosis. Chen, Y; Wang, J; Xia, H; Zhang, J; Zheng, Y, 2021)	1.7
"Liraglutide is a GLP-1 RA that is an option for treatment of T2DM. "	( Cardiovascular safety of liraglutide for the treatment of type 2 diabetes. Bain, S; Chudleigh, RA, 2017)	2.2
"Liraglutide is a glucagon-like peptide-1 analog for the treatment of type 2 diabetes. "	( Differential mobility spectrometry tandem mass spectrometry with multiple ion monitoring for the bioanalysis of liraglutide. Fawcett, JP; Gu, J; Li, J; Meng, X; Xu, H; Yang, Y; Zhang, Z, 2017)	2.11
"Liraglutide is a human glucagon-like peptide-1 analogue and has a marked effect in the treatment of type 2 diabetes."	( [Effect of liraglutide in treatment of non-alcoholic fatty liver disease: mechanism of action and research advances]. Feng, PP; Gong, JP; Liu, Y; Zhu, W, 2017)	1.57
"Liraglutide is a glucagon-like peptide-1 (GLP-1) analogue that has fascinated function in inhibiting β-cell apoptosis and preserving pancreatic β-cell mass."	( Glutamine up-regulates pancreatic sodium-dependent neutral aminoacid transporter-2 and mitigates islets apoptosis in diabetic rats. El-Sayed, NM; Medras, ZJH; Moustafa, YM; Sami, MM; Toraih, EA; Zaitone, SA, 2018)	1.2
"Liraglutide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist with anti-obesity and neuroprotective properties."	( Liraglutide prevents metabolic side-effects and improves recognition and working memory during antipsychotic treatment in rats. Babic, I; Else, P; Engel, M; Gorak, A; Huang, XF; Nealon, J; Osborne, AL; Pai, N; Sellers, D; Weston-Green, K, 2018)	2.64
"Liraglutide is a long-acting glucagon-like peptide-1 (GLP-1) analog that has been widely used to treat type 2 diabetes."	( The glucagon-like peptide-1 (GLP-1) analog liraglutide attenuates renal fibrosis. Hu, XF; Li, SL; Li, YK; Ma, DX; Shu, YW; Tian, HZ; Wang, MJ; Wang, ZM; Yang, J, 2018)	1.46
"Liraglutide is a glucagon-like peptide type 1 (GLP-1) analogue that is approved for long-term obesity management in North America. "	( Liraglutide Effects on Upper Gastrointestinal Investigations: Implications Prior to Bariatric Surgery. Birch, DW; Cawsey, S; Modi, R; Rye, P; Sharma, AM, 2018)	3.37
"Liraglutide is a glucagon-like 1 (GLP-1) agonist approved for treatment of type 2 diabetes and obesity."	( Cardiovascular Effects of Liraglutide. Mikhail, N, 2019)	2.26
"Liraglutide is a useful therapy in patients with advanced type 2 diabetes complicated by cardiovascular disease, except patients with severe heart failure. "	( Cardiovascular Effects of Liraglutide. Mikhail, N, 2019)	2.26
"Liraglutide is an efficient anti-type 2 diabetes incretin drug, with neuroprotective effects alongside anorectic properties."	( Dual Therapy with Liraglutide and Ghrelin Promotes Brain and Peripheral Energy Metabolism in the R6/2 Mouse Model of Huntington's Disease. Björkqvist, M; Duarte, AI; Moreira, PI; Oliveira, CR; Santos, MS; Sjögren, M, 2018)	1.54
"Liraglutide is a type of glucagon‑like‑peptide 1 receptor agonist, which has been reported as a novel type of antidiabetic agent with numerous benefits, including cardiovascular and neuroprotective effects. "	( Liraglutide improves cognitive impairment via the AMPK and PI3K/Akt signaling pathways in type 2 diabetic rats. Fang, H; Tian, J; Xu, G; Xu, J; Yang, Y; Zhang, D; Zhang, G; Zhang, Y; Zhen, Y, 2018)	3.37
"Liraglutide is a long-lasting GLP-1 analog clinically used as antidiabetic."	( The Antidiabetic Drug Liraglutide Minimizes the Non-Cholinergic Neurotoxicity of the Pesticide Mipafox in SH-SY5Y Cells. Dos Santos, AC; Dos Santos, NAG; Emerick, GL; Fernandes, LS, 2019)	1.55
"Liraglutide is an efficacious weight loss agent in patients with HFrEF. "	( Liraglutide and weight loss among patients with advanced heart failure and a reduced ejection fraction: insights from the FIGHT trial. Ambrosy, AP; Borlaug, BA; Cooper, LB; DeVore, AD; Groake, JD; Hernandez, AF; Lala, A; Margulies, KB; McNulty, SE; Mentz, RJ; Michael Felker, G; Sharma, A; Vader, J; Velazquez, EJ, 2018)	3.37
"Liraglutide (LIRA) is a novel antidiabetic therapy that may have anti-inflammatory and bone protective effects. "	( The effect of liraglutide on the proliferation, migration, and osteogenic differentiation of human periodontal ligament cells. Guo, J; Pang, Y; Wang, J; Wang, X; Yang, M; Yuan, X; Zhu, J, 2019)	2.32
"Liraglutide is a well-known once-daily GLP-1 receptor agonist that showed a cardiovascular and renal protection in patients with type 2 diabetes at high cardiovascular risk."	( [Basal insulin degludec - liraglutide fixed ratio combination (Xultophy®)]. Mathieu, C; Scheen, AJ, 2018)	1.5
"Liraglutide was shown to be a more effective option than insulin therapy because (1) glycemic levels were more stable; (2) the number of patients requiring additional insulin according to the insulin sliding scale was significantly smaller (Fisher's exact test, p = 0.005); (3) the insulin dosage required on the day of surgery was significantly smaller (Fisher's exact, p = 0.004); (4) the additional insulin volume required was significantly less for patients throughout the perioperative period (Fisher's exact test, p = 0.001); and (5) while lean body mass remained the same, body fat measurements, particularly visceral fat, tended to decrease."	( GLP1 Receptor Agonist Liraglutide Is an Effective Therapeutic Option for Perioperative Glycemic Control in Type 2 Diabetes within Enhanced Recovery After Surgery (ERAS) Protocols. Kaneko, S; Tahara, Y; Ueda, Y, 2018)	2.24
"Liraglutide is a long-acting glucagon-like peptide-1 (GLP-1) analog. "	( Scientific report: a case of acute pancreatitis due to liraglutide. Quesada-Vázquez, N, 2019)	2.2
"Liraglutide is a GLP-1 analog (glucagon like peptide-1) used primarily in the treatment of diabetes mellitus type 2 (DM2) and obesity. "	( Liraglutide and its Neuroprotective Properties-Focus on Possible Biochemical Mechanisms in Alzheimer's Disease and Cerebral Ischemic Events. Górski, K; Malinowski, B; Pawlak-Osińska, K; Socha, M; Słupski, M; Walczak, M; Wiciński, M; Wódkiewicz, E, 2019)	3.4
"Liraglutide is a glucagon-like peptide-1 (GLP-1) analogue currently approved for type 2 diabetes and obesity. "	( Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer's disease: study protocol for a randomised controlled trial (ELAD study). Archer, H; Ballard, C; Bannister, C; Brooks, DJ; Busza, G; Coulthard, E; Donaldson, A; Edison, P; Femminella, GD; Frangou, E; Harrison, J; Holmes, C; Hölscher, C; Junaid, K; Karim, S; Knight, L; Koranteng, P; Kshemendran, S; Lawrence, R; Love, SB; Macharouthu, A; Malik, N; Mate, V; McFarlane, B; McGuinness, B; Nilforooshan, R; Passmore, AP; Prasanna, A; Ridha, BH; Ritchie, C; Russell, G; Tadros, G; Thacker, S; Underwood, BR; Walker, Z, 2019)	2.21
"Liraglutide is a Glucagon-like peptide-1 (GLP-1) analogue used for the treatment of type II diabetes mellitus and obesity. "	( Liraglutide treatment effects on rat ovarian and uterine tissues. Abd El-Rahman, HA; Saber, SM, 2019)	3.4
"Liraglutide is a long-acting acylated human GLP-1 receptor agonist, with a 97% amino acid sequence identity to endogenous human GLP-1, and 100% amino acid sequence homology with canine GLP-1."	( Characterization of the use of liraglutide for glycemic control in healthy and Type 1 diabetes mellitus suffering dogs. Arai, T; Ishioka, K; Lee, P; Mori, A; Oda, H; Saeki, K; Sako, T, 2013)	1.4
"Liraglutide is a human glucagon-like peptide-1 (GLP-1) analogue approved for the treatment of type 2 diabetes. "	( In vitro protein binding of liraglutide in human plasma determined by reiterated stepwise equilibrium dialysis. Jensen, LB; Kristensen, JB; Plum, A, 2013)	2.13
"Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist approved for the treatment of type 2 diabetes mellitus (T2DM) which, in addition to its normoglycemic effects, induces a significant improvement in body weight and several cardiovascular risk factors."	( Is treatment with liraglutide efficient? Mezquita Raya, P; Reyes García, R, 2014)	1.46
"Liraglutide is a human glucagon-like peptide receptor analog approved for use in patients with type 2 diabetes mellitus (T2DM)."	( Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. Bergenstal, RM; Buse, JB; Daniels, GH; Frandsen, KB; Mann, JF; Marso, SP; Moses, AC; Nauck, MA; Nissen, SE; Pocock, S; Poulter, NR; Ravn, LS; Steinberg, WM; Zinman, B, 2013)	1.47
"Liraglutide is a long acting derivative of human GLP-1(7-37), which is a cleavage product encompassing amino acids 7-37 of GLP-1."	( GLP-1-related proteins attenuate the effects of mitochondrial membrane damage in pancreatic β cells. Ide, R; Iwasaki, N; Ogata, M; Takizawa, M; Uchigata, Y, 2014)	1.12
"Liraglutide is a glucagon-like peptide-1 (GLP-1) mimetic used for the treatment of Type 2 diabetes. "	( Glucagon-like peptide-1 (GLP-1) analog liraglutide inhibits endothelial cell inflammation through a calcium and AMPK dependent mechanism. Cacicedo, JM; Ido, Y; Krasner, NM; Ruderman, NB, 2014)	2.11
"Liraglutide (Victoza) is a GLP-1 analogue developed for the treatment of type 2 diabetes (T2D); however, its impact on cardiac function has not previously been investigated in patients with CHF."	( A protocol for a randomised, double-blind, placebo-controlled study of the effect of LIraglutide on left VEntricular function in chronic heart failure patients with and without type 2 diabetes (The LIVE Study). Boesgaard, TW; Flyvbjerg, A; Gustafsson, I; Holmager, P; Jorsal, A; Kistorp, C; Kumme, A; Møller, JE; Nielsen, R; Nilsson, B; Tarnow, L; Videbæk, L; Wiggers, H, 2014)	1.35
"Liraglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist, which has a protracted pharmacokinetic profile compared to native GLP-1 while maintaining its biological activity. "	( Liraglutide in the treatment of obesity. Ng, SY; Wilding, JP, 2014)	3.29
"Liraglutide is an anti-diabetic drug and human glucagon-like peptide-1 (GLP-1) analog that primarily functions in the pancreas. "	( Liraglutide enhances glucose transporter 4 translocation via regulation of AMP-activated protein kinase signaling pathways in mouse skeletal muscle cells. Chen, LM; Li, Z; Ni, CL; Niu, WY; Yao, Z, 2014)	3.29
"Liraglutide is a glucagon-like peptide-1 (GLP-1) analog marketed for the treatment of type 2 diabetes. "	( The arcuate nucleus mediates GLP-1 receptor agonist liraglutide-dependent weight loss. Baquero, AF; Bjerre Knudsen, L; Cowley, MA; Dalbøge, LS; Grove, KL; Hansen, G; Hecksher-Sørensen, J; Jelsing, J; Pyke, C; Raun, K; Schäffer, L; Secher, A; Tang-Christensen, M; Verma, S; Vrang, N; Witgen, BM, 2014)	2.1
"Liraglutide is likely to be a cost-effective option for the treatment of Type 2 diabetes in a Greek setting."	( Cost-effectiveness analysis of liraglutide versus sitagliptin or exenatide in patients with inadequately controlled Type 2 diabetes on oral antidiabetic drugs in Greece. Kourlaba, G; Maniadakis, N; Melidonis, A; Tzanetakos, C; Verras, C, 2014)	2.13
"Liraglutide is an agonist of the glucagon-like peptide I receptor, and is commonly recommended as a treatment for obesity and type 2 diabetes mellitus. "	( The effects of liraglutide on male fertility: a case report. Cardoso, MC; Erthal-Martins, MC; Fontoura, P; Ramos, CF; Sartorio, C; Werneck, C, 2014)	2.2
"Liraglutide is a glucagon-like peptide-1 analog and glucose-lowering agent whose effects on cardiovascular risk markers have not been fully elucidated."	( Liraglutide reduces oxidative stress and restores heme oxygenase-1 and ghrelin levels in patients with type 2 diabetes: a prospective pilot study. Abate, N; Banach, M; Barbagallo, I; Chandalia, M; Giglio, RV; Isenovic, ER; Li Volti, G; Marino Gammazza, A; Montalto, G; Nikolic, D; Rizvi, AA; Rizzo, M, 2015)	3.3
"Liraglutide is a fatty-acid derivative of GLP-1 with a protracted pharmacokinetic profile that is used in people for treatment of type II diabetes mellitus and obesity."	( Pharmacokinetics and pharmacodynamics of the glucagon-like peptide-1 analog liraglutide in healthy cats. Adin, CA; Borin-Crivellenti, S; Gilor, C; Hall, MJ; Lakritz, J; Rajala-Schultz, P; Rudinsky, AJ, 2015)	1.37
"Liraglutide is a glucagon-like peptide-1 analog and recently started to be using as an incretin-based treatment for diabetes mellitus. "	( Liraglutide-related cholelithiasis. Akarsu, E; Alkan, S; Araz, M; Korkmaz, H, 2015)	3.3
"Liraglutide is a glucagon-like peptide-1 receptor analog recently approved for the treatment of type 2 diabetes mellitus (T2DM). "	( Add-On Treatment with Liraglutide Improves Glycemic Control in Patients with Type 2 Diabetes on Metformin Therapy. Brunetti, A; Capula, C; Chiefari, E; Foti, D; Greco, M; Liguori, R; Oliverio, R; Puccio, L; Pullano, V; Tirinato, D; Vero, A; Vero, R, 2015)	2.17
"Liraglutide is a long acting GLP-1 receptor agonist used in the treatment of type 2 diabetes."	( After 10 Years of Clinical Trials with Liraglutide in Diabetes, What do we Know About its Effects on Clinical Cardiovascular Outcomes? Doggrell, SA, 2015)	1.41
"Liraglutide is an adjunct to lifestyle modifications to improve success rates among overweight or obese individuals without diabetes. "	( Liraglutide: an injectable option for the management of obesity. Clements, JN; Shealy, KM, 2015)	3.3
"Liraglutide is a glucagon-like peptide-1 receptor agonist that has been successfully used in the treatment of type 2 diabetes for several years."	( Liraglutide: A New Option for the Treatment of Obesity. Nuffer, WA; Trujillo, JM, 2015)	2.58
"Liraglutide is an acylated glucagon-like peptide-1 analogue with 97 % amino acid homology with native glucagon-like peptide-1 and greatly protracted action. "	( Liraglutide in Type 2 Diabetes Mellitus: Clinical Pharmacokinetics and Pharmacodynamics. Flint, A; Ingwersen, SH; Jacobsen, LV; Olsen, AK, 2016)	3.32
"Liraglutide is a GLP-1 analog and has independent glucose and body weight (BW)-reducing effects."	( Hepatic adenylate cyclase 3 is upregulated by Liraglutide and subsequently plays a protective role in insulin resistance and obesity. Gu, HF; Li, Y; Li, Z; Liang, S; Liang, Y; Lu, M; Xia, N; Yang, L, 2016)	1.41
"Liraglutide is a glucagon-like peptide-1 (GLP-1) analogue that has been demonstrated to successfully treat diabetes and promote weight loss. "	( GLP-1 receptors exist in the parietal cortex, hypothalamus and medulla of human brains and the GLP-1 analogue liraglutide alters brain activity related to highly desirable food cues in individuals with diabetes: a crossover, randomised, placebo-controlled Bowers, J; Dincer, F; Farr, OM; Filippaios, A; Gavrieli, A; Kanyuch, N; Ko, BJ; Liakou, C; Mantzoros, CS; Sahin-Efe, A; Sofopoulos, M; Srnka, A; Thakkar, B; Tseleni-Balafouta, S; Tsoukas, MA, 2016)	2.09
"Liraglutide is a relevant neuroprotective agent, which can decrease the microgliosis and stimulate the anti-apoptotic pathway, a significant effect in the treatment of obesity and its comorbidities."	( Effects of liraglutide in hypothalamic arcuate nucleus of obese mice. Aguila, MB; Barreto-Vianna, AR; Mandarim-de-Lacerda, CA, 2016)	1.55
"Liraglutide is a glucagon-like peptide-1 receptor (GLP-1R) agonist marketed for the treatment of type 2 diabetes. "	( Long-acting glucagon-like peptide-1 receptor agonists have direct access to and effects on pro-opiomelanocortin/cocaine- and amphetamine-stimulated transcript neurons in the mouse hypothalamus. Hecksher-Sørensen, J; Knudsen, LB; Pyke, C; Secher, A, 2016)	1.88
"Liraglutide is a new generation lipopeptide drug used for the treatment of type II diabetes. "	( Innovative chemical synthesis and conformational hints on the lipopeptide liraglutide. Biondi, B; Bondesan, A; Cabri, W; Formaggio, F; Guryanov, I; Orlandin, A; Ricci, A; Toniolo, C; Visentini, D; Zanon, J, 2016)	2.11
"Liraglutide is an analogue of Glucagon-Like Peptide-1 (GLP-1) already indicated under the trade name of Victoza for the treatment of type 2 diabetes, at usual doses of 1.2 or 1.8 mg as once daily subcutaneous injection. "	( [LIRAGUTIDE AT A DOSE OF 3.0 MG (SAXENDA): NEW INDICATION FOR THE TREATMENT OF OBESITY]. Scheen, AJ, 2016)	1.88
"Liraglutide is a human glucagon-like peptide-1 (GLP-1) analogue that was recently approved to treat obesity in some countries. "	( Single dose and repeated administrations of liraglutide alter energy metabolism in the brains of young and adult rats. Cardoso, LC; da Rosa, N; de Mello, AH; Ferreira, GK; Fortunato, JJ; Prá, M; Rezin, GT; Schraiber, RB; Souza, LD, 2016)	2.14
"Liraglutide is a once-daily human GLP-1 analog being developed as a Type 2 diabetes therapy. "	( Tolerability, pharmacokinetics and pharmacodynamics of the once-daily human GLP-1 analog liraglutide in Japanese healthy subjects: a randomized, double-blind, placebo-controlled dose-escalation study. Irie, S; Jacobsen, LV; Kageyama, S; Matsumura, Y; Zdravkovic, M, 2008)	2.01
"Liraglutide is a novel glucagon-like peptide-1 (GLP-1) receptor agonist with 97% amino acid sequence identity to native GLP-1. "	( Liraglutide: a new treatment for type 2 diabetes. Vilsboll, T, 2009)	3.24
"Liraglutide is a long-acting analog of GLP-1, being developed by Novo Nordisk and currently undergoing regulatory review for the treatment of type 2 diabetes. "	( Potential of liraglutide in the treatment of patients with type 2 diabetes. Deacon, CF, 2009)	2.16
"Liraglutide is a GLP-1 analog with pharmacokinetic properties suitable for once-daily administration. "	( Liraglutide: a once-daily incretin mimetic for the treatment of type 2 diabetes mellitus. Campbell, RK; Neumiller, JJ, 2009)	3.24
"Liraglutide (Victoza) is an acylated analogue of glucagon-like peptide-1 (GLP-1) indicated for the treatment of type 2 diabetes mellitus. "	( Liraglutide: a review of its use in type 2 diabetes mellitus. Croom, KF; McCormack, PL, 2009)	3.24
"Liraglutide is a new glucagon-like peptide-1 (GLP-1) receptor agonist and a true GLP-1 analogue. "	( The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Blonde, L; Russell-Jones, D, 2009)	2.09
"Liraglutide is a once-daily GLP-1 analog that has been recently approved by the European Union regulatory agency and is in late-stage review by the United States Food and Drug Administration for the treatment of type 2 diabetes."	( Pharmacokinetics and pharmacodynamics of liraglutide, a long-acting, potent glucagon-like peptide-1 analog. Meece, J, 2009)	1.34
"Liraglutide is a once-daily human glucagon-like peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes mellitus (T2DM). "	( Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes. Kaku, K; Nishida, T; Rasmussen, MF; Seino, Y, 2010)	2.05
"Liraglutide is a glucagon-like peptide-1 (GLP-1) analog developed for type 2 diabetes. "	( Glucagon-like Peptide-1 receptor agonists activate rodent thyroid C-cells causing calcitonin release and C-cell proliferation. Almholt, K; Andersen, S; Bjerre Knudsen, L; de Boer, AS; Drucker, DJ; Egerod, FL; Gotfredsen, C; Hegelund, AC; Jacobsen, H; Jacobsen, SD; Madsen, LW; Moerch, U; Moses, AC; Mølck, AM; Nielsen, HS; Nowak, J; Solberg, H; Thi, TD; Zdravkovic, M, 2010)	1.8
"Liraglutide is a glucagonlike peptide-1 receptor analogue that stimulates insulin secretion, reduces postprandial glucagon release, causes a mild delay in gastric emptying, and may slightly decrease appetite. "	( Is liraglutide a useful addition to diabetes therapy? Mikhail, NE, )	2.2
"Liraglutide is a novel once-daily human glucagon-like peptide (GLP)-1 analog in clinical use for the treatment of type 2 diabetes. "	( Metabolism and excretion of the once-daily human glucagon-like peptide-1 analog liraglutide in healthy male subjects and its in vitro degradation by dipeptidyl peptidase IV and neutral endopeptidase. Bjørnsdottir, I; Helleberg, H; Larsen, U; Malm-Erjefält, M; Olsen, AK; Oosterhuis, B; van Lier, JJ; Vanggaard, J; Zdravkovic, M, 2010)	2.03
"Liraglutide (Victoza) is a peptide produced by DNA recombinant technology, which presents 97% homology with human glucagon-like peptide-1 (GLP-1) but is resistant to dipeptidylpeptidase-4, the enzyme that degrades the natural hormone. "	( [Liraglutide (Victoza): human glucagon-like peptide-1 used in once daily injection for the treatment of type 2 diabetes]. Scheen, AJ; Van Gaal, LF, )	2.48
"Liraglutide is a full agonist of the GLP-1 receptor and shares 97% of its amino acid sequence identity with human GLP-1. "	( Liraglutide: the therapeutic promise from animal models. Knudsen, LB, 2010)	3.25
"Liraglutide is a long-acting glucagon-like peptide-1 (GLP-1) mimetic which is a treatment option for type 2 diabetes. "	( Four weeks administration of Liraglutide improves memory and learning as well as glycaemic control in mice with high fat dietary-induced obesity and insulin resistance. Flatt, PR; Gault, VA; Holscher, C; Kerr, BD; Porter, DW, 2010)	2.09
"Liraglutide is a once-daily treatment option that can be used in adults with type 2 diabetes regardless of gender, age (although therapeutic experience in patients over 75 years of age is limited) and ethnicity or race."	( Liraglutide in clinical practice: dosing, safety and efficacy. Peterson, GE; Pollom, RD, 2010)	3.25
"Liraglutide is a modified form of human glucagon-like peptide-1."	( Liraglutide in the management of type 2 diabetes. Amarah, A; Wajcberg, E, 2010)	2.52
"Liraglutide is a once-daily human GLP-1 analog for treatment of type 2 diabetes. "	( Treatment with liraglutide--a once-daily GLP-1 analog--does not reduce the bioavailability of ethinyl estradiol/levonorgestrel taken as an oral combination contraceptive drug. Hindsberger, C; Jacobsen, LV; Vouis, J; Zdravkovic, M, 2011)	2.16
"Liraglutide is an analog with 97% homology to human glucagon-like peptide (GLP-1) and acts as a GLP-1 receptor agonist. "	( Liraglutide: a review of the first once-daily GLP-1 receptor agonist. Bode, B, 2011)	3.25
"Liraglutide is a glucagonlike peptide (GLP)-1 analog that reduces blood glucose levels, increases insulin secretion and improves insulin sensitivity through mechanisms that are not completely understood. "	( Liraglutide prevents hypoadiponectinemia-induced insulin resistance and alterations of gene expression involved in glucose and lipid metabolism. Li, L; Liu, H; Liu, R; Miao, Z; Yang, G; Yang, M, 2011)	3.25
"Liraglutide is a United States Food and Drug Administration (FDA)-approved glucagon-like peptide-1 (GLP-1) analog that is 97% homologous to native human GLP-1. "	( Liraglutide: clinical pharmacology and considerations for therapy. Sisson, EM, 2011)	3.25
"Liraglutide is a new therapeutic option to improve glycemic control in patients with type 2 diabetes. "	( The efficacy and safety of liraglutide. Jeong, KH; Yoo, BK, 2011)	2.11
"Liraglutide (Victoza®) is a subcutaneously administered glucagon-like peptide-1 (GLP-1) receptor agonist produced by recombinant DNA technology and used as an adjunct to diet and exercise in the treatment of adults with type 2 diabetes mellitus. "	( Liraglutide: a review of its use in the management of type 2 diabetes mellitus. Perry, CM, 2011)	3.25
"Liraglutide is a representative of a new drug class which shows significant advantages over former medications."	( [Liraglutide in the treatment of diabetes type 2]. Metelko, Z; Novak, B, )	1.76
"Liraglutide is an effective and well tolerated option for the treatment of type 2 diabetes."	( An overview of the pharmacokinetics, efficacy and safety of liraglutide. Bode, B, 2012)	2.06
"Liraglutide is a GLP-1 analogue introduced in Italy in 2010; its efficacy and safety have been tested within the comprehensive "LEAD program". "	( Incretin-based therapies in clinical practice: from efficacy to effectiveness. Focus on liraglutide. Corsi, A; Ponzani, P, 2012)	2.04
"Liraglutide is a once-daily human glucagon-like peptide-1 analogue used in the treatment of type 2 diabetes (T2D). "	( The design of the liraglutide clinical trial programme. Nauck, MA, 2012)	2.16
"Liraglutide is a GLP-1 receptor agonist, a novel medication for type 2 diabetes. "	( Vesiculopustular dermatosis: an uncommon side-effect of liraglutide? Besemer, F; Diamant, M; Hoogma, RP; Verschoor, AJ, )	1.82
"Liraglutide is a glucagon-like peptide (GLP)-1 analog that controls appetite, decreases body weight and improves glycemic control."	( The glucagon-like peptide-1 analog liraglutide suppresses ghrelin and controls diabetes in a patient with Prader-Willi syndrome. Ito, S; Nako, K; Ogawa, S; Okamura, M; Sakamoto, T; Senda, M, 2012)	1.28
"Liraglutide is a Glucagon like Peptide-1 (GLP-1) receptor agonist, which stimulates GLP-1 receptors and consequently leads to various cardio-metabolic and glycemic improvements in individuals with Type 2 Diabetes Mellitus (T2DM). "	( Treatment evaluation of liraglutide in type 2 diabetes. Davies, MJ; Kela, R, 2012)	2.13
"Liraglutide is a glucagon-like peptide-1 analogue that stimulates insulin secretion and improves β-cell function. "	( Liraglutide increases FGF-21 activity and insulin sensitivity in high fat diet and adiponectin knockdown induced insulin resistance. Boden, G; Li, L; Liu, H; Wang, C; Yang, G; Yang, M; Zhang, L, 2012)	3.26
"Liraglutide is a long-acting glucagon-like peptide 1 analog designed for once daily injection. "	( Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial. Jakobsen, G; Madsbad, S; Matthews, DR; Ranstam, J; Schmitz, O, 2004)	1.96
"Liraglutide (NN2211) is a long-acting GLP-1 analogue, with a pharmacokinetic profile suitable for once-daily administration. "	( Effects of liraglutide (NN2211), a long-acting GLP-1 analogue, on glycaemic control and bodyweight in subjects with Type 2 diabetes. An, B; Feinglos, MN; Pi-Sunyer, FX; Saad, MF; Santiago, O, 2005)	2.16
"Liraglutide is a once-daily glucagon-like peptide-1 analogue being developed for the treatment of type 2 diabetes. "	( An open-label, parallel group study investigating the effects of age and gender on the pharmacokinetics of the once-daily glucagon-like peptide-1 analogue liraglutide. Damholt, B; Ekblom, M; Golor, G; Pedersen, P; Wierich, W; Zdravkovic, M, 2006)	1.97
"Liraglutide is a promising drug for the treatment of type 2 diabetes."	( Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes. Filipczak, R; Gumprecht, J; Hompesch, M; Le, TD; Nauck, MA; Zdravkovic, M, 2006)	1.31
"Liraglutide is a glucagon-like peptide-1 receptor analogue, which is obtained by derivatising glucagon-like peptide-1 with a fatty acid, providing a compound with pharmacokinetic properties that are suitable for once-daily dosing."	( Liraglutide: a once-daily GLP-1 analogue for the treatment of type 2 diabetes mellitus. Vilsbøll, T, 2007)	2.5

Excerpt	Reference	Relevance
"Liraglutide treatment has an important ability to reduce NT-proBNP and improve 6MWT for heart failure, but shows no important influence on LVEF, LVEDV, LVESV, hospitalization for heart failure, major adverse cardiovascular events, and cardiac death."	( The Influence of Liraglutide for Heart Failure: A Meta-Analysis of Randomized Controlled Trials. Chen, Q; Huang, G; Wang, L; Zhang, Y, 2019)	2.3
"Liraglutide has a protective effect on AD in vivo and in vitro, which may be mediated by preventing neuronal apoptosis and inhibiting the activation of tau and the expression of BACE1."	( The role of GLP-1/GIP receptor agonists in Alzheimer's disease. Cai, LY; Chen, HY; Hou, YH; Ma, D; Song, LL; Tao, Y; Wang, L; Yu, CJ; Zhai, ZN; Zhang, Y, 2020)	2
"Liraglutide has an additive benefit with respect to efficacy and a reduction in body fat when commenced after IGB retrieval. "	( Efficacy of Liraglutide to Prevent Weight Regain After Retrieval of an Adjustable Intra-gastric Balloon-a Case-Matched Study. Abbarh, S; Adam, A; Badurdeen, D; Barrichello, S; Farha, J; Hedjoudje, A; Hoff, AC; Itani, MI; Khashab, MA; Kumbhari, V; Neto, MG; Ngamruengphong, S; Oberbach, A; Singh, VK, 2021)	2.44
"Liraglutide has a convenient once-daily administration regimen, a low potential for drug-drug interactions and low propensity to cause hypoglycaemia."	( Liraglutide: a review of its use in adult patients with type 2 diabetes mellitus. Scott, LJ, 2014)	2.57
"Liraglutide has a neutral effect on myocardial infarct size in a porcine ischemia-reperfusion model."	( Lack of cardioprotection from subcutaneously and preischemic administered liraglutide in a closed chest porcine ischemia reperfusion model. Kristensen, J; Maeng, M; Mortensen, UM; Nielsen, PH; Nielsen, TT; Schmidt, M, 2009)	2.03
"Liraglutide has an important place in the management of T2DM."	( Liraglutide in type 2 diabetes mellitus. Baruah, MP; Chaudhury, T; Dharmalingam, M; Sethi, BK, 2012)	2.54
"Liraglutide has been approved for the treatment of obesity in the past few years. "	( A novel anti-obesity mechanism for liraglutide by improving adipose tissue leptin resistance in high-fat diet-fed obese mice. Gong, F; Guo, X; Lyu, X; Pan, H; Wang, L; Wang, X; Xu, H; Yan, K; Yang, H; Zhu, H, 2022)	2.44
"Liraglutide has been widely used as a therapeutic agent for diabetes."	( Liraglutide Improves the Angiogenic Capability of EPC and Promotes Ischemic Angiogenesis in Mice under Diabetic Conditions through an Nrf2-Dependent Mechanism. Chen, H; Dai, X; Fan, X; Gu, C; Li, Y; Liu, Z; Lu, Z; Su, Y; Sun, D; Wang, K; Wu, J; Yan, X; Yi, M; Zhang, C; Zhang, G; Zhang, Y; Zheng, C, 2022)	2.89
"Liraglutide has been recently discovered to penetrate the blood-brain barrier to exert neuroprotective effects. "	( GLP-1R knockdown abrogates the protective effects of liraglutide on ischaemic stroke via inhibition of M2 polarisation and activation of NLRP3 inflammasome by reducing Nrf2 activation. Chen, JY; Chen, PP; Chen, Q; Ding, YH; Shi, SS; Tu, XK, 2023)	2.6
"Liraglutide has been shown to improve the severity of psoriatic lesions in patients with type 2 diabetes."	( Effects of liraglutide among patients living with psoriasis and obesity. Masmiquel, L; Nadal, A; Nadal, C; Nicolau, J; Pujol, A; Sanchís, P, 2023)	2.02
"Liraglutide has been used to control blood sugar."	( Liraglutide attenuates type 2 diabetes mellitus-associated non-alcoholic fatty liver disease by activating AMPK/ACC signaling and inhibiting ferroptosis. Chen, L; Cui, X; Fan, K; Guo, T; Liu, J; Liu, N; Sun, Y; Wang, Z; Wei, X; Yan, W; Zhang, Y; Zhu, Y, 2023)	3.07
"Liraglutide has been shown to improve glucose tolerance and lose weight in individuals with type 2 diabetes. "	( The efficacy and safety of liraglutide in the obese, non-diabetic individuals: a systematic review and meta-analysis. Bai, J; Cui, Y; Liu, Y; Ren, Y; Zhang, G; Zhang, P, 2019)	2.25
"As liraglutide has been proposed to affect bone metabolism, we evaluated the effect of liraglutide on bone turnover markers (BTM) in patients with prediabetes and schizophrenia treated with olanzapine or clozapine."	( Liraglutide does not change bone turnover in clozapine- and olanzapine-treated schizophrenia overweight patients with prediabetes - randomized controlled trial. Fink-Jensen, A; Jørgensen, NR; Larsen, JR; Maagensen, H; Vilsbøll, T, 2021)	2.58
"The liraglutide has been found to have neuroprotective effects."	( Beneficial effects of liraglutide (GLP1 analog) in the hippocampal inflammation. Aguila, MB; Barreto-Vianna, ARC; Mandarim-de-Lacerda, CA, 2017)	1.25
"Liraglutide has been found to have neuroprotective action in the risk of central nervous system disease."	( Liraglutide Protects Neurite Outgrowth of Cortical Neurons Under Oxidative Stress though Activating the Wnt Pathway. He, W; Lv, M; Tian, X; Wang, H, 2018)	2.64
"Liraglutide has been widely used in the treatment of type 2 diabetes mellitus (T2DM), however, the results of a number of randomized placebo-controlled trials on the effects of liraglutide for the treatment of T2DM have varied. "	( Liraglutide for the treatment of type 2 diabetes mellitus: a meta-analysis of randomized placebo-controlled trials. Du, Q; Han, P; Wang, YJ; Yang, S; Zhao, YY, 2014)	3.29
"Liraglutide has been shown to significantly improve glycemic control and reduce body weight while minimizing the risk of hypoglycemia in adult patients with type 2 diabetes (T2D). "	( Predictors of glycemic control and diabetes-related costs among type 2 diabetes patients initiating therapy with liraglutide in the United States. Durden, E; Hammer, M; Langer, J; Lenhart, G; Lopez-Gonzalez, L, 2016)	2.09
"Liraglutide has been shown to have direct effects in the arcuate nucleus of the rodent brain, activating pro-opiomelanocortin neurons and increasing levels of the cocaine- and amphetamine-stimulated transcript neuropeptide messenger ribonucleic acid, which correlate nicely to clinical studies where liraglutide was shown to increase feelings of satiety."	( Long-acting glucagon-like peptide-1 receptor agonists have direct access to and effects on pro-opiomelanocortin/cocaine- and amphetamine-stimulated transcript neurons in the mouse hypothalamus. Hecksher-Sørensen, J; Knudsen, LB; Pyke, C; Secher, A, 2016)	1.16
"Liraglutide has been under investigation as adjunct treatment to insulin in type 1 diabetes mellitus (T1D)."	( Pharmacokinetic Properties of Liraglutide as Adjunct to Insulin in Subjects with Type 1 Diabetes Mellitus. Christiansen, E; Heller, S; Ingwersen, SH; Jensen, L; Mader, JK; Pieber, TR, 2016)	1.44
"Liraglutide has been previously demonstrated to prevent osteoblastic differentiation of human vascular smooth muscle cells, resulting in the slowing of arterial calciﬁcation, however, its effect on bone formation remains unclear."	( Liraglutide attenuates the osteoblastic differentiation of MC3T3‑E1 cells by modulating AMPK/mTOR signaling. Guo, CF; Hu, XK; Tang, MX; Yin, XH; Zhang, HQ, 2016)	2.6
"Liraglutide has been reported to active brown adipose tissue (BAT) thermogenesis and WAT browning by rapid intracerebroventricular injection in mice."	( Liraglutide suppresses obesity and induces brown fat-like phenotype via Soluble Guanylyl Cyclase mediated pathway in vivo and in vitro. Chen, L; Li, C; Li, Y; Sun, B; Yang, Y; Zhang, J; Zhu, E, 2016)	2.6
"Liraglutide has been studied as monotherapy and in combination with metformin, glimepiride, and rosiglitazone for the treatment of type 2 diabetes."	( Liraglutide: a once-daily incretin mimetic for the treatment of type 2 diabetes mellitus. Campbell, RK; Neumiller, JJ, 2009)	2.52
"Liraglutide has been approved for the combination with metformin and/or a sulfonylurea or with metformin and a thiazolidinedione, if treatment with one or a combination of these drugs is not sufficient for an adequate blood glucose control."	( [Liraglutide: a human GLP-1 analogue for the treatment of diabetes mellitus type 2]. Jahn, E; Sausele, T, 2009)	1.98
"Liraglutide has been shown to offer effective glycaemic control for patients with type 2 diabetes and is appropriate for use across the conventional continuum of care. "	( Glycaemic control with liraglutide: the phase 3 trial programme. Mora, PF; Raskin, P, 2010)	2.11
"Liraglutide has been well studied in dual and triple combination therapies with sulfonylureas, metformin and rosiglitazone and appears safe and effective. "	( Liraglutide: once-daily GLP-1 agonist for the treatment of type 2 diabetes. Hardy, Y; Ryan, GJ, 2011)	3.25
"Liraglutide has been shown to increase glucose-dependent insulin release by 34% to 118% and reduce postprandial glucagon levels by 20%."	( Review of the therapeutic uses of liraglutide. Foster, KT; Jobe, LJ; Ryan, GJ, 2011)	1.37
"Liraglutide has been shown to improve glucose control and weight loss compared to other pharmacologic treatments with diabetes and may offer improved control with a decrease in daily dosing compared to exenatide. "	( Place in therapy for liraglutide and saxagliptin for type 2 diabetes. Brock, M; McFarland, MS; Ryals, C, 2011)	2.13
"Liraglutide has been made available in India recently."	( Liraglutide in type 2 diabetes mellitus. Baruah, MP; Chaudhury, T; Dharmalingam, M; Sethi, BK, 2012)	2.54

Excerpt	Reference	Relevance
"Liraglutide did not increase side effects."	( Efficacy and safety of liraglutide in patients with type 2 diabetes mellitus and severe obstructive sleep apnea. Cheng, F; Cheng, J; Jiang, W; Li, W, 2023)	1.94
"The liraglutide group had a lower risk of a composite CVD outcome (hazard ratio (HR) 0.65; 95% confidence interval (CI) 0.50-0.85; p < 0.01), all-cause mortality (HR 0.40; 95% CI 0.28-0.59; p < 0.0001), and nonfatal stroke (HR 0.54; 95% CI 0.34-0.87; p = 0.01)."	( Cardiovascular outcomes and healthcare costs of liraglutide versus basal insulin for type 2 diabetes patients at high cardiovascular risk. Chen, YC; Huang, WC; Ko, Y; Wu, CH, 2021)	1.36
"Liraglutide can increase PI3K, Akt and PON3 expression, and decrease NF-κB expression. "	( Liver paraoxonase 3 expression and the effect of liraglutide treatment in a rat model of diabetes. Dong, G; Jiang, P; Liu, Y; Xiao, Y; Zeng, Y; Zhu, D, 2021)	2.32
"Liraglutide can enhance insulin-induced GLUT4 translocation by inhibiting IRS1 serine phosphorylation in PA-treated muscle cells."	( Liraglutide ameliorates palmitate-induced insulin resistance through inhibiting the IRS-1 serine phosphorylation in mouse skeletal muscle cells. Chen, L; Jiang, Z; Li, C; Li, D; Li, Z; Ni, CL; Niu, W; Tang, Y; Yang, M; Zhu, Y, 2018)	3.37
"Liraglutide did not increase urine sodium excretion."	( Effect of liraglutide on ambulatory blood pressure in patients with hypertension and type 2 diabetes: A randomized, double-blind, placebo-controlled trial. Avramidis, I; Bargiota, A; Boura, P; Dimitriadis, G; Gerou, S; Kitsios, K; Kotsa, K; Lambadiari, V; Liakos, A; Tentolouris, N; Tsapas, A, 2019)	1.64
"Liraglutide plays a role of organ protection by inhibiting the expression of TGF-β1 of pulmonary tissue of diabetic rats. "	( [Effects of liraglutide on the expression of local renin-angiotensin system, transforming growth factor-β1 and collagen type III in pulmonary tissue of diabetic rats]. Chen, G; Sun, B; Wu, Q; Zhang, H; Zhao, W; Zheng, X, 2014)	2.22
"Liraglutide exposure was lower when dosed as IDegLira but met the criterion for equivalence."	( Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. Bode, B; Ingwersen, SH; Jacobsen, LV; Kapitza, C; Poulsen, P, 2015)	1.36
"Liraglutide promotes the proliferation and migration of CMECs in vitro via PI3K/Akt and MAPK/ERK signaling pathways."	( [Liraglutide promotes proliferation and migration of cardiac microvascular endothelial cells through PI3K/Akt and MAPK/ERK signaling pathways]. Chen, Y; Hu, SY; Tian, F; Wang, S; Yin, T; Zhang, Y, 2015)	2.77
"Liraglutide could be the cause of skin eruptions in this patient, possibly by immunogenicity."	( Vesiculopustular dermatosis: an uncommon side-effect of liraglutide? Besemer, F; Diamant, M; Hoogma, RP; Verschoor, AJ, )	1.1

Excerpt	Reference	Relevance
"Liraglutide treatment also increased p-AMPK expression and reduced NF-κB protein level."	( Neuroprotective effects of liraglutide against inflammation through the AMPK/NF-κB pathway in a mouse model of Parkinson's disease. Cao, B; Chen, J; Dong, Y; Wang, Y; Wu, P; Zhang, Y, 2022)	1.74
"Liraglutide treatment improved bridging fibrosis and liver function, as well as lessening ROS levels and the protein levels of RAGE, NOX1, NOX2 and NOX4."	( Liraglutide inhibits receptor for advanced glycation end products (RAGE)/reduced form of nicotinamide-adenine dinucleotide phosphate (NAPDH) signaling to ameliorate non-alcoholic fatty liver disease (NAFLD) in vivo and vitro. Feng, M; Huang, Y; Ji, J; Niu, X, 2022)	2.89
"Liraglutide treatment, but not weight loss achieved by lifestyle counseling, decreased plasma sST2 levels (- 9%, beta = - 14.9, standard deviation 6.9, p = 0.037) while Gal-3 levels did not change."	( Effects of liraglutide vs. lifestyle changes on soluble suppression of tumorigenesis-2 (sST2) and galectin-3 in obese subjects with prediabetes or type 2 diabetes after comparable weight loss. Aukrust, P; Birkeland, KI; Ciotti, S; Cipollone, F; Consoli, A; Di Castelnuovo, A; Gulseth, HL; Halvorsen, B; Liani, R; Michelsen, A; Santilli, F; Simeone, P; Tripaldi, R; Ueland, T, 2022)	1.83
"Liraglutide treatment decreased levels of acute phase response that to reduce the systemic chronic inflammatory state and oxidative stress, and eventually improve the cardio-metabolic profile in these patients."	( Plasma proteomics reveals an improved cardio-metabolic profile in patients with type 2 diabetes post-liraglutide treatment. Alfadda, AA; Benabdelkamel, H; Ekhzaimy, AA; Elhassan, T; Masood, A; Musambil, M, )	1.79
"Liraglutide treatment significantly decreased MDA content, increased SOD, GSH-Px content, and augmented total antioxidant capacity levels in tissues."	( Liraglutide Attenuates Restenosis After Vascular Injury in Rabbits With Diabetes Via the TGF-β/Smad3 Signaling Pathway. Ding, HX; Dong, NX; Hou, L; Ma, HF; Wang, FJ; Xing, N; Zhou, CX, 2022)	2.89
"Liraglutide treatment limited the reduction of BDNF and Nrf2 levels in the hippocampus, maintaining them at the control levels."	( The effect of glucagon like peptide-1 receptor agonist on behavioral despair and anxiety-like behavior in ovariectomized rats: Modulation of BDNF/CREB, Nrf2 and lipocalin 2. Özaçmak, HS; Sağlam, C; Turan, İ, 2022)	1.44
"Liraglutide treatment is associated with decreased liver fibrosis in type 2 diabetic subjects."	( Association between use of liraglutide and liver fibrosis in patients with type 2 diabetes. Chen, L; Ding, X; Fan, N; Lin, R; Liu, F; Peng, Y; Shen, T; Tan, Y; Wang, Y; Zhang, Q; Zhen, Q, 2022)	2.46
"Liraglutide-treatment mice showed significant decrease in food intake, final body weight, fasting blood glucose, and significant increase in skeletal muscle mass, which coincided with the significant decrease in the expression levels of ubiquitin protease E3 MuRF1 and MAFbx."	( Hypoglycemic drug liraglutide alleviates low muscle mass by inhibiting the expression of MuRF1 and MAFbx in diabetic muscle atrophy. Fan, D; Liu, B; Wang, Y; Yin, F, 2023)	1.97
"Liraglutide treatment significantly reduced food intake and body weight and improved glucose tolerance and insulin sensitivity, relative to controls. "	( Growth hormone treatment does not augment the anti-diabetic effects of liraglutide in UCD-T2DM rats. Cox, CL; Graham, JL; Havel, PJ; Knudsen, LB; Raun, K; Stanhope, K; Swarbrick, MM, 2023)	2.59
"The liraglutide treatment showed an effect increasing with time and different outcomes in open and EP chinchillas."	( Hearing protection and damage mitigation in Chinchillas exposed to repeated low-intensity blasts. Gan, RZ; Jiang, S; Sanders, S, 2023)	1.39
"Liraglutide treatment may provide some benefits for protecting renal function in type 2 diabetes."	( The effect of liraglutide on renal function in type 2 diabetes: a meta-analysis of randomized controlled studies. He, D; Hu, Z; Luo, C; Yang, H; Zhu, C; Zhu, J, 2022)	2.52
"Liraglutide, a novel treatment for diabetes and obesity, also has beneficial effects on non-alcoholic steatohepatitis (NASH)."	( Liraglutide With Metformin Therapy Ameliorates Hepatic Steatosis and Liver Injury in a Mouse Model of Non-alcoholic Steatohepatitis. Cheng, CC; Chiu, HY; Chiu, YJ; Jhan, SR; Liu, TY; Lo, YH; Tsai, FJ; Tsai, SC; Yang, JS, )	2.3
"Liraglutide treatment did not significantly influence levels of circulating miRNAs."	( Glimepiride Compared to Liraglutide Increases Plasma Levels of miR-206, miR-182-5p, and miR-766-3p in Type 2 Diabetes Mellitus: A Randomized Controlled Trial. Jendle, J; Kruse, R; Nyström, T; Scherbak, NN, 2023)	1.94
"Liraglutide treatment was associated with a greater reduction in trunk fat mass (FMT) (p < 0.05)."	( Effect of liraglutide on cardiometabolic profile and on bioelectrical impedance analysis in patients with obesity and metabolic syndrome. Freitas, FPC; Rodrigues, CEM, 2023)	2.03
"The liraglutide treatment insignificantly facilitated the recovery of the DPOAE levels and ABR thresholds on days 14 and 28."	( Mitigation of Hearing Damage With Liraglutide Treatment in Chinchillas After Repeated Blast Exposures at Mild-TBI. Gan, RZ; Jiang, S; Sanders, S, 2023)	1.67
"Liraglutide treatment improved insulin sensitivity, accompanied with reduced expression of the phosphorylated Acetyl-CoA carboxylase-2 (ACC2) and upregulation of long chain acyl CoA dehydrogenase (LCAD) in insulin sensitive tissues."	( Liraglutide improves insulin sensitivity in high fat diet induced diabetic mice through multiple pathways. Chandramani-Shivalingappa, P; Li, L; Mekala, N; Poudel, A; Rosca, MG; Welchko, R; Zhou, JY, 2019)	2.68
"Liraglutide treatment corrected the diet-induced alterations in glucose metabolism and significantly reduced hepatic steatosis and inflammation."	( Liraglutide improves hepatic steatosis and metabolic dysfunctions in a 3-week dietary mouse model of nonalcoholic steatohepatitis. Briand, F; Combes, G; Duparc, T; Martinez, LO; Merian, J; Najib, S; Sulpice, T; Trenteseaux, C, 2019)	2.68
"Liraglutide treatment also protected retinal ganglion cells from cell death and optic nerve axons from degeneration."	( GLP-1 receptor agonist liraglutide has a neuroprotective effect on an aged rat model of Wolfram syndrome. Hasselholt, S; Jagomäe, T; Koppel, T; Krogsbæk Mikkelsen, M; Pallase, M; Plaas, M; Randel Nyengaard, J; Reimets, R; Seppa, K; Terasmaa, A; Toots, M; Vasar, E, 2019)	1.55
"Liraglutide treatment reduced HbA1c, total daily insulin dose and body weight without increasing the risk of hypoglycaemia in CSII-treated patients with type 1 diabetes and insufficient glycaemic control. "	( Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin-pump-treated patients with type 1 diabetes: The Lira Pump trial-a randomized, double-blinded, placebo-controlled trial. Andersen, HU; Dejgaard, TF; Frandsen, CS; Madsbad, S; Nørgaard, K; Schmidt, S; Vistisen, D, 2020)	3.44
"Liraglutide treatment for 26 weeks did not affect bone resorption and preserved hip BMD despite weight loss in patients with T2D, suggesting that liraglutide has some antiresorptive effect."	( Bone resorption is unchanged by liraglutide in type 2 diabetes patients: A randomised controlled trial. Harsløf, T; Hygum, K; Jørgensen, NR; Langdahl, BL; Pedersen, SB; Rungby, J, 2020)	2.28
"Liraglutide treatment has an important ability to reduce NT-proBNP and improve 6MWT for heart failure, but shows no important influence on LVEF, LVEDV, LVESV, hospitalization for heart failure, major adverse cardiovascular events, and cardiac death."	( The Influence of Liraglutide for Heart Failure: A Meta-Analysis of Randomized Controlled Trials. Chen, Q; Huang, G; Wang, L; Zhang, Y, 2019)	2.3
"The liraglutide treatment resulted in a decrease in"	( Effect of liraglutide therapy on serum fetuin A in patients with type 2 diabetes and non-alcoholic fatty liver disease. Qu, XN; Sun, ZY; Zhang, LY; Zhang, Y, 2020)	1.44
"Liraglutide treatment resulted in a decrease in hepatic fat content and fetuin-A compared with pioglitazone treatment in patients with T2DM and NAFLD. "	( Effect of liraglutide therapy on serum fetuin A in patients with type 2 diabetes and non-alcoholic fatty liver disease. Qu, XN; Sun, ZY; Zhang, LY; Zhang, Y, 2020)	2.4
"Liraglutide treatment did not prevent lipid deposition in the liver of MCD-fed mice but limited the accumulation of C16 and C24-ceramide/sphingomyelin species."	( The GLP-1R agonist liraglutide limits hepatic lipotoxicity and inflammatory response in mice fed a methionine-choline deficient diet. Bochaton-Piallat, ML; De Vito, C; Dibner, C; Gaïa, N; Jornayvaz, FR; Lazarevic, V; Loizides-Mangold, U; Montandon, SA; Perroud, E; Schrenzel, J; Somm, E, 2021)	1.67
"Liraglutide treatment (0.6 mg/d) alone maintained the patient's glycated hemoglobin level below 7.0% for at least 12 months after discharge. "	( Maturity-Onset diabetes of the young type 5 treated with the glucagon-like peptide-1 receptor agonist: A case report. Chujo, D; Hamano, S; Kajio, H; Nakamura, T; Ohsugi, M; Tanabe, A; Terakawa, A; Ueki, K; Ueno, K; Yasuda, K, 2020)	2
"Liraglutide treatment significantly induced weight loss (P < .0001), decreased blood triglycerides (P < .0001) and total cholesterol (P < .0001) in WD-fed mice but did not decrease plaque burden."	( Liraglutide treatment improves endothelial function in the Ldlr-/- mouse model of atherosclerosis and affects genes involved in vascular remodelling and inflammation. Bjørnholm, KD; Lykkesfeldt, J; Mitgaard-Thomsen, A; Povlsen, GK; Rakipovski, G; Skovsted, GF; Tveden-Nyborg, P, 2021)	2.79
"Liraglutide treatment was effective in weight loss, increased C0 and C3 levels and decreased values of all other studied parameters comparing with before treatment but still higher than control."	( Liraglutide treatment and acylcarnitine profiles in Egyptian obese insulin-resistant females. Ebied, SA; El-Kotishy, SM; Hussein, NA; Nour, HA; Salem, TM; Zaki, UK, 2021)	2.79
"Liraglutide treatment ameliorated the declined body weight, decreased food intake and mortality observed in infected mice."	( The active GLP-1 analogue liraglutide alleviates H9N2 influenza virus-induced acute lung injury in mice. Bai, Y; Li, J; Lian, P; Qiao, J; Zhang, Z, 2021)	1.64
"Liraglutide-treated patients reached target HbA1c more frequently: 23/45 (51%) vs 11/51 (22%), relative probability 2.4 (1.3-4.3), p = 0.002."	( Efficacy of liraglutide on glycemic endpoints in people of Western European and South Asian descent with T2DM using multiple daily insulin injections: results of the MAGNA VICTORIA studies. Bizino, MB; Geelhoed-Duijvestijn, PH; Jazet, IM; Kharagjitsingh, AV; Lamb, HJ; Paiman, EHM; Rensen, PCN; Smit, JW; van Eyk, HJ, 2021)	1.72
"Liraglutide treatment resulted in increased chance of reaching target HbA1c as compared to placebo. "	( Efficacy of liraglutide on glycemic endpoints in people of Western European and South Asian descent with T2DM using multiple daily insulin injections: results of the MAGNA VICTORIA studies. Bizino, MB; Geelhoed-Duijvestijn, PH; Jazet, IM; Kharagjitsingh, AV; Lamb, HJ; Paiman, EHM; Rensen, PCN; Smit, JW; van Eyk, HJ, 2021)	2.44
"Liraglutide treatment reduced body weight, food intake, blood glucose and blood pressure levels, as well as ameliorated renal pathologic findings with lower urinary albumin and L-FABP levels."	( Renoprotective effect of GLP-1 receptor agonist, liraglutide, in early-phase diabetic kidney disease in spontaneously diabetic Torii fatty rats. Hoshino, S; Ichikawa, D; Inoue, K; Kamijo-Ikemori, A; Kimura, K; Nagai, Y; Natsuki, Y; Ogura, Y; Ohata, K; Shibagaki, Y; Sugaya, T; Tanabe, J; Watanabe, S; Yamada, S, 2021)	1.6
"Liraglutide treatment reversed these effects, decreased WAT depots weight and increased glucose oxidation and lipogenesis in BAT and WAT."	( Liraglutide improves lipid and carbohydrate metabolism of ovariectomized rats. Araújo, ASDR; Lima, MV; Lopes Vogt, É; Model, JFA; Ohlweiler, R; Rocha, DS; Souza, SK; Türck, P; Vinagre, AS, 2021)	2.79
"Liraglutide treatment alone improved NOS activity followed by increased NO production, while empagliflozin had little effect."	( Empagliflozin, alone or in combination with liraglutide, limits cell death in vitro: role of oxidative stress and nitric oxide. Cessario, J; Li, Z; Pierre-Louis, V; Wahl, J, 2021)	1.6
"Liraglutide co-treatment prevented the time-dependent increase in feeding efficiency caused by olanzapine, which plateaued by six weeks. "	( Effect of liraglutide on neural and peripheral markers of metabolic function during antipsychotic treatment in rats. Babic, I; Else, PL; Nealon, J; Osborne, AL; Pai, N; Sellers, D; Weston-Green, K, 2021)	2.47
"Liraglutide treatment increased the biliary concentration of cholesterol, phospholipids and bile acids and thereby decreased the cholesterol saturation index."	( Glucagon-like peptide 1 analogue prevents cholesterol gallstone formation by modulating intestinal farnesoid X receptor activity. Du, Z; Fang, Z; He, J; Huang, C; Huang, H; Huang, Y; Li, R; Li, Y; Liu, Q; Tang, Q; Wu, T; Zhang, G; Zhang, J; Zhang, Z; Zhao, Y; Zhou, J, 2021)	1.34
"Liraglutide treatment resulted in a lower frequency of hypoglycaemia <3.9 mmol/L (13% vs 23%; P = 0.04), but there was no difference in the rate of clinically significant hypoglycaemia <3.0 mmol/L."	( Liraglutide hospital discharge trial: A randomized controlled trial comparing the safety and efficacy of liraglutide versus insulin glargine for the management of patients with type 2 diabetes after hospital discharge. Albury, B; Anzola, I; Cardona, S; Chaudhuri, A; Coronado, KWZ; Davis, GM; Farias, JM; Fayfman, M; Galindo, RJ; Gomez, P; Iacobellis, G; Migdal, AL; Palacios, J; Pasquel, FJ; Peng, L; Perez-Guzman, MC; Umpierrez, GE; Urrutia, MA; Vellanki, P, 2021)	2.79
"Liraglutide treatment in DN rats decreased blood glucose, 24-hour urine microalbumin, TC, TG, LDL-C, UA, Cr, UREA, ALT, and AST levels and increased the level of HDL-C ("	( Liraglutide Regulates the Kidney and Liver in Diabetic Nephropathy Rats through the miR-34a/SIRT1 Pathway. Liu, YT; Xiao, S; Yang, Y; Zhu, J, 2021)	3.51
"Liraglutide treatment reversed these effects."	( Liraglutide treatment counteracts alterations in adipose tissue metabolism induced by orchiectomy in rats. de Souza, SK; Lima, MV; Model, JFA; Ohlweiler, R; Rocha, DS; Sarapio, E; Vinagre, AS; Vogt, ÉL, 2021)	2.79
"Liraglutide treatment correlated with a significantly reduced body mass index (MD: -1.55; 95% CI, -1.76 to -1.34) and waist circumference (MD: -3.11 cm; 95% CI, -3.59 to -2.62) and significantly decreased blood pressure (systolic blood pressure, MD: -2.85 mm Hg; 95% CI, -3.36 to -2.35; diastolic blood pressure, MD: -0.66 mm Hg; 95% CI, -1.02 to -0.30), glycated hemoglobin (MD: -0.40%; 95% CI, -0.49 to -0.31), and low-density lipoprotein cholesterol (MD: -2.91 mg/dL; 95% CI, -5.28 to -0.53; MD: -0.87% change from baseline; 95% CI, -1.17 to -0.56)."	( Efficacy and Safety of the New Appetite Suppressant, Liraglutide: A Meta-Analysis of Randomized Controlled Trials. Chung, HS; Kim, YJ; Lee, J; Moon, S; Oh, CM; Yu, JM; Yu, SH, 2021)	1.59
"Liraglutide and metformin treatments reduced weight and improved liver function."	( Randomized trial comparing the effects of gliclazide, liraglutide, and metformin on diabetes with non-alcoholic fatty liver disease. Bi, Y; Chen, W; Feng, W; Gao, C; Li, P; Shen, S; Wu, M; Yin, T; Zhu, D, 2017)	1.42
"Liraglutide-treated patients with prior history of pancreatitis ("	( Amylase, Lipase, and Acute Pancreatitis in People With Type 2 Diabetes Treated With Liraglutide: Results From the LEADER Randomized Trial. Buse, JB; Ghorbani, MLM; Nauck, MA; Steinberg, WM; Ørsted, DD, 2017)	1.4
"Liraglutide treatment reduced serum AGEs levels, reduced the expression of RAGE in aorta, and relieved atherosclerotic lesions compared with the control."	( Glucagon-like peptide-1 analogue liraglutide ameliorates atherogenesis via inhibiting advanced glycation end product-induced receptor for advanced glycosylation end product expression in apolipoprotein-E deficient mice. Feng, B; Li, P; Tang, Z; Wang, L, 2017)	1.46
"Liraglutide pretreatment prevented diabetes-induced cognitive impairment as assessed by the Morris Water Maze test, and alleviated neuronal injuries and ultrastructural damage to synapses in the hippocampal CA1 region."	( Liraglutide ameliorates cognitive decline by promoting autophagy via the AMP-activated protein kinase/mammalian target of rapamycin pathway in a streptozotocin-induced mouse model of diabetes. Kong, FJ; Ma, LL; Sun, SY; Wu, JH; Zhou, JQ, 2018)	2.64
"Liraglutide co-treatment prevented olanzapine- and clozapine-induced reductions in the NOR test discrimination ratio ( p < 0.001). "	( Liraglutide prevents metabolic side-effects and improves recognition and working memory during antipsychotic treatment in rats. Babic, I; Else, P; Engel, M; Gorak, A; Huang, XF; Nealon, J; Osborne, AL; Pai, N; Sellers, D; Weston-Green, K, 2018)	3.37
"Liraglutide co-treatment improved aspects of cognition, prevented obesity side-effects of olanzapine, and the hyperglycaemia caused by clozapine, when administered from the start of APD treatment. "	( Liraglutide prevents metabolic side-effects and improves recognition and working memory during antipsychotic treatment in rats. Babic, I; Else, P; Engel, M; Gorak, A; Huang, XF; Nealon, J; Osborne, AL; Pai, N; Sellers, D; Weston-Green, K, 2018)	3.37
"Liraglutide treatment was without hypoglycemic effects."	( Comparative Study of Liraglutide and Insulin Glargine on Glycemic Control and Pancreatic β-Cell Function in db/db Mice. Li, W; Li, Y; Liu, M; Shen, Y; Wang, J; Wu, M; Zheng, J; Zhu, S, 2018)	1.52
"Liraglutide treatment reversed these epigenetic changes and increased Pdx-1 expression, which could be abrogated by GLP-1 receptor antagonist Exendin 9-39."	( Liraglutide protects β-cell function by reversing histone modification of Pdx-1 proximal promoter in catch-up growth male rats. Chen, LL; Cui, ZH; Deng, XL; Gao, M; Li, HQ; Liu, ZH; Song, HJ; Xiao, KL; Zheng, J, 2018)	2.64
"Liraglutide treatment induced significant weight loss in both obesity models, showed improvements in glycemic parameters and reduced inflammatory cell infiltration in the cecum and the liver."	( Liraglutide modulates gut microbiota and reduces NAFLD in obese mice. Azevedo, FF; Carvalho, C; Gama, P; Guadagnini, D; Liberti, EA; Moreira, GV; Ribeiro, LM; Saad, M; Santos, A, 2018)	2.64
"The liraglutide-treated groups were superior to IBT-alone on both outcomes."	( Intensive Behavioral Therapy for Obesity Combined with Liraglutide 3.0 mg: A Randomized Controlled Trial. Alamuddin, N; Bakizada, Z; Berkowitz, RI; Chao, AM; Gruber, K; Leonard, S; Mugler, K; Tronieri, JS; Wadden, TA; Walsh, OA, 2019)	1.24
"Liraglutide treatment led to a significant weight loss (mean 6.03 kg (95%CI: 5.22;6.84)) and decrease in systolic blood pressure (mean 10.95 mm Hg (95%CI: 4.60;17.30))."	( Effect of liraglutide on body weight and microvascular function in non-diabetic overweight women with coronary microvascular dysfunction. Bové, K; Holst, JJ; Madsbad, S; Prescott, E; Raft, KF; Suhrs, HE; Zander, M, 2019)	1.64
"Liraglutide treatment showed increased adiponectin expression and decreased number of cystic follicles, body weight, circulating glucose, triglyceride and testosterone levels in comparison to the PCOS induced mice."	( Liraglutide modulates adipokine expression during adipogenesis, ameliorating obesity, and polycystic ovary syndrome in mice. Banerjee, A; Chhabra, G; Fernandes, JRD; Krishna, A; Singh, A, 2019)	2.68
"Both liraglutide treatment protocols attenuated hepatotoxicity that was induced by CCl"	( The GLP-1 analog liraglutide attenuates acute liver injury in mice. Acco, A; Adami, ER; Beltrame, OC; Corso, CR; Galindo, CM; Milani, L; Stipp, MC; Turin de Oliveira, NM, )	0.98
"Liraglutide treatment was also associated with a reduction of systolic blood pressure and improvement of lipid profile."	( Long-term effectiveness and safety of liraglutide in clinical practice. Ponzani, P, 2013)	1.38
"Liraglutide treatment inhibited progression of early onset, low-burden atherosclerotic disease in a partially GLP-1R-dependent manner in the ApoE(-/-) mouse model."	( The GLP-1 receptor agonist liraglutide inhibits progression of vascular disease via effects on atherogenesis, plaque stability and endothelial function in an ApoE(-/-) mouse model. Dear, AE; Gaspari, T; Simpson, RW; Welungoda, I; Widdop, RE, 2013)	1.41
"Liraglutide treatment in patients with T2DM significantly reduced postprandial excursions of triglyceride and apolipoprotein B48 after a fat-rich meal, independently of gastric emptying. "	( Liraglutide suppresses postprandial triglyceride and apolipoprotein B48 elevations after a fat-rich meal in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, cross-over trial. Bækdal, TA; Düring, M; Flint, A; Hermansen, K; Jørgensen, H; Mortensen, LS; Pietraszek, A, 2013)	3.28
"Liraglutide-treated subjects also had a significant improvement in SSPG concentration (-3.2 vs."	( Benefits of liraglutide treatment in overweight and obese older individuals with prediabetes. Abbasi, F; Ariel, D; Chen, YD; Grove, K; Kim, SH; Lamendola, C; Liu, A; Liu, YV; Ochoa, H; Reaven, G; Schaaf, P; Tomasso, V, 2013)	1.49
"Liraglutide treatment not only ameliorated hyperglycemia and peripheral insulin resistance, but also reversed these brain abnormalities in a time-dependent manner."	( Subcutaneous administration of liraglutide ameliorates Alzheimer-associated tau hyperphosphorylation in rats with type 2 diabetes. Gong, CX; Hu, S; Ma, D; Shao, S; Yang, Y; Zhang, J; Zhang, M, 2013)	1.4
"Liraglutide treatment (n = 24) significantly (p ≤ 0.03) increased the insulin secretion rate (% mean change [95% CI]; 21% [12, 31] vs -4% [-11, 3]) and pancreatic beta cell sensitivity to intravenous glucose (229% [161, 276] vs -0.5% (-15, 14]), and decreased insulin clearance rate (-3.5% [-11, 4] vs 8.2 [0.2, 16]) as compared with placebo (n = 25). "	( Pancreatic beta cell function following liraglutide-augmented weight loss in individuals with prediabetes: analysis of a randomised, placebo-controlled study. Abbasi, F; Ariel, D; Grove, K; Kim, SH; Lamendola, C; Liu, A; Reaven, G; Tomasso, V, 2014)	2.11
"Liraglutide treatment can improve glycemic control with a concomitant weight loss, but the underlying mechanism on weight loss is not completely understood. "	( Changes in liraglutide-induced body composition are related to modifications in plasma cardiac natriuretic peptides levels in obese type 2 diabetic patients. Li, CJ; Lu, S; Yu, DM; Yu, P; Yu, Q; Yu, TL; Zhang, QM, 2014)	2.23
"Liraglutide treatment for 14 weeks in daily clinical practice led to reduction of BMI and improvement of glucose control and insulin sensitivity and resistance parameters. "	( Beneficial effects of liraglutide on adipocytokines, insulin sensitivity parameters and cardiovascular risk biomarkers in patients with Type 2 diabetes: a prospective study. Conde-Vicente, R; de Luis, DA; Díaz-Soto, G; Izaola-Jauregui, O; Ramos, C; Romero, E, 2014)	2.16
"Liraglutide treatment provided beneficial glucose-lowering effects in both chow- and high-fat-fed mice lacking GLP1R in the CNS or visceral nerves; however, liraglutide was ineffective at altering food intake, body weight, or causing a conditioned taste aversion in mice lacking neuronal GLP1R."	( Neuronal GLP1R mediates liraglutide's anorectic but not glucose-lowering effect. D'Alessio, DA; Gutierrez-Aguilar, R; Sandoval, DA; Scott, M; Seeley, RJ; Sisley, S, 2014)	1.43
"Liraglutide treatment was associated with a significant reduced risk of incident bone fractures (MH-OR=0.38, 95% CI 0.17-0.87); however, exenatide treatment was associated with an elevated risk of incident bone fractures (MH-OR=2.09, 95% CI 1.03-4.21)."	( Risk of bone fractures associated with glucagon-like peptide-1 receptor agonists' treatment: a meta-analysis of randomized controlled trials. Bu, L; Han, Y; Li, F; Li, L; Qu, S; Sheng, C; Sheng, H; Su, B; Wang, J; Yang, P; Zhang, M, 2015)	1.14
"Liraglutide treatment resulted in a bodyweight loss of 4.7 ± 2.5 kg compared with 1.6 ± 2.7 kg in the placebo group (P = 0.014) accompanied by decreased cholesterol levels."	( Lack of effect of the glucagon-like peptide-1 receptor agonist liraglutide on psoriasis in glucose-tolerant patients--a randomized placebo-controlled trial. Faurschou, A; Gyldenløve, M; Knop, FK; Rohde, U; Skov, L; Thyssen, JP; Vilsbøll, T; Zachariae, C, 2015)	1.38
"Liraglutide treatment for 8 weeks did not significantly change PASI, DLQI, or hsCRP in a small group of glucose-tolerant obese patients with plaque psoriasis compared with placebo. "	( Lack of effect of the glucagon-like peptide-1 receptor agonist liraglutide on psoriasis in glucose-tolerant patients--a randomized placebo-controlled trial. Faurschou, A; Gyldenløve, M; Knop, FK; Rohde, U; Skov, L; Thyssen, JP; Vilsbøll, T; Zachariae, C, 2015)	2.1
"Liraglutide treatment also increased the P-Akt (Ser473)/Akt ratio (P<0.05)."	( The GLP-1 analogue liraglutide protects cardiomyocytes from high glucose-induced apoptosis by activating the Epac-1/Akt pathway. Liu, J; Ou, QY; Wu, XM; Zhang, H; Zhao, W, 2014)	1.45
"Liraglutide treatment was associated with an initial increase in 24-h SBP, followed by a 7 mmHg reduction after escalation to 1.8 mg/day. "	( Time course and mechanisms of the anti-hypertensive and renal effects of liraglutide treatment. Goetze, JP; Lajer, M; Persson, F; Rossing, P; von Scholten, BJ, 2015)	2.09
"The liraglutide-treated group also had a significant shift away from small, dense low-density lipoprotein-particles, as well as decreases in apolipoprotein B concentration and ratio of apolipoprotein B/apolipoprotein A-1."	( Effect of liraglutide administration and a calorie-restricted diet on lipoprotein profile in overweight/obese persons with prediabetes. Abbasi, F; Ariel, D; Kim, SH; Lamendola, CA; Liu, A; Reaven, GM, 2014)	1.29
"Liraglutide pretreatment resulted in significantly (p<0.001) less neurological deficit compared to vehicle-treated MCAO rats."	( Neuroprotective and anti-apoptotic effects of liraglutide in the rat brain following focal cerebral ischemia. Briyal, S; Gulati, A; Shah, S, 2014)	1.38
"Liraglutide treatment alone also reduced meal size; an effect not enhanced with leptin co-administration."	( Liraglutide, leptin and their combined effects on feeding: additive intake reduction through common intracellular signalling mechanisms. Fortin, SM; Grill, HJ; Kanoski, SE; Ong, ZY; Schlessinger, ES, 2015)	2.58
"Liraglutide treatment caused significant reduction of the mean body weight (from 86.61±14.09 to 79.10±13.55 kg) and waist circumference (from 101.81±13.96 to 94.29±14.17 cm), resulting in body weight lose of 5%-10% in 43.67% patients, and body weight loss above 10% in 34.06% patients, who had significant lower plasma creatinine levels. "	( Liraglutide reduces the body weight and waist circumference in Chinese overweight and obese type 2 diabetic patients. Chang, BC; Chen, LM; Ding, SH; Feng, P; Guo, JC; Ji, QD; Li, HT; Li, SY; Lin, JN; Liu, J; Liu, ZD; Wang, MJ; Wang, SL; Wu, ST; Yang, JH; Yu, DM; Zhang, BZ; Zhu, M, 2015)	3.3
"Liraglutide treatment was also associated with a significant improvement in glycated hemoglobin (7.6% to 6.7% [59.8 to 50.2 mmol/mol], P < 0.001) but did not change MRS-PDFF (P = 0.80), liver mean MRI-PDFF (P = 0.15), liver volume (P = 0.30), or the total liver fat index (P = 0.39)."	( Effects of Insulin Glargine and Liraglutide Therapy on Liver Fat as Measured by Magnetic Resonance in Patients With Type 2 Diabetes: A Randomized Trial. Castel, H; Chartrand, G; Chiasson, JL; de Guise, J; Gilbert, G; Julien, AS; Massicotte-Tisluck, K; Olivié, D; Rabasa-Lhoret, R; Soulez, G; Tang, A; Wartelle-Bladou, C, 2015)	1.42
"Liraglutide treatment in the DHT implanted rats significantly improved glucose excursion during oral glucose tolerance test (area under the curve: DHT+ saline 28674±310 vs 24990± 420 in DHT +liraglutide p <0.01)."	( Liraglutide improves hypertension and metabolic perturbation in a rat model of polycystic ovarian syndrome. Bi, J; Hoang, V; Mohankumar, SM; Vyas, AK, 2015)	2.58
"Liraglutide 3.0 mg treatment also induced a decrease in waist circumference, serum triglycerides, insulin resistance, blood pressure and an increase in high density lipoprotein-cholesterol (HDL-C)."	( The Current Role of Liraglutide in the Pharmacotherapy of Obesity. Christou, GA; Katsiki, N; Kiortsis, DN, 2016)	1.48
"Liraglutide treatment of 30 µg/kg/day-300 µg/kg s.c."	( Molecular and cellular mechanisms of glucagon-like peptide-1 receptor agonist-mediated attenuation of cardiac fibrosis. Brdar, M; Dear, AE; Gaspari, T; Hu, Y; Lee, HW; Simpson, RW; Spizzo, I; Widdop, RE, 2016)	1.16
"Liraglutide treatment attenuated obesity, hypertension and age-induced increases in interstitial cardiac fibrosis and expression of inflammatory and oxidative stress markers."	( Molecular and cellular mechanisms of glucagon-like peptide-1 receptor agonist-mediated attenuation of cardiac fibrosis. Brdar, M; Dear, AE; Gaspari, T; Hu, Y; Lee, HW; Simpson, RW; Spizzo, I; Widdop, RE, 2016)	1.88
"Liraglutide treated groups showed significant reductions in fructosamine levels (p≤0.05) from baseline."	( Liraglutide in diabetes mellitus: More facts and findings. Bashir, M; Idrees, M; Jan, NU; Khan, MI; Rahim, H; Rahman, IU, 2016)	2.6
"The liraglutide treatment decreased body and fat pads weight along with blood glucose and triglyceride levels."	( The effects of liraglutide in mice with diet-induced obesity studied by metabolomics. Bugáňová, M; Haluzík, M; Holubová, M; Kačer, P; Kuneš, J; Kuzma, M; Maletínská, L; Pelantová, H; Šedivá, B; Železná, B, 2017)	1.29
"Liraglutide-treated animals also demonstrated improved glucose tolerance as assessed by an ip glucose tolerance test."	( Liraglutide, a long-acting human glucagon-like peptide 1 analog, improves glucose homeostasis in marginal mass islet transplantation in mice. Emamaullee, JA; Knudsen, LB; Merani, S; Shapiro, AM; Toso, C; Truong, W, 2008)	2.51
"Liraglutide treatment over 20 weeks is well tolerated, induces weight loss, improves certain obesity-related risk factors, and reduces prediabetes."	( Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Al Hakim, M; Astrup, A; Lean, ME; Madsen, J; Niskanen, L; Rasmussen, MF; Rissanen, A; Rössner, S; Van Gaal, L, 2009)	2.19
"Liraglutide treatment combined with OADs led to rapid improvements in FPG and SBP. "	( Adding liraglutide to oral antidiabetic drug therapy: onset of treatment effects over time. Falahati, A; Gallwitz, B; Madsbad, S; Vaag, A, 2010)	2.26
"Liraglutide treatment, as monotherapy and in combination with oral antidiabetic drugs (OADs), was associated with weight loss of up to 3.24 kg."	( A review of efficacy and safety data regarding the use of liraglutide, a once-daily human glucagon-like peptide 1 analogue, in the treatment of type 2 diabetes mellitus. Montanya, E; Sesti, G, 2009)	1.32
"Liraglutide treatment delayed diabetes onset by 4.1 ± 0.8 months compared with control (P < 0.0001) and by 1.3 ± 0.8 months compared with restricted animals (P < 0.05)."	( Chronic administration of the glucagon-like peptide-1 analog, liraglutide, delays the onset of diabetes and lowers triglycerides in UCD-T2DM rats. Baskin, DG; Cummings, BP; Graham, JL; Griffen, SC; Havel, PJ; Knudsen, LB; Nilsson, C; Raun, K; Sams, A; Stanhope, KL, 2010)	1.32
"Liraglutide treatment delays the development of diabetes in UCD-T2DM rats by reducing energy intake and body weight, and by improving insulin sensitivity, improving lipid profiles, and maintaining islet morphology."	( Chronic administration of the glucagon-like peptide-1 analog, liraglutide, delays the onset of diabetes and lowers triglycerides in UCD-T2DM rats. Baskin, DG; Cummings, BP; Graham, JL; Griffen, SC; Havel, PJ; Knudsen, LB; Nilsson, C; Raun, K; Sams, A; Stanhope, KL, 2010)	2.04
"Liraglutide treatment was associated with clinically relevant reductions in glycated haemoglobin (HbA(1c.) ) levels. "	( Clinical experience with liraglutide. Bain, SC; McKenna, J, 2010)	2.11
"Liraglutide treatment was associated with reductions in HbA(1c) levels as well as benefits beyond glycaemic control, such as weight loss and systolic blood pressure reductions. "	( Clinical experience with liraglutide. Bain, SC; McKenna, J, 2010)	2.11
"Liraglutide treatment resulted in significant time-dependent reduction in bodyweight and energy intake, whilst improving non-fasting glucose and normalizing glucose tolerance. "	( Four weeks administration of Liraglutide improves memory and learning as well as glycaemic control in mice with high fat dietary-induced obesity and insulin resistance. Flatt, PR; Gault, VA; Holscher, C; Kerr, BD; Porter, DW, 2010)	2.09
"Liraglutide treatment for 2 weeks improved metabolic variables and insulin sensitivity in db/db mice. "	( The human glucagon-like peptide-1 analogue liraglutide preserves pancreatic beta cells via regulation of cell kinetics and suppression of oxidative and endoplasmic reticulum stress in a mouse model of diabetes. Hamamoto, S; Hashiramoto, M; Kaku, K; Kanda, Y; Matsuki, M; Shimoda, M; Tawaramoto, K, 2011)	2.07
"Liraglutide treatment had little effect on littermate control mice, whose behavior was comparable to wild-type saline controls; however, synaptic plasticity was enhanced in the drug group."	( The diabetes drug liraglutide prevents degenerative processes in a mouse model of Alzheimer's disease. Faivre, E; Hölscher, C; McClean, PL; Parthsarathy, V, 2011)	1.42
"Liraglutide treatment also increased endothelial nitric oxide synthase (eNOS) and reduced intercellular adhesion molecule-1 (ICAM-1) expression in aortic endothelium, an effect again dependent on the GLP-1R."	( A GLP-1 receptor agonist liraglutide inhibits endothelial cell dysfunction and vascular adhesion molecule expression in an ApoE-/- mouse model. Dear, AE; Gaspari, T; Hu, Y; Knudsen, LB; Liu, H; Simpson, RW; Welungoda, I; Widdop, RE, 2011)	1.39
"Liraglutide treatment provides an additional strategy for improving glycemic control in type 1 diabetes. "	( Liraglutide as additional treatment for type 1 diabetes. Bellini, N; Chaudhuri, A; Dandona, P; Dhindsa, S; Makdissi, A; Rawal, D; Varanasi, A; Vora, M, 2011)	3.25
"Liraglutide treatment vs placebo was safe and well tolerated in patients with mild RI, as there were no significant differences in rates of renal injury, minor hypoglycemia, or nausea."	( Mild renal impairment and the efficacy and safety of liraglutide. Brett, J; Davidson, JA; Falahati, A; Scott, D, )	1.1
"Liraglutide-treated subjects experienced additional HbA1c reduction beyond that which appeared weight induced; thus, not all HbA1c-lowering effect appears weight mediated."	( Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Buse, J; Jensen, KH; Niswender, K; Pi-Sunyer, X; Russell-Jones, D; Toft, AD; Zinman, B, 2013)	1.44
"Liraglutide treatment markedly improved insulin resistance and increased FGF-21 expression in liver and FGFR-3 in adipose tissue, restored β-Klotho mRNA expression in adipose tissue as well as FGFR-1-3, β-Klotho levels and phosphorylation of FGFR1 up to the levels observed in control mice in liver."	( Liraglutide increases FGF-21 activity and insulin sensitivity in high fat diet and adiponectin knockdown induced insulin resistance. Boden, G; Li, L; Liu, H; Wang, C; Yang, G; Yang, M; Zhang, L, 2012)	2.54
"Liraglutide treatment for 12 weeks significantly increased circulating ZAG levels."	( Zinc-α2-glycoprotein is associated with insulin resistance in humans and is regulated by hyperglycemia, hyperinsulinemia, or liraglutide administration: cross-sectional and interventional studies in normal subjects, insulin-resistant subjects, and subject Boden, G; Chen, S; Li, L; Li, S; Liu, D; Liu, R; Luo, Y; Wang, Y; Xiong, Z; Yang, G; Yang, M; Zhang, L; Zhang, Y, 2013)	1.32
"Treatment with liraglutide involving a regimen of multiple doses resulted in 100% survival, remarkable preservation of renal function, a significant reduction in pathological damage, and blunted upregulation of TNF-α, IL-1β, IL-6, MCP-1, TLR-2, TLR-4, and RAGE mRNA."	( Liraglutide protects against lethal renal ischemia-reperfusion injury by inhibiting high-mobility group box 1 nuclear-cytoplasmic translocation and release. Chen, G; Chen, S; Chen, X; Hu, X; Li, Y; Sun, L; Tan, X; Wang, L; Xu, B; Yang, J; Zhu, L, 2021)	2.4
"Treatment with liraglutide induces a significant reduction of plasma PCSK9 in patients with T2DM not on statins. "	( Liraglutide reduces plasma PCSK9 in patients with type 2 diabetes not treated with statins. Bouillet, B; Duvillard, L; Hassid, J; Petit, JM; Rouland, A; Simoneau, I; Vergès, B, 2022)	2.52
"Pretreatment with liraglutide prevented downregulation of eNOS phosphorylation and NO secretion, and reduced apoptosis and oxidative stress of the human umbilical vein endothelial cells (HUVECs) exposed to high glucose."	( Liraglutide prevents high glucose induced HUVECs dysfunction via inhibition of PINK1/Parkin-dependent mitophagy. Chen, X; Fang, W; Wang, S; Wang, X; Wang, Z; Zhang, Y; Zheng, C; Zhou, Q, 2022)	2.49
"Treatment with liraglutide, a glucagon-like peptide 1 analog, is associated with weight loss, improved glycemic control, and reduced cardiovascular risk."	( Effects of liraglutide vs. lifestyle changes on soluble suppression of tumorigenesis-2 (sST2) and galectin-3 in obese subjects with prediabetes or type 2 diabetes after comparable weight loss. Aukrust, P; Birkeland, KI; Ciotti, S; Cipollone, F; Consoli, A; Di Castelnuovo, A; Gulseth, HL; Halvorsen, B; Liani, R; Michelsen, A; Santilli, F; Simeone, P; Tripaldi, R; Ueland, T, 2022)	1.45
"Treatment with liraglutide appeared to reduce the severity of blast-induced hearing injuries as observed from the drug-treated chinchillas comparing to the blast controls."	( Mitigation of Hearing Damage After Repeated Blast Exposures in Animal Model of Chinchilla. Gan, RZ; Jiang, S; Sanders, S; Welch, P, 2022)	1.06
"Pretreatment with liraglutide significantly alleviated the pathological changes induced by I/R and increased the overall survival of mice exposed to intestinal I/R injury. "	( Liraglutide attenuates intestinal ischemia/reperfusion injury via NF-κB and PI3K/Akt pathways in mice. Wang, Z; Zou, Z, 2022)	2.5
"Treatment with liraglutide and/or rabeprazole prior to cisplatin maintained the function and morphology of kidney via decreasing cisplatin renal uptake by significant inhibition of OCT2. "	( Augmented nephroprotective effect of liraglutide and rabeprazole via inhibition of OCT2 transporter in cisplatin-induced nephrotoxicity in rats. E M, EM; El-Sayed, EK; Sharaf, G, 2023)	1.54
"OECs treated with liraglutide at 100 nM showed improved cell viability and had modulated expression of N-cadherin and β1-integrin (two important cell adhesion molecules)."	( Liraglutide modulates adhesion molecules and enhances cell properties in three-dimensional cultures of olfactory ensheathing cells. Chen, M; Ekberg, J; Lai, R; Oieni, F; Smyth, G; St John, J; Standke, A; Tseng, YT; Yang, C, 2023)	2.68
"Treatment with liraglutide for 6 months promoted weight loss, improved cardiometabolic and inflammatory parameters and led to a significant reduction in FMT correlated with AC in obese MetS patients of both sexes."	( Effect of liraglutide on cardiometabolic profile and on bioelectrical impedance analysis in patients with obesity and metabolic syndrome. Freitas, FPC; Rodrigues, CEM, 2023)	1.65
"Treatment with liraglutide increased serum adiponectin [33.5 (3.5, 47.7) pg/mL, P=0.003] and heme oxygenase-1 levels [0.4 (-0.0, 1.8) ng/mL, P=0.001] and reduced serum leptin levels [-2.8 (3.9) pg/mL, P<0.001]."	( Use of flash glucose-sensing technology in patients with type 2 diabetes treated with liraglutide combined with CSII: a pilot study. Li, LQ; Li, YK; Ma, JX; Xue, P; Yao, MY, 2020)	1.12
"Treatment with liraglutide for 26 weeks did not decrease the fat fraction in supraclavicular BAT (-0.4 ± 1.7%; P = 0.447) compared to placebo (-0.4 ± 1.4%; P = 0.420; between group P = 0.911)."	( Liraglutide decreases energy expenditure and does not affect the fat fraction of supraclavicular brown adipose tissue in patients with type 2 diabetes. Bizino, MB; Boers, TGW; Burakiewicz, J; IJzermans, SL; Jazet, IM; Kan, HE; Kleiburg, F; Lamb, HJ; Paiman, EHM; Rappel, EJ; Rensen, PCN; Smit, JWA; van Eyk, HJ, 2020)	2.34
"Treatment with liraglutide decreases REE in the first 12 weeks and tends to decrease this after 26 weeks without affecting the fat fraction in the supraclavicular BAT depot. "	( Liraglutide decreases energy expenditure and does not affect the fat fraction of supraclavicular brown adipose tissue in patients with type 2 diabetes. Bizino, MB; Boers, TGW; Burakiewicz, J; IJzermans, SL; Jazet, IM; Kan, HE; Kleiburg, F; Lamb, HJ; Paiman, EHM; Rappel, EJ; Rensen, PCN; Smit, JWA; van Eyk, HJ, 2020)	2.35
"The treatment with liraglutide could reduce the body weight and the average daily food intake of the rats, as well as TG, TCh, and ectopic lipid droplet deposition in renal tubular."	( Liraglutide attenuates renal tubular ectopic lipid deposition in rats with diabetic nephropathy by inhibiting lipid synthesis and promoting lipolysis. Chen, C; Su, K; Xia, T; Yang, YF; Yao, BQ; Yi, B; Zhang, ZH, 2020)	2.32
"When treated with liraglutide, participants modified their ad libitum food consumption with decreased total intake and % fat and increased carbohydrates. "	( Effect of liraglutide on food consumption, appetite sensations and eating behaviours in overweight people with type 1 diabetes. D'Amours, M; Dubé, MC; Weisnagel, SJ, 2020)	1.29
"The treatment with liraglutide 3.0 mg, in combination with a hypocaloric diet and increased physical activity, provides a clinically meaningful weight loss."	( New-generation anti-obesity drugs: naltrexone/bupropion and liraglutide. An update for endocrinologists and nutritionists. Barrea, L; Colao, A; Laudisio, D; Muscogiuri, G; Pugliese, G; Savastano, S, 2020)	1.12
"Treatment with liraglutide improved CKD hallmarks including GFR, albuminuria, mesangial expansion, renal inflammation, and renal fibrosis. "	( Liraglutide Improves the Kidney Function in a Murine Model of Chronic Kidney Disease. Jensen, HE; Knudsen, LB; Kvist, PH; Ougaard, ME; Pyke, C; Sembach, FE, 2020)	2.35
"Treatment with liraglutide improved the kidney function and diminished renal lesions in NTN-induced mice. "	( Liraglutide Improves the Kidney Function in a Murine Model of Chronic Kidney Disease. Jensen, HE; Knudsen, LB; Kvist, PH; Ougaard, ME; Pyke, C; Sembach, FE, 2020)	2.35
"Treatment with liraglutide significantly (P ≤ .005) increased exogenous GLP-1A AUC (median 310 vs."	( Effect of the glucagon-like peptide-1 analogue liraglutide versus placebo treatment on circulating proglucagon-derived peptides that mediate improvements in body weight, insulin secretion and action: A randomized controlled trial. Abbasi, F; Kalra, B; Kim, SH; Kumar, A; Mantzoros, CS; Nachmanoff, C; Savjani, G; Stefanakis, K, 2021)	1.22
"Treatment with liraglutide did not affect the investigated cytokines."	( Proinflammatory biomarkers are associated with prediabetes in patients with schizophrenia. Fink-Jensen, A; Fredholm, S; Jensen, ME; Larsen, JR; Møller, M; Vilsbøll, T; Wörtwein, G; Ødum, N, 2022)	1.06
"Treatment with liraglutide 3.0 mg significantly decreased body weight (estimated marginal mean, 93.2 kg at baseline and 88.9 kg at 16 weeks; p < 0.001) as well as waist circumference, BMI and plasma glucose levels. "	( Effect of liraglutide 3.0mg treatment on weight reduction in obese antipsychotic-treated patients. Kim, KA; Kim, SH; Kim, YS; Lee, NY; Lee, SE, 2021)	1.38
"Treatment with liraglutide for 26 weeks was associated with a reduction in cardiac adipose tissue compared to placebo. "	( Liraglutide reduces cardiac adipose tissue in type 2 diabetes: A secondary analysis of the LIRAFLAME randomized placebo-controlled trial. Curovic, VR; Hansen, TW; Jensen, JK; Kjaer, A; Rasmussen, IKB; Ripa, RS; Rossing, P; von Scholten, BJ; Zobel, EH, 2021)	2.42
"Treatment with liraglutide decreased troponin I and CK-MB while increased SOD activity, AMPK, p-Akt with decrements in MDA, IL-6, TNF-α, GSK-3β, TGF-β1, and caspase-3 levels with attenuation of inflammation and necrosis while increased Bcl-2 expression."	( Liraglutide ameliorates cardiotoxicity induced by doxorubicin in rats through the Akt/GSK-3β signaling pathway. Abbas, NAT; Kabil, SL, 2017)	2.24
"Treatment with liraglutide and/or glutamine enhanced insulin production and hence glycemic control in diabetic male rats with favorable effects on apoptosis markers. "	( Glutamine up-regulates pancreatic sodium-dependent neutral aminoacid transporter-2 and mitigates islets apoptosis in diabetic rats. El-Sayed, NM; Medras, ZJH; Moustafa, YM; Sami, MM; Toraih, EA; Zaitone, SA, 2018)	0.83
"Treatment with liraglutide-restored animals' body weight, normalized blood glucose, decreased glycated hemoglobin, and increased insulin levels."	( Liraglutide ameliorated peripheral neuropathy in diabetic rats: Involvement of oxidative stress, inflammation and extracellular matrix remodeling. Abdelkader, NF; El Awdan, SA; El-Shabrawy, OA; Moustafa, PE; Zaki, HF, 2018)	2.26
"Treatment with liraglutide 3.0 mg has been associated with gallbladder-related adverse events. "	( Effects of liraglutide on gallbladder emptying: A randomized, placebo-controlled trial in adults with overweight or obesity. Agersnap, M; Baekdal, M; Brønden, A; Gustafsson, LN; Hausner, H; Knop, FK; Nexøe-Larsen, CC; Sonne, DP; Sørensen, PH; Vedtofte, L; Vilsbøll, T, 2018)	1.22
"Treatment with liraglutide did not affect the GBEF"	( Effects of liraglutide on gallbladder emptying: A randomized, placebo-controlled trial in adults with overweight or obesity. Agersnap, M; Baekdal, M; Brønden, A; Gustafsson, LN; Hausner, H; Knop, FK; Nexøe-Larsen, CC; Sonne, DP; Sørensen, PH; Vedtofte, L; Vilsbøll, T, 2018)	1.22
"Pretreatment with liraglutide in diabetic and non-diabetic animals reduced infarct size as compared to controls, while only non-diabetic liraglutide-treated rats presented neurologic deficit decreases. "	( Neuroprotective effect of glucagon-like peptide-1 receptor agonist is independent of glycaemia normalization in type two diabetic rats. Chefu, S; Filchenko, I; Kolpakova, M; Simanenkova, A; Vlasov, T, 2018)	0.81
"Treatment with liraglutide ameliorated our patient's glycaemic control and resulted in a 20% reduction of daily insulin dose along with an off-drug elevation of fasting C-peptide immunoreactivity. "	( Activation of GLP-1 receptor signalling alleviates cellular stresses and improves beta cell function in a mouse model of Wolfram syndrome. Amo-Shiinoki, K; Hatanaka, M; Kondo, M; Morii, T; Seino, S; Takahashi, H; Tanabe, K; Tanizawa, Y; Yamada, Y, 2018)	0.83
"Treatment with liraglutide in patients with type 2 diabetes and at high risk of CV events in the LEADER trial did not increase the risk of DFU events and was associated with a significantly lower risk of DFU-related amputations compared with placebo. "	( The Impact of Liraglutide on Diabetes-Related Foot Ulceration and Associated Complications in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events: Results From the LEADER Trial. Bain, SC; Buse, JB; Dhatariya, K; Kaltoft, MS; Pratley, RE; Simpson, R; Stellfeld, M; Tarnow, L; Tornøe, K, 2018)	1.19
"Pretreatment with liraglutide and H89 together did not exhibit this inhibitory effect as mentioned above."	( Liraglutide inhibited AGEs induced coronary smooth muscle cell phenotypic transition through inhibiting the NF-κB signal pathway. Di, B; Hua, B; Li, HW; Li, W, 2019)	2.28
"Treatment with liraglutide led to significant weight loss and lowering of blood pressure with no concomitant symptoms alleviation during treatment and no improvement in coronary microvascular function."	( Effect of liraglutide on body weight and microvascular function in non-diabetic overweight women with coronary microvascular dysfunction. Bové, K; Holst, JJ; Madsbad, S; Prescott, E; Raft, KF; Suhrs, HE; Zander, M, 2019)	1.27
"Treatment with liraglutide for 6 weeks led to increased insulin sensitivity and attenuation of HFD-induced insulin resistance. "	( Glucagon-like peptide-1 receptor agonist treatment reduces beta cell mass in normoglycaemic mice. Carlotti, F; de Graaf, N; de Koning, EJ; Ellenbroek, JH; Hanegraaf, MA; Rabelink, TJ; Töns, HA; Westerouen van Meeteren, MJ, 2013)	0.74
"Treatment with liraglutide caused a significant decrease in HbA1c from 7.4 ± 0.2% to 6.9 ± 0.3% (p = 0.04), and in body mass index (BMI) from 27.6 ± 0.9 kg/m² to 26.5 ± 0.8 kg/m² after 12 months (p < 0.001), while systolic blood pressure did not change."	( The glucagon-like peptide-1 receptor agonist, liraglutide, attenuates the progression of overt diabetic nephropathy in type 2 diabetic patients. Hirai, A; Hirai, K; Imamura, S, 2013)	0.99
"Treatment with liraglutide, and/or associated weight loss, significantly reduced PIIINP levels in obese women with PCOS. "	( Glucagon-like peptide-1 analogue, liraglutide, improves liver fibrosis markers in obese women with polycystic ovary syndrome and nonalcoholic fatty liver disease. Abouda, G; Atkin, SL; Coady, AM; Kahal, H; Kilpatrick, ES; Rigby, AS, 2014)	1.03
"Treatment with liraglutide, in addition with diet and exercise, induces sustained mean weight loss of 7.6 kg at 2 years (weight loss induced by orlistat = 5.7 kg, phentermine/topiramate controlled release 15/92 = 10.9 kg)."	( Liraglutide in the treatment of obesity. Ng, SY; Wilding, JP, 2014)	2.18
"Treatment with liraglutide was commenced in place of insulin, which improved the patient's glycemic control to an HbA1c level of 5.5% and markedly increased his QOL score with no hypoglycemia."	( Switching from insulin to liraglutide improved glycemic control and the quality of life scores in a case of type 2 diabetes and active Crohn's disease. Fujita, N; Furuya, M; Hayashino, Y; Iburi, T; Ishii, H; Kitatani, M; Kuwata, H; Mashitani, T; Okamura, S; Tsujii, S, 2014)	1.04
"Treatment with liraglutide was associated with a significant reduction from baseline values of fasting blood glucose (-42.1 mg/dl, P < 0.05), HbA1c (-1.5 %, -17 mmol/mol, P < 0.05), body weight (-7.1 kg, P < 0.05), waist circumference (-6.8 cm, P < 0.001), total-cholesterol (-27.4 mg/dl, P < 0.05), LDL-cholesterol (-25.4 mg/dl, P < 0.05), triglycerides (-56.1 mg/dl, P < 0.05), and non-HDL-C (-36.6 mg/dl, P < 0.05) and an increase of HDL-cholesterol concentrations (+9.3 mg/dl, P < 0.001), a significant reduction in both systolic and diastolic blood pressure (-14.7 mmHg, P < 0.001 and -9.0 mmHg, P < 0.05, respectively) and a decrease of VAI values (-1.6, P < 0.001). "	( Twelve-month treatment with Liraglutide ameliorates Visceral Adiposity Index and common cardiovascular risk factors in type 2 diabetes outpatients. Alibrandi, A; Cucinotta, D; Giandalia, A; Labate, AM; Perdichizzi, G; Romeo, EL; Russo, GT; Villari, P, 2015)	1.06
"Treatment with liraglutide plus modest calorie restriction led to enhanced weight loss, a decrease in fasting plasma glucose concentration, and improvement in multiple aspects of lipid/lipoprotein metabolism associated with increased cardiovascular disease (CVD) risk. "	( Effect of liraglutide administration and a calorie-restricted diet on lipoprotein profile in overweight/obese persons with prediabetes. Abbasi, F; Ariel, D; Kim, SH; Lamendola, CA; Liu, A; Reaven, GM, 2014)	1.16
"Treatment with liraglutide reduced intracellular lipid accumulation in differentiating ASC, together with FABP-4 mRNA expression (-18%, -23%, -46%, for 1 nM, 10 nM and 100 nM, respectively), whereas it stimulated adiponectin (APN) expression (1.86-, 2.64-, 2.28-fold increase, for 1 nM, 10 nM and 100 nM, respectively)."	( Effect of liraglutide on proliferation and differentiation of human adipose stem cells. Cantini, G; Di Franco, A; Forti, G; Luconi, M; Mannucci, E; Samavat, J, 2015)	1.16
"Treatment with liraglutide in randomized controlled trials is associated with significant reductions in glycated hemoglobin (HbA1c) and weight loss in type 2 diabetes patients. "	( Correlation between baseline characteristics and clinical outcomes in a large population of diabetes patients treated with liraglutide in a real-world setting in Italy. Balzano, S; Bax, G; Bettio, M; Bonsembiante, B; Brun, E; Cardone, C; Confortin, L; D'Ambrosio, M; Da Tos, V; Dal Frà, MG; Dal Pos, M; Ferrari, M; Frison, V; Gallo, A; Lamonica, M; Lapolla, A; Marangoni, A; Marin, N; Masin, M; Mesturino, CA; Panebianco, G; Pianta, A; Piarulli, F; Rocchini, P; Sartore, G; Simioni, N; Simoncini, M; Strazzabosco, M; Tadiotto, F; Zen, F, 2015)	0.98
"Treatment with liraglutide in a real-world setting is associated with low therapy failure, good glycemic response, weight loss, and improvement in systolic blood pressure and lipid profile. "	( Correlation between baseline characteristics and clinical outcomes in a large population of diabetes patients treated with liraglutide in a real-world setting in Italy. Balzano, S; Bax, G; Bettio, M; Bonsembiante, B; Brun, E; Cardone, C; Confortin, L; D'Ambrosio, M; Da Tos, V; Dal Frà, MG; Dal Pos, M; Ferrari, M; Frison, V; Gallo, A; Lamonica, M; Lapolla, A; Marangoni, A; Marin, N; Masin, M; Mesturino, CA; Panebianco, G; Pianta, A; Piarulli, F; Rocchini, P; Sartore, G; Simioni, N; Simoncini, M; Strazzabosco, M; Tadiotto, F; Zen, F, 2015)	0.98
"Treatment with Liraglutide (200 μg/kg) significantly reduced cerebral edema in pericontusional regions and improved sensorimotor function 48 hours after CCI."	( Preservation of the blood brain barrier and cortical neuronal tissue by liraglutide, a long acting glucagon-like-1 analogue, after experimental traumatic brain injury. Hakon, J; Romner, B; Ruscher, K; Tomasevic, G, 2015)	0.99
"Treatment with liraglutide resulted in mean decreases in hemoglobin A1c (HbA1c) of -1.4%, when compared with glimepiride (-0.4%) (P < 0.001), and was followed by a significant reduction (P < 0.001) in fasting plasma glucose. "	( Add-On Treatment with Liraglutide Improves Glycemic Control in Patients with Type 2 Diabetes on Metformin Therapy. Brunetti, A; Capula, C; Chiefari, E; Foti, D; Greco, M; Liguori, R; Oliverio, R; Puccio, L; Pullano, V; Tirinato, D; Vero, A; Vero, R, 2015)	1.08
"Pre-treatment with liraglutide rescued neuronal cells from oxidative stress- and glutamate excitotoxicity-induced cell death."	( Liraglutide is neurotrophic and neuroprotective in neuronal cultures and mitigates mild traumatic brain injury in mice. Bader, M; Greig, NH; Li, Y; Pick, CG; Rubovitch, V; Tamargo, I; Tweedie, D, 2015)	2.18
"Treatment with liraglutide was associated with a marked improvement in glycaemic control in daily routine practice as well as with a reduction of weight, without major side effects."	( ROOTS: A multicenter study in Belgium to evaluate the effectiveness and safety of liraglutide (Victoza®) in type 2 diabetic patients. Buysschaert, M; D'Hooge, D; Preumont, V, )	0.71
"Treatment with liraglutide leads to weight loss. "	( Transfer of liraglutide from blood to cerebrospinal fluid is minimal in patients with type 2 diabetes. Christensen, M; Grevstad, U; Hartmann, B; Holst, JJ; Knop, FK; Rosenkilde, MM; Sparre-Ulrich, AH; Vilsbøll, T, 2015)	1.15
"Treatment with liraglutide significantly improved insulin secretion, even in patients with long-standing T2D requiring high-dose insulin treatment. "	( Mechanisms of Action of Liraglutide in Patients With Type 2 Diabetes Treated With High-Dose Insulin. Adams-Huet, B; Dimitrov, I; Harrison, LB; Hulsey, K; Jaster, AW; Lenkinski, RE; Li, X; Lingvay, I; Pedrosa, I; Pinho, DF; Pop, LM; Vanderheiden, A; Warshauer, JT; Yokoo, T; Yuan, Q, 2016)	1.09
"Pre-treatment with liraglutide (75 and 150 μg/kg) significantly prevented the seizure severity, restored behavioural activity, oxidative defence enzymes, and altered level of neurochemicals in mice brain."	( Neurochemical modulation involved in the beneficial effect of liraglutide, GLP-1 agonist on PTZ kindling epilepsy-induced comorbidities in mice. Koshal, P; Kumar, P, 2016)	0.99
"Co-treatment with liraglutide (75 and 150 μg/kg) significantly prevented the seizure severity, restored behavioural activity, oxidative stress and restored the altered level of neurotransmitters observed in corneal kindled mouse."	( Effect of Liraglutide on Corneal Kindling Epilepsy Induced Depression and Cognitive Impairment in Mice. Koshal, P; Kumar, P, 2016)	1.16
"Pretreatment with liraglutide inhibited platelet-derived growth factor (PDGF)-BB stimulated PASMCs migration, which were associated with cell-cycle arrest at G0/G1 phase."	( Liraglutide prevents and reverses monocrotaline-induced pulmonary arterial hypertension by suppressing ET-1 and enhancing eNOS/sGC/PKG pathways. Hsu, JH; Lee, MY; Shin, SJ; Tsai, KB; Wu, JR; Yeh, JL, 2016)	2.2
"Treatment with liraglutide was associated with a significant decrease in body weight, HbA1C, and a marked relative reduction in LFC of 31% (P < 0.0001). "	( Effect of Liraglutide Therapy on Liver Fat Content in Patients With Inadequately Controlled Type 2 Diabetes: The Lira-NAFLD Study. Bouillet, B; Cercueil, JP; Chevallier, O; Denimal, D; Duvillard, L; Fourmont, C; Loffroy, R; Petit, JM; Vergès, B, 2017)	1.21
"Pre-treatment with liraglutide decreased the wet-to-dry weight ratio and protein concentrations in BAL fluid and neutrophil infiltration in the lung tissues."	( Liraglutide attenuates lipopolysaccharide-induced acute lung injury in mice. Chen, J; Hu, X; Xu, Y; Zhang, Y; Zhou, F, 2016)	2.2
"Treatment with liraglutide was associated with an increase in heart rate and more serious cardiac adverse events, and this raises some concern with respect to the use of liraglutide in patients with chronic heart failure and reduced left ventricular function."	( Effect of liraglutide, a glucagon-like peptide-1 analogue, on left ventricular function in stable chronic heart failure patients with and without diabetes (LIVE)-a multicentre, double-blind, randomised, placebo-controlled trial. Boesgaard, TW; Flyvbjerg, A; Gustafsson, I; Hänselmann, A; Hjort, J; Holmager, P; Jorsal, A; Kistorp, C; Møller, JE; Nielsen, R; Nilsson, B; Rasmussen, J; Schou, M; Tarnow, L; Tougaard, RS; Videbaek, L; Wiggers, H, 2017)	1.2
"Treatment with liraglutide 3.0 mg contributes to improved cardiometabolic parameters, AHI and health-related QoL through both weight-loss dependent and weight-loss independent mechanisms."	( Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Bays, H; Claudius, B; Hemmingsson, JU; Jensen, CB; Pi-Sunyer, X; Van Gaal, L, 2017)	2.25
"Pretreatment with liraglutide decreased ALT, AST, and GGT activities while increased glutathione content and Akt activation with decrements in MDA, TNF-α, and caspase-3 levels with attenuation of necrosis and inflammation while enhanced Bcl-2 expression in the liver."	( Liraglutide attenuates partial warm ischemia-reperfusion injury in rat livers. Abbas, NA; Abdel Raouf, SM; Abdelsameea, AA, 2017)	2.22
"Treatment with liraglutide 1.2 and 1.8 mg was non-inferior to glimepiride (mean HbA₁(c) reduction: 1.36% points, 1.45% points and 1.39% points, respectively)."	( Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, doubl Bech, OM; Bhattacharyya, A; Chen, L; Ji, Q; Kim, KW; Kumar, A; Liu, X; Ma, J; Tandon, N; Yang, W; Yoon, KH; Zychma, M, 2011)	2.15
"Treatment with liraglutide in type 1 diabetic patients reduces insulin dose with improved or unaltered glycemic control."	( Four weeks of treatment with liraglutide reduces insulin dose without loss of glycemic control in type 1 diabetic patients with and without residual beta-cell function. Holst, JJ; Kielgast, U; Krarup, T; Madsbad, S, 2011)	1.01
"Treatment with liraglutide decreases HbA1c by 1-2%, and additionally liraglutide has a reducing effect on weight, lipids and blood pressure."	( [Weight reducing and glucose reducing effects of liraglutide treatment for patients with type 2 diabetes]. Almdal, T; Færch, K; Penninga, E, 2011)	0.96
"Treatment with liraglutide 1.2 and 1.8 mg resulted, respectively, in mean increases in quality-adjusted life expectancy of 0.32 ± 0.15 and 0.28 ± 0.14 quality-adjusted life years vs. "	( Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus. Chubb, BD; Davies, MJ; Smith, IC; Valentine, WJ, 2012)	1.04
"Treatment with liraglutide (dose range: 0.3 to 0.9 mg/day) for 20.0 ± 6.4 days significantly reduced waist circumference, waist/hip ratio, eVFA. "	( Short-term effects of liraglutide on visceral fat adiposity, appetite, and food preference: a pilot study of obese Japanese patients with type 2 diabetes. Fujishima, Y; Funahashi, T; Hiuge-Shimizu, A; Imagawa, A; Inoue, K; Kashine, S; Kozawa, J; Maeda, N; Okita, K; Shimomura, I, 2011)	1.04
"Treatment with Liraglutide over 21 days increased expression of Mash1 in ob/ob mice (2.0-fold; P<0.01)."	( Liraglutide improves hippocampal synaptic plasticity associated with increased expression of Mash1 in ob/ob mice. Flatt, PR; Gault, VA; Hölscher, C; Porter, WD, 2013)	2.17

Excerpt	Reference	Relevance
" In subjects treated with NN2211 rather than placebo, there was a higher incidence of adverse events, most notably dizziness and adverse events related to the gastrointestinal system."	( The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Agersø, H; Elbrønd, B; Jensen, LB; Rolan, P; Zdravkovic, M, 2002)	0.31
"This study shows NN2211 has a pharmacokinetic profile supporting a daily dose in human beings, but also that subjects treated with NN2211 rather than placebo, had a higher incidence of adverse events, most notably dizziness and adverse events related to the gastrointestinal system."	( The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Agersø, H; Elbrønd, B; Jensen, LB; Rolan, P; Zdravkovic, M, 2002)	0.31
" Whereas no serious adverse events were observed, there was a higher incidence of adverse events after active treatment compared with placebo treatment (notably headache, dizziness, nausea, and vomiting)."	( Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects. Agersø, H; Elbrønd, B; Hatorp, V; Jakobsen, G; Jensen, LB; Larsen, S; Rolan, P; Sturis, J; Zdravkovic, M, 2002)	0.31
" Careful postmarketing surveillance for adverse effects, especially among the DPP4 inhibitors, and continued evaluation in longer-term studies and in clinical practice are required to determine the role of this new class among current pharmacotherapies for type 2 diabetes."	( Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. Amori, RE; Lau, J; Pittas, AG, 2007)	0.34
" This article reviews the profile of adverse effects for these agents in relation to their current (exenatide) and anticipated (liraglutide) role in the management of Type 2 diabetes."	( Safety and adverse effects associated with GLP-1 analogues. Bain, SC; Stephens, JW, 2007)	0.55
" Gastrointestinal adverse events were more common with liraglutide, but most occurred early and were transient."	( Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Blonde, L; Buse, JB; Gerich, J; Hale, PM; Lewin, A; Raskin, P; Schwartz, S; Zdravkovic, M; Zinman, B, 2009)	0.84
" The majority of adverse effects were gastrointestinal, the most frequent of which was nausea."	( The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Blonde, L; Russell-Jones, D, 2009)	0.65
" Nausea was the most common adverse event observed with liraglutide treatment, reported by 5% to 29% of patients; however, nausea was generally mild and transient."	( A review of efficacy and safety data regarding the use of liraglutide, a once-daily human glucagon-like peptide 1 analogue, in the treatment of type 2 diabetes mellitus. Montanya, E; Sesti, G, 2009)	0.84
"Therapeutic proteins/peptides can produce immunogenic responses that may increase the risk of adverse events or reduce efficacy."	( Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. Brett, JH; Buse, JB; Garber, A; Holst, J; Nauck, M; Rosenstock, J; Schmidt, WE; Videbæk, N, 2011)	1.81
"Although several classes of pharmacotherapy are available for type 2 diabetes, glycaemic control is often hampered by medication-related adverse effects and contraindications such as renal impairment."	( The safety and tolerability of GLP-1 receptor agonists in the treatment of type 2 diabetes: a review. Aroda, VR; Ratner, R, 2011)	0.37
" Patient-level results from all completed phase 2 and 3 studies from the liraglutide clinical development programme were pooled to determine rates of major adverse cardiovascular events (MACE): cardiovascular death, myocardial infarction, stroke."	( Cardiovascular safety of liraglutide assessed in a patient-level pooled analysis of phase 2: 3 liraglutide clinical development studies. Buse, JB; House, JA; Jensen, TM; Kennedy, KF; Lindsey, JB; Marso, SP; Martinez Ravn, G; Stolker, JM, 2011)	0.9
" Liraglutide treatment vs placebo was safe and well tolerated in patients with mild RI, as there were no significant differences in rates of renal injury, minor hypoglycemia, or nausea."	( Mild renal impairment and the efficacy and safety of liraglutide. Brett, J; Davidson, JA; Falahati, A; Scott, D, )	1.29
" They provide lesser effect on PPG, similar reduction in body weight, and result in a potentially favorable adverse event profile compared with exenatide twice daily."	( Efficacy and safety of long-acting glucagon-like peptide-1 receptor agonists compared with exenatide twice daily and sitagliptin in type 2 diabetes mellitus: a systematic review and meta-analysis. Hurren, KM; Pinelli, NR, 2011)	0.37
" Most common adverse events were gastrointestinal disturbance such as nausea, vomit, diarrhea, and constipation."	( The efficacy and safety of liraglutide. Jeong, KH; Yoo, BK, 2011)	0.67
" This meta-analysis was aimed at evaluating the risk of those serious adverse events associated with GLP-1 agonists in patients with type 2 diabetes."	( A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Alves, C; Batel-Marques, F; Macedo, AF, 2012)	0.61
" These rare and long-term adverse events deserve properly monitoring in future studies evaluating GLP-1 agonists."	( A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Alves, C; Batel-Marques, F; Macedo, AF, 2012)	0.61
" Glycosylated hemoglobin (HbA1c) values, blood glucose, total daily insulin dose, body weight, waist circumference, and the number of hypoglycemic events and adverse events were evaluated."	( Efficacy and safety comparison between liraglutide as add-on therapy to insulin and insulin dose-increase in Chinese subjects with poorly controlled type 2 diabetes and abdominal obesity. Chen, R; Li, CJ; Li, J; Lv, CF; Lv, L; Yu, DM; Yu, P; Zhang, QM, 2012)	0.65
" Gastrointestinal disorders were the most common adverse events in the liraglutide added treatment, but were transient."	( Efficacy and safety comparison between liraglutide as add-on therapy to insulin and insulin dose-increase in Chinese subjects with poorly controlled type 2 diabetes and abdominal obesity. Chen, R; Li, CJ; Li, J; Lv, CF; Lv, L; Yu, DM; Yu, P; Zhang, QM, 2012)	0.88
" In the meantime, much interest has recently been focused on the potential cardiovascular and oncological adverse effects of these new therapies."	( Thyroid safety in patients treated with liraglutide. Gallo, M, 2013)	0.66
" Glycosylated hemoglobin (HbA1c) values, fasting and postprandial blood glucose (FBG and P2BG), body weight, body mass index (BMI), episodes of hypoglycemia and adverse events were evaluated."	( Efficacy and safety comparison of add-on therapy with liraglutide, saxagliptin and vildagliptin, all in combination with current conventional oral hypoglycemic agents therapy in poorly controlled Chinese type 2 diabetes. Ding, M; Li, CJ; Liu, XJ; Yu, DM; Yu, P; Yu, Q; Zhang, QM, 2014)	0.65
" No serious adverse events (AEs), including severe hypoglycemia, occurred."	( Liraglutide's safety, tolerability, pharmacokinetics, and pharmacodynamics in pediatric type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Arslanian, S; Battelino, T; Chatterjee, DJ; Hale, PM; Jacobsen, LV; Klein, DJ, 2014)	1.85
" However, in the existing studies PHEN/TPM ER had a superior weight loss profile to lorcaserin but the incidence of adverse effects was lower with lorcaserin."	( Tolerability and safety of the new anti-obesity medications. Aldhoon-Hainerová, I; Hainer, V, 2014)	0.4
" IDegLira was generally well tolerated; fewer participants in the IDegLira group than in the liraglutide group reported gastrointestinal adverse events (nausea 8·8 vs 19·7%), although the insulin degludec group had the fewest participants with gastrointestinal adverse events (nausea 3·6%)."	( Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 di Bode, B; Buse, JB; Damgaard, LH; Gough, SC; Linjawi, S; Poulsen, P; Rodbard, HW; Woo, V, 2014)	0.85
"Available evidence about safety, tolerability and potential adverse events relative to GLP-1Rx agonists presently used."	( Potential side effects to GLP-1 agonists: understanding their safety and tolerability. Consoli, A; Formoso, G, 2015)	0.42
" Adverse events (AE) noted during course of therapy were recorded."	( Efficacy and safety of liraglutide therapy in 195 Indian patients with type 2 diabetes in real world setting. Gopalakrishnan, G; Jothydev, S; Kesavadev, J; Shankar, A, )	0.44
"28%) subjects reported adverse events (AE), the most common AEs being vomiting, tiredness, loose motion and nausea."	( Efficacy and safety of liraglutide therapy in 195 Indian patients with type 2 diabetes in real world setting. Gopalakrishnan, G; Jothydev, S; Kesavadev, J; Shankar, A, )	0.44
" Secondary endpoints included changes in daily glycemic profile, body weight, incidence of hypoglycemia and other adverse events."	( Efficacy and safety of liraglutide monotherapy compared with metformin in Japanese overweight/obese patients with type 2 diabetes. Atsumi, Y; Imai, T; Irie, J; Itoh, H; Kawai, T; Meguro, S; Morimoto, J; Saisho, Y; Shigihara, T; Takei, I; Tanaka, K; Tanaka, M; Yajima, K, 2015)	0.73
" Secondary end points include changes in the insulin dose, hypoglyacemic events, body weight, lean body mass, fat mass, food preferences and adverse events."	( Efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide added to insulin therapy in poorly regulated patients with type 1 diabetes--a protocol for a randomised, double-blind, placebo-controlled study: the Lira-1 study. Almdal, T; Andersen, HU; Dejgaard, TF; Frandsen, CS; Hansen, TS; Holst, JJ; Knop, FK; Madsbad, S; Tarnow, L, 2015)	0.65
" Changes from baseline in gastric emptying, 24-h plasma glucose profile, HbA1c, fasting plasma glucose (FPG), 24-h ambulatory heart rate and blood pressure, amylase and lipase levels, and adverse events (AEs) were also assessed."	( Contrasting Effects of Lixisenatide and Liraglutide on Postprandial Glycemic Control, Gastric Emptying, and Safety Parameters in Patients With Type 2 Diabetes on Optimized Insulin Glargine With or Without Metformin: A Randomized, Open-Label Trial. Coester, HV; Delfolie, A; Forst, T; Hincelin-Méry, A; Kapitza, C; Meier, JJ; Menge, BA; Rosenstock, J; Roy-Duval, C, 2015)	0.68
" Thus, if following the appropriate guidelines according to package labels, the practitioner can feel safe in prescribing these medications."	( Safety and tolerability of medications approved for chronic weight management. Fujioka, K, 2015)	0.42
" Overall, all treatments were well tolerated and no new adverse events or tolerability issues were observed for IDegLira."	( One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial. Bode, BW; Buse, JB; Gough, SC; Linjawi, S; Reiter, PD; Rodbard, HW; Woo, VC; Zacho, M, 2015)	0.65
" Adverse drug reactions were present in 24% of subjects, most frequently gastrointestinal disorders (11."	( ROOTS: A multicenter study in Belgium to evaluate the effectiveness and safety of liraglutide (Victoza®) in type 2 diabetic patients. Buysschaert, M; D'Hooge, D; Preumont, V, )	0.36
" Transient gastrointestinal adverse events (nausea: 22."	( Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial. Ahmann, A; Boopalan, A; de Loredo, L; Lahtela, JT; Nauck, MA; Rodbard, HW; Rosenstock, J; Tornøe, K, 2015)	0.73
" (5) No significant differences were observed in hypoglycemic episodes and adverse events between two groups."	( [The efficacy and safety of human glucagon-like peptide-1 analogue liraglutide in newly diagnosed type 2 diabetes with glycosylated hemoglobin A1c > 9]. Chen, C; Chen, P; Huang, Q; Shao, Z; Wang, S; Xu, X; Yan, L, 2015)	0.65
" Most adverse events were grade 1 (mild) to grade 2 (moderate) in severity, transient, and similar in the two treatment groups for all organ classes and symptoms, with the exception of gastrointestinal disorders in 21 (81%) of 23 patients in the liraglutide group and 17 (65%) of 22 patients in the placebo group, which included diarrhoea (ten [38%] patients in the liraglutide group vs five [19%] in the placebo group), constipation (seven [27%] vs none), and loss of appetite (eight [31%] vs two [8%])."	( Liraglutide safety and efficacy in patients with non-alcoholic steatohepatitis (LEAN): a multicentre, double-blind, randomised, placebo-controlled phase 2 study. Abouda, G; Aithal, GP; Aldersley, MA; Armstrong, MJ; Barton, D; Brown, RM; Gaunt, P; Gough, SC; Guo, K; Hazlehurst, JM; Hübscher, SG; Hull, D; Newsome, PN; Parker, R; Stocken, D; Tomlinson, JW, 2016)	2.06
" The most common adverse events were gastrointestinal (GI) adverse effects (liraglutide, 35."	( Efficacy and Safety of Liraglutide Versus Placebo as Add-on to Glucose-Lowering Therapy in Patients With Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL): A Randomized Clinical Trial. Atkin, SL; Bain, SC; Bosch-Traberg, H; Davies, MJ; Rossing, P; Scott, D; Shamkhalova, MS; Syrén, A; Umpierrez, GE, 2016)	0.97
"Liraglutide did not affect renal function and demonstrated better glycemic control, with no increase in hypoglycemia risk but with higher withdrawals due to GI adverse events than placebo in patients with type 2 diabetes and moderate renal impairment."	( Efficacy and Safety of Liraglutide Versus Placebo as Add-on to Glucose-Lowering Therapy in Patients With Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL): A Randomized Clinical Trial. Atkin, SL; Bain, SC; Bosch-Traberg, H; Davies, MJ; Rossing, P; Scott, D; Shamkhalova, MS; Syrén, A; Umpierrez, GE, 2016)	2.19
" This meta-analysis revealed the use of dulaglutide as a monotherapy or an add-on to OAM and lispro appeared to be effective and safe for adults with T2DM."	( Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review. Tong, N; Zhang, L; Zhang, M; Zhang, Y, 2016)	0.43
" Adverse events were similar across racial subgroups."	( Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials. Ard, J; Cannon, A; Lewis, CE; Lofton, H; Pi-Sunyer, X; Stevenin, B; Vang Skjøth, T, 2016)	0.74
"To compare weight loss and adverse events among drug treatments for obesity using a systematic review and network meta-analysis."	( Association of Pharmacological Treatments for Obesity With Weight Loss and Adverse Events: A Systematic Review and Meta-analysis. Camilleri, M; Chandar, AK; Dulai, PS; Khera, R; Loomba, R; Murad, MH; Prokop, LJ; Singh, S; Wang, Z, 2016)	0.43
"Proportions of patients with at least 5% weight loss and at least 10% weight loss, magnitude of decrease in weight, and discontinuation of therapy because of adverse events at 1 year."	( Association of Pharmacological Treatments for Obesity With Weight Loss and Adverse Events: A Systematic Review and Meta-analysis. Camilleri, M; Chandar, AK; Dulai, PS; Khera, R; Loomba, R; Murad, MH; Prokop, LJ; Singh, S; Wang, Z, 2016)	0.43
"35) were associated with the highest odds of adverse event-related treatment discontinuation."	( Association of Pharmacological Treatments for Obesity With Weight Loss and Adverse Events: A Systematic Review and Meta-analysis. Camilleri, M; Chandar, AK; Dulai, PS; Khera, R; Loomba, R; Murad, MH; Prokop, LJ; Singh, S; Wang, Z, 2016)	0.43
" The proportion of patients reporting adverse events was similar between groups."	( Efficacy and safety of liraglutide compared to sulphonylurea during Ramadan in patients with type 2 diabetes (LIRA-Ramadan): a randomized trial. Al Araj, S; Azar, ST; Berrah, A; Echtay, A; Kaltoft, MS; Mutha, A; Omar, M; Shehadeh, N; Tornøe, K; Wan Bebakar, WM, 2016)	0.74
" LIRA-Ramadan provides evidence for liraglutide being safe and efficacious for management of T2D during Ramadan fasting."	( Efficacy and safety of liraglutide compared to sulphonylurea during Ramadan in patients with type 2 diabetes (LIRA-Ramadan): a randomized trial. Al Araj, S; Azar, ST; Berrah, A; Echtay, A; Kaltoft, MS; Mutha, A; Omar, M; Shehadeh, N; Tornøe, K; Wan Bebakar, WM, 2016)	1.02
" Our main end-points were control of glycaemia, body weight, hypoglycaemia and gastrointestinal adverse events (AEs)."	( Efficacy and safety of once-weekly glucagon-like peptide-1 receptor agonists compared with exenatide and liraglutide in type 2 diabetes: a systemic review of randomised controlled trials. Liu, F; Ren, Z; Xue, X; Yang, Q; Zhang, A; Zhang, W, 2016)	0.65
" In conclusion, this meta-analysis confirmed the use of liraglutide as add-on to metformin appeared to be effective and safe for patients with T2DM."	( The efficacy and safety of liraglutide added to metformin in patients with diabetes: a meta-analysis of randomized controlled trials. Gu, J; Guo, Y; Liu, Y; Meng, X; Wang, D; Wang, L; Wu, B; Zheng, H, 2016)	0.98
" The aim of this study was to assess the risk of adverse events (AEs) with GLP-1 RAs and their relation to dose, background medication and duration of action."	( Occurrence of nausea, vomiting and diarrhoea reported as adverse events in clinical trials studying glucagon-like peptide-1 receptor agonists: A systematic analysis of published clinical trials. Abd El Aziz, MS; Bettge, K; Kahle, M; Meier, JJ; Nauck, MA, 2017)	0.46
" No participant developed a major adverse cardiac event during the 24 weeks of liraglutide treatment, defined as cardiac death, new onset or recurrence of myocardial infarction, or needing target lesion revascularization."	( Safety and efficacy of liraglutide treatment in Japanese type 2 diabetes patients after acute myocardial infarction: A non-randomized interventional pilot trial. Inoue, T; Kajiwara, M; Kawasaki, T; Koga, N; Nakao, K; Node, K; Sakamoto, T; Tanaka, A; Toyoda, S, 2017)	0.99
"The RCTs in the present analysis show that all GLP-1RAs improve glycaemic control, reduce body weight and increase the risk of adverse gastrointestinal symptoms compared with placebo."	( Efficacy and safety of glucagon-like peptide-1 receptor agonists in type 2 diabetes: A systematic review and mixed-treatment comparison analysis. Davies, MJ; Htike, ZZ; Khunti, K; Papamargaritis, D; Webb, DR; Zaccardi, F, 2017)	0.46
"To characterize gastrointestinal adverse events (AEs) with different glucagon-like peptide-1 receptor agonists (GLP-1RAs)."	( Upper and/or lower gastrointestinal adverse events with glucagon-like peptide-1 receptor agonists: Incidence and consequences. Aroda, VR; Han, J; Hardy, E; Horowitz, M; Rayner, CK, 2017)	0.46
" Treatment with the GLP-1RA lixisenatide has been shown to be safe in patients with type 2 diabetes and recent acute coronary syndrome."	( Cardiovascular safety and benefits of GLP-1 receptor agonists. Brønden, A; Dalsgaard, NB; Knop, FK; Vilsbøll, T, 2017)	0.46
" Expert opinion: IDegLira provides superior glycaemic control and mitigates the primary adverse effects associated with insulin therapy (weight gain and hypoglycaemia) and GLP-1RAs (gastrointestinal side effects) with no indication of additive effects."	( Efficacy and safety of fixed-ratio combination of insulin degludec and liraglutide (IDegLira) for the treatment of type 2 diabetes. Knop, FK; Vedtofte, L; Vilsbøll, T, 2017)	0.69
" In all treatment groups, the incidences of treatment-emergent adverse events tended to be greater among females than among males."	( Analysis of efficacy and safety of dulaglutide 0.75 mg stratified by sex in patients with type 2 diabetes in 2 randomized, controlled phase 3 studies in Japan. Iwamoto, N; Matsui, A; Matsuura, J; Onishi, Y; Oura, T, 2017)	0.46
"7 events/100 person-years) through adverse event reporting were similarly low in liraglutide and placebo groups."	( Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Aroda, VR; Astrup, A; Brett, J; Cancino, AP; Kushner, R; Lau, DCW; O'Neil, PM; Wadden, TA; Wilding, JPH, 2017)	0.97
" Although there was a small numerical imbalance in suicidal ideation with liraglutide through adverse event reporting, no between-treatment imbalances in suicidal ideation/behaviour or depression were noted through prospective questionnaire assessments."	( Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Aroda, VR; Astrup, A; Brett, J; Cancino, AP; Kushner, R; Lau, DCW; O'Neil, PM; Wadden, TA; Wilding, JPH, 2017)	0.98
"Doxorubicin (Dox)-induced cardiotoxicity constitutes the major adverse effect that limited its use."	( Liraglutide ameliorates cardiotoxicity induced by doxorubicin in rats through the Akt/GSK-3β signaling pathway. Abbas, NAT; Kabil, SL, 2017)	1.9
" Meanwhile, the adverse reactions such as gastrointestinal problems were common in the liraglutide treatment group."	( Efficacy and safety of liraglutide versus sitagliptin both in combination with metformin in patients with type 2 diabetes: A systematic review and meta-analysis. Jiang, D; Li, M; Wang, Y; Yang, Y; Ying, M; Zhao, R, 2017)	0.99
" The primary outcome investigated in this post-hoc analysis was the incidence of adverse events."	( Safety and efficacy of the combination of the glucagon-like peptide-1 receptor agonist liraglutide with an oral antidiabetic drug in Japanese patients with type 2 diabetes: Post-hoc analysis of a randomized, 52-week, open-label, parallel-group trial. Bosch-Traberg, H; Kaku, K; Kiyosue, A; Nishijima, K; Seino, Y, 2018)	0.7
"The proportions of patients experiencing adverse events across the different groups of pretrial OADs were comparable between liraglutide and additional OAD (α-glucosidase inhibitor 74."	( Safety and efficacy of the combination of the glucagon-like peptide-1 receptor agonist liraglutide with an oral antidiabetic drug in Japanese patients with type 2 diabetes: Post-hoc analysis of a randomized, 52-week, open-label, parallel-group trial. Bosch-Traberg, H; Kaku, K; Kiyosue, A; Nishijima, K; Seino, Y, 2018)	0.91
" In adults taking orlistat, rare but severe adverse events, including liver and renal events, have been reported."	( The safety of pharmacologic treatment for pediatric obesity. Berkowitz, RI; Chao, AM; Wadden, TA, 2018)	0.48
" Basal insulin/glucagon-like peptide-1 (GLP-1) agonist combination products have the benefit of being highly efficacious while having favorable effects on weight, reduced gastrointestinal adverse effects, and low hypoglycemic risks compared to the individual agents used alone."	( Efficacy and Safety of Basal Insulin/GLP-1 Receptor Agonist Used in Combination for Type 2 Diabetes Management. McCarty, BP; McCarty, D; Olenik, A, 2019)	0.51
" The main toxic mechanism of OPs is the inhibition of acetylcholinesterase (AChE); however, the delayed neuropathy induced by OPs (OPIDN) is mediated by other mechanisms such as the irreversible inhibition of 70% of NTE activity (neuropathy target esterase) that leads to axonal degeneration."	( The Antidiabetic Drug Liraglutide Minimizes the Non-Cholinergic Neurotoxicity of the Pesticide Mipafox in SH-SY5Y Cells. Dos Santos, AC; Dos Santos, NAG; Emerick, GL; Fernandes, LS, 2019)	0.83
" Therefore, the combined use of a basal insulin (insulin degludec) with an AR-GLP1 (liraglutide), in a single device (IdegLira), is proposed as an effective and safe therapeutic alternative for the treatment intensification in people with type 2 diabetes."	( [Efficacy and safety of IdegLira for the intensification of type 2 diabetes treatment]. Costa Gil, JE; Faingold, MC; Fuente, GV; Litwak, LE; Rodríguez, M, )	0.36
" In the present study, we investigate the toxic effect of high glucose and FFA levels on rat pancreatic RINm5F β-cells and demonstrate that the GLP-1 analogue liraglutide restores the expression of PDX1 by inactivating Mst1, thus ameliorating β-cell impairments."	( Liraglutide protects against glucolipotoxicity-induced RIN-m5F β-cell apoptosis through restoration of PDX1 expression. Bai, YC; Chang, YZ; Chen, WJ; Huang, CN; Kornelius, E; Li, HH; Lin, CL; Liu, S; Peng, CH; Yang, YS, 2019)	2.15
"A1C = hemoglobin A1C; AE = adverse event; CI = confidence interval; Degludec = insulin degludec; EOT = end of trial; ETD = estimated treatment difference; FPG = fasting plasma glucose; GLP-1RA = glucagon-like peptide 1 receptor agonist; IDegLira = insulin degludec/liraglutide; IGlar U100 = insulin glargine 100 U/mL; SU = sulfonylurea; T2D = type 2 diabetes."	( EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES. Halladin, N; Handelsman, Y; Liebl, A; Lingvay, I; Linjawi, S; Ranc, K; Vilsbøll, T, 2019)	0.69
"Older patients with type 2 diabetes are prone to developing adverse events with aggressive antihyperglycaemic therapy."	( Metformin-associated lactic acidosis precipitated by liraglutide use: adverse effects of aggressive antihyperglycaemic therapy. Hannallah, F; Hooda, A; Mehta, A, 2018)	0.73
" The primary endpoint was the number of adverse events."	( Liraglutide effects in a paediatric (7-11 y) population with obesity: A randomized, double-blind, placebo-controlled, short-term trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Carlsson Petri, KC; Hale, PM; Hedman, HK; Mastrandrea, LD; Riesenberg, RA; Witten, L, 2019)	1.96
" Thirty-seven adverse events were reported in nine liraglutide-treated participants (56."	( Liraglutide effects in a paediatric (7-11 y) population with obesity: A randomized, double-blind, placebo-controlled, short-term trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Carlsson Petri, KC; Hale, PM; Hedman, HK; Mastrandrea, LD; Riesenberg, RA; Witten, L, 2019)	2.21
" Expert opinion: Exenatide QW is an efficacious and safe treatment for T2D."	( The efficacy and safety of exenatide once weekly in patients with type 2 diabetes. Brønden, A; Dejgaard, TF; Heimbürger, SM; Johansen, NJ; Knop, FK; Vilsbøll, T, 2019)	0.51
" This treatment strategy is an effective and safe alternative to a basal-bolus insulin regimen."	( A randomized trial comparing the efficacy and safety of treating patients with type 2 diabetes and highly elevated HbA1c levels with basal-bolus insulin or a glucagon-like peptide-1 receptor agonist plus basal insulin: The SIMPLE study. Abreu, M; Adams-Huet, B; Dimachkie, P; Elhassan, A; Gunasekaran, U; Li, X; Lingvay, I; Meneghini, LF; Papacostea, O; Peicher, K; Pop, LM; Siddiqui, MS; Tumyan, A, 2019)	0.51
"We included five publications involving a total of 4,754 patients that compared liraglutide with placebo and found that liraglutide to be an effective and safe treatment for weight loss in individuals without diabetes."	( The efficacy and safety of liraglutide in the obese, non-diabetic individuals: a systematic review and meta-analysis. Bai, J; Cui, Y; Liu, Y; Ren, Y; Zhang, G; Zhang, P, 2019)	1.04
"This systematic review and meta-analysis indicates that liraglutide to be an effective and safe treatment for weight loss in the obese, non-diabetic individuals."	( The efficacy and safety of liraglutide in the obese, non-diabetic individuals: a systematic review and meta-analysis. Bai, J; Cui, Y; Liu, Y; Ren, Y; Zhang, G; Zhang, P, 2019)	1.06
" All long-acting GLP-1RAs have, at minimum, been shown to be safe and not increase cardiovascular (CV) risk and most (liraglutide, semaglutide injectable, dulaglutide, albiglutide) have been shown in CV outcomes trials (CVOTs) to significantly reduce the risk of major cardiac adverse events."	( Long-acting GLP-1RAs: An overview of efficacy, safety, and their role in type 2 diabetes management. Butts, A; Chun, JH, 2020)	0.77
" All long-acting GLP-1RAs have, at minimum, been shown to be safe and not increase cardiovascular (CV) risk and most (liraglutide, semaglutide injectable, dulaglutide, albiglutide) have been shown in CV outcomes trials (CVOTs) to significantly reduce the risk of major cardiac adverse events."	( Long-acting GLP-1RAs: An overview of efficacy, safety, and their role in type 2 diabetes management. Butts, A; Chun, JH, 2020)	0.77
" However, they are costly and may have adverse effects in some individuals."	( Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? Lee, SY; Tak, YJ, 2021)	0.62
" The incidence of gastrointestinal adverse events was higher with liraglutide than with insulin glargine (P < 0."	( Liraglutide hospital discharge trial: A randomized controlled trial comparing the safety and efficacy of liraglutide versus insulin glargine for the management of patients with type 2 diabetes after hospital discharge. Albury, B; Anzola, I; Cardona, S; Chaudhuri, A; Coronado, KWZ; Davis, GM; Farias, JM; Fayfman, M; Galindo, RJ; Gomez, P; Iacobellis, G; Migdal, AL; Palacios, J; Pasquel, FJ; Peng, L; Perez-Guzman, MC; Umpierrez, GE; Urrutia, MA; Vellanki, P, 2021)	2.3
"Compared to insulin glargine, treatment with liraglutide at hospital discharge resulted in better glycaemic control and greater weight loss, but increased gastrointestinal adverse events."	( Liraglutide hospital discharge trial: A randomized controlled trial comparing the safety and efficacy of liraglutide versus insulin glargine for the management of patients with type 2 diabetes after hospital discharge. Albury, B; Anzola, I; Cardona, S; Chaudhuri, A; Coronado, KWZ; Davis, GM; Farias, JM; Fayfman, M; Galindo, RJ; Gomez, P; Iacobellis, G; Migdal, AL; Palacios, J; Pasquel, FJ; Peng, L; Perez-Guzman, MC; Umpierrez, GE; Urrutia, MA; Vellanki, P, 2021)	2.32
"01], while the incidence of adverse reactions was relatively high [RR = 2."	( The effectiveness and safety of liraglutide in treating overweight/obese patients with polycystic ovary syndrome: a meta-analysis. Ge, JJ; Ge, WH; Shen, SM; Song, W; Wang, DJ, 2022)	1
" Liraglutide combined with metformin is more effective than metformin in improving PCOS, but it is necessary to master the correct medication method to reduce the occurrence of adverse reactions."	( The effectiveness and safety of liraglutide in treating overweight/obese patients with polycystic ovary syndrome: a meta-analysis. Ge, JJ; Ge, WH; Shen, SM; Song, W; Wang, DJ, 2022)	1.92
" Liraglutide was well tolerated, and the most common side effect was nausea."	( Effectiveness and Safety of Liraglutide in Managing Inadequate Weight Loss and Weight Regain after Primary and Revisional Bariatric Surgery: Anthropometric and Cardiometabolic Outcomes. El Ansari, W; Elhag, W, 2022)	1.93
" However, GLP-1RAs treatments had more gastrointestinal adverse events (such as nausea and vomiting) than placebo and Met."	( The Antiobesity Effect and Safety of GLP-1 Receptor Agonist in Overweight/Obese Patients Without Diabetes: A Systematic Review and Meta-Analysis. Gong, F; Guo, X; Lyu, X; Pan, H; Wang, L; Xu, H; Yang, H; Zhou, Z; Zhu, H, 2022)	0.72
" The adverse events were comparable to placebo; however, gastrointestinal adverse events were highly recorded in tirzepatide, oral and SC semaglutide groups."	( Semaglutide for the treatment of type 2 Diabetes Mellitus: A systematic review and network meta-analysis of safety and efficacy outcomes. Abdel-Aziz, W; Aladwan, H; Ali, AS; Elkady, S; Elmegeed, AA; Elshahawy, IM; Elshanbary, AA; Gbreel, MI; Hamdallah, A; Hasabo, EA; Helmy, SK; Nourelden, AZ; Rabie, S; Ragab, KM; Sayed, AK; Zaazouee, MS, 2022)	0.72
" No other adverse events were reported."	( Safety and efficacy of liraglutide versus colesevelam for the treatment of bile acid diarrhoea: a randomised, double-blind, active-comparator, non-inferiority clinical trial. Brønden, A; Dragsted, LO; Forman, JL; Haaber, A; Hansen, SH; Kårhus, ML; Knop, FK; Knudsen, E; Krakauer, M; Langholz, E; Sonne, DP; Vilsbøll, T, 2022)	1.03
" There were no significant differences between treatments in the incidence of adverse events, except that liraglutide+metformin had significant adverse effect such as abdominal pain."	( Comparative efficacy and safety of glucose-lowering drugs in children and adolescents with type 2 diabetes: A systematic review and network meta-analysis. Feng, Y; Ge, Y; He, Y; Hou, L; Huo, M; Ji, Y; Li, H; Liu, X; Liu, Y; Luo, Q; Qian, F; Wang, J; Wei, Y; Wu, S; Wu, Y; Xue, F; Yu, Y, 2022)	0.93
" Randomized clinical trials (RCTs) comparing pharmacological interventions in children with obesity are scarce; therefore, we aimed to analyze the relative efficacy and adverse reactions of these drugs and compare the effects of each drug on body mass index (BMI)."	( Comparison of weight loss and adverse events of obesity drugs in children and adolescents: a systematic review and meta-analysis. Liu, H; Wu, F; Xie, Y; Yin, S; Zhang, Q; Zhao, G, 2022)	0.72
" However, it was most associated with drug withdrawal due to adverse events while topiramate was least."	( Comparison of weight loss and adverse events of obesity drugs in children and adolescents: a systematic review and meta-analysis. Liu, H; Wu, F; Xie, Y; Yin, S; Zhang, Q; Zhao, G, 2022)	0.72
"In patients with HFrEF, liraglutide might increase the risk of cardiovascular adverse effects, an effect possibly driven by excess risk of arrhythmias and worsening HF events."	( Risk of adverse events with liraglutide in heart failure with reduced ejection fraction: A post hoc analysis of the FIGHT trial. Borges-Canha, M; Carvalho, D; Ferreira, JP; Leite, AR; Leite-Moreira, A; Neves, JS; Packer, M; Sharma, A; Vasques-Nóvoa, F; Zannad, F, 2023)	1.51
" Mild gastrointestinal reactions were the main adverse event of liraglutide."	( Safety and efficacy of liraglutide on reducing visceral and ectopic fat in adults with or without type 2 diabetes mellitus: A systematic review and meta-analysis. Bin, J; Chen, G; Chen, W; Chen, Y; He, F; Liao, Y; Lin, Z; Liu, D; Tang, Y; Xiao, Z; Xu, W, 2023)	1.46
" No network meta-analysis (NMA) analyzes the adverse events of antifibrotic drugs for NAFLD."	( Side effect profile of pharmacologic therapies for liver fibrosis in nonalcoholic fatty liver disease: a systematic review and network meta-analysis. Feng, P; Lei, H; Lei, R; Li, Y; Xie, F; Xiong, Q; Yao, C, 2023)	0.91
" However, real-world data concerning the difference in gastrointestinal adverse events (AEs) among different GLP-1 RAs are still lacking."	( Association between different GLP-1 receptor agonists and gastrointestinal adverse reactions: A real-world disproportionality study based on FDA adverse event reporting system database. Chen, C; Chen, J; Chen, L; Liu, L; Wang, L, 2022)	0.72
"Disproportionality analysis was used to evaluate the association between GLP-1 RAs and gastrointestinal adverse events."	( Association between different GLP-1 receptor agonists and gastrointestinal adverse reactions: A real-world disproportionality study based on FDA adverse event reporting system database. Chen, C; Chen, J; Chen, L; Liu, L; Wang, L, 2022)	0.72
"A total of 21,281 reports of gastrointestinal toxicity were analyzed out of 81,752 adverse event reports, and the median age of the included patients was 62 (interquartile range [IQR] 54-70) years old."	( Association between different GLP-1 receptor agonists and gastrointestinal adverse reactions: A real-world disproportionality study based on FDA adverse event reporting system database. Chen, C; Chen, J; Chen, L; Liu, L; Wang, L, 2022)	0.72
" The most common adverse events reported in STEP 1-5 were gastrointestinal events, which were transient, mild-to-moderate in severity, and typically resolved without permanent treatment discontinuation."	( Efficacy and safety of semaglutide for weight management: evidence from the STEP program. Amaro, A; Sugimoto, D; Wharton, S, 2022)	0.72
"To determine the effectiveness, persistence of use, adverse reactions, interactions of orlistat and liraglutide taken for weight loss by a group of obese patients in Colombia."	( Effectiveness, persistence of use, and safety of orlistat and liraglutide in a group of patients with obesity. Gaviria-Mendoza, A; Machado-Alba, JE; Machado-Duque, ME; Sánchez-Ramírez, N; Usma-Valencia, AF; Valladales-Restrepo, LF, 2023)	1.37
"3% had adverse drug reactions."	( Effectiveness, persistence of use, and safety of orlistat and liraglutide in a group of patients with obesity. Gaviria-Mendoza, A; Machado-Alba, JE; Machado-Duque, ME; Sánchez-Ramírez, N; Usma-Valencia, AF; Valladales-Restrepo, LF, 2023)	1.15
" Participant safety was assessed through monitoring of biochemical parameters, including kidney and liver function, physical examination, and assessment for adverse events."	( Safety and Efficacy of Liraglutide, 3.0 mg, Once Daily vs Placebo in Patients With Poor Weight Loss Following Metabolic Surgery: The BARI-OPTIMISE Randomized Clinical Trial. Adamo, M; Adeleke, MO; Batterham, RL; Brown, A; Carnemolla, A; Devalia, K; Elkalaawy, M; Fakih, N; Firman, C; Jassil, FC; Jenkinson, A; Magee, CG; Makahamadze, C; Makaronidis, J; Marvasti, P; Mok, J; Omar, RZ; Pucci, A, 2023)	1.22
"Liraglutide is safe and effective in weight-reducing and glycemic control in children and adolescents."	( Efficacy and safety of liraglutide for weight management in children and adolescents: a systematic review and meta-analysis of randomized controlled trials. Gou, H; Guo, J; Zhai, Y, 2023)	2.66
" • Liraglutide is safe and effective in weight-reducing and glycemic control in children and adolescents."	( Efficacy and safety of liraglutide for weight management in children and adolescents: a systematic review and meta-analysis of randomized controlled trials. Gou, H; Guo, J; Zhai, Y, 2023)	1.84
"This database study examines the association between glucagon-like peptide 1 agonists (eg, semaglutide, liraglutide) used for weight loss and reports of gastrointestinal adverse events."	( Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss. Etminan, M; Kezouh, A; Rezaeianzadeh, R; Sodhi, M, 2023)	1.12

Excerpt	Reference	Relevance
" However, the pharmacokinetic profile of native GLP-1 with a rapid elimination has limited its therapeutic potential."	( The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Agersø, H; Elbrønd, B; Jensen, LB; Rolan, P; Zdravkovic, M, 2002)	0.31
" administration the half-life of NN2211 was found to be 12."	( The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Agersø, H; Elbrønd, B; Jensen, LB; Rolan, P; Zdravkovic, M, 2002)	0.31
"This study shows NN2211 has a pharmacokinetic profile supporting a daily dose in human beings, but also that subjects treated with NN2211 rather than placebo, had a higher incidence of adverse events, most notably dizziness and adverse events related to the gastrointestinal system."	( The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Agersø, H; Elbrønd, B; Jensen, LB; Rolan, P; Zdravkovic, M, 2002)	0.31
"This study provides evidence that NN2211 has a pharmacokinetic profile consistent with once-daily dosing in humans."	( Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects. Agersø, H; Elbrønd, B; Hatorp, V; Jakobsen, G; Jensen, LB; Larsen, S; Rolan, P; Sturis, J; Zdravkovic, M, 2002)	0.31
"In the present work, the pharmacodynamic glucose and insulin response was modeled by fitting glucose and insulin data simultaneously with a nonlinear model incorporating known carbohydrate regulation mechanisms."	( Pharmacodynamics of NN2211, a novel long acting GLP-1 derivative. Agersø, H; Vicini, P, 2003)	0.32
" The area under the liraglutide plasma concentration curve from time 0 to last quantifiable concentration adjusted for body weight (significant covariate; P = ."	( An open-label, parallel group study investigating the effects of age and gender on the pharmacokinetics of the once-daily glucagon-like peptide-1 analogue liraglutide. Damholt, B; Ekblom, M; Golor, G; Pedersen, P; Wierich, W; Zdravkovic, M, 2006)	0.86
" Liraglutide showed dose-dependent increases in the pharmacokinetic parameters of AUC0-24 h, C(max) and C(trough), while t(max), t(1/2) and V(d/F) were constant."	( Tolerability, pharmacokinetics and pharmacodynamics of the once-daily human GLP-1 analog liraglutide in Japanese healthy subjects: a randomized, double-blind, placebo-controlled dose-escalation study. Irie, S; Jacobsen, LV; Kageyama, S; Matsumura, Y; Zdravkovic, M, 2008)	1.48
" Despite clear pharmacodynamic effects in this euglycemic cohort, a low risk for hypoglycemia was suggested together with good gastrointestinal tolerability."	( Tolerability, pharmacokinetics and pharmacodynamics of the once-daily human GLP-1 analog liraglutide in Japanese healthy subjects: a randomized, double-blind, placebo-controlled dose-escalation study. Irie, S; Jacobsen, LV; Kageyama, S; Matsumura, Y; Zdravkovic, M, 2008)	0.57
" The pharmacokinetic and pharmacodynamic properties of liraglutide and mechanisms behind its protracted action, which in turn enables enhanced glycemic control, are reviewed."	( Pharmacokinetics and pharmacodynamics of liraglutide, a long-acting, potent glucagon-like peptide-1 analog. Meece, J, 2009)	0.87
"75 mg subcutaneously, and completed serial blood sampling for plasma liraglutide measurements for pharmacokinetic estimation."	( Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide. Hindsberger, C; Jacobsen, LV; Robson, R; Zdravkovic, M, 2009)	0.82
" The aim of this work is to estimate the population pharmacokinetics of liraglutide and make a comparison to the pharmacokinetic profile of exenatide."	( Population pharmacokinetics of liraglutide, a once-daily human glucagon-like peptide-1 analog, in healthy volunteers and subjects with type 2 diabetes, and comparison to twice-daily exenatide. Ingwersen, SH; Jacobsen, LV; Jonker, DM; Watson, E, 2010)	0.88
"To compare the pharmacokinetic (PK) [area under the curve (AUC₀(-)₂₄ (h), C(max))] and pharmacodynamic (PD) (AUC(GIR) ₀(-)₂₄ (h), GIR(max)) properties of single-dose insulin detemir in the presence or absence of steady-state liraglutide (1."	( Co-administration of liraglutide with insulin detemir demonstrates additive pharmacodynamic effects with no pharmacokinetic interaction. Chang, D; Chatterjee, DJ; Guthrie, H; Hompesch, M; Morrow, L, 2011)	0.87
" The GLP-1-RA are administered subcutaneously and differ substantially in pharmacokinetic profiles."	( GLP-1 agonists for type 2 diabetes: pharmacokinetic and toxicological considerations. Christensen, M; Jespersen, MJ; Knop, FK, 2013)	0.39
" The difference in chemical structure have strong implications for key pharmacokinetic parameters such as absorption and clearance, and eventually the safety and efficacy of the individual GLP-1-RA."	( GLP-1 agonists for type 2 diabetes: pharmacokinetic and toxicological considerations. Christensen, M; Jespersen, MJ; Knop, FK, 2013)	0.39
"Liraglutide was well tolerated in youth with T2D, with safety, tolerability, and pharmacokinetic profiles similar to profiles in adults."	( Liraglutide's safety, tolerability, pharmacokinetics, and pharmacodynamics in pediatric type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Arslanian, S; Battelino, T; Chatterjee, DJ; Hale, PM; Jacobsen, LV; Klein, DJ, 2014)	3.29
" In this study, a population pharmacokinetic analysis was compared to the pediatric pharmacokinetic data with those from two clinical pharmacology trials in adults with T2D."	( Comparable liraglutide pharmacokinetics in pediatric and adult populations with type 2 diabetes: a population pharmacokinetic analysis. Jacobsen, LV; Klein, DJ; Petri, KC, 2015)	0.81
"A one-compartment pharmacokinetic model previously found to adequately describe the pharmacokinetics of liraglutide in adults with T2D was applied to the evaluation of 13 pediatric subjects (10-17 years of age) with T2D."	( Comparable liraglutide pharmacokinetics in pediatric and adult populations with type 2 diabetes: a population pharmacokinetic analysis. Jacobsen, LV; Klein, DJ; Petri, KC, 2015)	1.02
"Based on this population pharmacokinetic analysis, the liraglutide dose regimen that was found to be clinically effective in adults is predicted to achieve the same range of exposure in the pediatric population (10-17 years of age) with a pre-trial body weight range of 57-214 kg."	( Comparable liraglutide pharmacokinetics in pediatric and adult populations with type 2 diabetes: a population pharmacokinetic analysis. Jacobsen, LV; Klein, DJ; Petri, KC, 2015)	1.05
" Liraglutide is a fatty-acid derivative of GLP-1 with a protracted pharmacokinetic profile that is used in people for treatment of type II diabetes mellitus and obesity."	( Pharmacokinetics and pharmacodynamics of the glucagon-like peptide-1 analog liraglutide in healthy cats. Adin, CA; Borin-Crivellenti, S; Gilor, C; Hall, MJ; Lakritz, J; Rajala-Schultz, P; Rudinsky, AJ, 2015)	1.56
" The pharmacokinetic properties of liraglutide enable 24-h exposure coverage, a requirement for 24-h glycaemic control with once-daily dosing."	( Liraglutide in Type 2 Diabetes Mellitus: Clinical Pharmacokinetics and Pharmacodynamics. Flint, A; Ingwersen, SH; Jacobsen, LV; Olsen, AK, 2016)	2.15
"The pharmacokinetic properties of liraglutide, a glucagon-like peptide-1 receptor agonist approved for the treatment of type 2 diabetes mellitus (T2D), have been established in healthy individuals and subjects with T2D."	( Pharmacokinetic Properties of Liraglutide as Adjunct to Insulin in Subjects with Type 1 Diabetes Mellitus. Christiansen, E; Heller, S; Ingwersen, SH; Jensen, L; Mader, JK; Pieber, TR, 2016)	1
"The pharmacokinetic properties of liraglutide in T1D were comparable with those observed in healthy volunteers and subjects with T2D."	( Pharmacokinetic Properties of Liraglutide as Adjunct to Insulin in Subjects with Type 1 Diabetes Mellitus. Christiansen, E; Heller, S; Ingwersen, SH; Jensen, L; Mader, JK; Pieber, TR, 2016)	1
"Available pharmacokinetic data, clinical trials and abstracts regarding fixed-ratio combination of insulin degludec and liraglutide were reviewed."	( Pharmacokinetic evaluation of fixed-ratio combination of insulin degludec and liraglutide in the treatment of type 2 diabetes. Davis, SN; Lamos, EM, 2016)	0.87
"A short-acting (GUB09-123) and a half-life extended (GUB09-145) GLP-1/GLP-2 co-agonist were generated using solid-phase peptide synthesis and tested for effects on food intake, body weight, glucose homeostasis, and gut proliferation in lean mice and in diabetic db/db mice."	( Novel GLP-1/GLP-2 co-agonists display marked effects on gut volume and improves glycemic control in mice. Fosgerau, K; Hansen, G; Jelsing, J; Jeppesen, PB; Mannerstedt, K; Pedersen, PJ; Pedersen, SL; Vrang, N; Wismann, P, 2018)	0.48
" In contrast to GUB09-123, sub-chronic administration of a half-life extended GUB09-145 to lean mice caused marked dose-dependent effects on body weight while maintaining its potent intestinotrophic effect."	( Novel GLP-1/GLP-2 co-agonists display marked effects on gut volume and improves glycemic control in mice. Fosgerau, K; Hansen, G; Jelsing, J; Jeppesen, PB; Mannerstedt, K; Pedersen, PJ; Pedersen, SL; Vrang, N; Wismann, P, 2018)	0.48
" Effects on body weight and gastric emptying are also observed depending on the pharmacokinetic properties of the molecule."	( Novel GLP-1/GLP-2 co-agonists display marked effects on gut volume and improves glycemic control in mice. Fosgerau, K; Hansen, G; Jelsing, J; Jeppesen, PB; Mannerstedt, K; Pedersen, PJ; Pedersen, SL; Vrang, N; Wismann, P, 2018)	0.48
" Methods In this pharmacokinetic (PK) and exposure-response meta-analysis, data from two pediatric trials (including ellipse) and two adult trials of liraglutide were compiled (1,137 PK observations from 116 patients) to determine the impact of body weight, age and sex on liraglutide exposure."	( Liraglutide pharmacokinetics and exposure-response in pediatric patients with type 2 diabetes. Hale, PM; Hofman, PL; Jacobsen, LV; Petri, KCC, 2020)	2.2
"This study aimed to perform a population pharmacokinetic and exposure-response analysis of liraglutide by meta-analysis of data from trials conducted in children, adolescents and adults with obesity."	( Liraglutide pharmacokinetics and exposure-response in adolescents with obesity. Carlsson Petri, KC; Hale, PM; Hesse, D; Mastrandrea, LD; Rathor, N, 2021)	2.28
"The population pharmacokinetic analysis investigated the effect of covariates body weight, age group (children, adolescents and adults) and sex on liraglutide exposure in adolescents compared with previous results in adults."	( Liraglutide pharmacokinetics and exposure-response in adolescents with obesity. Carlsson Petri, KC; Hale, PM; Hesse, D; Mastrandrea, LD; Rathor, N, 2021)	2.26
"The population pharmacokinetic analysis supported similar liraglutide exposures in adolescents and adults; body weight was the most important covariate affecting exposure."	( Liraglutide pharmacokinetics and exposure-response in adolescents with obesity. Carlsson Petri, KC; Hale, PM; Hesse, D; Mastrandrea, LD; Rathor, N, 2021)	2.31
" Furthermore, we report a population pharmacokinetic analysis of a 26-week, phase III, treat-to-target, randomized trial of 720 Chinese individuals with type 2 diabetes."	( Preserved pharmacokinetics and pharmacodynamics of insulin degludec and liraglutide when administered as insulin degludec/liraglutide in a Chinese population. Chen, X; Hu, P; Ingwersen, SH; Jia, T; Liu, H; Luo, B; Vestergård Jacobsen, L, 2022)	0.95

Excerpt	Reference	Relevance
"8 mg) or liraglutide placebo in combination with metformin (1 g twice daily) and rosiglitazone (4 mg twice daily)."	( Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Blonde, L; Buse, JB; Gerich, J; Hale, PM; Lewin, A; Raskin, P; Schwartz, S; Zdravkovic, M; Zinman, B, 2009)	1.01
"Liraglutide combined with metformin and a thiazolidinedione is a well-tolerated combination therapy for type 2 diabetes, providing significant improvements in glycemic control."	( Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Blonde, L; Buse, JB; Gerich, J; Hale, PM; Lewin, A; Raskin, P; Schwartz, S; Zdravkovic, M; Zinman, B, 2009)	2.03
"The aim of the study was to compare the efficacy and safety of liraglutide in type 2 diabetes mellitus vs placebo and insulin glargine (A21Gly,B31Arg,B32Arg human insulin), all in combination with metformin and glimepiride."	( Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Antic, S; Lalic, N; Ravn, GM; Russell-Jones, D; Schmitz, O; Sethi, BK; Simó, R; Vaag, A; Zdravkovic, M, 2009)	2.04
"8 mg once daily (n = 232), liraglutide placebo (n = 115) and open-label insulin glargine (n = 234), all in combination with metformin (1 g twice daily) and glimepiride (4 mg once daily)."	( Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Antic, S; Lalic, N; Ravn, GM; Russell-Jones, D; Schmitz, O; Sethi, BK; Simó, R; Vaag, A; Zdravkovic, M, 2009)	2.09
"To assess and compare the efficacy and safety of liraglutide with those of glimepiride, both in combination with metformin for the treatment of type 2 diabetes in Asian population from China, South Korea and India."	( Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, doubl Bech, OM; Bhattacharyya, A; Chen, L; Ji, Q; Kim, KW; Kumar, A; Liu, X; Ma, J; Tandon, N; Yang, W; Yoon, KH; Zychma, M, 2011)	2.07
"8 mg once daily or glimepiride 4 mg once daily all in combination with metformin: 1 : 1 : 1 : 1)."	( Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, doubl Bech, OM; Bhattacharyya, A; Chen, L; Ji, Q; Kim, KW; Kumar, A; Liu, X; Ma, J; Tandon, N; Yang, W; Yoon, KH; Zychma, M, 2011)	1.81
" Herein, the results of clinical trials assessing the efficacy, safety and tolerability of liraglutide when used in combination with either one or two oral antidiabetic therapies are summarised, then contrasted with the effects of exenatide and dipeptidyl peptidase (DPP-4) inhibitors."	( Liraglutide in oral antidiabetic drug combination therapy. Garber, AJ, 2012)	2.04
" The aim of this study was to verify metabolic effects of liraglutide in combination with other antidiabetic drugs."	( Efficacy and tolerability of liraglutide in combination with other antidiabetic drugs in type 2 diabetes. Zenari, L, 2011)	0.9
"There was a significant lowering of HbA1c, fasting blood glucose levels, postprandial glucose levels and better blood pressure control by which we have proved that GLP1 analogues in combination with basal insulin and metformin provide a good glycaemic control with a cardio protective effect, and reduce the risk of late complications."	( Effects of Teraphy with Basal Insulin Analogues Combined with GLP 1 Analogues and Metformin in the Treatment of Obese Patients with Poorly Regulated Postprandial Glycemia. Buturovic, BA; Narancic, AM; Ristic, LB, 2014)	0.4
"The objective of this paper is to investigate the effects of liraglutide in combination with short-term continuous subcutaneous insulin infusion (CSII) therapy on glycemic control and beta cell function in patients with newly diagnosed type 2 diabetes mellitus (T2DM)."	( Effects of Liraglutide Combined with Short-Term Continuous Subcutaneous Insulin Infusion on Glycemic Control and Beta Cell Function in Patients with Newly Diagnosed Type 2 Diabetes Mellitus: A Pilot Study. Cao, X; Chen, A; Deng, W; Ke, W; Li, Y; Liao, Z; Liu, J; Liu, L; Xiao, H; Zhang, P, 2016)	1.07
"The safety and efficacy of liraglutide in combination with an oral antidiabetic drug (OAD) compared with combination of two OADs were assessed in Japanese patients with type 2 diabetes."	( Liraglutide is effective and well tolerated in combination with an oral antidiabetic drug in Japanese patients with type 2 diabetes: A randomized, 52-week, open-label, parallel-group trial. Bosch-Traberg, H; Kaku, K; Kaneko, S; Kiyosue, A; Nishijima, K; Ono, Y; Seino, Y; Shiraiwa, T, 2016)	2.17
"Eligibility criteria for subjects includes: type 2 diabetes mellitus with more than 10 years duration; having been treated with secretagogues, metformin and insulin in combination with LIRA for at least 6 months; poor glycemic control [glycosylated hemoglobin A1c(HbA1c) 7%-10%]."	( [The effect of liraglutide in combination with human umbilical cord mesenchymal stem cells treatment on glucose metabolism and β cell function in type 2 diabetes mellitus]. Chen, C; Chen, P; Guo, W; Huang, LH; Huang, Q; Li, CM; Shao, ZL; Xu, XJ; Yang, XZ, 2016)	0.79
"LIRA treatment in combination with hUC-MSCs improves glucose metabolism and the β cell function in type 2 diabetic patients."	( [The effect of liraglutide in combination with human umbilical cord mesenchymal stem cells treatment on glucose metabolism and β cell function in type 2 diabetes mellitus]. Chen, C; Chen, P; Guo, W; Huang, LH; Huang, Q; Li, CM; Shao, ZL; Xu, XJ; Yang, XZ, 2016)	0.79
"To evaluate the cost-effectiveness of metformin combined with liraglutide or exenatide in Chinese patient with T2DM."	( Long-Term Effectiveness and Cost-Effectiveness of Metformin Combined with Liraglutide or Exenatide for Type 2 Diabetes Mellitus Based on the CORE Diabetes Model Study. Li, Y; Liu, G; Liu, S; Tian, M; Wang, Y; Zhang, X, 2016)	0.91
"Patients with T2DM from the Third Hospital of Hebei Medical University were treated with oral metformin combined with liraglutide (0."	( Long-Term Effectiveness and Cost-Effectiveness of Metformin Combined with Liraglutide or Exenatide for Type 2 Diabetes Mellitus Based on the CORE Diabetes Model Study. Li, Y; Liu, G; Liu, S; Tian, M; Wang, Y; Zhang, X, 2016)	0.87
"2 mg in combination with metformin to liraglutide 3 mg monotherapy in obese PCOS."	( Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial. Goričar, K; Janez, A; Jensterle, M; Kravos, NA, 2017)	1
" We evaluated cardiac function before and after 16 weeks of treatment with the GLP-1RA liraglutide or placebo, combined with supervised exercise, in 33 dysregulated patients with type 2 diabetes on diet and/or metformin."	( Effect of exercise combined with glucagon-like peptide-1 receptor agonist treatment on cardiac function: A randomized double-blind placebo-controlled clinical trial. Jensen, JS; Jensen, MT; Jørgensen, PG; Knop, FK; Mensberg, P; Nyby, S; Storgaard, H; Vilsbøll, T, 2017)	0.68
"The aim of this systematic review was to evaluate the efficacy and safety of liraglutide versus sitagliptin both in combination with metformin in patients with type 2 diabetes and provide reference basis for rational use of clinical drugs."	( Efficacy and safety of liraglutide versus sitagliptin both in combination with metformin in patients with type 2 diabetes: A systematic review and meta-analysis. Jiang, D; Li, M; Wang, Y; Yang, Y; Ying, M; Zhao, R, 2017)	0.99
" Only randomized controlled trials (RCTs) of liraglutide versus sitagliptin both in combination with metformin up to 31 August 2016 were included."	( Efficacy and safety of liraglutide versus sitagliptin both in combination with metformin in patients with type 2 diabetes: A systematic review and meta-analysis. Jiang, D; Li, M; Wang, Y; Yang, Y; Ying, M; Zhao, R, 2017)	1.03
" Here, we investigated behavioral and neurochemical effects of liraglutide (LIRA), a GLP-1 receptor agonist, alone or combined with LEV in mice subjected to PTZ-induced kindling."	( Prevention of pentylenetetrazole-induced kindling and behavioral comorbidities in mice by levetiracetam combined with the GLP-1 agonist liraglutide: Involvement of brain antioxidant and BDNF upregulating properties. Chaves Filho, AJM; de Carvalho, MAJ; de França Fonteles, MM; de Lima, KA; de Souza, AG; de Souza, DAA; Florenço Sousa, FC; Lopes, IS; Macedo, D; Mendes Vasconcelos, SM; Souza Oliveira, JV, 2019)	0.96
"A total of 150 adults with obesity were randomly assigned to: IBT (IBT-alone), providing 21 counseling visits; IBT combined with liraglutide (IBT-liraglutide); or IBT-liraglutide combined for 12 weeks with a 1,000- to 1,200-kcal/d meal-replacement diet (Multicomponent)."	( Intensive Behavioral Therapy for Obesity Combined with Liraglutide 3.0 mg: A Randomized Controlled Trial. Alamuddin, N; Bakizada, Z; Berkowitz, RI; Chao, AM; Gruber, K; Leonard, S; Mugler, K; Tronieri, JS; Wadden, TA; Walsh, OA, 2019)	0.97
"To investigate the effects of liraglutide combined with insulin on oxidative stress and expression levels of serum monocyte chemoattractant protein-1 (MCP-1) and nuclear factor-kB (NF-kB) in patients with type 2 diabetes."	( Effects of Liraglutide Combined with Insulin on Oxidative Stress and Serum MCP-1 and NF-kB Levels in Type 2 Diabetes. He, J; Huang, J; Li, J; Liu, X; Mao, Q, 2019)	1.19
" The control group was treated with insulin alone, and the observation group was treated with liraglutide in combination with insulin."	( Effects of Liraglutide Combined with Insulin on Oxidative Stress and Serum MCP-1 and NF-kB Levels in Type 2 Diabetes. He, J; Huang, J; Li, J; Liu, X; Mao, Q, 2019)	1.12
"Liraglutide combined with insulin therapy can effectively improve blood glucose levels in type 2 diabetic, reduce oxidative stress status, decrease the expression of serum MCP-1 and NF-kB, and inhibit the internal inflammatory response."	( Effects of Liraglutide Combined with Insulin on Oxidative Stress and Serum MCP-1 and NF-kB Levels in Type 2 Diabetes. He, J; Huang, J; Li, J; Liu, X; Mao, Q, 2019)	2.35
" We investigated the effect of liraglutide combined with metformin on LGI and lipoprotein density profiles in patients with stable coronary artery disease (CAD) and newly diagnosed T2DM."	( Liraglutide in combination with metformin may improve the atherogenic lipid profile and decrease C-reactive protein level in statin treated obese patients with coronary artery disease and newly diagnosed type 2 diabetes: A randomized trial. Anholm, C; Fenger, M; Haugaard, SB; Kristiansen, OP; Kumarathurai, P; Madsbad, S; Nielsen, OW; Pedersen, LR; Sajadieh, A; Samkani, A; Walzem, RL, 2019)	2.24
"In patients with CAD and newly diagnosed T2DM on stable statin therapy, liraglutide combined with metformin may improve the atherogenic LDL lipid profile and CRP."	( Liraglutide in combination with metformin may improve the atherogenic lipid profile and decrease C-reactive protein level in statin treated obese patients with coronary artery disease and newly diagnosed type 2 diabetes: A randomized trial. Anholm, C; Fenger, M; Haugaard, SB; Kristiansen, OP; Kumarathurai, P; Madsbad, S; Nielsen, OW; Pedersen, LR; Sajadieh, A; Samkani, A; Walzem, RL, 2019)	2.19
"Liraglutide combined with hUC-MSCs improve glucose metabolism and inhibit islet beta-cell apoptosis in a ASK1/JNK/BAX pathway-dependent manner."	( Liraglutide combined with human umbilical cord mesenchymal stem cell transplantation inhibits beta-cell apoptosis via mediating the ASK1/JNK/BAX pathway in rats with type 2 diabetes. Chen, P; Guo, W; Huang, LH; Shao, ZL; Shi, XZ; Wang, W; Wu, RD; Xu, XJ, 2020)	3.44
"0 mg/day (IBT-liraglutide), and IBT-liraglutide combined with 12 weeks of a portion-controlled diet (Multicomponent) on changes in general health-related (HR) quality of life (QoL) and weight-related QoL."	( Changes in health-related quality of life with intensive behavioural therapy combined with liraglutide 3.0 mg per day. Alamuddin, N; Berkowitz, RI; Chao, AM; Gruber, KA; Tronieri, JS; Wadden, TA; Walsh, OA, 2019)	1.1
" This study randomly assigned poorly controlled type 2 diabetes mellitus patients treated with metformin and multiple daily injections of insulin (n=60) to either continuous subcutaneous insulin infusion (CSII) treatment or CSII in combination with liraglutide (CSII+Lira) treatment for 14 days during hospitalization."	( Use of flash glucose-sensing technology in patients with type 2 diabetes treated with liraglutide combined with CSII: a pilot study. Li, LQ; Li, YK; Ma, JX; Xue, P; Yao, MY, 2020)	0.96
" We evaluated whether liraglutide in combination with metformin (MET-LIRA) is more effective than metformin monotherapy (MET-P) in improving insulin action and reducing body weight in overweight prior GDM (pGDM) women."	( Postpartum treatment with liraglutide in combination with metformin versus metformin monotherapy to improve metabolic status and reduce body weight in overweight/obese women with recent gestational diabetes: A double-blind, randomized, placebo-controlled Elkind-Hirsch, KE; Harris, R; Shaler, D, 2020)	1.17
" In ALI animal models, we observed the effects of liraglutide alone, MSCs alone, and MSCs combined with liraglutide by H&E staining, cell counting, immunohistochemistry, and ELISA assay."	( Mesenchymal stem cells combined with liraglutide relieve acute lung injury through apoptotic signaling restrained by PKA/β-catenin. Chen, X; Don, O; Feng, Y; Liu, J; Ma, X; Qu, J; Song, Y; Yang, X, 2020)	1.08
" In the LPS-induced ALI model, MSCs combined with liraglutide showed a significant therapeutic effect, and hCMSCs combined with liraglutide have advantages in the treatment of ALI."	( Mesenchymal stem cells combined with liraglutide relieve acute lung injury through apoptotic signaling restrained by PKA/β-catenin. Chen, X; Don, O; Feng, Y; Liu, J; Ma, X; Qu, J; Song, Y; Yang, X, 2020)	1.08
" This study suggests that liraglutide in combination with hUC-MSCs could significantly improve glycolipid metabolism, insulin resistance and liver injury in T2DM/NAFLD rats."	( Liraglutide in combination with human umbilical cord mesenchymal stem cell could improve liver lesions by modulating TLR4/NF-kB inflammatory pathway and oxidative stress in T2DM/NAFLD rats. Chen, P; Lin, L; Wang, W; Xu, X, 2020)	2.3
" To revert type 1 diabetes, the suppression of the autoimmune attack should be combined with a β-cell replacement strategy."	( Antigen-specific immunotherapy combined with a regenerative drug in the treatment of experimental type 1 diabetes. Aguilera, E; Ampudia, RM; Cano-Sarabia, M; Gomez-Muñoz, L; Maspoch, D; Perna-Barrull, D; Pujol-Autonell, I; Risueño, RM; Rodriguez-Fernandez, S; Vázquez, F; Villalba, A; Vives-Pi, M, 2020)	0.56
"To compare the therapeutic efficacy of liraglutide (LRG) single drug combined with insulin (Ins) on osteoporosis in rats and its effect on bone mineral density (BMD)."	( Comparison between liraglutide alone and liraglutide in combination with insulin on osteoporotic rats and their effect on bone mineral density. Chen, K; Chen, M; Mo, B; Shen, D; Wu, R; Yan, X, 2021)	1.22
" A mouse model of diet-induced obesity (DIO) was used to investigate the potential metabolic benefits of chronic dosing of each antagonist, alone or in combination with liraglutide."	( Chronic peptide-based GIP receptor inhibition exhibits modest glucose metabolic changes in mice when administered either alone or combined with GLP-1 agonism. Bewick, GA; Ghosh, SS; Grønlund, RV; Maggs, D; Parkes, DG; Pedersen, PJ; Rajagopalan, H; Tsakmaki, A; West, JA, 2021)	0.82
" In conclusion, MSDC-0602K corrected glycemia and reduced insulinemia when given alone, or in combination with Lira."	( Novel insulin sensitizer MSDC-0602K improves insulinemia and fatty liver disease in mice, alone and in combination with liraglutide. Colca, JR; Healy, LN; Kamm, DR; McCommis, KS; Pyles, KD; Sharpe, MC, )	0.34
" The purpose of this article is to further explore the specific effect and mechanism of peptide drug liraglutide nano-formulation combined with sodium-glucose co-transporter-2(SGCT-2) inhibitor on blood lipids in patients with type 2 diabetes."	( Effect of Peptide Drug Liraglutide Nano-Formulation Combined with Sodium-Glucose Cotransporter-2 Inhibitor on Blood Lipids in Patients with Type 2 Diabetes. Liu, Z; She, Y, 2022)	1.25
"To study the effects of liraglutide or lifestyle interventions combined with other antidiabetic drugs on glucose metabolism and abdominal fat distribution in patients with obesity and type 2 diabetes mellitus (T2DM)."	( Effects of liraglutide or lifestyle interventions combined with other antidiabetic drugs on abdominal fat distribution in people with obesity and type 2 diabetes mellitus evaluated by the energy spectrum ct: A prospective randomized controlled study. Guo, L; Li, M; Pan, Q; Song, Y; Wang, X; Yu, D; Zhang, X; Zhou, Y; Zou, M, 2022)	1.42
"To assess clinical efficacy and safety of liraglutide combined with metformin (LMT) in obese patients with type 2 diabetes (ODP) by conducting a meta-analysis of randomized controlled trials (RCTs)."	( Liraglutide combined with metformin treatment for obese people with type 2 diabetes mellitus: a systematic review and meta-analysis. Long, Y; Zhang, Y, 2023)	2.62
"PubMed, EMBASE, Cochrane Library, CNKI, CNKI, and VIP databases were systematically searched for randomized controlled trials (RCTs) through January 1, 2015 to investigate the effectiveness of liraglutide combined with metformin treatment (LMT) in obesity patients with type 2 diabetes (ODP)."	( Liraglutide combined with metformin treatment for obese people with type 2 diabetes mellitus: a systematic review and meta-analysis. Long, Y; Zhang, Y, 2023)	2.54
"Liraglutide has benefits in terms of weight, percent body fat, and body mass index reduction when administered with intragastric balloon."	( The efficacy of liraglutide combined with intragastric balloon on weight loss. Demiral, G; Hanlioğlu, S; Karatepe, O; Yilmaz, A, 2023)	2.7

Excerpt	Reference	Relevance
" No clinically relevant reduction in bioavailability of ethinyl estradiol/levonorgestrel occurred."	( Treatment with liraglutide--a once-daily GLP-1 analog--does not reduce the bioavailability of ethinyl estradiol/levonorgestrel taken as an oral combination contraceptive drug. Hindsberger, C; Jacobsen, LV; Vouis, J; Zdravkovic, M, 2011)	0.72
" Orally bioavailable orthosteric small-molecule agonists are unlikely to be developed, whereas positive allosteric modulators (PAMs) may offer an improved therapeutic profile."	( A Duplexed High-Throughput Screen to Identify Allosteric Modulators of the Glucagon-Like Peptide 1 and Glucagon Receptors. Days, EL; Lindsley, CW; Mi, D; Morris, LC; Niswender, KD; Turney, M; Weaver, CD, 2014)	0.4
" A single-dose, randomized, 4-period crossover clinical pharmacology study in healthy subjects compared the bioavailability of IDegLira with its monocomponents."	( Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. Bode, B; Ingwersen, SH; Jacobsen, LV; Kapitza, C; Poulsen, P, 2015)	0.64
"5-fold increase in the oral bioavailability of liraglutide revealing great potential for the oral delivery of peptide drugs."	( Coating of PLA-nanoparticles with cyclic, arginine-rich cell penetrating peptides enables oral delivery of liraglutide. Cullis, PR; Fidelj, V; Fricker, G; Grundmann, C; Kleist, C; Kulkarni, JA; Leotta, K; Mier, W; Özbek, S; Roth, R; Sauter, M; Storck, P; Tursch, A; Uhl, P; Witzigmann, D, 2020)	1.03
" High ThAT sphingolipid secretion was significantly associated with reduced endothelial nitric oxide bioavailability and increased superoxide generated in human vessels."	( Fat-Secreted Ceramides Regulate Vascular Redox State and Influence Outcomes in Patients With Cardiovascular Disease. Akawi, N; Akbar, N; Akoumianakis, I; Antoniades, C; Antonopoulos, AS; Badi, I; Channon, KM; Checa, A; Choudhury, R; Chuaiphichai, S; Daskalaki, E; Kondo, H; Kotanidis, CP; Lee, K; Lundgren, J; Neubauer, S; Polkinghorne, M; Torekov, SS; Wheelock, CE; Yesilyurt, D, 2021)	0.62
"Increasing the bioavailability of peptide or protein drugs have always been an important topic in the field of pharmacy."	( Construction and Evaluation of Liraglutide Delivery System based on Milk Exosomes: A New Idea for Oral Peptide Delivery. Guo, S; Li, Y; Liang, Y; Liu, L; Shi, Y; Sun, K; Wang, A, 2022)	1.01
" However, the emerging GLP-1 analog peptide drugs for diabetes primarily rely on the injection route, and the development of oral dosage forms was hampered by the low oral bioavailability due to the structural vulnerability to digestive enzymes and molecule impermeability in the gastrointestinal tract."	( Intestinal epithelium penetration of liraglutide via cholic acid pre-complexation and zein/rhamnolipids nanocomposite delivery. Bao, X; Chen, Y; Lin, L; Pan, T; Qian, K; Wang, H; Wang, Z; Xu, M; Yao, P, 2023)	1.18
" Currently, the low bioavailability upon subcutaneous injection of an appetite suppressant, liraglutide, and health problems in the locally injected region remain to be overcome."	( Fabrication of liraglutide-encapsulated triple layer hyaluronic acid microneedles (TLMs) for the treatment of obesity. Jang, M; Juhng, S; Jung, H; Kang, G; Ko, HW; Park, J; Shin, J; Song, J; Yang, H; You, J, 2023)	1.48
"These results suggest EAC-Lira is a promising approach to improving the oral bioavailability and efficacy of liraglutide."	( Fabrication and Evaluation of a pH-Responsive Nanocomposite-Based Colonic Delivery System for Improving the Oral Efficacy of Liraglutide. Han, HK; Kim, DH; Song, JG, 2023)	1.33

Excerpt	Relevance	Reference
" Subchronic multiple dosing of NN2211 (200 microg/kg) twice daily for 10 days to normal and MSG-treated rats caused profound inhibition of food intake."	( Systemic administration of the long-acting GLP-1 derivative NN2211 induces lasting and reversible weight loss in both normal and obese rats. Fledelius, C; Knudsen, LB; Larsen, PJ; Tang-Christensen, M, 2001)	0.31
" Dosing with NN2211 was performed on day 1, and days 5-11."	( The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Agersø, H; Elbrønd, B; Jensen, LB; Rolan, P; Zdravkovic, M, 2002)	0.31
" After subcutaneous dosing with NN2211, 48-h pharmacokinetic, and 24-h glucose, insulin and glucagon profiles were assessed."	( Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects. Agersø, H; Elbrønd, B; Hatorp, V; Jakobsen, G; Jensen, LB; Larsen, S; Rolan, P; Sturis, J; Zdravkovic, M, 2002)	0.31
"This study provides evidence that NN2211 has a pharmacokinetic profile consistent with once-daily dosing in humans."	( Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects. Agersø, H; Elbrønd, B; Hatorp, V; Jakobsen, G; Jensen, LB; Larsen, S; Rolan, P; Sturis, J; Zdravkovic, M, 2002)	0.31
" 9 h after NN2211 dosing; the insulin response would then be expected to be improved (higher) in the subjects dosed with NN2211."	( Pharmacodynamics of NN2211, a novel long acting GLP-1 derivative. Agersø, H; Vicini, P, 2003)	0.32
" HbA(1c) decreased in all but the lowest liraglutide dosage group."	( Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial. Jakobsen, G; Madsbad, S; Matthews, DR; Ranstam, J; Schmitz, O, 2004)	0.79
" This multicentre, double-blind, parallel-group, double-dummy study explored the dose-response relationship of liraglutide effects on bodyweight and glycaemic control in subjects with Type 2 diabetes."	( Effects of liraglutide (NN2211), a long-acting GLP-1 analogue, on glycaemic control and bodyweight in subjects with Type 2 diabetes. An, B; Feinglos, MN; Pi-Sunyer, FX; Saad, MF; Santiago, O, 2005)	0.93
"To evaluate dose-response efficacy and safety of once-daily human GLP-1 analog liraglutide in Japanese subjects with type 2 diabetes."	( Dose-dependent improvement in glycemia with once-daily liraglutide without hypoglycemia or weight gain: A double-blind, randomized, controlled trial in Japanese patients with type 2 diabetes. Kaku, K; Rasmussen, MF; Seino, Y; Zdravkovic, M, 2008)	0.82
" Liraglutide also reduced, with significant dose-response (each p<0."	( Dose-dependent improvement in glycemia with once-daily liraglutide without hypoglycemia or weight gain: A double-blind, randomized, controlled trial in Japanese patients with type 2 diabetes. Kaku, K; Rasmussen, MF; Seino, Y; Zdravkovic, M, 2008)	1.5
" Additionally, these treatment modalities are often limited by inconvenient dosage regimens and safety and tolerability issues, the latter including hypoglycemia, bodyweight gain, edema, and gastrointestinal intolerance."	( Long-acting GLP-1 analogs for the treatment of type 2 diabetes mellitus. Knop, FK; Vilsbøll, T, 2008)	0.35
" Electrocardiograms were recorded periodically over 24 hours at the end of placebo and highest dosing periods."	( Absence of QTc prolongation in a thorough QT study with subcutaneous liraglutide, a once-daily human GLP-1 analog for treatment of type 2 diabetes. Chatterjee, DJ; Khutoryansky, N; Litwin, JS; Sprenger, CR; Zdravkovic, M, 2009)	0.59
" Advances in GLP-1 receptor agonist therapy include development of agents with longer durations of activity allowing for more convenient dosing of therapies for patients with type 2 diabetes, which should lead to better patient compliance, adherence, and overall clinical outcomes."	( Beyond glycemic control: treating the entire type 2 diabetes disorder. Brunton, S, 2009)	0.35
" * Whether dosing of the once-daily human glucagon-like peptide-1 analogue liraglutide should be modified in patients with renal impairment has not previously been studied."	( Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide. Hindsberger, C; Jacobsen, LV; Robson, R; Zdravkovic, M, 2009)	0.81
" It was concluded that pharmacokinetic profiles estimated by modeling showed that liraglutide has pharmacokinetic properties consistent with once-daily dosing in humans and provides better pharmacokinetic coverage in comparison with twice-daily exenatide."	( Population pharmacokinetics of liraglutide, a once-daily human glucagon-like peptide-1 analog, in healthy volunteers and subjects with type 2 diabetes, and comparison to twice-daily exenatide. Ingwersen, SH; Jacobsen, LV; Jonker, DM; Watson, E, 2010)	0.87
"The pharmacology, pharmacokinetics, efficacy, safety, dosage and administration, adverse effects, and place in therapy of liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, are reviewed."	( Liraglutide: a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes mellitus. Joffe, D, 2010)	2.01
"To use time trade-off (TTO) to compare patient preferences for profiles of two glucagon-like peptide (GLP-1) products for the treatment of type 2 diabetes (liraglutide and exenatide) that vary on four key attributes - efficacy (as measured by hemoglobin A(1C)), incidence of nausea, incidence of hypoglycemia, and dosing frequency (QD vs."	( A comparison of preferences for two GLP-1 products--liraglutide and exenatide--for the treatment of type 2 diabetes. Conner, C; Hammer, M; McDonald, S; Polster, M; Zanutto, E, 2010)	0.81
" Estimated preference scores from the conjoint analysis revealed that efficacy measured by hemoglobin A(1C) is the most important attribute, followed by nausea, hypoglycemia, and dosing schedule."	( A comparison of preferences for two GLP-1 products--liraglutide and exenatide--for the treatment of type 2 diabetes. Conner, C; Hammer, M; McDonald, S; Polster, M; Zanutto, E, 2010)	0.61
" Blood samples for ethinyl estradiol/levonorgestrel measurements were drawn until 74 hours post dosing of the contraceptive during liraglutide and placebo treatments."	( Treatment with liraglutide--a once-daily GLP-1 analog--does not reduce the bioavailability of ethinyl estradiol/levonorgestrel taken as an oral combination contraceptive drug. Hindsberger, C; Jacobsen, LV; Vouis, J; Zdravkovic, M, 2011)	0.93
"0%), even at maximal dosage levels of one or two oral agents, and are at increased risk for diabetes-related complications."	( Cost-effectiveness of liraglutide versus rosiglitazone, both in combination with glimepiride in treatment of type 2 diabetes in the US. Conner, C; Hammer, M; Lee, WC, 2011)	0.68
" Longer-acting GLP-1 agonists are dosed less frequently, appear to be associated with less nausea, and may be associated with better rates of adherence than shorter-acting agents."	( Optimizing outcomes for GLP-1 agonists. Freeman, JS, 2011)	0.37
" To address the need to directly compare the food intake- and body weight-suppressive effects of these two GLP-1R ligands, acute and chronic dosing experiments were performed."	( Comparative effects of the long-acting GLP-1 receptor ligands, liraglutide and exendin-4, on food intake and body weight suppression in rats. Alhadeff, AL; Grill, HJ; Hayes, MR; Kanoski, SE, 2011)	0.61
" Patients with normal renal function demonstrated decreases in body weight and systolic blood pressure with either dosage of liraglutide, whereas patients in either RI group also demonstrated a decrease in body weight and systolic blood pressure, but these differences were not significant compared with differences observed in the placebo group."	( Mild renal impairment and the efficacy and safety of liraglutide. Brett, J; Davidson, JA; Falahati, A; Scott, D, )	0.59
" Extended dosing periods have demonstrated the durability of response of liraglutide with respect to glycemic control, lack of weight gain, and blood pressure benefits."	( Liraglutide for the treatment of type 2 diabetes: a clinical update. Peters, KR, )	1.81
"Liraglutide has been shown to improve glucose control and weight loss compared to other pharmacologic treatments with diabetes and may offer improved control with a decrease in daily dosing compared to exenatide."	( Place in therapy for liraglutide and saxagliptin for type 2 diabetes. Brock, M; McFarland, MS; Ryals, C, 2011)	2.13
" The pharmacokinetic parameters of liraglutide are unaffected by age, sex, race, or ethnicity, and no special recommendations for altered dosing of liraglutide need apply to populations with hepatic or renal impairment."	( Liraglutide: clinical pharmacology and considerations for therapy. Sisson, EM, 2011)	2.09
" GLP-1R agonists-which can be dosed to pharmacologic levels-act directly upon the GLP-1R."	( The pharmacologic basis for clinical differences among GLP-1 receptor agonists and DPP-4 inhibitors. Morales, J, 2011)	0.37
" However, short-term treatment (14 weeks) with liraglutide increased b-cell maximal response capacity in a dose-response fashion."	( [Protective effects of glucagon-like peptide-1 on beta-cells: preclinical and clinical data]. Consoli, A; Di Biagio, R, 2011)	0.63
" This article provides insights into the use of pharmacometric analyses for regulatory review with a focus on the dosing recommendations."	( Dosing rationale for liraglutide in type 2 diabetes mellitus: a pharmacometric assessment. Ingwersen, SH; Jacobsen, LV; Jonker, DM; Khurana, M; Le Thi, TD; Madabushi, R; Tornøe, CW; Watson, E, 2012)	0.7
" After the acute test, rats were dosed bi-daily for 14 days in which period food intake and body weight was monitored."	( Liraglutide: short-lived effect on gastric emptying -- long lasting effects on body weight. Hansen, G; Jelsing, J; Knudsen, LB; Raun, K; Tang-Christensen, M; Vrang, N, 2012)	1.82
"While both compounds exerted robust acute reductions in GE, the effect was markedly diminished following 14 days of dosing with liraglutide."	( Liraglutide: short-lived effect on gastric emptying -- long lasting effects on body weight. Hansen, G; Jelsing, J; Knudsen, LB; Raun, K; Tang-Christensen, M; Vrang, N, 2012)	2.03
" Liraglutide dosing to mice was not found to activate RET."	( GLP-1 receptor agonists and the thyroid: C-cell effects in mice are mediated via the GLP-1 receptor and not associated with RET activation. Andersen, L; Andersen, S; Barlas, A; de Boer, AS; Fagin, JA; Gotfredsen, C; Knauf, JA; Knudsen, LB; Madsen, LW; Manova, K; Moelck, AM; Nyborg, NC; Pilling, A; Sjögren, I; Vundavalli, S, 2012)	1.29
" Neither pancreatitis nor preneoplastic proliferative lesions was found in monkeys dosed for 87 weeks, with plasma liraglutide exposure 60-fold higher than that observed in humans at the maximal clinical dose."	( The human GLP-1 analog liraglutide and the pancreas: evidence for the absence of structural pancreatic changes in three species. Knudsen, LB; Madsen, LW; Mølck, AM; Nyborg, NC, 2012)	0.9
" Clinicians should be aware of this possible complication and closely follow liraglutide's dosage titration recommendations in the package insert."	( Liraglutide-induced acute kidney injury. Boone, K; Kaakeh, Y; Kanjee, S; Sutton, J, 2012)	2.05
" To improve gastrointestinal tolerability, an incremental dosing approach is used with liraglutide and exenatide twice daily."	( Non-glycaemic effects mediated via GLP-1 receptor agonists and the potential for exploiting these for therapeutic benefit: focus on liraglutide. Garber, AJ; Vilsbøll, T, 2012)	0.81
" Male and female ZDF rats were dosed for 13 wk with liraglutide (0."	( The effects of 13 wk of liraglutide treatment on endocrine and exocrine pancreas in male and female ZDF rats: a quantitative and qualitative analysis revealing no evidence of drug-induced pancreatitis. Jelsing, J; Jensen, AE; Knudsen, LB; Simonsen, L; Søeborg, H; Thorup, I; Vrang, N, 2012)	0.94
" The future may hold interesting developments in terms of reduced dosing frequency, oral formulations and alternative therapeutic uses."	( A comparison of currently available GLP-1 receptor agonists for the treatment of type 2 diabetes. Montanya, E, 2012)	0.38
"Alternative dosing strategies for liraglutide in patients with type 2 diabetes mellitus are described."	( Alternative dosing strategies for liraglutide in patients with type 2 diabetes mellitus. Cole, SW; Marino, AB; Nuzum, DS, 2014)	0.96
" Due to dose-related adverse effects, it is reasonable to assume that smaller or slower dosage adjustments may improve tolerability and increase the likelihood that the patient will be able to continue therapy long term."	( Alternative dosing strategies for liraglutide in patients with type 2 diabetes mellitus. Cole, SW; Marino, AB; Nuzum, DS, 2014)	0.68
"Alternative dosing strategies that allow for slower dosage adjustments or smaller dosages may offer improved tolerability and increase the likelihood that patients will be able to continue long-term therapy with liraglutide."	( Alternative dosing strategies for liraglutide in patients with type 2 diabetes mellitus. Cole, SW; Marino, AB; Nuzum, DS, 2014)	0.87
" Novo Nordisk has conducted extensive toxicology studies, including data on pancreas weight and histology, in Cynomolgus monkeys dosed with two different human glucagon-like peptide-1 (GLP-1) receptor agonists."	( The human GLP-1 analogs liraglutide and semaglutide: absence of histopathological effects on the pancreas in nonhuman primates. Gotfredsen, CF; Knudsen, LB; Larsen, MO; Mølck, AM; Nyborg, NC; Salanti, Z; Thorup, I, 2014)	0.71
" Advantages include once-weekly dosing and fewer gastrointestinal side effects compared with liraglutide, but it is less effective at reducing A1C and weight compared to liraglutide."	( Albiglutide: a new GLP-1 receptor agonist for the treatment of type 2 diabetes. Nuffer, W; Trujillo, JM, 2014)	0.62
" It is an attractive option because it is dosed once-weekly, provides A1C lowering similar to liraglutide, weight reduction similar to exenatide, and has an adverse effect profile similar to exenatide and liraglutide."	( Dulaglutide: the newest GLP-1 receptor agonist for the management of type 2 diabetes. Thompson, AM; Trujillo, JM, 2015)	0.64
" With a half-life of approximately 12 h, once daily dosing might be feasible; however, significant effects on appetite and weight loss may necessitate dosage or dosing frequency reductions."	( Pharmacokinetics and pharmacodynamics of the glucagon-like peptide-1 analog liraglutide in healthy cats. Adin, CA; Borin-Crivellenti, S; Gilor, C; Hall, MJ; Lakritz, J; Rajala-Schultz, P; Rudinsky, AJ, 2015)	0.65
" The recent approval of insulin degludec/liraglutide administered in a fixed ratio combination is unique not simply for the additive benefits of the two agents, but because it now permits adjustable dosing of liraglutide together with insulin, providing better glucose control than with either agent alone at lower dose levels."	( First fixed-ratio combination of insulin degludec and liraglutide for the treatment of type 2 diabetes. Rendell, M, 2015)	0.93
" Further long-term studies, preferably in patients with more impaired microvascular function and using a higher dosage of GLP-1 analogues, are needed to confirm these findings."	( Effect of the glucagon-like peptide-1 analogue liraglutide on coronary microvascular function in patients with type 2 diabetes - a randomized, single-blinded, cross-over pilot study. Faber, R; Michelsen, MM; Mygind, ND; Pena, A; Prescott, E; Zander, M, 2015)	0.67
"These data show that d-Ala(8) GLP-1(Lys(37) ) pentasaccharide exerts significant antidiabetic actions and has a projected pharmacokinetic/pharmacodynamic profile that merits further evaluation in humans for a possible once-weekly dosing regimen."	( Pharmacological characterization and antidiabetic activity of a long-acting glucagon-like peptide-1 analogue conjugated to an antithrombin III-binding pentasaccharide. Bos, ES; de Kort, M; Dokter, WH; Flatt, PR; Irwin, N; Miltenburg, AM; Moffett, RC; Patterson, S, 2015)	0.42
" Liraglutide exposure was lower when dosed as IDegLira but met the criterion for equivalence."	( Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. Bode, B; Ingwersen, SH; Jacobsen, LV; Kapitza, C; Poulsen, P, 2015)	1.55
" dosing to mini-pigs."	( Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide. Bloch, P; Gram, DX; Knudsen, LB; Knudsen, SM; Kofoed, J; Kruse, T; Lau, J; Madsen, K; McGuire, J; Nielsen, FS; Pettersson, I; Reedtz-Runge, S; Schäffer, L; Spetzler, J; Steensgaard, DB; Strauss, HM; Thygesen, P, 2015)	0.42
"To investigate the dose-response relationship of semaglutide versus placebo and open-label liraglutide in terms of glycemic control in patients with type 2 diabetes."	( A Phase 2, Randomized, Dose-Finding Study of the Novel Once-Weekly Human GLP-1 Analog, Semaglutide, Compared With Placebo and Open-Label Liraglutide in Patients With Type 2 Diabetes. Atkin, SL; Courrèges, JP; Jensen, CB; Lindegaard, ML; Mannucci, E; Nauck, MA; Petrie, JR; Sesti, G, 2016)	0.86
"Forty-four subjects were recruited and randomly assigned to once-a-day dosage of either liraglutide, or glimepiride (4 mg) in a double-blinded double-dummy active-controlled study."	( Liraglutide treatment causes upregulation of adiponectin and downregulation of resistin in Chinese type 2 diabetes. Lee, KO; Li, D; Ma, J; Xu, X; Ye, L; Zhang, Y; Zhu, J, 2015)	2.08
" Differences may be due to dosing device differences for exenatide QW and liraglutide, which, in the case of liraglutide, allows the opportunity for daily self-titration dosing."	( Liraglutide Versus Exenatide Once Weekly: Persistence, Adherence, and Early Discontinuation. Fernandez Lando, L; Kabul, S; Swindle, RW; Xie, J; Yu, M, 2016)	2.11
"8 mg in combination with metformin (≥1500 mg) were randomized to addition of once-daily IDeg ('IDeg add-on to liraglutide' arm; n = 174) or placebo ('placebo add-on to liraglutide' arm; n = 172), with dosing of both IDeg and placebo based on titration guidelines."	( Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study). Andersen, TH; Aroda, VR; Bailey, TS; Cariou, B; Kumar, S; Leiter, LA; Philis-Tsimikas, A; Raskin, P; Zacho, J, 2016)	0.85
" In the full lesion model, vehicle dosing or liraglutide treatment was applied for a total of six weeks starting three weeks pre-lesion, or administered for three weeks starting on the lesion day."	( Characterization of liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, in rat partial and full nigral 6-hydroxydopamine lesion models of Parkinson's disease. Barkholt, P; Fabricius, K; Hansen, HH; Jelsing, J; Knudsen, LB; Mikkelsen, JD; Pyke, C; Vrang, N, 2016)	1.02
" In addition, we performed a detailed investigation of the effects of exogenous liraglutide dosing in a T-cell driven adoptive transfer (AdTr) colitis mouse model."	( GLP-1 Induces Barrier Protective Expression in Brunner's Glands and Regulates Colonic Inflammation. Bang-Berthelsen, CH; Fleckner, J; Folkersen, L; Frederiksen, KS; Heding, A; Heller, RS; Holm, TL; Jackerott, M; Knudsen, LB; Kvist, PH; Pociot, F; Pyke, C; Simonsen, L; Søkilde, R; Vilién, M, 2016)	0.66
" Upregulated transcripts after GLP-1 dosing included IL-33, chemokine ligand 20 (CCL20), and mucin 5b."	( GLP-1 Induces Barrier Protective Expression in Brunner's Glands and Regulates Colonic Inflammation. Bang-Berthelsen, CH; Fleckner, J; Folkersen, L; Frederiksen, KS; Heding, A; Heller, RS; Holm, TL; Jackerott, M; Knudsen, LB; Kvist, PH; Pociot, F; Pyke, C; Simonsen, L; Søkilde, R; Vilién, M, 2016)	0.43
"The primary outcome was a change in the dose-response relationship between calculated insulin secretion rate and blood glucose level after acute and chronic administration of liraglutide."	( Tolerance Does Not Develop Toward Liraglutide's Glucose-Lowering Effect. Sedman, T; Vasar, E; Volke, V, 2017)	0.93
" Despite glycated haemoglobin concentrations being lower with IDegLira at end of treatment, confirmed and nocturnal-confirmed hypoglycaemia rates were lower for IDegLira vs IDeg and IGlar U100, irrespective of dosing time."	( Rates of hypoglycaemia are lower in patients treated with insulin degludec/liraglutide (IDegLira) than with IDeg or insulin glargine, regardless of the hypoglycaemia definition used. Chen, R; Heller, S; Jaeckel, E; Jarlov, H; Lehmann, L; Lingvay, I; Norwood, P, 2017)	0.69
"Treatment with IDegLira, vs IDeg and IGlar U100, resulted in lower rates of hypoglycaemia regardless of dosing time and definition of hypoglycaemia used."	( Rates of hypoglycaemia are lower in patients treated with insulin degludec/liraglutide (IDegLira) than with IDeg or insulin glargine, regardless of the hypoglycaemia definition used. Chen, R; Heller, S; Jaeckel, E; Jarlov, H; Lehmann, L; Lingvay, I; Norwood, P, 2017)	0.69
" In diabetic mice, 4 weeks' dosing with ZP4165 reduced glycated haemoglobin levels vs vehicle by an extent similar to the GLP-1 agonist."	( A novel GIP analogue, ZP4165, enhances glucagon-like peptide-1-induced body weight loss and improves glycaemic control in rodents. Daugaard, JR; Deryabina, MA; Eriksson, PO; Fog, JU; Jessen, L; Larsen, LF; Nørregaard, PK; Tofteng Shelton, P, 2018)	0.48
"SGLT2 inhibitors canagliflozin and dapagliflozin resulted in a weight and A1c-independent reduction of ALT levels compared to incretin agents, with a dose-response observed at higher baseline ALT levels."	( SGLT2 inhibitors and incretin agents: Associations with alanine aminotransferase activity in type 2 diabetes. Aronson, R; Bajaj, HS; Bhullar, L; Brown, RE; Kalra, S; Sohi, N, 2018)	0.48
" Patients were treated according to an individualized treatment plan which included eating habit modification and dosed physical exercise."	( Assessment of complex treatment influence on systemic inflammation in overweight type 2 diabetes patients. Danylchuk, HO; Said, OV; Velychko, VI, )	0.13
" Average daily/weekly dosage (ADD/AWD) was calculated during persistence."	( Utilization patterns of glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes mellitus in Germany: a retrospective cohort study. Jung, H; Lebrec, J; Myland, M; Norrbacka, K; Otto, T; Richter, H, 2019)	0.51
" These analogs were characterized in vivo in DIO mice following acute dosing for effects on glycemic control, and following chronic dosing for effects on body weight and food intake."	( Optimized GIP analogs promote body weight lowering in mice through GIPR agonism not antagonism. DiMarchi, RD; Finan, B; Gelfanov, V; Mroz, PA; Perez-Tilve, D; Tschöp, MH; Yang, B, 2019)	0.51
" There was no evidence of a dose-response effect."	( Liraglutide use and evaluation of pancreatic outcomes in a US commercially insured population. Bosch-Traberg, H; Dore, DD; Funch, D; Gydesen, H; Li, L; Major-Pedersen, A; Mortimer, K; Norman, H; Seeger, JD; Ziyadeh, NJ, 2019)	1.96
" The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA."	( Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial. Astrup, A; Bartels, EM; Bartholdy, C; Bliddal, H; Boesen, MP; Christensen, R; Daugaard, C; Ellegaard, K; Gudbergsen, H; Heitmann, BL; Henriksen, M; Knop, FKK; Kristensen, LE; Overgaard, A; Rasmussen, MU; Wæhrens, EE, 2019)	1.12
"In patients with HbA1c ≥10% treatment with GLP1RA plus basal insulin, compared with basal-bolus insulin, resulted in better glycaemic control and body weight, lower insulin dosage and hypoglycaemia, and improved quality of life."	( A randomized trial comparing the efficacy and safety of treating patients with type 2 diabetes and highly elevated HbA1c levels with basal-bolus insulin or a glucagon-like peptide-1 receptor agonist plus basal insulin: The SIMPLE study. Abreu, M; Adams-Huet, B; Dimachkie, P; Elhassan, A; Gunasekaran, U; Li, X; Lingvay, I; Meneghini, LF; Papacostea, O; Peicher, K; Pop, LM; Siddiqui, MS; Tumyan, A, 2019)	0.51
" Intention-to-treat analysis was performed but one patient had statin dosage and was excluded from the analysis."	( Liraglutide in combination with metformin may improve the atherogenic lipid profile and decrease C-reactive protein level in statin treated obese patients with coronary artery disease and newly diagnosed type 2 diabetes: A randomized trial. Anholm, C; Fenger, M; Haugaard, SB; Kristiansen, OP; Kumarathurai, P; Madsbad, S; Nielsen, OW; Pedersen, LR; Sajadieh, A; Samkani, A; Walzem, RL, 2019)	1.96
" The results showed that acute pharmacological dosage of GLP-1RA (Liraglutide or Exenatide) could significantly influence food intake."	( Comparative study on anorexigenic effect of glucagon-like peptide-1 receptor agonists in rats. Gong, M; Jin, JL; Nguyen, T; Wang, CX; Wen, S; Xiao, WZ; Zhou, LG, 2019)	0.75
" GLP-1 RA dosing varies from once weekly to twice daily, and the class is well tolerated in patients with type 2 diabetes."	( Glucagon-like peptide 1 receptor agonists in type 1 diabetes mellitus. Brooks, A; Guyton, J; Jeon, M, 2019)	0.51
" In a dose-response comparison, DA-CH5 was more effective than the GLP-1 receptor agonist exendin-4."	( The Novel Dual GLP-1/GIP Receptor Agonist DA-CH5 Is Superior to Single GLP-1 Receptor Agonists in the MPTP Model of Parkinson's Disease. Hölscher, C; Li, L; Li, Y; Melchiorsen, JU; Rosenkilde, M; Zhang, L, 2020)	0.56
" Therefore, Ana dosing might be useful to prevent ischemia-induced bladder dysfunctions."	( Anagliptin, a dipeptidyl peptidase-4 inhibitor, improved bladder function and hemodynamics in rats with bilateral internal iliac artery ligation. Hamakawa, T; Hotta, Y; Kataoka, T; Kawata, R; Kimura, K; Maeda, K; Naiki-Ito, A; Ohta, Y; Takahashi, S; Tokoro, M; Yasui, T, 2020)	0.56
" Conclusions These results support use of the same liraglutide dosing regimen in children and adolescents, aged ≥10 years, as that used in adults."	( Liraglutide pharmacokinetics and exposure-response in pediatric patients with type 2 diabetes. Hale, PM; Hofman, PL; Jacobsen, LV; Petri, KCC, 2020)	2.25
" A dose-response study in the APP/PS1 mouse model of AD showed both a dose-dependent drug effect on the inflammation response and the reduction of amyloid plaques in the brain."	( The Dual GLP-1/GIP Receptor Agonist DA4-JC Shows Superior Protective Properties Compared to the GLP-1 Analogue Liraglutide in the APP/PS1 Mouse Model of Alzheimer's Disease. Gengler, S; Goulding, EM; Hölscher, C; Maskery, M; Melchiorsen, JU; Rosenkilde, MM, )	0.34
"To determine the efficacy and safety of liraglutide in a 30 mg/d dosing in patients with overweight/obesity and KOA."	( Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial. Astrup, A; Bartels, EM; Bartholdy, C; Bliddal, H; Boesen, M; Christensen, R; Danneskiold-Samsøe, B; Daugaard, CL; Ellegaard, K; Gudbergsen, H; Heitmann, BL; Henriksen, M; Knop, FK; Kristensen, LE; Nielsen, SM; Overgaard, A; Rasmussen, MU; Wæhrens, EE, 2021)	2.33
" However, medications in this class differ considerably in their dosing frequency, which may impact adherence."	( Medication adherence to injectable glucagon-like peptide-1 (GLP-1) receptor agonists dosed once weekly vs once daily in patients with type 2 diabetes: A meta-analysis. Brock, MD; Cannon, JM; Muraoka, AK; Weeda, ER, 2021)	0.62
" Studies of adults with T2D were included if they compared adherence (as measured by proportion of days covered [PDC]) to injectable GLP-1RAs dosed once weekly vs once daily."	( Medication adherence to injectable glucagon-like peptide-1 (GLP-1) receptor agonists dosed once weekly vs once daily in patients with type 2 diabetes: A meta-analysis. Brock, MD; Cannon, JM; Muraoka, AK; Weeda, ER, 2021)	0.62
"Once weekly dosing of injectable GLP-1RAs was associated with better adherence vs once daily dosing among patients with T2D."	( Medication adherence to injectable glucagon-like peptide-1 (GLP-1) receptor agonists dosed once weekly vs once daily in patients with type 2 diabetes: A meta-analysis. Brock, MD; Cannon, JM; Muraoka, AK; Weeda, ER, 2021)	0.62
" A mouse model of diet-induced obesity (DIO) was used to investigate the potential metabolic benefits of chronic dosing of each antagonist, alone or in combination with liraglutide."	( Chronic peptide-based GIP receptor inhibition exhibits modest glucose metabolic changes in mice when administered either alone or combined with GLP-1 agonism. Bewick, GA; Ghosh, SS; Grønlund, RV; Maggs, D; Parkes, DG; Pedersen, PJ; Rajagopalan, H; Tsakmaki, A; West, JA, 2021)	0.82
" Lack of meaningful Dialogue, incorrect Definition of Desired endpoints; missed Diagnosis of secondary obesity or characterization of Disease comorbidity/ Dysfunction; lack of Discipline, inappropriate Drug choice, dosage or administration; and Defective monitoring strategies or presence of "Dead weight" These causes, presented in a reader-friendly, pragmatic manner, make the concept relevant and useful for the obesity care provider."	( Difficult to defeat obesity: An 8D approach. Arora, S; Kalra, S; Kapoor, N, 2021)	0.62
" To obtain long half-lives allowing for up to once-weekly dosing regimen, fatty acid acylation (lipidation) have been used to non-covalently associate the peptide to serum albumin thus serving as a circulating depot."	( The effect of fatty diacid acylation of human PYY Christoffersen, BØ; Jeppesen, CB; Jørgensen, R; Kofoed, J; Nielsen, FS; Olsen, J; Paulsson, JF; Raun, K; Schleiss, LG; Sensfuss, U; Spetzler, J; Wulff, BS; Ynddal, L; Zosel, F; Østergaard, S, 2021)	0.62
" The dosage and the phenotype of the breast cancer should be considered as important factors for the rational administration of antidiabetic drugs, especially that of liraglutide in breast cancer patients."	( Glucagon-like peptide-1 receptor activation by liraglutide promotes breast cancer through NOX4/ROS/VEGF pathway. Duan, XX; Han, X; Hu, X; Lan, L; Liu, BW; Liu, ZZ; Qin, JF; Wang, Y; Yu, J; Yuan, MC, 2022)	1.17
" Since the efficacy in relation to reduction of HbA1c and body weight as well as tolerability and dosing frequency vary between agents, the GLP-1 RAs cannot be considered equal."	( Cardiovascular effects of incretins: focus on glucagon-like peptide-1 receptor agonists. Holst, JJ; Madsbad, S, 2023)	0.91
" Subgroup analyses were performed based on the type of disease (T2DM or non-T2DM), duration of intervention, dosage of liraglutide and whether life interventions were added to liraglutide therapy."	( Safety and efficacy of liraglutide on reducing visceral and ectopic fat in adults with or without type 2 diabetes mellitus: A systematic review and meta-analysis. Bin, J; Chen, G; Chen, W; Chen, Y; He, F; Liao, Y; Lin, Z; Liu, D; Tang, Y; Xiao, Z; Xu, W, 2023)	1.43
" Subgroup analysis revealed that an adequate dosage (≥1."	( Safety and efficacy of liraglutide on reducing visceral and ectopic fat in adults with or without type 2 diabetes mellitus: A systematic review and meta-analysis. Bin, J; Chen, G; Chen, W; Chen, Y; He, F; Liao, Y; Lin, Z; Liu, D; Tang, Y; Xiao, Z; Xu, W, 2023)	1.22
"Liraglutide significantly and safely reduces visceral and ectopic liver fat irrespective of T2DM status, and reduces visceral fat provided adequate dosage and duration of therapy are ensured."	( Safety and efficacy of liraglutide on reducing visceral and ectopic fat in adults with or without type 2 diabetes mellitus: A systematic review and meta-analysis. Bin, J; Chen, G; Chen, W; Chen, Y; He, F; Liao, Y; Lin, Z; Liu, D; Tang, Y; Xiao, Z; Xu, W, 2023)	2.66
" However, the emerging GLP-1 analog peptide drugs for diabetes primarily rely on the injection route, and the development of oral dosage forms was hampered by the low oral bioavailability due to the structural vulnerability to digestive enzymes and molecule impermeability in the gastrointestinal tract."	( Intestinal epithelium penetration of liraglutide via cholic acid pre-complexation and zein/rhamnolipids nanocomposite delivery. Bao, X; Chen, Y; Lin, L; Pan, T; Qian, K; Wang, H; Wang, Z; Xu, M; Yao, P, 2023)	1.18
" Liraglutide can be applied in cardiac surgery but a rearrangement of time and dosage should be further investigated."	( Comparison of glucose control by added liraglutide to only insulin infusion in diabetic patient undergoing cardiac surgery: A preliminary randomized-controlled trial. Jaiprasat, T; Ongcharit, P; Poopuangpairoj, W; Sindhvananda, W, )	1.31
" Adherence to therapy was assessed by the maximum dosage (MD) and treatment duration (TD)."	( Liraglutide 3.0 mg and mental health: can psychiatric symptoms be associated to adherence to therapy? Insights from a clinical audit. Atti, AR; Nuccitelli, C; Perazza, F; Petroni, ML; Pironi, L; Stecchi, M; Tempia Valenta, S; Villanova, N, 2023)	2.35

Role	Description
glucagon-like peptide-1 receptor agonist	An agonist that binds to and activates glucagon-like peptide-1 (GLP-1) receptors.
neuroprotective agent	Any compound that can be used for the treatment of neurodegenerative disorders.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Class	Description
lipopeptide	A compound consisting of a peptide with attached lipid.
polypeptide	A peptide containing ten or more amino acid residues.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Glucagon-like peptide 1 receptor	Homo sapiens (human)	IC50 (µMol)	0.0024	0.0001	0.0031	0.0140	AID1247343; AID1247344
Glucagon-like peptide 1 receptor	Homo sapiens (human)	Ki	0.0053	0.0001	0.0027	0.0063	AID1911939; AID1911940
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Glucagon-like peptide 1 receptor	Homo sapiens (human)	EC50 (µMol)	0.0082	0.0000	0.0417	0.7943	AID1066039; AID1247346; AID1601241; AID1911919; AID1911921; AID1911922; AID1911927; AID1911934; AID1911936
Glucagon-like peptide 1 receptor	Homo sapiens (human)	Kd	6.2700	0.0005	3.1353	6.2700	AID1867047
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Process	via Protein(s)	Taxonomy
cell surface receptor signaling pathway	Glucagon-like peptide 1 receptor	Homo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathway	Glucagon-like peptide 1 receptor	Homo sapiens (human)
activation of adenylate cyclase activity	Glucagon-like peptide 1 receptor	Homo sapiens (human)
positive regulation of cytosolic calcium ion concentration	Glucagon-like peptide 1 receptor	Homo sapiens (human)
learning or memory	Glucagon-like peptide 1 receptor	Homo sapiens (human)
regulation of heart contraction	Glucagon-like peptide 1 receptor	Homo sapiens (human)
cAMP-mediated signaling	Glucagon-like peptide 1 receptor	Homo sapiens (human)
post-translational protein targeting to membrane, translocation	Glucagon-like peptide 1 receptor	Homo sapiens (human)
negative regulation of blood pressure	Glucagon-like peptide 1 receptor	Homo sapiens (human)
hormone secretion	Glucagon-like peptide 1 receptor	Homo sapiens (human)
cellular response to glucagon stimulus	Glucagon-like peptide 1 receptor	Homo sapiens (human)
response to psychosocial stress	Glucagon-like peptide 1 receptor	Homo sapiens (human)
positive regulation of blood pressure	Glucagon-like peptide 1 receptor	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
transmembrane signaling receptor activity	Glucagon-like peptide 1 receptor	Homo sapiens (human)
protein binding	Glucagon-like peptide 1 receptor	Homo sapiens (human)
glucagon-like peptide 1 receptor activity	Glucagon-like peptide 1 receptor	Homo sapiens (human)
peptide hormone binding	Glucagon-like peptide 1 receptor	Homo sapiens (human)
glucagon receptor activity	Glucagon-like peptide 1 receptor	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
plasma membrane	Glucagon-like peptide 1 receptor	Homo sapiens (human)
membrane	Glucagon-like peptide 1 receptor	Homo sapiens (human)
plasma membrane	Glucagon-like peptide 1 receptor	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Assay ID	Title	Year	Journal	Article
AID1066036	Antidiabetic activity in Sprague-Dawley rat assessed as reduction of plasma glucose level at 25 nmol/kg, ip administered 0.5 hrs prior to glucose challenge by OGTT (Rvb = 13.32 +/- 1.84 mM)	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1911938	Agonist activity at FAP-tagged human GLP-1R expressed in HEK293 cells assessed as receptor internalization by measuring maximal efficacy relative to control	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID1911940	Displacement of [3H]PF-06883365 from FAP-tagged human GLP-1R expressed in CHO cells assessed as inhibition constant by radioligand binding assay	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID1247346	Agonist activity at human GLP1 receptor expressed in BHK cells after 3 hrs by CRE firefly luciferase reporter gene assay in absence of human serum albumin	2015	Journal of medicinal chemistry, Sep-24, Volume: 58, Issue:18	Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.
AID1874763	Anti-obesity activity in type 2 diabetes rhesus monkey model assessed as reduction in body weight at 30 ug/kg, sc qd for 2 weeks and measured during second week of dosing relative to control	2022	ACS medicinal chemistry letters, Aug-11, Volume: 13, Issue:8	Discovery of MK-1462: GLP-1 and Glucagon Receptor Dual Agonist for the Treatment of Obesity and Diabetes.
AID1601247	Antidiabetic activity against STZ-induced diabetic Kunming mouse assessed as reduction in cumulative food intake at 25 nmol/kg, ip qd administered for 3 weeks and measured every day	2019	Bioorganic & medicinal chemistry, 10-15, Volume: 27, Issue:20	Novel lipid side chain modified exenatide analogs emerged prolonged glucoregulatory activity and potential body weight management properties.
AID1066039	Activation of human GLP-1 receptor overexpressed in HEK293 cells assessed as cAMP accumulation after 20 mins by HTRF assay	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1867047	Binding affinity to GLP-1 receptor (unknown origin) assessed as equlibrium constant by surface plasmon resonance analysis	2022	Bioorganic & medicinal chemistry, 05-15, Volume: 62	Synthesis and biological evaluation of glucagon-like peptide-1 analogs with the C-terminal helix 3 of albumin-binding domain 3.
AID1247357	Mean residence time in Gottingen mini pig at 1 nmol/kg, sc	2015	Journal of medicinal chemistry, Sep-24, Volume: 58, Issue:18	Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.
AID1601250	Antidiabetic activity against STZ-induced diabetic Kunming mouse assessed as reduction in HbA1c level at 25 nmol/kg, ip qd administered for 3 weeks and measured after 24 days	2019	Bioorganic & medicinal chemistry, 10-15, Volume: 27, Issue:20	Novel lipid side chain modified exenatide analogs emerged prolonged glucoregulatory activity and potential body weight management properties.
AID1634961	Protective activity against palmitic acid-induced injury in mouse MIN6 cells assessed as increase in cell proliferation at 1 uM measured after 24 hrs by CCK8 assay	2016	Journal of natural products, Apr-22, Volume: 79, Issue:4	Bioactive Octahydroxylated C21 Steroids from the Root Bark of Lycium chinense.
AID1066038	Half life in Sprague-Dawley rat plasma at 1000 ng/mL by LC-MS/MS analysis	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID758121	Antidiabetic activity in obese human assessed as body weight reduction at 3 mg relative to placebo	2013	Bioorganic & medicinal chemistry letters, Jul-15, Volume: 23, Issue:14	Recent progress and future options in the development of GLP-1 receptor agonists for the treatment of diabesity.
AID758126	Antidiabetic activity in type 2 diabetes patient assessed as reduction of HbA1c at 1.2 to 1.8 mg after 26 weeks relative to control	2013	Bioorganic & medicinal chemistry letters, Jul-15, Volume: 23, Issue:14	Recent progress and future options in the development of GLP-1 receptor agonists for the treatment of diabesity.
AID1911922	Agonist activity at GLP-1R (unknown origin) expressed in candidate selection CHO cells assessed as cAMP accumulation incubated for 30 mins by plate reader method	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID1911919	Agonist activity at human GLP-1R expressed in CHO-K1 cells assessed as cAMP accumulation incubated for 30 mins in absence of BETP by plate reader method	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID1066040	Antidiabetic activity in Sprague-Dawley rat assessed as increase of plasma insulin level at 25 nmol/kg, ip administered 0.5 hrs prior to glucose challenge measured at 15 mins by ELISA	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1601248	Antidiabetic activity against STZ-induced diabetic Kunming mouse assessed as reduction in cumulative water intake at 25 nmol/kg, ip qd administered for 3 weeks and measured every day	2019	Bioorganic & medicinal chemistry, 10-15, Volume: 27, Issue:20	Novel lipid side chain modified exenatide analogs emerged prolonged glucoregulatory activity and potential body weight management properties.
AID1066028	Mean residence time in Sprague-Dawley rat at 15 nmol/kg, sc by LC-MS/MS analysis	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1066035	Antidiabetic activity in Sprague-Dawley rat assessed as increase of plasma insulin level at 25 nmol/kg, ip administered 0.5 hrs prior to glucose challenge measured at 45 mins by ELISA	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID758123	Antidiabetic activity in type 2 diabetes patient assessed as reduction of HbA1c at 1.8 mg, qd after 26 weeks relative to control	2013	Bioorganic & medicinal chemistry letters, Jul-15, Volume: 23, Issue:14	Recent progress and future options in the development of GLP-1 receptor agonists for the treatment of diabesity.
AID1874765	Anti-obesity activity in type 2 diabetes rhesus monkey model assessed as reduction in cumulative food intake at 30 ug/kg, sc qd for 3 weeks and measured daily for 21 days relative to baseline	2022	ACS medicinal chemistry letters, Aug-11, Volume: 13, Issue:8	Discovery of MK-1462: GLP-1 and Glucagon Receptor Dual Agonist for the Treatment of Obesity and Diabetes.
AID1247356	Tmax in Gottingen mini pig at 1 nmol/kg, sc	2015	Journal of medicinal chemistry, Sep-24, Volume: 58, Issue:18	Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.
AID1247345	Ratio of IC50 for human GLP1 receptor expressed in BHK cells in presence of 2% human serum albumin to IC50 for human GLP1 receptor expressed in BHK cells in absence of human serum albumin	2015	Journal of medicinal chemistry, Sep-24, Volume: 58, Issue:18	Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.
AID1601255	Anti-obesity activity in 12 hrs fasted diet-induced obese C57BL/6J mouse assessed as reduction in food intake at 25 nmol/kg, ip measured up to 360 mins	2019	Bioorganic & medicinal chemistry, 10-15, Volume: 27, Issue:20	Novel lipid side chain modified exenatide analogs emerged prolonged glucoregulatory activity and potential body weight management properties.
AID1066019	Hypoglycemic activity in C57BL/6J-m+/+Leprdb (db/db) mouse assessed as reduction of plasma glucose level at 25 nmol/kg, ip administered 0.5 hrs prior to glucose challenge measured at 18 to 24 hrs by IPGTT	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1601243	Antidiabetic activity in STZ-induced diabetic Kunming mouse assessed as decrease in postprandial blood glucose level at 25 nmol/kg, ip pretreated with STZ for 5 consecutive days and measured up to 48 hrs post induction by glucometric analysis (Rvb > 16.7	2019	Bioorganic & medicinal chemistry, 10-15, Volume: 27, Issue:20	Novel lipid side chain modified exenatide analogs emerged prolonged glucoregulatory activity and potential body weight management properties.
AID1911921	Agonist activity at FAP-tagged human GLP-1R expressed in HEK293 cells assessed as receptor internalization	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID758124	Antidiabetic activity in type 2 diabetes patient assessed as body weight loss at 1.2 to 1.8 mg after 26 weeks relative to control	2013	Bioorganic & medicinal chemistry letters, Jul-15, Volume: 23, Issue:14	Recent progress and future options in the development of GLP-1 receptor agonists for the treatment of diabesity.
AID1710484	Anti-diabetic activity in overnight fasted diabetic db/db C57BL/K mouse assessed as decrease in blood glucose level at 0.5 micromol/kg, sc administered on day 9 as a single dose followed by glucose challenge and measured after 0.5 to 2 hrs by glucose tole	2021	ACS medicinal chemistry letters, Jun-10, Volume: 12, Issue:6	Discovery of Novel PTP1B Inhibitors Derived from the BH3 Domain of Proapoptotic Bcl-2 Proteins with Antidiabetic Potency.
AID1247355	Half life in Gottingen mini pig at 0.5 nmol/kg, iv	2015	Journal of medicinal chemistry, Sep-24, Volume: 58, Issue:18	Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.
AID1890040	Anti-diabesity activity against high fat diet-induced DIO C57BL/6 mouse model assessed as decrease in body weight at 25 nmol/kg, sc administered for 2 weeks	2022	European journal of medicinal chemistry, Apr-05, Volume: 233	Peptide-based long-acting co-agonists of GLP-1 and cholecystokinin 1 receptors as novel anti-diabesity agents.
AID1066024	Hypoglycemic activity in C57BL/6J-m+/+Leprdb (db/db) mouse assessed as reduction of plasma glucose level at 25 nmol/kg, ip administered 0.5 hrs prior to glucose challenge measured up to 3 hrs by IPGTT	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1066003	Antidiabetic activity in C57BL/6J-m+/+Leprdb (db/db) mouse assessed as reduction of blood glucose level at 25 nmol/kg, ip qd administered for 49 days followed by glucose challenge on day 52 measured up to 90 mins post glucose challenge by IPGTT	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1874761	Anti-obesity activity in type 2 diabetes rhesus monkey model assessed as weight loss at 30 ug/kg, sc qd for 3 weeks relative to control	2022	ACS medicinal chemistry letters, Aug-11, Volume: 13, Issue:8	Discovery of MK-1462: GLP-1 and Glucagon Receptor Dual Agonist for the Treatment of Obesity and Diabetes.
AID1066033	Antidiabetic activity in Sprague-Dawley rat assessed as reduction of plasma glucose level at 25 nmol/kg, ip administered 0.5 hrs prior to glucose challenge measured at 15 to 60 mins by OGTT	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1066032	Tmax in Sprague-Dawley rat at 15 nmol/kg, sc by LC-MS/MS analysis	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1710487	Antidiabetic activity in diabetic db/db C57BL/K mouse assessed as reduction in blood glucose level at 0.5 umol/kg, sc administered as single dose on day 8 and measured for 12 hrs by blood glucose meter analysis	2021	ACS medicinal chemistry letters, Jun-10, Volume: 12, Issue:6	Discovery of Novel PTP1B Inhibitors Derived from the BH3 Domain of Proapoptotic Bcl-2 Proteins with Antidiabetic Potency.
AID1874762	Anti-obesity activity in type 2 diabetes rhesus monkey model assessed as reduction in body weight at 30 ug/kg, sc qd for 1 week and measured during 1 week relative to control	2022	ACS medicinal chemistry letters, Aug-11, Volume: 13, Issue:8	Discovery of MK-1462: GLP-1 and Glucagon Receptor Dual Agonist for the Treatment of Obesity and Diabetes.
AID1890045	Anorectic activity in ICR mouse assessed as decrease in food intake at 25 nmol/kg, ip and measured after 9 hrs	2022	European journal of medicinal chemistry, Apr-05, Volume: 233	Peptide-based long-acting co-agonists of GLP-1 and cholecystokinin 1 receptors as novel anti-diabesity agents.
AID1066016	Antidiabetic activity in C57BL/6J-m+/+Leprdb (db/db) mouse assessed as reduction of blood glucose AUC (0 to 48 hrs) at 25 nmol/kg, ip administered for 0.5 hrs	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID758129	Half life in human	2013	Bioorganic & medicinal chemistry letters, Jul-15, Volume: 23, Issue:14	Recent progress and future options in the development of GLP-1 receptor agonists for the treatment of diabesity.
AID1911939	Displacement of [125I]GLP-1 from FAP-tagged human GLP-1R expressed in CHO cells assessed as inhibition constant by radioligand binding assay	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID1601258	Antidiabetic activity in Sprague-Dawley rat assessed as decrease in glucose level at 25 nmol/kg, ip pretreated for 30 mins followed by glucose challenge and measured up to 180 mins by OGTT relative to control	2019	Bioorganic & medicinal chemistry, 10-15, Volume: 27, Issue:20	Novel lipid side chain modified exenatide analogs emerged prolonged glucoregulatory activity and potential body weight management properties.
AID1911935	Agonist activity at human GLP-1R expressed in PathHunter CHO-K1 GLP1R beta-arrestin-1 cell assessed as induction of beta-arrestin 1 recruitment by measuring maximum efficacy incubated for 90 mins by pathHunter assay relative to control	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID758131	Antidiabetic activity in type 2 diabetes patient assessed as reduction of body weight measured after 26 weeks	2013	Bioorganic & medicinal chemistry letters, Jul-15, Volume: 23, Issue:14	Recent progress and future options in the development of GLP-1 receptor agonists for the treatment of diabesity.
AID1890042	Anti-diabesity activity against high fat diet-induced DIO C57BL/6 mouse model assessed as reduction in fat mass accumulation at 25 nmol/kg, sc administered for 2 weeks and measured on day 15 by NMR analysis	2022	European journal of medicinal chemistry, Apr-05, Volume: 233	Peptide-based long-acting co-agonists of GLP-1 and cholecystokinin 1 receptors as novel anti-diabesity agents.
AID1911934	Agonist activity at human GLP-1R expressed in PathHunter CHO-K1 GLP1R beta-arrestin-1 cell assessed as induction of beta-arrestin 1 recruitment incubated for 90 mins by pathHunter assay	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID1247358	Bioavailability in Gottingen mini pig at 1 nmol/kg, sc	2015	Journal of medicinal chemistry, Sep-24, Volume: 58, Issue:18	Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.
AID1911923	Agonist activity at GLP-1R (unknown origin) expressed in candidate selection CHO cells assessed as cAMP accumulation by measuring maximal efficacy at 20 uM incubated for 30 mins by plate reader method relative to control	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID1066018	Hypoglycemic activity in C57BL/6J-m+/+Leprdb (db/db) mouse assessed as time required to reduce plasma glucose level below 8.35 mM at 25 nmol/kg, ip administered for 0.5 hrs	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1066030	AUC (0 to infinity) in Sprague-Dawley rat at 15 nmol/kg, sc by LC-MS/MS analysis	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1066037	Binding affinity to human serum albumin at 100 ug/mL after 3 hrs relative to control	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1874764	Anti-obesity activity in type 2 diabetes rhesus monkey model assessed as reduction in body weight at 30 ug/kg, sc qd for 3 weeks and measured during third week of dosing relative to control	2022	ACS medicinal chemistry letters, Aug-11, Volume: 13, Issue:8	Discovery of MK-1462: GLP-1 and Glucagon Receptor Dual Agonist for the Treatment of Obesity and Diabetes.
AID758136	Antidiabetic activity in type 2 diabetes patient assessed as reduction of HbA1c measured after 26 weeks relative to control	2013	Bioorganic & medicinal chemistry letters, Jul-15, Volume: 23, Issue:14	Recent progress and future options in the development of GLP-1 receptor agonists for the treatment of diabesity.
AID1601244	Antidiabetic activity in Sprague-Dawley rat assessed as increase in insulin level at 25 nmol/kg, ip pretreated for 30 mins followed by glucose challenge and measured after 15 to 60 mins by ELISA method	2019	Bioorganic & medicinal chemistry, 10-15, Volume: 27, Issue:20	Novel lipid side chain modified exenatide analogs emerged prolonged glucoregulatory activity and potential body weight management properties.
AID1890079	Anorectic activity in ICR mouse assessed as decrease in food intake at 25 nmol/kg, ip and measured after 24 hrs	2022	European journal of medicinal chemistry, Apr-05, Volume: 233	Peptide-based long-acting co-agonists of GLP-1 and cholecystokinin 1 receptors as novel anti-diabesity agents.
AID1601241	Agonist activity at human GLP1 receptor expressed in HEK293 cells assessed as induction of cAMP levels after 20 mins by time-resolved fluorescence analysis	2019	Bioorganic & medicinal chemistry, 10-15, Volume: 27, Issue:20	Novel lipid side chain modified exenatide analogs emerged prolonged glucoregulatory activity and potential body weight management properties.
AID1601253	Hepatoprotective activity against STZ-induced diabetic Kunming mouse assessed as reduction in AST levels at 25 nmol/kg, ip qd administered for 3 weeks and measured at day 24	2019	Bioorganic & medicinal chemistry, 10-15, Volume: 27, Issue:20	Novel lipid side chain modified exenatide analogs emerged prolonged glucoregulatory activity and potential body weight management properties.
AID1066025	Hypoglycemic activity in C57BL/6J-m+/+Leprdb (db/db) mouse assessed as reduction of plasma glucose level at 25 nmol/kg, ip administered 0.5 hrs prior to glucose challenge measured after 3 to 17 hrs by IPGTT	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1710480	Antidiabetic activity in diabetic db/db C57BL/K mouse assessed as decrease in blood glucose at 0.5 umol/kg, sc qd for 7 days measured at 1 hr post-last drug dosing by blood glucose meter analysis	2021	ACS medicinal chemistry letters, Jun-10, Volume: 12, Issue:6	Discovery of Novel PTP1B Inhibitors Derived from the BH3 Domain of Proapoptotic Bcl-2 Proteins with Antidiabetic Potency.
AID1066029	Elimination half life in Sprague-Dawley rat at 15 nmol/kg, sc by LC-MS/MS analysis	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1911928	Agonist activity at human GLP-1R expressed in PathHunter CHO-K1 GLP1R beta-arrestin-2 cells assessed as induction of beta-arrestin 2 recruitment by measuring maximum efficacy incubated for 90 mins in absence of BETP by PathHunter assay relative to control	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID1601252	Hepatoprotective activity against STZ-induced diabetic Kunming mouse assessed as reduction in ALT levels at 25 nmol/kg, ip qd administered for 3 weeks and measured at day 24	2019	Bioorganic & medicinal chemistry, 10-15, Volume: 27, Issue:20	Novel lipid side chain modified exenatide analogs emerged prolonged glucoregulatory activity and potential body weight management properties.
AID1911924	Agonist activity at human GLP-1R expressed in CHO-K1 cells assessed as cAMP accumulation by measuring maximal efficacy at 20 uM incubated for 30 mins in absence of BETP by plate reader method relative to control	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID1911937	Agonist activity at human GLP-1R expressed in PathHunter CHO-K1 GLP1R beta-arrestin-2 cell assessed as induction of beta-arrestin 2 recruitment by measuring maximum efficacy incubated for 90 mins by pathHunter assay relative to control	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID758125	Binding affinity to serum albumin (unknown origin) relative to control	2013	Bioorganic & medicinal chemistry letters, Jul-15, Volume: 23, Issue:14	Recent progress and future options in the development of GLP-1 receptor agonists for the treatment of diabesity.
AID1601257	Antidiabetic activity in STZ-induced diabetic Kunming mouse assessed as hypoglycemic time duration for glycemia under 8.35 mmol/L at 25 nmol/kg, ip pretreated with STZ for 5 consecutive days and measured up to 48 hrs	2019	Bioorganic & medicinal chemistry, 10-15, Volume: 27, Issue:20	Novel lipid side chain modified exenatide analogs emerged prolonged glucoregulatory activity and potential body weight management properties.
AID1247344	Displacement of [125I]-GLP1 from human GLP1 receptor expressed in BHK cells after 2 hrs in presence of 2% human serum albumin	2015	Journal of medicinal chemistry, Sep-24, Volume: 58, Issue:18	Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.
AID1874777	Antidiabetic activity in type 2 diabetes rhesus monkey model assessed as increase in total adiponectin level at 30 ug/kg, sc qd for 3 weeks and measured on day 22	2022	ACS medicinal chemistry letters, Aug-11, Volume: 13, Issue:8	Discovery of MK-1462: GLP-1 and Glucagon Receptor Dual Agonist for the Treatment of Obesity and Diabetes.
AID1890044	Hypoglycemic activity in ICR mouse assessed as improvement in glucose tolerance at 25 nmol/kg, ip administered 30 min before oral glucose administration and measured upto 120 mins by OGTT	2022	European journal of medicinal chemistry, Apr-05, Volume: 233	Peptide-based long-acting co-agonists of GLP-1 and cholecystokinin 1 receptors as novel anti-diabesity agents.
AID1066005	Antidiabetic activity in C57BL/6J-m+/+Leprdb (db/db) mouse assessed as reduction of HbA1c level at 25 to 50 nmol/kg, ip qd measured after 5 weeks	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1911936	Agonist activity at human GLP-1R expressed in PathHunter CHO-K1 GLP1R beta-arrestin-2 cell assessed as induction of beta-arrestin 2 recruitment incubated for 90 mins by pathHunter assay	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID1601254	Antidiabetic activity against STZ-induced diabetic Kunming mouse assessed as increase in insulin positive cells at 25 nmol/kg,ip qd administered for 3 weeks and measured after 24 days by immunohistochemical analysis	2019	Bioorganic & medicinal chemistry, 10-15, Volume: 27, Issue:20	Novel lipid side chain modified exenatide analogs emerged prolonged glucoregulatory activity and potential body weight management properties.
AID1874768	Antidiabetic activity in type 2 diabetes rhesus monkey model assessed as corrected fasting glucose level at 30 ug/kg, sc qd for 3 weeks and measured on day 22 by intravenous glucose tolerance test	2022	ACS medicinal chemistry letters, Aug-11, Volume: 13, Issue:8	Discovery of MK-1462: GLP-1 and Glucagon Receptor Dual Agonist for the Treatment of Obesity and Diabetes.
AID1247354	Apparent volume of distribution in Gottingen mini pig at 0.5 nmol/kg, iv	2015	Journal of medicinal chemistry, Sep-24, Volume: 58, Issue:18	Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.
AID1867046	Binding affinity to GLP-1 receptor (unknown origin) assessed as dissociation rate constant by surface plasmon resonance analysis	2022	Bioorganic & medicinal chemistry, 05-15, Volume: 62	Synthesis and biological evaluation of glucagon-like peptide-1 analogs with the C-terminal helix 3 of albumin-binding domain 3.
AID1247343	Displacement of [125I]-GLP1 from human GLP1 receptor expressed in BHK cells after 2 hrs in absence of human serum albumin	2015	Journal of medicinal chemistry, Sep-24, Volume: 58, Issue:18	Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.
AID1247360	Antihyperglycaemic activity in db/db mouse assessed as reduction of blood glucose level at 0.3 to 100 nmol/kg, sc after 48 hrs by glucose oxidase method	2015	Journal of medicinal chemistry, Sep-24, Volume: 58, Issue:18	Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.
AID1867045	Binding affinity to GLP-1 receptor (unknown origin) assessed as binding rate constant by surface plasmon resonance analysis	2022	Bioorganic & medicinal chemistry, 05-15, Volume: 62	Synthesis and biological evaluation of glucagon-like peptide-1 analogs with the C-terminal helix 3 of albumin-binding domain 3.
AID1066034	Antidiabetic activity in Sprague-Dawley rat assessed as increase of plasma insulin level at 25 nmol/kg, ip administered 0.5 hrs prior to glucose challenge measured for 120 mins by ELISA	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1874775	Antidiabetic activity in type 2 diabetes rhesus monkey model assessed as change in HOMA-IR at 30 ug/kg, sc qd for 3 weeks and measured on day 22	2022	ACS medicinal chemistry letters, Aug-11, Volume: 13, Issue:8	Discovery of MK-1462: GLP-1 and Glucagon Receptor Dual Agonist for the Treatment of Obesity and Diabetes.
AID1601242	Half life in Sprague-Dawley rat plasma at 1000 ng/ml measured up to 72 hrs by UPLC-MS/MS analysis	2019	Bioorganic & medicinal chemistry, 10-15, Volume: 27, Issue:20	Novel lipid side chain modified exenatide analogs emerged prolonged glucoregulatory activity and potential body weight management properties.
AID1247353	Clearance in Gottingen mini pig at 0.5 nmol/kg, iv	2015	Journal of medicinal chemistry, Sep-24, Volume: 58, Issue:18	Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.
AID1890041	Anti-diabesity activity against high fat diet-induced DIO C57BL/6 mouse model assessed as reduction in food intake at 25 nmol/kg, sc administered for 2 weeks	2022	European journal of medicinal chemistry, Apr-05, Volume: 233	Peptide-based long-acting co-agonists of GLP-1 and cholecystokinin 1 receptors as novel anti-diabesity agents.
AID1066001	Antidiabetic activity in C57BL/6J-m+/+Leprdb (db/db) mouse assessed as reduction of blood glucose level at 25 nmol/kg, ip qd administered for 49 days followed by glucose challenge on day 52 measured after 120 mins post glucose challenge by IPGTT	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1066031	Cmax in Sprague-Dawley rat at 15 nmol/kg, sc by LC-MS/MS analysis	2013	Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24	Design, synthesis, and biological activity of novel dicoumarol glucagon-like peptide 1 conjugates.
AID1911927	Agonist activity at human GLP-1R expressed in PathHunter CHO-K1 GLP1R beta-arrestin-2 cells assessed as induction of beta-arrestin 2 recruitment incubated for 90 mins in absence of BETP by PathHunter assay	2022	Journal of medicinal chemistry, 06-23, Volume: 65, Issue:12	A Small-Molecule Oral Agonist of the Human Glucagon-like Peptide-1 Receptor.
AID1874770	Anti-obesity activity in type 2 diabetes rhesus monkey model assessed as increase in FGF21 expression at 30 ug/kg, sc qd for 3 weeks and measured on day 22	2022	ACS medicinal chemistry letters, Aug-11, Volume: 13, Issue:8	Discovery of MK-1462: GLP-1 and Glucagon Receptor Dual Agonist for the Treatment of Obesity and Diabetes.
AID1345996	Human GLP-1 receptor (Glucagon receptor family)	2000	Journal of medicinal chemistry, May-04, Volume: 43, Issue:9	Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	112 (4.80)	29.6817
2010's	1479 (63.34)	24.3611
2020's	744 (31.86)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	481 (20.01%)	5.53%
Reviews	487 (20.26%)	6.00%
Case Studies	86 (3.58%)	4.05%
Observational	48 (2.00%)	0.25%
Other	1,302 (54.16%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (425)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting [NCT02963935]	Phase 3	282 participants (Actual)	Interventional	2017-02-06	Completed
Impact of Liraglutide on Endothelial Function and Microvascular Blood Flow in Type 2 Diabetes Mellitus [NCT01208012]	Phase 4	44 participants (Actual)	Interventional	2010-04-30	Completed
Conditions for Prescribing Liraglutide in Medical Practice and Assessment of Maintenance Level, Tolerability, and Efficacy of Victoza® (Liraglutide) in Subjects With Type 2 Diabetes [NCT01226966]		3,152 participants (Actual)	Observational	2010-09-30	Completed
Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With [NCT00318461]	Phase 3	1,091 participants (Actual)	Interventional	2006-05-31	Completed
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without [NCT03175120]	Phase 3	453 participants (Actual)	Interventional	2017-05-26	Completed
Liraglutide in the Prevention of Type 2 Diabetes After Gestational Diabetes [NCT04324229]		80 participants (Anticipated)	Interventional	2020-02-07	Active, not recruiting
Short-term Treatment With PDE-4 Inhibitor Roflumilast or GLP-1 Agonist Liraglutide or Metformin in Treatment Naive Obese Women With Polycystic Ovary Syndrome [NCT02187250]	Phase 4	45 participants (Actual)	Interventional	2014-03-31	Completed
A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes Mellitus [NCT01288326]		254 participants (Actual)	Observational	2011-02-28	Completed
Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus, a Retrospective Chart Review [NCT01299012]		30 participants (Actual)	Observational	2010-10-31	Completed
Impact of Liraglutide 3.0 on Body Fat Distribution, Visceral Adiposity, and Cardiometabolic Risk Markers In Overweight and Obese Adults at High Risk for Cardiovascular Disease [NCT03038620]	Phase 4	235 participants (Actual)	Interventional	2017-01-31	Completed
Effects of Liraglutide and Testosterone Replacement Therapy on Features of Hypogonadism and Weight Loss in Obese Men With Persistent Features of Hypogonadism. [NCT03619330]	Phase 4	30 participants (Actual)	Interventional	2014-12-31	Completed
Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes [NCT03018028]	Phase 3	243 participants (Actual)	Interventional	2017-01-10	Completed
A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination I [NCT02911948]	Phase 3	210 participants (Actual)	Interventional	2016-09-21	Completed
Cardiovascular Effects of GLP-1 Receptor Activation [NCT03101930]	Phase 4	329 participants (Actual)	Interventional	2017-05-01	Completed
A Randomized, Double-blind Placebo-controlled and Open-label Active-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Subjects [NCT03486392]	Phase 2	474 participants (Actual)	Interventional	2018-03-26	Completed
48-week Phase II, Randomised, Double Blinded Placebo Controlled Multicentre Trial on Liraglutide's Safety, Efficacy and Action on Liver Histology and Metabolism in Overweight Patients With NASH +/- Type II Diabetes [NCT01237119]	Phase 2	52 participants (Actual)	Interventional	2010-08-31	Completed
Investigation of the Metabolic Effects of 3mg Liraglutide on Patients With Overweight or Obesity [NCT03885297]		100 participants (Anticipated)	Observational	2019-01-18	Recruiting
A Randomized Controlled Trial Comparing the Safety and Efficacy of IDegLira Versus Basal Bolus in Patients With Poorly Controlled Type 2 Diabetes [NCT03737240]	Phase 3	145 participants (Actual)	Interventional	2019-01-15	Completed
Incretin-based Drugs and the Risk of Heart Failure: A Multi-center Network Observational Study [NCT02456428]		1,499,650 participants (Actual)	Observational	2014-03-31	Completed
Exploring the Neural Substrates of Cognitive Dysfunction With Glucagon-like Peptide-1 Agonists [NCT02423824]	Phase 3	21 participants (Actual)	Interventional	2015-05-31	Completed
Randomized Clinical Trial to Evaluate the Use of Liraglutide in Individuals With Brain Death and Anti-inflammatory and Anti-apoptotic Effects on Organs to be Transplanted [NCT03672812]	Phase 3	50 participants (Anticipated)	Interventional	2018-09-01	Recruiting
Effects of Administration of Growth Hormone, Without and With Liraglutide, on AgRP, Energy and Glucose Metabolism in Healthy and GH Deficient Humans [NCT05681299]	Phase 4	40 participants (Anticipated)	Interventional	2023-05-01	Not yet recruiting
Effects of Liraglutide on Epicardial Fat Pro-Inflammatory Genes in Type 2 Diabetes and Coronary Artery Disease [NCT03260881]	Phase 4	40 participants (Anticipated)	Interventional	2018-09-01	Recruiting
Does Glycated Hemoglobin Variability in Type 2 Diabetes Differ Depending on the Diabetes Treatment Threshold Used in the Qatari Population: Implication on Diabetes Complication Risk? [NCT02879409]		150 participants (Anticipated)	Interventional	2016-11-30	Active, not recruiting
Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus [NCT03707171]	Phase 3	30 participants (Actual)	Interventional	2018-10-01	Completed
Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin [NCT02963922]	Phase 3	396 participants (Actual)	Interventional	2017-02-06	Completed
Novel Strategies in Weight Loss in Women With Polycystic Ovary Syndrome: do Changes in the Gut Microbiome Play a Role? [NCT03642600]	Phase 4	21 participants (Actual)	Interventional	2019-02-28	Completed
A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects With Type 2 Diabetes M [NCT02059564]	Phase 1	44 participants (Anticipated)	Interventional	2013-12-31	Recruiting
Exploration of the Physiological Effect of GLP-1 in Obese Adults Diagnosed With Obesity Causing Genetic Mutations [NCT02082496]	Phase 2	50 participants (Actual)	Interventional	2014-06-30	Completed
An Exploratory Phase 2, Randomised, Double-blind, Placebo-controlled, and Open-label Active Comparator Study to Evaluate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus. [NCT03555994]	Phase 2	49 participants (Actual)	Interventional	2018-05-31	Completed
Effect of GLP-1 Receptor Agonism on Weight and Caloric Intake in Subjects After Sleeve Gastrectomy [NCT03115424]	Phase 3	75 participants (Anticipated)	Interventional	2017-06-22	Active, not recruiting
Incretin-based Therapy in Early Diagnosed Type 1 Diabetes [NCT02908087]	Phase 2	13 participants (Actual)	Interventional	2016-03-31	Completed
Randomisation to Endoluminal Intestinal Liner Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity) [NCT02055014]	Phase 4	72 participants (Anticipated)	Interventional	2013-07-31	Active, not recruiting
Prospective, Multicentre, Open-label, Single-arm, Non-interventional Regulatory Post-marketing Surveillance(rPMS) Study to Evaluate the Safety and Effectiveness of Saxenda® (Liraglutide 3.0 mg) in Obese Patients and Overweight Patients With Obesity-relate [NCT03560336]		758 participants (Actual)	Observational	2018-07-05	Completed
Central Effects of Endogenous Glucagon Like Peptide-1 (GLP-1) and the GLP-1 Analog Liraglutide on Brain Satiety and Reward Circuits and Feeding Behavior in Diabetes [NCT01363609]		50 participants (Actual)	Interventional	2011-10-31	Completed
A Retrospective Database Assessment of Clinical Effectiveness in Type 2 Diabetes Patients Treated With Liraglutide From Primary Care Centers in Sweden [NCT02077946]		1,059 participants (Actual)	Observational	2014-02-10	Completed
Effect of Repeated Administration of Liraglutide on Insulinogenic Indices [NCT02089256]	Phase 4	10 participants (Actual)	Interventional	2014-06-30	Completed
Liraglutide in the Treatment of Type 1 Diabetes Mellitus [NCT01722266]	Phase 3	72 participants (Actual)	Interventional	2012-11-30	Completed
Efficacy of Vildagliptin, Liraglutide and Empagliflozin in the Management of Fatty Liver Disease Among Patients With Type 2 Diabetes [NCT05041673]		120 participants (Anticipated)	Interventional	2021-02-23	Active, not recruiting
Autologous Hematopoietic Stem Cell Mobilization (Plerixafor) and Immunologic Reset in New Onset Type 1 Diabetes Mellitus [NCT03182426]	Phase 1/Phase 2	60 participants (Anticipated)	Interventional	2017-08-15	Active, not recruiting
Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome. [NCT02527200]	Phase 3	56 participants (Actual)	Interventional	2015-11-09	Completed
A Randomized Placebo-controlled Double Blind Trial of Liraglutide 3 mg [Saxenda] on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With Polycystic Ovary Syndrome (PCOS) [NCT03480022]	Phase 3	88 participants (Actual)	Interventional	2018-09-26	Completed
Effects of Liraglutide on Hemodynamic Parameters in Patients With Heart Failure [NCT02490176]		50 participants (Anticipated)	Interventional	2015-07-31	Recruiting
The Use of Incretin-based Drugs and the Risk of Acute Pancreatitis in Patients With Type 2 Diabetes [NCT02476760]		1,417,914 participants (Actual)	Observational	2014-03-31	Completed
The Effect of Liraglutide on Dietary Lipid Induced Insulin Resistance in Humans [NCT02403284]	Phase 4	35 participants (Anticipated)	Interventional	2013-03-31	Active, not recruiting
The Physiological Effects of GLP-1 on Haemodynamics During Exercise in Patients With Ischaemic Heart Disease [NCT02315001]	Phase 2	26 participants (Actual)	Interventional	2014-01-31	Completed
Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease [NCT04057261]	Phase 3	0 participants (Actual)	Interventional	2020-11-30	Withdrawn(stopped due to A study start is currently not foreseeable for organizational reasons. Due to the delays, research has also been focused on new compounds, which has reduced the interest in the potential results of the above-mentioned clinical trial.)
A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus [NCT02505334]	Phase 3	635 participants (Actual)	Interventional	2015-07-21	Completed
LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors [NCT02964247]	Phase 3	303 participants (Actual)	Interventional	2017-03-03	Completed
Pretreatment of Patients Expecting Bariatric Surgery With the GLP-1 Analogon [NCT02417103]	Phase 3	2 participants (Actual)	Interventional	2011-12-31	Terminated(stopped due to Recruiting failure)
Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity. 56-week, Double-blind, Randomised, Parallel-group, Placebo-controlled Multi-national Trial Followed by a 26-week Period Off Study-drug [NCT02918279]	Phase 3	251 participants (Actual)	Interventional	2016-09-29	Completed
A Phase III, Randomized, Parallel, Double-blind, and Non-inferiority Clinical Trial to Compare Efficacy and Safety of CinnaGen-liraglutide to Innovator Liraglutide Product (Victoza®) in Patients With Type II Diabetes (T2D) [NCT03421119]	Phase 3	300 participants (Anticipated)	Interventional	2019-06-20	Not yet recruiting
Obesity Treatment to Improve Diabetes [NCT05390307]		60 participants (Anticipated)	Interventional	2023-04-01	Recruiting
A Randomised, Open-label, Single-centre, Two-period, Cross-over Trial Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors [NCT02207348]	Phase 1	24 participants (Actual)	Interventional	2014-08-31	Completed
Effects of GLP-1 RAs on Weight and Metabolic Indicators in Obese Patients [NCT03671733]	Phase 3	150 participants (Anticipated)	Interventional	2018-09-01	Recruiting
Treatment With Liraglutide as add-on to Insulin in Type 1 Diabetic Patients. Effects on Glycemic Control and Counterregulation and Cognitive Performance During Hypoglycaemia [NCT02092896]	Phase 3	40 participants (Actual)	Interventional	2013-03-31	Completed
The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch) [NCT01676116]	Phase 3	438 participants (Actual)	Interventional	2012-08-29	Completed
In Market Utilisation of Liraglutide Used for Weight Management in the UK: a Study in the CPRD Primary Care Database [NCT03479762]		105 participants (Actual)	Observational	2018-04-20	Completed
Targeting Beta Cell Dysfunction in Longstanding T1D [NCT03632759]	Early Phase 1	16 participants (Actual)	Interventional	2018-08-15	Completed
Addition of Liraglutide to Overweight Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections (MDI) With Inadequate Glycaemic Control [NCT02113332]	Phase 2	124 participants (Actual)	Interventional	2013-01-31	Completed
Liraglutide's Effect on Weight Loss in Patients After Secondary Bariatric Surgery ; a Randomized Double-blind Controlled Study. [NCT05285397]		60 participants (Anticipated)	Interventional	2022-03-10	Not yet recruiting
A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Liraglutide vs. a Sulphonylurea [NCT02292290]	Phase 4	99 participants (Actual)	Interventional	2011-04-30	Completed
A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus. DUALTM IX - Add-on to SGLT2i [NCT02773368]	Phase 3	420 participants (Actual)	Interventional	2016-05-23	Completed
A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Tr [NCT01336023]	Phase 3	1,663 participants (Actual)	Interventional	2011-05-23	Completed
Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus [NCT02863419]	Phase 3	711 participants (Actual)	Interventional	2016-08-10	Completed
In-market Utilisation of Liraglutide Used for Weight Management in Europe: a Retrospective Medical Record Review Study. [NCT02967757]		316 participants (Actual)	Observational	2016-12-22	Completed
Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion [NCT02231658]	Phase 1	109 participants (Actual)	Interventional	2015-07-16	Terminated(stopped due to Too challenging to recruit appropriate participants at an acceptable speed.)
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of RO6807952 in Type 2 Diabetic Patients Inadequately Controlled With Metformin Alone [NCT01516476]	Phase 2	2 participants (Actual)	Interventional	2011-11-30	Terminated
Effect of Liraglutide on Vascular Inflammation in Type-2 Diabetes: A Randomized, Placebo-controlled, Double-blind, Parallel Clinical PET/CT Trial The Liraflame Trial [NCT03449654]	Phase 4	102 participants (Actual)	Interventional	2017-10-26	Completed
Glycaemic and Cardiovascular Efficacy of Liraglutide in Prediabetic Patients With End-stage Renal Disease [NCT02284230]	Phase 2	0 participants (Actual)	Interventional	2014-12-31	Withdrawn(stopped due to Inability to recruit participants)
Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes. [NCT02109315]	Phase 1	0 participants (Actual)	Interventional	2014-05-31	Withdrawn
Effects of Liraglutide on Hippocampal Structure and Function in Aging Adults With Prediabetes [NCT02140983]	Phase 1	41 participants (Actual)	Interventional	2013-08-31	Completed
Efficacy of Liraglutide vs. Sitagliptin vs. Insulin Glargine Per Day on Liver Fat When Combined With Metformin in T2DM Subjects With Non-alcoholic Fatty-liver Disease [NCT02147925]	Phase 4	75 participants (Actual)	Interventional	2014-08-31	Completed
The Effect of Liraglutide on Pancreatic Hormones and Its Size [NCT03520062]		14 participants (Actual)	Interventional	2017-08-15	Completed
Intensive Lifestyle Modifications With or Without Liraglutide 3 mg Versus Sleeve Gastrectomy: A 3 Arm Randomized Controlled Pilot Study (LETHE) [NCT03534310]		75 participants (Actual)	Interventional	2015-11-02	Completed
Efficacy and Safety of Semaglutide 1.0 mg Once-weekly Versus Liraglutide 1.2 mg Once-daily as add-on to 1-3 Oral Anti-diabetic Drugs (OADs) in Subjects With Type 2 Diabetes [NCT03191396]	Phase 3	577 participants (Actual)	Interventional	2017-06-27	Completed
Is Pharmacological Treatment With the Glucagon-like Peptide-1 Receptor Agonist Liraglutide 3mg (Saxenda®) Once-daily a Viable Treatment for Weight Management in Forensic Psychiatry Patients? A Feasibility Study. [NCT04781998]	Phase 4	24 participants (Actual)	Interventional	2021-07-01	Completed
A Post Marketing Surveillance (PMS) Study of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India [NCT01212133]		1,386 participants (Actual)	Observational	2010-11-30	Completed
A Trial to Investigate Pharmacokinetics, Safety and Tolerability of Insulin Degludec/Liraglutide (A3) Compared With Insulin Degludec and Liraglutide in Healthy Subjects [NCT01319240]	Phase 1	24 participants (Actual)	Interventional	2011-03-31	Completed
Post-marketing Surveillance (Special Use-results Surveillance) on Use With Liraglutide (Victoza®) [NCT02321878]		1,092 participants (Actual)	Observational	2014-12-15	Completed
Treatment of Hypoglycemia Following Gastric Bypass Surgery [NCT02527993]	Phase 4	11 participants (Actual)	Interventional	2015-10-31	Completed
A Multi-centre, Prospective, Non-interventional Study Investigating the Effect of Victoza® in Patients With Type 2 Diabetes in Iran Followed in a Real World Setting [NCT03888157]		839 participants (Actual)	Observational	2019-03-10	Completed
A Randomized Controlled Study Assessing the Effect of Liraglutide on the Preservation of Beta-Cell Function in Patients With Type 2 Diabetes Mellitus: The LIraglutide and Beta-cell RepAir (LIBRA) Study [NCT01270789]	Phase 3	63 participants (Actual)	Interventional	2011-01-31	Completed
Incretin-based Therapy in Late Preclinical Type 1 Diabetes [NCT02898506]	Phase 2	13 participants (Actual)	Interventional	2016-03-31	Completed
Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults [NCT02611232]	Phase 2	42 participants (Anticipated)	Interventional	2015-12-31	Enrolling by invitation
Changes of Gut Microbiome Following Liraglutide Treatment in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, 28-week Trial [NCT04525300]	Phase 3	300 participants (Anticipated)	Interventional	2020-05-24	Recruiting
A Phase IIb, Randomised, Parallel, Double-Blind Placebo-Controlled and Open-Label Active Comparator Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes Mellitus [NCT03235050]	Phase 2	834 participants (Actual)	Interventional	2017-08-02	Completed
Central Nervous System Effects of Liraglutide® 3.0 mg on Reward Mechanisms in Obese Patients Without Diabetes, in Relation to Food Addiction. A Randomized, Single-centre, Double-blind, Placebo Controlled Clinical Trial. [NCT03347890]	Phase 4	70 participants (Actual)	Interventional	2018-03-05	Completed
Effects of Glucagon Like Peptide-1 on No-reflow in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention [NCT02507128]		190 participants (Anticipated)	Interventional	2015-07-31	Recruiting
A 6-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TWO-ARM, PARALLEL METHODOLOGY STUDY TO ASSESS THE EFFECT OF LIRAGLUTIDE ON FOOD INTAKE IN OBESE SUBJECTS [NCT03041792]	Phase 1	61 participants (Actual)	Interventional	2017-02-20	Completed
Liraglutide Effectiveness and Safety Data From Routine Clinical Practice in Philippines Study. A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes Mell [NCT01345734]		1,056 participants (Actual)	Observational	2011-09-01	Completed
Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes. [NCT00154401]	Phase 2	177 participants (Actual)	Interventional	2005-01-31	Completed
Comparative Study of Gustatory Performance, Sensory Specific Satiation, Liking and Wanting in Patients With Type 2 Diabetes [NCT02674893]	Phase 4	48 participants (Actual)	Interventional	2014-02-04	Terminated(stopped due to Exploratory protocol, convincing results, robust analysis)
Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery [NCT03048578]	Phase 4	132 participants (Actual)	Interventional	2017-05-22	Completed
The Effect of GLP-1 on Postprandial Glucagon Secretion During Prolonged and Intermittent Stimulation of the GLP-1 Receptor Independent of The Gastric Emptying Rate. A Randomized, Open-label Study in People With Type 1 Diabetes [NCT02584582]	Phase 2/Phase 3	10 participants (Anticipated)	Interventional	2015-07-31	Enrolling by invitation
A Multiple Dose Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity [NCT02870231]	Phase 1	187 participants (Actual)	Interventional	2016-08-18	Completed
Insulin Detemir Co-administered With Liraglutide: An Open Label Trial to Assess Insulin Detemir and Liraglutide Pharmacokinetics and Pharmacodynamics Following Liraglutide Therapy in Subjects With Type 2 Diabetes [NCT00873223]	Phase 1	33 participants (Actual)	Interventional	2009-03-31	Completed
Advantages of Liraglutide Mediated Through Its Effect on Clock Gene mRNA Expression [NCT02783196]		14 participants (Anticipated)	Interventional	2016-07-31	Not yet recruiting
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects. [NCT02235961]	Phase 1	163 participants (Actual)	Interventional	2014-09-04	Completed
The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis - a Single-center Randomized Controlled Study [NCT02765399]	Phase 4	23 participants (Actual)	Interventional	2015-02-01	Completed
The Effect of Liraglutide on Bone Turnover, Bone Mass and Bone Cell Function [NCT02473809]	Phase 4	60 participants (Actual)	Interventional	2015-08-31	Completed
Clinical Evaluation of Psoriatic Arthritis Treated With Liraglutide. The PLAQUE Study: Psoriatic Arthritis Treated With Liraglutide Therapy: a QUality of Life and Efficacy Study [NCT02472717]	Phase 2	0 participants (Actual)	Interventional	2015-05-31	Withdrawn
A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects [NCT03292185]	Phase 1	24 participants (Actual)	Interventional	2017-09-29	Completed
Human Bioequivalence Test of Liraglutide Injection [NCT05029076]	Phase 1	28 participants (Actual)	Interventional	2019-05-21	Completed
The Differential Effects of Diabetes Therapy on Inflammation [NCT02150707]		17 participants (Actual)	Observational	2014-05-31	Completed
Effects of the Glucagon Like-peptide 1 (GLP-1) Receptor Agonist Liraglutide on Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: a Randomized Controlled Trial [NCT04881110]	Phase 4	50 participants (Anticipated)	Interventional	2021-04-28	Recruiting
Harmonizing RCT-Duplicate Emulations: A Real World Replication Program Analyzing Three Clinical Trials, CANVAS, LEADER, and SAVOR TIMI in Type 2 Diabetes Mellitus [NCT06099067]		239,990 participants (Actual)	Observational	2020-05-15	Completed
Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira (REMIT IDegLira): A Randomized Controlled Trial [NCT03862716]	Phase 3	159 participants (Actual)	Interventional	2019-04-23	Completed
EFFECTIVENESS AND COST OF INTEGRATING A PROTOCOL WITH USE OF LIRAGLUTIDE 3.0 MG INTO AN OBESITY SERVICE: (STRIVE Study) [NCT03036800]	Phase 4	392 participants (Actual)	Interventional	2017-11-28	Active, not recruiting
Effects of Degludec/Liraglutide on Time in Range, Markers of Inflammation and Endothelial Dysfunction Compared to Scheme Insulin Basal Bolus, in a Population of Diabetic Inpatients and Possible Correlation With Intra-hospital Mortality Rates [NCT05360537]	Phase 4	100 participants (Actual)	Interventional	2021-04-01	Completed
A Randomized, Double-blinded, Single-centre, Parallel-group, Placebo-controlled, Prospective Trial of Neuroprotective Effect of Liraglutide for Treatment of Diabetic Neuropathy. [NCT02138045]		39 participants (Actual)	Interventional	2014-05-31	Completed
Use of a GLP-1R Agonist to Treat Opioid Use Disorder [NCT04199728]	Phase 1/Phase 2	27 participants (Actual)	Interventional	2021-10-18	Completed
A Retrospective, Multi-centre, Non-interventional Study Investigating the Clinical Parameters Associated With Saxenda® Use and Discontinuation in Patients in Turkey. INSPIRE Turkey (INvestigate the Impact of Saxenda® on Patient's Weight In a REal World Se [NCT05438186]		0 participants (Actual)	Observational	2022-09-01	Withdrawn(stopped due to No participants enrolled since study start.)
Liraglutide Actions on the Liver: Effects on Glucose Phosphorylation [NCT02198209]	Phase 4	0 participants (Actual)	Interventional	2019-12-31	Withdrawn(stopped due to Investigator decided not to move forward with study prior to study start date)
The Effect of Liraglutide on MMC Activity, Gastrointestinal Hormones, Hunger Ratings and ad Libitum Food Intake in Healthy Volunteers [NCT04008290]	Phase 4	15 participants (Anticipated)	Interventional	2020-04-01	Not yet recruiting
Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes [NCT00393718]	Phase 3	400 participants (Actual)	Interventional	2006-11-30	Completed
Effect of Liraglutide in Combination With Sulfonylurea (SU) on Glycaemic Control in Subjects With Type 2 Diabetes [NCT00395746]	Phase 3	264 participants (Actual)	Interventional	2006-10-31	Completed
Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes [NCT00993720]	Phase 2/Phase 3	30 participants (Actual)	Interventional	2009-10-31	Completed
Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes and Inadequate Glycemic Control Treated With Lifestyle Modification and Oral Antidiabetic Medications [NCT01029886]	Phase 3	912 participants (Actual)	Interventional	2010-01-31	Completed
Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin: Results From a Randomized Double Blinded Clinical Trial [NCT04829903]		116 participants (Actual)	Interventional	2020-01-02	Completed
Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients [NCT02324842]		45 participants (Actual)	Interventional	2014-11-30	Completed
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years [NCT02696148]	Phase 1	24 participants (Actual)	Interventional	2016-03-14	Completed
Clinical Study on the Improvement of Diabetic Neuropathic Pain by Liraglutide [NCT04137328]		60 participants (Anticipated)	Interventional	2019-11-30	Not yet recruiting
Liraglutide: A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety/Tolerability, Pharmacokinetics & Pharmacodynamics of Liraglutide in Pediatric (10-17 Years Old) With Type 2 Diabetes [NCT00943501]	Phase 1	21 participants (Actual)	Interventional	2009-11-30	Completed
Effect of Liraglutide on Fatty Liver Content Evaluated by Proton-spectroscopy (1H-spectroscopy) and Lipoprotein Kinetic, in Patients With Type 2 Diabetes [NCT02721888]	Phase 4	120 participants (Anticipated)	Interventional	2012-07-31	Recruiting
Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans [NCT02718950]	Phase 3	20 participants (Anticipated)	Interventional	2016-06-30	Not yet recruiting
A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects [NCT02717858]	Phase 1	52 participants (Actual)	Interventional	2016-03-16	Completed
Effectiveness of the Combination Liraglutide and Metformin on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With Polycystic Ovarian Syndrome, Obesity and Infertility [NCT05952882]	Phase 3	188 participants (Anticipated)	Interventional	2023-11-01	Not yet recruiting
Effects of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With Type 2 Diabetes [NCT02650596]		68 participants (Anticipated)	Interventional	2016-01-31	Recruiting
Effect of Liraglutide on Macrophage Polarization in Human Adipose Tissue and Peripheral Blood [NCT02650206]	Phase 1	56 participants (Actual)	Interventional	2015-01-31	Completed
A Novel Preoperative Conditioning Therapy in Giant Obese Patients With the Combination of Liraglutide and a Leucine-Based Amino-Acid Infusion and Caloric Restriction [NCT02616003]	Phase 4	50 participants (Actual)	Interventional	2014-04-30	Completed
Influence of Liraglutide on Diastolic Cardiac Function and Myocardial Perfusion as Determined by Magnetic Resonance Imaging in Patients With Type 2 Diabetes: a Double-blind Randomized Parallel-group Trial [NCT02655770]	Phase 4	40 participants (Actual)	Interventional	2016-02-29	Completed
Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes [NCT00518882]	Phase 3	467 participants (Actual)	Interventional	2007-08-31	Completed
Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients [NCT03986008]	Phase 3	60 participants (Anticipated)	Interventional	2019-12-01	Recruiting
"Incretin and Treatment With Inhibition of Sodium-glucose Cotransporter-2 Combination Insights Into Mechanisms Implicated in Congestive Heart Failure: NATRIURETIC Trial" [NCT04535960]	Phase 2	36 participants (Anticipated)	Interventional	2019-01-24	Recruiting
A Trial to Test for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9068 and Compared With NN1250 and NN2211 in Healthy Subjects [NCT00983021]	Phase 1	24 participants (Actual)	Interventional	2009-09-30	Completed
Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus [NCT05360147]	Phase 3	30 participants (Actual)	Interventional	2021-01-20	Completed
Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice [NCT02255266]		1,788 participants (Actual)	Observational	2015-03-26	Completed
Synergy Effect of the Appetite Hormone GLP-1 (LiragluTide) and Exercise on Maintenance of Weight Loss and Health After a Low Calorie Diet - the S-LiTE Randomized Trial [NCT04122716]	Phase 4	215 participants (Actual)	Interventional	2016-09-30	Active, not recruiting
The Correlation Between Par-4 and Telomere-telomerase System in the New Dignosised Type 2 Diabetes Patients Who Received GLP-1 Analog or Metformin Treatment [NCT02535299]	Phase 4	200 participants (Anticipated)	Interventional	2016-06-30	Recruiting
Investigation of Safety and Efficacy of Five Doses of Semaglutide Versus Placebo and Open-label Liraglutide, as Add on Therapy, in Subjects Diagnosed With Type 2 Diabetes Currently Treated With Metformin or Controlled With Diet and Exercise A 12 Week Mult [NCT00696657]	Phase 2	415 participants (Actual)	Interventional	2008-06-03	Completed
A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events [NCT01179048]	Phase 3	9,341 participants (Actual)	Interventional	2010-08-31	Completed
Effect of GLP-1 on Angiogenesis, Angiosafe Type 2 Diabetes Study 1 [NCT02686177]	Phase 4	50 participants (Actual)	Interventional	2016-05-18	Completed
Effects of Liraglutide on Left Ventricular Function in Patients With Non-ST-Segment Elevation Myocardial Infarction [NCT02577848]		90 participants (Anticipated)	Interventional	2015-10-31	Recruiting
A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus [NCT01128894]	Phase 3	841 participants (Actual)	Interventional	2010-05-31	Completed
Effect of Liraglutide on Long-term Weight Maintenance and Additional Weight Loss Induced by a 4 to 12 Week Low Calorie Diet in Obese Subjects; A 56 Week Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial With a 12 Week Follow- [NCT00781937]	Phase 3	422 participants (Actual)	Interventional	2008-10-30	Completed
Antiproteinuric Effects of Liraglutide Treatment in Patients With Type 2 Diabetes and Albuminuria: A Randomised, Placebo-Controlled Trial [NCT02545738]	Phase 4	32 participants (Actual)	Interventional	2015-04-30	Completed
Comparison of Type 2 Diabetes Pharmacotherapy Regimens Using Targeted Learning [NCT05073692]		270,000 participants (Anticipated)	Observational	2021-07-01	Recruiting
A 24-week, Multicenter, International, Randomized (1:1), Parallel-group, Open-label, Comparative Study of Insulin Glargine Versus Liraglutide in Insulin-naïve Patients With Type 2 Diabetes Treated With Oral Agents and Not Adequately Controlled, Followed b [NCT01117350]	Phase 4	978 participants (Actual)	Interventional	2010-07-31	Completed
A Phase 1 Study of Liraglutide Injection and Victoza® in Healthy Chinese Subjects: An Open, Randomized, Single-Dose and Crossover Study [NCT05225974]	Phase 1	32 participants (Actual)	Interventional	2021-07-16	Completed
Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes vs Best Medical Treatment [NCT02041234]	Phase 4	40 participants (Anticipated)	Interventional	2014-02-28	Completed
Neurodegenerative Changes in Alzheimer's Disease: Identifying Potential Effects of Liraglutide on Degenerative Changes [NCT01469351]		34 participants (Actual)	Interventional	2012-01-31	Completed
Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the Pharmacodynamic Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Once-Weekly Subcutaneous Dosing in Adul [NCT01658501]	Phase 2	593 participants (Actual)	Interventional	2012-07-31	Completed
Phase 1/ Phase 2 Study of the Therapeutic Effect of Ex-vivo Expanded Umbilical Cord Blood Regulatory T Cells With Liraglutide on Autoimmune Diabetes [NCT03011021]	Phase 1/Phase 2	40 participants (Anticipated)	Interventional	2017-01-31	Recruiting
Safety and Effect of Liraglutide in Patients With Type 2 Diabetes and Severe Renal Insufficiency [NCT01394341]	Phase 4	40 participants (Actual)	Interventional	2011-09-30	Completed
Endoscopic Ultrasound Guided Gastric Botulinum Toxin Injections Versus Glucagon Like Peptide 1 Receptor Agonist in Weight Loss [NCT05268627]		38 participants (Anticipated)	Interventional	2022-01-27	Recruiting
Effect of Liraglutide on Glycemic Control, Glucagon Secretion and Inflammatory Markers in Adolescents With Type 1 Diabetes Mellitus [NCT02516657]	Phase 3	5 participants (Actual)	Interventional	2012-05-31	Active, not recruiting
Randomized Trial of Liraglutide and Insulin Therapy on Hepatic Steatosis as Measured by MRI and MRS in Metformin-treated Patients With Type 2 Diabetes: an Open Pilot Study [NCT01399645]	Phase 2	35 participants (Actual)	Interventional	2011-05-31	Completed
A Multi-centre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Victoza® in Subjects With Type 2 Diabetes Mellitus [NCT01403025]		4,121 participants (Actual)	Observational	2011-07-19	Completed
PILGRIM - Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus Type II [NCT02036372]		150 participants (Actual)	Interventional	2014-01-31	Completed
Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in a Sub Saharan African Population With Type 2 Diabetes [NCT02832999]	Phase 4	14 participants (Actual)	Interventional	2016-01-31	Completed
A Dose Escalation Study to Investigate the Pharmacokinetics, Tolerability and Safety of Liraglutide After Multiple s.c. Doses in Healthy Chinese Male Subjects [NCT00761540]	Phase 1	37 participants (Actual)	Interventional	2008-10-31	Completed
A Trial to Assess the Effect of Liraglutide on Postprandial Triglyceride Levels in Subjects With Type 2 Diabetes [NCT00993304]	Phase 1	20 participants (Actual)	Interventional	2009-10-31	Completed
Effects of Single Doses of Liraglutide and Dapagliflozin on Hyperglycemia and Ketogenesis in Type 1 Diabetes [NCT02777073]	Phase 3	2 participants (Actual)	Interventional	2016-03-31	Completed
Effect of Glucagon-like Peptide-1 Stimulation on Coronary Microvascular Dysfunction in Women With Angina Pectoris and no Obstructive Stenosis of Major Coronary Vessels [NCT02602600]	Phase 4	33 participants (Actual)	Interventional	2015-11-19	Completed
Effect of GLP-1 on Microvascular Myocardial Function in Patients With Type 2 [NCT01931982]	Phase 4	20 participants (Actual)	Interventional	2013-05-31	Completed
Impact of Liraglutide on Cardiac Function and Structure in Young Adults With Type 2 Diabetes: an Open-label, Randomised Active-comparator Trial [NCT02043054]	Phase 3	90 participants (Actual)	Interventional	2013-12-16	Completed
Could Gut Microbiome Contribute to the Therapeutic Effect of Liraglutide 3.0 mg? A Randomized Double Blind Placebo Controlled Trial [NCT04046822]	Phase 4	70 participants (Anticipated)	Interventional	2019-01-09	Recruiting
A Randomised, Placebo-controlled, Double-blind, Incomplete Cross-over Design Trial to Evaluate the Effects of Liraglutide on Gastric Emptying, Energy Expenditure and Appetite, and to Evaluate Liraglutide Pharmacokinetics in Non-diabetic Obese Subjects [NCT00978393]	Phase 1	49 participants (Actual)	Interventional	2009-09-16	Completed
Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis Following Liraglutide Treatment, Investigating the Impact on Inflammation [NCT02928679]	Phase 4	150 participants (Anticipated)	Interventional	2016-11-30	Completed
Effects of Exercise and GLP-1 Agonism on Muscle Microvascular Perfusion and Insulin Action in Adults With Metabolic Syndrome [NCT04575844]	Phase 4	80 participants (Anticipated)	Interventional	2020-11-01	Recruiting
Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes: A 20-week Randomised, Double-blind, Placebo-controlled, Six Armed Parallel Group, Multi-centre, Multinational Trial With an Open Label Orlistat Comparator Arm and With an 84-week Ext [NCT00422058]	Phase 2	564 participants (Actual)	Interventional	2007-01-10	Completed
Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes [NCT00294723]	Phase 3	746 participants (Actual)	Interventional	2006-02-28	Terminated(stopped due to The trial was terminated at week 195 due to an insufficient number of subjects remaining to obtain reasonable statistical power)
A Randomised, Double-blind, Placebo-controlled Study of the Effect of LIraglutide on Left VEntricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes (The LIVE-study) [NCT01472640]		240 participants (Actual)	Interventional	2011-11-30	Completed
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Trial of Liraglutide Treatment in Subjects With Newly Diagnosed Type 1 Diabetes. [NCT01879917]	Phase 2/Phase 3	65 participants (Actual)	Interventional	2014-02-28	Completed
Short-term Combined Treatment With Liraglutide and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome and Previous Poor Response to Metformin [NCT01911468]	Phase 4	36 participants (Actual)	Interventional	2011-11-30	Completed
A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects [NCT01916174]	Phase 1	50 participants (Actual)	Interventional	2013-08-31	Completed
Effects of KATP Channel Blockers on GLP-1 and Its Analogues' Mediated Microvascular Function [NCT01934816]		2 participants (Actual)	Interventional	2013-06-30	Terminated(stopped due to Technical Issues with intervention)
A Randomized, Placebo-Controlled Study of Liraglutide 3mg Daily (Saxenda®) in Obese or Overweight Patients With Stable Bipolar Disorder [NCT03158805]	Phase 2	60 participants (Actual)	Interventional	2017-04-26	Completed
Effect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007) [NCT03883412]	Phase 4	60 participants (Anticipated)	Interventional	2019-02-28	Recruiting
Protective Effect of Glucagonlike Peptide-1 on Reperfusion Injury in Patients With Acute Myocardial Infarction [NCT02001363]		90 participants (Anticipated)	Interventional	2013-11-30	Recruiting
Effect of Liraglutide on Different Parameters (Clinical , Metabolic and Hormonal) in Obese Women With Polycystic Ovary Syndrome [NCT05965908]	Phase 3	120 participants (Anticipated)	Interventional	2023-07-30	Not yet recruiting
Therapeutic Targets in African-American Youth With Type 2 Diabetes [NCT02960659]	Phase 1/Phase 2	24 participants (Actual)	Interventional	2017-05-09	Completed
[NCT02016846]	Phase 3	36 participants (Anticipated)	Interventional	2014-01-31	Not yet recruiting
Cardiovascular and Metabolic Effects of Drugs for the Treatment of Obesity [NCT04575194]	Phase 4	40 participants (Anticipated)	Interventional	2020-09-08	Recruiting
Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus and South Asian Descent [NCT02660047]	Phase 4	51 participants (Actual)	Interventional	2015-08-31	Completed
Effect and Safety of Liraglutide 3.0 mg on Weight Management in Children With Obesity Aged 6 to Below 12 Years: 56-week, Double-blind, Randomised, Placebo-controlled Trial [NCT04775082]	Phase 3	78 participants (Anticipated)	Interventional	2021-03-04	Active, not recruiting
Glucagon-like Peptide-1 Receptor Agonists as Novel Pharmacotherapies for Nicotine Dependence [NCT03712098]	Phase 2	40 participants (Actual)	Interventional	2018-11-29	Completed
An Open-label, Randomized Two-arm Parallel Group Study to Compare the Effects of 4-week QD Treatment With Lixisenatide or Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin [NCT01175473]	Phase 2	148 participants (Actual)	Interventional	2010-08-31	Completed
The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes. A 26 Week, Randomised, Open-label, Parallel-group, Multicentre, Multinational Trial With a 26 Week Extensio [NCT00856986]	Phase 3	987 participants (Actual)	Interventional	2009-03-31	Completed
A European Multi-centre, Retrospective, Non-interventional Study of the Effectiveness of Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus [NCT02754817]		611 participants (Actual)	Observational	2016-04-26	Completed
Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity [NCT03523273]	Phase 2	136 participants (Actual)	Interventional	2017-11-29	Completed
A 52 Week Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multi-Center, Multinational Trial In Islet Cell Transplant Subjects With Type 1 Diabetes Mellitus To Determine If The Early Use Of Liraglutide As An Adjunct To Standard Care Increases [NCT01206101]	Phase 2	3 participants (Actual)	Interventional	2012-03-21	Terminated(stopped due to The decision to close the NN2211-3619 trial was based on the very low recruitment rate as well as challenges relating to trial execution and study completion.)
Comparing Effects of Liraglutide and Bariatric Surgery on Weight Loss, Liver Function, Body Composition, Insulin Resistance, Endothelial Function and Biomarkers of Non-alcoholic Steatohepatitis (NASH) in Obese Asian Adults [NCT02654665]	Phase 3	36 participants (Anticipated)	Interventional	2014-03-31	Recruiting
Effects of Intervention With the Glucagon-like Peptide 1 (GLP-1) Analog Liraglutide Plus Metformin Versus Metformin Monotherapy in Overweight/Obese Women With Metabolic Defects and Recent History of Gestational Diabetes Mellitus (GDM) [NCT01234649]	Phase 3	153 participants (Actual)	Interventional	2011-08-11	Completed
Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity. [NCT03500484]	Phase 2	14 participants (Actual)	Interventional	2018-06-06	Completed
Liraglutide for Low-responders After Bariatric Surgery [NCT04643301]		0 participants (Actual)	Interventional	2020-12-21	Withdrawn(stopped due to Cancellation by sponsor)
The Effect of Liraglutide on Insulin-associated wEight GAiN in Patients With Type 2 Diabetes Mellitus (ELEGANT Trial) [NCT01392898]		50 participants (Actual)	Interventional	2012-02-29	Active, not recruiting
A Phase Ib, Multicenter, Placebo and Active- Comparator-Controlled, Randomized, Double-Blind, Clinical Trial to Evaluate the Safety and Efficacy of MK-8521 Compared to Placebo and a Diabetes Drug in Subjects With Type 2 Diabetes Mellitus [NCT01982630]	Phase 1	87 participants (Actual)	Interventional	2013-11-07	Completed
Effects on Subclinical Heart Failure in Type 2 Diabetic Subjects on Liraglutide Treatment Versus Glimepiride Both in Combination With Metformin [NCT01425580]	Phase 2	62 participants (Actual)	Interventional	2012-01-31	Completed
An ObEsity-centric Approach With and Without Anti-obesity Medications ComPared to the Usual-care ApprOach to Management of Patients With Obesity and Type 2 Diabetes in an Employer Setting: A Pragmatic Randomized Controlled Trial [NCT04531176]	Phase 4	69 participants (Actual)	Interventional	2020-09-01	Active, not recruiting
The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus: A 12-week Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-center Trial With an Open-label Glimepiride Arm [NCT00620282]	Phase 3	49 participants (Actual)	Interventional	2008-02-29	Completed
Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes [NCT00614120]	Phase 3	929 participants (Actual)	Interventional	2008-01-31	Completed
A Randomized, Double-blinded Placebo-controlled, Paralleled Designed, Investigator Sponsored Study of the Effect of the GLP-1 Receptor Agonist Liraglutide on Beta-cell Function in C-peptide Positive Type 1 Diabetic Patients [NCT02617654]	Phase 2	18 participants (Actual)	Interventional	2015-11-30	Completed
Effects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus [NCT05779644]		300 participants (Anticipated)	Interventional	2023-02-23	Recruiting
A Prospective, Randomized, Open Label, Parallel, 12-month Study to Explore and Evaluate the Therapeutic Effects ofLiraglutide, Empagliflozin and Linagliptin on the Cognitive Function, Olfactory Function, and Odor-induced Brain Activation in T2DM Patients [NCT05313529]		324 participants (Anticipated)	Interventional	2022-10-08	Recruiting
Feasibility Study of GLP-1 Analogues for the Optimization of Outcomes in High BMI Patients Undergoing AbLation for Atrial Fibrillation [NCT05221229]		30 participants (Anticipated)	Observational	2022-04-17	Recruiting
"The Association Between Weight Loss With Subsequent Maintenance Using Liraglutide and Changes in Skin Autoflouresence in Overweight or Obese Patients With Knee Osteoarthritis - a Substudy to Effect of Liraglutide on Body Weight and Pain in Overweight or [NCT02910570]	Phase 4	150 participants (Anticipated)	Interventional	2016-11-30	Completed
Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis Following Liraglutide Treatment, Investigating the Impact on Inflammation [NCT02931383]	Phase 4	150 participants (Anticipated)	Interventional	2016-11-30	Completed
Liraglutide Efficacy and Action on Type 2 Diabetes With Peripheral Atherosclerotic intErmittent Claudication (LEADPACE STUDY): a Prospective, 24-week, Multicenter, Randomized, Controlled Clinical Study [NCT04146155]	Phase 4	200 participants (Anticipated)	Interventional	2020-05-01	Recruiting
Multicentre Randomized Double Blind, Crossover, Placebo Controlled Clinical Trial to Evaluate the Effect of Liraglutide on Lung Function in Patients With Type 2 Diabetes Mellitus (LIRALUNG Study) [NCT02889510]	Phase 3	76 participants (Actual)	Interventional	2016-10-04	Completed
Combining Lifestyle Modification and Liraglutide to Improve Weight Loss and Health Outcomes [NCT02911818]	Phase 4	150 participants (Actual)	Interventional	2016-09-30	Completed
The Use of Incretin-based Drugs and the Risk of Pancreatic Cancer in Patients With Type 2 Diabetes [NCT02475499]		886,172 participants (Actual)	Observational	2014-03-31	Completed
Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus: A Prospective, Multicenter, Randomized, Blank-controlled，Blinded End-point Study. [NCT03948347]		1,708 participants (Anticipated)	Interventional	2019-06-25	Recruiting
A Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing the Efficacy and Safety of a Sitagliptin-Based Treatment Paradigm to a Liraglutide-Based Treatment Paradigm in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Co [NCT01296412]	Phase 3	653 participants (Actual)	Interventional	2011-03-11	Completed
To Predict Weight Loss Response to Liraglutide (Saxenda®), From fMRI-based Determination of Food Cue Reactivity [NCT03795701]		73 participants (Actual)	Interventional	2019-01-08	Completed
Randomized Clinical Trial to Evaluate The Effect of Metformin-GLP-1 Receptor Agonist Versus Oral Contraceptive (OC) Therapy on Reproductive Disorders and Cardiovascular Risks in Overweight Polycystic Ovarian Syndrome (PCOS) Patients [NCT03151005]	Phase 4	70 participants (Actual)	Interventional	2017-07-01	Completed
Chinese People's Liberation Army General Hospital [NCT02930265]		400 participants (Anticipated)	Interventional	2016-09-30	Enrolling by invitation
Reduction of Antigen-Lipid-Driven Monoclonal Gammopathies by Targeting Epicardial Fat and Its Lipids Content With Liraglutide: A Glucagon Like Peptide-1 Receptor Analogue (GLP-1RA) [NCT02920190]	Phase 4	0 participants (Actual)	Interventional	2020-09-01	Withdrawn(stopped due to Lack of funds to cover the costs of the study medications)
Liraglutide in Type 1 Diabetes [NCT01722240]	Phase 3	96 participants (Actual)	Interventional	2012-11-30	Completed
Megestrol Acetate Versus Liraglutide Plus Megestrol Acetate in Obese Women With Endometrial Atypical Hyperplasia: A Randomized Controlled Pilot Clinical Study [NCT04683237]	Phase 2/Phase 3	0 participants (Actual)	Interventional	2021-03-20	Withdrawn(stopped due to Based on our latest research results, we will revise the protocol and design a better study. Since no participants are enrolled till now, we withdraw this study.)
Efficacy of Liraglutide Therapy in Patients With an Ileal -Pouch Anal Anastomosis (IPAA) and Chronic High Bowel Frequency [NCT04763564]	Phase 2	8 participants (Actual)	Interventional	2022-03-22	Completed
Biomarkers in Obese Patients With Knee Osteoarthritis Following Long-term Weight Maintenance [NCT02928614]	Phase 4	150 participants (Anticipated)	Interventional	2016-11-30	Completed
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase 2a Study With an Open-Label Active Group to Assess the Efficacy and Safety of Once-Daily NNC0090-2746 in Type 2 Diabetic Patients Inadequately Controlled With Metformin [NCT02205528]	Phase 2	108 participants (Actual)	Interventional	2014-08-18	Completed
A Phase II, 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, International Trial to Assess the Effect on Glycaemic Control of Five Doses of HM11260C Versus Placebo or Open-label Liraglutide in Subjects With Type 2 Diabetes [NCT02057172]	Phase 2	254 participants (Actual)	Interventional	2014-01-31	Completed
[NCT02909933]	Phase 4	30 participants (Actual)	Interventional	2015-07-31	Completed
Effects of Liraglutide on Cognition, Chronic Inflammation and Glycemic Control in Overweight and Obese, HIV-infected Subjects With Type 2 Diabetes. [NCT02743598]	Phase 4	4 participants (Actual)	Interventional	2016-09-30	Terminated(stopped due to Lack of funding and time)
Effect of Tirzepatide on Energy Intake and Appetite-and Reward-Related Brain Areas in Overweight/Obese Subjects: A Placebo-Controlled 6-Week Study With Functional MRI [NCT04311411]	Phase 1	114 participants (Actual)	Interventional	2020-08-24	Completed
Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity [NCT02647944]	Phase 2	40 participants (Actual)	Interventional	2015-12-18	Completed
A Phase III,Randomized,Parallel,Open-label,Multicenter Trial to Compare the Efficacy and Safety of Liraglutide and Victoza® in Patients With Type 2 Diabetes Inadequately Controlled by Oral Metformin Alone [NCT04373967]	Phase 3	424 participants (Anticipated)	Interventional	2020-04-29	Recruiting
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 Diabetes Mellitus in Routine Clinical [NCT03070704]		0 participants (Actual)	Observational	2017-08-16	Withdrawn(stopped due to Request for the study waived by Indian Health Authorities)
Short Term Weight Loss With Liraglutide and Metformin Before IVF in Infertile Obese PCOS Patients [NCT03034941]	Phase 4	35 participants (Actual)	Interventional	2014-04-30	Completed
The Influence of Appetite-Related Central and Gut Hormones in Modulating Binge Eating Behaviour in Obese and Overweight Healthy Subjects [NCT01739049]	Phase 4	42 participants (Actual)	Interventional	2012-11-30	Completed
Risk of Hypoglycemia in the Transition From Inpatient to Outpatient Setting. Comparative Study of Basal-bolus Insulin Versus Basal Insulin Plus GLP-1 Analogue [NCT05767255]	Phase 3	66 participants (Anticipated)	Interventional	2022-12-01	Recruiting
Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2 [NCT01484262]		1,344 participants (Actual)	Observational	2011-11-14	Completed
A Phase 2, Open-label, Randomised, Dose-Finding Study of XW003, Once-Weekly Human Glucagon-Like Peptide 1 Analogue, Compared With Once-Daily Liraglutide 3 mg in Adult Participants With Obesity [NCT05111912]	Phase 2	206 participants (Actual)	Interventional	2021-11-30	Completed
Effect on Glycemic Control of Liraglutide in Combination With Rosiglitazone Plus Metformin Versus Rosiglitazone Plus Metformin in Subjects With Type 2 Diabetes [NCT00333151]	Phase 3	576 participants (Actual)	Interventional	2006-05-31	Completed
Examining the Utility of GLP-1 Agonists as Neuroprotective Agents Through a Pilot Clinical Trial in High Risk Population With Neurocognitive Deficits and Obesity [NCT06171152]	Early Phase 1	30 participants (Anticipated)	Interventional	2024-04-01	Not yet recruiting
Novel Medical Adjunctive Therapy to Catheter Ablation For Atrial Fibrillation (AF) [NCT03856632]	Phase 4	60 participants (Actual)	Interventional	2019-03-18	Active, not recruiting
Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake [NCT01232946]		30 participants (Actual)	Interventional	2012-01-31	Completed
NNC 90-1170 Mechanism of Action: A Single-centre, Randomised, Double-blind, Parallel-group, Placebo-controlled Trial Evaluating the Effect of NNC 90-1170 on Weight and Appetite in Obese Subjects With Type 2 Diabetes [NCT01508949]	Phase 2	35 participants (Actual)	Interventional	2001-06-30	Completed
A Randomised, Double-blind, Placebo-controlled, Dose-escalation, Parallel-group, Single and Multiple Dosing Trial of NN90-1170 in Healthy Volunteers and Patients With Type 2 Diabetes to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics [NCT01507285]	Phase 1	24 participants (Actual)	Interventional	1999-08-31	Completed
Effect of Liraglutide on Body Weight and Pain in Overweight or Obese Patients With Knee Osteoarthritis: A Randomised, Double Blind, Placebo-controlled, Parallel Group, Single-centre Trial [NCT02905864]	Phase 4	150 participants (Anticipated)	Interventional	2016-11-30	Completed
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec / Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Ro [NCT04952779]		750 participants (Anticipated)	Observational	2021-06-02	Enrolling by invitation
Effect of Laparoscopic Sleeve Gastrectomy and Liraglutide on Glucose Homeostasis and Intrapancreatic Fat in Obese Patients [NCT04325581]	Phase 3	16 participants (Actual)	Interventional	2016-08-01	Completed
A 4 Week Single Center, Double-dummy, Randomised Double-blind, Balanced Incomplete Latin Square Design Study to Evaluate the Effects of Liraglutide on Appetite in Subjects With Type 2 Diabetes Compared to Glimepiride and Placebo [NCT01511692]	Phase 1	43 participants (Actual)	Interventional	2005-11-30	Completed
A Randomised, Open-label, Single Centre, Three Period Cross-over Trial in Healthy Subjects Comparing the Pharmacokinetic Profiles After Single Dose Administration of Liraglutide at Three Different Injection Sites [NCT01513525]	Phase 1	21 participants (Actual)	Interventional	2007-02-28	Completed
A Randomised, Double-blind, Single-centre, Three-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Each of the Two New Liraglutide Formulations at pH 7.9 and 8.15 and the Planned Phase 3 Formulation at pH 7.7 [NCT01514487]	Phase 1	24 participants (Actual)	Interventional	2005-01-13	Completed
A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 3a Formulation of Liraglutide (Formulation 4) and the Planned Phase 3b Formulation (Final Formulation 4) [NCT01515553]	Phase 1	22 participants (Actual)	Interventional	2007-01-31	Completed
A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 2 Formulation of Liraglutide at pH 7.7 (Formulation 3) and the Phase 3 Formulation at pH 8.15 (Formulation 4) [NCT01515579]	Phase 1	22 participants (Actual)	Interventional	2006-04-30	Completed
A Randomised, Double-blind Within Dose Group, Single Centre, Placebo-controlled, Dose Escalation, Multiple s.c. Dose Study to Assess the Safety and Tolerability of Liraglutide 20 ug/kg and 25 ug/kg in Healthy Japanese Male Subjects [NCT01515592]	Phase 1	24 participants (Actual)	Interventional	2006-01-31	Completed
A Thorough QTc Evaluation of the Effect of Liraglutide on Cardiac Repolarization in Healthy Volunteers: A Randomized, Double-blind, Placebo-controlled, Two Period Crossover Study Followed by Open-label Moxifloxacin (Positive Control) Administration [NCT01516255]	Phase 1	64 participants (Actual)	Interventional	2006-07-31	Completed
A Single Centre, Randomised, Double-blind, Placebo Controlled Trial to Evaluate the Possible Drug-drug Interaction Between Liraglutide and Paracetamol and the Effects of Liraglutide on Postprandial Glucose and Insulin, Gastric Emptying, Appetite Sensation [NCT01517555]	Phase 1	18 participants (Actual)	Interventional	2006-10-31	Completed
A Single-Centre, Open Label Trial Investigating the Metabolites in Plasma, Urine and Faeces After a Single Subcutaneous Dose of [3H]-Liraglutide to Healthy Subjects [NCT01517568]	Phase 1	7 participants (Anticipated)	Interventional	2006-11-30	Completed
A Two-way Cross-over, Placebo-controlled Interaction Trial in Two Parts (in Healthy Subjects), Studying Liraglutide's Potential Influence on the Absorption Pharmacokinetics of Lisinopril, Atorvastatin, Griseofulvin and Digoxin, and Liraglutide's Potential [NCT01518166]	Phase 1	70 participants (Actual)	Interventional	2006-05-31	Completed
The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes [NCT01536665]	Phase 1	45 participants (Actual)	Interventional	2012-02-29	Completed
Liraglutide Effects on Memory in Healthy Subjects [NCT01550653]	Phase 1	40 participants (Actual)	Interventional	2012-05-31	Completed
A Randomized, Open-label, Cross-over Study to Evaluate Patient Preferences for Eucreas® Versus Victoza® as add-on to Metformin in Type 2 Diabetes Mellitus Patients Who Did Not Have Adequate Glycaemic Control With Metformin. [NCT01518101]	Phase 4	62 participants (Actual)	Interventional	2012-01-31	Completed
Liraglutide 3.0mg/d for the Treatment of Binge Eating Disorder [NCT03279731]	Phase 3	36 participants (Actual)	Interventional	2017-09-29	Terminated(stopped due to The study was not meeting recruitment goals.)
[NCT01542242]	Phase 4	1 participants (Actual)	Interventional	2012-02-29	Terminated(stopped due to Subject withdrew)
A Randomised, Double-blind Within Dose Group, Single-centre, Placebo-controlled, Parallel 2-different Dose Group, 14-day Multiple s.c. Doses Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Liraglutide (NNC 90-1170) in Subjects With Ty [NCT01615978]	Phase 1	15 participants (Actual)	Interventional	2003-12-31	Completed
The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Ext [NCT00700817]	Phase 3	665 participants (Actual)	Interventional	2008-06-30	Completed
Effect of Liraglutide on Glycaemic Control in Japanese Subjects With Type 2 Diabetes. [NCT00154414]	Phase 2	226 participants (Actual)	Interventional	2005-01-31	Completed
A Phase Ib/IIa, Single Ascending Dose Study of the Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus [NCT05268237]	Phase 1/Phase 2	15 participants (Anticipated)	Interventional	2023-04-25	Recruiting
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3325656 After Single Dose in Healthy Subjects and Patients With Type 2 Diabetes [NCT03115099]	Phase 1	80 participants (Actual)	Interventional	2017-05-31	Completed
A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants With Type 1 Diabetes [NCT05794581]	Phase 1	24 participants (Anticipated)	Interventional	2023-03-21	Recruiting
The Microvascular Function of GLP-1 and Its Analogues in Humans, in Vivo: the Role of DPP-IV Inhibition [NCT01677104]		63 participants (Anticipated)	Interventional	2012-08-31	Completed
Efficacy and Safety of Liraglutide-bolus (Liraglutide Plus Prandial Insulin) Versus Glargine-bolus Therapy in Overweight / Obese Patients With Uncontrolled Type 2 Diabetes (LiraGooD)--A Multicenter Randomized Controlled Study [NCT03087032]	Phase 4	140 participants (Anticipated)	Interventional	2019-01-10	Recruiting
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study [NCT05220917]		781,430 participants (Anticipated)	Observational	2021-08-01	Active, not recruiting
LIRAGLUTIDE IN OVERWEIGHT PATIENTS WITH TYPE 1 DIABETES [NCT01753362]	Phase 3	84 participants (Actual)	Interventional	2012-12-31	Completed
Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes. [NCT01787916]	Phase 4	15 participants (Actual)	Interventional	2013-04-30	Completed
Antidiabetic Effects of Adding a DPP-4 Inhibitor (Sitagliptin) to Pre-Existing Treatment With an Incretin Mimetic (Liraglutide) in Patients With Type 2 Diabetes Treated With Metformin [NCT01937598]	Phase 3	16 participants (Actual)	Interventional	2013-08-31	Completed
Clinical and Histopathological Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients [NCT01687582]		10 participants (Actual)	Interventional	2012-01-31	Completed
Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes [NCT01499108]	Phase 4	32 participants (Actual)	Interventional	2012-08-31	Completed
A Multicenter Prospective Non-interventional Study Investigating the Treatment Effect of Xultophy® Intensification in a Real World Population With Type 2 Diabetes in United Arab Emirates [NCT03823339]		300 participants (Actual)	Observational	2019-01-29	Completed
A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Doses of NNC90-1170 to Assess Tolerability, Pharmacokinetics, Pharmacodynamics and Absolute Bioavailability in Healthy Male Subjects [NCT01507272]	Phase 1	34 participants (Actual)	Interventional	1999-03-31	Completed
Effect of NNC90-1170 on Pulsatile Insulin Secretion in Type 2 Diabetic Patients. A Double-blind, Placebo-controlled, Randomised, Single-dose, Cross-over Trial [NCT01507311]	Phase 1	11 participants (Actual)	Interventional	1999-09-30	Completed
An Open Label, Single Dose Trial With Two Groups Comparing the Pharmacokinetics of Liraglutide in Young Versus Elderly Healthy Subjects of Both Sexes [NCT01507337]	Phase 1	32 participants (Actual)	Interventional	2004-04-30	Completed
A Single-centre, Open-label Trial Investigating the Pharmacokinetics and the Safety Profile After a Single Dose of Liraglutide in Subjects With Hepatic Impairment and in Subjects With Normal Hepatic Function [NCT01507389]	Phase 1	24 participants (Actual)	Interventional	2006-03-31	Completed
A Single-centre, Open-label, Trial Investigating the Pharmacokinetics and the Tolerability of Liraglutide in Subjects With Normal Renal Function and in Subjects With Impaired Renal Function [NCT01508806]	Phase 1	30 participants (Actual)	Interventional	2005-08-31	Completed
A Double-blind, Two Period Cross-over, Single Centre Trial in Healthy Subjects Investigating the Influence on the Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Drug After Multiple Dose Administration of Liraglutide [NCT01508858]	Phase 1	21 participants (Actual)	Interventional	2006-11-30	Completed
A Randomized, Single-blind, Single-centre, Two-period, Cross-over Trial Investigating the Bioequivalence Between Completed Phase 2 and Planned Phase 3 Formulations of Liraglutide in Healthy Subjects [NCT01508897]	Phase 1	22 participants (Actual)	Interventional	2004-05-28	Completed
Effect of NNC 90-1170 on 24-hour Glucose and Hormonal Profiles, Gastric Emptying, and Fasting Gluconeogenesis in Type 2 Diabetic Subjects. A Double-blind, Placebo-controlled, Randomised, Cross-over Trial [NCT01508923]	Phase 2	17 participants (Actual)	Interventional	2001-05-31	Completed
Effect of NNC 90-1170 on Hypoglycaemic Counterregulation During Stepwise Hypoglycaemic Clamp in Type 2 Diabetic Subjects. A Double-blind, Placebo-controlled, Randomised, 2-period Cross-over Trial [NCT01509742]	Phase 1	19 participants (Actual)	Interventional	2001-04-30	Completed
Dose-response Relationship of Five Dose Levels of NNC90-1170 and Placebo on Glycaemic Control in Type 2 Diabetic Patients Compared to OHA Treatment. A 12-week Multi-centre, Double-blind, Randomised, Parallel Group Trial With an Open Labelled OHA Arm [NCT01509755]	Phase 2	196 participants (Anticipated)	Interventional	2000-10-31	Completed
A Single-Centre, Open-Label, Five-Period Crossover Trial In Healthy Male Volunteers Investigating the Relative Bioavailability of NNC 90-1170 By Pulmonary Administration Compared To A Subcutaneous Injection [NCT01511159]	Phase 1	32 participants (Actual)	Interventional	2001-10-31	Completed
Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Doubl [NCT01511172]	Phase 2	145 participants (Actual)	Interventional	2002-08-31	Completed
NNC 90-1170 Mechanism of Action: A Double-blind, Randomized, Single-center, Placebo Controlled, Crossover Study to Examine Beta-cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes [NCT01511185]	Phase 1	20 participants (Actual)	Interventional	2001-02-28	Completed
NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes [NCT01511198]	Phase 2	223 participants (Actual)	Interventional	2001-02-28	Completed
A Randomised, Double-blind, Single-centre, Placebo-controlled, Ascending Single s.c. Dose, Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 90-1170 in Healthy Japanese Male Subjects [NCT01620463]	Phase 1	32 participants (Actual)	Interventional	2002-12-31	Completed
A Randomised, Double-blind, Single-centre, Placebo-controlled, 21-day Multiple s.c. Doses, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide (NNC 90-1170) in Healthy Japanese Male Subjects [NCT01620476]	Phase 1	24 participants (Actual)	Interventional	2003-09-30	Completed
Phase 3 Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin [NCT01628445]	Phase 3	52 participants (Actual)	Interventional	2012-08-31	Terminated(stopped due to Error made by local pharmacy caused mixed randomization of 20 participants)
Liraglutide With or Without NEAT in Type 2 Diabetes Mellitus; Effects on HbA1c, Weight, Blood Pressure, Quality of Life and Health Care Costs. [NCT01638260]	Phase 4	22 participants (Actual)	Interventional	2012-10-31	Terminated(stopped due to Terminated because of insufficient number of subjects included.)
Liraglutide and Insulin-001 A Randomized Prospective Trial of Liraglutide Added to High-Dose Insulin Therapy vs. High-Dose Insulin Therapy Alone in Insulin-Resistant Patients With Type 2 Diabetes [NCT01654120]	Phase 4	37 participants (Actual)	Interventional	2011-12-31	Completed
A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients [NCT01664676]	Phase 4	11 participants (Actual)	Interventional	2012-12-31	Completed
A Randomized, Open-label, Two-period, and Double-cross Comparative Study on the Pharmacokinetics of Liraglutide Injection (RD12014) and Victoza® in Healthy Volunteers [NCT05294536]	Phase 1	50 participants (Actual)	Interventional	2020-06-22	Completed
A 26-Week Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus [NCT02973321]	Phase 2	296 participants (Actual)	Interventional	2016-12-02	Completed
A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and [NCT02787551]	Phase 3	514 participants (Actual)	Interventional	2016-07-06	Completed
The Influence of Liraglutide on the Reward Properties of Food: an fMRI Study on Healthy Volunteers [NCT01695109]	Phase 4	16 participants (Actual)	Interventional	2010-11-30	Completed
The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes [NCT01617434]	Phase 3	451 participants (Actual)	Interventional	2012-09-30	Completed
Does Glucagon-like Polypeptide 1 Improve Vascular Function and Inflammation? [NCT01740921]		39 participants (Actual)	Interventional	2011-01-31	Completed
A Phase IV, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Effect of 12-week Treatment With the Glucagon-like Peptide-1 Receptor Agonist (GLP-1RA) Liraglutide or Dipeptidyl Peptidase-4 Inhibitor (DPP-4i) Sitagliptin on th [NCT01744236]	Phase 4	70 participants (Actual)	Interventional	2013-04-30	Completed
An Open-Label, Multi-Center, Randomized, Phase 3b Study to Evaluate the Safety and Tolerability of Switching to One of Two Dosing Strategies of ITCA 650 in Patients With Type 2 Diabetes Receiving Stable Doses of Liraglutide [NCT02638805]	Phase 3	136 participants (Actual)	Interventional	2015-12-31	Completed
Hormonal Regulation of Systolic Blood Pressure in Response to the GLP-1 (Glucagon-Like Peptide-1) Receptor Agonist, Liraglutide. [NCT01755572]	Phase 4	22 participants (Actual)	Interventional	2013-01-31	Completed
Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus [NCT01761318]	Phase 4	50 participants (Actual)	Interventional	2013-11-30	Completed
Restoring Insulin Secretion Adult Medication Study [NCT01779362]	Phase 3	267 participants (Actual)	Interventional	2013-04-30	Completed
Pilot Study on Incretin Effect on the Immunological Phenotype in Healthy Subjects and in Type 1 Diabetic Subjects [NCT01782261]	Phase 2	15 participants (Actual)	Interventional	2012-02-29	Completed
Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users: A Randomized, Open-label, Parallel-group and Active Controlled Trial [NCT01785043]	Phase 4	13 participants (Actual)	Interventional	2013-03-31	Completed
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of Liraglutide in Obese Adolescent Subjects Aged 12 to 17 Years [NCT01789086]	Phase 1	21 participants (Actual)	Interventional	2013-02-28	Completed
The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Gestational Diabetes Mellitus [NCT01795248]	Phase 4	105 participants (Actual)	Interventional	2012-07-31	Completed
The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification [NCT01664247]	Phase 3	346 participants (Actual)	Interventional	2012-10-01	Completed
A 6-month, Multi-centre, Open Labelled, Non-randomized, Non-interventional, Safety Study of Liraglutide (Victoza®) in Subjects With Type 2 Diabetes Mellitus in Korea [NCT01821846]		64 participants (Actual)	Observational	2013-11-20	Completed
Evaluating the Effects of the Novel GLP-1 Analogue, Liraglutide, in Patients With Mild Alzheimer's Disease (ELAD Study) [NCT01843075]	Phase 2	204 participants (Actual)	Interventional	2014-01-31	Active, not recruiting
Does a GLP-1 Receptor Agonist Change Glucose Tolerance in Antipsychotic-treated Patients? A Randomized, Double-blinded, Placebo-controlled Clinical Trial [NCT01845259]	Phase 2	103 participants (Actual)	Interventional	2013-04-30	Active, not recruiting
Pilot Study of the GLP-1 Agonist, Liraglutide, on Decreasing Parenteral Support Requirements in Short Bowel Patients. [NCT03371862]	Phase 2	0 participants (Actual)	Interventional	2017-10-20	Withdrawn(stopped due to No participants recruited. Not able to recruit due to COVID 19.)
Evaluation of the Glucoregulatory Effects of GLP-1 Receptor Activation in Patients With Type 2 Diabetes Mellitus [NCT01373450]	Phase 1	12 participants (Actual)	Interventional	2011-06-30	Completed
Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study [NCT01794143]	Phase 3	5,047 participants (Actual)	Interventional	2013-05-31	Completed
A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus [NCT02420262]	Phase 3	506 participants (Actual)	Interventional	2015-07-26	Completed
Liraglutide in Obesity and Diabetes: Identification of CNS Targets Using fMRI [NCT01562678]	Phase 4	28 participants (Actual)	Interventional	2012-03-31	Completed
Effects of Agonists of Glucagon Like Peptide - 1 Receptors (GLP-1R) on Arterial Stiffness, Endothelial Glycocalyx and Coronary Flow Reserve in Patients With Coronary Artery Disease and Patients With Diabetes Mellitus [NCT03010683]		60 participants (Actual)	Interventional	2015-11-30	Completed
A Double-blind [Sponsor Unblinded], Randomized, Placebo-controlled, Staggered-parallel Study to Investigate the Safety, Tolerability, and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes [NCT01725126]	Phase 2	53 participants (Actual)	Interventional	2013-02-10	Completed
A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms [NCT02298192]	Phase 3	420 participants (Actual)	Interventional	2014-11-21	Completed
Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function in Newly-diagnosed Type 2 Diabetic Patients [NCT01790308]	Phase 4	100 participants (Anticipated)	Interventional	2013-02-28	Enrolling by invitation
A Phase II, Randomized, Double-blinded, Placebo-controlled Trial of Liraglutide in Parkinson's Disease [NCT02953665]	Phase 2	63 participants (Actual)	Interventional	2017-04-03	Completed
Weight Loss and Treatment Patterns in a Real World Population of Adults Receiving Saxenda® for Weight Management in Routine Clinical Practice in Switzerland [NCT05153590]		269 participants (Actual)	Observational	2021-12-03	Completed
Replication of the LEAD-2 Diabetes Trial in Healthcare Claims Data [NCT05162183]		3,474 participants (Actual)	Observational	2019-09-01	Completed
Replication of the LEADER Diabetes Trial in Healthcare Claims [NCT03936049]		168,690 participants (Actual)	Observational	2017-09-22	Completed
The Effect of GLP-1 in Psoriasis [NCT01460069]		20 participants (Anticipated)	Interventional	2011-10-31	Completed
A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide With Once-Daily Liraglutide in Patients With Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6) [NCT01624259]	Phase 3	599 participants (Actual)	Interventional	2012-06-30	Completed
[NCT01451905]		12 participants (Anticipated)	Interventional	2011-08-31	Recruiting
Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes. A Randomized Clinical Trial [NCT02518945]	Phase 3	30 participants (Anticipated)	Interventional	2015-08-31	Completed
Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy and Treated in a Pr [NCT02730377]	Phase 4	1,991 participants (Actual)	Interventional	2016-03-28	Completed
An Open-label, Randomized, Three-parallel-group Study on Pharmacodynamic Effects of 8-week QD Treatment With Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin [NCT01596504]	Phase 2	142 participants (Actual)	Interventional	2012-05-31	Completed
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus [NCT02607306]	Phase 3	819 participants (Actual)	Interventional	2015-11-18	Completed
Adding Liraglutide to High Dose Insulin: Breaking the Cycle [NCT01505673]	Phase 4	71 participants (Actual)	Interventional	2012-01-31	Completed
Investigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial. [NCT03856047]	Phase 2	706 participants (Actual)	Interventional	2019-03-01	Completed
Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial [NCT03374956]	Phase 3	193 participants (Actual)	Interventional	2017-12-11	Completed
Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes [NCT01541215]	Phase 3	135 participants (Actual)	Interventional	2012-11-13	Completed
A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Multi-centre Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preserv [NCT02443155]	Phase 2	308 participants (Actual)	Interventional	2015-11-10	Completed
A Phase IIa, Multicenter, Placebo- and Active-controlled, Randomized, Double-Blind, Clinical Trial to Evaluate the Safety and Efficacy of MK-8521 Compared to Placebo in Subjects With Type 2 Diabetes Mellitus [NCT02492763]	Phase 2	176 participants (Actual)	Interventional	2015-07-27	Terminated
Effect and Safety of Subcutaneous Semaglutide 2.4 mg Once Weekly Compared to Liraglutide 3.0 mg Once Daily on Weight Management in Subjects With Overweight or Obesity [NCT04074161]	Phase 3	338 participants (Actual)	Interventional	2019-09-11	Completed
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 1820237 Alone (Trial Parts 1+2) or Together With a Low Dose of Liraglutide (Trial Part 3) in Otherwise Healthy Male Subjects With Overweight/Obesity (Si [NCT04903509]	Phase 1	95 participants (Actual)	Interventional	2021-06-08	Completed
Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes [NCT01722227]	Phase 3	0 participants (Actual)	Interventional	2012-11-30	Withdrawn(stopped due to No Funding Received from ADA)
DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists [NCT01575301]		411 participants (Actual)	Interventional	2011-03-31	Completed
The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy [NCT01618162]	Phase 3	435 participants (Actual)	Interventional	2012-08-29	Completed
[NCT01592279]	Phase 4	124 participants (Anticipated)	Interventional	2012-06-30	Not yet recruiting
A Long-term, Randomized, Open-labeled, Parallel-group Trial to Compare the Effects of Liraglutide and Sulphonylurea (Glimepiride) Both in Combination With Metformin on Clinical, Endothelial and Image Markers of Cardiovascular Risk in Patients With Type 2 [NCT01593137]	Phase 4	0 participants (Actual)	Interventional	2012-05-31	Withdrawn(stopped due to Lack of patients with the criteria established in the protocol.)
Adding Liraglutide to the Backbone Therapy of Biguanide in Patients With Coronary Artery Disease and Newly Diagnosed Type-2 Diabetes [NCT01595789]	Phase 4	41 participants (Actual)	Interventional	2012-05-31	Completed
LIRAGLUTIDE AND ORLISTAT TREATMENT FOR PERSISTENT TYPE 2 DIABETES AFTER GASTRIC BANDING: A PILOT STUDY [NCT01597531]	Phase 4	1 participants (Actual)	Interventional	2012-06-30	Terminated(stopped due to Difficulty recruiting patients)
Influence du Victoza (Liraglutide,Analogue GLP-1) Sur Les Performances Gustatives, le Rassasiement Sensoriel spécifique, le Liking et le Wanting Chez Les Patients diabétiques de Type 2. [NCT01599338]		30 participants (Actual)	Interventional	2011-01-31	Completed
Comparison of Efficacy and Safety of POSE 2.0 Procedure Compared to GLP-1 Agonist in a Cohort of Patients for Management of Obesity: a Single-center Randomized Crossover-controlled Trial [NCT05705388]		50 participants (Anticipated)	Interventional	2023-01-16	Recruiting
Phase 2 Study: A Double-blind, Randomised, Clinical Cross-over Trial to Investigate the Treatment Potential of Liraglutide Compared to Glimepiride in MODY Patients [NCT01610934]	Phase 2/Phase 3	15 participants (Actual)	Interventional	2012-08-31	Completed
Liraglutide in Type 1 Diabetes. A Randomised, Double-blind, Placebo Controlled Study of the Effect of Liraglutide as an Additional Treatment to Insulin on HbA1c, Body Weight and Hypoglycaemia in Poorly Regulated Type 1 Diabetes Patients [NCT01612468]	Phase 4	100 participants (Actual)	Interventional	2012-06-30	Completed
Effect of Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus [NCT03011008]	Phase 4	20 participants (Anticipated)	Interventional	2017-01-31	Recruiting
Liraglutide Effect and Action in Diabetes (LEAD-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy in Subje [NCT00318422]	Phase 3	1,041 participants (Actual)	Interventional	2006-05-31	Completed
Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine [NCT00331851]	Phase 3	584 participants (Actual)	Interventional	2006-05-31	Completed
A Phase 3 Study of LY2189265 Monotherapy Compared to Placebo and Liraglutide in Patients With Type 2 Diabetes Mellitus [NCT01558271]	Phase 3	492 participants (Actual)	Interventional	2012-03-31	Completed
Effect of Liraglutide on Subclinical Atherosclerosis in Patients With Type 1 Diabetes Mellitus [NCT05467514]	Phase 3	35 participants (Actual)	Interventional	2022-07-01	Completed
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of LY3537021 When Combined With GLP-1 Receptor Agonist in Healthy Participants [NCT05444569]	Phase 1	47 participants (Actual)	Interventional	2022-08-08	Completed
A 26-weeks Randomised, Insulin Capped, Placebo-controlled, Double-blind, Parallel Group, Multinational, Multi-centre Trial [NCT02098395]	Phase 3	835 participants (Actual)	Interventional	2014-05-31	Completed
Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes [NCT02014740]	Phase 4	100 participants (Actual)	Interventional	2014-03-31	Completed
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus [NCT02453711]	Phase 2	957 participants (Actual)	Interventional	2015-10-01	Completed
Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment. A 26-week Double-blind Placebo-controlled, Randomised, Multicentre, Multi-national, Parallel-group [NCT01620489]	Phase 3	279 participants (Actual)	Interventional	2012-06-14	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Monotherapy Study to Determine the Efficacy and Safety of 2 Dose Levels of Albiglutide in Subjects With Type 2 Diabetes Mellitus [NCT01733758]	Phase 3	494 participants (Actual)	Interventional	2013-02-28	Completed
Efficacy and Tolerance of Liraglutide for Weight Loss in Obese Type 2 Diabetic Hemodialysis Patients [NCT04529278]	Phase 2	18 participants (Actual)	Interventional	2021-01-18	Active, not recruiting
To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study [NCT02299388]	Phase 4	11 participants (Actual)	Interventional	2014-10-31	Completed
The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes.(LIRA-DPP-4 CHINA™) [NCT02008682]	Phase 4	368 participants (Actual)	Interventional	2013-12-31	Completed
Saxenda: Underlying Mechanisms and Clinical Outcomes [NCT02944500]	Phase 4	28 participants (Actual)	Interventional	2016-11-30	Active, not recruiting
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs) [NCT03172494]	Phase 3	720 participants (Actual)	Interventional	2017-05-26	Completed
A Prospective, Non-interventional, Single Arm Study Investigating Long-term Glycaemic Control in Patients With Type 2 Diabetes Initiating Xultophy® (IDegLira) in a Realworld Setting in Italy [NCT04666987]		359 participants (Actual)	Observational	2020-10-21	Completed
Pathophysiological Study of the Increase in Pancreatic Volume in Type 2 Diabetes Treatments. [NCT02244164]		5 participants (Actual)	Interventional	2014-10-31	Terminated(stopped due to Recruitment too slow)
The Lira Pump Trial. The Effects of Liraglutide in Patients With Insulin Pump Treated Type 1 Diabetes: A Randomized Placebo-Controlled Trial [NCT02351232]	Phase 2/Phase 3	44 participants (Actual)	Interventional	2015-02-28	Completed
Investigation on Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects. A Randomised, Double-blind, Placebo-controlled Trial Investigating Subcutaneously Single Dose Escalation of a Sustained Release Formulation of Liraglutide [NCT01473953]	Phase 1	31 participants (Actual)	Interventional	2011-10-31	Completed
What is the Effects of Incretin on the Blood Pressure and Lipid in Overweight or Obese Diabetes Patients With Masked Hypertension: Liraglutide Plus Mitiglinide Comparing Metformin Plus Mitiglinide or Mitiglinide Alone（BLOOD STUDY） [NCT02503943]	Phase 4	90 participants (Anticipated)	Interventional	2015-05-31	Active, not recruiting
The Effect and the Pharmacogenomics Study of Liraglutide in Obese Patients [NCT04839237]	Phase 2	0 participants (Actual)	Interventional	2017-12-01	Withdrawn(stopped due to The sponsor decides withdrawn this study.)
A Randomized, Double Blind, Two-period Cross-over Trial Investigating the Effect of Liraglutide as Add on to Intensive Insulin Treatment on the Endogenous Glucose Production in Subjects With C-peptide Positive Type 1 Diabetes Mellitus [NCT02408705]	Phase 2	14 participants (Actual)	Interventional	2015-01-31	Completed
Evaluation of Life Style Modification Medical and Surgical Treatment Modalities in Patients With Obesity: An Observational Study [NCT04417582]		1,000 participants (Anticipated)	Observational [Patient Registry]	2020-01-01	Recruiting
Targeting Beta-cell Failure in Lean Patients With Type 2 Diabetes [NCT04657939]	Phase 4	57 participants (Actual)	Interventional	2020-12-01	Completed
A 36-week, Randomised, Multi-centre, Double-blind, Parallel Group Trial to Investigate the Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus [NCT01572740]	Phase 3	257 participants (Actual)	Interventional	2012-04-05	Completed
A Multicenter, Randomized, Double-blinded, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Liraglutide on Body Weight Loss in Obese and Overweight Patients [NCT04605861]	Phase 3	414 participants (Actual)	Interventional	2020-08-18	Completed
Functional Impact of GLP-1 for Heart Failure Treatment [NCT01800968]	Phase 2	300 participants (Actual)	Interventional	2013-04-30	Completed
Effects of Liraglutide on Endoplasmic (ER) Stress in Obese Patients With Type 2 Diabetes [NCT02344186]	Phase 4	12 participants (Anticipated)	Interventional	2014-05-31	Active, not recruiting
Phase II Trial of Liraglutide (Saxenda(R), Novo Nordisk) in Adolescents With Obesity After Sleeve Gastrectomy: A Pilot Open-Label Study [NCT04883346]	Phase 2	50 participants (Anticipated)	Interventional	2021-06-21	Recruiting
Short-term Liraglutide Treatment in Obese Women With Polycystic Ovary Syndrome [NCT01899430]	Phase 4	32 participants (Actual)	Interventional	2011-11-30	Completed
Phase 1 Study of Medtronic Closed Loop Device With ePID Algorithm and Enlite Sensors on Adjuvant Therapy With Insulin and Liraglutide to Minimize Post-prandial Hyperglycemia [NCT01755416]	Phase 2	18 participants (Actual)	Interventional	2013-01-31	Completed
A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes [NCT01392573]	Phase 3	413 participants (Actual)	Interventional	2011-11-28	Completed
A Trial Comparing the Efficacy and Safety of Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEG [NCT01388361]	Phase 3	413 participants (Actual)	Interventional	2011-09-30	Completed
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3025876 in Patients With Type 2 Diabetes Mellitus [NCT01870297]	Phase 1	72 participants (Actual)	Interventional	2013-06-30	Completed
The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes. A 52-week Randomised, Treat-to-target, Placebo-controlled, Double Blinded, Parallel Group, Multinational, Multi-centre Trial [NCT01836523]	Phase 3	1,398 participants (Actual)	Interventional	2013-11-30	Completed
Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: A 56 Week Randomised, Double-blind, Placebo-controlled, Three Armed Parallel Group, Multi-centre, Multinational Trial With a 12 Week Observational Follow-up Period [NCT01272232]	Phase 3	846 participants (Actual)	Interventional	2011-06-01	Completed
Addition of a Glucagon-like Peptide-1 to a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and Cardiovascular Disease. [NCT01784965]	Phase 3	69 participants (Actual)	Interventional	2009-12-31	Completed
Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes [NCT01973231]	Phase 4	404 participants (Actual)	Interventional	2013-10-31	Completed
A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 598 in Subjects With Obesity [NCT03757130]	Phase 1	50 participants (Actual)	Interventional	2018-11-26	Completed
A Randomized Controlled Trial Comparing the Safety and Efficacy of Liraglutide Versus Glargine Insulin for the Management of Patients With Type 2 Diabetes After Hospital Discharge [NCT01919489]	Phase 4	273 participants (Actual)	Interventional	2014-03-31	Completed
Comparison of Efficacy of Liraglutide, Metformin and Gliclazide MR on Hepatic Lipid Content in Patients With Type 2 Diabetes (T2DM) and Non-alcoholic Fatty Liver (NAFLD) [NCT03068065]	Phase 4	87 participants (Actual)	Interventional	2014-05-31	Completed
Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes [NCT01856790]	Early Phase 1	15 participants (Actual)	Interventional	2013-02-28	Completed
Pilot 2: Glucagon-like Peptide-1 in Sleep Disordered Breathing [NCT01832532]	Phase 1/Phase 2	34 participants (Actual)	Interventional	2013-04-30	Completed
Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes [NCT01917656]	Phase 4	343 participants (Actual)	Interventional	2014-01-09	Completed
The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a) [NCT02501850]	Phase 4	40 participants (Anticipated)	Interventional	2014-10-31	Recruiting
Effects of GLP-1 Receptor Agonist Treatment on Pulmonary Function and Quality of Life in Obese Patients With Chronic Obstructive Pulmonary Disease. [NCT03466021]	Phase 4	40 participants (Actual)	Interventional	2018-01-01	Completed
Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes? [NCT01455441]	Phase 4	40 participants (Actual)	Interventional	2011-10-31	Completed
Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe [NCT01890993]		952 participants (Actual)	Observational	2013-08-31	Completed
The Effect of Simple Insulin Detemir Titration, Metformin Plus Liraglutide Compared to Simple Insulin Detemir Titration Plus Insulin Aspart and Metformin for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study: A 26 Week, Randomized, Open Label, P [NCT01966978]	Phase 4	157 participants (Actual)	Interventional	2014-11-30	Completed
A 52-week, Multi-centre, Open-labelled, Randomised (2:1), Parallel-group Trial With an Active Control (Two OADs Combination Therapy) to Evaluate the Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficien [NCT01512108]	Phase 3	363 participants (Actual)	Interventional	2012-01-10	Completed
The Benefit of a Liraglutide-based Weight Management Alone or in Addition to Standard CPAP Therapy on Metabolic Function in Patients With Obstructive Sleep Apnoea (OSA) - an Explorative, Proof-of-concept Study [NCT04186494]		30 participants (Actual)	Interventional	2019-12-02	Completed
Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients [NCT02773355]		27 participants (Actual)	Observational	2016-05-16	Completed
Effectiveness of Semaglutide 2.4 mg vs. Commercially Available Medications for Chronic Weight Management in Participants With Obesity in a Multi-employer Setting in The US - a Pragmatic Clinical Study [NCT05579249]	Phase 4	500 participants (Anticipated)	Interventional	2023-01-19	Recruiting
The Effects of Liraglutide on Sudomotor Function and Inflammation in Type 2 Diabetes [NCT03426085]	Phase 2	44 participants (Anticipated)	Interventional	2016-05-31	Recruiting
Treatment of Bile Acid Malabsorption With Liraglutide [NCT03955575]	Phase 4	52 participants (Actual)	Interventional	2019-03-07	Completed
Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 o [NCT01272219]	Phase 3	3,731 participants (Actual)	Interventional	2011-06-01	Completed
An Individualized treatMent aPproach for oldER patIents: A Randomized, Controlled stUdy in Type 2 Diabetes Mellitus (IMPERIUM) [NCT02072096]	Phase 4	192 participants (Actual)	Interventional	2014-02-28	Terminated(stopped due to The trial was terminated per protocol because of lack of feasibility.)
A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Int [NCT02100475]	Phase 3	31 participants (Actual)	Interventional	2014-04-30	Completed
A Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or Acromegaly [NCT02060383]	Phase 4	249 participants (Actual)	Interventional	2014-05-23	Completed
Phase 3 Study of the Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Renal Outcomes in Humans With Diabetic Kidney Disease [NCT01847313]	Phase 3	20 participants (Actual)	Interventional	2013-04-30	Completed
A Randomised, Double-blind, Placebo-controlled Study of the Effect of Liraglutide in Polycystic Ovary Syndrome on Risk Markers of Vascular Thrombosis. [NCT02073929]	Phase 4	72 participants (Actual)	Interventional	2014-03-31	Completed
Improving Beta Cell Function in Mexican American Women With Prediabetes [NCT02488057]	Phase 4	360 participants (Actual)	Interventional	2016-05-31	Completed
[NCT02483299]	Phase 4	40 participants (Actual)	Interventional	2014-01-31	Completed
Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes [NCT02461589]	Phase 2	706 participants (Actual)	Interventional	2015-09-21	Completed
Efficacy and Safety of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, 28-week Trial [NCT04487743]	Phase 3	300 participants (Anticipated)	Interventional	2020-05-09	Recruiting
BARI-OPTIMISE: a Double-blinded, Randomised, Placebo-controlled Trial of Liraglutide 3.0 mg in Patients With Poor Weight-loss and a Suboptimal Glucagon-like Peptide-1 Response Following Bariatric Surgery [NCT03341429]	Phase 4	70 participants (Actual)	Interventional	2018-08-22	Completed
Pilot Study of the Effect of Weight Loss by Pharmacotherapy on Chronic Pro-tumor Inflammatory Cells [NCT05756764]		24 participants (Anticipated)	Observational	2023-05-23	Recruiting
A Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus [NCT02501161]	Phase 3	1,012 participants (Actual)	Interventional	2016-01-31	Completed
Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin [NCT01907854]	Phase 4	407 participants (Actual)	Interventional	2013-12-02	Completed
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V - Basal Insulin Switch) [NCT01952145]	Phase 3	557 participants (Actual)	Interventional	2013-09-20	Completed
Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea. A 32 Week Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre and Multinational Trial [NCT01557166]	Phase 3	359 participants (Actual)	Interventional	2012-06-07	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00294723 (17) [back to overview]	Change in Fasting Plasma Glucose at Week 156
NCT00294723 (17) [back to overview]	Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52
NCT00294723 (17) [back to overview]	Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104
NCT00294723 (17) [back to overview]	Hypoglycaemic Episodes
NCT00294723 (17) [back to overview]	Hypoglycaemic Episodes
NCT00294723 (17) [back to overview]	Change in Body Weight at Week 104
NCT00294723 (17) [back to overview]	Change in Body Weight at Week 156
NCT00294723 (17) [back to overview]	Change in Body Weight at Week 52
NCT00294723 (17) [back to overview]	Change in Fasting Plasma Glucose at Week 104
NCT00294723 (17) [back to overview]	Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52
NCT00294723 (17) [back to overview]	Change in Fasting Plasma Glucose at Week 52
NCT00294723 (17) [back to overview]	Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104
NCT00294723 (17) [back to overview]	Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156
NCT00294723 (17) [back to overview]	Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104
NCT00294723 (17) [back to overview]	Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156
NCT00294723 (17) [back to overview]	Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156
NCT00294723 (17) [back to overview]	Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
NCT00318461 (14) [back to overview]	Change in Glycosylated A1c (HbA1c) at Week 104
NCT00318461 (14) [back to overview]	Change in Glycosylated A1c (HbA1c) at Week 26
NCT00318461 (14) [back to overview]	Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26
NCT00318461 (14) [back to overview]	Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104
NCT00318461 (14) [back to overview]	Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104
NCT00318461 (14) [back to overview]	Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26
NCT00318461 (14) [back to overview]	Hypoglycaemic Episodes at Week 104
NCT00318461 (14) [back to overview]	Hypoglycaemic Episodes at Week 26
NCT00318461 (14) [back to overview]	Change in Fasting Plasma Glucose (FPG) at Week 26
NCT00318461 (14) [back to overview]	Change in Beta-cell Function at Week 104
NCT00318461 (14) [back to overview]	Change in Beta-cell Function at Week 26
NCT00318461 (14) [back to overview]	Change in Body Weight at Week 104
NCT00318461 (14) [back to overview]	Change in Body Weight at Week 26
NCT00318461 (14) [back to overview]	Change in Fasting Plasma Glucose (FPG) at Week 104
NCT00393718 (13) [back to overview]	Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
NCT00393718 (13) [back to overview]	Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
NCT00393718 (13) [back to overview]	Postprandial Glucose AUC After 24 Weeks of Treatment
NCT00393718 (13) [back to overview]	Postprandial Glucose AUC After 52 Weeks of Treatment
NCT00393718 (13) [back to overview]	Fasting Plasma Glucose After 52 Weeks of Treatment
NCT00393718 (13) [back to overview]	Body Weight After 52 Weeks of Treatment
NCT00393718 (13) [back to overview]	Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
NCT00393718 (13) [back to overview]	Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
NCT00393718 (13) [back to overview]	Fasting Plasma Glucose After 24 Weeks of Treatment
NCT00393718 (13) [back to overview]	Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
NCT00393718 (13) [back to overview]	Hypoglycaemic Episodes
NCT00393718 (13) [back to overview]	Body Weight After 24 Weeks of Treatment
NCT00393718 (13) [back to overview]	Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
NCT00395746 (13) [back to overview]	Hypoglycaemic Episodes
NCT00395746 (13) [back to overview]	Postprandial Glucose AUC After 52 Weeks of Treatment
NCT00395746 (13) [back to overview]	Postprandial Glucose AUC After 24 Weeks of Treatment
NCT00395746 (13) [back to overview]	Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
NCT00395746 (13) [back to overview]	Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
NCT00395746 (13) [back to overview]	Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
NCT00395746 (13) [back to overview]	Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
NCT00395746 (13) [back to overview]	Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
NCT00395746 (13) [back to overview]	Fasting Plasma Glucose After 52 Weeks of Treatment
NCT00395746 (13) [back to overview]	Fasting Plasma Glucose After 24 Weeks of Treatment
NCT00395746 (13) [back to overview]	Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
NCT00395746 (13) [back to overview]	Body Weight After 24 Weeks of Treatment
NCT00395746 (13) [back to overview]	Body Weight After 52 Weeks of Treatment
NCT00422058 (20) [back to overview]	Mean Change From Baseline in Body Weight at Week 104
NCT00422058 (20) [back to overview]	Change From Baseline in Waist Circumference at Week 20
NCT00422058 (20) [back to overview]	Change From Baseline in Waist Circumference at Week 104
NCT00422058 (20) [back to overview]	Mean Change From Baseline in Body Weight at Week 20
NCT00422058 (20) [back to overview]	Change From Baseline in Adiponectin at Week 104
NCT00422058 (20) [back to overview]	Change From Baseline in Adiponectin at Week 20
NCT00422058 (20) [back to overview]	Change From Baseline in Blood Pressure at Week 104
NCT00422058 (20) [back to overview]	Change From Baseline in Blood Pressure at Week 20
NCT00422058 (20) [back to overview]	Change From Baseline in Fasting Insulin at Week 104
NCT00422058 (20) [back to overview]	Change From Baseline in Fasting Insulin at Week 20
NCT00422058 (20) [back to overview]	Change From Baseline in Fasting Plasma Glucose at Week 104
NCT00422058 (20) [back to overview]	Change From Baseline in Fasting Plasma Glucose at Week 20
NCT00422058 (20) [back to overview]	Change From Baseline in Fibrinogen at Week 104
NCT00422058 (20) [back to overview]	Change From Baseline in Fibrinogen at Week 20
NCT00422058 (20) [back to overview]	Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
NCT00422058 (20) [back to overview]	Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
NCT00422058 (20) [back to overview]	Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104
NCT00422058 (20) [back to overview]	Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20
NCT00422058 (20) [back to overview]	Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104
NCT00422058 (20) [back to overview]	Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20
NCT00518882 (55) [back to overview]	Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78
NCT00518882 (55) [back to overview]	Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26
NCT00518882 (55) [back to overview]	Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78
NCT00518882 (55) [back to overview]	Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Total Cholesterol at Week 26
NCT00518882 (55) [back to overview]	Change in Total Cholesterol at Week 78
NCT00518882 (55) [back to overview]	Change in Triglyceride at Week 26
NCT00518882 (55) [back to overview]	Change in Triglyceride at Week 78
NCT00518882 (55) [back to overview]	Change in Triglyceride, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Very Low-density Lipoprotein-cholesterol at Week 26
NCT00518882 (55) [back to overview]	Change in Very Low-density Lipoprotein-cholesterol at Week 78
NCT00518882 (55) [back to overview]	Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78
NCT00518882 (55) [back to overview]	Hypoglycaemic Episodes at Week 26
NCT00518882 (55) [back to overview]	Hypoglyceamic Episodes, Weeks 26-78
NCT00518882 (55) [back to overview]	Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26
NCT00518882 (55) [back to overview]	Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78
NCT00518882 (55) [back to overview]	Change in Fasting Plasma Glucose at Week 78
NCT00518882 (55) [back to overview]	Change in Apolipoprotein B at Week 26
NCT00518882 (55) [back to overview]	Change in Apolipoprotein B at Week 78
NCT00518882 (55) [back to overview]	Change in Apolipoprotein B, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Beta-cell Function at Week 26
NCT00518882 (55) [back to overview]	Change in Beta-cell Function at Week 78
NCT00518882 (55) [back to overview]	Change in Beta-cell Function, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Body Weight at Week 26
NCT00518882 (55) [back to overview]	Change in Body Weight at Week 78
NCT00518882 (55) [back to overview]	Change in Body Weight, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Fasting Plasma Glucose at Week 26
NCT00518882 (55) [back to overview]	Change in Fasting Plasma Glucose, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Free Fatty Acid at Week 26
NCT00518882 (55) [back to overview]	Change in Free Fatty Acid at Week 78
NCT00518882 (55) [back to overview]	Change in Total Cholesterol, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Free Fatty Acid, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Glycosylated A1c (HbA1c) at Week 26
NCT00518882 (55) [back to overview]	Change in Glycosylated A1c (HbA1c) at Week 78
NCT00518882 (55) [back to overview]	Change in Glycosylated A1c (HbA1c), Weeks 26-78
NCT00518882 (55) [back to overview]	Change in High-density Lipoprotein-cholesterol at Week 26
NCT00518882 (55) [back to overview]	Change in High-density Lipoprotein-cholesterol at Week 78
NCT00518882 (55) [back to overview]	Change in High-density Lipoprotein-cholesterol, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Low-density Lipoprotein-cholesterol at Week 26
NCT00518882 (55) [back to overview]	Change in Low-density Lipoprotein-cholesterol at Week 78
NCT00518882 (55) [back to overview]	Change in Low-density Lipoprotein-cholesterol, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26
NCT00518882 (55) [back to overview]	Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78
NCT00518882 (55) [back to overview]	Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26
NCT00518882 (55) [back to overview]	Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78
NCT00518882 (55) [back to overview]	Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26
NCT00518882 (55) [back to overview]	Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78
NCT00518882 (55) [back to overview]	Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26
NCT00518882 (55) [back to overview]	Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78
NCT00518882 (55) [back to overview]	Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
NCT00518882 (55) [back to overview]	Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26
NCT00614120 (8) [back to overview]	Change in Fasting Lipid Profile, APO-B
NCT00614120 (8) [back to overview]	Change in Body Weight
NCT00614120 (8) [back to overview]	Change in Beta-cell Function
NCT00614120 (8) [back to overview]	Change in Self-measured Fasting Plasma Glucose
NCT00614120 (8) [back to overview]	Change in Glycosylated Haemoglobin A1c (HbA1c)
NCT00614120 (8) [back to overview]	Hypoglycaemic Episodes
NCT00614120 (8) [back to overview]	Change in Fasting Lipid Profile
NCT00614120 (8) [back to overview]	7-point Self-measured Plasma Glucose Profiles
NCT00620282 (14) [back to overview]	Number of Hypoglycaemic Episodes
NCT00620282 (14) [back to overview]	Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range
NCT00620282 (14) [back to overview]	Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range
NCT00620282 (14) [back to overview]	Fasting Lipid Profile - Change in Triglycerides (TG)
NCT00620282 (14) [back to overview]	Change in Body Weight
NCT00620282 (14) [back to overview]	Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)
NCT00620282 (14) [back to overview]	Fasting Lipid Profile - Change in HDL-C
NCT00620282 (14) [back to overview]	Fasting Lipid Profile - Change in LDL-C
NCT00620282 (14) [back to overview]	Biomarkers of Cardiovascular Risk - Change in TNF-alpha
NCT00620282 (14) [back to overview]	Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)
NCT00620282 (14) [back to overview]	Fasting Lipid Profile - Change in Total Cholesterol (TC)
NCT00620282 (14) [back to overview]	Change in Fasting Plasma Glucose (FPG)
NCT00620282 (14) [back to overview]	Change in HbA1c (Glycosylated Haemoglobin A1c)
NCT00620282 (14) [back to overview]	Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)
NCT00696657 (35) [back to overview]	Change From Baseline in Vital Signs (Blood Pressure; DBP)
NCT00696657 (35) [back to overview]	Change From Baseline in Vital Signs (Blood Pressure; SBP)
NCT00696657 (35) [back to overview]	Change From Baseline in Vital Signs (Pulse)
NCT00696657 (35) [back to overview]	HbA1c
NCT00696657 (35) [back to overview]	Percentage of Subjects Developing Anti-semaglutide Antibodies
NCT00696657 (35) [back to overview]	Percentage of Subjects With an Adverse Events
NCT00696657 (35) [back to overview]	Change From Baseline in ECG
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
NCT00696657 (35) [back to overview]	Percentage of Subjects With Hypoglycaemic Episode
NCT00696657 (35) [back to overview]	Change From Baseline in Calcitonin
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)
NCT00696657 (35) [back to overview]	Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)
NCT00700817 (75) [back to overview]	Mean Change in Beta-cell Function From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in Body Weight From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Apolipoprotein B at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Adiponectin at Week 26.
NCT00700817 (75) [back to overview]	Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in Pulse From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in Total Cholesterol From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in Triglycerides (TG) From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in Waist Circumference From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Mean Change in Waist to Hip Ratio From Week 52 to Week 78
NCT00700817 (75) [back to overview]	Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26
NCT00700817 (75) [back to overview]	Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52
NCT00700817 (75) [back to overview]	Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
NCT00700817 (75) [back to overview]	Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
NCT00700817 (75) [back to overview]	Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26
NCT00700817 (75) [back to overview]	Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52
NCT00700817 (75) [back to overview]	Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
NCT00700817 (75) [back to overview]	Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
NCT00700817 (75) [back to overview]	Hypoglycaamic Episodes, Weeks 52-78
NCT00700817 (75) [back to overview]	Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
NCT00700817 (75) [back to overview]	Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52
NCT00700817 (75) [back to overview]	Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78
NCT00700817 (75) [back to overview]	Hypoglyceamic Episodes, Weeks 0-26
NCT00700817 (75) [back to overview]	Hypoglyceamic Episodes, Weeks 0-52
NCT00700817 (75) [back to overview]	Hypoglyceamic Episodes, Weeks 0-78
NCT00700817 (75) [back to overview]	Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Body Weight at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Body Weight at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Beta-cell Function at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Beta-cell Function at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Apolipoprotein B at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.
NCT00700817 (75) [back to overview]	Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Pulse at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Pulse at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Total Cholesterol at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Total Cholesterol at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Triglycerides (TG) at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Triglycerides (TG) at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Waist Circumference at Week 26.
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Waist Circumference at Week 52
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Waist to Hip Ratio at Week 26.
NCT00700817 (75) [back to overview]	Mean Change From Baseline in Waist to Hip Ratio at Week 52
NCT00700817 (75) [back to overview]	Mean Change in Apolipoprotein B From Week 52 to Week 78
NCT00781937 (26) [back to overview]	Change From Baseline in Fasting Lipid Profile: Total Cholesterol
NCT00781937 (26) [back to overview]	Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)
NCT00781937 (26) [back to overview]	Change From Baseline in Fasting Lipid Profile: Triglycerides
NCT00781937 (26) [back to overview]	Change From Baseline in Fasting Weight
NCT00781937 (26) [back to overview]	Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period
NCT00781937 (26) [back to overview]	Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)
NCT00781937 (26) [back to overview]	Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin
NCT00781937 (26) [back to overview]	Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)
NCT00781937 (26) [back to overview]	Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)
NCT00781937 (26) [back to overview]	Change From Baseline in Blood Pressure
NCT00781937 (26) [back to overview]	Change From Baseline in Pulse
NCT00781937 (26) [back to overview]	Change From Baseline in Waist Circumference
NCT00781937 (26) [back to overview]	Mean Percentage Change in Fasting Body Weight From Baseline
NCT00781937 (26) [back to overview]	Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56
NCT00781937 (26) [back to overview]	Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0
NCT00781937 (26) [back to overview]	Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0
NCT00781937 (26) [back to overview]	Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0
NCT00781937 (26) [back to overview]	Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)
NCT00781937 (26) [back to overview]	Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0
NCT00781937 (26) [back to overview]	Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0
NCT00781937 (26) [back to overview]	Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0
NCT00781937 (26) [back to overview]	Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0
NCT00781937 (26) [back to overview]	Binge Eating Scale Scores by Week and Severity
NCT00781937 (26) [back to overview]	Change From Baseline in Body Mass Index (BMI)
NCT00781937 (26) [back to overview]	Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)
NCT00781937 (26) [back to overview]	Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Hip Circumference at Week 26
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Hip Circumference at Week 52
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Fasting Pro-insulin at Week 52
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Lipids: Triglycerides at Week 26
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Lipids: Triglycerides at Week 52
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Waist Circumference at Week 26.
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Waist Circumference at Week 52.
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Waist to Hip Ratio at Week 26
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Fasting Plasma Glucose at Week 26
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Fasting Pro-insulin at Week 26.
NCT00856986 (30) [back to overview]	Mean Changes From Randomisation in Cholesterol Lipids at Week 26.
NCT00856986 (30) [back to overview]	Mean Changes From Randomisation in Cholesterol Lipids at Week 52.
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Fasting C-peptide at Week 52.
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Fasting C-peptide at Week 26.
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Body Weight at Week 52
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Waist to Hip Ratio at Week 52
NCT00856986 (30) [back to overview]	Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Body Weight at Week 26
NCT00856986 (30) [back to overview]	Adverse Events From Run-in (Week -12) to Week 52
NCT00856986 (30) [back to overview]	Hypoglycaemic Episodes Weeks 0-52
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in Fasting Plasma Glucose at Week 52
NCT00856986 (30) [back to overview]	Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52
NCT01029886 (10) [back to overview]	Percentage of Patients Achieving HbA1c <7.0% at Week 26
NCT01029886 (10) [back to overview]	Ratio of Fasting Triglycerides at Week 26 to Baseline
NCT01029886 (10) [back to overview]	Assessment of Event Rate of Treatment-emergent Hypoglycemic Events
NCT01029886 (10) [back to overview]	Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
NCT01029886 (10) [back to overview]	Change in HbA1c From Baseline to Week 26
NCT01029886 (10) [back to overview]	Change in Total Cholesterol From Baseline to Week 26
NCT01029886 (10) [back to overview]	Change in Fasting Serum Glucose From Baseline to Week 26
NCT01029886 (10) [back to overview]	Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26
NCT01029886 (10) [back to overview]	Change in Body Weight From Baseline to Week 26
NCT01029886 (10) [back to overview]	Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
NCT01117350 (17) [back to overview]	Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period
NCT01117350 (17) [back to overview]	Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period
NCT01117350 (17) [back to overview]	Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period
NCT01117350 (17) [back to overview]	Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period
NCT01117350 (17) [back to overview]	Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period
NCT01117350 (17) [back to overview]	Body Weight: Change From Beginning to End of the Extension Period
NCT01117350 (17) [back to overview]	Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period
NCT01117350 (17) [back to overview]	Daily Dose of Liraglutide
NCT01117350 (17) [back to overview]	Body Weight: Change From Baseline to the End of the Comparative Period
NCT01117350 (17) [back to overview]	Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period
NCT01117350 (17) [back to overview]	Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period
NCT01117350 (17) [back to overview]	Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period
NCT01117350 (17) [back to overview]	Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period
NCT01117350 (17) [back to overview]	Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period
NCT01117350 (17) [back to overview]	Daily Dose of Insulin Glargine
NCT01117350 (17) [back to overview]	Daily Dose of Insulin Glargine Administered During the Extension Period
NCT01117350 (17) [back to overview]	Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period
NCT01128894 (7) [back to overview]	Mean Change From Baseline in Body Weight at Week 32
NCT01128894 (7) [back to overview]	Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32
NCT01128894 (7) [back to overview]	Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32
NCT01128894 (7) [back to overview]	Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32
NCT01128894 (7) [back to overview]	Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26
NCT01128894 (7) [back to overview]	Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26
NCT01128894 (7) [back to overview]	Time to Hyperglycemia Rescue at Week 32
NCT01175473 (10) [back to overview]	Change From Time-matched Baseline in Obestatin Concentration at Day 28
NCT01175473 (10) [back to overview]	Percentages of Patients by Ranges of Oxyntomodulin Levels
NCT01175473 (10) [back to overview]	Change From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28
NCT01175473 (10) [back to overview]	Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28
NCT01175473 (10) [back to overview]	Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28
NCT01175473 (10) [back to overview]	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29
NCT01175473 (10) [back to overview]	Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28
NCT01175473 (10) [back to overview]	Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28
NCT01175473 (10) [back to overview]	Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28
NCT01175473 (10) [back to overview]	Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28
NCT01179048 (6) [back to overview]	Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.
NCT01179048 (6) [back to overview]	Time From Randomisation to All Cause Death
NCT01179048 (6) [back to overview]	Time From Randomisation to First Occurrence of a Composite Microvascular Outcome
NCT01179048 (6) [back to overview]	Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)
NCT01179048 (6) [back to overview]	Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
NCT01179048 (6) [back to overview]	Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.
NCT01232946 (3) [back to overview]	Myocardial Glucose Uptake
NCT01232946 (3) [back to overview]	Myocardial Fatty Acid Oxidation Rate
NCT01232946 (3) [back to overview]	Myocardial Fatty Acid Esterification Rate
NCT01234649 (22) [back to overview]	Matsuda Insulin Sensitivity Index Derived From OGTT
NCT01234649 (22) [back to overview]	Low Density Lipoprotein Cholesterol (LDL-C) Levels
NCT01234649 (22) [back to overview]	Insulinogenic Index (IGI) /HOMA-IR
NCT01234649 (22) [back to overview]	Total Cholesterol (CHOL) Levels
NCT01234649 (22) [back to overview]	Absolute Body Weight
NCT01234649 (22) [back to overview]	Alanine Aminotransferase (ALT) Levels
NCT01234649 (22) [back to overview]	Alanine Aminotransferase /Aspartate Aminotransferase (ALT/AST) Ratio
NCT01234649 (22) [back to overview]	Aspartate Aminotransferase (AST)
NCT01234649 (22) [back to overview]	Body Mass Index (BMI)
NCT01234649 (22) [back to overview]	Change in Body Weight From Baseline to End of Study (Expressed as % Compared to Baseline)
NCT01234649 (22) [back to overview]	Insulin Secretion-Sensitivity Index (IS-SI)
NCT01234649 (22) [back to overview]	Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
NCT01234649 (22) [back to overview]	High Density Lipoprotein Cholesterol (HDL-C) Levels
NCT01234649 (22) [back to overview]	Diastolic Blood Pressure
NCT01234649 (22) [back to overview]	Systolic Blood Pressure
NCT01234649 (22) [back to overview]	Mean Glucose During OGTT (MBG)
NCT01234649 (22) [back to overview]	Fasting Blood Glucose (FBG)
NCT01234649 (22) [back to overview]	Triglyceride (TRG) Levels
NCT01234649 (22) [back to overview]	Triglyceride to High Density Lipoprotein Cholesterol Ratio TRG/HDL-C)
NCT01234649 (22) [back to overview]	Waist Circumference (WC)
NCT01234649 (22) [back to overview]	Waist-to-Hip Ratio (WHR)
NCT01234649 (22) [back to overview]	Waist to Height Ratio (WHtR)
NCT01272219 (12) [back to overview]	Change From Baseline in Fasting Body Weight
NCT01272219 (12) [back to overview]	Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)
NCT01272219 (12) [back to overview]	Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)
NCT01272219 (12) [back to overview]	Change From Baseline in Waist Circumference (cm)
NCT01272219 (12) [back to overview]	Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
NCT01272219 (12) [back to overview]	Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.
NCT01272219 (12) [back to overview]	Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight
NCT01272219 (12) [back to overview]	Proportion of Subjects With Onset of Type 2 Diabetes
NCT01272219 (12) [back to overview]	Pre-diabetes Status After 56 Weeks of Treatment
NCT01272219 (12) [back to overview]	Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment
NCT01272219 (12) [back to overview]	Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)
NCT01272219 (12) [back to overview]	Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
NCT01272232 (12) [back to overview]	Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%
NCT01272232 (12) [back to overview]	Proportion of Subjects Reaching Target HbA1c Below 7%
NCT01272232 (12) [back to overview]	Proportion of Subjects Losing More Than 10% of Baseline Body Weight
NCT01272232 (12) [back to overview]	Proportion of Subjects Losing at Least 5% of Baseline Body Weight
NCT01272232 (12) [back to overview]	Incidence of Hypoglycaemic Episodes
NCT01272232 (12) [back to overview]	Change From Week 56 to 68 in Waist Circumference
NCT01272232 (12) [back to overview]	Change From Baseline in Waist Circumference
NCT01272232 (12) [back to overview]	Change From Baseline in Waist Circumference
NCT01272232 (12) [back to overview]	Change (%) From Baseline in Body Weight (Fasting)
NCT01272232 (12) [back to overview]	Change (%) From Baseline in Body Weight (Fasting)
NCT01272232 (12) [back to overview]	Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)
NCT01272232 (12) [back to overview]	Change (%) From Week 56 to 68 in Body Weight (Fasting)
NCT01296412 (4) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01296412 (4) [back to overview]	Change From Baseline in Hemoglobin A1c (A1C)
NCT01296412 (4) [back to overview]	Percentage of Participants Reaching A1C Goal of <6.5%
NCT01296412 (4) [back to overview]	Percentage of Participants Reaching A1C Goal of <7.0%
NCT01336023 (5) [back to overview]	Number of Hypoglycaemic Episodes
NCT01336023 (5) [back to overview]	Mean Change From Baseline in Body Weight at Week 26
NCT01336023 (5) [back to overview]	Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.
NCT01336023 (5) [back to overview]	Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test
NCT01336023 (5) [back to overview]	Mean Actual Daily Insulin Dose
NCT01373450 (6) [back to overview]	Change From Baseline in Maximum Ambient Glucose Concentration (Gmax) After a Single Dose of OXM
NCT01373450 (6) [back to overview]	Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM)
NCT01373450 (6) [back to overview]	Change From Baseline in Insulinotrophic Effect (ISR/G) After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM
NCT01373450 (6) [back to overview]	Change From Baseline in Insulinotrophic Effect (ISR/G) at the Highest Glucose Infusion Rate After Two Periods of Placebo Treatment
NCT01373450 (6) [back to overview]	Change From Baseline in Gmax After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM
NCT01373450 (6) [back to overview]	Change From Baseline in Beta Cell Sensitivity to Glucose (Φ) After a Single Dose of OXM
NCT01388361 (4) [back to overview]	Change From Baseline in Body Weight
NCT01388361 (4) [back to overview]	Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
NCT01388361 (4) [back to overview]	Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
NCT01388361 (4) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01392573 (2) [back to overview]	Change in Body Weight
NCT01392573 (2) [back to overview]	Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT01473953 (6) [back to overview]	Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity
NCT01473953 (6) [back to overview]	Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment
NCT01473953 (6) [back to overview]	Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
NCT01473953 (6) [back to overview]	Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
NCT01473953 (6) [back to overview]	Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up
NCT01473953 (6) [back to overview]	Number of Treatment Emergent Adverse Events (TEAEs)
NCT01505673 (27) [back to overview]	Glycemic Control Measured by HbA1c
NCT01505673 (27) [back to overview]	Matsuda Index as a Measure of Beta Cell Function
NCT01505673 (27) [back to overview]	Hypoglycemic Events
NCT01505673 (27) [back to overview]	Pancreatic and Hepatic Triglyceride Content
NCT01505673 (27) [back to overview]	Weight
NCT01505673 (27) [back to overview]	AUC Glucose
NCT01505673 (27) [back to overview]	Beta-cell Function
NCT01505673 (27) [back to overview]	Number of Daily Injections
NCT01505673 (27) [back to overview]	Quality of Life Survey (QoL) - Current Health Perception
NCT01505673 (27) [back to overview]	Quality of Life Survey (QoL) - General Health Perception
NCT01505673 (27) [back to overview]	Quality of Life Survey (QoL) - Glycemia Control Perception
NCT01505673 (27) [back to overview]	Quality of Life Survey (QoL) - Hypoglycemia Fear
NCT01505673 (27) [back to overview]	Blood Pressure
NCT01505673 (27) [back to overview]	Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment
NCT01505673 (27) [back to overview]	Quality of Life Survey (QoL) - Social or Vocational Worry
NCT01505673 (27) [back to overview]	Quality of Life Survey (QoL) - Social Stigma
NCT01505673 (27) [back to overview]	Lipid Profile
NCT01505673 (27) [back to overview]	Liver Function Blood Test
NCT01505673 (27) [back to overview]	Total Daily Insulin Dose
NCT01505673 (27) [back to overview]	Quality of Life Survey (QoL) - Lifestyle Flexibility
NCT01505673 (27) [back to overview]	Beta-Cell Function
NCT01505673 (27) [back to overview]	Beta-Cell Function
NCT01505673 (27) [back to overview]	Quality of Life Survey (QoL) - Treatment Impact
NCT01505673 (27) [back to overview]	Quality of Life Survey (QoL) - Treatment Satisfaction
NCT01505673 (27) [back to overview]	Glucagon
NCT01505673 (27) [back to overview]	Ratio (AUC C-peptide/AUC Glucose)
NCT01505673 (27) [back to overview]	Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment
NCT01512108 (4) [back to overview]	Change in FPG From Baseline to Week 52
NCT01512108 (4) [back to overview]	Incidence of Treatment Emergent Adverse Events (AEs)
NCT01512108 (4) [back to overview]	Number of Confirmed Hypoglycaemic Episodes
NCT01512108 (4) [back to overview]	Change in HbA1c From Baseline to Week 52
NCT01541215 (80) [back to overview]	Number of Hypoglycaemic Episodes
NCT01541215 (80) [back to overview]	Number of Adverse Events (Week 53-156)
NCT01541215 (80) [back to overview]	Number of Adverse Events (Week 53-104)
NCT01541215 (80) [back to overview]	Number of Adverse Events (Week 0-52)
NCT01541215 (80) [back to overview]	Number of Adverse Events (Week 0-26)
NCT01541215 (80) [back to overview]	Height Velocity SDS- Week 156
NCT01541215 (80) [back to overview]	Height Velocity SDS- Week 104
NCT01541215 (80) [back to overview]	Height Velocity SDS
NCT01541215 (80) [back to overview]	Height Velocity SDS
NCT01541215 (80) [back to overview]	Growth (Height Velocity)- Week 156
NCT01541215 (80) [back to overview]	Growth (Height Velocity)- Week 104
NCT01541215 (80) [back to overview]	Growth (Height Velocity)
NCT01541215 (80) [back to overview]	Growth (Height Velocity)
NCT01541215 (80) [back to overview]	Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
NCT01541215 (80) [back to overview]	Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
NCT01541215 (80) [back to overview]	Change in Mean 7-point Self-measured Plasma Glucose
NCT01541215 (80) [back to overview]	Change in HbA1c (Glycosylated Haemoglobin)
NCT01541215 (80) [back to overview]	Change in HbA1c
NCT01541215 (80) [back to overview]	Change in FPG
NCT01541215 (80) [back to overview]	Change in Bone Age Assessment (X-ray of Left Hand and Wrist)
NCT01541215 (80) [back to overview]	Change From Week 52 in Height SDS- Week 156
NCT01541215 (80) [back to overview]	Change From Week 52 in Height SDS- Week 104
NCT01541215 (80) [back to overview]	Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156
NCT01541215 (80) [back to overview]	Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104
NCT01541215 (80) [back to overview]	Change From Baseline in Pulse
NCT01541215 (80) [back to overview]	Change From Baseline in Pulse
NCT01541215 (80) [back to overview]	Change From Baseline in Height SDS
NCT01541215 (80) [back to overview]	Change From Baseline in Height SDS
NCT01541215 (80) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01541215 (80) [back to overview]	Change From Baseline in Body Weight
NCT01541215 (80) [back to overview]	Change From Baseline in Body Weight
NCT01541215 (80) [back to overview]	Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)
NCT01541215 (80) [back to overview]	Change From Baseline in BMI Standard Deviation Score (SDS)
NCT01541215 (80) [back to overview]	Change From Baseline in 7-point Self-measured Plasma Glucose
NCT01541215 (80) [back to overview]	Number of Serious Adverse Events (Week 53-104)
NCT01541215 (80) [back to overview]	Pubertal Assessment/Progression (Tanner Staging)
NCT01541215 (80) [back to overview]	Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156
NCT01541215 (80) [back to overview]	Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104
NCT01541215 (80) [back to overview]	Number of Subjects Having HbA1c Maximum 6.5%
NCT01541215 (80) [back to overview]	Number of Subjects Having HbA1c Maximum 6.5%
NCT01541215 (80) [back to overview]	Number of Subjects Having HbA1c Below 7.5%
NCT01541215 (80) [back to overview]	Number of Subjects Having HbA1c Below 7.5%
NCT01541215 (80) [back to overview]	Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
NCT01541215 (80) [back to overview]	Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
NCT01541215 (80) [back to overview]	Number of Subjects Having HbA1c Below 7.0%
NCT01541215 (80) [back to overview]	Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
NCT01541215 (80) [back to overview]	Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
NCT01541215 (80) [back to overview]	Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
NCT01541215 (80) [back to overview]	Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
NCT01541215 (80) [back to overview]	Ratio to Baseline: VLDL Cholesterol
NCT01541215 (80) [back to overview]	Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol
NCT01541215 (80) [back to overview]	Ratio to Baseline: Triglycerides
NCT01541215 (80) [back to overview]	Ratio to Baseline: Triglycerides
NCT01541215 (80) [back to overview]	Ratio to Baseline: Total Cholesterol
NCT01541215 (80) [back to overview]	Ratio to Baseline: Total Cholesterol
NCT01541215 (80) [back to overview]	Ratio to Baseline: Pro-insulin/Insulin Ratio
NCT01541215 (80) [back to overview]	Ratio to Baseline: Pro-insulin/Insulin Ratio
NCT01541215 (80) [back to overview]	Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol
NCT01541215 (80) [back to overview]	Ratio to Baseline: LDL Cholesterol
NCT01541215 (80) [back to overview]	Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
NCT01541215 (80) [back to overview]	Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
NCT01541215 (80) [back to overview]	Ratio to Baseline: HOMA-IR
NCT01541215 (80) [back to overview]	Ratio to Baseline: HOMA-B
NCT01541215 (80) [back to overview]	Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol
NCT01541215 (80) [back to overview]	Ratio to Baseline: HDL Cholesterol
NCT01541215 (80) [back to overview]	Ratio to Baseline: Free Fatty Acids
NCT01541215 (80) [back to overview]	Ratio to Baseline: Free Fatty Acids
NCT01541215 (80) [back to overview]	Ratio to Baseline: Fasting Pro-insulin
NCT01541215 (80) [back to overview]	Ratio to Baseline: Fasting Pro-insulin
NCT01541215 (80) [back to overview]	Ratio to Baseline: Fasting Insulin
NCT01541215 (80) [back to overview]	Ratio to Baseline: Fasting Insulin
NCT01541215 (80) [back to overview]	Ratio to Baseline: Fasting Glucagon
NCT01541215 (80) [back to overview]	Ratio to Baseline: Fasting Glucagon
NCT01541215 (80) [back to overview]	Ratio to Baseline: Fasting C-peptide
NCT01541215 (80) [back to overview]	Ratio to Baseline: Fasting C-peptide
NCT01541215 (80) [back to overview]	Number of Subjects Having HbA1c Below 7.0%
NCT01541215 (80) [back to overview]	Number of Serious Adverse Events (Week 53-156)
NCT01541215 (80) [back to overview]	Number of Serious Adverse Events (Week 0-52)
NCT01541215 (80) [back to overview]	Number of Serious Adverse Events (Week 0-26)
NCT01541215 (80) [back to overview]	Number of Hypoglycaemic Episodes
NCT01557166 (4) [back to overview]	Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
NCT01557166 (4) [back to overview]	Change From Baseline in Fasting Plasma Glucose
NCT01557166 (4) [back to overview]	Change From Baseline in Body Weight (kg)
NCT01557166 (4) [back to overview]	Change From Baseline in Apnoea-hypopnoea Index (AHI)
NCT01558271 (19) [back to overview]	Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks
NCT01558271 (19) [back to overview]	Percentage of Participants Who Achieved HbA1c <=6.5% or <7%
NCT01558271 (19) [back to overview]	Percentage of Participants With Hypoglycemic Episodes
NCT01558271 (19) [back to overview]	Change From Baseline in Body Weight at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	Number of Participants With Treatment-Emergent LY2189265 Anti-Drug Antibodies (ADAs) at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	Change From Baseline in Pulse Rate at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	Change From Baseline in Serum Calcitonin at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	Number of Participants With Adjudicated Cardiovascular Events at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	Number of Participants With Adjudicated Pancreatitis at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
NCT01558271 (19) [back to overview]	30-Day Rate of Hypoglycemic Episodes
NCT01558271 (19) [back to overview]	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks
NCT01562678 (1) [back to overview]	Change Between Highly Desirable vs. Less Desirable Food Cues in the Effect Size of Cortical Activation During Food Visualization
NCT01572740 (12) [back to overview]	Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36
NCT01572740 (12) [back to overview]	Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16
NCT01572740 (12) [back to overview]	Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36
NCT01572740 (12) [back to overview]	Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16
NCT01572740 (12) [back to overview]	Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
NCT01572740 (12) [back to overview]	Change in Body Weight From Baseline to Week 36
NCT01572740 (12) [back to overview]	Change in Body Weight From Baseline to Week 16
NCT01572740 (12) [back to overview]	Number of Adverse Events (AEs)
NCT01572740 (12) [back to overview]	Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36
NCT01572740 (12) [back to overview]	Number of Confirmed Hypoglycaemic Episodes
NCT01572740 (12) [back to overview]	Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36
NCT01572740 (12) [back to overview]	Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16
NCT01596504 (17) [back to overview]	Change From Baseline to Day 56 in Corrected C-Peptide AUC From Time 0.5 Hours to 5.5 Hours
NCT01596504 (17) [back to overview]	Change From Baseline to Day 55 in Gastric Emptying Coefficient
NCT01596504 (17) [back to overview]	Change From Baseline to Day 55 in Gastric Emptying Half Life (t1/2)
NCT01596504 (17) [back to overview]	Change From Baseline to Day 56 in Average 7-Point Self-Monitored Plasma Glucose (SMPG)
NCT01596504 (17) [back to overview]	Change From Baseline to Day 57/58 in 24-Hour Mean Systolic Blood Pressure and Diastolic Blood Pressure
NCT01596504 (17) [back to overview]	Change From Baseline to Day 56 in Corrected Glucagon AUC From Time 0.5 Hours to 5.5 Hours
NCT01596504 (17) [back to overview]	Number of Participants With 2-Hour Post-prandial Plasma Glucose (PPG) <7.77 (mmol/L) at Day 56
NCT01596504 (17) [back to overview]	Change From Baseline to Day 57/58 in 24-Hour Mean Heart Rate
NCT01596504 (17) [back to overview]	Change From Baseline to Day 57 in Waist Circumference
NCT01596504 (17) [back to overview]	Change From Baseline to Day 57 in Body Weight
NCT01596504 (17) [back to overview]	Change From Baseline to Day 56 in PPG Excursion
NCT01596504 (17) [back to overview]	Change From Baseline to Day 56 in Plasma Glucose Corrected AUC From Time 0.5 Hours to 5.5 Hours
NCT01596504 (17) [back to overview]	Change From Baseline to Day 56 in the Cumulative Score Mean on the Appetite Perception Using a Visual Analogue Scale After Standardized Solid Breakfast
NCT01596504 (17) [back to overview]	Change From Baseline to Day 56 in HbA1c
NCT01596504 (17) [back to overview]	Change From Baseline to Day 56 in Fasting Plasma Glucose (FPG)
NCT01596504 (17) [back to overview]	Change From Baseline to Day 56 in Average Daily Insulin Glargine Dose
NCT01596504 (17) [back to overview]	Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours
NCT01617434 (9) [back to overview]	Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26
NCT01617434 (9) [back to overview]	Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period
NCT01617434 (9) [back to overview]	Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period
NCT01617434 (9) [back to overview]	Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)
NCT01617434 (9) [back to overview]	Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)
NCT01617434 (9) [back to overview]	Number of Adverse Events (AEs) During The Randomised Treatment Period
NCT01617434 (9) [back to overview]	Change in Body Weight From Baseline to Week 26
NCT01617434 (9) [back to overview]	Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
NCT01617434 (9) [back to overview]	Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26
NCT01618162 (7) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01618162 (7) [back to overview]	Change From Baseline in Body Weight
NCT01618162 (7) [back to overview]	Number of Adverse Events (AEs)
NCT01618162 (7) [back to overview]	Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes
NCT01618162 (7) [back to overview]	Change in Glycosylated Haemoglobin (HbA1c)
NCT01618162 (7) [back to overview]	Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
NCT01618162 (7) [back to overview]	Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
NCT01620489 (6) [back to overview]	Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment
NCT01620489 (6) [back to overview]	Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment
NCT01620489 (6) [back to overview]	Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)
NCT01620489 (6) [back to overview]	Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)
NCT01620489 (6) [back to overview]	Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles
NCT01620489 (6) [back to overview]	Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)
NCT01624259 (23) [back to overview]	Change From Baseline in Blood Pressure (BP) at 26 Weeks
NCT01624259 (23) [back to overview]	Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia
NCT01624259 (23) [back to overview]	Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia
NCT01624259 (23) [back to overview]	Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose
NCT01624259 (23) [back to overview]	Number of Participants With Allergic or Hypersensitivity Reactions
NCT01624259 (23) [back to overview]	Number of Participants With Adjudicated Acute Pancreatitis Events
NCT01624259 (23) [back to overview]	Change From Baseline in Calcitonin at 26 Weeks
NCT01624259 (23) [back to overview]	Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks
NCT01624259 (23) [back to overview]	Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks
NCT01624259 (23) [back to overview]	Change From Baseline in Heart Rate (HR) at 26 Weeks
NCT01624259 (23) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks
NCT01624259 (23) [back to overview]	Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks
NCT01624259 (23) [back to overview]	Percent Change From Baseline in Lipid Parameters at 26 Weeks
NCT01624259 (23) [back to overview]	Change From Baseline in Body Weight at 26 Weeks
NCT01624259 (23) [back to overview]	Change From Baseline in Body Mass Index (BMI) at 26 Weeks
NCT01624259 (23) [back to overview]	Change From Baseline in Amylase at 26 Weeks
NCT01624259 (23) [back to overview]	Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks
NCT01624259 (23) [back to overview]	Change From Baseline in Lipase at 26 Weeks
NCT01624259 (23) [back to overview]	Number of Participants With Reported and Adjudicated Cardiovascular Events
NCT01624259 (23) [back to overview]	Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals at 26 Weeks
NCT01624259 (23) [back to overview]	Rate of Hypoglycemic Events Adjusted Per 30 Days
NCT01624259 (23) [back to overview]	Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
NCT01624259 (23) [back to overview]	Percentage of Participants With Self-Reported Hypoglycemia Events
NCT01664247 (9) [back to overview]	Change From Baseline in Mean Pre-breakfast Measurements Used for Titration
NCT01664247 (9) [back to overview]	Change From Baseline in Mean of the 8-point Profile
NCT01664247 (9) [back to overview]	Number of Hypoglycaemic Episodes
NCT01664247 (9) [back to overview]	Number of Responders for HbA1c (Below 7.0 %)
NCT01664247 (9) [back to overview]	Number of Adverse Events
NCT01664247 (9) [back to overview]	Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
NCT01664247 (9) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01664247 (9) [back to overview]	Change From Baseline in 8-point Profile
NCT01664247 (9) [back to overview]	Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)
NCT01676116 (9) [back to overview]	Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
NCT01676116 (9) [back to overview]	Number of Severe or Minor Hypoglycaemic Episodes
NCT01676116 (9) [back to overview]	Number of Adverse Events (AEs)
NCT01676116 (9) [back to overview]	Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)
NCT01676116 (9) [back to overview]	Change From Baseline in Body Weight
NCT01676116 (9) [back to overview]	Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
NCT01676116 (9) [back to overview]	Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).
NCT01676116 (9) [back to overview]	Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)
NCT01676116 (9) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG)
NCT01722266 (5) [back to overview]	Change in HbA1c From Baseline at 12 Weeks
NCT01722266 (5) [back to overview]	Change in Body Weight From Baseline at Week 12
NCT01722266 (5) [back to overview]	Carbohydrate Intake
NCT01722266 (5) [back to overview]	Change in Total Insulin Dose From Baseline at 12 Weeks
NCT01722266 (5) [back to overview]	Change in Mean Weekly Glucose Concentrations From Baseline at 12 Weeks
NCT01725126 (61) [back to overview]	Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Hematology Parameters of Red Blood Cell (RBC) Count and Reticulocytes During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Change From Baseline in Hematology Parameters of RBC Count and Reticulocytes During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Change From Baseline in Hematology Parameters of Hemoglobin and MCHC During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Change From Baseline in Hematology Parameter of MCV During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Hematology Parameter of MCH During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Change From Baseline in Fasting Plasma Glucose (Safety Laboratory) Values During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Fasting Insulin and Weighted Mean Insulin AUC (0-4 Hour) and AUC (0-24 Hour) During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Electrocardiogram (ECG) Intervals During Part A
NCT01725126 (61) [back to overview]	Change From Baseline in ECG Intervals During Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of Total Thyroxine and Total T3 During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of Thyroid Stimulating Hormone During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of Thyroid Stimulating Hormone During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic, BUN and Cholesterol During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic and Urea/Blood Urea Nitrogen (BUN) During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of Amylase and Lipase the Double-blind Treatment Period of Part B of Study
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of ALP, ALT, AST and GGT During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), ALT, Aspartate Aminotransferase (AST) and Gamma Glutamyltransferase (GGT) During Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	AUC of Metformin From Time 0 to 10 Hours Post-dose (AUC [0-10 Hour]) During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Area Under Plasma Concentration From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Liraglutide During the Double-blind Treatment Period of Part B
NCT01725126 (61) [back to overview]	Number of Participants With Any Hypoglycemic Events During Part B and Part C
NCT01725126 (61) [back to overview]	Number of Participants With Any Hypoglycemic Events During Part A
NCT01725126 (61) [back to overview]	Change From Baseline in Matsuda Index During the Double Blind-treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR]) During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Glycated Hemoglobin (HbA1c) During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Fasting Glucose During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Clinical Chemistry Parameter of Triiodothyronine (T3) Uptake During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part C
NCT01725126 (61) [back to overview]	Tmax of Metformin During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Time of Occurrence of Cmax (Tmax) of Liraglutide During the Double-blind Treatment Period of Part B
NCT01725126 (61) [back to overview]	Percent Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Number of Participants With Any AE, SAE or Death During Part B and Part C
NCT01725126 (61) [back to overview]	Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE) or Death During Part A
NCT01725126 (61) [back to overview]	Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part B
NCT01725126 (61) [back to overview]	Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Mean pH Values of Urine During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Mean pH Values of Urine During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Maximum Observed Concentration (Cmax) of Liraglutide During the Double-blind Treatment Period of Part B
NCT01725126 (61) [back to overview]	Cmax of Metformin During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Change From Baseline in Weighted Mean Glucose Area Under the Curves From Time 0 to 24 Hours (AUC [0-24 Hours]) During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Change From Baseline in Vital Sign Parameter of SBP and DBP During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Vital Sign Parameter of HR During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in Vital Sign Parameter of Heart Rate (HR) During the Double-blind Treatment Period of Part A
NCT01725126 (61) [back to overview]	Change From Baseline in the Overall GSRS Score During the Double-blind Treatment Period of Part B and C
NCT01725126 (61) [back to overview]	Change From Baseline in the Overall Gastrointestinal (GI) Symptoms Rating Scale (GSRS) Score During the Double-blind Treatment Period of Part A
NCT01733758 (11) [back to overview]	Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52
NCT01733758 (11) [back to overview]	Change From Baseline in HbA1c at Week 52
NCT01733758 (11) [back to overview]	Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
NCT01733758 (11) [back to overview]	Change From Baseline in Body Weight at Week 52
NCT01733758 (11) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
NCT01733758 (11) [back to overview]	Time to Study Withdrawal Due to Hyperglycemia
NCT01733758 (11) [back to overview]	Time to Study Withdrawal for Any Reason
NCT01733758 (11) [back to overview]	Change From Baseline in Body Weight at Week 24
NCT01733758 (11) [back to overview]	Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24
NCT01733758 (11) [back to overview]	Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24
NCT01733758 (11) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
NCT01753362 (2) [back to overview]	Glucose Concentrations
NCT01753362 (2) [back to overview]	HbA1c
NCT01755416 (1) [back to overview]	Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone
NCT01779362 (4) [back to overview]	ACPRg
NCT01779362 (4) [back to overview]	ß-cell Response Measured by Hyperglycemic Clamp
NCT01779362 (4) [back to overview]	ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12
NCT01779362 (4) [back to overview]	Insulin Sensitivity, M/I
NCT01784965 (3) [back to overview]	Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction
NCT01784965 (3) [back to overview]	Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H
NCT01784965 (3) [back to overview]	Change in Weight Reported at 14 Weeks
NCT01787916 (1) [back to overview]	Assessment of Changes in Glycemic Control by HbA1c.
NCT01800968 (19) [back to overview]	Individual Component of the Primary Endpoint- Heart Failure Hospitalization
NCT01800968 (19) [back to overview]	Individual Component of the Primary Endpoint- Mortality
NCT01800968 (19) [back to overview]	Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
NCT01800968 (19) [back to overview]	Global Ranking of Predefined Events
NCT01800968 (19) [back to overview]	Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.
NCT01800968 (19) [back to overview]	Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP
NCT01800968 (19) [back to overview]	Change in Lateral Filling Pressure
NCT01800968 (19) [back to overview]	Global Ranking of Predefined Events
NCT01800968 (19) [back to overview]	Change in Medial Filling Pressure
NCT01800968 (19) [back to overview]	Change in Left Ventricular End-systolic Volume Index
NCT01800968 (19) [back to overview]	Change in Left Ventricular Ejection Fraction
NCT01800968 (19) [back to overview]	Change in 6 Minute Walk Distance
NCT01800968 (19) [back to overview]	Change in 6 Minute Walk Distance
NCT01800968 (19) [back to overview]	Change in 6 Minute Walk Distance
NCT01800968 (19) [back to overview]	Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
NCT01800968 (19) [back to overview]	Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
NCT01800968 (19) [back to overview]	Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
NCT01800968 (19) [back to overview]	Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
NCT01800968 (19) [back to overview]	Change in Left Ventricular End-Diastolic Volume Index
NCT01832532 (1) [back to overview]	Change in Apnea Hypopnea Index (AHI) From Baseline
NCT01836523 (4) [back to overview]	Change From Baseline in Body Weight
NCT01836523 (4) [back to overview]	Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT01836523 (4) [back to overview]	Change From Baseline in Total Daily Insulin Dose
NCT01836523 (4) [back to overview]	Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes
NCT01847313 (4) [back to overview]	Urinary Albumin Excretion Rate
NCT01847313 (4) [back to overview]	sCD163 in Serum
NCT01847313 (4) [back to overview]	sCD163:Creatinine Ratio in Urine
NCT01847313 (4) [back to overview]	MCP-1:Creatinine Ratio in Urine
NCT01856790 (10) [back to overview]	the Incremental Meal-related Glucose Area Under Curve (AUC)
NCT01856790 (10) [back to overview]	Mean Nocturnal Glucose Levels
NCT01856790 (10) [back to overview]	AUC Plasma Glucagon During MMTT
NCT01856790 (10) [back to overview]	Differences in Daily Insulin Requirements
NCT01856790 (10) [back to overview]	Incremental Glucagon Peak
NCT01856790 (10) [back to overview]	Mean 24-hour Glucose Levels
NCT01856790 (10) [back to overview]	Mean Daytime Glucose Levels
NCT01856790 (10) [back to overview]	Mean Time to Peak Post-meal Glucose Value
NCT01856790 (10) [back to overview]	Peak Post-prandial Venous Glucose Levels
NCT01856790 (10) [back to overview]	Prandial Insulin Delivery During Closed Loop Therapy
NCT01870297 (5) [back to overview]	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
NCT01870297 (5) [back to overview]	Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose
NCT01870297 (5) [back to overview]	PK: Maximum Concentration (Cmax) of LY3025876
NCT01870297 (5) [back to overview]	Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies
NCT01870297 (5) [back to overview]	Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876
NCT01907854 (7) [back to overview]	Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)
NCT01907854 (7) [back to overview]	Change in Systolic Blood Pressure and Diastolic Blood Pressure
NCT01907854 (7) [back to overview]	Change in Fasting Blood Lipids
NCT01907854 (7) [back to overview]	Change in HbA1c (Glycosylated Haemoglobin)
NCT01907854 (7) [back to overview]	Number of Treatment Emergent Adverse Events (TEAEs)
NCT01907854 (7) [back to overview]	Change in Fasting Plasma Glucose
NCT01907854 (7) [back to overview]	Change in Body Weight
NCT01917656 (10) [back to overview]	Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.
NCT01917656 (10) [back to overview]	Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)
NCT01917656 (10) [back to overview]	Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes
NCT01917656 (10) [back to overview]	Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.
NCT01917656 (10) [back to overview]	Change in Fructosamine From Start of Ramadan to End of Ramadan
NCT01917656 (10) [back to overview]	Fructosamine at End of Ramadan
NCT01917656 (10) [back to overview]	Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)
NCT01917656 (10) [back to overview]	Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)
NCT01917656 (10) [back to overview]	Change From Baseline to End of Ramadan in Fasting Plasma Glucose
NCT01917656 (10) [back to overview]	Change From Baseline to End of Ramadan in Body Weight
NCT01919489 (15) [back to overview]	Hypoglycemic Episodes
NCT01919489 (15) [back to overview]	HbA1c <7.0% and no Weight Gain
NCT01919489 (15) [back to overview]	Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up
NCT01919489 (15) [back to overview]	Change in Body Weight From Baseline
NCT01919489 (15) [back to overview]	Total Daily Dose of Insulin
NCT01919489 (15) [back to overview]	Cardiovascular Risk Factor: Heart Rate
NCT01919489 (15) [back to overview]	Change in BMI
NCT01919489 (15) [back to overview]	HbA1c <7.0% and no Hypoglycemia
NCT01919489 (15) [back to overview]	Cardiovascular Risk Factor: Lipid Profile
NCT01919489 (15) [back to overview]	Acute Renal Failure
NCT01919489 (15) [back to overview]	HbA1c <7.0% and no Hypoglycemia
NCT01919489 (15) [back to overview]	Change in Cardiovascular Risk Factors: Blood Pressure
NCT01919489 (15) [back to overview]	Emergency Room Visits and Readmissions
NCT01919489 (15) [back to overview]	Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks
NCT01919489 (15) [back to overview]	Glycemic Control at Hospital Discharge and 6 Months Follow up
NCT01937598 (9) [back to overview]	AUC Total GIP
NCT01937598 (9) [back to overview]	AUC Total GLP-1
NCT01937598 (9) [back to overview]	Incremental Area Under the Plasma Glucose (BG) Concentration-time Profile (AUC)
NCT01937598 (9) [back to overview]	AUC Active GIP
NCT01937598 (9) [back to overview]	AUC Active GLP-1
NCT01937598 (9) [back to overview]	AUC C-peptide
NCT01937598 (9) [back to overview]	AUC Glucagon
NCT01937598 (9) [back to overview]	AUC Insulin
NCT01937598 (9) [back to overview]	AUC Plasma Glucose
NCT01952145 (3) [back to overview]	Change From Baseline in Body Weight
NCT01952145 (3) [back to overview]	Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT01952145 (3) [back to overview]	Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
NCT01966978 (8) [back to overview]	Change in Short Form-36 (SF-36) Questionnaire Score
NCT01966978 (8) [back to overview]	Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means
NCT01966978 (8) [back to overview]	Percentage of Participants Reaching Target A1c of <7% at Week 26
NCT01966978 (8) [back to overview]	Mean Change From Randomization in Body Weight
NCT01966978 (8) [back to overview]	Mean Change From Randomization in A1c at Week 26
NCT01966978 (8) [back to overview]	Hypoglycemic Episodes
NCT01966978 (8) [back to overview]	"Percentage of Participants Reaching Pre-specified Treatment Failure Outcome"
NCT01966978 (8) [back to overview]	Composite End-point
NCT01973231 (7) [back to overview]	Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no)
NCT01973231 (7) [back to overview]	Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)
NCT01973231 (7) [back to overview]	Change in Body Weight From Baseline
NCT01973231 (7) [back to overview]	Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)
NCT01973231 (7) [back to overview]	Number of Treatment Emergent Adverse Events (TEAEs)
NCT01973231 (7) [back to overview]	Change in Glycosylated Haemoglobin (HbA1c) From Baseline
NCT01973231 (7) [back to overview]	Change in Fasting Plasma Glucose (FPG) From Baseline
NCT01982630 (53) [back to overview]	Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs) in Part 1
NCT01982630 (53) [back to overview]	Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs) in Part 2
NCT01982630 (53) [back to overview]	Number of Participants Experiencing Adverse Events (AEs) in Part 1
NCT01982630 (53) [back to overview]	Number of Participants Experiencing Adverse Events (AEs) in Part 2
NCT01982630 (53) [back to overview]	Time to Maximum Concentration (Tmax) of MK-8521 on Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
NCT01982630 (53) [back to overview]	Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Maximum Concentration (Cmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
NCT01982630 (53) [back to overview]	Maximum Concentration (Cmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
NCT01982630 (53) [back to overview]	Maximum Concentration (Cmax) of MK-8521 on Days 1 and 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Time to Maximum Concentration (Tmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
NCT01982630 (53) [back to overview]	Time to Maximum Concentration (Tmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
NCT01982630 (53) [back to overview]	Time to Maximum Concentration (Tmax) of MK-8521 on Days 1 and 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Trough Concentration (Ctrough) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
NCT01982630 (53) [back to overview]	Trough Concentration (Ctrough) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
NCT01982630 (53) [back to overview]	Trough Concentration (Ctrough) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Accumulation Ratio of the Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
NCT01982630 (53) [back to overview]	Accumulation Ratio of the Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Accumulation Ratio of the Maximum Concentration (Cmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Accumulation Ratio of the Trough Concentration (Ctrough) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Apparent Terminal Half Life (t1/2) of MK-8521 on Day 14 for Non-Diabetic Overweight/Obese Participants in Part 2
NCT01982630 (53) [back to overview]	Apparent Terminal Half Life (t1/2) of MK-8521 on Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Apparent Terminal Half Life (t1/2) of MK-8521 on Day 29 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 19 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 24 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 29 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) at Day 19 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) at Day 24 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) at Day 29 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) at Day 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Change From Baseline in Peak Heart Rate (PHR) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Peak Heart Rate (PHR) at Day 19 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Peak Heart Rate (PHR) at Day 24 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Peak Heart Rate (PHR) at Day 29 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Peak Heart Rate (PHR) at Day 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 14 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 19 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 24 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 29 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 7 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 14 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 14 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 19 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 24 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 29 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 7 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT01982630 (53) [back to overview]	Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 7 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
NCT01982630 (53) [back to overview]	Maximum Concentration (Cmax) of MK-8521 on Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
NCT02008682 (6) [back to overview]	Change From Baseline in Fasting Plasma Glucose
NCT02008682 (6) [back to overview]	Change From Baseline in Glycosylated Haemoglobin (HbA1c)
NCT02008682 (6) [back to overview]	Number of Confirmed Hypoglycaemic Episodes
NCT02008682 (6) [back to overview]	Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target)
NCT02008682 (6) [back to overview]	Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)
NCT02008682 (6) [back to overview]	Change From Baseline in 7-point Self-measured Plasma Glucose Profile
NCT02014740 (1) [back to overview]	Echocardiographic Epicardial Fat Thickness
NCT02060383 (7) [back to overview]	Change in HbA1c From Randomization to Approximately 16 Weeks
NCT02060383 (7) [back to overview]	Change in HbA1c From Randomization (R) Over Time Per Randomized Arm
NCT02060383 (7) [back to overview]	Percentage of Participants in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin
NCT02060383 (7) [back to overview]	Percentage of Participants With ≤ 0.3% HbA1c Increase to End of Core Phase
NCT02060383 (7) [back to overview]	Absolute Change in FPG From Baseline to End of Core Phase
NCT02060383 (7) [back to overview]	Absolute Change in HbA1c From Baseline to End of Core Phase
NCT02060383 (7) [back to overview]	Change in FPG (Fasting Plasma Glucose) From Randomization Until End of Core Phase
NCT02072096 (6) [back to overview]	Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)
NCT02072096 (6) [back to overview]	Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia
NCT02072096 (6) [back to overview]	Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy
NCT02072096 (6) [back to overview]	Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia
NCT02072096 (6) [back to overview]	Change From Baseline of Urinary Albumin to Creatinine Ratio
NCT02072096 (6) [back to overview]	Change From Baseline in Body Mass Index (BMI)
NCT02073929 (11) [back to overview]	Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)
NCT02073929 (11) [back to overview]	Change in Endogenous Thrombin Potential (ETP)
NCT02073929 (11) [back to overview]	Change in Body Composition (VAT)
NCT02073929 (11) [back to overview]	Change in Bleeding Pattern (Bleeding Ratio)
NCT02073929 (11) [back to overview]	Change in Plasma Level of Atrial Natriuretic Peptide (ANP)
NCT02073929 (11) [back to overview]	Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1
NCT02073929 (11) [back to overview]	Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)
NCT02073929 (11) [back to overview]	Change in Serum Levels of Anti-Müllerian Hormone
NCT02073929 (11) [back to overview]	Change in Plasma Level of Copeptin
NCT02073929 (11) [back to overview]	Change in Plasma Level of Adrenomedullin
NCT02073929 (11) [back to overview]	Change in Percent Liver Fat Content
NCT02098395 (3) [back to overview]	Change From Baseline in Body Weight
NCT02098395 (3) [back to overview]	Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes
NCT02098395 (3) [back to overview]	Change From Baseline in Glycosylated Haemoglobin (HbA1c)
NCT02100475 (3) [back to overview]	Change From Baseline in HbA1c (Glycosylated Haemoglobin)
NCT02100475 (3) [back to overview]	Change From Baseline in Body Weight
NCT02100475 (3) [back to overview]	Number of Treatment-emergent Confirmed Hypoglycaemic Episodes
NCT02298192 (4) [back to overview]	HbA1c Below or Equal to 6.5%
NCT02298192 (4) [back to overview]	HbA1c Below 7.0%
NCT02298192 (4) [back to overview]	Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
NCT02298192 (4) [back to overview]	Change From Baseline in HbA1c
NCT02299388 (2) [back to overview]	Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.
NCT02299388 (2) [back to overview]	Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors.
NCT02324842 (8) [back to overview]	Change in Matsuda Index of Insulin Sensitivity, Insulin Secretion, and Beta Cell Function During Oral Glucose Tolerance Test (OGTT)
NCT02324842 (8) [back to overview]	Change in Free Plasma Insulin at the End of the Study From Baseline Value
NCT02324842 (8) [back to overview]	Change in 24-hour Blood Pressure at Study End Compared to Baseline.
NCT02324842 (8) [back to overview]	Change in Plasma Glucagon Concentration at the End of the Study Compared to Baseline
NCT02324842 (8) [back to overview]	Change in Total Body Weight at Study End Compared to Baseline
NCT02324842 (8) [back to overview]	Fasting Plasma Glucose (FPG) at 4 Months
NCT02324842 (8) [back to overview]	HbA1c at 4 Months
NCT02324842 (8) [back to overview]	Body Mass Index (BMI) at 4 Months
NCT02420262 (5) [back to overview]	Responder for HbA1c Below or Equal to 6.5 %
NCT02420262 (5) [back to overview]	Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.
NCT02420262 (5) [back to overview]	Change in HbA1c (Glycosylated Haemoglobin)
NCT02420262 (5) [back to overview]	Change in Body Weight
NCT02420262 (5) [back to overview]	Responder for HbA1c Below 7.0%
NCT02443155 (115) [back to overview]	Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner
NCT02443155 (115) [back to overview]	Change in Biochemistry: Alanine Aminotransferase (ALAT)
NCT02443155 (115) [back to overview]	Change in Biochemistry: Albumin
NCT02443155 (115) [back to overview]	Change in Biochemistry: Alkaline Phosphatase (ALP)
NCT02443155 (115) [back to overview]	Change in Biochemistry: Amylase
NCT02443155 (115) [back to overview]	Change in Biochemistry: Aspartate Aminotransferase (ASAT)
NCT02443155 (115) [back to overview]	Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006)
NCT02443155 (115) [back to overview]	Change in Biochemistry: Blood Urea Nitrogen Serum
NCT02443155 (115) [back to overview]	Change in Biochemistry: C-reactive Protein Serum
NCT02443155 (115) [back to overview]	Change in Biochemistry: Calcium Corrected
NCT02443155 (115) [back to overview]	Change in Biochemistry: Chloride
NCT02443155 (115) [back to overview]	Occurrence of Anti-NNC0114-0006 Antibodies
NCT02443155 (115) [back to overview]	Occurrence of Anti-liraglutide Antibodies
NCT02443155 (115) [back to overview]	Diabetes Retinopathy
NCT02443155 (115) [back to overview]	Change in Urinalysis: Urine Dipsticks
NCT02443155 (115) [back to overview]	Change in Physical Examination
NCT02443155 (115) [back to overview]	Change in Eye-examination
NCT02443155 (115) [back to overview]	Change in Electrocardiogram (ECG)
NCT02443155 (115) [back to overview]	Autoantibodies Against Zinc-transporter 8 (ZnT8)
NCT02443155 (115) [back to overview]	Autoantibodies Against Islet Antigen-2 (IA2)
NCT02443155 (115) [back to overview]	Autoantibodies Against Insulin Autoantibodies (IAA)
NCT02443155 (115) [back to overview]	Autoantibodies Against Glutamic Acid Decarboxylase (GAD)
NCT02443155 (115) [back to overview]	Number of Weeks Off Bolus Insulin
NCT02443155 (115) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA)
NCT02443155 (115) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions
NCT02443155 (115) [back to overview]	Number of Treatment Emergent Hyperglycaemic Episodes
NCT02443155 (115) [back to overview]	Number of Treatment Emergent Episodes of Diabetic Ketoacidosis
NCT02443155 (115) [back to overview]	Number of Treatment Emergent Adverse Events
NCT02443155 (115) [back to overview]	Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline
NCT02443155 (115) [back to overview]	Change in Total Immunoglobulin E (IgE)
NCT02443155 (115) [back to overview]	Change in Haematology: Eosinophil
NCT02443155 (115) [back to overview]	Change in Systolic and Diastolic Blood Pressure
NCT02443155 (115) [back to overview]	Change in Short Form 36 Health Survey (SF-36)
NCT02443155 (115) [back to overview]	Change in Respiratory Rate
NCT02443155 (115) [back to overview]	Change in Pulse
NCT02443155 (115) [back to overview]	Change in Number of Insulin Injections
NCT02443155 (115) [back to overview]	Change in Mean of 7-point Profiles
NCT02443155 (115) [back to overview]	Change in Lipids: Triglycerides (TG) (Ratio to Baseline)
NCT02443155 (115) [back to overview]	Change in Lipids: Total Cholesterol (Ratio to Baseline)
NCT02443155 (115) [back to overview]	Change in Lipids: LDL Cholesterol (Ratio to Baseline)
NCT02443155 (115) [back to overview]	Change in Lipids: HDL Cholesterol (Ratio to Baseline)
NCT02443155 (115) [back to overview]	Change in Lipids: Free Fatty Acids (Ratio to Baseline)
NCT02443155 (115) [back to overview]	Change in International Normalised Ratio (INR)
NCT02443155 (115) [back to overview]	Change in Insulin Dose
NCT02443155 (115) [back to overview]	Change in Hormone Level: Thyroid Stimulating Hormone (TSH)
NCT02443155 (115) [back to overview]	Change in Hormone Level: Calcitonin
NCT02443155 (115) [back to overview]	Change in HbA1c
NCT02443155 (115) [back to overview]	Change in Haematology: Thrombocytes
NCT02443155 (115) [back to overview]	Change in Haematology: Neutrophils
NCT02443155 (115) [back to overview]	Change in Haematology: Monocytes
NCT02443155 (115) [back to overview]	Change in Haematology: Mean Corpuscular Volume
NCT02443155 (115) [back to overview]	Change in Haematology: Mean Corpuscular Hemoglobin Concentration
NCT02443155 (115) [back to overview]	Change in Haematology: Mean Corpuscular Hemoglobin
NCT02443155 (115) [back to overview]	Change in Haematology: Lymphocytes
NCT02443155 (115) [back to overview]	Change in Haematology: Leukocytes
NCT02443155 (115) [back to overview]	Change in Haematology: Haemoglobin
NCT02443155 (115) [back to overview]	Change in Haematology: Haematocrit
NCT02443155 (115) [back to overview]	Change in Biochemistry: Creatinine
NCT02443155 (115) [back to overview]	Change in Biochemistry: Gamma-glutamyl Transferase (GGT)
NCT02443155 (115) [back to overview]	Change in Biochemistry: Lactate Dehydrogenase
NCT02443155 (115) [back to overview]	Change in Biochemistry: Lipase
NCT02443155 (115) [back to overview]	Change in Biochemistry: Magnesium
NCT02443155 (115) [back to overview]	Change in Biochemistry: Phosphate
NCT02443155 (115) [back to overview]	Change in Biochemistry: Potassium
NCT02443155 (115) [back to overview]	Change in Biochemistry: Sodium
NCT02443155 (115) [back to overview]	Change in Biochemistry: Total Bilirubin
NCT02443155 (115) [back to overview]	Change in Biochemistry: Total Protein
NCT02443155 (115) [back to overview]	Change in Biochemistry: Uric Acid
NCT02443155 (115) [back to overview]	Change in Biomarker: Immune Phenotyping- B Cell Panel
NCT02443155 (115) [back to overview]	Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel
NCT02443155 (115) [back to overview]	Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel
NCT02443155 (115) [back to overview]	Change in Biomarker: Immune Phenotyping- T Cell Panel
NCT02443155 (115) [back to overview]	Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel
NCT02443155 (115) [back to overview]	Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol)
NCT02443155 (115) [back to overview]	Change in Biomarker: Total Interleukin-21 (IL-21)
NCT02443155 (115) [back to overview]	Change in Body Temperature
NCT02443155 (115) [back to overview]	Change in Body Weight (kg)
NCT02443155 (115) [back to overview]	Change in Cytokines- Interleukin (IL)-10
NCT02443155 (115) [back to overview]	Change in Cytokines: Interferon (IFN) Gamma
NCT02443155 (115) [back to overview]	Change in Cytokines: Interleukin (IL)-17
NCT02443155 (115) [back to overview]	Change in Cytokines: Interleukin (IL)-6
NCT02443155 (115) [back to overview]	Change in Cytokines: TNF-alpha
NCT02443155 (115) [back to overview]	Change in D-Dimer
NCT02443155 (115) [back to overview]	Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
NCT02443155 (115) [back to overview]	Change in Experience of Treatment Benefits and Barriers (ETBB)
NCT02443155 (115) [back to overview]	Change in Fasting C-peptide- Ratio to Baseline
NCT02443155 (115) [back to overview]	Change in Fasting Glucagon- Ratio to Baseline
NCT02443155 (115) [back to overview]	Change in Fasting Plasma Glucose
NCT02443155 (115) [back to overview]	Change in Haematology: Basophils
NCT02443155 (115) [back to overview]	Change in Haematology: Erythrocytes
NCT02443155 (115) [back to overview]	Cmax of C-peptide at Week 54 Relative to Baseline
NCT02443155 (115) [back to overview]	Cmax of C-peptide at Week 80 Relative to Baseline
NCT02443155 (115) [back to overview]	Cmax of Glucose at Week 54 Relative to Baseline
NCT02443155 (115) [back to overview]	Cmax of Glucose at Week 80 Relative to Baseline
NCT02443155 (115) [back to overview]	Liraglutide Concentration at Steady State (C Liraglutide)
NCT02443155 (115) [back to overview]	Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006)
NCT02443155 (115) [back to overview]	Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion
NCT02443155 (115) [back to overview]	Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006)
NCT02443155 (115) [back to overview]	Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006)
NCT02443155 (115) [back to overview]	Change in Biochemistry: Creatine Kinase
NCT02443155 (115) [back to overview]	Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006)
NCT02443155 (115) [back to overview]	Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006)
NCT02443155 (115) [back to overview]	Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline
NCT02443155 (115) [back to overview]	Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline
NCT02443155 (115) [back to overview]	Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006)
NCT02443155 (115) [back to overview]	AUC0-2h of C-peptide at Week 54 Relative to Baseline
NCT02443155 (115) [back to overview]	AUC0-2h of C-peptide at Week 80 Relative to Baseline
NCT02443155 (115) [back to overview]	AUC0-2h of Glucose at Week 54 Relative to Baseline
NCT02443155 (115) [back to overview]	AUC0-2h of Glucose at Week 80 Relative to Baseline
NCT02443155 (115) [back to overview]	AUC0-4h of Glucose at Week 80 Relative to Baseline
NCT02443155 (115) [back to overview]	Terminal Half-life (t½) After Last Dose of NNC0114-0006
NCT02443155 (115) [back to overview]	7-point SMPG Profiles
NCT02443155 (115) [back to overview]	Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG)
NCT02443155 (115) [back to overview]	Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals)
NCT02443155 (115) [back to overview]	AUC0-4h of Glucose at Week 54 Relative to Baseline
NCT02453711 (35) [back to overview]	Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week
NCT02453711 (35) [back to overview]	Change in Haematology: Haematocrit
NCT02453711 (35) [back to overview]	Change in Haematology: Erythrocytes
NCT02453711 (35) [back to overview]	Change in FPG
NCT02453711 (35) [back to overview]	Change in DBP
NCT02453711 (35) [back to overview]	Change in Body Weight (kg)
NCT02453711 (35) [back to overview]	Participants With Weight Loss of ≥10% of Baseline Body Weight
NCT02453711 (35) [back to overview]	Change in BMI
NCT02453711 (35) [back to overview]	Change in Biochemistry: TSH
NCT02453711 (35) [back to overview]	Change in Biochemistry: Calcitonin
NCT02453711 (35) [back to overview]	Change in ECG
NCT02453711 (35) [back to overview]	Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)
NCT02453711 (35) [back to overview]	Change in Biochemistry: Albumin
NCT02453711 (35) [back to overview]	Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score
NCT02453711 (35) [back to overview]	Compliance With Nutritional Counselling
NCT02453711 (35) [back to overview]	Change in SF-36
NCT02453711 (35) [back to overview]	Change in Mental Health Assessed by PHQ-9
NCT02453711 (35) [back to overview]	Change in Mental Health Assessed by C-SSRS
NCT02453711 (35) [back to overview]	Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)
NCT02453711 (35) [back to overview]	Change in Haematology: Thrombocytes, Leucocytes and Differential Count
NCT02453711 (35) [back to overview]	Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)
NCT02453711 (35) [back to overview]	Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP
NCT02453711 (35) [back to overview]	Change in Biochemistry: Creatinine and Bilirubin (Total)
NCT02453711 (35) [back to overview]	Relative Change in Body Weight (%)
NCT02453711 (35) [back to overview]	Participants With Weight Loss of ≥5% of Baseline Body Weight
NCT02453711 (35) [back to overview]	Anti-semaglutide Antibodies During and After Treatment
NCT02453711 (35) [back to overview]	Number of Hypoglycaemic Episodes During the Trial
NCT02453711 (35) [back to overview]	Number of AEs During the Trial
NCT02453711 (35) [back to overview]	Change in Waist to Hip Circumference Ratio
NCT02453711 (35) [back to overview]	Change in Waist Circumference
NCT02453711 (35) [back to overview]	Change in SBP
NCT02453711 (35) [back to overview]	Change in Pulse
NCT02453711 (35) [back to overview]	Change in hsCRP
NCT02453711 (35) [back to overview]	Change in HbA1c
NCT02453711 (35) [back to overview]	Change in Haematology: Haemoglobin
NCT02461589 (4) [back to overview]	Body Weight Change
NCT02461589 (4) [back to overview]	Change in Fasting Plasma Glucose (FPG)
NCT02461589 (4) [back to overview]	Change in HbA1c (Glycosylated Haemoglobin)
NCT02461589 (4) [back to overview]	Change in Systolic and Diastolic Blood Pressure
NCT02492763 (12) [back to overview]	Number of Participants With an Adverse Event (AE)
NCT02492763 (12) [back to overview]	Number of Participants With an AE of Symptomatic Hypoglycemia
NCT02492763 (12) [back to overview]	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12
NCT02492763 (12) [back to overview]	Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12
NCT02492763 (12) [back to overview]	Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12
NCT02492763 (12) [back to overview]	Number of Participants Who Discontinued Study Treatment Due to an AE
NCT02492763 (12) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
NCT02492763 (12) [back to overview]	Change From Baseline in Fasting Triglycerides at Week 12
NCT02492763 (12) [back to overview]	Change From Baseline in Heart Rate at Week 12
NCT02492763 (12) [back to overview]	Change From Baseline in Body Weight at Week 12
NCT02492763 (12) [back to overview]	Change From Baseline in Hemoglobin A1C (A1C) at Week 12
NCT02492763 (12) [back to overview]	Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
NCT02501161 (54) [back to overview]	Change in Fasting Human Insulin
NCT02501161 (54) [back to overview]	Change in Fasting Free Fatty Acids
NCT02501161 (54) [back to overview]	Change in Fasting C-peptide
NCT02501161 (54) [back to overview]	Change in Calcitonin
NCT02501161 (54) [back to overview]	Change in Body Weight
NCT02501161 (54) [back to overview]	Change in Blood Pressure (Systolic and Diastolic)
NCT02501161 (54) [back to overview]	Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase
NCT02501161 (54) [back to overview]	Change in Biochemistry Parameter- Sodium, Potassium and Calcium
NCT02501161 (54) [back to overview]	Change in Biochemistry Parameter- Creatinine, Total Bilirubin
NCT02501161 (54) [back to overview]	Change in Biochemistry Parameter- Albumin
NCT02501161 (54) [back to overview]	Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment
NCT02501161 (54) [back to overview]	Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment
NCT02501161 (54) [back to overview]	Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment
NCT02501161 (54) [back to overview]	Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment
NCT02501161 (54) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment
NCT02501161 (54) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment
NCT02501161 (54) [back to overview]	Number of TEAEs During 26 Weeks of Treatment
NCT02501161 (54) [back to overview]	Number of TEAEs During 104 Weeks of Treatment
NCT02501161 (54) [back to overview]	Change in Urine Albumin/Creatinine Ratio
NCT02501161 (54) [back to overview]	Change in HbA1c
NCT02501161 (54) [back to overview]	Change in Fasting LDL-cholesterol
NCT02501161 (54) [back to overview]	Change in Fasting Total Cholesterol
NCT02501161 (54) [back to overview]	Change in Fasting Triglycerides
NCT02501161 (54) [back to overview]	Change in Fasting VLDL-cholesterol
NCT02501161 (54) [back to overview]	Change in FPG
NCT02501161 (54) [back to overview]	Change in Haematological Parameter- Basophils
NCT02501161 (54) [back to overview]	Change in Haematological Parameter- Eosinophils
NCT02501161 (54) [back to overview]	Change in Haematological Parameter- Erythrocytes
NCT02501161 (54) [back to overview]	Change in Haematological Parameter- Haematocrit
NCT02501161 (54) [back to overview]	Change in Haematological Parameter- Haemoglobin
NCT02501161 (54) [back to overview]	Change in Haematological Parameter- Lymphocytes
NCT02501161 (54) [back to overview]	Change in Haematological Parameter- Monocytes
NCT02501161 (54) [back to overview]	Change in Haematological Parameter- Neutrophils
NCT02501161 (54) [back to overview]	Change in Haematological Parameter- Thrombocytes and Leukocytes
NCT02501161 (54) [back to overview]	Change in Pulse Rate
NCT02501161 (54) [back to overview]	Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
NCT02501161 (54) [back to overview]	Change in SMPG-mean 9-point Profile
NCT02501161 (54) [back to overview]	Change in SMPG-mean Postprandial Increment Over All Meals
NCT02501161 (54) [back to overview]	Change in TRIM-D
NCT02501161 (54) [back to overview]	ECG Evaluation
NCT02501161 (54) [back to overview]	Eye Examination Category
NCT02501161 (54) [back to overview]	Insulin Dose
NCT02501161 (54) [back to overview]	Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
NCT02501161 (54) [back to overview]	Participants Who Achieved (Yes/no): HbA1c <7.0%
NCT02501161 (54) [back to overview]	Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
NCT02501161 (54) [back to overview]	Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain
NCT02501161 (54) [back to overview]	Participants Who Achieved (Yes/no): HbA1c ≤6.5%
NCT02501161 (54) [back to overview]	Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02501161 (54) [back to overview]	Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
NCT02501161 (54) [back to overview]	Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain
NCT02501161 (54) [back to overview]	SMPG-9-point Profile (Individual Points in the Profile)
NCT02501161 (54) [back to overview]	Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits
NCT02501161 (54) [back to overview]	Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification
NCT02501161 (54) [back to overview]	Change in Fasting HDL-cholesterol
NCT02505334 (120) [back to overview]	Triglycerides
NCT02505334 (120) [back to overview]	Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02505334 (120) [back to overview]	Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02505334 (120) [back to overview]	Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02505334 (120) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
NCT02505334 (120) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
NCT02505334 (120) [back to overview]	Number of Treatment Emergent Adverse Events
NCT02505334 (120) [back to overview]	Number of Treatment Emergent Adverse Events
NCT02505334 (120) [back to overview]	Change in Biochemistry: Albumin Corrected Calcium
NCT02505334 (120) [back to overview]	Low Density Lipoprotein (LDL) Cholesterol
NCT02505334 (120) [back to overview]	Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
NCT02505334 (120) [back to overview]	Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
NCT02505334 (120) [back to overview]	Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
NCT02505334 (120) [back to overview]	Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
NCT02505334 (120) [back to overview]	High Density Lipoprotein (HDL) Cholesterol
NCT02505334 (120) [back to overview]	High Density Lipoprotein (HDL) Cholesterol
NCT02505334 (120) [back to overview]	Free Fatty Acids
NCT02505334 (120) [back to overview]	Free Fatty Acids
NCT02505334 (120) [back to overview]	Fasting Insulin
NCT02505334 (120) [back to overview]	Fasting Insulin
NCT02505334 (120) [back to overview]	Fasting Glucagon
NCT02505334 (120) [back to overview]	Fasting Glucagon
NCT02505334 (120) [back to overview]	Fasting C-peptide
NCT02505334 (120) [back to overview]	Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
NCT02505334 (120) [back to overview]	Change in Glycosylated Haemoglobin (HbA1c) (Week 26)
NCT02505334 (120) [back to overview]	Fasting C-peptide
NCT02505334 (120) [back to overview]	Change in Waist Circumference
NCT02505334 (120) [back to overview]	Change in Waist Circumference
NCT02505334 (120) [back to overview]	Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)
NCT02505334 (120) [back to overview]	Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)
NCT02505334 (120) [back to overview]	Change in SMBG 7-point Profile: Mean of 7-point Profile
NCT02505334 (120) [back to overview]	Change in SMBG 7-point Profile: Mean of 7-point Profile
NCT02505334 (120) [back to overview]	Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
NCT02505334 (120) [back to overview]	Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
NCT02505334 (120) [back to overview]	Change in Pulse
NCT02505334 (120) [back to overview]	Change in Pulse
NCT02505334 (120) [back to overview]	Change in Physical Examination
NCT02505334 (120) [back to overview]	Change in Electrocardiogram (ECG)
NCT02505334 (120) [back to overview]	Change in Electrocardiogram (ECG)
NCT02505334 (120) [back to overview]	Change in Calcitonin
NCT02505334 (120) [back to overview]	Change in Calcitonin
NCT02505334 (120) [back to overview]	Change in Body Weight
NCT02505334 (120) [back to overview]	Change in Body Weight
NCT02505334 (120) [back to overview]	Change in Body Mass Index (BMI)
NCT02505334 (120) [back to overview]	Change in Body Mass Index (BMI)
NCT02505334 (120) [back to overview]	Change in Blood Pressure (Systolic and Diastolic)
NCT02505334 (120) [back to overview]	Change in Blood Pressure (Systolic and Diastolic)
NCT02505334 (120) [back to overview]	Change in Biochemistry: Urea
NCT02505334 (120) [back to overview]	Change in Biochemistry: Urea
NCT02505334 (120) [back to overview]	Change in Biochemistry: Total Bilirubin
NCT02505334 (120) [back to overview]	Change in Biochemistry: Total Bilirubin
NCT02505334 (120) [back to overview]	Low Density Lipoprotein (LDL) Cholesterol
NCT02505334 (120) [back to overview]	Change in Biochemistry: Sodium
NCT02505334 (120) [back to overview]	Change in Biochemistry: Sodium
NCT02505334 (120) [back to overview]	Change in Biochemistry: Potassium
NCT02505334 (120) [back to overview]	Change in Biochemistry: Potassium
NCT02505334 (120) [back to overview]	Change in Biochemistry: Lipase
NCT02505334 (120) [back to overview]	Change in Biochemistry: Lipase
NCT02505334 (120) [back to overview]	Change in Biochemistry: eGFR
NCT02505334 (120) [back to overview]	Change in Biochemistry: eGFR
NCT02505334 (120) [back to overview]	Change in Biochemistry: Creatinine
NCT02505334 (120) [back to overview]	Change in Biochemistry: Creatinine
NCT02505334 (120) [back to overview]	Change in Biochemistry: Creatine Kinase
NCT02505334 (120) [back to overview]	Change in Biochemistry: Creatine Kinase
NCT02505334 (120) [back to overview]	Change in Biochemistry: Calcium
NCT02505334 (120) [back to overview]	Change in Biochemistry: Calcium
NCT02505334 (120) [back to overview]	Change in Biochemistry: Aspartate Aminotransferase
NCT02505334 (120) [back to overview]	Change in Biochemistry: Aspartate Aminotransferase
NCT02505334 (120) [back to overview]	Change in Biochemistry: Amylase
NCT02505334 (120) [back to overview]	Change in Biochemistry: Amylase
NCT02505334 (120) [back to overview]	Change in Biochemistry: Alkaline Phosphatase
NCT02505334 (120) [back to overview]	Change in Biochemistry: Alkaline Phosphatase
NCT02505334 (120) [back to overview]	Change in Biochemistry: Albumin Corrected Calcium
NCT02505334 (120) [back to overview]	Change in Eye Examination
NCT02505334 (120) [back to overview]	Change in Eye Examination
NCT02505334 (120) [back to overview]	Change in Fasting Plasma Glucose (FPG)
NCT02505334 (120) [back to overview]	Change in Fasting Plasma Glucose (FPG)
NCT02505334 (120) [back to overview]	Change in Haematology: Basophils
NCT02505334 (120) [back to overview]	Change in Haematology: Basophils
NCT02505334 (120) [back to overview]	Change in Haematology: Eosinophils
NCT02505334 (120) [back to overview]	Change in Haematology: Eosinophils
NCT02505334 (120) [back to overview]	Change in Haematology: Erythrocytes
NCT02505334 (120) [back to overview]	Change in Haematology: Erythrocytes
NCT02505334 (120) [back to overview]	Change in Haematology: Haematocrit
NCT02505334 (120) [back to overview]	Change in Haematology: Haematocrit
NCT02505334 (120) [back to overview]	Change in Haematology: Haemoglobin
NCT02505334 (120) [back to overview]	Change in Haematology: Haemoglobin
NCT02505334 (120) [back to overview]	Change in Haematology: Leukocytes
NCT02505334 (120) [back to overview]	Change in Haematology: Leukocytes
NCT02505334 (120) [back to overview]	Change in Physical Examination
NCT02505334 (120) [back to overview]	Change in HbA1c (Week 52)
NCT02505334 (120) [back to overview]	Change in Haematology: Thrombocytes
NCT02505334 (120) [back to overview]	Change in Haematology: Thrombocytes
NCT02505334 (120) [back to overview]	Change in Haematology: Neutrophils
NCT02505334 (120) [back to overview]	Change in Haematology: Neutrophils
NCT02505334 (120) [back to overview]	Change in Haematology: Monocytes
NCT02505334 (120) [back to overview]	Change in Haematology: Monocytes
NCT02505334 (120) [back to overview]	Change in Haematology: Lymphocytes
NCT02505334 (120) [back to overview]	Change in Haematology: Lymphocytes
NCT02505334 (120) [back to overview]	Change in Biochemistry: Alanine Aminotransferase
NCT02505334 (120) [back to overview]	Change in Biochemistry: Alanine Aminotransferase
NCT02505334 (120) [back to overview]	Change in Biochemistry: Albumin
NCT02505334 (120) [back to overview]	Change in Biochemistry: Albumin
NCT02505334 (120) [back to overview]	Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02505334 (120) [back to overview]	Proinsulin
NCT02505334 (120) [back to overview]	Proinsulin
NCT02505334 (120) [back to overview]	Proinsulin/Insulin
NCT02505334 (120) [back to overview]	Proinsulin/Insulin
NCT02505334 (120) [back to overview]	Responder for HbA1c Below 7.0% (53 mmol/Mol)
NCT02505334 (120) [back to overview]	Responder for HbA1c Below 7.0% (53 mmol/Mol)
NCT02505334 (120) [back to overview]	Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
NCT02505334 (120) [back to overview]	Responder for HbA1c Below 7.0% Without Weight Gain
NCT02505334 (120) [back to overview]	Responder for HbA1c Below 7.0% Without Weight Gain
NCT02505334 (120) [back to overview]	Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)
NCT02505334 (120) [back to overview]	Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)
NCT02505334 (120) [back to overview]	Total Cholesterol
NCT02505334 (120) [back to overview]	Total Cholesterol
NCT02505334 (120) [back to overview]	Triglycerides
NCT02505334 (120) [back to overview]	Very Low Density Lipoprotein (VLDL) Cholesterol
NCT02505334 (120) [back to overview]	Very Low Density Lipoprotein (VLDL) Cholesterol
NCT02527200 (106) [back to overview]	Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in FPG From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Haematology: Erythrocytes From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Haematology: Erythrocytes From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Haematology: Haematocrit From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Haematology: Haematocrit From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Haematology: Haemoglobin From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Haematology: Haemoglobin From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in HbA1c From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Hormone Level: Calcitonin From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Hormone Level: Calcitonin From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Hormone Level: Estradiol (Females) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Hormone Level: Estradiol (Females) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Hormone Level: Testosterone (Males) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Hormone Level: Testosterone (Males) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Pulse From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Total Cholesterol From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Total Cholesterol From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Triglycerides From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Triglycerides From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Waist Circumference From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Waist Circumference From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Waist-to-hip Circumference Ratio From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Waist-to-hip Circumference Ratio From Baseline at Week 52
NCT02527200 (106) [back to overview]	Height Velocity at Week 16
NCT02527200 (106) [back to overview]	Height Velocity at Week 52
NCT02527200 (106) [back to overview]	Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia
NCT02527200 (106) [back to overview]	Number of Severe Treatment Emergent Episodes of Hypoglycaemia
NCT02527200 (106) [back to overview]	Number of Treatment Emergent Adverse Events
NCT02527200 (106) [back to overview]	Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52
NCT02527200 (106) [back to overview]	Number of Participants in Glycaemic Category at Week 16
NCT02527200 (106) [back to overview]	Number of Participants in Glycaemic Category at Week 52
NCT02527200 (106) [back to overview]	Number of Participants With Change in ECG From Baseline at Week 52
NCT02527200 (106) [back to overview]	Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Number of Participants With Occurrence of Anti-liraglutide Antibodies
NCT02527200 (106) [back to overview]	Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16
NCT02527200 (106) [back to overview]	Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52
NCT02527200 (106) [back to overview]	Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16
NCT02527200 (106) [back to overview]	Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52
NCT02527200 (106) [back to overview]	Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16
NCT02527200 (106) [back to overview]	Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52
NCT02527200 (106) [back to overview]	Percentage of Participants With no Increase in BMI SDS at Week 16
NCT02527200 (106) [back to overview]	Percentage of Participants With no Increase in BMI SDS at Week 52
NCT02527200 (106) [back to overview]	Number of Participants With Change in Physical Examination From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Pulse From Baseline at Week 52
NCT02527200 (106) [back to overview]	Number of Participants With Change in Pubertal Status From Baseline at Week 52
NCT02527200 (106) [back to overview]	Number of Participants With Change in Physical Examination From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Biochemistry: Albumin From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Biochemistry: Albumin From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in BMI From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in BMI From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks
NCT02527200 (106) [back to overview]	Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks
NCT02527200 (106) [back to overview]	Change in Body Weight (%) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Body Weight (kg) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Body Weight (Kilogram (kg)) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Body Weight (lb) From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Body Weight (Percentage [%]) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Body Weight (Pounds (lb)) From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Fasting C Peptide From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Fasting C Peptide From Baseline at Week 52
NCT02527200 (106) [back to overview]	Change in Fasting Insulin From Baseline at Week 16
NCT02527200 (106) [back to overview]	Change in Fasting Insulin From Baseline at Week 52
NCT02527200 (106) [back to overview]	Number of Participants With Change in Pubertal Status From Baseline at Week 16
NCT02607306 (40) [back to overview]	Change in SMBG 9-point Profile - Mean of the 9-point Profile
NCT02607306 (40) [back to overview]	Plasma Concentrations of Liraglutide
NCT02607306 (40) [back to overview]	Responder (Yes/no): HbA1c Less Than 6.5%
NCT02607306 (40) [back to overview]	Proinsulin as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]	Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02607306 (40) [back to overview]	Total Cholesterol as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]	Responder (Yes/no): HbA1c Less Than 7.0%
NCT02607306 (40) [back to overview]	Change in Waist Circumference
NCT02607306 (40) [back to overview]	Fasting C-peptide as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]	Fasting Glucagon as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]	Fasting Human Insulin as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]	Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.
NCT02607306 (40) [back to overview]	Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero
NCT02607306 (40) [back to overview]	Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero
NCT02607306 (40) [back to overview]	Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02607306 (40) [back to overview]	Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.
NCT02607306 (40) [back to overview]	Free Fatty Acids as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]	Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
NCT02607306 (40) [back to overview]	Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)
NCT02607306 (40) [back to overview]	Serum Concentrations of Insulin Degludec
NCT02607306 (40) [back to overview]	Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)
NCT02607306 (40) [back to overview]	Change in Clinical Evaluation: Pulse
NCT02607306 (40) [back to overview]	High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]	Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg
NCT02607306 (40) [back to overview]	Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira
NCT02607306 (40) [back to overview]	Insulin Dose
NCT02607306 (40) [back to overview]	Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]	Number of Treatment Emergent Adverse Events (TEAEs)
NCT02607306 (40) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition
NCT02607306 (40) [back to overview]	Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02607306 (40) [back to overview]	Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
NCT02607306 (40) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG)
NCT02607306 (40) [back to overview]	Change From Baseline in Body Weight (kg)
NCT02607306 (40) [back to overview]	Anti-drug Antibodies: Anti-insulin Degludec Antibodies
NCT02607306 (40) [back to overview]	Triglycerides as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]	Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks
NCT02607306 (40) [back to overview]	Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies
NCT02607306 (40) [back to overview]	Change in Blood Pressure (Systolic and Diastolic)
NCT02607306 (40) [back to overview]	Change in Clinical Evaluation: Electrocardiogram (ECG)
NCT02607306 (40) [back to overview]	Change in Clinical Evaluation: Fundoscopy or Fundus Photography
NCT02647944 (10) [back to overview]	Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks
NCT02647944 (10) [back to overview]	Gastric Accommodation Volume at 16 Weeks
NCT02647944 (10) [back to overview]	Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks
NCT02647944 (10) [back to overview]	Weight Change at 16 Weeks
NCT02647944 (10) [back to overview]	Weight Change at 5 Weeks
NCT02647944 (10) [back to overview]	Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks
NCT02647944 (10) [back to overview]	Gastric Fasting Volume at 16 Weeks
NCT02647944 (10) [back to overview]	Satiation Volume to Fullness at 16 Weeks
NCT02647944 (10) [back to overview]	Satiation Maximum Tolerated Volume at 16 Weeks
NCT02647944 (10) [back to overview]	Gastric Postprandial Volume at 16 Weeks
NCT02730377 (19) [back to overview]	Change in Pulse
NCT02730377 (19) [back to overview]	Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control)
NCT02730377 (19) [back to overview]	Number of AEs Leading to Permanent Discontinuation of Trial Product
NCT02730377 (19) [back to overview]	Number of Documented Symptomatic Hypoglycaemic Episodes (ADA)
NCT02730377 (19) [back to overview]	Number of Serious Adverse Events (SAEs)
NCT02730377 (19) [back to overview]	Number of Severe Hypoglycaemic Episodes
NCT02730377 (19) [back to overview]	Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02730377 (19) [back to overview]	Time to Inadequate Glycaemic Control
NCT02730377 (19) [back to overview]	Change in Biochemistry- Creatinine, Total Bilirubin
NCT02730377 (19) [back to overview]	Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum
NCT02730377 (19) [back to overview]	Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
NCT02730377 (19) [back to overview]	Change in Body Mass Index (BMI)
NCT02730377 (19) [back to overview]	Change in Body Weight
NCT02730377 (19) [back to overview]	Change in Fasting Plasma Glucose (FPG)
NCT02730377 (19) [back to overview]	Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase
NCT02730377 (19) [back to overview]	Change in Haemoglobin
NCT02730377 (19) [back to overview]	Change in HbA1c
NCT02730377 (19) [back to overview]	Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides
NCT02730377 (19) [back to overview]	Change in Potassium
NCT02765399 (21) [back to overview]	Mean apoB48 FTR to VLDL1 Particles
NCT02765399 (21) [back to overview]	Change in fP-glucose Level
NCT02765399 (21) [back to overview]	Change in Direct CM-apoB48 Clearance
NCT02765399 (21) [back to overview]	Change in ApoCIII Level
NCT02765399 (21) [back to overview]	Body Weight
NCT02765399 (21) [back to overview]	Mean CM FDC of apoB48
NCT02765399 (21) [back to overview]	Change in HbA1c Level
NCT02765399 (21) [back to overview]	Change in Hepatic de Novo Lipogenesis
NCT02765399 (21) [back to overview]	Change in Insulin Level
NCT02765399 (21) [back to overview]	Change in Liver Fat Content
NCT02765399 (21) [back to overview]	Change in Matsuda Index
NCT02765399 (21) [back to overview]	Change in SAT Area
NCT02765399 (21) [back to overview]	Plasma Triglyceride (TG) Area Under Curve (AUC)
NCT02765399 (21) [back to overview]	Mean CM-apoB48 Transfer Rates to VLDL1
NCT02765399 (21) [back to overview]	Mean TG Fractional Catabolic Rates in CM
NCT02765399 (21) [back to overview]	Mean Fractional Catabolic Rate of VLDL2-apoB100
NCT02765399 (21) [back to overview]	Mean Total Production of apoB48
NCT02765399 (21) [back to overview]	Mean VLDL1-TG Production Rates
NCT02765399 (21) [back to overview]	Mean Production Rate of apoB48 in CM
NCT02765399 (21) [back to overview]	Change in Systolic RR
NCT02765399 (21) [back to overview]	Change in VAT Area
NCT02773368 (33) [back to overview]	Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile
NCT02773368 (33) [back to overview]	Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile
NCT02773368 (33) [back to overview]	Change in Body Weight
NCT02773368 (33) [back to overview]	Change in Fasting Plasma Glucose (FPG)
NCT02773368 (33) [back to overview]	Change in HbA1c (Glycosylated Haemoglobin)
NCT02773368 (33) [back to overview]	Change From Baseline in Diastolic Blood Pressure
NCT02773368 (33) [back to overview]	Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks
NCT02773368 (33) [back to overview]	Responder (Yes/No) for HbA1c Below 7.0%
NCT02773368 (33) [back to overview]	Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
NCT02773368 (33) [back to overview]	Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain
NCT02773368 (33) [back to overview]	Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02773368 (33) [back to overview]	Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
NCT02773368 (33) [back to overview]	Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02773368 (33) [back to overview]	Change From Baseline in Fasting Lipid Profile: Free Fatty Acids
NCT02773368 (33) [back to overview]	Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain
NCT02773368 (33) [back to overview]	Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments
NCT02773368 (33) [back to overview]	Insulin Dose, Total Daily Dose (U)
NCT02773368 (33) [back to overview]	Number of Treatment-emergent Adverse Events
NCT02773368 (33) [back to overview]	Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks
NCT02773368 (33) [back to overview]	Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes
NCT02773368 (33) [back to overview]	Change From Baseline After 26 Weeks in Waist Circumference
NCT02773368 (33) [back to overview]	Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)
NCT02773368 (33) [back to overview]	Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography
NCT02773368 (33) [back to overview]	Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate
NCT02773368 (33) [back to overview]	Change From Baseline in Fasting Lipid Profile: Cholesterol
NCT02773368 (33) [back to overview]	Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)
NCT02773368 (33) [back to overview]	Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)
NCT02773368 (33) [back to overview]	Change From Baseline in Fasting Lipid Profile: Triglycerides
NCT02773368 (33) [back to overview]	Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)
NCT02773368 (33) [back to overview]	Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)
NCT02773368 (33) [back to overview]	Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)
NCT02773368 (33) [back to overview]	Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%
NCT02773368 (33) [back to overview]	Change From Baseline in Systolic Blood Pressure
NCT02787551 (18) [back to overview]	Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Core Period
NCT02787551 (18) [back to overview]	Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period
NCT02787551 (18) [back to overview]	Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period
NCT02787551 (18) [back to overview]	Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period
NCT02787551 (18) [back to overview]	Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period
NCT02787551 (18) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period
NCT02787551 (18) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period
NCT02787551 (18) [back to overview]	Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period
NCT02787551 (18) [back to overview]	Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period
NCT02787551 (18) [back to overview]	Change From Baseline in Body Weight to Week 52: Single Arm Extension Period
NCT02787551 (18) [back to overview]	Change From Baseline in Body Weight at Week 26: Core Period
NCT02787551 (18) [back to overview]	Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period
NCT02787551 (18) [back to overview]	Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period
NCT02787551 (18) [back to overview]	Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period
NCT02787551 (18) [back to overview]	Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period
NCT02787551 (18) [back to overview]	Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period
NCT02787551 (18) [back to overview]	Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Single Arm Extension Period
NCT02787551 (18) [back to overview]	Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period
NCT02863419 (39) [back to overview]	Change in Body Mass Index
NCT02863419 (39) [back to overview]	Change in Amylase - Ratio to Baseline
NCT02863419 (39) [back to overview]	Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
NCT02863419 (39) [back to overview]	Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)
NCT02863419 (39) [back to overview]	Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
NCT02863419 (39) [back to overview]	Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)
NCT02863419 (39) [back to overview]	Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
NCT02863419 (39) [back to overview]	Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product
NCT02863419 (39) [back to overview]	Change in HbA1c (Week 52)
NCT02863419 (39) [back to overview]	Change in Body Weight (Week 52)
NCT02863419 (39) [back to overview]	Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
NCT02863419 (39) [back to overview]	Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
NCT02863419 (39) [back to overview]	Change in Lipase - Ratio to Baseline
NCT02863419 (39) [back to overview]	Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
NCT02863419 (39) [back to overview]	Change in HbA1c (Week 26)
NCT02863419 (39) [back to overview]	Change in Triglycerides - Ratio to Baseline
NCT02863419 (39) [back to overview]	Change in Free Fatty Acids - Ratio to Baseline
NCT02863419 (39) [back to overview]	Change in Fasting Plasma Glucose
NCT02863419 (39) [back to overview]	Participants Who Achieve Weight Loss ≥5% (Yes/no)
NCT02863419 (39) [back to overview]	Participants Who Achieve Weight Loss ≥ 10% (Yes/no)
NCT02863419 (39) [back to overview]	Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)
NCT02863419 (39) [back to overview]	Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)
NCT02863419 (39) [back to overview]	Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)
NCT02863419 (39) [back to overview]	Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no)
NCT02863419 (39) [back to overview]	Change in Physical Examination
NCT02863419 (39) [back to overview]	Change in Eye Examination Category
NCT02863419 (39) [back to overview]	Time to Rescue Medication
NCT02863419 (39) [back to overview]	Time to Additional Anti-diabetic Medication
NCT02863419 (39) [back to overview]	Change in Waist Circumference
NCT02863419 (39) [back to overview]	Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline
NCT02863419 (39) [back to overview]	Change in ECG Evaluation
NCT02863419 (39) [back to overview]	Change in Total Cholesterol - Ratio to Baseline
NCT02863419 (39) [back to overview]	Change in SMPG - Mean Postprandial Increment Over All Meals
NCT02863419 (39) [back to overview]	Change in SMPG - Mean 7-point Profile
NCT02863419 (39) [back to overview]	Change in SBP and DBP
NCT02863419 (39) [back to overview]	Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed)
NCT02863419 (39) [back to overview]	Change in Body Weight (Week 26)
NCT02863419 (39) [back to overview]	Change in Body Weight (%)
NCT02863419 (39) [back to overview]	Change in Pulse Rate
NCT02889510 (7) [back to overview]	Changes From Baseline on Measurements of Respiratory Function Defined by Forced Vital Capacity (FVC)
NCT02889510 (7) [back to overview]	Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC)
NCT02889510 (7) [back to overview]	Changes From Baseline in Serum Levels of Surfactant A and D Protein
NCT02889510 (7) [back to overview]	Changes From Baseline on Measurements of Respiratory Function Defined by Total Lung Capacity (TLC)
NCT02889510 (7) [back to overview]	Changes From Baseline on Measurements of Respiratory Function Defined by Residual Volume (RV)
NCT02889510 (7) [back to overview]	Changes From Baseline on Measurements of Respiratory Function Defined by Maximum Mid-expiratory Flow (FEF25-75)
NCT02889510 (7) [back to overview]	Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second (FEV1)
NCT02911818 (34) [back to overview]	Change in 36-Item Short Form Survey (SF-36) - Physical Component Summary
NCT02911818 (34) [back to overview]	Change in C Reactive Protein
NCT02911818 (34) [back to overview]	Change in Diastolic Blood Pressure
NCT02911818 (34) [back to overview]	Change in Fasting Glucose
NCT02911818 (34) [back to overview]	Change in Fasting Insulin
NCT02911818 (34) [back to overview]	Change in HbA1c
NCT02911818 (34) [back to overview]	Change in HDL Cholesterol
NCT02911818 (34) [back to overview]	Change in Heart Rate
NCT02911818 (34) [back to overview]	Change in HOMA-IR
NCT02911818 (34) [back to overview]	Change in LDL Cholesterol
NCT02911818 (34) [back to overview]	Change in Patient Health Questionnaire (PHQ-9)
NCT02911818 (34) [back to overview]	Change in Systolic Blood Pressure
NCT02911818 (34) [back to overview]	Change in Total Cholesterol
NCT02911818 (34) [back to overview]	Change in Triglycerides
NCT02911818 (34) [back to overview]	Change in Waist Circumference
NCT02911818 (34) [back to overview]	Extension Study Primary Outcome: Percent Change in Re-randomization Weight
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Change in c-Reactive Protein
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Change in Diastolic Blood Pressure
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Change in Fasting Glucose
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Change in Fasting Insulin
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Change in HbA1c
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Change in HDL Cholesterol
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Change in Heart Rate
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Change in HOMA-IR
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Change in LDL Cholesterol
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Change in Systolic Blood Pressure
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Change in Total Cholesterol
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Change in Triglycerides
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Change in Waist Circumference
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: Patient Health Questionnaire (PHQ-9)
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: SF-36 - Mental Health Component
NCT02911818 (34) [back to overview]	Percent Change in Baseline Weight
NCT02911818 (34) [back to overview]	Extension Study Secondary Outcome: SF-36 - Physical Health Component
NCT02911818 (34) [back to overview]	Change 36-Item Short Form Survey (SF-36) - Mental Component Summary
NCT02911948 (28) [back to overview]	Fasting Lipid Profile
NCT02911948 (28) [back to overview]	Number of Treatment Emergent Adverse Events (TEAE)
NCT02911948 (28) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition
NCT02911948 (28) [back to overview]	Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02911948 (28) [back to overview]	Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT02911948 (28) [back to overview]	Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
NCT02911948 (28) [back to overview]	Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: Diabetes Therapy-Related Quality of Life (DTR-QOL)Questionnaire
NCT02911948 (28) [back to overview]	Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: EuroQol-5D (EQ-5D-5L) Questionnaire
NCT02911948 (28) [back to overview]	Change in Blood Pressure (Systolic and Diastolic)
NCT02911948 (28) [back to overview]	Change in Clinical Evaluation: Electrocardiogram (ECG)
NCT02911948 (28) [back to overview]	Change in Clinical Evaluation: Fundoscopy or Fundus Photography
NCT02911948 (28) [back to overview]	Daily Insulin Dose
NCT02911948 (28) [back to overview]	Responder (Yes/no): HbA1c Less Than 7.0%
NCT02911948 (28) [back to overview]	Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain
NCT02911948 (28) [back to overview]	Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02911948 (28) [back to overview]	Change in Fasting Plasma Glucose (FPG)
NCT02911948 (28) [back to overview]	Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02911948 (28) [back to overview]	Responder (Yes/no): HbA1c Less Than or Equal to 6.5%
NCT02911948 (28) [back to overview]	Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain
NCT02911948 (28) [back to overview]	Change in Body Weight
NCT02911948 (28) [back to overview]	Change in SMBG 9-point Profile: Mean of Postprandial Plasma Glucose Increments (From Before Meal to 90 Minutes After Breakfast, Lunch and Dinner)
NCT02911948 (28) [back to overview]	Change in Glycosylated Haemoglobin (HbA1c)
NCT02911948 (28) [back to overview]	Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02911948 (28) [back to overview]	Responder (Yes/no): HbA1c Less Than or Equal to 6.5% Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
NCT02911948 (28) [back to overview]	Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile)
NCT02911948 (28) [back to overview]	Change in Waist Circumference
NCT02911948 (28) [back to overview]	Change in SMBG 9-point Profile: Mean of the 9-point Profile
NCT02911948 (28) [back to overview]	Change in Pulse
NCT02918279 (60) [back to overview]	Change in BMI
NCT02918279 (60) [back to overview]	Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))
NCT02918279 (60) [back to overview]	Change in BMI SDS (%)
NCT02918279 (60) [back to overview]	Change in Body Weight (%)
NCT02918279 (60) [back to overview]	Change in Body Weight (kg)
NCT02918279 (60) [back to overview]	Change in C-SSRS
NCT02918279 (60) [back to overview]	Change in CTX1
NCT02918279 (60) [back to overview]	Change in Fasting C-peptide (Ratio to Baseline)
NCT02918279 (60) [back to overview]	Change in Fasting Insulin (Ratio to Baseline)
NCT02918279 (60) [back to overview]	Change in Fasting Lipid: FFA (Ratio to Baseline)
NCT02918279 (60) [back to overview]	Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)
NCT02918279 (60) [back to overview]	Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)
NCT02918279 (60) [back to overview]	Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline)
NCT02918279 (60) [back to overview]	Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)
NCT02918279 (60) [back to overview]	Change in Fasting Lipid: Triglycerides (Ratio to Baseline)
NCT02918279 (60) [back to overview]	Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline)
NCT02918279 (60) [back to overview]	Change in FPG
NCT02918279 (60) [back to overview]	Change in Haematology: Erythrocytes
NCT02918279 (60) [back to overview]	Change in Haematology: Haematocrit
NCT02918279 (60) [back to overview]	Change in Haematology: Haemoglobin
NCT02918279 (60) [back to overview]	Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes
NCT02918279 (60) [back to overview]	Change in HbA1c
NCT02918279 (60) [back to overview]	Change in Height SDS
NCT02918279 (60) [back to overview]	Change in HOMA-B (Ratio to Baseline)
NCT02918279 (60) [back to overview]	Change in HOMA-IR (Ratio to Baseline)
NCT02918279 (60) [back to overview]	Change in Hormone Level: Calcitonin
NCT02918279 (60) [back to overview]	Change in Hormone Level: DHEAS
NCT02918279 (60) [back to overview]	Change in Hormone Level: Estradiol (Females)
NCT02918279 (60) [back to overview]	Change in Hormone Level: Free T4 and ACTH
NCT02918279 (60) [back to overview]	Change in Hormone Level: IGF-1 and Cortisol
NCT02918279 (60) [back to overview]	Change in Hormone Level: LH and FSH
NCT02918279 (60) [back to overview]	Change in Hormone Level: Testosterone (Males)
NCT02918279 (60) [back to overview]	Change in Hormone Level: TSH and Prolactin
NCT02918279 (60) [back to overview]	Change in hsCRP
NCT02918279 (60) [back to overview]	Number of Treatment Emergent Adverse Events
NCT02918279 (60) [back to overview]	Change in NTX1
NCT02918279 (60) [back to overview]	Change in Nutritional Compliance
NCT02918279 (60) [back to overview]	Change in IWQOL-Kids
NCT02918279 (60) [back to overview]	Change in PHQ-9
NCT02918279 (60) [back to overview]	Change in Pulse
NCT02918279 (60) [back to overview]	Change in Systolic and Diastolic Blood Pressure
NCT02918279 (60) [back to overview]	Change in Waist Circumference
NCT02918279 (60) [back to overview]	Change in Waist-to-hip Circumference Ratio
NCT02918279 (60) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification)
NCT02918279 (60) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification)
NCT02918279 (60) [back to overview]	Occurrence of Anti-liraglutide Antibodies
NCT02918279 (60) [back to overview]	Percent of Subjects Achieving ≥10% Reduction in Baseline BMI
NCT02918279 (60) [back to overview]	Percent of Subjects Achieving ≥5% Reduction in Baseline BMI
NCT02918279 (60) [back to overview]	Change in P1NP
NCT02918279 (60) [back to overview]	Change in Glycaemic Category
NCT02918279 (60) [back to overview]	Change in Physical Examination
NCT02918279 (60) [back to overview]	Change in Pubertal Status
NCT02918279 (60) [back to overview]	Change in Alkaline Phosphatase (Bone)
NCT02918279 (60) [back to overview]	Change in BMI SDS (Week 0, Week 56)
NCT02918279 (60) [back to overview]	Change in Biochemistry: Albumin
NCT02918279 (60) [back to overview]	Change in Biochemistry: CEA
NCT02918279 (60) [back to overview]	Change in Biochemistry: Creatinine and Bilirubin (Total)
NCT02918279 (60) [back to overview]	Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP
NCT02918279 (60) [back to overview]	Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected
NCT02918279 (60) [back to overview]	Change in ECG
NCT02960659 (8) [back to overview]	Change in Palmitate Turnover From Baseline to 12 Weeks
NCT02960659 (8) [back to overview]	Change in Whole Body Insulin Sensitivity From Baseline to 12 Weeks
NCT02960659 (8) [back to overview]	Change in Glycerol Turnover From Baseline to 12 Weeks
NCT02960659 (8) [back to overview]	Change in Absolute Gluconeogenesis From Baseline to 12 Weeks
NCT02960659 (8) [back to overview]	Change in GIP AUC During OGTT and Meal Absorption
NCT02960659 (8) [back to overview]	Change in Glucose Production Rate From Baseline to 12 Weeks
NCT02960659 (8) [back to overview]	Change in Hepatic Insulin Sensitivity Index From Baseline to 12 Weeks
NCT02960659 (8) [back to overview]	Change in Insulin AUC Concentrations During an OGTT and Meal Absorption
NCT02963922 (46) [back to overview]	Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U)
NCT02963922 (46) [back to overview]	Change in Body Weight (%)
NCT02963922 (46) [back to overview]	Change in SF-36: Physical Component Summary (PCS)
NCT02963922 (46) [back to overview]	Change in SF-36: Mental Component Summary (MCS)
NCT02963922 (46) [back to overview]	Change in Resting Pulse
NCT02963922 (46) [back to overview]	Change in Electrocardiogram (ECG)
NCT02963922 (46) [back to overview]	Change in Laboratory Parameters (Biochemistry) - Uric Acid
NCT02963922 (46) [back to overview]	Change in Laboratory Parameters (Biochemistry) - Thyroid Stimulating Hormone
NCT02963922 (46) [back to overview]	Change in Laboratory Parameters (Biochemistry) - High Sensitive C-reactive Protein
NCT02963922 (46) [back to overview]	Change in Laboratory Parameters (Biochemistry) - eGFR
NCT02963922 (46) [back to overview]	Change in Laboratory Parameters (Biochemistry) - Calcitonin
NCT02963922 (46) [back to overview]	Change in Laboratory Parameters (Biochemistry) - Albumin
NCT02963922 (46) [back to overview]	Change in Laboratory Measurements (Haematology) - Haemoglobin
NCT02963922 (46) [back to overview]	Change in Laboratory Measurements (Haematology) - Haematocrit
NCT02963922 (46) [back to overview]	Change in IWQoL-Lite for CT: Total Score
NCT02963922 (46) [back to overview]	Change in IWQoL-Lite for CT: Psychosocial Domain Score
NCT02963922 (46) [back to overview]	Change in FPG
NCT02963922 (46) [back to overview]	Change in HbA1c
NCT02963922 (46) [back to overview]	Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score
NCT02963922 (46) [back to overview]	Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes
NCT02963922 (46) [back to overview]	Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase
NCT02963922 (46) [back to overview]	Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea
NCT02963922 (46) [back to overview]	Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine
NCT02963922 (46) [back to overview]	Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA
NCT02963922 (46) [back to overview]	Change in Physical Examination
NCT02963922 (46) [back to overview]	Change in sBP and dBP
NCT02963922 (46) [back to overview]	Change in IWQoL-Lite for CT: Pain/Discomfort Domain Score
NCT02963922 (46) [back to overview]	Change in 7-point SMPG Profile Mean Daytime Glucose Value
NCT02963922 (46) [back to overview]	Adverse Events (AEs)
NCT02963922 (46) [back to overview]	Participants Losing More Than 10% of Baseline Body Weight at Week 56
NCT02963922 (46) [back to overview]	Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses
NCT02963922 (46) [back to overview]	Responder Definition Value for IWQoL-Lite for CT Physical Function Domain Score
NCT02963922 (46) [back to overview]	Change in Total Daily Basal Insulin Dose (U/kg)
NCT02963922 (46) [back to overview]	Change in Laboratory Measurements (Haematology) - Erythrocytes
NCT02963922 (46) [back to overview]	Change in SF-36: Sub-domains
NCT02963922 (46) [back to overview]	Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score
NCT02963922 (46) [back to overview]	Change in Waist Circumference
NCT02963922 (46) [back to overview]	Participants Losing at Least 5% of Baseline Body Weight
NCT02963922 (46) [back to overview]	Participants Who Achieved (Yes/no): HbA1c <7%, Weight Loss ≥5% and no Documented Symptomatic Hypoglycaemia
NCT02963922 (46) [back to overview]	Participants Who Achieved (Yes/no): HbA1c <7% and Weight Loss ≥5%
NCT02963922 (46) [back to overview]	Participants Who Achieved (Yes/no): ≥4.6 T-score Points Increase From Baseline in SF-36 Acute MCS
NCT02963922 (46) [back to overview]	Participants Who Achieved (Yes/no): ≥4.3 T-score Points Increase From Baseline in SF-36 Acute Physical Functioning Score
NCT02963922 (46) [back to overview]	Participants Who Achieved (Yes/no): ≥3.8 T-score Points Increase From Baseline in SF-36 Acute PCS
NCT02963922 (46) [back to overview]	Number of Hypoglycaemic Episodes
NCT02963922 (46) [back to overview]	Change in Total Daily Insulin Dose (U/kg)
NCT02963922 (46) [back to overview]	Change in Total Daily Insulin Dose (U)
NCT02963935 (51) [back to overview]	Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score
NCT02963935 (51) [back to overview]	AEs From Randomisation Until and Including the Follow-up Period
NCT02963935 (51) [back to overview]	Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score
NCT02963935 (51) [back to overview]	Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score
NCT02963935 (51) [back to overview]	Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score
NCT02963935 (51) [back to overview]	Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score
NCT02963935 (51) [back to overview]	Proportion of Subjects Losing 4% or More of Baseline Body Weight
NCT02963935 (51) [back to overview]	Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product
NCT02963935 (51) [back to overview]	Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity
NCT02963935 (51) [back to overview]	Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product
NCT02963935 (51) [back to overview]	Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56
NCT02963935 (51) [back to overview]	Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity
NCT02963935 (51) [back to overview]	Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet
NCT02963935 (51) [back to overview]	Change in Laboratory Measurements: Biochemistry (Albumin)
NCT02963935 (51) [back to overview]	Change in Laboratory Measurements: Biochemistry (Calcitonin)
NCT02963935 (51) [back to overview]	Change in Laboratory Measurements: Biochemistry (Glomerular Filtration Rate, Serum)
NCT02963935 (51) [back to overview]	Change in Laboratory Measurements: Biochemistry (Thyroid Stimulating Hormone)
NCT02963935 (51) [back to overview]	Change in Laboratory Measurements: Haematology (Erythrocytes)
NCT02963935 (51) [back to overview]	Change in Laboratory Measurements: Haematology (Haematocrit Blood)
NCT02963935 (51) [back to overview]	Change in Laboratory Measurements: Haematology (Haemoglobin Blood)
NCT02963935 (51) [back to overview]	Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS))
NCT02963935 (51) [back to overview]	Change From Baseline dBP (mmHg)
NCT02963935 (51) [back to overview]	Change From Baseline in FPG (mg/dL)
NCT02963935 (51) [back to overview]	Change From Baseline in HbA1c (%)
NCT02963935 (51) [back to overview]	Change From Baseline in Lipids - FFA
NCT02963935 (51) [back to overview]	Change From Baseline in Lipids - HDL Cholesterol
NCT02963935 (51) [back to overview]	Change in Resting Pulse
NCT02963935 (51) [back to overview]	Change From Baseline in Lipids - LDL Cholesterol
NCT02963935 (51) [back to overview]	Change From Baseline in Lipids - TG
NCT02963935 (51) [back to overview]	Change From Baseline in Lipids - VLDL Cholesterol
NCT02963935 (51) [back to overview]	Change From Baseline in Lipids -Total Cholesterol
NCT02963935 (51) [back to overview]	Change From Baseline sBP (mmHg)
NCT02963935 (51) [back to overview]	Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score
NCT02963935 (51) [back to overview]	Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS)
NCT02963935 (51) [back to overview]	Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score
NCT02963935 (51) [back to overview]	Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase)
NCT02963935 (51) [back to overview]	Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine)
NCT02963935 (51) [back to overview]	Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid)
NCT02963935 (51) [back to overview]	Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea)
NCT02963935 (51) [back to overview]	Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes)
NCT02963935 (51) [back to overview]	Change in Physical Examination
NCT02963935 (51) [back to overview]	Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score
NCT02963935 (51) [back to overview]	Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains)
NCT02963935 (51) [back to overview]	Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score
NCT02963935 (51) [back to overview]	Change in Six Minutes Walking Distance Test (6MWT)
NCT02963935 (51) [back to overview]	Change in Waist Circumference (cm)
NCT02963935 (51) [back to overview]	Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56
NCT02963935 (51) [back to overview]	Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56
NCT02963935 (51) [back to overview]	Change in Body Weight (%)
NCT02963935 (51) [back to overview]	Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score
NCT02963935 (51) [back to overview]	Change in ECG
NCT02964247 (26) [back to overview]	Change in Body Mass Index (BMI)
NCT02964247 (26) [back to overview]	Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association Target
NCT02964247 (26) [back to overview]	Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), no Weight Gain and Systolic Blood Pressure Below 140 mmHg.
NCT02964247 (26) [back to overview]	Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target
NCT02964247 (26) [back to overview]	Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol)
NCT02964247 (26) [back to overview]	Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and no Weight Gain
NCT02964247 (26) [back to overview]	Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and Weight Loss Above or Equal to 3%.
NCT02964247 (26) [back to overview]	Subjects Who Achieve Weight Loss by 3% or More
NCT02964247 (26) [back to overview]	Change in Self-measured Plasma Glucose 7-point Profile - Mean 7-point Profile
NCT02964247 (26) [back to overview]	Change in Self-measured Plasma Glucose 7-point Profile - Mean Post Prandial Increments (Over All Meals)
NCT02964247 (26) [back to overview]	Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes
NCT02964247 (26) [back to overview]	Change in Fasting Plasma Glucose
NCT02964247 (26) [back to overview]	Change in Fasting Blood Lipids-triglycerides
NCT02964247 (26) [back to overview]	Change in Body Weight
NCT02964247 (26) [back to overview]	Change in HbA1c
NCT02964247 (26) [back to overview]	Number of Treatment Emergent Adverse Events
NCT02964247 (26) [back to overview]	Change in Systolic Blood Pressure
NCT02964247 (26) [back to overview]	Change in Waist Circumference
NCT02964247 (26) [back to overview]	Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain
NCT02964247 (26) [back to overview]	Change in Fasting Blood Lipids- Free Fatty Acids (FFA)
NCT02964247 (26) [back to overview]	Change in Fasting Blood Lipids - Very Low Density Lipoprotein (VLDL) Cholesterol
NCT02964247 (26) [back to overview]	Change in Fasting Blood Lipids - Total Cholesterol
NCT02964247 (26) [back to overview]	Change in Fasting Blood Lipids - Low Density Lipoprotein (LDL) Cholesterol
NCT02964247 (26) [back to overview]	Change in Fasting Blood Lipids - High Density Lipoprotein (HDL) Cholesterol
NCT02964247 (26) [back to overview]	Change in Diastolic Blood Pressure
NCT02964247 (26) [back to overview]	Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain.
NCT02973321 (10) [back to overview]	Change From Baseline in HbA1c to Week 26
NCT02973321 (10) [back to overview]	Change From Baseline in Insulin Resistance to Week 26
NCT02973321 (10) [back to overview]	Mean Change From Baseline in Body Weight to Week 26
NCT02973321 (10) [back to overview]	Percentage of Participants Requiring Rescue Therapy
NCT02973321 (10) [back to overview]	Percentage of Participants Achieving >=5% or >=10% Body Weight Loss at Week 26
NCT02973321 (10) [back to overview]	Percentage of Participants Reached HbA1c Target of <6.5% or <7% at Week 26
NCT02973321 (10) [back to overview]	Change From Baseline in Pharmacodynamic Biomarkers to Week 26 - Waist and Hip Circumferences
NCT02973321 (10) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26
NCT02973321 (10) [back to overview]	Change From Baseline in Average 7 Point Self-Monitoring Plasma Glucose (SMPG) to Week 26
NCT02973321 (10) [back to overview]	Change From Baseline in Beta-Cell Function to Week 26
NCT03010683 (4) [back to overview]	Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.
NCT03010683 (4) [back to overview]	Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.
NCT03010683 (4) [back to overview]	Endothelial Glycocalyx and Pulse Wave Velocity.
NCT03010683 (4) [back to overview]	Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.
NCT03018028 (51) [back to overview]	Change in HbA1c (Week 26)
NCT03018028 (51) [back to overview]	Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No)
NCT03018028 (51) [back to overview]	Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No)
NCT03018028 (51) [back to overview]	Change in HbA1c (Week 52)
NCT03018028 (51) [back to overview]	Number of Treatment-emergent Adverse Events (TEAEs)
NCT03018028 (51) [back to overview]	Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
NCT03018028 (51) [back to overview]	Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
NCT03018028 (51) [back to overview]	Anti-semaglutide Binding Antibodies (Yes/no)
NCT03018028 (51) [back to overview]	Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
NCT03018028 (51) [back to overview]	Anti-semaglutide Binding Antibody Levels
NCT03018028 (51) [back to overview]	Anti-semaglutide Binding Antibody Levels
NCT03018028 (51) [back to overview]	Anti-semaglutide Neutralising Antibodies (Yes/no)
NCT03018028 (51) [back to overview]	Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
NCT03018028 (51) [back to overview]	Change From Baseline in DTR-QOL: Sub-domains
NCT03018028 (51) [back to overview]	Change From Baseline in DTR-QOL: Total Score
NCT03018028 (51) [back to overview]	Change in Amylase (Ratio to Baseine)
NCT03018028 (51) [back to overview]	Change in Beta-cell Function (HOMA-B) (Ratio to Baseline)
NCT03018028 (51) [back to overview]	Change in Blood Pressure
NCT03018028 (51) [back to overview]	Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no)
NCT03018028 (51) [back to overview]	Time to Rescue Medication
NCT03018028 (51) [back to overview]	Change in Pulse Rate
NCT03018028 (51) [back to overview]	Time to Additional Anti-diabetic Medication
NCT03018028 (51) [back to overview]	Change in Body Weight (%)
NCT03018028 (51) [back to overview]	Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile
NCT03018028 (51) [back to overview]	Change in Body Weight (kg)
NCT03018028 (51) [back to overview]	Change in ECG Evaluation
NCT03018028 (51) [back to overview]	Change in Eye Examination Category
NCT03018028 (51) [back to overview]	Change in Fasting C-peptide (Ratio to Baseline)
NCT03018028 (51) [back to overview]	Change in Fasting Glucagon (Ratio to Baseline)
NCT03018028 (51) [back to overview]	Change in Fasting Insulin (Ratio to Baseline)
NCT03018028 (51) [back to overview]	Change in Fasting Plasma Glucose
NCT03018028 (51) [back to overview]	Change in Fasting Pro-insulin (Ratio to Baseline)
NCT03018028 (51) [back to overview]	Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline)
NCT03018028 (51) [back to overview]	Semaglutide Plasma Concentration
NCT03018028 (51) [back to overview]	Change in HDL Cholesterol (Ratio to Baseline)
NCT03018028 (51) [back to overview]	Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline)
NCT03018028 (51) [back to overview]	Change in LDL Cholesterol (Ratio to Baseline)
NCT03018028 (51) [back to overview]	Change in Lipase (Ratio to Baseine)
NCT03018028 (51) [back to overview]	Change in Mean Postprandial Increment Over All Meals in SMPG
NCT03018028 (51) [back to overview]	Change in Physical Examination
NCT03018028 (51) [back to overview]	Change in Body Mass Index
NCT03018028 (51) [back to overview]	Change in SF-36: Mental Component Summary (MCS)
NCT03018028 (51) [back to overview]	Change in SF-36: Physical Component Summary (PCS)
NCT03018028 (51) [back to overview]	Change in SF-36: Sub-domains
NCT03018028 (51) [back to overview]	Change in Total Cholesterol (Ratio to Baseline)
NCT03018028 (51) [back to overview]	Change in Triglycerides (Ratio to Baseline)
NCT03018028 (51) [back to overview]	Change in VLDL Cholesterol (Ratio to Baseline)
NCT03018028 (51) [back to overview]	Change in Waist Circumference
NCT03018028 (51) [back to overview]	Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)
NCT03018028 (51) [back to overview]	Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No)
NCT03018028 (51) [back to overview]	Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3%
NCT03038620 (37) [back to overview]	Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI
NCT03038620 (37) [back to overview]	Relative Percent Reduction in Waist Circumference
NCT03038620 (37) [back to overview]	Relative Percent Reduction in Body Weight
NCT03038620 (37) [back to overview]	Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue
NCT03038620 (37) [back to overview]	Relative Percent Change in Triglyceride/HDL-C Ratio
NCT03038620 (37) [back to overview]	Relative Percent Change in Nt-proBNP
NCT03038620 (37) [back to overview]	Relative Percent Change in Insulin
NCT03038620 (37) [back to overview]	Relative Percent Change in HOMA-IR
NCT03038620 (37) [back to overview]	Relative Percent Change in Fasting Blood Glucose
NCT03038620 (37) [back to overview]	Relative Percent Change in C-reactive Protein
NCT03038620 (37) [back to overview]	Relative Percent Reduction in Total Thigh Muscle Volume
NCT03038620 (37) [back to overview]	Change From Baseline in VAT/SAT Ratio
NCT03038620 (37) [back to overview]	Change From Baseline in Total Fat/Fat-free Mass Ratio
NCT03038620 (37) [back to overview]	Change From Baseline in Heart Rate
NCT03038620 (37) [back to overview]	Change From Baseline in Blood Pressure
NCT03038620 (37) [back to overview]	Absolute Reduction in Waist Circumference
NCT03038620 (37) [back to overview]	Absolute Reduction in Visceral Adipose Tissue Volume
NCT03038620 (37) [back to overview]	Absolute Reduction in Total Thigh Muscle Volume
NCT03038620 (37) [back to overview]	Absolute Reduction in Total Body Lean Volume
NCT03038620 (37) [back to overview]	Absolute Reduction in Total Body Adipose Tissue
NCT03038620 (37) [back to overview]	Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
NCT03038620 (37) [back to overview]	Absolute Reduction in Lower Body Subcutaneous Adipose Tissue
NCT03038620 (37) [back to overview]	Absolute Reduction in Body Weight
NCT03038620 (37) [back to overview]	Absolute Reduction in Abdominal Subcutaneous Adipose Tissue
NCT03038620 (37) [back to overview]	Absolute Change in Triglyceride/HDL-C Ratio
NCT03038620 (37) [back to overview]	On-treatment Time, Weeks
NCT03038620 (37) [back to overview]	Absolute Change in Nt-proBNP
NCT03038620 (37) [back to overview]	Absolute Change in Insulin
NCT03038620 (37) [back to overview]	Absolute Change in HOMA-IR
NCT03038620 (37) [back to overview]	Absolute Change in Fasting Blood Glucose
NCT03038620 (37) [back to overview]	Absolute Reduction in Liver Fat Percent
NCT03038620 (37) [back to overview]	Absolute Change in CRP
NCT03038620 (37) [back to overview]	Relative Percent Reduction in Total Body Lean Volume
NCT03038620 (37) [back to overview]	Relative Percent Reduction in Total Body Adipose Tissue
NCT03038620 (37) [back to overview]	Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
NCT03038620 (37) [back to overview]	Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue
NCT03038620 (37) [back to overview]	Relative Percent Reduction in Liver Fat Percent
NCT03041792 (9) [back to overview]	Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5
NCT03041792 (9) [back to overview]	Number of Participants With Vital Signs Data Meeting Categorical Criteria
NCT03041792 (9) [back to overview]	Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
NCT03041792 (9) [back to overview]	Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5
NCT03041792 (9) [back to overview]	Change From Baseline in Area Under the Plasma Concentration-Time Profile of Acetaminophen for 0-60 Minutes and 0-300 Minutes (AUC0-60min and AUC0-300min) After Acetaminophen Dose at Visits 4 and 5
NCT03041792 (9) [back to overview]	Change From Baseline in Appetite Score (Mean Rating Area Under Curve From Time 30 to 120 Minutes [AUC30-120min]) for Mean Lunch at Visits 4 and 5
NCT03041792 (9) [back to overview]	Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5
NCT03041792 (9) [back to overview]	Number of Participants With Treatment-Emergent Adverse Events (All-Causality)
NCT03041792 (9) [back to overview]	Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
NCT03048578 (1) [back to overview]	Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test
NCT03101930 (8) [back to overview]	Urine Albumin-to-creatinine Ratio
NCT03101930 (8) [back to overview]	Heart Rate
NCT03101930 (8) [back to overview]	Fasting Insulin
NCT03101930 (8) [back to overview]	Fasting Glucose
NCT03101930 (8) [back to overview]	Change in Plasminogen Activator Inhibitor-1
NCT03101930 (8) [back to overview]	Change in Flow-mediated Dilation
NCT03101930 (8) [back to overview]	Blood Pressure
NCT03101930 (8) [back to overview]	Change in Weight
NCT03151005 (5) [back to overview]	Assessment of Reproductive Functions
NCT03151005 (5) [back to overview]	Assessment of Blood Pressure
NCT03151005 (5) [back to overview]	Assessment of Reproductive Function
NCT03151005 (5) [back to overview]	Basic Vital Signs
NCT03151005 (5) [back to overview]	Assessment of Liver Function
NCT03172494 (53) [back to overview]	Change in Haematology: Haemoglobin Blood
NCT03172494 (53) [back to overview]	Change in Haemotological Parameter- Eosinophils
NCT03172494 (53) [back to overview]	Change in Haemotological Parameter- Monocytes
NCT03172494 (53) [back to overview]	Change in HbA1c
NCT03172494 (53) [back to overview]	Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1
NCT03172494 (53) [back to overview]	Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes
NCT03172494 (53) [back to overview]	Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1)
NCT03172494 (53) [back to overview]	Occurence of Antibodies Cross-reacting to Human Insulin
NCT03172494 (53) [back to overview]	Occurence of Anti-insulin Degludec Specific Antibodies
NCT03172494 (53) [back to overview]	Number of Treatment-emergent Adverse Events (TEAE)
NCT03172494 (53) [back to overview]	Change in Fasting Triglycerides - Ratio to Baseline.
NCT03172494 (53) [back to overview]	Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.
NCT03172494 (53) [back to overview]	Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT03172494 (53) [back to overview]	Occurence of Neutralising Liraglutide Antibodies
NCT03172494 (53) [back to overview]	Occurence of Total Insulin Antibodies
NCT03172494 (53) [back to overview]	Change in Fasting Total Cholesterol - Ratio to Baseline
NCT03172494 (53) [back to overview]	Serum Concentrations of Insulin Degludec
NCT03172494 (53) [back to overview]	9-point SMPG Profile
NCT03172494 (53) [back to overview]	Change in Biochemistry Parameters (Albumin Serum, Total Protein)
NCT03172494 (53) [back to overview]	Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum
NCT03172494 (53) [back to overview]	Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum
NCT03172494 (53) [back to overview]	Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
NCT03172494 (53) [back to overview]	Change in Calcitonin
NCT03172494 (53) [back to overview]	Change in Electrocardiogram (ECG)
NCT03172494 (53) [back to overview]	Change in Physical Examination
NCT03172494 (53) [back to overview]	Eye Examination
NCT03172494 (53) [back to overview]	Urinalysis (Protein, Glucose, Erythrocytes and Ketones)
NCT03172494 (53) [back to overview]	Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes.
NCT03172494 (53) [back to overview]	Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
NCT03172494 (53) [back to overview]	Insulin Dose
NCT03172494 (53) [back to overview]	Change in Waist Circumferance
NCT03172494 (53) [back to overview]	Change in Fasting Plasma Glucose (FPG)
NCT03172494 (53) [back to overview]	Change in Haematological Parameter: Haematocrits
NCT03172494 (53) [back to overview]	Change in Fasting Human Insulin - Ratio to Baseline
NCT03172494 (53) [back to overview]	Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline
NCT03172494 (53) [back to overview]	Change in Fasting Glucagon - Ratio to Baseline
NCT03172494 (53) [back to overview]	Change in Pulse
NCT03172494 (53) [back to overview]	Change in Mean Post-prandial Plasma Glucose (PG) Increments
NCT03172494 (53) [back to overview]	Change in Mean of 9-point SMPG Profile
NCT03172494 (53) [back to overview]	Change in HOMA-B (Beta Cell Function)- Ratio to Baseline
NCT03172494 (53) [back to overview]	Change in Fasting Free Fatty Acid - Ratio to Baseline
NCT03172494 (53) [back to overview]	Change in Fasting C-peptide - Ratio to Baseline
NCT03172494 (53) [back to overview]	Change in Body Weight
NCT03172494 (53) [back to overview]	Plasma Concentration of Liraglutide
NCT03172494 (53) [back to overview]	Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline
NCT03172494 (53) [back to overview]	Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum
NCT03172494 (53) [back to overview]	Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline
NCT03172494 (53) [back to overview]	Change in Haematologcal Parameter: Leukocytes
NCT03172494 (53) [back to overview]	Change in Haematological Parameter - Lymphocytes
NCT03172494 (53) [back to overview]	Change in Haematological Parameter - Neutrophils
NCT03172494 (53) [back to overview]	Change in Haematological Parameter: Basophils
NCT03172494 (53) [back to overview]	Change in Haematological Parameter: Erythrocytes Blood
NCT03172494 (53) [back to overview]	Change in Haematological Parameter: Thrombocytes
NCT03175120 (49) [back to overview]	Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline
NCT03175120 (49) [back to overview]	Change in Fasting Glucagon- Ratio to Baseline
NCT03175120 (49) [back to overview]	Change in Fasting Free Fatty Acids- Ratio to Baseline
NCT03175120 (49) [back to overview]	Change in Fasting C-peptide- Ratio to Baseline
NCT03175120 (49) [back to overview]	Change in Creatinine
NCT03175120 (49) [back to overview]	Change in Body Weight
NCT03175120 (49) [back to overview]	Change in Albumin
NCT03175120 (49) [back to overview]	Antibodies Cross-reacting to Human Insulin
NCT03175120 (49) [back to overview]	Anti-insulin Degludec Specific Antibodies
NCT03175120 (49) [back to overview]	Eye Examination
NCT03175120 (49) [back to overview]	Change in Physical Examination
NCT03175120 (49) [back to overview]	Change in Electrocardiogram (ECG)
NCT03175120 (49) [back to overview]	Change in Calcitonin
NCT03175120 (49) [back to overview]	SMPG-9-point Profile (Individual Points in the Profile)
NCT03175120 (49) [back to overview]	Change in Haematological Parameter- Leukocytes and Thrombocytes
NCT03175120 (49) [back to overview]	Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
NCT03175120 (49) [back to overview]	Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea
NCT03175120 (49) [back to overview]	Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
NCT03175120 (49) [back to overview]	Total Insulin Antibodies
NCT03175120 (49) [back to overview]	Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
NCT03175120 (49) [back to overview]	Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT03175120 (49) [back to overview]	Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
NCT03175120 (49) [back to overview]	Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes
NCT03175120 (49) [back to overview]	Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition
NCT03175120 (49) [back to overview]	Number of Treatment-emergent Adverse Events (TEAEs)
NCT03175120 (49) [back to overview]	Insulin Dose
NCT03175120 (49) [back to overview]	Urinalysis (Erythrocytes, Protein, Glucose and Ketones)
NCT03175120 (49) [back to overview]	Change in Total Protein
NCT03175120 (49) [back to overview]	Change in Total Bilirubin
NCT03175120 (49) [back to overview]	Change in SMPG-mean Post Prandial Increments
NCT03175120 (49) [back to overview]	Change in Pulse
NCT03175120 (49) [back to overview]	Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile
NCT03175120 (49) [back to overview]	Change in HOMA-B (Beta-cell Function)- Ratio to Baseline
NCT03175120 (49) [back to overview]	Change in HbA1c
NCT03175120 (49) [back to overview]	Change in Haematological Parameter- Neutrophils
NCT03175120 (49) [back to overview]	Change in Haematological Parameter- Monocytes
NCT03175120 (49) [back to overview]	Change in Haematological Parameter- Lymphocytes
NCT03175120 (49) [back to overview]	Change in Haematological Parameter- Haemoglobin
NCT03175120 (49) [back to overview]	Change in Haematological Parameter- Haematocrit
NCT03175120 (49) [back to overview]	Change in Haematological Parameter- Erythrocytes
NCT03175120 (49) [back to overview]	Change in Haematological Parameter- Eosinophils
NCT03175120 (49) [back to overview]	Change in Haematological Parameter- Basophils
NCT03175120 (49) [back to overview]	Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline
NCT03175120 (49) [back to overview]	Change in Fasting Triglycerides- Ratio to Baseline
NCT03175120 (49) [back to overview]	Change in Fasting Total Cholesterol- Ratio to Baseline
NCT03175120 (49) [back to overview]	Change in Fasting Plasma Glucose (FPG)
NCT03175120 (49) [back to overview]	Change in Waist Circumference
NCT03175120 (49) [back to overview]	Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline
NCT03175120 (49) [back to overview]	Change in Fasting Insulin- Ratio to Baseline
NCT03191396 (41) [back to overview]	Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately
NCT03191396 (41) [back to overview]	Change in Fasting Blood Lipids: Total Cholesterol
NCT03191396 (41) [back to overview]	Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol
NCT03191396 (41) [back to overview]	Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol
NCT03191396 (41) [back to overview]	Change in Diastolic Blood Pressure
NCT03191396 (41) [back to overview]	Change in Calcitonin
NCT03191396 (41) [back to overview]	Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain
NCT03191396 (41) [back to overview]	Change in Body Weight (kg)
NCT03191396 (41) [back to overview]	Change in Body Mass Index (BMI)
NCT03191396 (41) [back to overview]	Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR).
NCT03191396 (41) [back to overview]	Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains
NCT03191396 (41) [back to overview]	Change in Haematology - Thrombocytes and Leukocytes
NCT03191396 (41) [back to overview]	Change in Biochemistry - Albumin
NCT03191396 (41) [back to overview]	Change in Biochemistry - Creatinine and Bilirubin
NCT03191396 (41) [back to overview]	Change in Biochemistry - Calcium, Pottassium and Sodium
NCT03191396 (41) [back to overview]	Change in Biochemistry - Amylase and Lipase
NCT03191396 (41) [back to overview]	Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase.
NCT03191396 (41) [back to overview]	Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes
NCT03191396 (41) [back to overview]	Subjects Who Achieve Weight Loss Above or Equal to 5%
NCT03191396 (41) [back to overview]	Subjects Who Achieve Weight Loss Above or Equal to 3%
NCT03191396 (41) [back to overview]	Subjects Who Achieve Weight Loss Above or Equal to 10%
NCT03191396 (41) [back to overview]	Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%
NCT03191396 (41) [back to overview]	Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%
NCT03191396 (41) [back to overview]	Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%
NCT03191396 (41) [back to overview]	Subjects Who Achieve HbA1c Reduction Above or Equal to 1%
NCT03191396 (41) [back to overview]	Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target
NCT03191396 (41) [back to overview]	Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target
NCT03191396 (41) [back to overview]	Change in Body Weight (%)
NCT03191396 (41) [back to overview]	Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
NCT03191396 (41) [back to overview]	Number of Treatment-emergent Adverse Events (TEAE)
NCT03191396 (41) [back to overview]	Change in Waist Circumference
NCT03191396 (41) [back to overview]	Change in Systolic Blood Pressure
NCT03191396 (41) [back to overview]	Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)
NCT03191396 (41) [back to overview]	Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile
NCT03191396 (41) [back to overview]	Change in Pulse Rate
NCT03191396 (41) [back to overview]	Change in HbA1c
NCT03191396 (41) [back to overview]	Change in Haematology - Haemoglobin
NCT03191396 (41) [back to overview]	Change in Haematology - Haematocrit
NCT03191396 (41) [back to overview]	Change in Haematology - Erythrocytes
NCT03191396 (41) [back to overview]	Change in Fasting Plasma Glucose (FPG)
NCT03191396 (41) [back to overview]	Change in Fasting Blood Lipids: Triglycerides
NCT03235050 (13) [back to overview]	Percent Change in Body Weight Versus Active Comparator
NCT03235050 (13) [back to overview]	Percent Change in Body Weight
NCT03235050 (13) [back to overview]	Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)
NCT03235050 (13) [back to overview]	Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants
NCT03235050 (13) [back to overview]	Change in HbA1c
NCT03235050 (13) [back to overview]	Absolute Change in Body Weight
NCT03235050 (13) [back to overview]	Percent Change in Body Weight
NCT03235050 (13) [back to overview]	Change in HbA1c
NCT03235050 (13) [back to overview]	Absolute Change in Body Weight Versus Active Comparator
NCT03235050 (13) [back to overview]	Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)
NCT03235050 (13) [back to overview]	Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control
NCT03235050 (13) [back to overview]	Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%
NCT03235050 (13) [back to overview]	Percentage of Participants Achieving an HbA1c Target < 7.0%
NCT03279731 (4) [back to overview]	Binge Episodes
NCT03279731 (4) [back to overview]	Assessment of Improvement of Binge Eating Symptoms
NCT03279731 (4) [back to overview]	Remission From Binge-eating
NCT03279731 (4) [back to overview]	Change in Body Weight
NCT03374956 (3) [back to overview]	Percentage of Responders
NCT03374956 (3) [back to overview]	Percentage of Responders
NCT03374956 (3) [back to overview]	Change in Total Body Weight
NCT03480022 (29) [back to overview]	Triglyceride Levels (TRG)
NCT03480022 (29) [back to overview]	Corrected First Phase Insulin Secretion (IGI/HOMA-IR)
NCT03480022 (29) [back to overview]	Change in Percent Body Weight
NCT03480022 (29) [back to overview]	Body Mass Index (BMI)
NCT03480022 (29) [back to overview]	Android-Gynoid Ratio (AGR) by DXA
NCT03480022 (29) [back to overview]	Adrenal Dehydroepiandrosterone Sulfate (DHEAS)
NCT03480022 (29) [back to overview]	Absolute Body Weight (BW)
NCT03480022 (29) [back to overview]	Abdominal Adiposity (Waist Circumference [WC]
NCT03480022 (29) [back to overview]	5% Weight Loss From Baseline
NCT03480022 (29) [back to overview]	10% Body Weight Loss From Baseline
NCT03480022 (29) [back to overview]	Total Fat Mass Evaluated by DEXA
NCT03480022 (29) [back to overview]	Total Cholesterol Levels
NCT03480022 (29) [back to overview]	Total Body Fat (%) by DXA
NCT03480022 (29) [back to overview]	Systolic Blood Pressure
NCT03480022 (29) [back to overview]	Total Testosterone Concentrations (T)
NCT03480022 (29) [back to overview]	OGTT Mean Blood Glucose (MBG)
NCT03480022 (29) [back to overview]	Menstrual Cycle Frequency
NCT03480022 (29) [back to overview]	Insulin Secretion- Insulin Sensitivity Index (Oral Disposition Index-IS-SI)
NCT03480022 (29) [back to overview]	High Density Lipoprotein Cholesterol (HDL-C)
NCT03480022 (29) [back to overview]	Free Androgen Index (FAI)
NCT03480022 (29) [back to overview]	Fasting Insulin Sensitivity (HOMA-IR)
NCT03480022 (29) [back to overview]	Fasting Blood Glucose (FG)
NCT03480022 (29) [back to overview]	Diastolic Blood Pressure (BP)
NCT03480022 (29) [back to overview]	Matsuda Insulin Sensitivity Index Derived From the OGTT (SI OGTT)
NCT03480022 (29) [back to overview]	Trunk/Leg Fat Ratio (TLR) by DXA
NCT03480022 (29) [back to overview]	Triglyceride to HDL-Cholesterol Ratio (TRG/HDL-C)
NCT03480022 (29) [back to overview]	Waist-to Height Ratio [WHtR])
NCT03480022 (29) [back to overview]	Triglyceride and Glucose Index (TyG)
NCT03480022 (29) [back to overview]	Waist-to-Hip Ratio
NCT03486392 (5) [back to overview]	Percent Change From Baseline in Body Weight at Week 26
NCT03486392 (5) [back to overview]	Number of Participants With Treatment Emergent Adverse Events (TEAEs)
NCT03486392 (5) [back to overview]	Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26
NCT03486392 (5) [back to overview]	Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26
NCT03486392 (5) [back to overview]	Change From Baseline in Body Weight at Week 26
NCT03523273 (10) [back to overview]	Satiety
NCT03523273 (10) [back to overview]	Satiation Volume to Fullness
NCT03523273 (10) [back to overview]	Maximum Satiation
NCT03523273 (10) [back to overview]	Gastric Volume After Meal
NCT03523273 (10) [back to overview]	Change in Weight at 5 Weeks
NCT03523273 (10) [back to overview]	Gastric Emptying of Solids (T1/2)
NCT03523273 (10) [back to overview]	Change in Weight at 16 Weeks
NCT03523273 (10) [back to overview]	Gastric Emptying of Solids (T1/2)
NCT03523273 (10) [back to overview]	Gastric Accommodation
NCT03523273 (10) [back to overview]	Fasting Gastric Volume Prior to Meal
NCT03712098 (5) [back to overview]	Number of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date
NCT03712098 (5) [back to overview]	Body Weight at 26 Weeks Post-Target Quit Date
NCT03712098 (5) [back to overview]	Body Weight at 12 Weeks Post-Target Quit Date
NCT03712098 (5) [back to overview]	Calories Consumed Per Day
NCT03712098 (5) [back to overview]	Number of Participants With 7-day Point Prevalence Smoking Abstinence at 26 Weeks Post-Target Quit Date
NCT03737240 (26) [back to overview]	Number of Hospital Readmissions
NCT03737240 (26) [back to overview]	Number of Participants With Severe Hypoglycemic Events
NCT03737240 (26) [back to overview]	Participants With HbA1c <7.0% and no Hypoglycemia
NCT03737240 (26) [back to overview]	Participants With HbA1c <7.0% and no Hypoglycemia
NCT03737240 (26) [back to overview]	Participants With HbA1c <7.0% and no Weight Gain
NCT03737240 (26) [back to overview]	Participants With HbA1c <7.0% and no Weight Gain and no Hypoglycemia
NCT03737240 (26) [back to overview]	Participants With HbA1c <7.5% and no Weight Gain and no Hypoglycemia
NCT03737240 (26) [back to overview]	Participants With HbA1c >10% Achieving HbA1c <7.5%
NCT03737240 (26) [back to overview]	Participants With HbA1c >10% Achieving HbA1c <8.0%
NCT03737240 (26) [back to overview]	Participants With HbA1c >11% Achieving HbA1c <7.5%
NCT03737240 (26) [back to overview]	Participants With HbA1c >11% Achieving HbA1c <8.0%
NCT03737240 (26) [back to overview]	Percentage of Time With Interstitial Glucose <54 mg/dL
NCT03737240 (26) [back to overview]	Percentage of Time With Interstitial Glucose <70 mg/dL
NCT03737240 (26) [back to overview]	Percentage of Time With Interstitial Glucose Between 70 and 180 mg/dL
NCT03737240 (26) [back to overview]	Average Daily Blood Glucose
NCT03737240 (26) [back to overview]	Average Fasting Blood Glucose
NCT03737240 (26) [back to overview]	Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score
NCT03737240 (26) [back to overview]	Glycemic Variability
NCT03737240 (26) [back to overview]	Number of Participants With Documented Symptomatic Hypoglycemic Events
NCT03737240 (26) [back to overview]	Total Daily Insulin Dose
NCT03737240 (26) [back to overview]	Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score
NCT03737240 (26) [back to overview]	Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) Score
NCT03737240 (26) [back to overview]	Change in Hemoglobin A1c (HbA1c)
NCT03737240 (26) [back to overview]	Nocturnal Asymptomatic Hypoglycemic Events
NCT03737240 (26) [back to overview]	Nocturnal Symptomatic Hypoglycemic Events
NCT03737240 (26) [back to overview]	Number of Emergency Room (ER) Visits
NCT03757130 (11) [back to overview]	Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
NCT03757130 (11) [back to overview]	Accumulation Ratio (AR) for Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
NCT03757130 (11) [back to overview]	Dose-normalized AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
NCT03757130 (11) [back to overview]	Area Under the Concentration-time Curve From Time 0 to 28 Days (AUC0-28) for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
NCT03757130 (11) [back to overview]	Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
NCT03757130 (11) [back to overview]	Dose-normalized Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
NCT03757130 (11) [back to overview]	Accumulation Ratio of AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
NCT03757130 (11) [back to overview]	Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of AMG 598 After Subcutaneous Injection on Day 57
NCT03757130 (11) [back to overview]	Terminal Half-life (T1/2,z) of AMG 598 After Subcutaneous Injection on Day 57
NCT03757130 (11) [back to overview]	Number of Participants With Treatment-emergent Adverse Events
NCT03757130 (11) [back to overview]	Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings
NCT03856047 (26) [back to overview]	Change in Waist Circumference
NCT03856047 (26) [back to overview]	Change in Body Weight (Kg)
NCT03856047 (26) [back to overview]	Change in Diastolic Blood Pressure (DBP)
NCT03856047 (26) [back to overview]	Change in FPG (mg/dL)
NCT03856047 (26) [back to overview]	Change in Glycosylated Haemoglobin (HbA1c) (%-Point)
NCT03856047 (26) [back to overview]	Change in HbA1c (mmol/Mol)
NCT03856047 (26) [back to overview]	Change in High Density Lipoprotein (HDL) Cholesterol
NCT03856047 (26) [back to overview]	Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks
NCT03856047 (26) [back to overview]	Number of Treatment-emergent Serious Adverse Events (TESAEs)
NCT03856047 (26) [back to overview]	Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
NCT03856047 (26) [back to overview]	Number of Treatment-emergent Adverse Events (TEAEs)
NCT03856047 (26) [back to overview]	Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide
NCT03856047 (26) [back to overview]	Change in Very Low Density Lipoprotein (VLDL) Cholesterol
NCT03856047 (26) [back to overview]	Change in Triglycerides
NCT03856047 (26) [back to overview]	Change in Total Cholesterol
NCT03856047 (26) [back to overview]	Change in Systolic Blood Pressure (SBP)
NCT03856047 (26) [back to overview]	Change in Renin Activity
NCT03856047 (26) [back to overview]	Change in Pulse
NCT03856047 (26) [back to overview]	Change in Low Density Lipoprotein (LDL) Cholesterol
NCT03856047 (26) [back to overview]	Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks
NCT03856047 (26) [back to overview]	Change in Fasting Insulin
NCT03856047 (26) [back to overview]	Change in High Sensitivity C-reactive Protein (hsCRP)
NCT03856047 (26) [back to overview]	Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta)
NCT03856047 (26) [back to overview]	Change in Fasting Plasma Glucose (FPG) (mmol/L)
NCT03856047 (26) [back to overview]	Change in Aldosterone
NCT03856047 (26) [back to overview]	Change in Body Weight (%)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol))
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L)
NCT04074161 (32) [back to overview]	Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)
NCT04074161 (32) [back to overview]	Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D))
NCT04074161 (32) [back to overview]	Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75
NCT04074161 (32) [back to overview]	Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Pooled Placebo and Liraglutide 3.0 mg Versus Pooled Placebo)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))
NCT04074161 (32) [back to overview]	Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)
NCT04074161 (32) [back to overview]	Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75
NCT04074161 (32) [back to overview]	Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Waist Circumference
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline)
NCT04074161 (32) [back to overview]	Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline)

Change in Fasting Plasma Glucose at Week 156

Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks (NCT00294723)
Timeframe: week 0, week 156

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	-12.06
Lira 1.2	-5.45
Glimepiride	4.57

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Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52

Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. (NCT00294723)
Timeframe: week 0, week 52

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	-37.4
Lira 1.2	-30.8
Glimepiride	-24.5

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Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104

Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three. (NCT00294723)
Timeframe: week 0, week 104

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	-11.76
Lira 1.2	-8.28
Glimepiride	-7.95

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Hypoglycaemic Episodes

Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL. (NCT00294723)
Timeframe: weeks 104-195

Intervention	episodes (Number)
	Major	Minor	Symptoms only
Glimepiride	1	34	4
Lira 1.2	0	3	1
Lira 1.8	0	13	3

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Hypoglycaemic Episodes

Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL. (NCT00294723)
Timeframe: weeks 0-104

Intervention	episodes (Number)
	Major	Minor	Symptoms only
Glimepiride	0	533	405
Lira 1.2	0	68	133
Lira 1.8	1	71	87

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Change in Body Weight at Week 104

Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension) (NCT00294723)
Timeframe: week 0, week 104

Intervention	kg (Least Squares Mean)
Lira 1.8	-2.70
Lira 1.2	-1.89
Glimepiride	0.95

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Change in Body Weight at Week 156

Change in body weight from baseline (week 0) to 156 weeks (NCT00294723)
Timeframe: week 0, week 156

Intervention	kg (Least Squares Mean)
Lira 1.8	-2.43
Lira 1.2	-1.68
Glimepiride	1.05

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Change in Body Weight at Week 52

Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period) (NCT00294723)
Timeframe: week 0, week 52

Intervention	kg (Least Squares Mean)
Lira 1.8	-2.45
Lira 1.2	-2.05
Glimepiride	1.12

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Change in Fasting Plasma Glucose at Week 104

Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension) (NCT00294723)
Timeframe: week 0, week 104

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	-15.82
Lira 1.2	-9.36
Glimepiride	1.97

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Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52

Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three. (NCT00294723)
Timeframe: week 0, week 52

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	-9.6
Lira 1.2	-8.4
Glimepiride	-5.6

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Change in Fasting Plasma Glucose at Week 52

Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period) (NCT00294723)
Timeframe: week 0, week 52

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	-25.57
Lira 1.2	-15.21
Glimepiride	-5.29

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Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104

Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension) (NCT00294723)
Timeframe: week 0, week 104

Intervention	percentage point of total HbA1c (Least Squares Mean)
Lira 1.8	-0.88
Lira 1.2	-0.59
Glimepiride	-0.28

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Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156

Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks (NCT00294723)
Timeframe: week 0, week 156

Intervention	percentage point of total HbA1c (Least Squares Mean)
Lira 1.8	-0.71
Lira 1.2	-0.44
Glimepiride	-0.16

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Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104

Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. (NCT00294723)
Timeframe: week 0, week 104

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	-37.15
Lira 1.2	-27.34
Glimepiride	-24.85

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Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156

Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three. (NCT00294723)
Timeframe: week 0, week 156

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	-11.01
Lira 1.2	-7.53
Glimepiride	-7.97

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Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156

Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. (NCT00294723)
Timeframe: week 0, week 156

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	-34.83
Lira 1.2	-25.68
Glimepiride	-23.84

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Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52

Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period) (NCT00294723)
Timeframe: week 0, week 52

Intervention	percentage point of total HbA1c (Least Squares Mean)
Lira 1.8	-1.14
Lira 1.2	-0.84
Glimepiride	-0.51

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Change in Glycosylated A1c (HbA1c) at Week 104

Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation) (NCT00318461)
Timeframe: week 0, week 104

Intervention	percentage of total haemoglobin (Least Squares Mean)
Lira 0.6 + Met	-0.36
Lira 1.2 + Met	-0.56
Lira 1.8 + Met	-0.58
Met Mono	0.25
Met + Glim	-0.50

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Change in Glycosylated A1c (HbA1c) at Week 26

Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation) (NCT00318461)
Timeframe: week 0, week 26

Intervention	Percentage point of total HbA1c (Least Squares Mean)
Lira 0.6 + Met	-0.69
Lira 1.2 + Met	-0.97
Lira 1.8 + Met	-1.00
Met Mono	0.09
Met + Glim	-0.98

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Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26

Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three. (NCT00318461)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Lira 0.6 + Met	-1.68
Lira 1.2 + Met	-2.33
Lira 1.8 + Met	-2.57
Met Mono	-0.62
Met + Glim	-2.46

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Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104

"Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.~Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three." (NCT00318461)
Timeframe: week 0, week 104

Intervention	mmol/L (Least Squares Mean)
Lira 0.6 + Met	-0.27
Lira 1.2 + Met	-0.56
Lira 1.8 + Met	-0.44
Met Mono	-0.20
Met + Glim	-0.29

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Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104

Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three. (NCT00318461)
Timeframe: week 0, week 104

Intervention	mmol/L (Least Squares Mean)
Lira 0.6 + Met	-1.59
Lira 1.2 + Met	-2.22
Lira 1.8 + Met	-2.10
Met Mono	-0.43
Met + Glim	-1.80

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Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26

"Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.~Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three." (NCT00318461)
Timeframe: week 0, week 26

Intervention	mmol/l (Least Squares Mean)
Lira 0.6 + Met	-0.23
Lira 1.2 + Met	-0.40
Lira 1.8 + Met	-0.56
Met Mono	-0.44
Met + Glim	-0.44

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Hypoglycaemic Episodes at Week 104

Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00318461)
Timeframe: weeks 0-104

,,,,

Intervention	episodes (Number)
	All	Major	Minor	Symptoms only
Lira 0.6 + Met	52	0	23	29
Lira 1.2 + Met	51	1	26	24
Lira 1.8 + Met	49	0	22	27
Met + Glim	524	0	284	240
Met Mono	18	0	6	12

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Hypoglycaemic Episodes at Week 26

Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00318461)
Timeframe: weeks 0-26

,,,,

Intervention	episodes (Number)
	Major	Minor	Symptoms only
Lira 0.6 + Met	0	15	17
Lira 1.2 + Met	0	3	7
Lira 1.8 + Met	0	9	22
Met + Glim	0	136	175
Met Mono	0	6	10

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Change in Fasting Plasma Glucose (FPG) at Week 26

Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation) (NCT00318461)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Lira 0.6 + Met	-1.13
Lira 1.2 + Met	-1.63
Lira 1.8 + Met	-1.68
Met Mono	0.40
Met + Glim	-1.31

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Change in Beta-cell Function at Week 104

"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)." (NCT00318461)
Timeframe: week 0, week 104

Intervention	percentage point (%point) (Least Squares Mean)
Lira 0.6 + Met	64.48
Lira 1.2 + Met	27.30
Lira 1.8 + Met	17.81
Met Mono	-7.89
Met + Glim	11.25

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Change in Beta-cell Function at Week 26

Intervention	percentage point (%point) (Least Squares Mean)
Lira 0.6 + Met	20.45
Lira 1.2 + Met	20.33
Lira 1.8 + Met	26.12
Met Mono	-1.63
Met + Glim	24.68

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Change in Body Weight at Week 104

Change in body weight from baseline (week 0) to 104 weeks (end of treatment) (NCT00318461)
Timeframe: week 0, week 104

Intervention	kg (Least Squares Mean)
Lira 0.6 + Met	-2.07
Lira 1.2 + Met	-3.03
Lira 1.8 + Met	-2.91
Met Mono	-1.80
Met + Glim	0.70

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Change in Body Weight at Week 26

Change in body weight from baseline (week 0) to 26 weeks (end of randomisation) (NCT00318461)
Timeframe: week 0, week 26

Intervention	kg (Least Squares Mean)
Lira 0.6 + Met	-1.78
Lira 1.2 + Met	-2.58
Lira 1.8 + Met	-2.79
Met Mono	-1.51
Met + Glim	0.95

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Change in Fasting Plasma Glucose (FPG) at Week 104

Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment) (NCT00318461)
Timeframe: week 0, week 104

Intervention	mmol/L (Least Squares Mean)
Lira 0.6 + Met	-0.80
Lira 1.2 + Met	-1.20
Lira 1.8 + Met	-1.18
Met Mono	0.75
Met + Glim	-0.64

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Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment

(NCT00393718)
Timeframe: after 24 weeks of treatment

Intervention	percentage of total haemoglobin (Least Squares Mean)
Liraglutide	6.99
Glibenclamide	7.50

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Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. (NCT00393718)
Timeframe: after 52 weeks of treatment

Intervention	mg/dL (Least Squares Mean)
Liraglutide	63.56
Glibenclamide	76.59

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Postprandial Glucose AUC After 24 Weeks of Treatment

Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment (NCT00393718)
Timeframe: after 24 weeks of treatment

Intervention	mg/dL *h (Least Squares Mean)
Liraglutide	557.54
Glibenclamide	670.60

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Postprandial Glucose AUC After 52 Weeks of Treatment

Postprandial glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment (NCT00393718)
Timeframe: after 52 weeks of treatment

Intervention	mg/dL *h (Least Squares Mean)
Liraglutide	608.66
Glibenclamide	683.17

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Fasting Plasma Glucose After 52 Weeks of Treatment

(NCT00393718)
Timeframe: after 52 weeks of treatment

Intervention	mg/dL (Least Squares Mean)
Liraglutide	145.8
Glibenclamide	157.5

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Body Weight After 52 Weeks of Treatment

(NCT00393718)
Timeframe: after 52 weeks of treatment

Intervention	kg (Least Squares Mean)
Liraglutide	64.30
Glibenclamide	66.01

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Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment

(NCT00393718)
Timeframe: after 52 weeks of treatment

Intervention	percentage of total haemoglobin (Least Squares Mean)
Liraglutide	7.31
Glibenclamide	7.80

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Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

Plasma glucose (PG) profile measured after 24 weeks of treatment. The time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. (NCT00393718)
Timeframe: after 24 weeks of treatment

Intervention	mg/dL (Least Squares Mean)
Liraglutide	155.98
Glibenclamide	173.61

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Fasting Plasma Glucose After 24 Weeks of Treatment

(NCT00393718)
Timeframe: after 24 weeks of treatment

Intervention	mg/dL (Least Squares Mean)
Liraglutide	137.2
Glibenclamide	150.1

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Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. (NCT00393718)
Timeframe: after 24 weeks of treatment

Intervention	mg/dL (Least Squares Mean)
Liraglutide	59.69
Glibenclamide	79.66

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Hypoglycaemic Episodes

Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00393718)
Timeframe: over 52 weeks of treatment

Intervention	number of events per year of exposure (Number)
	All hypoglycaemic episodes	Major	Minor	Symptoms only
Glibenclamide	3.843	0.000	1.103	2.740
Liraglutide	0.694	0.000	0.187	0.507

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Body Weight After 24 Weeks of Treatment

(NCT00393718)
Timeframe: after 24 weeks of treatment

Intervention	kg (Least Squares Mean)
Liraglutide	64.06
Glibenclamide	65.97

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Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

Mean plasma glucose(PG) in 7-point plasma glucose profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. (NCT00393718)
Timeframe: after 52 weeks of treatment

Intervention	mg/dL (Least Squares Mean)
Liraglutide	167.39
Glibenclamide	184.60

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Hypoglycaemic Episodes

Intervention	number of events per year of exposure (Number)
	All hypoglycaemic episodes	Major	Minor	Symptoms only
0.6 mg + SU	3.131	0.0000	1.438	1.693
0.9 mg + SU	3.715	0.0000	1.365	2.350
SU Mono	2.990	0.0000	1.285	1.705

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Postprandial Glucose AUC After 52 Weeks of Treatment

Postprandial Glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment (NCT00395746)
Timeframe: after 52 weeks of treatment

Intervention	mg/dL *h (Least Squares Mean)
0.6 mg + SU	648.87
0.9 mg + SU	589.98
SU Mono	717.55

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Postprandial Glucose AUC After 24 Weeks of Treatment

Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment (NCT00395746)
Timeframe: after 24 weeks of treatment

Intervention	mg/dL *h (Least Squares Mean)
0.6 mg + SU	614.58
0.9 mg + SU	575.50
SU Mono	725.72

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Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

Intervention	mg/dL (Least Squares Mean)
0.6 mg + SU	82.28
0.9 mg + SU	76.09
SU Mono	89.39

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Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

Intervention	mg/dL (Least Squares Mean)
0.6 mg + SU	86.38
0.9 mg + SU	68.34
SU Mono	79.71

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Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

7-point plasma glucose (PG) profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. (NCT00395746)
Timeframe: after 52 weeks of treatment

Intervention	mg/dL (Least Squares Mean)
0.6 mg + SU	171.42
0.9 mg + SU	159.58
SU Mono	205.92

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Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment

(NCT00395746)
Timeframe: after 52 weeks of treatment

Intervention	percentage of total haemoglobin (Least Squares Mean)
0.6 mg + SU	7.42
0.9 mg + SU	7.06
SU Mono	8.39

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Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment

(NCT00395746)
Timeframe: after 24 weeks of treatment

Intervention	percentage of total haemoglobin (Least Squares Mean)
0.6 mg + SU	7.02
0.9 mg + SU	6.75
SU Mono	8.02

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Fasting Plasma Glucose After 52 Weeks of Treatment

(NCT00395746)
Timeframe: after 52 weeks of treatment

Intervention	mg/dL (Least Squares Mean)
0.6 mg + SU	140.3
0.9 mg + SU	134.5
SU Mono	164.6

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Fasting Plasma Glucose After 24 Weeks of Treatment

(NCT00395746)
Timeframe: after 24 weeks of treatment

Intervention	mg/dL (Least Squares Mean)
0.6 mg + SU	132.2
0.9 mg + SU	126.2
SU Mono	158.8

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Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

Plasma glucose (PG) profile measured after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. (NCT00395746)
Timeframe: after 24 weeks of treatment

Intervention	mg/dL (Least Squares Mean)
0.6 mg + SU	160.20
0.9 mg + SU	150.05
SU Mono	194.50

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Body Weight After 24 Weeks of Treatment

(NCT00395746)
Timeframe: after 24 weeks of treatment

Intervention	kg (Least Squares Mean)
0.6 mg + SU	65.77
0.9 mg + SU	65.34
SU Mono	64.59

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Body Weight After 52 Weeks of Treatment

(NCT00395746)
Timeframe: after 52 weeks of treatment

Intervention	kg (Least Squares Mean)
0.6 mg + SU	65.96
0.9 mg + SU	65.87
SU Mono	64.83

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Mean Change From Baseline in Body Weight at Week 104

Calculated as mean body weight at week 104 - baseline (NCT00422058)
Timeframe: Week 0, week 104

,,,,,

Intervention	kg (Mean)
	Baseline	Change at Week 104
Lira 1.2 mg/Lira 3.0 mg	96.4	-4.9
Lira 1.8 mg/Lira 3.0 mg	98.0	-5.6
Lira 2.4 mg/Lira 3.0 mg	98.4	-6.4
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	97.3	-5.4
Liraglutide 3.0 mg	97.5	-8.2
Orlistat	96.0	-3.8

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Change From Baseline in Waist Circumference at Week 20

Calculated as mean waist circumference at week 20-baseline. (NCT00422058)
Timeframe: Week 0, week 20

,,,,,

Intervention	cm (Mean)
	Baseline	Change at Week 20
Lira 1.2 mg/Lira 3.0 mg	109.0	-5.8
Lira 1.8 mg/Lira 3.0 mg	108.2	-5.9
Lira 2.4 mg/Lira 3.0 mg	110.4	-7.2
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	108.3	-4.2
Liraglutide 3.0 mg	108.7	-7.9
Orlistat	107.6	-6.0

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Change From Baseline in Waist Circumference at Week 104

Calculated as mean waist circumference at week 104-baseline. (NCT00422058)
Timeframe: Week 0, week 104

,,,,,

Intervention	cm (Mean)
	Baseline	Change at Week 104
Lira 1.2 mg/Lira 3.0 mg	109.0	-8.6
Lira 1.8 mg/Lira 3.0 mg	108.2	-9.0
Lira 2.4 mg/Lira 3.0 mg	110.4	-10.4
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	108.3	-10.0
Liraglutide 3.0 mg	108.7	-9.8
Orlistat	107.6	-9.5

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Mean Change From Baseline in Body Weight at Week 20

Calculated as mean body weight at week 20 - baseline (NCT00422058)
Timeframe: Week 0, week 20

,,,,,

Intervention	kg (Mean)
	Baseline	Change at Week 20
Lira 1.2 mg/Lira 3.0 mg	96.4	-5.1
Lira 1.8 mg/Lira 3.0 mg	98.0	-5.9
Lira 2.4 mg/Lira 3.0 mg	98.4	-6.6
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	97.3	-3.0
Liraglutide 3.0 mg	97.5	-7.6
Orlistat	96.0	-4.4

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Change From Baseline in Adiponectin at Week 104

Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk (NCT00422058)
Timeframe: Week 0, week 104

,,,,,

Intervention	mcg/mL (Mean)
	Baseline	Change at Week 104
Lira 1.2 mg/Lira 3.0 mg	5.8	3.3
Lira 1.8 mg/Lira 3.0 mg	6.7	1.3
Lira 2.4 mg/Lira 3.0 mg	6.2	3.4
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	5.1	3.5
Liraglutide 3.0 mg	6.1	3.2
Orlistat	5.4	3.1

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Change From Baseline in Adiponectin at Week 20

Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk (NCT00422058)
Timeframe: Week 0, week 20

,,,,,

Intervention	mcg/mL (Mean)
	Baseline	Change at Week 20
Lira 1.2 mg/Lira 3.0 mg	5.8	1.2
Lira 1.8 mg/Lira 3.0 mg	6.7	1.7
Lira 2.4 mg/Lira 3.0 mg	6.2	1.6
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	5.1	2.3
Liraglutide 3.0 mg	6.1	2.3
Orlistat	5.4	1.7

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Change From Baseline in Blood Pressure at Week 104

Calculated as mean blood pressure at week 104-baseline. (NCT00422058)
Timeframe: Week 0, week 104

,,,,,

Intervention	mmHg (Mean)
	Baseline (Systolic )	Change at Week 104 (Systolic)	Baseline (Diastolic)	Change at Week 104 (Diastolic)
Lira 1.2 mg/Lira 3.0 mg	127.2	-4.0	79.71	-0.98
Lira 1.8 mg/Lira 3.0 mg	123.4	-3.8	77.91	-1.00
Lira 2.4 mg/Lira 3.0 mg	126.3	-6.5	78.53	-1.99
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	123.6	-2.0	76.78	1.64
Liraglutide 3.0 mg	124.3	-5.6	77.84	-1.92
Orlistat	122.7	-2.0	76.94	-1.11

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Change From Baseline in Blood Pressure at Week 20

Calculated as mean blood pressure at week 20-baseline. (NCT00422058)
Timeframe: Week 0, week 20

,,,,,

Intervention	mmHg (Mean)
	Baseline (Systolic )	Change at Week 20 (Systolic)	Baseline (Diastolic)	Change at Week 20 (Diastolic)
Lira 1.2 mg/Lira 3.0 mg	127.2	-6.1	79.71	-1.53
Lira 1.8 mg/Lira 3.0 mg	123.4	-4.8	77.91	-1.61
Lira 2.4 mg/Lira 3.0 mg	126.3	-9.1	78.53	-1.39
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	123.6	-3.2	76.78	-0.32
Liraglutide 3.0 mg	124.3	-6.4	77.84	-2.37
Orlistat	122.7	-4.3	76.94	-1.96

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Change From Baseline in Fasting Insulin at Week 104

Calculated as mean fasting insulin at week 104 - baseline (NCT00422058)
Timeframe: Week 0, week 104

,,,,,

Intervention	pmol/L (Mean)
	Baseline	Change at Week 104
Lira 1.2 mg/Lira 3.0 mg	82.9	-13.5
Lira 1.8 mg/Lira 3.0 mg	85.7	18.6
Lira 2.4 mg/Lira 3.0 mg	88.7	-2.1
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	99.5	0.7
Liraglutide 3.0 mg	89.1	-19.6
Orlistat	85.5	-15.3

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Change From Baseline in Fasting Insulin at Week 20

Calculated as mean fasting insulin at week 20 - baseline (NCT00422058)
Timeframe: Week 0, week 20

,,,,,

Intervention	pmol/L (Mean)
	Baseline	Change at Week 20
Lira 1.2 mg/Lira 3.0 mg	82.9	8.7
Lira 1.8 mg/Lira 3.0 mg	85.7	-0.7
Lira 2.4 mg/Lira 3.0 mg	88.7	-3.9
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	99.5	-15.0
Liraglutide 3.0 mg	89.1	-12.3
Orlistat	85.5	-16.7

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Change From Baseline in Fasting Plasma Glucose at Week 104

Calculated as mean fasting plasma glucose at week 104 - baseline (NCT00422058)
Timeframe: Week 0, week 104

,,,,,

Intervention	mmol/L (Mean)
	Baseline	Change at Week 104
Lira 1.2 mg/Lira 3.0 mg	5.30	-0.09
Lira 1.8 mg/Lira 3.0 mg	5.29	-0.09
Lira 2.4 mg/Lira 3.0 mg	5.27	-0.20
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	5.42	-0.22
Liraglutide 3.0 mg	5.36	-0.23
Orlistat	5.30	0.02

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Change From Baseline in Fasting Plasma Glucose at Week 20

Calculated as mean fasting plasma glucose at week 20 - baseline (NCT00422058)
Timeframe: Week 0, week 20

,,,,,

Intervention	mmol/L (Mean)
	Baseline	Change at Week 20
Lira 1.2 mg/Lira 3.0 mg	5.30	-0.39
Lira 1.8 mg/Lira 3.0 mg	5.29	-0.44
Lira 2.4 mg/Lira 3.0 mg	5.27	-0.38
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	5.42	-0.09
Liraglutide 3.0 mg	5.36	-0.44
Orlistat	5.3	-0.10

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Change From Baseline in Fibrinogen at Week 104

Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk (NCT00422058)
Timeframe: Week 0, week 104

,,,,,

Intervention	g/L (Mean)
	Baseline	Change at Week 104
Lira 1.2 mg/Lira 3.0 mg	3.67	-0.14
Lira 1.8 mg/Lira 3.0 mg	3.75	-0.15
Lira 2.4 mg/Lira 3.0 mg	3.64	-0.24
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	3.60	-0.10
Liraglutide 3.0 mg	3.61	-0.22
Orlistat	3.68	-0.39

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Change From Baseline in Fibrinogen at Week 20

Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk (NCT00422058)
Timeframe: Week 0, week 20

,,,,,

Intervention	g/L (Mean)
	Baseline	Change at Week 20
Lira 1.2 mg/Lira 3.0 mg	3.67	0.01
Lira 1.8 mg/Lira 3.0 mg	3.75	0.02
Lira 2.4 mg/Lira 3.0 mg	3.64	0.10
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	3.60	-0.06
Liraglutide 3.0 mg	3.61	0.05
Orlistat	3.68	-0.12

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Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104

Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline (NCT00422058)
Timeframe: Week 0, week 104

,,,,,

Intervention	percentage (%) of total haemoglobin (Mean)
	Baseline	Change at Week 104
Lira 1.2 mg/Lira 3.0 mg	5.58	-0.25
Lira 1.8 mg/Lira 3.0 mg	5.60	-0.30
Lira 2.4 mg/Lira 3.0 mg	5.54	-0.25
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	5.60	-0.32
Liraglutide 3.0 mg	5.57	-0.35
Orlistat	5.55	-0.18

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Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20

Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline (NCT00422058)
Timeframe: Week 0, week 20

,,,,,

Intervention	percentage (%) of total haemoglobin (Mean)
	Baseline	Change at Week 20
Lira 1.2 mg/Lira 3.0 mg	5.58	-0.14
Lira 1.8 mg/Lira 3.0 mg	5.60	-0.21
Lira 2.4 mg/Lira 3.0 mg	5.54	-0.22
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	5.60	0.01
Liraglutide 3.0 mg	5.57	-0.24
Orlistat	5.55	0.00

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Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104

Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk (NCT00422058)
Timeframe: Week 0, week 104

,,,,,

Intervention	mg/L (Mean)
	Baseline	Change at Week 104
Lira 1.2 mg/Lira 3.0 mg	5.1	-1.6
Lira 1.8 mg/Lira 3.0 mg	4.4	-0.6
Lira 2.4 mg/Lira 3.0 mg	4.0	-0.9
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	3.6	-0.5
Liraglutide 3.0 mg	3.8	-2.1
Orlistat	4.6	2.4

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Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20

Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk (NCT00422058)
Timeframe: Week 0, week 20

,,,,,

Intervention	mg/L (Mean)
	Baseline	Change at Week 20
Lira 1.2 mg/Lira 3.0 mg	5.1	0.1
Lira 1.8 mg/Lira 3.0 mg	4.4	-0.8
Lira 2.4 mg/Lira 3.0 mg	4.0	0.5
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	3.6	0.8
Liraglutide 3.0 mg	3.8	-1.1
Orlistat	4.6	-0.3

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Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104

Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk (NCT00422058)
Timeframe: Week 0, week 104

,,,,,

Intervention	U/mL (Mean)
	Baseline	Change at Week 104
Lira 1.2 mg/Lira 3.0 mg	19.5	-0.3
Lira 1.8 mg/Lira 3.0 mg	19.7	-0.8
Lira 2.4 mg/Lira 3.0 mg	17.6	0.3
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	21.6	-1.4
Liraglutide 3.0 mg	19.0	0.4
Orlistat	17.4	2.9

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Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20

Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk (NCT00422058)
Timeframe: Week 0, week 20

,,,,,

Intervention	U/mL (Mean)
	Baseline	Change at Week 20
Lira 1.2 mg/Lira 3.0 mg	19.5	-2.0
Lira 1.8 mg/Lira 3.0 mg	19.7	-3.5
Lira 2.4 mg/Lira 3.0 mg	17.6	-2.3
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg	21.6	-3.0
Liraglutide 3.0 mg	19.0	-4.5
Orlistat	17.4	-1.2

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Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78

Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. (NCT00518882)
Timeframe: week 0, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.35
Exenatide -> Liraglutide -> Liraglutide	-0.95

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Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78

Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. (NCT00518882)
Timeframe: week 26, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.22
Exenatide -> Liraglutide -> Liraglutide	1.07

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Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26

Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. (NCT00518882)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.06
Exenatide -> Liraglutide -> Liraglutide	0.06

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Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78

Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. (NCT00518882)
Timeframe: week 0, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.26
Exenatide -> Liraglutide -> Liraglutide	-0.37

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Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78

Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch. (NCT00518882)
Timeframe: week 26, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.05
Exenatide -> Liraglutide -> Liraglutide	-0.09

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Change in Total Cholesterol at Week 26

Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation) (NCT00518882)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.20
Exenatide -> Liraglutide -> Liraglutide	-0.09

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Change in Total Cholesterol at Week 78

Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 0, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.07
Exenatide -> Liraglutide -> Liraglutide	0.09

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Change in Triglyceride at Week 26

Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation) (NCT00518882)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.41
Exenatide -> Liraglutide -> Liraglutide	-0.23

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Change in Triglyceride at Week 78

Change in triglyceride (TG) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 0, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.3
Exenatide -> Liraglutide -> Liraglutide	-0.1

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Change in Triglyceride, Weeks 26-78

Change in Triglyceride (TG) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 26, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.1
Exenatide -> Liraglutide -> Liraglutide	-0.0

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Change in Very Low-density Lipoprotein-cholesterol at Week 26

Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation) (NCT00518882)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.20
Exenatide -> Liraglutide -> Liraglutide	0.27

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Change in Very Low-density Lipoprotein-cholesterol at Week 78

Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 0, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.27
Exenatide -> Liraglutide -> Liraglutide	0.31

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Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78

Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 26, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.06
Exenatide -> Liraglutide -> Liraglutide	0.03

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Hypoglycaemic Episodes at Week 26

Total number of hypoglycaemic episodes occurring after baseline (week 0) and until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00518882)
Timeframe: weeks 0-26

Intervention	episodes (Number)
	Major	Minor	Symptoms only
Exenatide -> Liraglutide -> Liraglutide	2	264	93
Liraglutide -> Liraglutide -> Liraglutide	0	208	79

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Hypoglyceamic Episodes, Weeks 26-78

Total number of hypoglycaemic episodes occurring after end of randomisation (week 26) and until week 78 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00518882)
Timeframe: weeks 26-78

Intervention	episodes (Number)
	Major	Minor	Symptoms only
Exenatide -> Liraglutide -> Liraglutide	0	172	32
Liraglutide -> Liraglutide -> Liraglutide	1	140	37

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Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26

Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation) (NCT00518882)
Timeframe: week 0, week 26

Intervention	percentage (%) of subjects (Number)
	Treatment target HbA1c < 7%	Treatment target HbA1c =< 6.5%
Exenatide -> Liraglutide -> Liraglutide	42	20
Liraglutide -> Liraglutide -> Liraglutide	53	34

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Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78

Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment) (NCT00518882)
Timeframe: week 0, week 78

Intervention	percentage (%) of subjects (Number)
	Treatment target HbA1c < 7%	Treatment target HbA1c =< 6.5%
Exenatide -> Liraglutide -> Liraglutide	48	35
Liraglutide -> Liraglutide -> Liraglutide	47	31

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Change in Fasting Plasma Glucose at Week 78

Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group) (NCT00518882)
Timeframe: week 0, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-1.3
Exenatide -> Liraglutide -> Liraglutide	-0.8

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Change in Apolipoprotein B at Week 26

Change in apolipoprotein B (ApoB) from baseline (week 0) to 26 weeks (end of randomisation) (NCT00518882)
Timeframe: week 0, week 26

Intervention	g/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.06
Exenatide -> Liraglutide -> Liraglutide	-0.03

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Change in Apolipoprotein B at Week 78

Change in apolipoprotein B (ApoB) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 0, week 78

Intervention	g/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.08
Exenatide -> Liraglutide -> Liraglutide	-0.07

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Change in Apolipoprotein B, Weeks 26-78

Change in apolipoprotein B (ApoB) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 26, week 78

Intervention	g/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.02
Exenatide -> Liraglutide -> Liraglutide	-0.03

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Change in Beta-cell Function at Week 26

"Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)." (NCT00518882)
Timeframe: week 0, week 26

Intervention	percentage point (%point) (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	32.12
Exenatide -> Liraglutide -> Liraglutide	2.74

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Change in Beta-cell Function at Week 78

"Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)." (NCT00518882)
Timeframe: week 0, week 78

Intervention	percentage point (%point) (Mean)
Liraglutide -> Liraglutide -> Liraglutide	24.86
Exenatide -> Liraglutide -> Liraglutide	11.13

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Change in Beta-cell Function, Weeks 26-78

"Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)." (NCT00518882)
Timeframe: week 26, week 78

Intervention	percentage point (%point) (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-18.18
Exenatide -> Liraglutide -> Liraglutide	2.29

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Change in Body Weight at Week 26

Change in body weight from baseline (week 0) to 26 weeks (end of randomisation) (NCT00518882)
Timeframe: week 0, week 26

Intervention	kg (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-3.24
Exenatide -> Liraglutide -> Liraglutide	-2.87

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Change in Body Weight at Week 78

Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group) (NCT00518882)
Timeframe: week 0, week 78

Intervention	kg (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-3.3
Exenatide -> Liraglutide -> Liraglutide	-3.2

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Change in Body Weight, Weeks 26-78

Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group) (NCT00518882)
Timeframe: week 26, week 78

Intervention	kg (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.4
Exenatide -> Liraglutide -> Liraglutide	-0.7

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Change in Fasting Plasma Glucose at Week 26

Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation) (NCT00518882)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-1.61
Exenatide -> Liraglutide -> Liraglutide	-0.60

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Change in Fasting Plasma Glucose, Weeks 26-78

Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group) (NCT00518882)
Timeframe: week 26, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.7
Exenatide -> Liraglutide -> Liraglutide	-0.1

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Change in Free Fatty Acid at Week 26

Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation) (NCT00518882)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.17
Exenatide -> Liraglutide -> Liraglutide	-0.10

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Change in Free Fatty Acid at Week 78

Change in Free Fatty Acid (FFA) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 0, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.10
Exenatide -> Liraglutide -> Liraglutide	-0.07

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Change in Total Cholesterol, Weeks 26-78

Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 26, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.11
Exenatide -> Liraglutide -> Liraglutide	0.12

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Change in Free Fatty Acid, Weeks 26-78

Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 26, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.06
Exenatide -> Liraglutide -> Liraglutide	0.01

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Change in Glycosylated A1c (HbA1c) at Week 26

Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation) (NCT00518882)
Timeframe: week 0, week 26

Intervention	percentage point of total HbA1c (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-1.12
Exenatide -> Liraglutide -> Liraglutide	-0.79

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Change in Glycosylated A1c (HbA1c) at Week 78

Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group) (NCT00518882)
Timeframe: week 0, week 78

Intervention	percentage point of total HbA1c (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.98
Exenatide -> Liraglutide -> Liraglutide	-0.85

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Change in Glycosylated A1c (HbA1c), Weeks 26-78

Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group) (NCT00518882)
Timeframe: week 26, week 78

Intervention	percentage point of total HbA1c (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.25
Exenatide -> Liraglutide -> Liraglutide	-0.00

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Change in High-density Lipoprotein-cholesterol at Week 26

Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation) (NCT00518882)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.04
Exenatide -> Liraglutide -> Liraglutide	-0.05

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Change in High-density Lipoprotein-cholesterol at Week 78

Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 0, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.03
Exenatide -> Liraglutide -> Liraglutide	-0.02

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Change in High-density Lipoprotein-cholesterol, Weeks 26-78

Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 26, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.01
Exenatide -> Liraglutide -> Liraglutide	0.00

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Change in Low-density Lipoprotein-cholesterol at Week 26

Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation) (NCT00518882)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.44
Exenatide -> Liraglutide -> Liraglutide	-0.40

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Change in Low-density Lipoprotein-cholesterol at Week 78

Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 0, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.30
Exenatide -> Liraglutide -> Liraglutide	-0.21

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Change in Low-density Lipoprotein-cholesterol, Weeks 26-78

Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). (NCT00518882)
Timeframe: week 26, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.03
Exenatide -> Liraglutide -> Liraglutide	0.08

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Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26

Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. (NCT00518882)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-3.20
Exenatide -> Liraglutide -> Liraglutide	-3.93

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Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78

Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. (NCT00518882)
Timeframe: week 0, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-3.31
Exenatide -> Liraglutide -> Liraglutide	-3.13

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Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78

Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. (NCT00518882)
Timeframe: week 26, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.06
Exenatide -> Liraglutide -> Liraglutide	0.72

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Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26

Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. (NCT00518882)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-3.05
Exenatide -> Liraglutide -> Liraglutide	-3.59

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Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78

Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. (NCT00518882)
Timeframe: week 0, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-2.21
Exenatide -> Liraglutide -> Liraglutide	-2.55

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Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78

Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. (NCT00518882)
Timeframe: week 26, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.32
Exenatide -> Liraglutide -> Liraglutide	0.58

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Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26

Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. (NCT00518882)
Timeframe: week 0. week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-2.74
Exenatide -> Liraglutide -> Liraglutide	-2.35

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Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78

Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. (NCT00518882)
Timeframe: week 0, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-1.93
Exenatide -> Liraglutide -> Liraglutide	-2.17

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Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78

Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. (NCT00518882)
Timeframe: week 26, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	0.67
Exenatide -> Liraglutide -> Liraglutide	-0.09

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Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26

Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast. (NCT00518882)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.83
Exenatide -> Liraglutide -> Liraglutide	-2.16

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Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78

Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. (NCT00518882)
Timeframe: week 0, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-1.08
Exenatide -> Liraglutide -> Liraglutide	-0.99

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Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78

Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. (NCT00518882)
Timeframe: week 26, week 78

Intervention	mmol/L (Mean)
Liraglutide -> Liraglutide -> Liraglutide	-0.22
Exenatide -> Liraglutide -> Liraglutide	1.15

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Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26

Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. (NCT00518882)
Timeframe: week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide -> Liraglutide -> Liraglutide	-1.10
Exenatide -> Liraglutide -> Liraglutide	-2.11

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Change in Fasting Lipid Profile, APO-B

Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment). (NCT00614120)
Timeframe: week 0, week 16

Intervention	g/L (Median)
Lira 0.6 + Met	0.02
Lira 1.2 + Met	0.00
Lira 1.8 + Met	-0.00
Glim + Met	0.01

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Change in Body Weight

Change in body weight from baseline (week 0) to 16 weeks (end of treatment) (NCT00614120)
Timeframe: week 0, week 16

Intervention	kg (Mean)
Lira 0.6 + Met	-1.8
Lira 1.2 + Met	-2.3
Lira 1.8 + Met	-2.4
Glim + Met	0.1

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Change in Beta-cell Function

Intervention	percentage point (%point) (Mean)
Lira 0.6 + Met	15.3
Lira 1.2 + Met	17.8
Lira 1.8 + Met	21.7
Glim + Met	21.8

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Change in Self-measured Fasting Plasma Glucose

Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary. (NCT00614120)
Timeframe: week 0, week 16

Intervention	mg/dL (Mean)
Lira 0.6 + Met	-1.83
Lira 1.2 + Met	-1.96
Lira 1.8 + Met	-2.28
Glim + Met	-2.13

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Change in Glycosylated Haemoglobin A1c (HbA1c)

Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment). (NCT00614120)
Timeframe: week 0, week 16

Intervention	percentage point of total HbA1c (Mean)
Lira 0.6 + Met	-1.0
Lira 1.2 + Met	-1.3
Lira 1.8 + Met	-1.4
Glim + Met	-1.3

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Hypoglycaemic Episodes

Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00614120)
Timeframe: weeks 0-16

,,,

Intervention	episodes (Number)
	Major	Minor	Symptoms only
Glim + Met	2	80	86
Lira 0.6 + Met	0	6	12
Lira 1.2 + Met	0	0	11
Lira 1.8 + Met	0	5	9

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Change in Fasting Lipid Profile

"Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on:~Total Cholesterol (TC)~Low-density Lipoprotein-cholesterol (LDL-C)~Very Low-density Lipoprotein-cholesterol (VLDL-C)~High-density Lipoprotein-cholesterol (HDL-C)~Triglyceride (TG)~Free Fatty Acid (FFA)" (NCT00614120)
Timeframe: week 0, week 16

,,,

Intervention	mmol/L (Mean)
	Change in TC (Absolute), N=221, 216, 216, 228	Change in LDL-C (Absolute), N=221, 216, 216, 228	Change in VLDL-C (Absolute), N=213, 210, 207, 220	Change in HDL-C (Absolute), N=217, 212, 212, 220	Change in TG (Absolute), N=220, 212, 213, 226	Change in FFA (Absolute), N=218, 214, 216, 227
Glim + Met	0.02	0.04	0.05	-0.01	-0.07	-0.02
Lira 0.6 + Met	0.06	0.06	0.03	-0.02	-0.08	-0.03
Lira 1.2 + Met	-0.01	-0.03	0.05	-0.05	-0.06	-0.04
Lira 1.8 + Met	-0.03	0.00	0.01	-0.05	-0.22	-0.10

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7-point Self-measured Plasma Glucose Profiles

Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16). (NCT00614120)
Timeframe: week 0, 8, 12 and 16

,,,

Intervention	mg/dl (Mean)
	Week 0 - Before breakfast	Week 0 - 90 minutes after breakfast	Week 0 - Before lunch	Week 0 - 90 minutes after lunch	Week 0 - Before dinner	Week 0 - 90 minutes after dinner	Week 0 - Bedtime	Week 8 - Before breakfast	Week 8 - 90 minutes after breakfast	Week 8 - Before lunch	Week 8 - 90 minutes after lunch	Week 8 - Before dinner	Week 8 - 90 minutes after dinner	Week 8 - Bedtime	Week 12 - Before breakfast	Week 12 - 90 minutes after breakfast	Week 12 - Before lunch	Week 12 - 90 minutes after lunch	Week 12 - Before dinner	Week 12 - 90 minutes after dinner	Week 12 - Bedtime	Week 16 - Before breakfast	Week 16 - 90 minutes after breakfast	Week 16 - Before lunch	Week 16 - 90 minutes after lunch	Week 16 - Before dinner	Week 16 - 90 minutes after dinner	Week 16 - Bedtime
Glim + Met	163.8	238.5	175.8	227.6	180.2	231.6	202.7	130.1	201.2	132.6	184.3	143.3	190.2	163.6	128.5	200.8	129.3	185.3	144.2	188.5	159.9	131.0	195.1	128.8	182.2	144.9	192.6	157.7
Lira 0.6 + Met	168.2	245.9	178.5	234.2	194.8	239.6	205.7	137.0	198.5	144.8	187.2	159.1	193.7	169.1	137.8	197.5	141.8	183.7	156.4	197.2	168.2	137.3	195.6	140.5	185.8	151.5	195.0	166.4
Lira 1.2 + Met	167.5	248.0	180.5	232.3	184.8	239.6	208.1	130.4	190.1	136.5	176.9	147.8	187.1	161.6	130.2	185.7	135.6	174.7	143.4	185.7	158.9	132.9	188.7	137.0	181.4	148.4	183.3	159.8
Lira 1.8 + Met	168.8	245.4	176.9	234.4	190.9	244.0	219.3	133.7	178.5	138.0	177.9	144.2	183.3	155.8	130.2	178.6	134.1	173.7	144.5	183.5	158.9	128.6	177.6	137.8	173.2	140.9	173.2	151.6

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Number of Hypoglycaemic Episodes

Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL. (NCT00620282)
Timeframe: weeks 0-12

Intervention	episodes (Number)
	Major	Minor	Symptoms Only
Glimepiride	0	10	4
Lira 1.8	0	1	3
Placebo	0	0	0

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Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range

Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL). (NCT00620282)
Timeframe: week 0, week 12

Intervention	participants (Number)
	Week 0	Week 12
Glimepiride	5	2
Lira 1.8	1	1
Placebo	3	2

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Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range

Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL). (NCT00620282)
Timeframe: week 0, week 12

Intervention	participants (Number)
	Week 0	Week 12
Glimepiride	1	0
Lira 1.8	1	1
Placebo	0	2

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Fasting Lipid Profile - Change in Triglycerides (TG)

Change in TG (NCT00620282)
Timeframe: week 0, week 12

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	-8.163
Placebo	28.546
Glimepiride	-4.377

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Change in Body Weight

(NCT00620282)
Timeframe: week 0, week 12

Intervention	kg (Least Squares Mean)
Lira 1.8	-1.821
Placebo	-0.293
Glimepiride	1.038

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Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)

Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute. (NCT00620282)
Timeframe: week 0, week 12

Intervention	mL/100 mL/min (Least Squares Mean)
Lira 1.8	3.455
Placebo	-1.044
Glimepiride	2.746

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Fasting Lipid Profile - Change in HDL-C

Change in HDL-C (NCT00620282)
Timeframe: week 0, week 12

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	0.393
Placebo	0.562
Glimepiride	1.116

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Fasting Lipid Profile - Change in LDL-C

Change in LDL-C (NCT00620282)
Timeframe: week 0, week 12

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	1.243
Placebo	-2.459
Glimepiride	-1.529

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Biomarkers of Cardiovascular Risk - Change in TNF-alpha

Change in TNF-alpha (NCT00620282)
Timeframe: week 0, week 12

Intervention	pg/mL (Least Squares Mean)
Lira 1.8	-0.024
Placebo	0.397
Glimepiride	-0.0050

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Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)

Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute. (NCT00620282)
Timeframe: week 0, week 12

Intervention	mL/100 mL/min (Least Squares Mean)
Lira 1.8	4.244
Placebo	-3.187
Glimepiride	2.164

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Fasting Lipid Profile - Change in Total Cholesterol (TC)

Change in TC (NCT00620282)
Timeframe: week 0, week 12

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	2.006
Placebo	4.243
Glimepiride	0.094

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Change in Fasting Plasma Glucose (FPG)

Change in FPG (NCT00620282)
Timeframe: week 0, week 12

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	-41.672
Placebo	-6.067
Glimepiride	-32.019

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Change in HbA1c (Glycosylated Haemoglobin A1c)

Percentage point change in HbA1c (NCT00620282)
Timeframe: week 0, week 12

Intervention	percentage of total haemoglobin (Least Squares Mean)
Lira 1.8	-0.629
Placebo	-0.094
Glimepiride	-0.552

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Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles

The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime. (NCT00620282)
Timeframe: week 0, week 12

Intervention	mg/dL (Least Squares Mean)
Lira 1.8	-32.175
Placebo	-20.304
Glimepiride	-35.99

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Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)

Change from baseline in haematocrit (the proportion of blood that consists of red blood cells) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12

Intervention	Litre/litre (L/L) (Mean)
Placebo	-0.01
Semaglutide 0.1 mg	-0.01
Semaglutide 0.2 mg	-0.01
Semaglutide 0.4 mg	0.00
Semaglutide 0.8 mg	-0.01
Semaglutide 0.8 mg (With Titration)	-0.00
Semaglutide 1.6 mg (With Titration)	-0.00
Liraglutide 1.2 mg	0.00
Liraglutide 1.8 mg	-0.01

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Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)

Change from baseline in haemoglobin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12

Intervention	Gram/litre (g/L) (Mean)
Placebo	0.1
Semaglutide 0.1 mg	-0.4
Semaglutide 0.2 mg	-1.2
Semaglutide 0.4 mg	2.8
Semaglutide 0.8 mg	-0.3
Semaglutide 0.8 mg (With Titration)	1.5
Semaglutide 1.6 mg (With Titration)	1.0
Liraglutide 1.2 mg	2.1
Liraglutide 1.8 mg	1.1

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Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)

Change from baseline in leukocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12

Intervention	Billion cells/litre (10^9/L) (Mean)
Placebo	0.05
Semaglutide 0.1 mg	0.04
Semaglutide 0.2 mg	-0.16
Semaglutide 0.4 mg	0.59
Semaglutide 0.8 mg	0.14
Semaglutide 0.8 mg (With Titration)	0.41
Semaglutide 1.6 mg (With Titration)	0.70
Liraglutide 1.2 mg	0.40
Liraglutide 1.8 mg	0.26

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Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)

Change from baseline in lymphocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12

Intervention	Billion cells/litre (10^9/L) (Mean)
Placebo	-0.1
Semaglutide 0.1 mg	0.0
Semaglutide 0.2 mg	-0.1
Semaglutide 0.4 mg	0.2
Semaglutide 0.8 mg	-0.0
Semaglutide 0.8 mg (With Titration)	-0.1
Semaglutide 1.6 mg (With Titration)	0.1
Liraglutide 1.2 mg	0.0
Liraglutide 1.8 mg	-0.1

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Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)

Change from baseline in monocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12

Intervention	Billion cells/litre (10^9/L) (Mean)
Placebo	0.1
Semaglutide 0.1 mg	0.0
Semaglutide 0.2 mg	-0.0
Semaglutide 0.4 mg	0.1
Semaglutide 0.8 mg	0.1
Semaglutide 0.8 mg (With Titration)	0.0
Semaglutide 1.6 mg (With Titration)	0.1
Liraglutide 1.2 mg	0.1
Liraglutide 1.8 mg	0.1

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Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)

Change from baseline in neutrophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12

Intervention	Billion cells/litre (10^9/L) (Mean)
Placebo	0.1
Semaglutide 0.1 mg	0.0
Semaglutide 0.2 mg	-0.1
Semaglutide 0.4 mg	0.3
Semaglutide 0.8 mg	-0.1
Semaglutide 0.8 mg (With Titration)	0.5
Semaglutide 1.6 mg (With Titration)	0.5
Liraglutide 1.2 mg	0.3
Liraglutide 1.8 mg	0.3

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Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)

Change from baseline in thrombocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12

Intervention	Billion cells/litre (10^9/L) (Mean)
Placebo	9.0
Semaglutide 0.1 mg	16.1
Semaglutide 0.2 mg	10.8
Semaglutide 0.4 mg	10.7
Semaglutide 0.8 mg	5.4
Semaglutide 0.8 mg (With Titration)	5.5
Semaglutide 1.6 mg (With Titration)	15.9
Liraglutide 1.2 mg	10.1
Liraglutide 1.8 mg	16.7

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Change From Baseline in Vital Signs (Blood Pressure; DBP)

Change from baseline in diastolic blood pressure (DBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12

Intervention	mmHg (Mean)
Placebo	-2.3
Semaglutide 0.1 mg	1.5
Semaglutide 0.2 mg	-0.4
Semaglutide 0.4 mg	-1.5
Semaglutide 0.8 mg	-1.5
Semaglutide 0.8 mg (With Titration)	-2.3
Semaglutide 1.6 mg (With Titration)	-3.0
Liraglutide 1.2 mg	-2.1
Liraglutide 1.8 mg	-0.0

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Change From Baseline in Vital Signs (Blood Pressure; SBP)

Change from baseline in systolic blood pressure (SBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12

Intervention	mmHg (Mean)
Placebo	-3.2
Semaglutide 0.1 mg	3.3
Semaglutide 0.2 mg	-2.5
Semaglutide 0.4 mg	-3.6
Semaglutide 0.8 mg	-6.7
Semaglutide 0.8 mg (With Titration)	-7.7
Semaglutide 1.6 mg (With Titration)	-5.9
Liraglutide 1.2 mg	-2.9
Liraglutide 1.8 mg	-5.4

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Change From Baseline in Vital Signs (Pulse)

Change from baseline in pulse was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12

Intervention	Beats/minute (Mean)
Placebo	0.5
Semaglutide 0.1 mg	-0.0
Semaglutide 0.2 mg	0.5
Semaglutide 0.4 mg	1.5
Semaglutide 0.8 mg	1.5
Semaglutide 0.8 mg (With Titration)	2.9
Semaglutide 1.6 mg (With Titration)	3.9
Liraglutide 1.2 mg	4.4
Liraglutide 1.8 mg	2.1

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HbA1c

Change from baseline in HbA1c was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the last observation carried forward (LOCF) approach. (NCT00696657)
Timeframe: After 12 weeks of treatment.

Intervention	Percentage (%) of HbA1c (Mean)
Placebo	-0.5
Semaglutide 0.1 mg	-0.6
Semaglutide 0.2 mg	-0.9
Semaglutide 0.4 mg	-1.0
Semaglutide 0.8 mg	-1.4
Semaglutide 0.8 mg (With Titration)	-1.4
Semaglutide 1.6 mg (With Titration)	-1.5
Liraglutide 1.2 mg	-1.1
Liraglutide 1.8 mg	-1.3

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Percentage of Subjects Developing Anti-semaglutide Antibodies

Antibodies were measured after 12-week of treatment at week 17; percentage of participants with positive anti-semaglutide antibodies are presented here. Assessments of antibodies were not done for subjects allocated to the open-label liraglutide treatment arms. (NCT00696657)
Timeframe: After 12 weeks of treatment

Intervention	Percentage (%) of participants (Number)
Placebo	0
Semaglutide 0.1 mg	0
Semaglutide 0.2 mg	0
Semaglutide 0.4 mg	0
Semaglutide 0.8 mg	0
Semaglutide 0.8 mg (With Titration)	0
Semaglutide 1.6 mg (With Titration)	3

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Percentage of Subjects With an Adverse Events

The results of adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product. (NCT00696657)
Timeframe: After 12 weeks of treatment.

Intervention	Percentage (%) of subjects (Number)
Placebo	43.5
Semaglutide 0.1 mg	59.6
Semaglutide 0.2 mg	55.8
Semaglutide 0.4 mg	72.9
Semaglutide 0.8 mg	85.7
Semaglutide 0.8 mg (With Titration)	72.1
Semaglutide 1.6 mg (With Titration)	93.6
Liraglutide 1.2 mg	55.6
Liraglutide 1.8 mg	62.0

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Change From Baseline in ECG

"A standard 12 lead electrocardiogram (ECG) with a 10-second rhythm strip was performed at screening (week -2) and at the end of treatment (week 12). The time frame should be read as week -2, week 12. Change from baseline in ECG was measured in terms of number of subjects in each category (normal, abnormal, not clinically significant [NCS] or abnormal clinically significant [CS]) at week -2 and week 12 (i.e., change in each category in terms of number of subjects from week -2 to week 12)." (NCT00696657)
Timeframe: Week 0, week 12.

,,,,,,,,

Intervention	Participants (Count of Participants)
	Week -2: Normal	Week -2: Abnormal, NCS	Week -2: Abnormal, CS	Week 12: Normal	Week 12: Abnormal, NCS	Week 12: Abnormal, CS	Week 12: ECG not done (ND)
Liraglutide 1.2 mg	39	6	0	37	6	0	2
Liraglutide 1.8 mg	41	9	0	42	5	0	2
Placebo	42	4	0	39	6	0	1
Semaglutide 0.1 mg	33	14	0	32	14	0	1
Semaglutide 0.2 mg	37	6	0	34	3	1	5
Semaglutide 0.4 mg	34	12	2	36	7	2	1
Semaglutide 0.8 mg	31	10	1	29	7	1	3
Semaglutide 0.8 mg (With Titration)	28	15	0	33	9	0	1
Semaglutide 1.6 mg (With Titration)	37	8	2	36	5	3	2

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Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)

Change from baseline in urine-glucose was measured in terms of number of subjects in each category (negative, positive, >=55 mmol/L, or missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12). (NCT00696657)
Timeframe: Week 0, week 12

,,,,,,,,

Intervention	Participants (Count of Participants)
	Week 0: Negative	Week 0: Positive	Week 0: >=55 mmol/L	Week 0: Missing	Week 12: Negative	Week 12: Positive	Week 12: >=55 mmol/L	Week 12: Missing
Liraglutide 1.2 mg	30	10	3	2	35	7	1	0
Liraglutide 1.8 mg	22	20	5	3	39	6	0	2
Placebo	31	13	1	1	34	8	2	0
Semaglutide 0.1 mg	26	18	3	0	28	15	2	1
Semaglutide 0.2 mg	23	15	5	0	28	8	3	2
Semaglutide 0.4 mg	35	11	2	0	35	8	1	1
Semaglutide 0.8 mg	23	15	3	0	30	2	2	3
Semaglutide 0.8 mg (With Titration)	28	10	3	2	39	1	0	1
Semaglutide 1.6 mg (With Titration)	32	12	2	1	39	3	0	1

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Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)

Change from baseline in urine-haemoglobin was measured in terms of number of subjects in each category (negative, trace, small, moderate/large and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12). (NCT00696657)
Timeframe: Week 0, week 12

,,,,,,,,

Intervention	Participants (Count of Participants)
	Week 0: Negative	Week 0: Trace	Week 0: Small	Week 0: Moderate	Week 0: Missing	Week 12: Negative	Week 12: Trace	Week 12: Small	Week 12: Large	Week 12: Missing
Liraglutide 1.2 mg	43	0	0	0	2	43	0	0	0	0
Liraglutide 1.8 mg	45	1	1	0	3	44	1	0	0	2
Placebo	45	0	0	0	1	42	0	1	1	0
Semaglutide 0.1 mg	45	2	0	0	0	45	0	0	0	1
Semaglutide 0.2 mg	41	1	1	0	0	38	1	0	0	2
Semaglutide 0.4 mg	45	1	0	2	0	42	2	0	0	1
Semaglutide 0.8 mg	38	2	0	1	0	30	1	2	1	3
Semaglutide 0.8 mg (With Titration)	39	1	1	0	2	38	1	0	1	1
Semaglutide 1.6 mg (With Titration)	43	2	1	0	1	39	2	1	0	1

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Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)

Change from baseline in urine-ketone was measured in terms of number of subjects in each category (negative, positive, >=55 mmol/L and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12). (NCT00696657)
Timeframe: Week 0, week 12

,,,,,,,,

Intervention	Participants (Count of Participants)
	Week 0: Negative	Week 0: Positive	Week 0: Missing	Week 12: Negative	Week 12: Positive	Week 12: Missing
Liraglutide 1.2 mg	42	1	2	41	2	0
Liraglutide 1.8 mg	46	1	3	43	2	2
Placebo	45	0	1	43	1	0
Semaglutide 0.1 mg	47	0	0	44	1	1
Semaglutide 0.2 mg	39	4	0	35	4	2
Semaglutide 0.4 mg	46	2	0	44	0	1
Semaglutide 0.8 mg	41	0	0	34	0	3
Semaglutide 0.8 mg (With Titration)	41	0	2	40	0	1
Semaglutide 1.6 mg (With Titration)	45	1	1	38	4	1

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Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)

Change from baseline in urine-pH was measured in terms of number of subjects in each category (pH=6.0, 6.5, 7.0, 7.5, 8.0, >=8.5 and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12). (NCT00696657)
Timeframe: Week 0, week 12

,,,,,,,,

Intervention	Participants (Count of Participants)
	Week 0: 6.0	Week 0: 6.5	Week 0: 7.0	Week 0: 7.5	Week 0: 8.0	Week 0: >=8.5	Week 0: Missing	Week 12: 6.0	Week 12: 6.5	Week 12: 7.0	Week 12: 7.5	Week 12: 8.0	Week 12: >=8.5	Week 12: Missing
Liraglutide 1.2 mg	8	16	14	3	2	0	2	9	13	16	4	0	1	0
Liraglutide 1.8 mg	12	11	19	2	1	2	3	10	14	15	3	2	1	2
Placebo	16	13	11	4	0	1	1	11	15	15	3	0	0	0
Semaglutide 0.1 mg	13	18	12	3	0	1	0	14	14	13	2	1	1	1
Semaglutide 0.2 mg	19	15	8	0	1	0	0	19	9	6	4	1	0	2
Semaglutide 0.4 mg	11	21	10	5	1	0	0	9	14	11	7	2	1	1
Semaglutide 0.8 mg	10	13	12	5	0	0	1	10	7	11	3	2	1	3
Semaglutide 0.8 mg (With Titration)	11	13	8	8	0	1	2	8	10	15	5	1	1	1
Semaglutide 1.6 mg (With Titration)	14	10	12	7	3	0	1	13	11	10	5	1	2	1

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Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)

Change from baseline in urine-protein was measured in terms of number of subjects in each category at week 0 (negative, 0.3 g/L, 1.0 g/L and missing) and week 12 (negative, trace, 0.3 g/L, 1.0 g/L, >=3.0 g/L and missing). i.e., change in each category in terms of number of subjects from week 0 to week 12. (NCT00696657)
Timeframe: Week 0, week 12

,,,,,,,,

Intervention	Participants (Count of Participants)
	Week 0: Negative	Week 0: 0.3	Week 0: 1.0	Week 0: Missing	Week 12: Negative	Week 12: Trace	Week 12: 0.3	Week 12: 1.0	Week 12: >=3.0	Week 12: Missing
Liraglutide 1.2 mg	41	2	0	2	40	0	1	1	1	0
Liraglutide 1.8 mg	45	1	1	3	41	0	3	1	0	2
Placebo	45	0	0	1	40	0	4	0	0	0
Semaglutide 0.1 mg	47	0	0	0	43	0	2	0	0	1
Semaglutide 0.2 mg	41	2	0	0	35	0	3	1	0	2
Semaglutide 0.4 mg	44	4	0	0	41	0	3	0	0	1
Semaglutide 0.8 mg	39	2	0	0	31	0	3	0	0	3
Semaglutide 0.8 mg (With Titration)	40	0	1	2	36	0	3	1	0	1
Semaglutide 1.6 mg (With Titration)	46	0	0	1	39	1	2	0	0	1

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Percentage of Subjects With Hypoglycaemic Episode

The results of hypoglycaemic episode presented here are treatment emergent. Hypoglycaemic episodes were defined as treatment emergent if they had onset on or after the first day of randomised treatment (in week 0) and no later than 5 weeks after the last date on trial product (week 17). Hypoglycaemic episodes are classified as follows: Major: If the subject was not able to treat himself or herself and was needed to be administered food, glucagon or intravenous (i.v.) glucose by another person. Minor: If the subject was able to treat himself or herself and measured plasma glucose was <3.1 mmol/L (56 mg/dL). Symptoms only: If the subject was able to treat himself or herself and measured plasma glucose was >=3.1 mmol/L (56 mg/dL) or no plasma glucose measurement was done. (NCT00696657)
Timeframe: After 12 weeks of treatment

,,,,,,,,

Intervention	Percentage (%) of subjects (Number)
	Major	Minor	Symptoms only
Liraglutide 1.2 mg	0	4.4	8.9
Liraglutide 1.8 mg	0	2.0	2.0
Placebo	0	0	2.2
Semaglutide 0.1 mg	0	4.3	2.1
Semaglutide 0.2 mg	0	0	2.3
Semaglutide 0.4 mg	0	4.2	0
Semaglutide 0.8 mg	0	0	0
Semaglutide 0.8 mg (With Titration)	0	2.3	0
Semaglutide 1.6 mg (With Titration)	0	0	6.4

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Change From Baseline in Calcitonin

Change from baseline in calcitonin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12.

Intervention	ng/L (Mean)
Placebo	0.43
Semaglutide 0.1 mg	0.48
Semaglutide 0.2 mg	-0.48
Semaglutide 0.4 mg	0.62
Semaglutide 0.8 mg	0.45
Semaglutide 0.8 mg (With Titration)	0.87
Semaglutide 1.6 mg (With Titration)	0.76
Liraglutide 1.2 mg	0.55
Liraglutide 1.8 mg	0.01

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Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)

Change from baseline in urea was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12.

Intervention	mmol/L (Mean)
Placebo	-0.1
Semaglutide 0.1 mg	0.1
Semaglutide 0.2 mg	-0.1
Semaglutide 0.4 mg	-0.4
Semaglutide 0.8 mg	-0.3
Semaglutide 0.8 mg (With Titration)	-0.5
Semaglutide 1.6 mg (With Titration)	-0.5
Liraglutide 1.2 mg	-0.1
Liraglutide 1.8 mg	-0.4

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Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)

Change from baseline in total bilirubin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12.

Intervention	umol/L (Mean)
Placebo	0.7
Semaglutide 0.1 mg	-0.4
Semaglutide 0.2 mg	0.6
Semaglutide 0.4 mg	0.8
Semaglutide 0.8 mg	0.7
Semaglutide 0.8 mg (With Titration)	1.3
Semaglutide 1.6 mg (With Titration)	0.4
Liraglutide 1.2 mg	-0.5
Liraglutide 1.8 mg	0.2

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Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)

Change from baseline in sodium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12.

Intervention	mmol/L (Mean)
Placebo	0.1
Semaglutide 0.1 mg	0.0
Semaglutide 0.2 mg	-0.1
Semaglutide 0.4 mg	-0.1
Semaglutide 0.8 mg	0.4
Semaglutide 0.8 mg (With Titration)	0.2
Semaglutide 1.6 mg (With Titration)	0.5
Liraglutide 1.2 mg	0.7
Liraglutide 1.8 mg	0.6

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Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)

Change from baseline in potassium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12.

Intervention	mmol/L (Mean)
Placebo	0.07
Semaglutide 0.1 mg	0.08
Semaglutide 0.2 mg	0.06
Semaglutide 0.4 mg	-0.02
Semaglutide 0.8 mg	0.04
Semaglutide 0.8 mg (With Titration)	-0.02
Semaglutide 1.6 mg (With Titration)	-0.07
Liraglutide 1.2 mg	0.10
Liraglutide 1.8 mg	-0.12

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Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)

Change from baseline in creatinine was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12.

Intervention	umol/L (Mean)
Placebo	-1.02
Semaglutide 0.1 mg	0.936
Semaglutide 0.2 mg	-0.349
Semaglutide 0.4 mg	-2.31
Semaglutide 0.8 mg	-0.658
Semaglutide 0.8 mg (With Titration)	-1.67
Semaglutide 1.6 mg (With Titration)	2.089
Liraglutide 1.2 mg	0.841
Liraglutide 1.8 mg	-0.917

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Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)

Change from baseline in calcium, total was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12.

Intervention	mmol/L (Mean)
Placebo	0.0
Semaglutide 0.1 mg	-0.0
Semaglutide 0.2 mg	-0.0
Semaglutide 0.4 mg	-0.0
Semaglutide 0.8 mg	0.0
Semaglutide 0.8 mg (With Titration)	0.0
Semaglutide 1.6 mg (With Titration)	-0.0
Liraglutide 1.2 mg	-0.0
Liraglutide 1.8 mg	0.0

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Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)

Change from baseline in basophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12

Intervention	Billion cells/litre (10^9/L) (Mean)
Placebo	-0.0
Semaglutide 0.1 mg	0.0
Semaglutide 0.2 mg	-0.0
Semaglutide 0.4 mg	0.0
Semaglutide 0.8 mg	-0.0
Semaglutide 0.8 mg (With Titration)	-0.0
Semaglutide 1.6 mg (With Titration)	-0.0
Liraglutide 1.2 mg	0.0
Liraglutide 1.8 mg	0.0

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Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)

Change from baseline in aspartate aminotransferase (AST) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12.

Intervention	U/L (Mean)
Placebo	-1.09
Semaglutide 0.1 mg	1.23
Semaglutide 0.2 mg	0.24
Semaglutide 0.4 mg	-1.81
Semaglutide 0.8 mg	-0.37
Semaglutide 0.8 mg (With Titration)	-2.60
Semaglutide 1.6 mg (With Titration)	-4.07
Liraglutide 1.2 mg	-0.16
Liraglutide 1.8 mg	-2.13

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Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)

Change from baseline in alkaline phosphatase was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12.

Intervention	U/L (Mean)
Placebo	-0.52
Semaglutide 0.1 mg	-1.66
Semaglutide 0.2 mg	-2.37
Semaglutide 0.4 mg	-2.35
Semaglutide 0.8 mg	-1.39
Semaglutide 0.8 mg (With Titration)	-2.81
Semaglutide 1.6 mg (With Titration)	-3.98
Liraglutide 1.2 mg	-1.89
Liraglutide 1.8 mg	-4.25

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Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)

Change from baseline in eosinophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12

Intervention	Billion cells/litre (10^9/L) (Mean)
Placebo	-0.0
Semaglutide 0.1 mg	0.0
Semaglutide 0.2 mg	-0.0
Semaglutide 0.4 mg	0.0
Semaglutide 0.8 mg	-0.0
Semaglutide 0.8 mg (With Titration)	0.0
Semaglutide 1.6 mg (With Titration)	0.1
Liraglutide 1.2 mg	0.0
Liraglutide 1.8 mg	-0.0

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Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)

Change from baseline in erythrocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12

Intervention	Trillion cells/litre (10^12/L) (Mean)
Placebo	-0.04
Semaglutide 0.1 mg	-0.06
Semaglutide 0.2 mg	-0.03
Semaglutide 0.4 mg	0.08
Semaglutide 0.8 mg	-0.05
Semaglutide 0.8 mg (With Titration)	0.03
Semaglutide 1.6 mg (With Titration)	0.04
Liraglutide 1.2 mg	0.04
Liraglutide 1.8 mg	0.02

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Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)

Change from baseline in alanine aminotransferase (ALAT) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12.

Intervention	U/L (Mean)
Placebo	-2.41
Semaglutide 0.1 mg	0.83
Semaglutide 0.2 mg	0.68
Semaglutide 0.4 mg	-4.21
Semaglutide 0.8 mg	-2.13
Semaglutide 0.8 mg (With Titration)	-6.19
Semaglutide 1.6 mg (With Titration)	-6.55
Liraglutide 1.2 mg	-0.88
Liraglutide 1.8 mg	-1.83

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Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)

Change from baseline in albumin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12.

Intervention	g/L (Mean)
Placebo	0.402
Semaglutide 0.1 mg	0.130
Semaglutide 0.2 mg	-0.091
Semaglutide 0.4 mg	-0.177
Semaglutide 0.8 mg	0.303
Semaglutide 0.8 mg (With Titration)	0.607
Semaglutide 1.6 mg (With Titration)	0.271
Liraglutide 1.2 mg	0.916
Liraglutide 1.8 mg	0.846

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Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)

Change from baseline in calcium, ionised was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. (NCT00696657)
Timeframe: Week 0, week 12.

Intervention	mmol/L (Mean)
Placebo	0.00
Semaglutide 0.1 mg	-0.01
Semaglutide 0.2 mg	-0.04
Semaglutide 0.4 mg	-0.01
Semaglutide 0.8 mg	-0.01
Semaglutide 0.8 mg (With Titration)	0.01
Semaglutide 1.6 mg (With Titration)	-0.02
Liraglutide 1.2 mg	-0.02
Liraglutide 1.8 mg	-0.01

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Mean Change in Beta-cell Function From Week 52 to Week 78

Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B). (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	percentage point (Mean)
Sita -> Sita -> Lira 1.2 mg	13.31
Sita -> Sita -> Lira 1.8 mg	23.09

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Mean Change in Body Weight From Week 52 to Week 78

Mean change in body weight from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	kg (Mean)
Sita -> Sita -> Lira 1.2 mg	-1.64
Sita -> Sita -> Lira 1.8 mg	-2.48

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Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78

Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	mmHg (Mean)
Sita -> Sita -> Lira 1.2 mg	-0.60
Sita -> Sita -> Lira 1.8 mg	0.03

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Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78

Mean change in fasting plasma glucose (FPG) Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	mmol/L (Mean)
Sita -> Sita -> Lira 1.2 mg	-0.84
Sita -> Sita -> Lira 1.8 mg	-1.42

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Mean Change From Baseline in Apolipoprotein B at Week 26

Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	g/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.06
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.07
Sita -> Sita	-0.05

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Mean Change From Baseline in Adiponectin at Week 26.

Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	mcg/mL (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	1.69
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	1.51
Sita -> Sita	1.35

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Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78

Mean change in free fatty acids (FFA) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	mmol/L (Mean)
Sita -> Sita -> Lira 1.2 mg	0.02
Sita -> Sita -> Lira 1.8 mg	-0.01

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Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78

Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78 (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	Percentage point of total HbA1c (Mean)
Sita -> Sita -> Lira 1.2 mg	-0.24
Sita -> Sita -> Lira 1.8 mg	-0.45

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Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78

Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	mmol/L (Mean)
Sita -> Sita -> Lira 1.2 mg	0.02
Sita -> Sita -> Lira 1.8 mg	-0.01

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Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78

Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	mmol/L (Mean)
Sita -> Sita -> Lira 1.2 mg	-0.22
Sita -> Sita -> Lira 1.8 mg	-0.25

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Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78

The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	scores on a scale (Mean)
Sita -> Sita -> Lira 1.2 mg	1.48
Sita -> Sita -> Lira 1.8 mg	0.98

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Mean Change in Pulse From Week 52 to Week 78

Mean change in pulse from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	beats/minute (Mean)
Sita -> Sita -> Lira 1.2 mg	0.90
Sita -> Sita -> Lira 1.8 mg	2.19

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Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78

Mean change in systolic blood pressure (SBP) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	mmHg (Mean)
Sita -> Sita -> Lira 1.2 mg	-2.12
Sita -> Sita -> Lira 1.8 mg	0.35

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Mean Change in Total Cholesterol From Week 52 to Week 78

Mean change in total cholesterol from Week 52 to Week 78 (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	mmol/L (Mean)
Sita -> Sita -> Lira 1.2 mg	-0.16
Sita -> Sita -> Lira 1.8 mg	-0.24

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Mean Change in Triglycerides (TG) From Week 52 to Week 78

Mean change in triglycerides (TG) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	mmol/L (Mean)
Sita -> Sita -> Lira 1.2 mg	-0.20
Sita -> Sita -> Lira 1.8 mg	-0.26

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Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78

Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	mmol/L (Mean)
Sita -> Sita -> Lira 1.2 mg	0.03
Sita -> Sita -> Lira 1.8 mg	0.02

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Mean Change in Waist Circumference From Week 52 to Week 78

Mean change in Waist Circumference from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	kg (Mean)
Sita -> Sita -> Lira 1.2 mg	-1.33
Sita -> Sita -> Lira 1.8 mg	-2.05

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Mean Change in Waist to Hip Ratio From Week 52 to Week 78

Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	cm/cm (Mean)
Sita -> Sita -> Lira 1.2 mg	-0.01
Sita -> Sita -> Lira 1.8 mg	-0.00

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Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26

Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26 (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	percentage of subjects (Number)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	43
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	55
Sita -> Sita	22

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Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52 (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	percentage of subjects (Number)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	50
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	63
Sita -> Sita	27

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Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS. (NCT00700817)
Timeframe: Week 0, Week 78

Intervention	percentage of subjects (Number)
Sita -> Sita -> Lira 1.2 mg	49
Sita -> Sita -> Lira 1.8 mg	50

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Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS. (NCT00700817)
Timeframe: Week 0, Week 78

Intervention	percentage of subjects (Number)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	35
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	51

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Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26

Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26 (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	percentage of subjects (Number)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	23
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	36
Sita -> Sita	12

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Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52 (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	percentage of subjects (Number)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	24
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	40
Sita -> Sita	17

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Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS. (NCT00700817)
Timeframe: Week 0, Week 78

Intervention	percentage of subjects (Number)
Sita -> Sita -> Lira 1.2 mg	29
Sita -> Sita -> Lira 1.8 mg	25

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Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS. (NCT00700817)
Timeframe: Week 0, Week 78

Intervention	percentage of subjects (Number)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	12
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	27

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Hypoglycaamic Episodes, Weeks 52-78

Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Week 52-78

,,,

Intervention	episodes (Number)
	Major	Minor	Symptoms only	Unclassified
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	1	12	3	0
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0	5	11	0
Sita -> Sita -> Lira 1.2 mg	0	3	1	0
Sita -> Sita -> Lira 1.8 mg	0	6	0	0

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Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-26

Intervention	episodes (Number)
	Major	Minor	Symptoms only	Unclassified
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	1	17	12	0
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0	16	15	1
Sita -> Sita	0	11	10	0

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Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52

Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-52

Intervention	episodes (Number)
	Major	Minor	Symptoms only	Unclassified
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	1	24	14	0
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0	28	29	1
Sita -> Sita	0	25	12	0

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Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78

Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-78

Intervention	episodes (Number)
	Major	Minor	Symptoms only	Unclassified
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	2	36	18	0
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0	33	40	1
Sita -> Sita	0	34	13	0

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Hypoglyceamic Episodes, Weeks 0-26

Intervention	episodes (Number)
	Major	Minor	Symptoms only	Unclassified
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	1	17	12	0
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0	37	15	1
Sita -> Sita	0	11	10	0

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Hypoglyceamic Episodes, Weeks 0-52

Intervention	episodes (Number)
	Major	Minor	Symptoms only	Unclassified
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	1	24	14	0
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0	51	29	1
Sita -> Sita	0	25	12	0

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Hypoglyceamic Episodes, Weeks 0-78

Intervention	episodes (Number)
	Major	Minor	Symptoms only	Unclassified
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	2	36	18	0
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0	56	40	1
Sita -> Sita	0	34	13	0

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Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26

Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	0.00
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0.00
Sita -> Sita	0.00

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Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78. (NCT00700817)
Timeframe: Week 0, Week 78

Intervention	Percentage point of total HbA1c (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.94
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-1.28

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Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	Percentage point of total HbA1c (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.29
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-1.51
Sita -> Sita	-0.88

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Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	Percentage point of total HbA1c (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.24
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-1.5
Sita -> Sita	-0.9

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Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52

Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.07
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.10
Sita -> Sita	-0.06

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Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26

Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.03
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.07
Sita -> Sita	-0.05

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Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78

Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78. (NCT00700817)
Timeframe: Week 0, Week 78

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.30
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-1.65

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Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.71
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-2.04
Sita -> Sita	-0.59

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Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.87
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-2.14
Sita -> Sita	-0.83

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Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52

Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	mmHg (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.53
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.87
Sita -> Sita	-1.47

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Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26

Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	mmHg (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.71
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0.07
Sita -> Sita	-1.78

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Mean Change From Baseline in Body Weight at Week 52

Calculated as an estimate of the mean change from baseline in body weight at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	kg (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-2.78
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-3.68
Sita -> Sita	-1.16

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Mean Change From Baseline in Body Weight at Week 26

Calculated as an estimate of the mean change from baseline in body weight at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	kg (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-2.86
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-3.38
Sita -> Sita	-0.96

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Mean Change From Baseline in Beta-cell Function at Week 52

"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)." (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	percentage point (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	22.58
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	25.76
Sita -> Sita	3.98

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Mean Change From Baseline in Beta-cell Function at Week 26

"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)." (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	percentage point (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	27.23
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	28.70
Sita -> Sita	4.18

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Mean Change From Baseline in Apolipoprotein B at Week 52

Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	g/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.03
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.03
Sita -> Sita	-0.03

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Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.

Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	pg/mL (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.70
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	1.71
Sita -> Sita	0.91

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Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52

Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	0.01
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0.02
Sita -> Sita	0.01

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Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26

Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	mg/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.02
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.99
Sita -> Sita	-0.66

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Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26

Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	0.08
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0.05
Sita -> Sita	0.13

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Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52

Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	0.09
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	0.09
Sita -> Sita	0.17

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Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	pmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	5.19
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	3.74
Sita -> Sita	3.71

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Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26

Intervention	scores on a scale (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	3.51
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	4.35
Sita -> Sita	2.96

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Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52

Intervention	scores on a scale (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	3.32
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	4.31
Sita -> Sita	2.96

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Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.

Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	U/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-833
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-561
Sita -> Sita	586

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Mean Change From Baseline in Pulse at Week 26

Calculated as an estimate of the mean change from baseline in pulse at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	beats/minute (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	2.32
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	3.94
Sita -> Sita	-0.64

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Mean Change From Baseline in Pulse at Week 52

Calculated as an estimate of the mean change from baseline in pulse at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	mmHg (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	1.72
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	3.09
Sita -> Sita	0.09

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Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26

Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26 (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	mmHg (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.55
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.72
Sita -> Sita	-0.94

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Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52

Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	mmHg (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.37
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-2.55
Sita -> Sita	-1.03

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Mean Change From Baseline in Total Cholesterol at Week 26

Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.03
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.17
Sita -> Sita	-0.02

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Mean Change From Baseline in Total Cholesterol at Week 52

Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.01
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.09
Sita -> Sita	0.03

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Mean Change From Baseline in Triglycerides (TG) at Week 26

Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.19
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.43
Sita -> Sita	-0.40

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Mean Change From Baseline in Triglycerides (TG) at Week 52

Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.10
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.32
Sita -> Sita	-0.23

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Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	pg/mL (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.55
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.74
Sita -> Sita	-0.53

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Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26

Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.11
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.20
Sita -> Sita	-0.15

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Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52

Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	mmol/L (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.11
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.19
Sita -> Sita	-0.15

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Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.

Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	percentage point (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.73
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-4.34
Sita -> Sita	-1.8

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Mean Change From Baseline in Waist Circumference at Week 26.

Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26 (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	cm (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-2.69
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-2.63
Sita -> Sita	-1.12

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Mean Change From Baseline in Waist Circumference at Week 52

Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	participants (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-2.36
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-3.02
Sita -> Sita	-1.23

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Mean Change From Baseline in Waist to Hip Ratio at Week 26.

Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip. (NCT00700817)
Timeframe: Week 0, Week 26

Intervention	cm/cm (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.01
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.01
Sita -> Sita	-0.00

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Mean Change From Baseline in Waist to Hip Ratio at Week 52

Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip. (NCT00700817)
Timeframe: Week 0, Week 52

Intervention	cm/cm (Least Squares Mean)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.00
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-0.01
Sita -> Sita	-0.00

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Mean Change in Apolipoprotein B From Week 52 to Week 78

Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78

Intervention	mmol/L (Mean)
Sita -> Sita -> Lira 1.2 mg	0.23
Sita -> Sita -> Lira 1.8 mg	0.17

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Change From Baseline in Fasting Lipid Profile: Total Cholesterol

Subjects were tested having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	mmol/L (Least Squares Mean)
Lira 3.0 mg	0.22
Placebo	0.33

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Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)

Number of subjects using concomitant medications at Week 0 and Week 56, respectively (NCT00781937)
Timeframe: Week 0 and week 56

Intervention	Subjects (Number)
	Antihypertensive drug - Week 0	Antihypertensive drug - Week 56	Antipsychotic drug - Week 0	Antipsychotic drug - Week 56	Lipid lowering drug - Week 0	Lipid lowering drug - Week 56
Lira 3.0 mg	65	63	18	20	45	52
Placebo	66	63	25	29	45	50

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Change From Baseline in Fasting Lipid Profile: Triglycerides

Subjects were tested having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	mmol/L (Least Squares Mean)
Lira 3.0 mg	0.02
Placebo	0.12

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Change From Baseline in Fasting Weight

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	kg (Least Squares Mean)
Lira 3.0 mg	-5.7
Placebo	0.16

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Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 68

Intervention	kg (Least Squares Mean)
Lira 3.0 mg	-3.83
Placebo	0.41

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Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)

Subjects were tested having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	mmol/L (Least Squares Mean)
Lira 3.0 mg	-0.52
Placebo	-0.14

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Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin

Subjects were tested having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	pmol/L (Least Squares Mean)
Lira 3.0 mg	0.50
Placebo	2.35

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Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)

Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%]. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	percentage point (Least Squares Mean)
Lira 3.0 mg	-0.14
Placebo	0.13

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Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)

Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median beta-cell function indexed at 100%. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	percent change (Least Squares Mean)
Lira 3.0 mg	8.51
Placebo	6.16

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Change From Baseline in Blood Pressure

(NCT00781937)
Timeframe: Week 0, week 56

Intervention	mmHg (Least Squares Mean)
	Change in Systolic Blood Pressure	Change in Diastolic Blood Pressure
Lira 3.0 mg	1.31	1.81
Placebo	4.03	2.15

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Change From Baseline in Pulse

(NCT00781937)
Timeframe: Week 0, week 56

Intervention	beats/minute (Least Squares Mean)
Lira 3.0 mg	4.12
Placebo	3.15

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Change From Baseline in Waist Circumference

(NCT00781937)
Timeframe: Week 0, week 56

Intervention	cm (Least Squares Mean)
Lira 3.0 mg	-4.36
Placebo	-0.86

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Mean Percentage Change in Fasting Body Weight From Baseline

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	percentage (Least Squares Mean)
Lira 3.0 mg	-6.11
Placebo	-0.05

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Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56

Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides >1.7mmol/L; High density lipoprotein cholesterol (men <0.9mmol/L, women <1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy. (NCT00781937)
Timeframe: Week 56

Intervention	percentage of subjects (Number)
Lira 3.0 mg	31.4
Placebo	36.7

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Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	percentage of subjects (Number)
Lira 3.0 mg	26.1
Placebo	6.3

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Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	percentage of subjects (Number)
Lira 3.0 mg	50.5
Placebo	21.9

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Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0

Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	percentage of subjects (Number)
Lira 3.0 mg	80.8
Placebo	47.9

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Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)

Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated [X - Y]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median insulin resistance indexed at 1.00. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	proportion (Least Squares Mean)
Lira 3.0 mg	-0.01
Placebo	0.08

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Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	percentage of subjects (Number)
Lira 3.0 mg	93.2
Placebo	70.9

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Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	percentage of subjects (Number)
Lira 3.0 mg	87.4
Placebo	54.4

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Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	percentage of subjects (Number)
Lira 3.0 mg	0
Placebo	2.9

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Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	percentage of subjects (Number)
Lira 3.0 mg	1.9
Placebo	17.5

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Binge Eating Scale Scores by Week and Severity

Binge Eating Scale (BES) scores are based on responses to the Binge Eating Scale Questionnaire, a 16-item self-reporting diagnostic tool scaled 0-46 (Non-binging: 0-17; Moderate: 17-26; Severe: 27-46) (NCT00781937)
Timeframe: Week 0, week 50 and week 57

Intervention	scores on a scale (Mean)
	Week 0, baseline	Week 50	Week 57
Lira 3.0 mg	7.8	6.6	6.6
Placebo	7.8	8.6	6.9

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Change From Baseline in Body Mass Index (BMI)

(NCT00781937)
Timeframe: Week 0, week 56

Intervention	kg/m^2 (Least Squares Mean)
Lira 3.0 mg	-1.90
Placebo	0.15

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Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)

(NCT00781937)
Timeframe: Week 0, week 56

Intervention	nmol/L (Least Squares Mean)
Lira 3.0 mg	-11.31
Placebo	1.70

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Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol

Subjects were tested having fasted (consumed only water) since midnight the night before the visit. (NCT00781937)
Timeframe: Week 0, week 56

Intervention	mmol/L (Least Squares Mean)
Lira 3.0 mg	0.24
Placebo	0.33

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Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Intervention	mmHg (Least Squares Mean)
	Systolic Blood Pressure	Diastolic Blood Pressure
Insulin Detemir + Lira 1.8	0.41	-0.4
Lira 1.8	1.11	-1.1

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Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.

(NCT00856986)
Timeframe: Week 0, Week 52

Intervention	mmHg (Least Squares Mean)
	Systolic Blood Pressure	Diastolic Blood Pressure
Insulin Detemir + Lira 1.8	0.16	0.11
Lira 1.8	-0.74	-0.66

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Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)

(NCT00856986)
Timeframe: Week 0, Week 52

Intervention	Percentage point of total HbA1c (Least Squares Mean)
Lira 1.8	0.01
Insulin Detemir + Lira 1.8	-0.5

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Mean Change From Randomisation in Hip Circumference at Week 26

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Intervention	cm (Least Squares Mean)
Lira 1.8	-0.36
Insulin Detemir + Lira 1.8	-0.38

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Mean Change From Randomisation in Hip Circumference at Week 52

(NCT00856986)
Timeframe: Week 0, week 52

Intervention	cm (Least Squares Mean)
Lira 1.8	-0.79
Insulin Detemir + Lira 1.8	-0.28

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Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Intervention	mmol/L (Least Squares Mean)
Lira 1.8	-0.03
Insulin Detemir + Lira 1.8	-0.11

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Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)

(NCT00856986)
Timeframe: Week 0, Week 52

Intervention	Percentage point of total HbA1c (Least Squares Mean)
Lira 1.8	-0.1
Insulin Detemir + Lira 1.8	-0.51

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Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.

(NCT00856986)
Timeframe: Week 0 (Randomisation), week 26

Intervention	Percentage point of total HbA1c (Least Squares Mean)
Lira 1.8	0.02
Insulin Detemir + Lira 1.8	-0.51

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Mean Change From Randomisation in Fasting Pro-insulin at Week 52

(NCT00856986)
Timeframe: Week 0, Week 52

Intervention	pmol/L (Least Squares Mean)
Lira 1.8	1.47
Insulin Detemir + Lira 1.8	-4

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Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52

(NCT00856986)
Timeframe: Week 0, Week 52

Intervention	mmol/L (Least Squares Mean)
Lira 1.8	-0.03
Insulin Detemir + Lira 1.8	-0.07

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Mean Change From Randomisation in Lipids: Triglycerides at Week 26

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Intervention	mmol/L (Least Squares Mean)
Lira 1.8	-0.24
Insulin Detemir + Lira 1.8	-0.33

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Mean Change From Randomisation in Lipids: Triglycerides at Week 52

(NCT00856986)
Timeframe: Week 0, Week 52

Intervention	mmol/L (Least Squares Mean)
Lira 1.8	-0.22
Insulin Detemir + Lira 1.8	-0.37

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Mean Change From Randomisation in Waist Circumference at Week 26.

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Intervention	cm (Least Squares Mean)
Lira 1.8	-0.66
Insulin Detemir + Lira 1.8	-0.78

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Mean Change From Randomisation in Waist Circumference at Week 52.

(NCT00856986)
Timeframe: Week 0, Week 52

Intervention	participants (Least Squares Mean)
Lira 1.8	-0.83
Insulin Detemir + Lira 1.8	-0.83

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Mean Change From Randomisation in Waist to Hip Ratio at Week 26

Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference (NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Intervention	cm/cm (Least Squares Mean)
Lira 1.8	-0.00356
Insulin Detemir + Lira 1.8	-0.00332

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Mean Change From Randomisation in Fasting Plasma Glucose at Week 26

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Intervention	mmol/L (Least Squares Mean)
Lira 1.8	-0.39
Insulin Detemir + Lira 1.8	-2.12

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Mean Change From Randomisation in Fasting Pro-insulin at Week 26.

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Intervention	pmol/L (Least Squares Mean)
Lira 1.8	-1.12
Insulin Detemir + Lira 1.8	-9.78

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Mean Changes From Randomisation in Cholesterol Lipids at Week 26.

Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C) (NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Intervention	mmol/L (Least Squares Mean)
	Change in Total Cholesterol	Change in LDL-C	Change in VLDL-C	Change in HDL-C
Insulin Detemir + Lira 1.8	0.05	-0.03	0.01	0.05
Lira 1.8	0.04	-0.04	0.05	0.02

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Mean Changes From Randomisation in Cholesterol Lipids at Week 52.

Intervention	mmol/L (Least Squares Mean)
	Change in Total Cholesterol	Change in LDL-C	Change in VLDL-C	Change in HDL-C
Insulin Detemir + Lira 1.8	-0.03	-0.1	-0.03	0.07
Lira 1.8	-0.02	-0.08	0.03	0.02

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Mean Change From Randomisation in Fasting C-peptide at Week 52.

(NCT00856986)
Timeframe: Week 0, Week 52

Intervention	mmol/L (Least Squares Mean)
Lira 1.8	0.02
Insulin Detemir + Lira 1.8	-0.34

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Mean Change From Randomisation in Fasting C-peptide at Week 26.

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Intervention	mmol/L (Least Squares Mean)
Lira 1.8	-0.08
Insulin Detemir + Lira 1.8	-0.32

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Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26

Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively. (NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Intervention	mmol/L (Least Squares Mean)
	Change at Breakfast, N=133, 144	Change at Lunch, N= 134, 143	Change at Dinner, N= 133, 139
Insulin Detemir + Lira 1.8	-2.09	-1.43	-1.18
Lira 1.8	-0.97	-0.83	-0.48

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Mean Change From Randomisation in Body Weight at Week 52

(NCT00856986)
Timeframe: Week 0, Week 52

Intervention	kg (Least Squares Mean)
Lira 1.8	-1.02
Insulin Detemir + Lira 1.8	-0.05

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Mean Change From Randomisation in Waist to Hip Ratio at Week 52

Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference (NCT00856986)
Timeframe: Week 0, Week 52

Intervention	cm/cm (Least Squares Mean)
Lira 1.8	-0.00146
Insulin Detemir + Lira 1.8	-0.00438

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Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26

Intervention	episodes (Number)
	Major	Minor	Symptoms only
Insulin Detemir + Lira 1.8	0	22	19
Lira 1.8	0	2	9
Non-Randomised Lira 1.8	0	31	26

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Mean Change From Randomisation in Body Weight at Week 26

(NCT00856986)
Timeframe: Week 0 (Randomisation), Week 26

Intervention	kg (Least Squares Mean)
Lira 1.8	-0.95
Insulin Detemir + Lira 1.8	-0.16

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Adverse Events From Run-in (Week -12) to Week 52

(NCT00856986)
Timeframe: Run-in (week -12) to Week 52

Intervention	events (Number)
Lira 1.8	716
Insulin Detemir + Lira 1.8	845
Non-Randomised Lira 1.8	2389
Early Withdrawals Lira 1.8	383
Intensified Group	30

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Hypoglycaemic Episodes Weeks 0-52

,,,

Intervention	episodes (Number)
	Major	Minor	Symptoms only	Unknown
Insulin Detemir + Lira 1.8	0	33	57	1
Intensified Group	0	1	2	0
Lira 1.8	0	4	14	0
Non-Randomised Lira 1.8	0	53	42	2

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Mean Change From Randomisation in Fasting Plasma Glucose at Week 52

(NCT00856986)
Timeframe: Week 0, Week 52

Intervention	mmol/L (Least Squares Mean)
Lira 1.8	-0.14
Insulin Detemir + Lira 1.8	-1.91

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Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52

Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively. (NCT00856986)
Timeframe: Week 0, Week 52

Intervention	mmol/L (Least Squares Mean)
	Change at Breakfast, N=148, 135	Change at Lunch, N= 145, 136	Change at Dinner, N= 144, 135
Insulin Detemir + Lira 1.8	-2.43	-1.14	-1.4
Lira 1.8	-0.68	-0.51	-0.96

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Percentage of Patients Achieving HbA1c <7.0% at Week 26

Percentage of patients achieving HbA1c <7.0% at treatment endpoint at Week 26. (NCT01029886)
Timeframe: Baseline, Week 26

Intervention	percentage of patients (Number)
Exenatide Once Weekly	52.7
Liraglutide Once Daily	60.2

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Ratio of Fasting Triglycerides at Week 26 to Baseline

Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline. (NCT01029886)
Timeframe: Baseline, Week 26

Intervention	ratio (Least Squares Mean)
Exenatide Once Weekly	0.97
Liraglutide Once Daily	0.89

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Assessment of Event Rate of Treatment-emergent Hypoglycemic Events

Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT. (NCT01029886)
Timeframe: Baseline to Week 26

,,,

Intervention	events per subject-year (Mean)
	Major Hypoglycemia	Minor Hypoglycemia
Exenatide Once Weekly With SU Use at Screening	0.00	0.76
Exenatide Once Weekly Without SU Use at Screening	0.00	0.67
Liraglutide Once Daily With SU Use at Screening	0.00	0.55
Liraglutide Once Daily Without SU Use at Screening	0.00	0.05

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Change in Systolic Blood Pressure (SBP) From Baseline to Week 26

Change in SBP from baseline to the treatment endpoint at Week 26. (NCT01029886)
Timeframe: Baseline, Week 26

Intervention	mmHg (Least Squares Mean)
Exenatide Once Weekly	-2.48
Liraglutide Once Daily	-3.45

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Change in HbA1c From Baseline to Week 26

Change in HbA1c from baseline to the treatment endpoint at Week 26. (NCT01029886)
Timeframe: Baseline, Week 26

Intervention	percentage of total hemoglobin (Least Squares Mean)
Exenatide Once Weekly	-1.28
Liraglutide Once Daily	-1.48

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Change in Total Cholesterol From Baseline to Week 26

Change in total cholesterol from baseline to the treatment endpoint at Week 26. (NCT01029886)
Timeframe: Baseline, Week 26

Intervention	mmol/L (Least Squares Mean)
Exenatide Once Weekly	-0.06
Liraglutide Once Daily	-0.15

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Change in Fasting Serum Glucose From Baseline to Week 26

Change in fasting serum glucose from baseline to the treatment endpoint at Week 26. (NCT01029886)
Timeframe: Baseline, Week 26

Intervention	mmol/L (Least Squares Mean)
Exenatide Once Weekly	-1.76
Liraglutide Once Daily	-2.12

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Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26

Change in DBP from baseline to the treatment endpoint at Week 26. (NCT01029886)
Timeframe: Baseline, Week 26

Intervention	mmHg (Least Squares Mean)
Exenatide Once Weekly	-0.49
Liraglutide Once Daily	-0.51

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Change in Body Weight From Baseline to Week 26

Change in body weight from baseline to the treatment endpoint at Week 26. (NCT01029886)
Timeframe: Baseline, Week 26

Intervention	kg (Least Squares Mean)
Exenatide Once Weekly	-2.68
Liraglutide Once Daily	-3.57

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Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26

Change in HDL-C from baseline to the treatment endpoint at Week 26. (NCT01029886)
Timeframe: Baseline, Week 26

Intervention	mmol/L (Least Squares Mean)
Exenatide Once Weekly	0.02
Liraglutide Once Daily	0.02

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Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period

Change in HbA1C from baseline to the last observation carried forward (LOCF) measured during the comparative period = LOCF value - baseline value (NCT01117350)
Timeframe: baseline (week -2), week 12, week 24

Intervention	percent (Mean)
Insulin Glargine	-1.92
Liraglutide	-1.81

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Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period

Change in HbA1C from beginning of the extension period (week 24) to the last observation carried forward (LOCF) measured during the extension period = LOCF value - week 24 value (NCT01117350)
Timeframe: week 24, week 36, week 48

Intervention	percent (Mean)
Insulin Glargine (Extension Period)	-0.26

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Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period

The value at the end of the comparative period was defined as the last available HbA1c value measured during the comparative period plus 14 days after the last dose of Investigational Product (i.e. last-observation-carried-forward [LOCF] value). (NCT01117350)
Timeframe: week 12, week 24

Intervention	percentage of participants (Number)
Insulin Glargine	48.4
Liraglutide	45.9

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Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period

"Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit~Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - baseline value" (NCT01117350)
Timeframe: baseline (week 0), week 12, week 24

Intervention	mg/dL (Mean)
	Before breakfast (N ig = 448 & N l = 409)	After breakfast (N ig = 440 & N l = 397)	Before lunch (N ig = 438 & N l = 404)	After lunch (N ig = 433 & N l = 406)	Before dinner (N ig = 434 & N l = 400)	After dinner (N ig = 426 & N l = 396)	At bedtime (N ig = 380 & N l = 351)
Insulin Glargine	-65.92	-66.70	-50.16	-43.00	-40.84	-42.6	-43.11
Liraglutide	-38.64	-55.35	-39.13	-41.82	-36.88	-45.04	-44.06

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Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period

"Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit~Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - week 24 value" (NCT01117350)
Timeframe: week 24, week 36, week 48

Intervention	mg/dL (Mean)
	Before breakfast (N=143)	After breakfast (N=134)	Before lunch (N=131)	After lunch (N=134)	Before dinner (N=133)	After dinner (N=130)	At bedtime (N=127)
Insulin Glargine (Extension Period)	-46.13	-27.67	-20.32	-11.50	-12.56	-2.28	-14.94

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Body Weight: Change From Beginning to End of the Extension Period

Change = Last weight value measured during the extension period (LOCF value) - weight value at beginning of the Extension Period (Week 24) (NCT01117350)
Timeframe: week 24, week 30, week 36, week 48

Intervention	kg (Mean)
Insulin Glargine (Extension Period)	4.35

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Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period

Value at the end of the extension period defined as last available HbA1c value measured during the extension period (i.e. last observation carried forward (LOCF) value) (NCT01117350)
Timeframe: week 36, week 48

Intervention	percentage of participants (Number)
Insulin Glargine (Extension Period)	22.7

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Daily Dose of Liraglutide

(NCT01117350)
Timeframe: week 1, week 2, week 6, week 12, week 24

Intervention	mg (Mean)
	Start of treatment (N=470)	Week 1 (N=463)	Week 2 (N=458)	Week 6 (N=444)	Week 12 (N=426)	Week 18 (N=415)	Week 24 (N=431)	End comparative period (LOCF) (N=470)
Liraglutide	0.60	0.91	1.49	1.72	1.73	1.74	1.73	1.71

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Body Weight: Change From Baseline to the End of the Comparative Period

Change = Last weight value measured during the comparative period (LOCF value) - weight value at baseline (NCT01117350)
Timeframe: baseline (week 0), week 2, week 6, week 12, week 18, week 24

Intervention	kg (Mean)
Insulin Glargine	1.98
Liraglutide	-2.99

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Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period

"SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit~Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - baseline value" (NCT01117350)
Timeframe: baseline (week 0), week 6, week 12, week 18, week 24

Intervention	mg/dL (Mean)
Insulin Glargine	-65.25
Liraglutide	-37.23

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Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period

"Percentage of patients with:~* HbA1c value at end of the comparative period (LOCF) lower than HbA1c baseline value~AND~* HbA1c value at end of the comparative period (LOCF) ≥7%" (NCT01117350)
Timeframe: baseline (week -2), week 12, week 24

Intervention	percentage of participants (Number)
Insulin Glargine	47.1
Liraglutide	46.3

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Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period

Percentage of patients with HbA1c value at end of the comparative period (LOCF) higher than HbA1c baseline value (NCT01117350)
Timeframe: baseline (week -2), week 12, week 24

Intervention	percentage of participants (Number)
Insulin Glargine	4.1
Liraglutide	6.6

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Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period

"Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.~Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:~The event was associated with a measured PG level < 36 mg/dL (2 mmol/L),~Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration." (NCT01117350)
Timeframe: all across the comparative period (from week 0 to week 24)

Intervention	participants (Number)
	symptomatic hypoglycemia	severe symptomatic hypoglycemia
Insulin Glargine	219	0
Liraglutide	85	2

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Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period

"SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit~Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - week 24 value" (NCT01117350)
Timeframe: week 24, week 30, week 36, week 48

Intervention	mg/dL (Mean)
Insulin Glargine (Extension Period)	-44.63

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Daily Dose of Insulin Glargine

(NCT01117350)
Timeframe: week 1, week 2, week 6, week 12, week 24

Intervention	Unit (U) (Mean)
	Start of treatment (N=472)	Week 1 (N=470)	Week 2 (N=470)	Week 6 (N=470)	Week 12 (N=463)	Week 18 (N=454)	Week 24 (N=459)	End comparative period (LOCF) (N=474)
Insulin Glargine	13.39	17.74	22.06	34.67	44.40	48.65	51.67	51.24

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Daily Dose of Insulin Glargine Administered During the Extension Period

(NCT01117350)
Timeframe: week 30, week 36, week 48

Intervention	Unit (U) (Mean)
	Start of treatment (N=154)	Week 30 (N=151)	Week 36 (N=150)	Week 48 (N=151)
Insulin Glargine (Extension Period)	15.77	37.49	46.21	50.68

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Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period

Intervention	participants (Number)
	symptomatic hypoglycemia	severe symptomatic hypoglycemia
Insulin Glargine (Extension Period)	58	0

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Mean Change From Baseline in Body Weight at Week 32

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline weight as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. (NCT01128894)
Timeframe: Baseline and Week 32

Intervention	Kilograms (Mean)
Albiglutide 50 mg	-0.62
Liraglutide 1.8 mg	-2.21

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Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. (NCT01128894)
Timeframe: Baseline and Week 32

Intervention	Percentage of HbA1c in the blood (Least Squares Mean)
Albiglutide 50 mg	-0.78
Liraglutide 1.8 mg	-0.99

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Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32

Number of participants who achieved HbA1c response levels of <6.5% and <7.0% at Week 32 were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. (NCT01128894)
Timeframe: Week 32

Intervention	Participants (Number)
	HbA1c <6.5%	HbA1c <7.0%
Albiglutide 50 mg	78	168
Liraglutide 1.8 mg	113	208

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Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline FPG as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week. (NCT01128894)
Timeframe: Baseline and Week 32

Intervention	Millimoles per liter (mmol/L) (Least Squares Mean)
Albiglutide 50 mg	-1.22
Liraglutide 1.8 mg	-1.68

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Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week. (NCT01128894)
Timeframe: Baseline, Weeks 4, 6, 12, 18 and 26

Intervention	Percentage of HbA1c in the blood (Mean)
	Week 4, n=387, 392	Week 6, n=398, 401	Week 12, n=398, 402	Week 18, n=398, 402	Week 26, n=398, 402
Albiglutide 50 mg	-0.52	-0.66	-0.88	-0.87	-0.79
Liraglutide 1.8 mg	-0.73	-0.94	-1.18	-1.13	-1.00

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Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week. (NCT01128894)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26

Intervention	Millimoles per liter (mmol/L) (Mean)
	Week 1, n=386, 381	Week 2, n= 399, 398	Week 3, n= 400, 402	Week 4, n= 400, 402	Week 6, n= 400, 402	Week 12, n= 400, 402	Week 18, n= 400, 402	Week 26, n= 400, 402
Albiglutide 50 mg	-0.98	-1.33	-1.61	-1.52	-1.25	-1.73	-1.44	-1.14
Liraglutide 1.8 mg	-1.62	-2.25	-2.43	-2.45	-2.11	-2.10	-1.74	-1.64

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Time to Hyperglycemia Rescue at Week 32

Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) >=280 milligram/decilitre (mg/dL) >= Week 2 and < Week 4, FPG >=250 mg/dL >= Week 4 and = Week 12 and = Week 26. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus one day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus one day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. All times extending beyond Week 32 relevant to hyperglycemia rescue were censored at Week 32. (NCT01128894)
Timeframe: Week 32

Intervention	Weeks (Median)
Albiglutide 50 mg	NA
Liraglutide 1.8 mg	NA

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Change From Time-matched Baseline in Obestatin Concentration at Day 28

Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched obestatin assessment. (NCT01175473)
Timeframe: 0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28

Intervention	nmol/L (Mean)
	Change at Day 28: 0.5 h	Change at Day 28: 2.5 h	Change at Day 28: 4.5 h
Liraglutide	0.02	0.01	-0.01
Lixisenatide	0.04	0.03	-0.01

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Percentages of Patients by Ranges of Oxyntomodulin Levels

Percentage of patients with oxyntomodulin level less than or equal to (<=) limit of detection (LOD), above limit of quantification (LOQ) and between LOD and LOQ were reported. The LOD and LOQ values for oxyntomodulin were 70 and 200 picogram per milliliter (pg/mL) respectively. (NCT01175473)
Timeframe: 0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28

Intervention	percentage of participants (Number)
	Day -1, 0.5 h: <=LOD (n = 75, 68)	Day -1, 0.5 h: LOD-LOQ (n = 75, 68)	Day -1, 0.5 h: >LOQ (n = 75, 68)	Day -1, 2.5 h: <=LOD (n = 75, 68)	Day -1, 2.5 h: LOD-LOQ (n = 75, 68)	Day -1, 2.5 h: >LOQ (n = 75, 68)	Day -1, 4.5 h: <=LOD (n = 75, 68)	Day -1, 4.5 h: LOD-LOQ (n = 75, 68)	Day -1, 4.5 h: >LOQ (n = 75, 68)	Day 28, 0.5 h: <=LOD (n = 75, 68)	Day 28, 0.5 h: LOD-LOQ (n = 75, 68)	Day 28, 0.5 h: >LOQ (n = 75, 68)	Day 28, 2.5 h: <=LOD (n = 74, 68)	Day 28, 2.5 h: LOD-LOQ (n = 74, 68)	Day 28, 2.5 h: >LOQ (n = 74, 68)	Day 28, 4.5 h: <=LOD (n = 75, 68)	Day 28, 4.5 h: LOD-LOQ (n = 75, 68)	Day 28, 4.5 h: >LOQ (n = 75, 68)
Liraglutide	20.6	55.9	23.5	8.8	23.5	67.6	11.8	39.7	48.5	30.9	51.5	17.6	16.2	48.5	35.3	20.6	52.9	26.5
Lixisenatide	33.3	49.3	17.3	12.0	25.3	62.7	17.3	34.7	48.0	38.7	40.0	21.3	52.7	32.4	14.9	52.0	33.3	14.7

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Change From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28

Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched PYY-36 assessment. (NCT01175473)
Timeframe: 0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28

Intervention	pmol/L (Mean)
	Change at Day 28: 0.5 h	Change at Day 28: 2.5 h	Change at Day 28: 4.5 h
Liraglutide	-0.79	-3.14	-2.47
Lixisenatide	0.02	-7.09	-8.33

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Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28

The area under the plasma glucose concentration time curve (GLU-AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). GLU-AUC0:30-4:30h on Day -1 was the baseline. Change in GLU-AUC0:30-4:30h = GLU-AUC0:30-4:30h on Day 28 minus GLU-AUC0:30-4:30h on Day -1. (NCT01175473)
Timeframe: 0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

Intervention	h*mg/dL (Least Squares Mean)
Lixisenatide	-227.25
Liraglutide	-72.83

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Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28

The area under the glucagon concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast glucagon concentration (time: 0.5 hours). Glucagon AUC0:30-4:30h on Day -1 was the baseline. Change in glucagon AUC0:30-4:30h = glucagon AUC0:30-4:30h on Day 28 minus glucagon AUC0:30-4:30h on Day -1. (NCT01175473)
Timeframe: 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

Intervention	h*pg/mL (Least Squares Mean)
Lixisenatide	-46.71
Liraglutide	-25.28

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Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29

Change = HbA1c value at Day 29 (24 hours post-dose on Day 28) minus HbA1c value at baseline (pre-dose [Hour 0] on Day 1). (NCT01175473)
Timeframe: Pre-dose (Hour 0) on Day 1 and 29 (that is, 24 hours post-dose on Day 28)

Intervention	percentage of hemoglobin (Least Squares Mean)
Lixisenatide	-0.32
Liraglutide	-0.45

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Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28

The area under the insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast insulin concentration (time: 0.5 hours). Insulin AUC0:30-4:30h on Day -1 was the baseline. Change in insulin AUC0:30-4:30h = insulin AUC0:30-4:30h on Day 28 minus insulin AUC0:30-4:30h on Day -1. (NCT01175473)
Timeframe: 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

Intervention	hour*micro international unit/milliliter (Least Squares Mean)
Lixisenatide	-64.22
Liraglutide	5.34

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Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28

The area under the pro-insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast pro-insulin concentration (time: 0.5 hours). Pro-insulin AUC0:30-4:30h on Day -1 was the baseline. Change in pro-insulin AUC0:30-4:30h = pro-insulin AUC0:30-4:30h on Day 28 minus pro-insulin AUC0:30-4:30h on Day -1. (NCT01175473)
Timeframe: 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

Intervention	hour*micro international unit/milliliter (Least Squares Mean)
Lixisenatide	-1.27
Liraglutide	-2.47

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Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28

The area under the C-peptide concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast C-peptide concentration (time: 0.5 hours). C-peptide AUC0:30-4:30h on Day -1 was the baseline. Change in C-peptide AUC0:30-4:30h = C-peptide AUC0:30-4:30h on Day 28 minus C-peptide AUC0:30-4:30h on Day -1. (NCT01175473)
Timeframe: 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

Intervention	h*ng/mL (Least Squares Mean)
Lixisenatide	-5.03
Liraglutide	1.04

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Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28

PPG excursion was determined on Day -1 (Baseline) and 28 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 4 hours later subtracted from pre-meal plasma concentration. (NCT01175473)
Timeframe: 0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

Intervention	mg/dL (Least Squares Mean)
Lixisenatide	-70.43
Liraglutide	-24.93

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Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.

Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented. (NCT01179048)
Timeframe: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Intervention	percentage of subjects (Number)
Liraglutide	20.3
Placebo	22.7

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Time From Randomisation to All Cause Death

Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented. (NCT01179048)
Timeframe: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Intervention	percentage of subjects (Number)
Liraglutide	8.2
Placebo	9.6

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Time From Randomisation to First Occurrence of a Composite Microvascular Outcome

"Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following:~new onset of persistent macroalbuminuria~persistent doubling of serum creatinine~need for continuous renal replacement therapy~death due to renal disease~need for retinal photocoagulation or treatment with intravitreal agents~vitreous haemorrhage~diabetes-related blindness~The percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented." (NCT01179048)
Timeframe: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Intervention	Percentage of subjects (Number)
Liraglutide	7.6
Placebo	8.9

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Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)

Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented. (NCT01179048)
Timeframe: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Intervention	percentage of subjects (Number)
Liraglutide	13.0
Placebo	14.9

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Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome

Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented. (NCT01179048)
Timeframe: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Intervention	percentage of subjects (Number)
	Cardiovascular death	Non-fatal stroke	Non-fatal myocardial infarction	Unstable angina pectoris (hospitalisation)	Coronary revascularisation	Heart failure (hospitalisation)
Liraglutide	4.7	3.4	6.0	2.6	8.7	4.7
Placebo	6.0	3.8	6.8	2.7	9.4	5.3

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Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.

Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented. (NCT01179048)
Timeframe: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Intervention	Percentage of subjects (Number)
	Nephropathy composite	New onset of persistent macroalbuminuria	Persistent doubling of serum creatinine	Need for continuous renal-replacement therapy	Death due to renal disease	Retinopathy composite	Treatment with photocoagulation/intravitreal agent	Development of diabetes-related blindness	Vitreous haemorrhage
Liraglutide	5.7	3.4	1.9	1.2	0.2	2.3	2.1	0.0	0.7
Placebo	7.2	4.6	2.1	1.4	0.1	2.0	1.8	0.02	0.5

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Myocardial Glucose Uptake

PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir (NCT01232946)
Timeframe: 3 months

Intervention	umol/g/min (Median)
Iiraglutide	0.055
Insulin Detemir	0.0399
Liraglutide Plus Insulin Detemir	0.0373

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Myocardial Fatty Acid Oxidation Rate

PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir (NCT01232946)
Timeframe: 3 months

Intervention	umol/g/min (Median)
Iiraglutide	0.1019
Insulin Detemir	0.1234
Liraglutide Plus Insulin Detemir	0.0992

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Myocardial Fatty Acid Esterification Rate

PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir (NCT01232946)
Timeframe: 3 months

Intervention	umol/g/min (Median)
Iiraglutide	0.00274
Insulin Detemir	0.00358
Liraglutide Plus Insulin Detemir	0.00146

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Matsuda Insulin Sensitivity Index Derived From OGTT

OGTT- derived insulin sensitivity index in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	index (Mean)
Metformin XR Plus Liraglutide	5.9
Metformin XR Plus Placebo	5.4

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Low Density Lipoprotein Cholesterol (LDL-C) Levels

LDL-Cholesterol levels in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	mg/dL (Mean)
Metformin XR Plus Liraglutide	110
Metformin XR Plus Placebo	107

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Insulinogenic Index (IGI) /HOMA-IR

IGI/HOMA-IR, a measure of early insulin response corrected by fasting insulin resistance, in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	index (Mean)
Metformin XR Plus Liraglutide	0.8
Metformin XR Plus Placebo	0.62

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Total Cholesterol (CHOL) Levels

CHOL levels in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	mg/dL (Mean)
Metformin XR Plus Liraglutide	183.7
Metformin XR Plus Placebo	183.8

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Absolute Body Weight

Body weight in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	kilograms (Mean)
Metformin XR Plus Liraglutide	94.2
Metformin XR Plus Placebo	91.3

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Alanine Aminotransferase (ALT) Levels

Hepatic enzyme, ALT, associated with insulin resistance, in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	U/L (Mean)
Metformin XR Plus Liraglutide	32.3
Metformin XR Plus Placebo	31

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Alanine Aminotransferase /Aspartate Aminotransferase (ALT/AST) Ratio

ALT/AST ratio, used to assess liver function in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	ratio of ALT (U/L)/ AST (U/L) (Mean)
Metformin XR Plus Liraglutide	1.2
Metformin XR Plus Placebo	1.18

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Aspartate Aminotransferase (AST)

The hepatic marker, AST, associated with insulin resistance in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	U/L (Mean)
Metformin XR Plus Liraglutide	27
Metformin XR Plus Placebo	28

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Body Mass Index (BMI)

BMI, a measure of total body adiposity, in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	weight (kg) /height (m) squared (Mean)
Metformin XR Plus Liraglutide	33.8
Metformin XR Plus Placebo	32.8

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Change in Body Weight From Baseline to End of Study (Expressed as % Compared to Baseline)

Change in body weight from baseline to end o f study in LIRA-MET group compared with PL-MET group. The number was derived from final weight minus baseline and normalized to a percent. (NCT01234649)
Timeframe: Change from baseline (time 0) to study end (84 weeks)

Intervention	percent change in weight from baseline (Mean)
Metformin XR Plus Liraglutide	-7.2
Metformin XR Plus Placebo	-3.1

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Insulin Secretion-Sensitivity Index (IS-SI)

IS-SI in liraglutide-metformin (LIRA-MET) therapy compared to metformin alone (PLacebo-MET) (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	index (Mean)
Metformin XR Plus Liraglutide	418.4
Metformin XR Plus Placebo	333

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Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

HOMA-IR, a measure of insulin resistance derived from fasting values, in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	index (Mean)
Metformin XR Plus Liraglutide	2.2
Metformin XR Plus Placebo	2.45

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High Density Lipoprotein Cholesterol (HDL-C) Levels

HDL-C levels in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	mg/dL (Mean)
Metformin XR Plus Liraglutide	51
Metformin XR Plus Placebo	48.7

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Diastolic Blood Pressure

DBP in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	mmHg (Mean)
Metformin XR Plus Liraglutide	77.6
Metformin XR Plus Placebo	77

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Systolic Blood Pressure

SBP in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	mmHg (Mean)
Metformin XR Plus Liraglutide	122
Metformin XR Plus Placebo	123

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Mean Glucose During OGTT (MBG)

MBG derived from average glucose measured during OGTT in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	mg/dL (Mean)
Metformin XR Plus Liraglutide	121.6
Metformin XR Plus Placebo	118.8

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Fasting Blood Glucose (FBG)

Fasting glucose levels in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	mg/dL (Mean)
Metformin XR Plus Liraglutide	90
Metformin XR Plus Placebo	91.7

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Triglyceride (TRG) Levels

TRG concentrations in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	mg/dL (Mean)
Metformin XR Plus Liraglutide	120
Metformin XR Plus Placebo	125

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Triglyceride to High Density Lipoprotein Cholesterol Ratio TRG/HDL-C)

TRG/HDL-Cholesterol levels in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	ratio of TRG (mg/dL)/HDL-C (mg/dl) (Mean)
Metformin XR Plus Liraglutide	2.56
Metformin XR Plus Placebo	2.95

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Waist Circumference (WC)

Waist size (measure of truncal adiposity) with LIRA-MET compared to PL-MET (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	centimeters (Mean)
Metformin XR Plus Liraglutide	94.3
Metformin XR Plus Placebo	95.3

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Waist-to-Hip Ratio (WHR)

Waist circumference divided by hip circumference (a measure of central adiposity) in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	ratio of waist/hip circumference (Mean)
Metformin XR Plus Liraglutide	.81
Metformin XR Plus Placebo	.81

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Waist to Height Ratio (WHtR)

Waist circumference divided by height (measure of body fat distribution) in LIRA-MET group compared with PL-MET group (NCT01234649)
Timeframe: 84 weeks of treatment

Intervention	ratio of waist /height (Mean)
Metformin XR Plus Liraglutide	.56
Metformin XR Plus Placebo	.57

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Change From Baseline in Fasting Body Weight

The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period). (NCT01272219)
Timeframe: Week 0, Week 56

Intervention	percent change (Mean)
Liraglutide 3.0 mg (56-Week)	-7.98
Liraglutide Placebo (56-Week)	-2.62

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Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)

The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). (NCT01272219)
Timeframe: Week 0, week 160

Intervention	percent change (Mean)
Liraglutide 3.0 mg (160-Week)	-6.14
Liraglutide Placebo (160-Week)	-1.89

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Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)

The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). (NCT01272219)
Timeframe: Week 0, week 160

Intervention	cm (Mean)
Liraglutide 3.0 mg (160-Week)	-6.87
Liraglutide Placebo (160-Week)	-3.37

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Change From Baseline in Waist Circumference (cm)

The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period). (NCT01272219)
Timeframe: Week 0, Week 56

Intervention	cm (Mean)
Liraglutide 3.0 mg (56-Week)	-8.19
Liraglutide Placebo (56-Week)	-3.94

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Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)

The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period). (NCT01272219)
Timeframe: Week 0, Week 68

Intervention	percent change (Mean)
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)	-8.44
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)	-6.77
Liraglutide Placebo, no Pre-diabetes	-3.11

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Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.

Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period). (NCT01272219)
Timeframe: At Week 56

Intervention	percentage of subjects (Number)
Liraglutide 3.0 mg (56-Week)	63.2
Liraglutide Placebo (56-Week)	27.1

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Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight

Percentage of subjects losing >10% of baseline fasting body weight after 56-weeks of treatment (main treatment period). (NCT01272219)
Timeframe: At 56 weeks

Intervention	percentage of subjects (Number)
Liraglutide 3.0 mg (56-Week)	33.1
Liraglutide Placebo (56-Week)	10.6

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Proportion of Subjects With Onset of Type 2 Diabetes

Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). (NCT01272219)
Timeframe: At 160 weeks

Intervention	Subject (Number)
Liraglutide 3.0 mg (160-Week)	26
Liraglutide Placebo (160-Week)	46

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Pre-diabetes Status After 56 Weeks of Treatment

Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period). (NCT01272219)
Timeframe: Week 0, Week 56

Intervention	percentage of subjects (Number)
	With No Pre-diabetes	With Pre-diabetes	With Transient Type 2 Diabetes	With Confirmed Type 2 Diabetes
Liraglutide 3.0 mg (56-Week)	78.3	20.6	0.9	0.2
Liraglutide Placebo (56-Week)	50.9	46.1	1.8	1.1

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Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment

Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). (NCT01272219)
Timeframe: Week 0, week 160

Intervention	percentage of subjects (Number)
	With No Pre-diabetes	With Pre-diabetes	With Transient Type 2 Diabetes	With Confirmed Type 2 Diabetes
Liraglutide 3.0 mg (160-Week)	65.9	31.3	1.1	1.8
Liraglutide Placebo (160-Week)	36.3	54.9	2.6	6.2

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Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)

Percentage of subjects losing >=5% and percentage of subjects losing >10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). (NCT01272219)
Timeframe: At 160 weeks

Intervention	percentage of subjects (Number)
	Losing >=5% of baseline body weight	Losing >10% of baseline body weight
Liraglutide 3.0 mg (160-Week)	49.6	24.8
Liraglutide Placebo (160-Week)	23.7	9.9

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Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)

The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period). (NCT01272219)
Timeframe: Week 56, Week 68

Intervention	percent change (Mean)
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)	0.69
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)	2.91
Liraglutide Placebo, no Pre-diabetes	0.28

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Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%

(NCT01272232)
Timeframe: at 56 weeks

Intervention	percentage of subjects (Number)
	Yes	No
Liraglutide 1.8 mg	45.6	54.4
Liraglutide 3.0 mg	56.5	43.5
Liraglutide Placebo	15.0	85.0

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Proportion of Subjects Reaching Target HbA1c Below 7%

(NCT01272232)
Timeframe: at 56 weeks

Intervention	percentage of subjects (Number)
	Yes	No
Liraglutide 1.8 mg	66.7	33.3
Liraglutide 3.0 mg	69.2	30.8
Liraglutide Placebo	27.2	72.8

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Proportion of Subjects Losing More Than 10% of Baseline Body Weight

Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial. (NCT01272232)
Timeframe: at 56 weeks

Intervention	percentage of subjects (Number)
	Yes	No
Liraglutide 1.8 mg	14.4	85.6
Liraglutide 3.0 mg	23.4	76.6
Liraglutide Placebo	4.3	95.7

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Proportion of Subjects Losing at Least 5% of Baseline Body Weight

Intervention	percentage of subjects (Number)
	Yes	No
Liraglutide 1.8 mg	35.6	64.4
Liraglutide 3.0 mg	49.9	50.1
Liraglutide Placebo	13.8	86.2

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Incidence of Hypoglycaemic Episodes

Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level below 3.1 mmol/L [56 mg/dL]). (NCT01272232)
Timeframe: Weeks 0-56

Intervention	Episodes/100 years of patient exposure (Number)
	Minor	ADA: Severe	ADA: Documented, symptomatic	ADA: Asymptomatic	ADA: Probable, symptomatic	ADA: Relative	ADA: Unclassifiable
Liraglutide 1.8 mg	46	2	95	142	2	16	7
Liraglutide 3.0 mg	34	1	87	151	2	17	14
Liraglutide Placebo	13	0	31	46	1	5	3

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Change From Week 56 to 68 in Waist Circumference

(NCT01272232)
Timeframe: Week 56, week 68

Intervention	cm (Mean)
Liraglutide 3.0 mg	1.21
Liraglutide 1.8 mg	1.02
Liraglutide Placebo	-0.22

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Change From Baseline in Waist Circumference

(NCT01272232)
Timeframe: Week 0, week 68

Intervention	cm (Mean)
Liraglutide 3.0 mg	-5.7
Liraglutide 1.8 mg	-4.4
Liraglutide Placebo	-3.2

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Change From Baseline in Waist Circumference

(NCT01272232)
Timeframe: Week 0, week 56

Intervention	cm (Mean)
Liraglutide 3.0 mg	-6.1
Liraglutide 1.8 mg	-4.8
Liraglutide Placebo	-2.7

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Change (%) From Baseline in Body Weight (Fasting)

Intervention	percent change (Mean)
Liraglutide 3.0 mg	-4.7
Liraglutide 1.8 mg	-3.6
Liraglutide Placebo	-2.7

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Change (%) From Baseline in Body Weight (Fasting)

Intervention	percent change (Mean)
Liraglutide 3.0 mg	-5.9
Liraglutide 1.8 mg	-4.6
Liraglutide Placebo	-2.0

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Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)

Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56. (NCT01272232)
Timeframe: Week 0, week 56

Intervention	percentage point change of HbA1c (Mean)
Liraglutide 3.0 mg	-1.3
Liraglutide 1.8 mg	-1.1
Liraglutide Placebo	-0.3

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Change (%) From Week 56 to 68 in Body Weight (Fasting)

Intervention	percent change (Mean)
Liraglutide 3.0 mg	2.3
Liraglutide 1.8 mg	2.0
Liraglutide Placebo	-0.1

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Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline at Week 26 is defined as Week 26 minus Week 0. (NCT01296412)
Timeframe: Baseline and Week 26

Intervention	mg/dL (Least Squares Mean)
Sitagliptin +/- Glimepiride	-33.7
Liraglutide	-39.6

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Change From Baseline in Hemoglobin A1c (A1C)

A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent. (NCT01296412)
Timeframe: Baseline and Week 26

Intervention	percent (Least Squares Mean)
Sitagliptin +/- Glimepiride	-1.32
Liraglutide	-1.42

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Percentage of Participants Reaching A1C Goal of <6.5%

(NCT01296412)
Timeframe: Week 26

Intervention	percentage of participants (Number)
Sitagliptin +/- Glimepiride	33.8
Liraglutide	38.3

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Percentage of Participants Reaching A1C Goal of <7.0%

(NCT01296412)
Timeframe: Week 26

Intervention	percentage of participants (Number)
Sitagliptin +/- Glimepiride	62.8
Liraglutide	72.3

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Number of Hypoglycaemic Episodes

Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure. (NCT01336023)
Timeframe: Weeks 0-26

Intervention	Events per 100 patient years of exposure (Number)
IDeg	256.7
IDegLira	180.2
Liraglutide	22.0

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Mean Change From Baseline in Body Weight at Week 26

Values of mean change in body weight. (NCT01336023)
Timeframe: Week 0, Week 26

Intervention	kg (Mean)
IDeg	1.6
IDegLira	-0.5
Liraglutide	-3.0

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Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.

Values of mean change in HbA1c. (NCT01336023)
Timeframe: Week 0, week 26

Intervention	Percentage of glycosylated haemoglobin (Mean)
IDeg	-1.44
IDegLira	-1.91
Liraglutide	-1.28

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Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test

Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point. (NCT01336023)
Timeframe: Week 0, Week 26

Intervention	mmol/L (Mean)
IDeg	-0.17
IDegLira	-0.87
Liraglutide	-0.78

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Mean Actual Daily Insulin Dose

Mean of the actual doses recorded at visit 28 (Week 26). (NCT01336023)
Timeframe: Week 26

Intervention	units (Mean)
IDeg	53
IDegLira	38

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Change From Baseline in Maximum Ambient Glucose Concentration (Gmax) After a Single Dose of OXM

Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline. (NCT01373450)
Timeframe: Baseline and up to 160 minutes after start of GGI

Intervention	mg/dL (Least Squares Mean)
Oxyntomodulin	211.0
Placebo	272.9

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Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM)

Participants received on Day (-1) an overnight intravenous (IV) infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of liraglutide (Lg) or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of graded glucose infusion (GGI). During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI at the following minutes: 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 in order to calculate the time-weighted average change from baseline in glucose AUC from 0-160 minutes. (NCT01373450)
Timeframe: Baseline and during GGI at time points 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 minutes

Intervention	mg/dL (Least Squares Mean)
Oxyntomodulin	106.3
Placebo	122.6

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Change From Baseline in Insulinotrophic Effect (ISR/G) After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM

Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR) and hence determine ISR/G. (NCT01373450)
Timeframe: Baseline and up to 160 minutes after start of GGI

Intervention	ISR (ng/min) / Glucose (mg/dL) (Least Squares Mean)
Liraglutide 0.6 mg	0.026
Liraglutide 1.2 mg	0.035
Oxyntomodulin	0.019
Placebo	0.006

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Change From Baseline in Insulinotrophic Effect (ISR/G) at the Highest Glucose Infusion Rate After Two Periods of Placebo Treatment

The reproducibility of insulinotrophic effects was compared after two separate placebo treatment periods within the same treatment sequence. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single subcutaneous dose of placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Over these two treatment periods glucose (G), insulin and C-peptide levels were measured from blood collected at the highest glucose infusion rate; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR), and hence to determine the insulinotrophic effect, ISR/G. (NCT01373450)
Timeframe: Baseline and 160 minutes after start of GGI at each placebo treatment period

Intervention	ISR (ng/mg) / Glucose (mg/dL) (Mean)
Placebo Period 1	0.0075
Placebo Period 2	0.0070

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Change From Baseline in Gmax After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM

Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline. (NCT01373450)
Timeframe: Baseline and up to 160 minutes after start of GGI

Intervention	mg/dL (Least Squares Mean)
Liraglutide 0.6 mg	209.7
Liraglutide 1.2 mg	157.9
Oxyntomodulin	211.0
Placebo	272.9

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Change From Baseline in Beta Cell Sensitivity to Glucose (Φ) After a Single Dose of OXM

Beta cell sensitivity measures the ability to mount an insulin secretory response relative to the level of ambient plasma glucose. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI, with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR). Beta Cell Sensitivity (Φ) was determined from the regression of the ISR on ambient plasma glucose (G). (NCT01373450)
Timeframe: Baseline and up to160 minutes after start of GGI

Intervention	ISR (ng/mL) / Glucose (mg/dL) (Least Squares Mean)
Oxyntomodulin	0.019
Placebo	0.006

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Change From Baseline in Body Weight

Corresponds to the values of change in body weight in kilograms from baseline to week 26. (NCT01388361)
Timeframe: week 0, week 26

Intervention	kg (Mean)
IDeg	0.1
IDeg + Liraglutide	-1.0
IDeg + IAsp OD	0.3

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Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes

Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value < 3.1 mmol/L (56 mg/dL). (NCT01388361)
Timeframe: Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.

Intervention	events (Number)
	Confirmed(severe+minor)	Severe
IDeg	313	1
IDeg + IAsp OD	330	0
IDeg + Liraglutide	40	0

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Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)

Values for change in HbA1c from baseline to 26 weeks of treatment period. (NCT01388361)
Timeframe: week 0, week 26

Intervention	percentage of glycosylated haemoglobin (Mean)
IDeg	0.10
IDeg + Liraglutide	-0.74
IDeg + IAsp OD	-0.39

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Change From Baseline in Fasting Plasma Glucose (FPG)

Values for change in FPG in mmol/L from baseline to week 26 of randomised period. (NCT01388361)
Timeframe: week 0, week 26

Intervention	mmol/L (Mean)
IDeg	-1.23
IDeg + Liraglutide	-0.14
IDeg + IAsp OD	-0.04

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Change in Body Weight

Observed mean change from baseline in body weight after 26 Weeks of treatment. (NCT01392573)
Timeframe: Week 0, week 26

Intervention	kg (Mean)
IDegLira	-2.7
IDeg	0.0

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Observed mean change from baseline in HbA1c after 26 Weeks of treatment. (NCT01392573)
Timeframe: Week 0, week 26

Intervention	percentage of glycosylated haemoglobin (Mean)
IDegLira	-1.90
IDeg	-0.89

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Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity

(NCT01473953)
Timeframe: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose

Intervention	pmol.h/L (Geometric Mean)
Cohort 1a: Lira-depot 2.25 mg	43840
Cohort 2a: Lira-depot 6.75 mg	116935
Cohort 3a: Lira-depot 15 mg	360000
Cohort 4a: Lira-depot 30 mg	1443038

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Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment

(NCT01473953)
Timeframe: 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose

Intervention	pmol.h/L (Geometric Mean)
Cohort 1a: Lira-depot 2.25 mg	37298
Cohort 2a: Lira-depot 6.75 mg	114101
Cohort 3a: Lira-depot 15 mg	316642
Cohort 4a: Lira-depot 30 mg	1363187

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Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot

(NCT01473953)
Timeframe: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose

Intervention	pmol/L (Geometric Mean)
Cohort 1a: Lira-depot 2.25 mg	690
Cohort 2a: Lira-depot 6.75 mg	2141
Cohort 3a: Lira-depot 15 mg	6977
Cohort 4a: Lira-depot 30 mg	40041

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Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot

(NCT01473953)
Timeframe: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose

Intervention	hours (Geometric Mean)
Cohort 1a: Lira-depot 2.25 mg	15.13
Cohort 2a: Lira-depot 6.75 mg	8.09
Cohort 3a: Lira-depot 15 mg	13.74
Cohort 4a: Lira-depot 30 mg	10.46

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Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up

(NCT01473953)
Timeframe: Day 0 and Day 21

,,,,

Intervention	participants (Number)
	Positive	Negative
Cohort 1a: Lira-depot 2.25 mg	0	6
Cohort 2a: Lira-depot 6.75 mg	0	6
Cohort 3a: Lira-depot 15 mg	0	6
Cohort 4a: Lira-depot 30 mg	0	5
Placebo	0	8

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Number of Treatment Emergent Adverse Events (TEAEs)

TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect. (NCT01473953)
Timeframe: Day 0 and up to 21 days after treatment

,,,,

Intervention	events (Number)
	Total adverse events (AEs)	Serious AE	Severe AE	Moderate AE	Mild AE	Fatal AE
Cohort 1a: Lira-depot 2.25 mg	3	0	0	0	3	0
Cohort 2a: Lira-depot 6.75 mg	3	0	0	0	3	0
Cohort 3a: Lira-depot 15 mg	4	0	0	0	4	0
Cohort 4a: Lira-depot 30 mg	21	0	1	9	11	0
Placebo	13	0	0	1	12	0

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Glycemic Control Measured by HbA1c

HbA1c (%) (NCT01505673)
Timeframe: 6-months

Intervention	Percent HbA1c (Mean)
Liraglutide	7.9
Saline Injection	8.9

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Matsuda Index as a Measure of Beta Cell Function

The Matsuda index is a measure of insulin sensitivity and has no minimum/maximum values. Index values are calculated as 500,000/square root of ((fasting glucose x fasting c-peptide x 333) x (mean 120 min post-meal glucose x mean 120 min post-meal c-peptide x 333)). Higher/lower values = better/worse insulin sensitivity. (NCT01505673)
Timeframe: 6 months

Intervention	index (Mean)
Liraglutide	2.88
Saline Injection	3.12

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Hypoglycemic Events

Reported as hypoglycemic events per month by patient as any blood glucose <70 mg/dl or symptoms of hypoglycemia with blood glucose >70 mg/dl (NCT01505673)
Timeframe: 6-months

Intervention	events per month per patient (Median)
Liraglutide	1.1
Saline Injection	0.7

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Pancreatic and Hepatic Triglyceride Content

Liver Triglyceride and Pancreatic Triglyceride (NCT01505673)
Timeframe: 6-months

Intervention	Percent Triglyceride (Mean)
	Liver Triglyceride	Pancreatic Triglyceride
Liraglutide	12.3	12.53
Saline Injection	12.2	14.64

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Weight

(NCT01505673)
Timeframe: 6-months

Intervention	Kilograms (Mean)
Liraglutide	114
Saline Injection	117

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AUC Glucose

(NCT01505673)
Timeframe: 6 months

Intervention	mg/(dL/min) (Mean)
Liraglutide	71747
Saline Injection	79278

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Beta-cell Function

AUC c-peptide (NCT01505673)
Timeframe: 6 Months

Intervention	ug/(L/min) (Mean)
Liraglutide	1234.6
Saline Injection	922.9

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Number of Daily Injections

The 3 days average of the number of daily injections performed within 3 consecutive days prior office visit 6 month. (NCT01505673)
Timeframe: 6-months

Intervention	number/day (Mean)
Liraglutide	3.7
Saline Injection	3.8

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Quality of Life Survey (QoL) - Current Health Perception

Current health perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 = much better than 3 months ago; 2 - Somewhat better now than 3 months ago; 3 - About the same; 4 - Somewhat worse now than 3 months ago; 5 Much worse now than 3 months ago. (NCT01505673)
Timeframe: 6 months

Intervention	score on a scale (Mean)
Liraglutide	2.1
Saline Injection	2.6

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Quality of Life Survey (QoL) - General Health Perception

General health perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 = excellent; 2 = very good; 3 = good; 4 = fair; 5 = poor. (NCT01505673)
Timeframe: 6-months

Intervention	score on a scale (Mean)
Liraglutide	3.1
Saline Injection	3.6

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Quality of Life Survey (QoL) - Glycemia Control Perception

Glycemia control perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1-7, where 1 - extremely controlled and 7 - not at all controlled. (NCT01505673)
Timeframe: 6 months

Intervention	score on a scale (Mean)
Liraglutide	2.0
Saline Injection	2.9

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Quality of Life Survey (QoL) - Hypoglycemia Fear

Hypoglycemia fear was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - never worry; 2 - rarely water; 3 - sometimes worry; 4 - often worry; 5 - very often worry. (NCT01505673)
Timeframe: 6 months

Intervention	score on a scale (Mean)
Liraglutide	1.9
Saline Injection	2.0

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Blood Pressure

(NCT01505673)
Timeframe: 6-months

Intervention	mmHg (Mean)
	Systolic	Diastolic
Liraglutide	134	80.5
Saline Injection	135	74.3

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Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment

Satisfaction with insulin treatment was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely satisfied to 7 - not at all satisfied. (NCT01505673)
Timeframe: 6 months

Intervention	score on a scale (Mean)
Liraglutide	1.6
Saline Injection	2.3

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Quality of Life Survey (QoL) - Social or Vocational Worry

Social or vocational worry was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 0-5, where 0 - does not apply; 1 - never; 2 - seldom; 3 - sometimes; 4 - often; 5 - all of the time. (NCT01505673)
Timeframe: 6 months

Intervention	score on a scale (Mean)
Liraglutide	1.5
Saline Injection	1.0

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Quality of Life Survey (QoL) - Social Stigma

Social stigma was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 strongly agree; 2 - somewhat agree; 3 - neither agree nor disagree; 4 - somewhat disagree; 5 - strongly disagree. (NCT01505673)
Timeframe: 6 months

Intervention	score on a scale (Mean)
Liraglutide	2.5
Saline Injection	2.4

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Lipid Profile

(NCT01505673)
Timeframe: 6-months

Intervention	mg/dL (Mean)
	Total cholesterol	LDL	HDL
Liraglutide	154	83.9	36.6
Saline Injection	152	76.3	37.6

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Liver Function Blood Test

(NCT01505673)
Timeframe: 6-months

Intervention	U/L (Mean)
	ALT	AST
Liraglutide	25.8	26.4
Saline Injection	36.0	32.1

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Total Daily Insulin Dose

The 3 days average of the total daily dose of insulin used within 3 consecutive days prior office visit 6 month. (NCT01505673)
Timeframe: 6-months

Intervention	IU (Median)
Liraglutide	200
Saline Injection	218

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Quality of Life Survey (QoL) - Lifestyle Flexibility

Lifestyle flexibility was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 - a great deal of choice; 2 - a lot of choice; 3 - some choice; 4 - a little choice; 5 - no choice. (NCT01505673)
Timeframe: 6 months

Intervention	score on a scale (Mean)
Liraglutide	2.2
Saline Injection	2.6

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Beta-Cell Function

Fasting C-peptide as a Measure of Beta-Cell Function (NCT01505673)
Timeframe: 6 months

Intervention	microgram/L (Mean)
Liraglutide	2.48
Saline Injection	1.75

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Beta-Cell Function

Fasting Glucose as a Measure of Beta-Cell Function (NCT01505673)
Timeframe: 6-months

Intervention	mg/dL (Mean)
Liraglutide	179
Saline Injection	197

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Quality of Life Survey (QoL) - Treatment Impact

Treatment impact was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied. (NCT01505673)
Timeframe: 6 months

Intervention	score on a scale (Mean)
Liraglutide	2.3
Saline Injection	2.6

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Quality of Life Survey (QoL) - Treatment Satisfaction

Quality of Life Survey (QoL) - treatment satisfactionTreatment satisfaction was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied. (NCT01505673)
Timeframe: 6 months

Intervention	score on a scale (Mean)
Liraglutide	2.4
Saline Injection	2.7

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Glucagon

Measured during mixed meal challenge test. (NCT01505673)
Timeframe: 6-months

Intervention	pg/mL (Mean)
Liraglutide	107.3
Saline Injection	93.8

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Ratio (AUC C-peptide/AUC Glucose)

(NCT01505673)
Timeframe: 6 months

Intervention	Ratio (Mean)
Liraglutide	0.019
Saline Injection	0.013

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Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment

Willingness to continue insulin treatment was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely willing to 7 - not at all willing. (NCT01505673)
Timeframe: 6 months

Intervention	score on a scale (Mean)
Liraglutide	1.0
Saline Injection	2.1

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Change in FPG From Baseline to Week 52

Estimated mean change from baseline in FPG after 52 Weeks of treatment (NCT01512108)
Timeframe: Week 0, week 52

Intervention	mmol/L (Mean)
Liraglutide 0.9 mg/Day	-1.55
Additional OAD	-1.24

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Incidence of Treatment Emergent Adverse Events (AEs)

Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly. (NCT01512108)
Timeframe: Week 0 to Week 52 + 7 days

Intervention	Events/100 years of patient exposure (Number)
	All AEs	Mild AEs	Moderate AEs	Severe AEs	Serious AEs
Additional OAD	331	321	9	2	9
Liraglutide 0.9 mg/Day	361	345	14	2	5

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Number of Confirmed Hypoglycaemic Episodes

Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes [An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose <3.1 mmol/L (56 mg/dL) or full blood glucose <2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or full blood glucose value <2.8 mmol/L (50 mg/dL)] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL). (NCT01512108)
Timeframe: Week 0 to Week 52

Intervention	episodes (Number)
Liraglutide 0.9 mg/Day	7
Additional OAD	2

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Change in HbA1c From Baseline to Week 52

Estimated mean change in HbA1c from baseline after 52 Weeks of treatment (NCT01512108)
Timeframe: Week 0, week 52

Intervention	percentage of glycosylated haemoglobin (Mean)
Liraglutide 0.9 mg/Day	-1.21
Additional OAD	-0.94

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Number of Hypoglycaemic Episodes

Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26. (NCT01541215)
Timeframe: 0-26 weeks

Intervention	hypoglycaemic episodes (Number)
Liraglutide 1.8 mg	92
Placebo	43

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Number of Adverse Events (Week 53-156)

This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during the follow-up period (weeks 53 to 156). (NCT01541215)
Timeframe: Week 53-156

Intervention	events (Number)
Liraglutide 1.8 mg: Follow-up 1 and 2	47

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Number of Adverse Events (Week 53-104)

This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during follow-up 1 (week 53 to 104). (NCT01541215)
Timeframe: Week 53-104

Intervention	events (Number)
Liraglutide 1.8 mg: Follow-up 1	30

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Number of Adverse Events (Week 0-52)

Total number of adverse events during entire treatment period. (NCT01541215)
Timeframe: 0-52 weeks

Intervention	events (Number)
Liraglutide 1.8 mg	426
Placebo	321

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Number of Adverse Events (Week 0-26)

Total number of adverse events during 26 weeks. (NCT01541215)
Timeframe: 0-26 weeks

Intervention	events (Number)
Liraglutide 1.8 mg	310
Placebo	230

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Height Velocity SDS- Week 156

The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 0, week 156

Intervention	SDS score (Mean)
Liraglutide 1.8 mg: Follow-up 1 and 2	0.142

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Height Velocity SDS- Week 104

The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 0, week 104

Intervention	SDS score (Mean)
Liraglutide 1.8 mg: Follow-up 1	-0.523

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Height Velocity SDS

Height velocity SDS scores at week 52. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	SDS score (Mean)
Liraglutide 1.8 mg	-0.887
Placebo	-0.551

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Height Velocity SDS

Height velocity SDS scores at week 26. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	SDS score (Mean)
Liraglutide 1.8 mg	-1.24
Placebo	-0.557

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Growth (Height Velocity)- Week 156

Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 0, week 156

Intervention	cm/year (Mean)
Liraglutide 1.8 mg: Follow-up 1 and 2	1.100

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Growth (Height Velocity)- Week 104

Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 0, week 104

Intervention	cm/year (Mean)
Liraglutide 1.8 mg: Follow-up 1	1.149

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Growth (Height Velocity)

Intervention	cm/year (Mean)
Liraglutide 1.8 mg	1.345
Placebo	1.817

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Growth (Height Velocity)

Intervention	cm/year (Mean)
Liraglutide 1.8 mg	1.633
Placebo	2.486

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Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)

Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	mmol/L (Mean)
Liraglutide 1.8 mg	-0.747
Placebo	-0.397

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Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)

Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Liraglutide 1.8 mg	-0.428
Placebo	-0.362

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Change in Mean 7-point Self-measured Plasma Glucose

Change in mean 7-point self-measured plasma glucose after 26 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Liraglutide 1.8 mg	-2.384
Placebo	0.198

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Change in HbA1c (Glycosylated Haemoglobin)

Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	Percentage of HbA1c (Least Squares Mean)
Liraglutide 1.8 mg	-0.643
Placebo	0.415

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Change in HbA1c

Change in HbA1c from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	percentage of HbA1c (Mean)
Liraglutide 1.8 mg	-0.732
Placebo	0.677

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Change in FPG

Change in FPG from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	mmol/L (Mean)
Liraglutide 1.8 mg	-1.627
Placebo	0.983

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Change in Bone Age Assessment (X-ray of Left Hand and Wrist)

Change in bone age from baseline to week 52. If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	years (Mean)
Liraglutide 1.8 mg	1.197
Placebo	1.088

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Change From Week 52 in Height SDS- Week 156

Change in height SDS from week 52 to week 156. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 52, week 156

Intervention	SDS score (Mean)
Liraglutide 1.8 mg: Follow-up 1 and 2	-0.224

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Change From Week 52 in Height SDS- Week 104

Change in height SDS from week 52 to week 104. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 52, week 104

Intervention	SDS score (Mean)
Liraglutide 1.8 mg: Follow-up 1	-0.133

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Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156

Change in bone age from week 52 to week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 52, week 156

Intervention	Years (Mean)
Liraglutide 1.8 mg: Follow-up 1 and 2	1.778

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Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104

Change in bone age from week 52 to week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. (NCT01541215)
Timeframe: Week 52, week 104

Intervention	Years (Mean)
Liraglutide 1.8 mg: Follow-up 1	1.231

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Change From Baseline in Pulse

Change from baseline in pulse 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	beats/minute (Mean)
Liraglutide 1.8 mg	-0.05
Placebo	-0.28

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Change From Baseline in Pulse

Change from baseline in pulse 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	beats/minute (Mean)
Liraglutide 1.8 mg	1.40
Placebo	0.33

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Change From Baseline in Height SDS

Change in height SDS from baseline to week 52. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	SDS score (Mean)
Liraglutide 1.8 mg	-0.192
Placebo	-0.134

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Change From Baseline in Height SDS

Change in height SDS from baseline to week 26. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	SDS score (Mean)
Liraglutide 1.8 mg	-0.100
Placebo	-0.042

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Change From Baseline in Fasting Plasma Glucose (FPG)

Change in FPG from baseline to week 26. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	mmol/L (Least Squares Mean)
Liraglutide 1.8 mg	-1.076
Placebo	0.801

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Change From Baseline in Body Weight

Change from baseline in body weight after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	kg (Mean)
Liraglutide 1.8 mg	-2.27
Placebo	1.02

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Change From Baseline in Body Weight

Change from baseline in body weight after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	kg (Mean)
Liraglutide 1.8 mg	-2.48
Placebo	-0.87

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Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)

Change in BMI SDS from baseline to week 26. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	SDS score (Least Squares Mean)
Liraglutide 1.8 mg	-0.254
Placebo	-0.208

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Change From Baseline in BMI Standard Deviation Score (SDS)

Change in BMI SDS from baseline to week 52. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	SDS score (Mean)
Liraglutide 1.8 mg	-0.361
Placebo	-0.166

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Change From Baseline in 7-point Self-measured Plasma Glucose

Change in mean 7-point self-measured plasma glucose after 52 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	mmol/L (Mean)
Liraglutide 1.8 mg	-2.309
Placebo	-0.748

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Number of Serious Adverse Events (Week 53-104)

This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during follow up 1 (week 53 to 104). (NCT01541215)
Timeframe: Weeks 53-104

Intervention	events (Number)
Liraglutide 1.8 mg: Follow-up 1	7

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Pubertal Assessment/Progression (Tanner Staging)

Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52. (NCT01541215)
Timeframe: Week 0, week 26, week 52

Intervention	Participants (Count of Participants)
	Female - Breast development - Week 072043035					Female - Breast development - Week 072043034	Female - Breast development - Week 2672043034	Female - Breast development - Week 2672043035	Female - Breast development - Week 5272043034	Female - Breast development - Week 5272043035	Male - Penis Development - Week 072043034	Male - Penis Development - Week 072043035	Male - Penis Development - Week 2672043034	Male - Penis Development - Week 2672043035	Male - Penis Development - Week 5272043034	Male - Penis Development - Week 5272043035	Pubic Hair Development - Week 072043035	Pubic Hair Development - Week 072043034	Pubic Hair Development - Week 2672043034	Pubic Hair Development - Week 2672043035	Pubic Hair Development - Week 5272043034	Pubic Hair Development - Week 5272043035
	Stage II	Stage I	Stage III	Stage IV	Stage V
Liraglutide 1.8 mg	1
Liraglutide 1.8 mg	2
Placebo	0
Liraglutide 1.8 mg	4
Placebo	10
Placebo	9
Liraglutide 1.8 mg	26
Placebo	23
Liraglutide 1.8 mg	0
Liraglutide 1.8 mg	5
Liraglutide 1.8 mg	29
Placebo	22
Liraglutide 1.8 mg	27
Placebo	3
Placebo	6
Liraglutide 1.8 mg	9
Placebo	11
Liraglutide 1.8 mg	11
Placebo	1
Placebo	4
Liraglutide 1.8 mg	7
Placebo	8
Liraglutide 1.8 mg	13
Liraglutide 1.8 mg	15
Placebo	13
Liraglutide 1.8 mg	3
Liraglutide 1.8 mg	8
Liraglutide 1.8 mg	14
Placebo	25
Liraglutide 1.8 mg	38
Placebo	29
Placebo	18
Liraglutide 1.8 mg	43
Placebo	2
Placebo	17
Placebo	34

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Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156

"Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents pre-adoloscent development and stage V represents pubertal development equivalent to that of an adult. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm." (NCT01541215)
Timeframe: Week 52, week 156

Intervention	Participants (Count of Participants)
	Female- Breast development- Week 5272043037					Female- Breast development- Week 15672043037	Male- Penis development- Week 5272043037	Male- Penis development- Week 15672043037	Female- Pubic hair development- Week 5272043037	Female- Pubic hair development- Week 15672043037	Male- Pubic hair development- Week 5272043037	Male- Pubic hair development- Week 15672043037
	Stage I	Stage II	Stage III	Stage V	Stage IV
Liraglutide 1.8 mg: Follow-up 1 and 2	1
Liraglutide 1.8 mg: Follow-up 1 and 2	5
Liraglutide 1.8 mg: Follow-up 1 and 2	21
Liraglutide 1.8 mg: Follow-up 1 and 2	0
Liraglutide 1.8 mg: Follow-up 1 and 2	11
Liraglutide 1.8 mg: Follow-up 1 and 2	7
Liraglutide 1.8 mg: Follow-up 1 and 2	3
Liraglutide 1.8 mg: Follow-up 1 and 2	9
Liraglutide 1.8 mg: Follow-up 1 and 2	22
Liraglutide 1.8 mg: Follow-up 1 and 2	2
Liraglutide 1.8 mg: Follow-up 1 and 2	6
Liraglutide 1.8 mg: Follow-up 1 and 2	14
Liraglutide 1.8 mg: Follow-up 1 and 2	10

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Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104

"Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents pre-adoloscent development and stage V represents pubertal development equivalent to that of an adult. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm." (NCT01541215)
Timeframe: Week 52, week 104

Intervention	Participants (Count of Participants)
	Female- Breast development- Week 5272043036					Female- Breast development- Week 10472043036	Male- Penis development- Week 5272043036	Male- Penis development- Week 10472043036	Female- Pubic hair development- Week 5272043036	Female- Pubic hair development- Week 10472043036	Male- Pubic hair development- Week 5272043036	Male- Pubic hair development- Week 10472043036
	Stage III	Stage IV	Stage II	Stage I	Stage V
Liraglutide 1.8 mg: Follow-up 1	21
Liraglutide 1.8 mg: Follow-up 1	0
Liraglutide 1.8 mg: Follow-up 1	5
Liraglutide 1.8 mg: Follow-up 1	11
Liraglutide 1.8 mg: Follow-up 1	7
Liraglutide 1.8 mg: Follow-up 1	1
Liraglutide 1.8 mg: Follow-up 1	8
Liraglutide 1.8 mg: Follow-up 1	22
Liraglutide 1.8 mg: Follow-up 1	2
Liraglutide 1.8 mg: Follow-up 1	13
Liraglutide 1.8 mg: Follow-up 1	6
Liraglutide 1.8 mg: Follow-up 1	14
Liraglutide 1.8 mg: Follow-up 1	4
Liraglutide 1.8 mg: Follow-up 1	9

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Number of Subjects Having HbA1c Maximum 6.5%

Number of subjects achieving HbA1c <=6.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 52

Intervention	Participants (Count of Participants)
	Yes	No
Liraglutide 1.8 mg	25	31
Placebo	13	39

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Number of Subjects Having HbA1c Maximum 6.5%

Number of subjects achieving HbA1c <=6.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 26

Intervention	Participants (Count of Participants)
	Yes	No
Liraglutide 1.8 mg	28	31
Placebo	19	39

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Number of Subjects Having HbA1c Below 7.5%

Number of subjects achieving HbA1c <7.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 52

Intervention	Participants (Count of Participants)
	Yes	No
Liraglutide 1.8 mg	36	20
Placebo	23	29

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Number of Subjects Having HbA1c Below 7.5%

Number of subjects achieving HbA1c <7.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 26

Intervention	Participants (Count of Participants)
	Yes	No
Liraglutide 1.8 mg	43	16
Placebo	29	29

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Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes

"Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 52 weeks.~Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.~Minor hypoglycaemia was defined as meeting either of the below criteria:~an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself~any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication." (NCT01541215)
Timeframe: Week 52

Intervention	Participants (Count of Participants)
	Yes	No
Liraglutide 1.8 mg	22	34
Placebo	16	36

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Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes

"Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 26 weeks.~Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.~Minor hypoglycaemia was defined as meeting either of the below criteria:~an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself~any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication." (NCT01541215)
Timeframe: Week 26

Intervention	Participants (Count of Participants)
	Yes	No
Liraglutide 1.8 mg	31	28
Placebo	21	37

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Number of Subjects Having HbA1c Below 7.0%

Number of subjects achieving HbA1c <7.0% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 52

Intervention	Participants (Count of Participants)
	Yes	No
Liraglutide 1.8 mg	27	29
Placebo	16	36

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Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)

Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	mmol/L (Mean)
	Breakfast	Lunch	Dinner
Liraglutide 1.8 mg	-1.802	-0.735	-0.028
Placebo	0.053	-1.219	-0.195

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Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)

Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
	Breakfast	Lunch	Dinner
Liraglutide 1.8 mg	-1.528	-0.358	0.397
Placebo	-0.319	-0.658	-0.226

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Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Change in blood pressure (systolic and diastolic blood pressure) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	mmHg (Mean)
	Systolic Blood Pressure	Diastolic Blood Pressure
Liraglutide 1.8 mg	-0.77	0.46
Placebo	2.81	1.83

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Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	mmHg (Mean)
	Systolic Blood Pressure	Diastolic Blood Pressure
Liraglutide 1.8 mg	-1.65	-1.27
Placebo	0.03	0.97

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Ratio to Baseline: VLDL Cholesterol

Ratio to baseline (VLDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.983
Placebo	1.003

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Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol

Ratio to baseline (VLDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.890
Placebo	1.035

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Ratio to Baseline: Triglycerides

Ratio to baseline (triglycerides) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.964
Placebo	1.036

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Ratio to Baseline: Triglycerides

Ratio to baseline (triglycerides) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.894
Placebo	1.038

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Ratio to Baseline: Total Cholesterol

Ratio to baseline (total cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	1.013
Placebo	1.026

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Ratio to Baseline: Total Cholesterol

Ratio to baseline (total cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.975
Placebo	1.008

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Ratio to Baseline: Pro-insulin/Insulin Ratio

Ratio to baseline (Pro-insulin/insulin ratio) after week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.689
Placebo	0.770

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Ratio to Baseline: Pro-insulin/Insulin Ratio

Ratio to baseline (Pro-insulin/insulin ratio) after week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.690
Placebo	0.923

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Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol

Ratio to baseline (LDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.998
Placebo	0.993

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Ratio to Baseline: LDL Cholesterol

Ratio to baseline (LDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	1.042
Placebo	1.035

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Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)

Ratio to baseline (HOMA-B) after 26 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	1.24
Placebo	1.01

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Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)

Ratio to baseline (HOMA-IR) after 26 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.73
Placebo	0.98

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Ratio to Baseline: HOMA-IR

Ratio to baseline (HOMA-IR) after 52 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.82
Placebo	1.08

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Ratio to Baseline: HOMA-B

Ratio to baseline (HOMA-B) after 52 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	1.48
Placebo	0.93

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Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol

Ratio to baseline (HDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.997
Placebo	0.981

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Ratio to Baseline: HDL Cholesterol

Ratio to baseline (HDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	1.028
Placebo	1.000

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Ratio to Baseline: Free Fatty Acids

Ratio to baseline (free fatty acids) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.928
Placebo	0.868

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Ratio to Baseline: Free Fatty Acids

Ratio to baseline (free fatty acids) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	1.023
Placebo	0.985

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Ratio to Baseline: Fasting Pro-insulin

Ratio to baseline (fasting pro-insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.62
Placebo	0.79

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Ratio to Baseline: Fasting Pro-insulin

Ratio to baseline (fasting pro-insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.62
Placebo	0.88

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Ratio to Baseline: Fasting Insulin

Ratio to baseline (fasting insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	1.0
Placebo	1.1

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Ratio to Baseline: Fasting Insulin

Ratio to baseline (fasting insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.9
Placebo	1.0

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Ratio to Baseline: Fasting Glucagon

Ratio to baseline (fasting glucagon) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	1.01
Placebo	1.05

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Ratio to Baseline: Fasting Glucagon

Ratio to baseline (fasting glucagon) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.98
Placebo	1.03

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Ratio to Baseline: Fasting C-peptide

Ratio to baseline (fasting C-peptide) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.94
Placebo	0.83

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Ratio to Baseline: Fasting C-peptide

Ratio to baseline (fasting C-peptide) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 0, week 26

Intervention	ratio (Geometric Mean)
Liraglutide 1.8 mg	0.93
Placebo	0.84

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Number of Subjects Having HbA1c Below 7.0%

Percentage of subjects having HbA1c <7.0%. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. (NCT01541215)
Timeframe: Week 26

Intervention	Percentage of subjects (Number)
Liraglutide 1.8 mg	63.7
Placebo	36.5

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Number of Serious Adverse Events (Week 53-156)

This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during the follow up period (week 53 to 156). (NCT01541215)
Timeframe: Weeks 53-156

Intervention	events (Number)
Liraglutide 1.8 mg: Follow-up 1 and 2	9

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Number of Serious Adverse Events (Week 0-52)

Total number of serious adverse events during entire treatment period. (NCT01541215)
Timeframe: 0-52 weeks

Intervention	events (Number)
Liraglutide 1.8 mg	10
Placebo	5

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Number of Serious Adverse Events (Week 0-26)

Total number of serious adverse events during 26 weeks. (NCT01541215)
Timeframe: 0-26 weeks

Intervention	events (Number)
Liraglutide 1.8 mg	7
Placebo	4

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Number of Hypoglycaemic Episodes

Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 52. (NCT01541215)
Timeframe: 0-52 weeks

Intervention	hypoglycaemic episodes (Number)
Liraglutide 1.8 mg	160
Placebo	63

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Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)

Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment. (NCT01557166)
Timeframe: Week 0, week 32

Intervention	percentage of glycosylated haemoglobin (Mean)
Liraglutide 3.0 mg	-0.36
Placebo	-0.17

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Change From Baseline in Fasting Plasma Glucose

Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment. (NCT01557166)
Timeframe: Week 0, week 32

Intervention	mmol/L (Mean)
Liraglutide 3.0 mg	-0.15
Placebo	0.17

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Change From Baseline in Body Weight (kg)

Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment. (NCT01557166)
Timeframe: Week 0, week 32

Intervention	kg (Mean)
Liraglutide 3.0 mg	-6.73
Placebo	-1.87

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Change From Baseline in Apnoea-hypopnoea Index (AHI)

Observed mean change from baseline in AHI (events/hour) after 32 weeks of treatment. AHI (apnoea and hypopnoea events per hour of sleep) is a measure used for the diagnosis and severity classification of obstructive sleep apnoea. AHI severity category: none ≤4.9; mild 5.0-14.9; moderate 15.0-29.9; severe ≥30.0 events/hour. (NCT01557166)
Timeframe: Week 0, Week 32

Intervention	events/hour (Mean)
Liraglutide 3.0 mg	-12.22
Placebo	-6.08

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Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks

LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline FBG as a covariate, and participant as a random effect. (NCT01558271)
Timeframe: Baseline, 26 weeks, 52 weeks

Intervention	milligrams per deciliter (mg/dL) (Least Squares Mean)
	26 weeks	52 weeks
Liraglutide	-39.75	-37.15
LY2189265	-39.18	-38.93
Placebo/LY2189265	1.03	-40.93

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Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks

Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline blood pressure as a covariate. (NCT01558271)
Timeframe: Baseline, 26 weeks, 52 weeks

Intervention	milliliters of mercury (mmHG) (Least Squares Mean)
	SBP, 26 weeks	DBP, 26 weeks	SBP, 52 weeks	DBP, 52 weeks
Liraglutide	-2.10	0.43	-1.86	1.17
LY2189265	0.62	1.09	1.32	1.41
Placebo/LY2189265	0.53	0.29	0.37	1.16

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Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks

Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, prestudy therapy (oral antihyperglycemic medication [OAM] yes/no), baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect. (NCT01558271)
Timeframe: Baseline, 26 weeks

Intervention	percentage of HbA1c (Least Squares Mean)
LY2189265	-1.43
Placebo	0.14
Liraglutide	-1.33

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Percentage of Participants Who Achieved HbA1c <=6.5% or <7%

The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% at Week 26 and Week 52 was analyzed with a Cochran-Mantel-Haenszel test stratified by prestudy therapy (OAM yes/no) and baseline BMI group (<25 or >=25 kg/m^2). (NCT01558271)
Timeframe: Up to 26 and 52 weeks

Intervention	percentage of participants (Number)
	HbA1c <7%, 26 weeks	HbA1c <=6.5%, 26 weeks	HbA1c <7%, 52 weeks	HbA1c <=6.5%, 52 weeks
Liraglutide	69.1	49.3	60.3	41.2
LY2189265	71.4	50.0	67.9	49.3
Placebo/LY2189265	5.9	1.5	70.6	52.9

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Percentage of Participants With Hypoglycemic Episodes

The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least one hypoglycemic episode over the 26-week or 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01558271)
Timeframe: Baseline through 26 weeks and Baseline through 52 weeks

Intervention	percentage of participants (Number)
	26 weeks	52 weeks
Liraglutide	1.5	2.9
LY2189265	2.1	2.9
Placebo/LY2189265	1.4	2.9

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Change From Baseline in Body Weight at 26 Weeks and 52 Weeks

LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline body weight as a covariate, and participant as a random effect. (NCT01558271)
Timeframe: Baseline, 26 weeks, 52 weeks

Intervention	kilograms (kg) (Least Squares Mean)
	26 weeks	52 weeks
Liraglutide	-0.36	-0.13
LY2189265	-0.02	-0.17
Placebo/LY2189265	-0.63	-1.03

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Number of Participants With Treatment-Emergent LY2189265 Anti-Drug Antibodies (ADAs) at 26 Weeks and 52 Weeks

A participant was considered to have treatment-emergent LY2189265 ADAs if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from the baseline measurement. (NCT01558271)
Timeframe: Baseline through 26 weeks and Baseline through 52 weeks

Intervention	participants (Number)
	26 weeks (n=279, 68, 133)	52 weeks (n=279, 68, 134)
Liraglutide	0	0
LY2189265	3	3
Placebo/LY2189265	0	0

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Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks

HOMA 2 quantifies insulin resistance and beta-cell function. HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Change in insulin sensitivity was assessed based on change from baseline of HOMA2-%S using fasting insulin (FI) and fasting C-peptide (FCP). LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline HOMA2-%S as a covariate. (NCT01558271)
Timeframe: Baseline, 26 weeks, 52 weeks

Intervention	percentage of HOMA2 (Least Squares Mean)
	HOMA2-%S based on FI, 26 weeks (n=254, 57, 115)	HOMA2-%S based on FCP, 26 weeks (n=275, 62, 131)	HOMA2-%S based on FI, 52 weeks (n=260, 60, 120)	HOMA2-%S based on FCP, 52 weeks (n=275, 62, 131)
Liraglutide	-4.82	-2.46	-5.26	-10.68
LY2189265	-4.83	-5.48	-7.75	-11.72
Placebo/LY2189265	-2.97	-6.32	NA	NA

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Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks

Pancreatic enzyme (lipase and total amylase) concentrations were measured. (NCT01558271)
Timeframe: Baseline, 26 weeks, 52 weeks

Intervention	units/liter (Median)
	Lipase, 26 weeks	Total Amylase, 26 weeks	Lipase, 52 weeks	Total Amylase, 52 weeks
Liraglutide	11.0	7.0	9.0	6.0
LY2189265	7.0	7.0	6.0	7.0
Placebo/LY2189265	1.0	0.0	6.0	9.0

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Change From Baseline in Pulse Rate at 26 Weeks and 52 Weeks

Sitting pulse rate was measured. LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline pulse rate as a covariate. (NCT01558271)
Timeframe: Baseline, 26 weeks, 52 weeks

Intervention	beats per minute (bpm) (Least Squares Mean)
	26 weeks	52 weeks
Liraglutide	4.77	5.13
LY2189265	3.35	3.11
Placebo/LY2189265	1.49	4.42

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Change From Baseline in Serum Calcitonin at 26 Weeks and 52 Weeks

(NCT01558271)
Timeframe: Baseline, 26 weeks, 52 weeks

Intervention	picograms/milliliter (Median)
	26 weeks	52 weeks
Liraglutide	0.0	0.0
LY2189265	0.0	0.0
Placebo/LY2189265	0.0	0.0

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Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26 Weeks and 52 Weeks

Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26 and 52 weeks. (NCT01558271)
Timeframe: Baseline through 26 weeks and Baseline through 52 weeks

Intervention	participants (Number)
	26 weeks	52 weeks
Liraglutide	0	0
LY2189265	0	0
Placebo/LY2189265	0	0

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Number of Participants With Adjudicated Cardiovascular Events at 26 Weeks and 52 Weeks

Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01558271)
Timeframe: Baseline through 26 weeks and Baseline through 52 weeks

Intervention	participants (Number)
	26 weeks	52 weeks
Liraglutide	0	0
LY2189265	0	0
Placebo/LY2189265	0	0

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Number of Participants With Adjudicated Pancreatitis at 26 Weeks and 52 Weeks

Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01558271)
Timeframe: Baseline through 26 weeks and Baseline through 52 weeks

Intervention	participants (Number)
	26 weeks	52 weeks
Liraglutide	0	0
LY2189265	0	0
Placebo/LY2189265	0	0

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Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks

Fridericia Corrected QT (QTcF) Interval and PR Interval are summarized. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. LS means were calculated using ANCOVA model with treatment as a fixed effect and the baseline ECG parameter as the covariate. (NCT01558271)
Timeframe: Baseline, 26 weeks, 52 weeks

Intervention	milliseconds (msec) (Least Squares Mean)
	QTcF, 26 weeks (n=273, 64, 128)	QTcF, 52 weeks (n=274, 64, 128)	PR, 26 weeks (n=269, 65, 126)	PR, 52 weeks (n=270, 65, 126)
Liraglutide	-1.89	-4.35	2.07	3.71
LY2189265	-2.02	-2.76	2.20	2.81
Placebo/LY2189265	-0.96	-0.80	-0.45	2.60

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Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks

HOMA 2 quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta-cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Change in beta-cell function was assessed based on change from baseline of HOMA2-%B using fasting insulin (FI) and fasting C-peptide (FCP). LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline HOMA2-%B as a covariate. (NCT01558271)
Timeframe: Baseline, 26 weeks, 52 weeks

Intervention	percentage of HOMA2 (Least Squares Mean)
	HHOMA2-%B based on FI, 26 weeks (n=254, 57, 115)	HOMA2-%B based on FCP, 26 weeks (n=275, 62, 131)	HOMA2-%B based on FI, 52 weeks (n=260, 60, 120)	HOMA2-%B based on FCP, 52 weeks (n=275, 62, 131)
Liraglutide	25.35	25.86	25.89	28.85
LY2189265	28.42	27.77	27.81	29.59
Placebo/LY2189265	0.08	2.94	NA	NA

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Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks

Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, and at bedtime. LS means were calculated using analysis of covariance (ANCOVA) model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline SMBG as a covariate. (NCT01558271)
Timeframe: Baseline, 26 weeks, 52 weeks

Intervention	milligrams per deciliter (mg/dL) (Least Squares Mean)
	Pre-morning meal, 26 weeks	2 hours post-morning meal, 26 weeks	Pre-midday meal, 26 weeks	2 hours post-midday meal, 26 weeks	Pre-evening meal, 26 weeks	2 hours post-evening meal	Bedtime, 26 weeks	Pre-morning meal, 52 weeks	2 hours post-morning meal, 52 weeks	Pre-midday meal, 52 weeks	2 hours post-midday meal, 52 weeks	Pre-evening meal, 52 weeks	2 hours post-evening meal, 52 weeks	Bedtime, 52 weeks
Liraglutide	-34.93	-61.67	-45.08	-66.71	-36.62	-53.14	-51.07	-33.41	-60.69	-46.25	-62.57	-32.86	-42.30	-49.10
LY2189265	-39.65	-69.64	-48.47	-67.57	-39.64	-56.70	-53.39	-37.46	-66.96	-47.03	-68.21	-41.04	-55.01	-55.76
Placebo/LY2189265	-0.15	-9.29	3.91	-1.50	9.25	0.93	4.26	-30.12	-65.91	-45.15	-58.52	-36.13	-55.26	-51.19

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30-Day Rate of Hypoglycemic Episodes

The 30-day total hypoglycemia rate over 26 weeks and 52 weeks of treatment is summarized. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01558271)
Timeframe: Baseline through 26 weeks and Baseline through 52 weeks

Intervention	events per participant per 30 days (Mean)
	26 weeks	52 weeks
Liraglutide	0.00	0.01
LY2189265	0.01	0.00
Placebo/LY2189265	0.00	0.01

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Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks

LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect. (NCT01558271)
Timeframe: Baseline, 52 weeks

Intervention	percentage of HbA1c (Least Squares Mean)
LY2189265	-1.39
Placebo/LY2189265	-1.55
Liraglutide	-1.19

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Change Between Highly Desirable vs. Less Desirable Food Cues in the Effect Size of Cortical Activation During Food Visualization

Effect size (region of interest z-scores, derived from z-maps of the brain) shown below is the difference in parietal cortex activation to highly desirable (high fat or high calorie, e.g. cakes, pies, fries) versus less desirable (low fat or low calorie, e.g. vegetables, fruits) food cues for each treatment condition (liraglutide or placebo) at the end of the treatment period. (NCT01562678)
Timeframe: 18 days of Liraglutide or placebo treatment

Intervention	z-scores of activation in cortex (Mean)
Liraglutide	-0.42
Placebo	0.53

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Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36

Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment. (NCT01572740)
Timeframe: Week 0, Week 36

Intervention	mmol/L (Mean)
Lira + Insulin	-2.65
Placebo + Insulin	-1.37

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Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16

Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment. (NCT01572740)
Timeframe: Week 0, Week 16

Intervention	mmol/L (Mean)
Lira + Insulin	-2.41
Placebo + Insulin	-0.53

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Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36

Estimated mean change from baseline in HbA1c after 36 Weeks of treatment (NCT01572740)
Timeframe: Week 0, Week 36

Intervention	percentage of glycosylated haemoglobin (Mean)
Lira + Insulin	-1.68
Placebo + Insulin	-0.88

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Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16

Estimated mean change from baseline in HbA1c after 16 Weeks of treatment. (NCT01572740)
Timeframe: Week 0, Week 16

Intervention	percentage of glycosylated haemoglobin (Mean)
Lira + Insulin	-1.73
Placebo + Insulin	-0.43

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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16

Estimated mean change from baseline in FPG after 16 Weeks of treatment. (NCT01572740)
Timeframe: Week 0, Week 16

Intervention	mmol/L (Mean)
Lira + Insulin	-1.31
Placebo + Insulin	-0.48

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Change in Body Weight From Baseline to Week 36

Estimated mean change in body weight after 36 Weeks of treatment (NCT01572740)
Timeframe: Week 0, Week 36

Intervention	kg (Mean)
Lira + Insulin	0.17
Placebo + Insulin	0.52

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Change in Body Weight From Baseline to Week 16

Estimated mean change in body weight after 16 Weeks of treatment (NCT01572740)
Timeframe: Week 0, Week 16

Intervention	kg (Mean)
Lira + Insulin	-0.42
Placebo + Insulin	-0.28

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Number of Adverse Events (AEs)

An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. (NCT01572740)
Timeframe: Week 0 to Week 36 (inclusive)

Intervention	Events/100 years of patient exposure (Number)
	Adverse Events	Serious Adverse Events	Severe Adverse Events	Moderate Adverse Events	Mild Adverse Events
Lira + Insulin	449	8	5	8	436
Placebo + Insulin	350	5	1	14	335

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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36

Estimated mean change from baseline in FPG after 36 Weeks of treatment. (NCT01572740)
Timeframe: Week 0, Week 36

Intervention	mmol/L (Mean)
Lira + Insulin	-1.55
Placebo + Insulin	-1.29

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Number of Confirmed Hypoglycaemic Episodes

"A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episode was defined as hypoglycaemic episodes categorised to severe and/or minor hypoglycaemic episodes.~Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded PG < 3.1 mmol/L (56 mg/dL). Minor: PG < 3.1 mmol/L (56 mg/dL)." (NCT01572740)
Timeframe: Week 0 to week 36 (inclusive)

Intervention	Episodes/100 years of patient exposure (Number)
Lira + Insulin	146
Placebo + Insulin	187

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Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36

Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment. (NCT01572740)
Timeframe: Week 0, Week 36

Intervention	mmol/L (Mean)
Lira + Insulin	-1.34
Placebo + Insulin	-0.94

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Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16

Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment. (NCT01572740)
Timeframe: Week 0, Week 16

Intervention	mmol/L (Mean)
Lira + Insulin	-1.34
Placebo + Insulin	-0.61

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Change From Baseline to Day 56 in Corrected C-Peptide AUC From Time 0.5 Hours to 5.5 Hours

C-peptide was assessed using the Electro Chemiluminescence Immuno Assay.The range of the method was 0.2 to 25 nanogram per millilitre (ng/mL) and the LOD was 0.07 ng/mL. Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in C-peptide from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration. (NCT01596504)
Timeframe: 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day-3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56

Intervention	h*nmol/L (Least Squares Mean)
Lixisenatide 20 µg	-1.16
Liraglutide 1.2 mg	1.23
Liraglutide 1.8 mg	0.88

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Change From Baseline to Day 55 in Gastric Emptying Coefficient

Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry. Gastric emptying coefficient was derived from a mathematical formula that describes the gastric emptying rate and gives an overall index of gastric emptying. (NCT01596504)
Timeframe: 0 (7:30 clock time, prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55

Intervention	coefficient (unit-less) (Mean)
Lixisenatide 20 µg	-0.33
Liraglutide 1.2 mg	-0.34
Liraglutide 1.8 mg	-0.28

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Change From Baseline to Day 55 in Gastric Emptying Half Life (t1/2)

Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry. (NCT01596504)
Timeframe: 0 (prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55

Intervention	minutes (min) (Least Squares Mean)
Lixisenatide 20 µg	453.56
Liraglutide 1.2 mg	175.31
Liraglutide 1.8 mg	130.49

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Change From Baseline to Day 56 in Average 7-Point Self-Monitored Plasma Glucose (SMPG)

Seven-point SMPG (before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime) was measured using Freestyle Precision glucometer and average of the 7 measurements was calculated. (NCT01596504)
Timeframe: Before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime on Day -3 (Baseline) and on Day 56

Intervention	mmol/L (Mean)
Lixisenatide 20 µg	-0.69
Liraglutide 1.2 mg	-0.76
Liraglutide 1.8 mg	-1.2

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Change From Baseline to Day 57/58 in 24-Hour Mean Systolic Blood Pressure and Diastolic Blood Pressure

The baseline value was the 24-hour means on Day -2/-1 determined as overall, night and day-time mean. Measurements were made every 15 minutes from 07:00 to 23:00 (day-time) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and at Day 57/58. Measurements were obtained after 10 minutes in the supine resting position. (NCT01596504)
Timeframe: Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/ -1 (Baseline) and Day 57/58

Intervention	mmHg (Mean)
	24-Hour Mean Systolic Blood Pressure	24-Hour Mean Diastolic Blood Pressure
Liraglutide 1.2 mg	-0.5	2.4
Liraglutide 1.8 mg	-2.5	1.6
Lixisenatide 20 µg	0.4	0.8

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Change From Baseline to Day 56 in Corrected Glucagon AUC From Time 0.5 Hours to 5.5 Hours

Glucagon was assessed using the radioimmunoassay. The range of the method was 4.7 to 150 picomole per litre (pmol/L). Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in glucagon from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration. (NCT01596504)
Timeframe: 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56

Intervention	h*ng/L (Least Squares Mean)
Lixisenatide 20 µg	-16.56
Liraglutide 1.2 mg	11.58
Liraglutide 1.8 mg	5.6

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Number of Participants With 2-Hour Post-prandial Plasma Glucose (PPG) <7.77 (mmol/L) at Day 56

Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The 2-hour PPG test measured blood glucose 2 hours after start of a standardised breakfast. (NCT01596504)
Timeframe: Day 56

Intervention	participants (Number)
Lixisenatide 20 µg	35
Liraglutide 1.2 mg	13
Liraglutide 1.8 mg	11

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Change From Baseline to Day 57/58 in 24-Hour Mean Heart Rate

The baseline value was the 24-hour mean on Day -2/-1 determined as overall, night and daytime mean. Measurements were made every 15 minutes from 07:00 to 23:00 (daytime) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and Day 57/58. Measurements were obtained after 10 minutes in the supine resting position. (NCT01596504)
Timeframe: Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/-1 (Baseline) and Day 57/58

Intervention	beats per minute (Least Squares Mean)
Lixisenatide 20 µg	3.34
Liraglutide 1.2 mg	9.33
Liraglutide 1.8 mg	9.17

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Change From Baseline to Day 57 in Waist Circumference

(NCT01596504)
Timeframe: 0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to IMP administration on Day 57

Intervention	cm (Mean)
Lixisenatide 20 µg	-1.40
Liraglutide 1.2 mg	-1.93
Liraglutide 1.8 mg	-2.12

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Change From Baseline to Day 57 in Body Weight

(NCT01596504)
Timeframe: 0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to study drug administration on Day 57

Intervention	kg (Least Squares Mean)
Lixisenatide 20 µg	-1.61
Liraglutide 1.2 mg	-1.78
Liraglutide 1.8 mg	-2.42

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Change From Baseline to Day 56 in PPG Excursion

Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. PPG excursion was determined on Day -3 (Baseline) and Day 56 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration. (NCT01596504)
Timeframe: 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56

Intervention	mmol/L (Least Squares Mean)
Lixisenatide 20 µg	-3.26
Liraglutide 1.2 mg	-1.79
Liraglutide 1.8 mg	-2.5

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Change From Baseline to Day 56 in Plasma Glucose Corrected AUC From Time 0.5 Hours to 5.5 Hours

Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 5 hours after breakfast start (time: 5.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). (NCT01596504)
Timeframe: 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56

Intervention	h*mmol/L (Least Squares Mean)
Lixisenatide 20 µg	-13.82
Liraglutide 1.2 mg	-9.09
Liraglutide 1.8 mg	-10.33

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Change From Baseline to Day 56 in the Cumulative Score Mean on the Appetite Perception Using a Visual Analogue Scale After Standardized Solid Breakfast

Visual Analogue Scale, 100 mm in length with words anchored at each end, expressing the most positive (100 mm) and the most negative rating (0 mm), was used to assess hunger, satiety, fullness and prospective food consumption. Responses were measured as distance from the left end of the line to the mark. Mean change from baseline was calculated for each parameter separately. (NCT01596504)
Timeframe: 0.5 (8:00 clock time, prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours on Day -3; 0 (prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56

Intervention	mm (Mean)
	How hungry do you feel?	How satisfied do you feel?	How full do you feel?	How much do you think you can eat?
Liraglutide 1.2 mg	-3.1	8.9	9.3	-4.5
Liraglutide 1.8 mg	-1.0	3.6	6.4	-7.2
Lixisenatide 20 µg	-3.7	4.5	4.9	-6.4

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Change From Baseline to Day 56 in HbA1c

HbA1C was assessed using the high performance liquid chromatography method. (NCT01596504)
Timeframe: Pre-dose (Hour 0) on Day 1 (Baseline) and Day 56

Intervention	percentage of HbA1c (Least Squares Mean)
Lixisenatide 20 µg	-0.58
Liraglutide 1.2 mg	-0.66
Liraglutide 1.8 mg	-0.74

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Change From Baseline to Day 56 in Fasting Plasma Glucose (FPG)

Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The value of FPG on Day -3 was the baseline. (NCT01596504)
Timeframe: 0.5 hour (prior to standardized breakfast) on Day -3; 0.5 hour (prior to standardized breakfast) on Day 56

Intervention	mmol/L (Least Squares Mean)
Lixisenatide 20 µg	0.1
Liraglutide 1.2 mg	0.12
Liraglutide 1.8 mg	0.13

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Change From Baseline to Day 56 in Average Daily Insulin Glargine Dose

(NCT01596504)
Timeframe: Day -7 (Baseline), Day 56

Intervention	units (Mean)
Lixisenatide 20 µg	-4.7
Liraglutide 1.2 mg	-4.6
Liraglutide 1.8 mg	-4.0

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Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours

Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 milligram per decilitre (mg/dL) with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). (NCT01596504)
Timeframe: 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 56

Intervention	h*mmol/L (Least Squares Mean)
Lixisenatide 20 μg	-13.33
Liraglutide 1.2 mg	-7.32
Liraglutide 1.8 mg	-8.72

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Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26

The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment. (NCT01617434)
Timeframe: Week 0 to Week 26

Intervention	mmol/L (Mean)
Liraglutide	-2.61
Placebo	-1.02

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Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period

A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL). (NCT01617434)
Timeframe: Week 0 to Week 26 + 7 days follow up

Intervention	Events/100 years of patient exposure (Number)
Liraglutide	126
Placebo	83

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Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period

Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions. (NCT01617434)
Timeframe: Week 0 to Week 26 + 7 days follow up

Intervention	Events/100 years of patient exposure (Number)
Liraglutide	0
Placebo	0

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Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)

Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment (NCT01617434)
Timeframe: At Week 26

Intervention	percentage of subjects (Number)
Liraglutide	59.24
Placebo	14.02

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Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)

Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment. (NCT01617434)
Timeframe: At Week 26

Intervention	percentage of subjects (Number)
Liraglutide	42.91
Placebo	3.60

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Number of Adverse Events (AEs) During The Randomised Treatment Period

An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events. (NCT01617434)
Timeframe: Week 0 to Week 26 + 7 days follow up

Intervention	Events/1000 years of patient exposure (Number)
	Adverse Events	Serious Adverse Events	Severe Adverse Events	Moderate Adverse Events	Mild Adverse Events
Liraglutide	4918	149	169	1274	3474
Placebo	3737	101	101	1060	2575

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Change in Body Weight From Baseline to Week 26

The estimated mean change in body weight after 26 weeks of treatment. (NCT01617434)
Timeframe: Week 0 to Week 26

Intervention	kg (Mean)
Liraglutide	-3.54
Placebo	-0.42

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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

The estimated mean change from baseline in FPG after 26 weeks of treatment. (NCT01617434)
Timeframe: Week 0 to Week 26

Intervention	mmol/L (Mean)
Liraglutide	-1.44
Placebo	-0.16

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Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26

The estimated mean change from baseline in HbA1c after 26 weeks of treatment. (NCT01617434)
Timeframe: Week 0 to Week 26

Intervention	percentage of glycosylated haemoglobin (Mean)
Liraglutide	-1.30
Placebo	-0.11

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Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline in FPG at week 26. (NCT01618162)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
IDegLira	-2.6
Placebo	-0.31

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Change From Baseline in Body Weight

Change from baseline in body weight at week 26. (NCT01618162)
Timeframe: Week 0, week 26

Intervention	kilogram (Mean)
IDegLira	0.5
Placebo	-1

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Number of Adverse Events (AEs)

An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE. (NCT01618162)
Timeframe: After 26 weeks of treatment

Intervention	event rate per 100 PYE (Number)
IDegLira	401.4
Placebo	367

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Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes

"An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration.~Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor.~Minor hypoglycaemic episodes were defined as:~An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself.~Any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or blood glucose value <2.8 mmol/L (50 mg/dL).~Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.~Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE)." (NCT01618162)
Timeframe: After 26 weeks of treatment

Intervention	event rate per 100 PYE (Number)
IDegLira	351.7
Placebo	135.2

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Change in Glycosylated Haemoglobin (HbA1c)

Change in HbA1c from baseline to 26 weeks. (NCT01618162)
Timeframe: Week 0, Week 26

Intervention	percentage of glycosylated haemoglobin (Mean)
IDegLira	-1.45
Placebo	-0.46

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Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)

Percentage of subjects having HbA1c below 6.5% at week 26 (NCT01618162)
Timeframe: Week 26

Intervention	percentage of subjects (Number)
IDegLira	64
Placebo	12.3

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Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)

Percentage of subjects having HbA1c below 7% at week 26. (NCT01618162)
Timeframe: Week 26

Intervention	percentage of subjects (Number)
IDegLira	79.2
Placebo	28.8

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Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment

Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no minor or severe hypoglycaemic episodes observed within 26 weeks of treatment based on the statistical model. (NCT01620489)
Timeframe: At week 26

Intervention	percentage of patients (Number)
Lira 1.8 mg	33.23
Placebo	11.23

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Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment

Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no weight gain after 26 weeks of treatment based on the statistical model. (NCT01620489)
Timeframe: At week 26

Intervention	percentage of patients (Number)
Lira 1.8 mg	46.03
Placebo	15.99

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Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)

Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model. (NCT01620489)
Timeframe: Week 0, week 26

Intervention	kg/m^2 (Mean)
Lira 1.8 mg	-0.88
Placebo	-0.38

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Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)

Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model. (NCT01620489)
Timeframe: Week 0, Week 26

Intervention	percentage (%) (Mean)
Lira 1.8 mg	-1.05
Placebo	-0.38

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Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles

SMPG was measured before and 90 minutes after breakfast, lunch and dinner and at bedtime at Week 0, 12 and 26. A summary measure of the 7 values was derived for each applicable visit as the area under the curve divided by the period of time elapsed between the first and last measurement. The change from baseline to week 26 was estimated using the statistical model. (NCT01620489)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Lira 1.8 mg	-1.59
Placebo	-0.51

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Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)

Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 Weeks of treatment based on the statistical model. (NCT01620489)
Timeframe: Week 0, week 26

Intervention	mL/min/1.73m˄2 (Geometric Mean)
Lira 1.8 mg	0.99
Placebo	1.01

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Change From Baseline in Blood Pressure (BP) at 26 Weeks

Descriptive statistics for the actual measurements and change from baseline for sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline BP as a covariate, and participant as a random effect. (NCT01624259)
Timeframe: Baseline, 26 Weeks

Intervention	milliliters of mercury (mmHg) (Least Squares Mean)
	Sitting DBP	Sitting SBP
1.5 mg LY2189265	-0.22	-3.36
1.8 mg Liraglutide	-0.31	-2.82

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Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia

An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. (NCT01624259)
Timeframe: Baseline through 26 Weeks

Intervention	weeks (Median)
1.5 mg LY2189265	NA
1.8 mg Liraglutide	NA

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Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia

Intervention	percentage of participants (Number)
1.5 mg LY2189265	0.3
1.8 mg Liraglutide	1.0

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Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose

LY2189265 (dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation in dulaglutide-treated participants. A participant was considered to have treatment emergent LY2189265 ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The number of participants with treatment-emergent LY2189265 ADA from postbaseline to follow up were summarized. (NCT01624259)
Timeframe: Baseline up to 4 Weeks Post Last Dose of Study Drug

Intervention	participants (Number)
1.5 mg LY2189265	3

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Number of Participants With Allergic or Hypersensitivity Reactions

Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module. (NCT01624259)
Timeframe: Baseline through 26 Weeks

Intervention	participants (Number)
1.5 mg LY2189265	1
1.8 mg Liraglutide	5

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Number of Participants With Adjudicated Acute Pancreatitis Events

"The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 26 weeks (including a 30-day follow up). Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor.~A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module." (NCT01624259)
Timeframe: Baseline up to 30 Weeks

Intervention	participants (Number)
1.5 mg LY2189265	0
1.8 mg Liraglutide	0

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Change From Baseline in Calcitonin at 26 Weeks

A summary of participants having changes in calcitonin values from baseline to primary endpoint of 26 weeks is presented. (NCT01624259)
Timeframe: Baseline, Up to 26 Weeks

Intervention	picograms/milliliter (pcg/mL) (Median)
1.5 mg LY2189265	0.00
1.8 mg Liraglutide	0.00

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Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks

The percentage of participants who achieved the target HbA1c values at the primary endpoint were analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes pooled country, treatment, visit, treatment-by-visit interaction, and baseline HbA1c as continuous covariates. (NCT01624259)
Timeframe: Up to 26 Weeks

Intervention	percentage of participants (Number)
	HbA1c levels ≤6.5%	HbA1c levels <7.0%
1.5 mg LY2189265	54.6	68.3
1.8 mg Liraglutide	50.9	67.9

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Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks

"The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%.~LS means of the HOMA2-%B change from baseline to primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline HOMA2-%B value as covariate, via an ANCOVA analysis using LOCF." (NCT01624259)
Timeframe: Baseline, Up to 26 Weeks

Intervention	percentage of HOMA2-%B (Least Squares Mean)
1.5 mg LY2189265	37.03
1.8 mg Liraglutide	35.59

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Change From Baseline in Heart Rate (HR) at 26 Weeks

Descriptive statistics for the actual measurements and LS means of change from baseline for HR (sitting) by treatment arm were analyzed using the MMRM model with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline rate as a covariate, and participant as a random effect. (NCT01624259)
Timeframe: Baseline, 26 Weeks

Intervention	bpm (Least Squares Mean)
1.5 mg LY2189265	2.37
1.8 mg Liraglutide	3.12

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Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks

LS means of the FPG from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FPG as covariates, via ANCOVA with LOCF. (NCT01624259)
Timeframe: Baseline, Up to 26 Weeks

Intervention	milligrams/deciliter (mg/dL) (Least Squares Mean)
1.5 mg LY2189265	-34.81
1.8 mg Liraglutide	-34.25

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Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks

ECG HR was measured. LS means of change from baseline were analyzed using ANCOVA with HbA1c strata, country, and treatment as fixed effects and baseline HR as a covariate. (NCT01624259)
Timeframe: Baseline, Up to 26 Weeks

Intervention	beats per minute (bpm) (Least Squares Mean)
1.5 mg LY2189265	1.9
1.8 mg Liraglutide	4.1

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Percent Change From Baseline in Lipid Parameters at 26 Weeks

A summary of percent change in lipid parameters (total cholesterol, high-density lipoprotein cholesterol [HDL-C], low density lipoprotein cholesterol [LDL-C], very low-density lipoprotein cholesterol [VLDL], and triglycerides) from baseline to primary endpoint of 26 weeks is presented. LS means of the lipid parameter from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and lipid parameter baseline as covariates, via ANCOVA with LOCF. (NCT01624259)
Timeframe: Baseline, Up to 26 Weeks

Intervention	percent (Least Squares Mean)
	Total cholesterol (n=286, 284)	HDL-C (n=286, 284)	LDL-C (n=276, 276)	VLDL (n=276, 276)	Triglycerides (n=286, 284)
Liraglutide	0.67	6.46	3.20	2.92	1.35
LY2189265	-1.64	6.21	-1.09	1.56	0.59

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Change From Baseline in Body Weight at 26 Weeks

LS means of the weight change from baseline to primary endpoint at Week 26 were calculated using analysis of covariance (ANCOVA) with HbA1c Strata, country, and treatment as fixed effects and baseline body weight as a covariate. (NCT01624259)
Timeframe: Baseline, Up to 26 Weeks

Intervention	kilograms (kg) (Least Squares Mean)
1.5 mg LY2189265	-2.90
1.8 mg Liraglutide	-3.61

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Change From Baseline in Body Mass Index (BMI) at 26 Weeks

BMI is an estimate of body fat based on body weight divided by height squared. LS means of the BMI change from baseline to primary endpoint at Week 26 were calculated using ANCOVA with HbA1c Strata, country, and treatment as fixed effects and baseline BMI as a covariate. (NCT01624259)
Timeframe: Baseline, Up to 26 Weeks

Intervention	kilograms/square meter (kg/m^2) (Least Squares Mean)
1.5 mg LY2189265	-1.05
1.8 mg Liraglutide	-1.30

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Change From Baseline in Amylase at 26 Weeks

A summary of participants having changes in amylase evaluation from baseline to primary endpoint of 26 weeks is presented. (NCT01624259)
Timeframe: Baseline, Up to 26 Weeks

Intervention	U/L (Median)
1.5 mg LY2189265	7.0
1.8 mg Liraglutide	6.0

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Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks

"The SMPG data were collected at the following 7 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; and bedtime. The mean of the 7 time points (Daily Mean) was also calculated.~LS means of the SMPG change from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, HbA1c strata, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG as a covariate, via a MMRM analysis using REML." (NCT01624259)
Timeframe: Baseline, 26 Weeks

Intervention	mg/dL (Least Squares Mean)
1.5 mg LY2189265	-40.76
1.8 mg Liraglutide	-38.51

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Change From Baseline in Lipase at 26 Weeks

A summary of participants having changes in lipase evaluation from baseline to primary endpoint of 26 weeks is presented. (NCT01624259)
Timeframe: Baseline, Up to 26 Weeks

Intervention	units/liter (U/L) (Median)
1.5 mg LY2189265	7.0
1.8 mg Liraglutide	11.0

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Number of Participants With Reported and Adjudicated Cardiovascular Events

Deaths and nonfatal cardiovascular (CV) adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal CV AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with reported CV events, number of participants with nonfatal CV events confirmed by adjudication, and number of deaths confirmed by adjudication are summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01624259)
Timeframe: Baseline up to 26 Weeks

Intervention	participants (Number)
	Any reported CV events	Any adjudicated nonfatal CV events	Any confirmed adjudicated deaths
1.5 mg LY2189265	0	0	0
1.8 mg Liraglutide	3	1	0

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Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals at 26 Weeks

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. QTcF is the measure of the time between the start of the Q wave and the end of the T wave adjusted using Fridericia's formula. PR is the interval between the P wave and the QRS complex. These parameters were calculated from electrocardiogram (ECG) data. LS means of change from baseline for the PR and QTcF intervals will be analyzed using the MMRM similar to MMRM model for primary outcome, using corresponding baseline and HbA1c strata. Only ECGs obtained at scheduled visits will be used in these summaries and analyses. (NCT01624259)
Timeframe: Baseline, 26 Weeks

Intervention	milliseconds (msec) (Least Squares Mean)
	PR interval (n=270, 278)	QTcF interval (n=273, 284)
1.5 mg LY2189265	3.8	0.39
1.8 mg Liraglutide	3.3	-0.72

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Rate of Hypoglycemic Events Adjusted Per 30 Days

HE were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL). The hypoglycemia rate per 30 days was calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01624259)
Timeframe: Baseline through 26 Weeks

Intervention	number of events/participant/30 days (Mean)
	Total HE	Documented symptomatic HE	Asymptomatic HE	Severe HE	Nocturnal HE	Probable symptomatic HE
1.5 mg LY2189265	0.03	0.01	0.02	0.00	0.01	0.00
1.8 mg Liraglutide	0.04	0.02	0.01	0.00	0.01	0.01

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Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Least Squares (LS) means of the glycosylated hemoglobin A1c (HbA1c) change from baseline to the primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect, and baseline HbA1c as covariates, via a mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML). (NCT01624259)
Timeframe: Baseline, 26 Weeks

Intervention	percentage of glycosylated hemoglobin (Least Squares Mean)
1.5 mg LY2189265	-1.42
1.8 mg Liraglutide	-1.36

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Percentage of Participants With Self-Reported Hypoglycemia Events

"Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a plasma glucose [PG] concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL).~A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module." (NCT01624259)
Timeframe: Baseline through 26 Weeks

Intervention	percentage of participants (Number)
	Documented symptomatic HE	Asymptomatic HE	Severe HE	Nocturnal HE	Probable symptomatic HE
1.5 mg LY2189265	2.7	6.7	0.0	1.3	1.0
1.8 mg Liraglutide	2.7	3.3	0.0	2.0	1.0

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Change From Baseline in Mean Pre-breakfast Measurements Used for Titration

Change from baseline after 26 weeks of treatment in the average of the pre-breakfast self measured plasma glucose (SMPG) measured on the day of the contact and the two days immediately prior to the contact. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline. (NCT01664247)
Timeframe: Week 0, week 26

Intervention	mmol/L (Least Squares Mean)
IDeg	5.88
Placebo	8.23

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Change From Baseline in Mean of the 8-point Profile

Change from baseline in mean of the 8-point profile after 26 weeks of randomised treatment. (NCT01664247)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
IDeg	-2.3
Placebo	-0.5

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Number of Hypoglycaemic Episodes

Number of confirmed hypoglycaemic episodes from week 0 to 26 weeks of randomised treatment. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes. (NCT01664247)
Timeframe: Weeks 0 - 26

Intervention	events (Number)
IDeg	47
Placebo	9

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Number of Responders for HbA1c (Below 7.0 %)

Number of responders for HbA1c below 7.0%, after 26 weeks of randomised treatment. (NCT01664247)
Timeframe: After 26 weeks of randomised treatment.

Intervention	percentage (%) of subjects (Number)
IDeg	77.6
Placebo	35.5

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Number of Adverse Events

Number of treatment emergent AEs (TEAEs) from week 0 to week 26 of the randomised treatment. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. (NCT01664247)
Timeframe: Weeks 0 - 26

Intervention	events (Number)
IDeg	285
Placebo	252

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Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)

Change from baseline in HbA1c after 26 weeks of treatment (NCT01664247)
Timeframe: Week 0, week 26

Intervention	percentage of glycosylated haemoglobin (Least Squares Mean)
IDeg	-0.99
Placebo	-0.07

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Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline in FPG after 26 weeks of treatment (NCT01664247)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
IDeg	-2.60
Placebo	-0.28

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Change From Baseline in 8-point Profile

The change from baseline in the 8-point SMPG profile after 26 weeks of randomised treatment. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline. (NCT01664247)
Timeframe: Week 0, week 26

Intervention	mmol/L (Least Squares Mean)
	Before breakfast, N=170, 164	90 min after breakfast, N=153, 148	Before lunch, N=151,149	90 min after lunch, N=152,150	Before evening meal, N=154,148	90 mins after evening meal, N=147,145	Before bedtime, N=148, 142	Before breakfast the next day, N=164,161
IDeg	5.85	7.65	6.33	7.73	6.77	7.93	7.21	6.05
Placebo	8.54	9.75	8.34	9.67	9.51	9.65	8.95	8.55

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Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)

Change in subject's quality of life was evaluated using the Short-Form 36 Health Survey version 2 (SF-36®v2). Evaluations were performed at baseline and at the last treatment visit (week 26). SF-36 was assessed on a scale range of 0.65 to 80.73 for physical health and -8.81 to 81.65 for mental health respectively, where higher scores indicated a better quality of life. 0-100 scores from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. (NCT01664247)
Timeframe: Week 0, week 26

Intervention	T-scores (Mean)
	Physical health	Mental health
IDeg	0.5	0.6
Placebo	0.0	-0.7

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Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)

Percentage of responders achieving pre-defined target for HbA1c - HbA1c ≤ 6.5% (48 mmol/mol). (NCT01676116)
Timeframe: Week 26

Intervention	Percentage (Number)
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	63
Liraglutide or Exenatide + OADs	22.6

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Number of Severe or Minor Hypoglycaemic Episodes

Rate (events per 100 patient years of exposure) of treatment-emergent confirmed hypoglycaemic episodes. The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes. Severe hypoglycaemia was categorised as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or PG <3.1 mmol/L (56 mg/dL), and which was handled by the subject himself/herself, or any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or PG value <3.1 mmol/L (56 mg/dL). (NCT01676116)
Timeframe: After 26 weeks of treatment

Intervention	events per 100 patient years of exposure (Number)
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	281.7
Liraglutide or Exenatide + OADs	12.1

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Number of Adverse Events (AEs)

Rate (events per 100 exposure years) of treatment-emergent adverse events (an event that had onset date (or an increase in severity) on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment) which occurred during the 26 weeks of treatment. (NCT01676116)
Timeframe: After 26 weeks of treatment

Intervention	events per 100 exposure years (Number)
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	410.1
Liraglutide or Exenatide + OADs	364.3

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Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)

(NCT01676116)
Timeframe: Week 0, week 26

Intervention	percentage of glycosylated haemoglobin (Least Squares Mean)
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	-1.32
Liraglutide or Exenatide + OADs	-0.37

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Change From Baseline in Body Weight

Mean change in body weight after 26 weeks of treatment. (NCT01676116)
Timeframe: Week 0, week 26

Intervention	kg (Mean)
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	2
Liraglutide or Exenatide + OADs	-0.8

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Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)

Percentage of subjects achieving HbA1c below 7.0% after 26 weeks of treatment. (NCT01676116)
Timeframe: Week 26

Intervention	Percentage (Number)
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	75.3
Liraglutide or Exenatide + OADs	35.6

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Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).

Mean change in diabetes treatment satisfaction questionnaire (DTSQs) scores from baseline. The scores ranged from 0 to 6. Higher total score on a 0-6 point scale indicates a general higher treatment satisfaction, whereas higher score on perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia indicate that blood glucose levels are out of the target range. (NCT01676116)
Timeframe: Week 0, week 26

Intervention	Scores on a scale (Mean)
	Treatment satisfaction scale total	Hyperglycaemia	Hypoglycaemia
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	3.1	-1.8	0.2
Liraglutide or Exenatide + OADs	1.1	-0.6	-0.1

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Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)

The patient related outcome is calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total score are later transformed to a 0-100 scale for analysis. The mean change in scores from baseline to 26 weeks for all the individual sub domains and total scores are presented here. (NCT01676116)
Timeframe: Week 0, week 26

Intervention	Scores on a scale (Mean)
	TRIM-D Treatment Burden Score	TRIM-D Daily Life Score	TRIM-D Diabetes Management Score	TRIM-D Compliance Score	TRIM-D Psychological Health Score	TRIM-D Total Score
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	10.8	6.3	10.9	8.9	7.3	8.7
Liraglutide or Exenatide + OADs	5.7	0.8	4.1	4.3	1.4	3.1

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Change From Baseline in Fasting Plasma Glucose (FPG)

Mean change in fasting plasma glucose from baseline, after 26 weeks of treatment. (NCT01676116)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	-2.98
Liraglutide or Exenatide + OADs	-0.6

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Change in HbA1c From Baseline at 12 Weeks

(NCT01722266)
Timeframe: Baseline and 12 Weeks

Intervention	Percent (Mean)
Placebo	-0.30
Liraglutide 1.8mg	-0.42
Liraglutide 1.2mg	-0.78
Liraglutide 0.6 mg	-0.26

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Change in Body Weight From Baseline at Week 12

(NCT01722266)
Timeframe: Baseline and 12 weeks

Intervention	Kg (Mean)
Placebo	-0.3
Liraglutide 1.8mg	-4.8
Liraglutide 1.2mg	-5.0
Liraglutide 0.6 mg	-2.7

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Carbohydrate Intake

(NCT01722266)
Timeframe: 12 weeks

Intervention	grams (Mean)
Placebo	-13.4
Liraglutide 1.8mg	-46.4
Liraglutide 1.2mg	-47.6
Liraglutide 0.6 mg	-23.7

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Change in Total Insulin Dose From Baseline at 12 Weeks

Total insulin dose = Basal insulin dose plus bolus insulin dose. (NCT01722266)
Timeframe: Baseline and 12 weeks

Intervention	Units (Mean)
Placebo	-3.4
Liraglutide 1.8mg	-10
Liraglutide 1.2mg	-12.1
Liraglutide 0.6 mg	-2.8

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Change in Mean Weekly Glucose Concentrations From Baseline at 12 Weeks

The primary endpoint of the study is to detect a difference from baseline in mean weekly blood glucose concentrations before and after 12 weeks of treatment in each of the Liraglutide groups. (NCT01722266)
Timeframe: 12 Weeks

Intervention	mg/dl (Mean)
Placebo	1
Liraglutide 1.8mg	-10
Liraglutide 1.2mg	-10
Liraglutide 0.6 mg	-0.3

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Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C

During the assessment of body weight in the unit, the participant wore lightweight indoor clothing and removed shoes. The assessments were done pre-dose at Day -1, Day 1, Day 7, Day 14, Day 28, Day 42 and Day 43. Baseline value was defined as the average of Day -1 and Day 1 values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. Day 42 value was the average of Day 42 and Day 43 values. (NCT01725126)
Timeframe: Baseline (Day -1 and Day 1) up to Day 42

,,,

Intervention	Kilograms (kg) (Mean)
	Day 7	Day 14	Day 28	Day 42
Part B-GSK2890457+Liraglutide	0.20	0.05	0.47	-0.39
Part B-Placebo+Liraglutide	-0.12	0.37	0.15	-0.74
Part C-GSK2890457+Metformin	0.47	0.56	0.27	0.42
Part C-Placebo+Metformin	0.28	0.61	0.52	-0.47

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Change From Baseline in Hematology Parameters of Red Blood Cell (RBC) Count and Reticulocytes During the Double-blind Treatment Period of Part A

The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42

Intervention	Trillion cells (TI)/L (Mean)
	RBC count, Day 7	RBC count, Day 14	RBC count, Day 28	RBC count, Day 42	Reticulocytes, Day 7	Reticulocytes, Day 14	Reticulocytes, Day 28	Reticulocytes, Day 42
Part A-GSK2890457	-0.116	-0.084	-0.045	-0.115	0.0014	-0.0017	0.0071	0.0044
Part A-Placebo	-0.008	0.090	0.258	0.107	0.0115	0.0077	0.0073	0.0022

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Change From Baseline in Hematology Parameters of RBC Count and Reticulocytes During the Double-blind Treatment Period of Part B and C

The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42

,,,

Intervention	TI/L (Mean)
	RBC count, Day 7	RBC count, Day 14	RBC count, Day 28	RBC count, Day 42	Reticulocytes, Day 7	Reticulocytes, Day 14	Reticulocytes, Day 28	Reticulocytes, Day 42
Part B-GSK2890457+Liraglutide	0.004	-0.011	-0.023	-0.031	-0.0003	0.0095	0.0035	0.0096
Part B-Placebo+Liraglutide	0.018	-0.030	0.002	0.032	0.0020	-0.0019	0.0029	0.0062
Part C-GSK2890457+Metformin	-0.085	-0.072	-0.003	-0.168	-0.0015	0.0147	-0.0052	-0.0042
Part C-Placebo+Metformin	-0.107	0.093	0.020	-0.053	-0.0210	-0.0286	-0.0304	-0.0200

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Change From Baseline in Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) During the Double-blind Treatment Period of Part A

Intervention	g/L (Mean)
	Hemoglobin, Day 7	Hemoglobin, Day 14	Hemoglobin, Day 28	Hemoglobin, Day 42	MCHC, Day 7	MCHC, Day 14	MCHC, Day 28	MCHC, Day 42
Part A-GSK2890457	-2.0	-0.9	0.5	0.9	5.4	0.0	6.3	9.0
Part A-Placebo	0.8	4.0	11.3	9.8	1.8	-0.5	8.5	17.5

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Change From Baseline in Hematology Parameters of Hemoglobin and MCHC During the Double-blind Treatment Period of Part B and C

,,,

Intervention	g/L (Mean)
	Hemoglobin, Day 7	Hemoglobin, Day 14	Hemoglobin, Day 28	Hemoglobin, Day 42	MCHC, Day 7	MCHC, Day 14	MCHC, Day 28	MCHC, Day 42
Part B-GSK2890457+Liraglutide	-1.0	-1.1	-1.1	-0.8	-4.1	-3.8	-1.9	0.2
Part B-Placebo+Liraglutide	0.2	0.2	0.3	0.0	-2.0	2.0	1.7	2.0
Part C-GSK2890457+Metformin	-3.4	-2.1	-0.3	-4.8	-2.8	-2.6	-1.4	0.8
Part C-Placebo+Metformin	-4.3	1.7	-1.2	-2.8	-4.5	-1.2	-2.0	-0.2

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Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count During the Double-blind Treatment Period of Part A

Intervention	Giga cells (GI)/L (Mean)
	Basophils, Day 7	Basophils, Day 14	Basophils, Day 28	Basophils, Day 42	Eosinophils, Day 7	Eosinophils, Day 14	Eosinophils, Day 28	Eosinophils, Day 42	Lymphocytes, Day 7	Lymphocytes, Day 14	Lymphocytes, Day 28	Lymphocytes, Day 42	Monocytes, Day 7	Monocytes, Day 14	Monocytes, Day 28	Monocytes, Day 42	Total Neutrophils, Day 7	Total Neutrophils, Day 14	Total Neutrophils, Day 28	Total Neutrophils, Day 42	Platelet count, Day 7	Platelet count, Day 14	Platelet count, Day 28	Platelet count, Day 42	WBC count, Day 7	WBC count, Day 14	WBC count, Day 28	WBC count, Day 42
Part A-GSK2890457	0.00	0.01	0.00	0.00	-0.03	0.00	0.00	0.00	-0.01	-0.06	-0.32	0.05	-0.05	-0.05	0.01	-0.06	0.02	-0.13	0.14	-0.01	-1.9	3.8	9.7	3.1	-0.11	-0.15	-0.16	-0.01
Part A-Placebo	0.00	-0.03	0.00	0.00	-0.03	-0.03	0.10	0.03	-0.22	-0.22	-0.23	0.15	-0.08	-0.10	-0.05	-0.05	0.15	0.50	-0.32	0.48	-4.8	-14.0	-11.5	-8.8	-0.15	0.18	-0.50	0.65

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Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count During the Double-blind Treatment Period of Part B and C

,,,

Intervention	GI/L (Mean)
	Basophils, Day 7	Basophils, Day 14	Basophils, Day 28	Basophils, Day 42	Eosinophils, Day 7	Eosinophils, Day 14	Eosinophils, Day 28	Eosinophils, Day 42	Lymphocytes, Day 7	Lymphocytes, Day 14	Lymphocytes, Day 28	Lymphocytes, Day 42	Monocytes, Day 7	Monocytes, Day 14	Monocytes, Day 28	Monocytes, Day 42	Total Neutrophils, Day 7	Total Neutrophils, Day 14	Total Neutrophils, Day 28	Total Neutrophils, Day 42	Platelet count, Day 7	Platelet count, Day 14	Platelet count, Day 28	Platelet count, Day 42	WBC count, Day 7	WBC count, Day 14	WBC count, Day 28	WBC count, Day 42
Part B-GSK2890457+Liraglutide	0.0047	0.0041	0.0050	0.0019	0.04	0.03	0.02	0.06	0.11	0.04	0.05	-0.11	-0.01	-0.04	-0.03	-0.06	-0.13	-0.19	-0.17	-0.14	8.9	7.0	10.8	-13.2	-0.01	-0.17	-0.13	-0.26
Part B-Placebo+Liraglutide	0.0270	0.0037	-0.0002	0.0098	0.02	0.01	0.01	0.01	0.31	0.18	0.08	0.02	0.04	-0.05	0.03	0.00	0.27	0.38	-0.01	-0.24	18.3	12.8	4.5	-2.0	0.65	0.52	0.08	-0.20
Part C-GSK2890457+Metformin	-0.0078	-0.0066	-0.0068	-0.0122	-0.03	-0.00	-0.00	-0.01	0.14	0.18	0.25	-0.07	0.00	0.06	0.03	-0.03	0.38	0.64	0.36	-0.10	5.8	12.9	10.4	-15.3	0.48	0.88	0.63	-0.22
Part C-Placebo+Metformin	0.0047	-0.0015	-0.0065	-0.0190	-0.01	-0.02	0.01	-0.02	0.09	0.08	0.05	-0.11	0.01	0.06	0.06	-0.00	-0.54	-0.27	-0.48	-0.50	5.0	1.2	0.5	-13.8	-0.43	-0.13	-0.35	-0.62

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Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) During the Double-blind Treatment Period of Part A

Intervention	Femtoliters (Mean)
	Day 7	Day 14	Day 28	Day 42
Part A-GSK2890457	-0.55	0.95	-0.62	0.35
Part A-Placebo	0.15	0.85	-0.30	-0.90

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Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) During the Double-blind Treatment Period of Part A

Intervention	Picograms (Mean)
	Day 7	Day 14	Day 28	Day 42
Part A-GSK2890457	0.31	0.32	0.37	0.89
Part A-Placebo	0.25	0.27	0.70	1.40

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Change From Baseline in Hematology Parameter of MCV During the Double-blind Treatment Period of Part B and C

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Intervention	Femtoliters (Mean)
	Day 7	Day 14	Day 28	Day 42
Part B-GSK2890457+Liraglutide	0.39	0.54	0.55	0.07
Part B-Placebo+Liraglutide	0.35	0.02	0.05	-0.90
Part C-GSK2890457+Metformin	0.25	0.76	0.17	-0.27
Part C-Placebo+Metformin	0.40	-0.47	-0.18	-0.78

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Change From Baseline in Hematology Parameter of MCH During the Double-blind Treatment Period of Part B and C

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Intervention	Picograms (Mean)
	Day 7	Day 14	Day 28	Day 42
Part B-GSK2890457+Liraglutide	-0.21	-0.10	0.01	0.08
Part B-Placebo+Liraglutide	-0.02	0.18	0.17	-0.12
Part C-GSK2890457+Metformin	-0.18	0.03	-0.08	0.02
Part C-Placebo+Metformin	-0.23	-0.25	-0.20	-0.28

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Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part B and C

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Intervention	Ratio (Mean)
	Day 7	Day 14	Day 28	Day 42
Part B-GSK2890457+Liraglutide	0.0019	0.0011	-0.0003	-0.0025
Part B-Placebo+Liraglutide	0.0032	-0.0028	-0.0003	-0.0022
Part C-GSK2890457+Metformin	-0.0072	-0.0036	0.0003	-0.0159
Part C-Placebo+Metformin	-0.0082	0.0057	-0.0010	-0.0087

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Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part A

Intervention	Ratio (Mean)
	Day 7	Day 14	Day 28	Day 42
Part A-GSK2890457	-0.0128	-0.0026	-0.0066	-0.0089
Part A-Placebo	0.0000	0.0128	0.0228	0.0060

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Change From Baseline in Fasting Plasma Glucose (Safety Laboratory) Values During the Double-blind Treatment Period of Part B and C

The assessments were done at Day -1, Day 7, Day 14, Day 28, Day 42 and Follow-up Visit. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline (Day 7, 14, 28, 42 and Follow-up visit) values. (NCT01725126)
Timeframe: Baseline (Day -1) up to Follow-up (Day 56)

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Intervention	mmol/L (Mean)
	Day 7	Day 14	Day 28	Day 42	Follow-up
Part B-GSK2890457+Liraglutide	0.285	0.210	-0.201	-0.098	0.444
Part B-Placebo+Liraglutide	-0.278	-0.093	-0.111	0.194	0.962
Part C-GSK2890457+Metformin	-1.665	-2.216	-1.989	0.074	-1.226
Part C-Placebo+Metformin	0.879	0.518	1.536	1.184	1.249

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Change From Baseline in Fasting Insulin and Weighted Mean Insulin AUC (0-4 Hour) and AUC (0-24 Hour) During the Double-blind Treatment Period of Part B and C

Two fasting samples 5 minutes apart were taken for insulin. Baseline insulin level was the average of the 2 fasting samples. For insulin weighted mean AUC (0-4 hour) and weighted mean AUC (0-24 hour) was calculated for Baseline (Day -1) and end of treatment (Day 42). AUC was calculated using the linear trapezoid method that is the sum of the areas between each chronological pair of assessments at the time points (at Day -1 and Day 42). The weighted mean was then calculated by dividing the AUC by the length of the time interval over which it was calculated. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data is reported for weighted mean insulin AUC (0-4 hour) post-breakfast and AUC (0-24 hour) post-breakfast. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42

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Intervention	pmol/L (Mean)
	Fasting Insulin	Insulin Weighted Mean AUC 0-4 hour	Insulin Weighted Mean AUC 0-24 hour
Part B-GSK2890457+Liraglutide	1.133	14.589	-13.905
Part B-Placebo+Liraglutide	-4.887	69.635	1.626
Part C-GSK2890457+Metformin	12.300	10.322	17.134
Part C-Placebo+Metformin	-11.946	57.887	22.740

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Change From Baseline in Electrocardiogram (ECG) Intervals During Part A

Single 12-lead ECGs was obtained after participants rested in a supine position for at least 10 minutes using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, QT duration corrected for HR by Fridericia's formula (QTcF) and QT duration corrected for HR by Bazett's formula (QTcB intervals. The assessments were done at Day 1 (pre-dose, triplicate), Day 42 (pre-dose) and Follow-up Visit. Baseline value was defined as the average of the triplicate pre-dose assessments done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42 and Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Follow-up (Day 56)

Intervention	Milliseconds (Mean)
	PR Interval, Day 42	PR Interval, Follow-up	QRS Duration, Day 42	QRS Duration, Follow-up	QT Interval, Day 42	QT Interval, Follow-up	QTcB, Day 42	QTcB, Follow-up	QTcF, Day 42	QTcF, Follow-up
Part A-GSK2890457	1.1	1.5	-2.1	-0.7	16.4	-10.2	-3.3	6.3	3.2	0.7
Part A-Placebo	6.3	9.0	2.2	3.9	10.8	0.3	8.2	6.9	9.1	4.8

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Change From Baseline in ECG Intervals During Part B and C

Single 12-lead ECGs was obtained after participants rested in a supine position for at least 10 minutes using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, QTcB, QTcF and RR intervals. The assessments were done at Day -1 (pre-dose, triplicate), Day 42 (pre-dose) and Follow-up Visit. Baseline value was defined as the average of the triplicate pre-dose assessments done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42 and Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Follow-up (Day 56)

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Intervention	Milliseconds (Mean)
	PR Interval, Day 42	PR Interval, Follow-up	QRS Duration, Day 42	QRS Duration, Follow-up	QT Interval, Day 42	QT Interval, Follow-up	QTcB, Day 42	QTcB, Follow-up	QTcF, Day 42	QTcF, Follow-up	RR Interval, Day 42	RR Interval, Follow-up
Part B-GSK2890457+Liraglutide	3.08	-3.69	-2.62	-1.69	-1.69	-5.69	-1.51	-10.95	-1.49	-9.10	-0.00	0.02
Part B-Placebo+Liraglutide	5.56	-1.11	0.78	0.11	8.11	1.44	-2.87	-5.89	1.17	-3.17	0.04	0.03
Part C-GSK2890457+Metformin	-4.44	-6.28	-1.06	0.11	0.78	-5.56	-4.23	-2.14	-2.58	-3.50	0.02	-0.01
Part C-Placebo+Metformin	-6.44	-3.11	0.11	0.78	2.78	0.78	0.43	-3.20	1.22	-1.78	0.01	0.02

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Change From Baseline in Clinical Chemistry Parameters of Total Thyroxine and Total T3 During the Double-blind Treatment Period of Part B and C

The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42

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Intervention	Nanomoles (nmol)/L (Mean)
	Total thyroxine	Total T3
Part B-GSK2890457+Liraglutide	1.0891	0.1
Part B-Placebo+Liraglutide	0.8578	-0.3
Part C-GSK2890457+Metformin	-2.3597	-0.2
Part C-Placebo+Metformin	-5.1478	-0.2

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Change From Baseline in Clinical Chemistry Parameters of Thyroid Stimulating Hormone During the Double-blind Treatment Period of Part B and C

The assessments were done pre-dose at Day -1, Day 7 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42

Intervention	Milliunits (mu/L) (Mean)
	Day 7	Day 42
Part B-GSK2890457+Liraglutide	-5.790	-0.067

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Change From Baseline in Clinical Chemistry Parameters of Thyroid Stimulating Hormone During the Double-blind Treatment Period of Part B and C

Intervention	Milliunits (mu/L) (Mean)
	Day 42
Part B-Placebo+Liraglutide	0.137
Part C-GSK2890457+Metformin	0.149
Part C-Placebo+Metformin	-0.187

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Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part B and C

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Intervention	pmol/L (Mean)
	Day 7	Day 14	Day 28	Day 42
Part B-GSK2890457+Liraglutide	-20.05	-9.62	-35.18	-8.12
Part B-Placebo+Liraglutide	-20.21	-21.65	-53.41	-12.99
Part C-GSK2890457+Metformin	-29.59	-41.14	-7.22	35.28
Part C-Placebo+Metformin	45.11	-79.39	34.28	34.28

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Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part A

Intervention	Picomoles (pmol)/L (Mean)
	Day 7	Day 14	Day 28	Day 42
Part A-GSK2890457	12.516	1.973	8.969	-13.735
Part A-Placebo	-1.256	8.072	-11.659	-22.721

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Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic, BUN and Cholesterol During the Double-blind Treatment Period of Part B and C

The electrolytes include calcium, chloride, carbon dioxide content/bicarbonate, potassium, magnesium and sodium. Assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42

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Intervention	mmol/L (Mean)
	Calcium, Day 7	Calcium, Day 14	Calcium, Day 28	Calcium, Day 42	Chloride, Day 7	Chloride, Day 14	Chloride, Day 28	Chloride, Day 42	Carbon dioxide/Bicarbonate, Day 7	Carbon dioxide/Bicarbonate, Day 14	Carbon dioxide/Bicarbonate, Day 28	Carbon dioxide/Bicarbonate, Day 42	Glucose, Day 7	Glucose, Day 14	Glucose, Day 28	Glucose, Day 42	Potassium, Day 7	Potassium, Day 14	Potassium, Day 28	Potassium, Day 42	Magnesium, Day 7	Magnesium, Day 14	Magnesium, Day 28	Magnesium, Day 42	Sodium, Day 7	Sodium, Day 14	Sodium, Day 28	Sodium, Day 42	Urea/BUN, Day 7	Urea/BUN, Day 14	Urea/BUN, Day 28	Urea/BUN, Day 42	Cholesterol, Day 42	Phosphorus inorganic, Day 7	Phosphorus inorganic, Day 14	Phosphorus inorganic, Day 28	Phosphorus inorganic, Day 42
Part B-GSK2890457+Liraglutide	0.053	0.041	0.046	-0.040	-1.2	-0.1	0.2	0.2	-2.0	-1.9	-0.4	-1.8	0.3	0.2	-0.2	-0.1	0.09	0.20	0.08	0.01	0.0294	0.0176	0.0379	0.0063	0.2	1.4	1.7	-0.4	0.383	0.128	0.302	-0.412	-0.103	0.01	0.05	-0.01	-0.04
Part B-Placebo+Liraglutide	0.083	0.050	0.021	-0.025	-1.5	-0.8	0.8	-1.0	0.0	-1.8	-1.0	0.5	-0.3	-0.1	-0.1	0.2	0.33	0.17	0.28	-0.05	0.0206	-0.0206	0.0274	-0.0137	1.2	1.3	1.8	0.5	-0.000	-0.297	0.119	-0.595	-0.853	0.10	0.01	0.06	0.01
Part C-GSK2890457+Metformin	-0.004	0.017	0.035	-0.056	0.4	0.6	0.3	0.3	-0.6	-0.7	-0.3	-1.3	-1.7	-2.2	-2.0	0.1	0.06	0.07	-0.07	0.08	-0.0206	0.0206	0.0240	-0.0171	0.8	1.5	0.6	-1.0	-0.208	-0.268	0.863	-0.387	-0.155	0.01	0.03	0.12	-0.00
Part C-Placebo+Metformin	0.025	0.067	0.004	-0.071	0.8	0.5	1.0	0.5	-2.0	-2.0	-2.3	-2.8	0.9	0.5	1.5	1.2	0.28	0.17	0.10	-0.05	0.0206	0.0069	0.0411	-0.0274	1.3	1.5	1.0	-1.0	0.179	0.178	0.714	-0.655	-0.052	-0.03	-0.10	-0.12	-0.05

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Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic and Urea/Blood Urea Nitrogen (BUN) During the Double-blind Treatment Period of Part A

The electrolytes include calcium, chloride, carbon dioxide content/bicarbonate, potassium, magnesium and sodium. Assessments were done pre-dose at on Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42

Intervention	Millimoles (mmol)/L (Mean)
	Calcium, Day 7	Calcium, Day 14	Calcium, Day 28	Calcium, Day 42	Chloride, Day 7	Chloride, Day 14	Chloride, Day 28	Chloride, Day 42	Carbon dioxide/Bicarbonate, Day 7	Carbon dioxide/Bicarbonate, Day 14	Carbon dioxide/Bicarbonate, Day 28	Carbon dioxide/Bicarbonate, Day 42	Glucose, Day 7	Glucose, Day 14	Glucose, Day 28	Glucose, Day 42	Potassium, Day 7	Potassium, Day 14	Potassium, Day 28	Potassium, Day 42	Magnesium, Day 7	Magnesium, Day 14	Magnesium, Day 28	Magnesium, Day 42	Sodium, Day 7	Sodium, Day 14	Sodium, Day 28	Sodium, Day 42	Urea/BUN, Day 7	Urea/BUN, Day 14	Urea/BUN, Day 28	Urea/BUN, Day 42	Phosphorus inorganic, Day 7	Phosphorus inorganic, Day 14	Phosphorus inorganic, Day 28	Phosphorus inorganic, Day 42
Part A-GSK2890457	-0.023	-0.023	-0.010	-0.022	1.2	0.4	0.5	0.4	-1.2	-1.9	-1.2	-2.8	-0.1	-0.3	-0.2	-0.3	-0.15	-0.15	-0.13	-0.16	-0.0299	-0.0486	-0.0288	-0.0247	0.8	-0.2	1.9	-0.6	-0.325	-0.746	-0.643	-0.678	-0.04	-0.05	-0.09	-0.03
Part A-Placebo	-0.025	0.056	0.056	0.050	0.8	1.0	-1.5	-0.8	0.3	-1.0	-0.5	-2.5	-0.0	-0.0	-0.1	-0.2	0.15	0.20	-0.07	0.30	-0.0206	-0.0617	-0.0411	-0.0308	0.3	-0.3	1.0	-1.3	-0.179	-0.268	-0.536	-0.625	-0.07	-0.14	-0.02	0.01

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Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part B and C

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Intervention	umol/L (Mean)
	Direct bilirubin, Day 7	Direct bilirubin, Day 14	Direct bilirubin, Day 28	Direct bilirubin, Day 42	Total bilirubin, Day 7	Total bilirubin, Day 14	Total bilirubin, Day 28	Total bilirubin, Day 42	Creatinine, Day 7	Creatinine, Day 14	Creatinine, Day 28	Creatinine, Day 42	Uric acid, Day 7	Uric acid, Day 14	Uric acid, Day 28	Uric acid, Day 42
Part B-GSK2890457+Liraglutide	-0.208	-0.305	-0.197	-0.197	-0.855	-0.611	0.132	0.263	3.0	4.2	2.0	-2.4	25.1	15.3	16.9	7.8
Part B-Placebo+Liraglutide	0.542	0.314	0.513	0.599	0.570	-0.570	-0.000	-1.425	4.6	-0.1	1.9	-1.0	15.9	-11.9	2.0	-5.0
Part C-GSK2890457+Metformin	-0.200	-0.185	-0.014	-0.328	0.000	0.285	0.998	-0.428	3.4	4.6	8.2	-0.8	9.9	25.3	34.7	0.5
Part C-Placebo+Metformin	-0.513	-0.086	-0.171	-0.200	-3.705	-0.855	-0.855	-0.285	6.9	5.7	4.9	0.6	3.0	-21.8	-13.9	9.9

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Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part A

Intervention	Micromoles (umol)/L (Mean)
	Direct bilirubin, Day 7	Direct bilirubin, Day 14	Direct bilirubin, Day 28	Direct bilirubin, Day 42	Total bilirubin, Day 7	Total bilirubin, Day 14	Total bilirubin, Day 28	Total bilirubin, Day 42	Creatinine, Day 7	Creatinine, Day 14	Creatinine, Day 28	Creatinine, Day 42	Uric acid, Day 7	Uric acid, Day 14	Uric acid, Day 28	Uric acid, Day 42
Part A-GSK2890457	-0.311	-0.466	-0.855	-0.171	-0.777	-0.933	-2.565	0.513	-6.4	-4.8	-7.1	-8.8	-10.3	-17.8	4.2	-26.2
Part A-Placebo	0.000	0.428	-0.428	-0.855	0.000	0.428	1.283	0.855	2.2	-4.4	0.0	-2.2	-7.4	-14.9	-1.5	-7.4

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Change From Baseline in Clinical Chemistry Parameters of Amylase and Lipase the Double-blind Treatment Period of Part B of Study

The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42

Intervention	Units (U)/L (Mean)
	Amylase, Day 42	Lipase, Day 42
Part B-GSK2890457+Liraglutide	9.2	18.8
Part B-Placebo+Liraglutide	6.0	7.5

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Change From Baseline in Clinical Chemistry Parameters of ALP, ALT, AST and GGT During the Double-blind Treatment Period of Part B and C

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Intervention	IU/L (Mean)
	ALP, Day 7	ALP, Day 14	ALP, Day 28	ALP, Day 42	ALT, Day 7	ALT, Day 14	ALT, Day 28	ALT, Day 42	AST, Day 7	AST, Day 14	AST, Day 28	AST, Day 42	GGT, Day 7	GGT, Day 14	GGT, Day 28	GGT, Day 42
Part B-GSK2890457+Liraglutide	5.5	1.8	2.8	2.2	-0.1	0.6	0.9	1.0	1.1	1.9	2.2	3.8	-1.2	-1.4	0.8	0.2
Part B-Placebo+Liraglutide	5.3	5.2	-0.3	4.3	-1.3	-2.3	-2.5	-4.3	-1.2	-1.3	-2.0	-3.8	0.7	0.8	0.0	-0.7
Part C-GSK2890457+Metformin	-2.2	-3.7	-2.5	-2.8	-1.0	-6.3	-3.8	-4.2	0.2	-0.3	1.4	1.9	1.3	2.3	0.5	-0.9
Part C-Placebo+Metformin	1.8	6.7	6.3	0.5	1.5	3.0	0.7	-0.5	-0.5	-1.0	0.7	1.0	0.3	5.3	2.3	-0.7

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Change From Baseline in Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), ALT, Aspartate Aminotransferase (AST) and Gamma Glutamyltransferase (GGT) During Double-blind Treatment Period of Part A

Intervention	International unit per liter (IU/L) (Mean)
	ALP, Day 7	ALP, Day 14	ALP, Day 28	ALP, Day 42	ALT, Day 7	ALT, Day 14	ALT, Day 28	ALT, Day 42	AST, Day 7	AST, Day 14	AST, Day 28	AST, Day 42	GGT, Day 7	GGT, Day 14	GGT, Day 28	GGT, Day 42
Part A-GSK2890457	-3.8	-1.4	-1.8	-1.8	-4.1	-4.4	-8.2	-7.7	-0.4	1.4	-3.1	-0.3	-0.1	-0.1	-2.9	-0.5
Part A-Placebo	-6.0	-1.3	0.0	-1.0	5.5	1.3	2.0	5.3	2.3	-2.3	-0.8	2.3	1.5	1.0	0.8	2.5

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Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part B and C

,,,

Intervention	g/L (Mean)
	Albumin, Day 7	Albumin, Day 14	Albumin, Day 28	Albumin, Day 42	Total protein, Day 7	Total protein, Day 14	Total protein, Day 28	Total protein, Day 42
Part B-GSK2890457+Liraglutide	3.1	2.6	2.8	0.4	2.9	2.7	3.2	-0.6
Part B-Placebo+Liraglutide	2.0	2.7	1.8	0.0	3.0	4.0	3.2	0.5
Part C-GSK2890457+Metformin	0.5	1.6	1.9	-1.3	1.1	2.2	3.1	-1.5
Part C-Placebo+Metformin	1.3	0.8	2.3	-0.8	1.0	1.7	2.8	-0.7

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Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part A

Intervention	g/L (Mean)
	Albumin, Day 7	Albumin, Day 14	Albumin, Day 28	Albumin, Day 42	Total protein, Day 7	Total protein, Day 14	Total protein, Day 28	Total protein, Day 42
Part A-GSK2890457	-0.3	0.4	0.4	0.0	-2.1	-1.2	-2.2	-3.1
Part A-Placebo	0.0	2.0	2.5	2.5	-0.8	-0.3	1.0	0.8

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AUC of Metformin From Time 0 to 10 Hours Post-dose (AUC [0-10 Hour]) During the Double-blind Treatment Period of Part A

Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The AUC (0-10 hour) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The analysis population included Metformin PK Population in Part A comprising of all participants in All Subjects Population for whom a PK sample was obtained and analyzed for metformin. (NCT01725126)
Timeframe: Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose

Intervention	Hour*nanograms/mL (Geometric Mean)
	Day 1	Day 42
Part A-GSK2890457	3402.6	2231.7
Part A-Placebo	4346.8	5081.9

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Area Under Plasma Concentration From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Liraglutide During the Double-blind Treatment Period of Part B

Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post dose. The AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The analysis population included Liraglutide Pharmacokinetic (PK) Population in Part B comprising of all participants in All Subjects Population for whom a PK sample was obtained and analyzed for Liraglutide. (NCT01725126)
Timeframe: Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose

Intervention	Hour*nanograms/mL (Geometric Mean)
	Day -1	Day 42
Part B-GSK2890457+Liraglutide	1268.65	1265.92
Part B-Placebo+Liraglutide	2210.15	2505.23

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Number of Participants With Any Hypoglycemic Events During Part B and Part C

Hypoglycemia is defined as symptoms consistent with hypoglycemia (e.g. dizziness, light-headedness, shakiness) which are confirmed by glucometer measurement of CBG or plasma glucose value of <50 mg/dL for Part A or <70 mg/dL for Parts B and C (when possible, CBG values were confirmed with a laboratory measurement). In situations when no glucose sample could be measured at the time of the event, the investigator, at his or her discretion, characterized an event as 'hypoglycemia' based on reported signs and symptoms alone. Healthy participant also had asymptomatic blood glucose values <70 mg/dL as a physiological response to altered food intake (e.g., fasting). (NCT01725126)
Timeframe: Up to Follow-up (8 weeks)

Intervention	Participants (Count of Participants)
Part B-Placebo+Liraglutide	0
Part B-GSK2890457+Liraglutide	0
Part C-Placebo+Metformin	0
Part C-GSK2890457+Metformin	0

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Number of Participants With Any Hypoglycemic Events During Part A

Hypoglycemia is defined as symptoms consistent with hypoglycemia (e.g. dizziness, light-headedness, shakiness) which are confirmed by glucometer measurement of complete blood count (CBG) or plasma glucose value of <50 milligram per deciliter (mg/dL) for Part A or <70 mg/dL for Parts B and C (when possible, CBG values were confirmed with a laboratory measurement). In situations when no glucose sample could be measured at the time of the event, the investigator, at his or her discretion, characterized an event as 'hypoglycemia' based on reported signs and symptoms alone. Healthy participant also had asymptomatic blood glucose values <70 mg/dL as a physiological response to altered food intake (e.g., fasting). (NCT01725126)
Timeframe: Up to Follow-up (8 weeks)

Intervention	Participants (Count of Participants)
Part A-Placebo	0
Part A-GSK2890457	0

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Change From Baseline in Matsuda Index During the Double Blind-treatment Period of Part B and C

The matsuda index was calculated from the Day -1 and Day 42 glucose and insulin results as 10,000 divided by (fasting plasma glucose x fasting plasma insulin x mean glucose at 0-2 hour post-dose x mean insulin at 0-2 hour post dose)^1/2, where glucose was measured in mmol/L and insulin in pmol/L. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42

Intervention	DecilitermL/mgmU (Mean)
Part B-Placebo+Liraglutide	-0.991
Part B-GSK2890457+Liraglutide	-0.602

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Change From Baseline in Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR]) During the Double-blind Treatment Period of Part B and C

HOMA-IR was calculated from the Day -1 and Day 42 fasting glucose and insulin values using dataset generated from the HOMA-2 model. It contained the estimates for HOMA-% insulin sensitivity (S) for pairs of fasting glucose and fasting insulin values. Study data was merged with the HOMA dataset by glucose and insulin. HOMA-IR was calculated as 100/HOMA-%S. HOMA-IR was not determined for any values outside the ranges of plasma glucose 3.5 to 25.0 mmol/L (63 - 450 mg/dL) and plasma insulin 20 to 400 pmol/L. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42

Intervention	mU*mmol/L^2 (Mean)
Part B-Placebo+Liraglutide	-0.150
Part B-GSK2890457+Liraglutide	0.017

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Change From Baseline in Glycated Hemoglobin (HbA1c) During the Double-blind Treatment Period of Part B and C

Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Adjusted mean is reported as LS mean. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42

Intervention	Percent of TL hemoglobin (Least Squares Mean)
Part B-Placebo+Liraglutide	-0.214
Part B-GSK2890457+Liraglutide	-0.278
Part C-Placebo+Metformin	0.018
Part C-GSK2890457+Metformin	-0.201

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Change From Baseline in Fasting Glucose During the Double-blind Treatment Period of Part B and C

Intervention	mmol/L (Least Squares Mean)
Part B-Placebo+Liraglutide	-0.384
Part B-GSK2890457+Liraglutide	-0.230
Part C-Placebo+Metformin	0.136
Part C-GSK2890457+Metformin	-0.387

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Change From Baseline in Clinical Chemistry Parameter of Triiodothyronine (T3) Uptake During the Double-blind Treatment Period of Part B and C

Intervention	Ratio (Mean)
Part B-Placebo+Liraglutide	-0.018
Part B-GSK2890457+Liraglutide	-0.009
Part C-Placebo+Metformin	0.002
Part C-GSK2890457+Metformin	-0.001

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Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part C

The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. The participants were categorized as few, many, moderate, trace, +1, 2+, 3+, 0-3, 10-20, 0-5, 6-10, 20-40, 40-60. Protein and ketone ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. Bacteria and uric acid crystals ranged from few to moderate, few indicated lowest and moderate indicated highest concentration. Trace was the highest concentration of occult blood. Epithelial cells ranged from 0-5 to >10, 0-5 indicated lowest and >10 indicated highest concentration. Glucose ranged from trace to 3+, trace indicated lowest and 3+ indicated highest concentration. 0-1 was highest concentration for hyaline casts. RBC and WBC ranged from 0-3 to 40-60, 0-3 indicated lowest and 20-40 indicated highest concentration. Highest concentration indicated worse outcome. (NCT01725126)
Timeframe: Up to Day 42

Intervention	Participants (Count of Participants)
	Protein, 1+, Day 7	Protein, Trace, Day 7	Protein, Trace, Day 14	Protein, 1+, Day 28	Bacteria, Few, Day -1	Bacteria, Many, Day -1	Bacteria, Few, Day 7	Bacteria, Many, Day 7	Bacteria, Many, Day 14	Bacteria, Moderate, Day 14	Bacteria, Few, Day 28	Bacteria, Many, Day 28	Bacteria, Many, Day 42	Bacteria, Moderate, Day 42	Occult Blood, Trace, Day 42	Epithelial Cells, 0-10, Day -1	Epithelial Cells, 0-10, Day 7	Epithelial Cells, 0-5, Day 7	Epithelial Cells, 6-10, Day 7	Epithelial Cells, 0-5, Day 14	Epithelial Cells, >10, Day 14	Epithelial Cells, 0-10, Day 28	Epithelial Cells, 0-10, Day 42	Glucose, 1+, Day -1	Glucose, 2+, Day -1	Glucose, 3+, Day -1	Glucose, 1+, Day 7	Glucose, 2+, Day 7	Glucose, 3+, Day 7	Glucose, Trace, Day 7	Glucose, 1+, Day 14	Glucose, 3+, Day 14	Glucose, Trace, Day 14	Glucose, 2+, Day 28	Glucose, 3+, Day 28	Glucose, Trace, Day 28	Glucose, 1+, Day 42	Glucose, 2+, Day 42	Glucose, 3+, Day 42	Glucose, Trace, Day 42	Hyaline Casts, 0-1, Day 7	Ketones, 1+, Day 7	Ketones, Trace, Day 7	Ketones, Trace, Day 14	Ketones, Trace, Day 28	RBC's, 0-3, Day -1	RBC's, 0-3, Day 7	RBC's, 0-3, Day 14	RBC's, 0-3, Day 28	RBC's, 0-3, Day 42	Uric acid crystals, Moderate, Day 7	Uric acid crystals, Few, Day 14	WBC's, 0-5, Day -1	WBC's, 0-5, Day 7	WBC's, 6-10, Day 7	WBC's, 0-5, Day 14	WBC's, 0-5, Day 28	WBC's, 40-60, Day 28	WBC's, 6-10, Day 42
Part C-GSK2890457+Metformin	1	2	1	1	1	0	4	0	1	0	1	0	0	1	1	1	1	1	1	1	1	1	1	1	1	6	0	2	1	2	2	2	4	2	1	2	2	1	4	1	1	1	2	1	1	1	2	2	1	1	1	1	1	3	1	2	1	0	1
Part C-Placebo+Metformin	0	0	1	0	0	1	0	1	0	1	1	1	1	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	1	1	1	0	0	1	1	0	3	0	0	0	0	0	0	1	1	0	0	0	1	0	0	0	1	1	0	1	1	1	1

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Tmax of Metformin During the Double-blind Treatment Period of Part A

Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The time at which Cmax was observed was determined directly from the raw concentration-time data. (NCT01725126)
Timeframe: Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose

Intervention	Hours (Median)
	Day 1	Day 42
Part A-GSK2890457	2.000	2.000
Part A-Placebo	3.010	4.000

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Time of Occurrence of Cmax (Tmax) of Liraglutide During the Double-blind Treatment Period of Part B

Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The time at which Cmax was observed was determined directly from the raw concentration-time data. (NCT01725126)
Timeframe: Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose

Intervention	Hours (Median)
	Day -1	Day 42
Part B-GSK2890457+Liraglutide	8.00	9.98
Part B-Placebo+Liraglutide	9.74	9.92

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Percent Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C

During the assessment of body weight in the unit, the participant wore lightweight indoor clothing and removed shoes. The assessments were done pre-dose at Day -1, Day 1, Day 7, Day 14, Day 28, Day 42 and Day 43. Baseline value was defined as the average of Day -1 and Day 1 values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. Percent change was calculated by multiplying the change from Baseline value with 100. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. Day 42 value was the average of Day 42 and Day 43 values. (NCT01725126)
Timeframe: Baseline (Day -1 and Day 1) up to Day 42

,,,

Intervention	Percent change (Mean)
	Day 7	Day 14	Day 28	Day 42
Part B-GSK2890457+Liraglutide	0.18	-0.04	0.39	-0.51
Part B-Placebo+Liraglutide	-0.16	0.47	0.25	-0.80
Part C-GSK2890457+Metformin	0.59	0.60	0.30	0.50
Part C-Placebo+Metformin	0.36	0.79	0.66	-0.53

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Number of Participants With Any AE, SAE or Death During Part B and Part C

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as ALT >=3 x ULN, and total bilirubin >=2 x ULN or international normalized ratio >1.5. (NCT01725126)
Timeframe: Up to Follow-up (8 weeks)

,,,

Intervention	Participants (Count of Participants)
	Any AE	Any SAE	Any Death
Part B-GSK2890457+Liraglutide	3	0	0
Part B-Placebo+Liraglutide	1	0	0
Part C-GSK2890457+Metformin	3	0	0
Part C-Placebo+Metformin	3	0	0

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Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE) or Death During Part A

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5. (NCT01725126)
Timeframe: Up to Follow-up (8 weeks)

Intervention	Participants (Count of Participants)
	Any AE	Any SAE	Any Death
Part A-GSK2890457	10	0	0
Part A-Placebo	3	0	0

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Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part B

The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Only those parameters for which at least one value of abnormal urinalysis result was reported are summarized. The participants were categorized as few, trace, +1, 2+, 3+, 0-3, 10-20, 0-5, 6-10, and 20-40. Few was the highest concentration of bacteria. Occult blood ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. Epithelial cell ranged from 0-5 to 10-20, 0-5 indicated lowest and 10-20 indicated highest concentration. Glucose ranged from trace to 3+, trace indicated lowest and 3+ indicated highest concentration. 0-5 was highest concentration for hyaline casts. Ketone ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. RBC and WBC ranged from 0-3 to 20-40, 0-3 indicated lowest and 20-40 indicated highest concentration. Highest concentration indicated worse outcome. (NCT01725126)
Timeframe: Up to Day 42

Intervention	Participants (Count of Participants)
	Bacteria, Few, Day -1	Occult Blood, 1+, Day 14	Occult Blood, Trace, Day 28	Occult Blood, Trace, Day 42	Epithelial Cells, 10-20, Day -1	Epithelial Cells, 0-5, Day 7	Epithelial Cells, 6-10, Day 7	Epithelial Cells, 0-5, Day 14	Epithelial Cells, 0-5, Day 42	Glucose, 1+, Day -1	Glucose, 3+, Day -1	Glucose, Trace, Day -1	Glucose, 1+, Day 7	Glucose, 3+, Day 7	Glucose, Trace, Day 7	Glucose, 1+, Day 14	Glucose, 2+, Day 14	Glucose, 3+, Day 14	Glucose, Trace, Day 14	Glucose, 1+, Day 28	Glucose, 2+, Day 28	Glucose, 3+, Day 28	Glucose, Trace, Day 28	Glucose, 1+, Day 42	Glucose, 2+, Day 42	Glucose, 3+, Day 42	Glucose, Trace, Day 42	Hyaline Casts, 0-5, Day 14	Ketones, 1+, Day 7	Ketones, Trace, Day 14	Ketones, Trace, Day 28	RBC's, 0-3, Day-1	RBC's, 0-3, Day 7	RBC's, 0-3, Day 14	RBC's, 0-3, Day 28	RBC's, 0-3, Day 42	WBC's, 20-40, Day -1	WBC's, 0-5, Day 7	WBC's, 6-10, Day 7	WBC's, 0-5, Day 14	WBC's, 0-5, Day 28	WBC's, 0-5, Day 42
Part B-GSK2890457+Liraglutide	0	1	1	1	0	1	0	2	1	4	2	1	1	2	3	1	1	1	3	2	1	2	1	0	2	3	3	0	1	1	1	0	0	1	1	1	0	1	0	1	1	1
Part B-Placebo+Liraglutide	1	0	0	0	1	1	1	1	1	0	0	2	0	1	0	0	0	1	0	0	1	0	0	2	0	0	1	1	0	2	0	1	1	0	0	0	1	1	1	1	0	1

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Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part A

The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Only those parameters for which at least one value of abnormal urinalysis result was reported are summarized. The participants were categorized as rare, trace, +1, 2+, RBC's and WBC's as <1, 1, 2, 3 and 4. Protein concentration ranged from trace to 1+, where trace indicated lowest concentration and 1+ indicated highest concentration. Trace was the highest concentration for occult blood. Bacteria concentration ranged from rare to moderate, where rare indicated lowest concentration and moderate indicated highest concentration. Ketones ranged from trace to 1+, where trace indicated lowest concentration and 1+ indicated highest concentration. RBC and WBC ranged from <1 to 4, where <1 indicated lowest concentration and 4 indicated highest concentration. Highest concentration indicated worse outcome. (NCT01725126)
Timeframe: Up to Day 42

Intervention	Participants (Count of Participants)
	Protein, Trace, Day 1	Protein, Trace, Day 7	Protein, 1+, Day 7	Protein, Trace, Day 14	Protein, Trace, Day 28	Protein, Trace, Day 42	Bacteria, Rare, Day 1	Bacteria, Rare, Day 42	Bacteria, Moderate, Day 42	Occult blood, Trace, Day 1	Occult blood, Trace, Day 14	Occult blood, Trace, Day 28	Ketones, 1+, Day 1	Ketones, 1+, Day 7	Ketones, Trace, Day 14	Ketones, Trace, Day 28	Ketones, Trace, Day 42	RBC's, 1, Day 1	RBC's, 3, Day 1	RBC's, <1, Day 1	RBC's, 1, Day 7	RBC's, <1, Day 7	RBC's, 2, Day 14	RBC's, <1, Day 14	RBC's, 1, Day 28	RBC's, <1, Day 28	RBC's, 1, Day 42	RBC's, 2, Day 42	RBC's, <1, Day 42	WBC's, 1, Day 1	WBC's, <1, Day 1	WBC's, 1, Day 7	WBC's, <1, Day 7	WBC's, 2, Day 14	WBC's, <1, Day 14	WBC's, 1, Day 28	WBC's, <1, Day 28	WBC's, 1, Day 42	WBC's, 2, Day 42	WBC's, 4, Day 42
Part A-GSK2890457	3	2	1	1	4	2	0	1	0	0	1	1	0	1	0	0	0	1	0	1	1	1	0	2	2	2	1	0	1	2	1	2	1	1	1	0	1	1	0	1
Part A-Placebo	1	0	0	0	1	2	1	0	1	1	1	0	1	0	1	1	1	1	1	0	0	0	1	0	0	2	0	2	0	2	0	0	0	1	1	2	0	0	1	1

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Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part B and C

Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. (NCT01725126)
Timeframe: Up to Day 42

,,,

Intervention	Ratio (Mean)
	Day -1	Day 7	Day 14	Day 28	Day 42
Part B-GSK2890457+Liraglutide	1.0174	1.0191	1.0196	1.0239	1.0188
Part B-Placebo+Liraglutide	1.0168	1.0208	1.0202	1.0232	1.0137
Part C-GSK2890457+Metformin	1.0187	1.0208	1.0201	1.0213	1.0172
Part C-Placebo+Metformin	1.0172	1.0197	1.0198	1.0213	1.0110

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Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part A

Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were done pre-dose at Da y 1, Day 7, Day 14, Day 28 and Day 42. (NCT01725126)
Timeframe: Up to Day 42

Intervention	Ratio (Mean)
	Day 1	Day 7	Day 14	Day 28	Day 42
Part A-GSK2890457	1.0175	1.0165	1.0152	1.0122	1.0161
Part A-Placebo	1.0193	1.0133	1.0153	1.0125	1.0155

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Mean pH Values of Urine During the Double-blind Treatment Period of Part B and C

Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessments were done pre-dose on Day -1, Day 7, Day 14, Day 28 and Day 42. (NCT01725126)
Timeframe: Up to Day 42

,,,

Intervention	pH (Mean)
	Day -1	Day 7	Day 14	Day 28	Day 42
Part B-GSK2890457+Liraglutide	6.25	5.89	6.07	5.96	6.08
Part B-Placebo+Liraglutide	5.92	5.83	5.67	5.75	6.00
Part C-GSK2890457+Metformin	5.83	5.42	5.63	5.63	5.58
Part C-Placebo+Metformin	5.67	5.83	5.67	5.67	5.58

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Mean pH Values of Urine During the Double-blind Treatment Period of Part A

Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessments were done pre-dose on Day 1, Day 7, Day 14, Day 28 and Day 42. (NCT01725126)
Timeframe: up to Day 42

Intervention	pH (Mean)
	Day 1	Day 7	Day 14	Day 28	Day 42
Part A-GSK2890457	5.95	5.86	5.91	6.05	6.20
Part A-Placebo	5.25	5.88	5.50	6.13	5.63

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Maximum Observed Concentration (Cmax) of Liraglutide During the Double-blind Treatment Period of Part B

Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The first occurrence of the Cmax was determined directly from the raw concentration-time data. (NCT01725126)
Timeframe: Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose

Intervention	Nanograms/mL (Geometric Mean)
	Day -1	Day 42
Part B-GSK2890457+Liraglutide	72.24	70.86
Part B-Placebo+Liraglutide	120.00	128.57

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Cmax of Metformin During the Double-blind Treatment Period of Part A

Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The first occurrence of the Cmax was determined directly from the raw concentration-time data. (NCT01725126)
Timeframe: Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose

Intervention	Nanograms/mL (Geometric Mean)
	Day 1	Day 42
Part A-GSK2890457	576.2	374.1
Part A-Placebo	681.8	860.1

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Change From Baseline in Weighted Mean Glucose Area Under the Curves From Time 0 to 24 Hours (AUC [0-24 Hours]) During the Double-blind Treatment Period of Part B and C

AUC was calculated using the linear trapezoid method that is the sum of the areas between each chronological pair of assessments at the time points (at Day -1 and Day 42). The weighted mean was then calculated by dividing the AUC by the length of the time interval over which it was calculated. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data is reported for weighted mean glucose AUC (0-4 hour) post-breakfast and AUC (0-24 hour) post-breakfast. Adjusted mean is reported as least square (LS) mean. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42

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Intervention	mmol/L (Least Squares Mean)
	AUC (0-4 hour)	AUC (0-24 hour)
Part B-GSK2890457+Liraglutide	-0.164	-0.968
Part B-Placebo+Liraglutide	0.018	-0.613
Part C-GSK2890457+Metformin	0.341	0.156
Part C-Placebo+Metformin	1.194	1.376

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Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During the Double-blind Treatment Period of Part A

Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42

Intervention	Millimeters of mercury (mmHg) (Mean)
	SBP, Day 7	SBP, Day 14	SBP, Day 28	SBP, Day 42	DBP, Day 7	DBP, Day 14	DBP, Day 28	DBP, Day 42
Part A-GSK2890457	-4.0	-3.9	-5.5	-7.5	-6.2	-5.0	-8.4	-6.4
Part A-Placebo	0.8	-0.5	-3.3	-1.0	-5.3	-1.8	-1.3	-0.8

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Change From Baseline in Vital Sign Parameter of SBP and DBP During the Double-blind Treatment Period of Part B and C

Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42

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Intervention	mmHg (Mean)
	SBP, Day 7	SBP, Day 14	SBP, Day 28	SBP, Day 42	DBP, Day 7	DBP, Day 14	DBP, Day 28	DBP, Day 42
Part B-GSK2890457+Liraglutide	2.0	3.6	0.2	0.1	0.4	0.8	0.4	0.8
Part B-Placebo+Liraglutide	1.6	5.6	-0.6	-2.6	-2.4	2.1	-3.3	-1.5
Part C-GSK2890457+Metformin	-3.7	-2.8	-7.4	-3.0	-0.8	-2.5	-3.4	-3.2
Part C-Placebo+Metformin	3.2	3.2	4.5	0.0	0.9	-0.8	-0.4	1.1

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Change From Baseline in Vital Sign Parameter of HR During the Double-blind Treatment Period of Part B and C

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Intervention	Beats per minute (Mean)
	Day 7	Day 14	Day 28	Day 42
Part B-GSK2890457+Liraglutide	0.3	0.4	3.7	1.6
Part B-Placebo+Liraglutide	-3.6	-3.3	-7.8	-4.8
Part C-GSK2890457+Metformin	1.6	3.6	1.5	0.5
Part C-Placebo+Metformin	0.1	0.8	1.8	-3.2

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Change From Baseline in Vital Sign Parameter of Heart Rate (HR) During the Double-blind Treatment Period of Part A

Intervention	Beats per minute (Mean)
	Day 7	Day 14	Day 28	Day 42
Part A-GSK2890457	4.6	0.6	3.3	-4.4
Part A-Placebo	8.0	6.3	5.5	-1.3

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Change From Baseline in the Overall GSRS Score During the Double-blind Treatment Period of Part B and C

The impact of GI symptoms on health-related quality of life was assessed using the GSRS. The GSRS is a 15-item related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Overall GSRS was the mean of items 1 to 15. Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms and higher scores indicating a lower quality of life with respect to GI symptoms. Baseline was defined as the assessment done on Day -2. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, 14, 28 and 41) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -2) up to Day 41

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Intervention	Scores on scale (Mean)
	Day 7	Day 14	Day 28	Day 41
Part B-GSK2890457+Liraglutide	-0.03	0.05	0.03	-0.12
Part B-Placebo+Liraglutide	0.03	-0.09	-0.21	-0.11
Part C-GSK2890457+Metformin	0.13	0.28	0.27	0.10
Part C-Placebo+Metformin	0.24	0.20	0.14	0.02

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Change From Baseline in the Overall Gastrointestinal (GI) Symptoms Rating Scale (GSRS) Score During the Double-blind Treatment Period of Part A

The impact of GI symptoms on health-related quality of life was assessed using the GSRS. The GSRS is a 15-item related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Overall GSRS was the mean of items 1 to 15. Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms and higher scores indicating a lower quality of life with respect to GI symptoms. Baseline was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, 14 and 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42

Intervention	Scores on scale (Mean)
	Day 7	Day 14	Day 42
Part A-GSK2890457	0.08	0.04	-0.02
Part A-Placebo	0.02	0.08	0.02

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Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52

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Intervention	Percentage of participants (Number)
	HbA1c <6.5% at Week 52	HbA1c <7.0% at Week 52
Albiglutide 30 mg Weekly	44	82
Albiglutide 50 mg Weekly	53	85
Open-Label Liraglutide 0.9 mg Daily	27	57
Placebo	14	33

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Change From Baseline in HbA1c at Week 52

Intervention	Percentage of HbA1c in the blood (Mean)
Placebo	-1.07
Albiglutide 30 mg Weekly	-1.07
Albiglutide 50 mg Weekly	-1.34
Open-Label Liraglutide 0.9 mg Daily	-1.17

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Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure. (NCT01733758)
Timeframe: Baseline and Week 24

Intervention	Percentage of HbA1c in the blood (Least Squares Mean)
Placebo	0.25
Albiglutide 30 mg Weekly	-1.10
Albiglutide 50 mg Weekly	-1.30

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Change From Baseline in Body Weight at Week 52

The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline. (NCT01733758)
Timeframe: Baseline and Week 52

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Intervention	Kilograms (kg) (Mean)
	Baseline	Week 52	Change from Baseline at Week 52
Albiglutide 30 mg Weekly	70.07	70.15	0.08
Albiglutide 50 mg Weekly	71.27	70.96	-0.31
Open-Label Liraglutide 0.9 mg Daily	72.43	71.93	-0.50
Placebo	68.07	68.00	-0.07

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Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline. (NCT01733758)
Timeframe: Baseline and Week 52

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Intervention	Milligrams per deciliter (mg/dL) (Mean)
	Baseline	Week 52	Change from Baseline at Week 52
Albiglutide 30 mg Weekly	154.7	131.9	-22.8
Albiglutide 50 mg Weekly	159.8	126.3	-33.5
Open-Label Liraglutide 0.9 mg Daily	157.4	127.0	-30.4
Placebo	154.5	131.7	-22.7

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Time to Study Withdrawal Due to Hyperglycemia

Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to NCT01733758)
Timeframe: Baseline through Week 52

Intervention	Weeks (Median)
Placebo	NA
Albiglutide 30 mg Weekly	NA
Albiglutide 50 mg Weekly	NA
Open-Label Liraglutide 0.9 mg Daily	NA

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Time to Study Withdrawal for Any Reason

Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit. (NCT01733758)
Timeframe: Baseline through Week 52

Intervention	Weeks (Median)
Placebo	NA
Albiglutide 30 mg Weekly	NA
Albiglutide 50 mg Weekly	NA
Open-Label Liraglutide 0.9 mg Daily	NA

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Change From Baseline in Body Weight at Week 24

The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug. (NCT01733758)
Timeframe: Baseline and Week 24

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Intervention	Kilograms (kg) (Mean)
	Baseline	Week 24	Change from Baseline at Week 24
Albiglutide 30 mg Weekly	69.46	69.78	0.32
Albiglutide 50 mg Weekly	71.54	71.50	-0.04
Open-Label Liraglutide 0.9 mg Daily	72.65	72.30	-0.34
Placebo	68.65	68.15	-0.50

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Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug. (NCT01733758)
Timeframe: Week 24

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Intervention	Percentage of participants (Number)
	HbA1c <6.5% at Week 24	HbA1c <7.0% at Week 24
Albiglutide 30 mg Weekly	31	92
Albiglutide 50 mg Weekly	47	100
Open-Label Liraglutide 0.9 mg Daily	29	66
Placebo	1	4

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Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints. (NCT01733758)
Timeframe: Baseline and Week 24

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Intervention	Percentage of HbA1c in the blood (Mean)
	Baseline	Week 24	Change from Baseline
Albiglutide 30 mg Weekly	8.06	6.98	-1.08
Albiglutide 50 mg Weekly	8.15	6.83	-1.32
Open-Label Liraglutide 0.9 mg Daily	8.07	6.87	-1.19
Placebo	8.16	8.39	0.24

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Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug. (NCT01733758)
Timeframe: Baseline and Week 24

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Intervention	Milligrams per deciliter (mg/dL) (Mean)
	Baseline	Week 24	Change from Baseline at Week 24
Albiglutide 30 mg Weekly	157.1	132.2	-24.9
Albiglutide 50 mg Weekly	158.7	128.8	-30.0
Open-Label Liraglutide 0.9 mg Daily	157.2	128.1	-29.1
Placebo	159.3	167.0	7.7

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Glucose Concentrations

Mean daily glucose concentrations at baseline and 26 weeks (NCT01753362)
Timeframe: 26 weeks

Intervention	mg/dL (Mean)
	baseline	26 week
Liraglutide	173	171
Placebo	183	172

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HbA1c

The primary endpoint of the study is to detect a difference in HbA1c percent at baseline and after 26 weeks of treatment with Liraglutide or placebo. (NCT01753362)
Timeframe: 26 weeks

Intervention	percent (Mean)
	baseline	26 week
Liraglutide	7.94	7.60
Placebo	7.77	7.64

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Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone

Measure of targeted blood glucose levels in the Closed Loop setting in the treatment arm, with the addition of Liraglutide compared to insulin monotherapy (continuous subcutaneous insulin infusion) (NCT01755416)
Timeframe: 0-1500 min

Intervention	mg/dl (Mean)
Closed Loop/Insulin	159.7
Closed Loop/Insulin/Liraglutide	144.6

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ACPRg

First phase response from the hyperglycemic clamp (NCT01779362)
Timeframe: 3-months after a medication washout

Intervention	nmol/L (Geometric Mean)
Metformin Alone	1.68
Glargine Followed by Metformin	1.68
Placebo	1.68
Liraglutide + Metformin	1.68

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ß-cell Response Measured by Hyperglycemic Clamp

Clamp measures of ß-cell response, co-primary outcomes (NCT01779362)
Timeframe: 3-months after medication washout (Month 15)

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Intervention	nmol/L (Geometric Mean)
	Steady State C-peptide	ACPRmax
Glargine Followed by Metformin	3.58	4.32
Liraglutide + Metformin	3.73	4.58
Metformin Alone	3.65	4.61
Placebo	3.60	4.45

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ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12

Participants had 12-months of active therapy. Secondary results at the end of active intervention. (NCT01779362)
Timeframe: Secondary analysis was on all participants with a Month 12 visit.

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Intervention	nmol/L (Geometric Mean)
	ACRPg	Steady State C-peptide	ACRPmax
Glargine Followed by Metformin	1.88	11.6	14.1
Liraglutide + Metformin	2.68	21.2	10.1
Metformin Alone	1.93	11.7	13.4
Placebo	1.69	10.8	13.6

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Insulin Sensitivity, M/I

Clamp measure of insulin sensitivity (NCT01779362)
Timeframe: 3-months after a medication washout

Intervention	x 10-5 mmol/kg/min per pmol/L (Geometric Mean)
Metformin Alone	3.53
Glargine Followed by Metformin	3.38
Placebo	3.63
Liraglutide + Metformin	3.49

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Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction

Mean (+/- SD) change in insulin resistance associated with caloric restriction plus liraglutide vs. caloric restriction and placebo. (NCT01784965)
Timeframe: Baseline, 14 weeks

Intervention	mg/dL (Mean)
Placebo	2.8
Liraglutide	-57.5

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Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H

Absolute change in glucose-stimulated insulin secretion (GS-IS) associated with caloric restriction plus liraglutide vs. caloric restriction and placebo at 14 weeks (NCT01784965)
Timeframe: Baseline, 14 weeks

Intervention	pmol/l x4 h (Mean)
Placebo	-7.3
Liraglutide	34

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Change in Weight Reported at 14 Weeks

Change in weight with caloric restriction plus liraglutide vs. caloric restriction and placebo over 14 weeks. (NCT01784965)
Timeframe: Baseline and 14 weeks

Intervention	kg (Mean)
Placebo	-3.3
Liraglutide	-6.8

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Assessment of Changes in Glycemic Control by HbA1c.

To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c. (NCT01787916)
Timeframe: Measure changes in HbA1c at 24 and 52 weeks from baseline

Intervention	percentage of HbA1c (Mean)
Liraglutide	0.3
Placebo	0.2

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Individual Component of the Primary Endpoint- Heart Failure Hospitalization

Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days (NCT01800968)
Timeframe: Randomization to 180 days

Intervention	participants (Number)
Liraglutide	63
Placebo	50

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Individual Component of the Primary Endpoint- Mortality

Individual component of the primary endpoint of mortality at 180 days after randomization (NCT01800968)
Timeframe: Randomization to 180 days

Intervention	participants (Number)
Liraglutide	19
Placebo	16

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Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. (NCT01800968)
Timeframe: Baseline to 90 days

Intervention	units on a scale (Mean)
Liraglutide	13.86
Placebo	11.72

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Global Ranking of Predefined Events

A rank score based on time to death, time to adjudicated heart failure hospitalization, time to emergency department visit and time-averaged proportional change in NTproBNP through d180. See Outcome Measure 1 for a general description of the outcome derivation. (NCT01800968)
Timeframe: Baseline to 180 days

Intervention	rank (Mean)
Liraglutide	144.29
Placebo	157.05

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Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.

Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 180 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. (NCT01800968)
Timeframe: Baseline to 180 days

Intervention	units on a scale (Mean)
Liraglutide	13.44
Placebo	13.25

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Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP

Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days (NCT01800968)
Timeframe: Baseline to 180 days

Intervention	weighted average of ratio to baseline (Mean)
Liraglutide	335.81
Placebo	317

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Change in Lateral Filling Pressure

Change in lateral filling pressure baseline to day 180. (NCT01800968)
Timeframe: Baseline to 180 days

Intervention	m/sec (Mean)
Liraglutide	-0.05
Placebo	0.39

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Global Ranking of Predefined Events

A rank score based on time to death, time to adjudicated heart failure hospitalization, and time-averaged proportional change in NTproBNP through d180. For patients that died, the patient with the shortest time from randomization to death is assigned rank 1, the second shortest time is assigned rank 2, etc. The patient with the longest time from randomization to death is assigned rank X. For patients that did not die but had a heart failure hospitalization, the patient with the shortest time from randomization to re-admission is assigned rank X+1 and the patient with the longest time from randomization to heart failure hospitalization is assigned rank Y. For patients that did not die or have a heart failure hospitalization, increases in time-averaged proportional change in NTproBNP indicate a worse result and the largest increase is assigned rank Y+1. The patient with the largest decrease is assigned rank N, where N is the sample size. (NCT01800968)
Timeframe: Randomization to 180 days

Intervention	rank (Mean)
Liraglutide	145.5
Placebo	155.7

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Change in Medial Filling Pressure

Change in medial filling pressure baseline to day 180. (NCT01800968)
Timeframe: Baseline to 180 days

Intervention	m/sec (Mean)
Liraglutide	1.12
Placebo	0.25

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Change in Left Ventricular End-systolic Volume Index

Change in left ventricular end-systolic volume index from baseline to day 180. (NCT01800968)
Timeframe: Baseline to 180 days

Intervention	ml per meter squared (Mean)
Liraglutide	1.16
Placebo	-3.47

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Change in Left Ventricular Ejection Fraction

Change in left ventricular ejection fraction from baseline to day 180 (NCT01800968)
Timeframe: Baseline to 180 days

Intervention	percent (Mean)
Liraglutide	1.07
Placebo	1.37

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Change in 6 Minute Walk Distance

Change in 6 minute walk distance baseline to 180 days. (NCT01800968)
Timeframe: Baseline to 180 days

Intervention	meters (Mean)
Liraglutide	55.7
Placebo	55.3

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Change in 6 Minute Walk Distance

Change in 6 minute walk distance baseline to 90 days. (NCT01800968)
Timeframe: Baseline to 90 days

Intervention	meters (Mean)
Liraglutide	56.8
Placebo	38.7

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Change in 6 Minute Walk Distance

Change in 6 minute walk distance baseline to day 30 (NCT01800968)
Timeframe: Baseline to day 30

Intervention	meters (Mean)
Liraglutide	50.4
Placebo	37.3

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Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 30 days. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. (NCT01800968)
Timeframe: Baseline to 30 days

Intervention	units on a scale (Mean)
Liraglutide	14.69
Placebo	14.44

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Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to day 180.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. (NCT01800968)
Timeframe: Baseline to day 180

Intervention	units on a scale (Mean)
Liraglutide	13.79
Placebo	13.14

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Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. (NCT01800968)
Timeframe: Baseline to 90 days

Intervention	units on a scale (Mean)
Liraglutide	14.17
Placebo	10.62

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Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 30 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status. (NCT01800968)
Timeframe: Baseline to 30 days

Intervention	units on a scale (Mean)
Liraglutide	12.98
Placebo	14.01

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Change in Left Ventricular End-Diastolic Volume Index

Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days. (NCT01800968)
Timeframe: Baseline to 180 days

Intervention	ml per meter squared (Mean)
Liraglutide	3.37
Placebo	-2.91

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Change in Apnea Hypopnea Index (AHI) From Baseline

Change in the number of apneas plus hypopnea events per hour of sleep from baseline at end of study. (NCT01832532)
Timeframe: Baseline and 4 weeks

Intervention	apnea / hypopnea events per hour sleep (Mean)
Treatment Group- Liraglutide	38.2
Control Group	34

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Change From Baseline in Body Weight

Change from baseline in body weight at week 52. Missing values were handled by using a MMRM. (NCT01836523)
Timeframe: Week 0, week 52

Intervention	kg (Mean)
Liraglutide 0.6 mg	-1.34
Liraglutide 1.2 mg	-2.73
Liraglutide 1.8 mg	-4.02
Placebo	0.94

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c at week 52. Missing values were handled by using a mixed model for repeated measurements (MMRM). (NCT01836523)
Timeframe: Week 0, week 52

Intervention	percentage of glycosylated haemoglobin (Mean)
Liraglutide 0.6 mg	-0.45
Liraglutide 1.2 mg	-0.50
Liraglutide 1.8 mg	-0.54
Placebo	-0.34

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Change From Baseline in Total Daily Insulin Dose

Change from baseline in total daily insulin dose at week 52. Change from baseline was represented in terms of ratio to baseline for insulin dose i.e. Total daily insulin dose at week 52/total daily insulin dose at baseline. Missing values were handled by using a MMRM. (NCT01836523)
Timeframe: Week 0, week 52

Intervention	ratio (Geometric Mean)
Liraglutide 0.6 mg	1.04
Liraglutide 1.2 mg	0.98
Liraglutide 1.8 mg	0.95
Placebo	1.04

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Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes

This is a confirmatory secondary endpoint. Symptomatic hypoglycaemic episodes were defined as: 1) Severe according to the American Diabetes Association (ADA) classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. OR 2) Self-monitoring of plasma glucose value of <3.1 mmol/L, with symptoms consistent with hypoglycaemia. A treatment emergent episode is defined as an episode with onset date (or increase in severity) on or after first day of exposure to randomised treatment and up to last dose + 7 days. (NCT01836523)
Timeframe: Weeks 0-52

Intervention	episodes (Number)
Liraglutide 0.6 mg	4954
Liraglutide 1.2 mg	4602
Liraglutide 1.8 mg	4614
Placebo	3654

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Urinary Albumin Excretion Rate

Albuminuria as Measured by 24 Hour Albumin Excretion Rate (NCT01847313)
Timeframe: Up to 26 weeks

Intervention	µg/min (Mean)
Liraglutide	144.1
Control	132.4

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sCD163 in Serum

Serum sample for sCD163 (NCT01847313)
Timeframe: Up to 26 weeks

Intervention	ng/ml (Mean)
Liraglutide	82
Control	84

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sCD163:Creatinine Ratio in Urine

Spot urine sample for MCP-1 and creatinine (NCT01847313)
Timeframe: Up to 26 weeks

Intervention	pg/mmol (Mean)
Liraglutide	27.9
Control	24.3

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MCP-1:Creatinine Ratio in Urine

Spot urine sample for MCP-1 and creatinine (NCT01847313)
Timeframe: Up to 26 weeks

Intervention	ng/mmol (Mean)
Liraglutide	27.9
Control	24.3

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the Incremental Meal-related Glucose Area Under Curve (AUC)

(NCT01856790)
Timeframe: 5-hour post prandial period after breakfast, lunch, and dinner

Intervention	mg*hr/dL (Mean)
Closed Loop Insulin Delivery	789
Closed Loop + Liraglutide	500

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Mean Nocturnal Glucose Levels

(NCT01856790)
Timeframe: 11p.m.-6a.m.

Intervention	mg/dL (Mean)
Closed Loop Insulin Delivery	104
Closed Loop + Liraglutide	113

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AUC Plasma Glucagon During MMTT

(NCT01856790)
Timeframe: 2 hours

Intervention	pg*min/mL (Mean)
Closed Loop Insulin Delivery	1904
Closed Loop + Liraglutide	1801

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Differences in Daily Insulin Requirements

(NCT01856790)
Timeframe: 24 hours

Intervention	units (Mean)
Pre-Liraglutide Treatment	51.5
Post-Liraglutide Treatment	37.5

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Incremental Glucagon Peak

(NCT01856790)
Timeframe: 5 hours

Intervention	pg/mL/min (Mean)
Closed Loop Insulin Delivery	29
Closed Loop + Liraglutide	35

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Mean 24-hour Glucose Levels

(NCT01856790)
Timeframe: 24- hours

Intervention	mg/dL (Mean)
Closed Loop Insulin Delivery	130
Closed Loop + Liraglutide	135

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Mean Daytime Glucose Levels

(NCT01856790)
Timeframe: 8a.m.-11p.m.

Intervention	mg/dL (Mean)
ePID Closed Loop System Without Liraglutide	143
ePID Closed Loop System With Liraglutide	146

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Mean Time to Peak Post-meal Glucose Value

(NCT01856790)
Timeframe: 5- hour postprandial period

Intervention	hours (Mean)
Closed Loop Insulin Delivery	1.8
Closed Loop + Liraglutide	1.8

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Peak Post-prandial Venous Glucose Levels

peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between closed loop (CL) alone and CL + liraglutide (NCT01856790)
Timeframe: 48 hours

Intervention	mg/dL (Mean)
Closed Loop Insulin Delivery	98
Closed Loop + Liraglutide	76

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Prandial Insulin Delivery During Closed Loop Therapy

(NCT01856790)
Timeframe: Average of the 5-hour post prandial period for breakfast, lunch, dinner combined

Intervention	units (Mean)
Closed Loop Insulin Delivery	22.6
Closed Loop + Liraglutide	16.3

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Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. (NCT01870297)
Timeframe: Predose on Day 1 up to Day 56 in each Part

Intervention	participants (Number)
Placebo Part A	0
0.5 mg LY3025876	0
1.5 mg LY3025876	0
5.0 mg LY3025876	0
15 mg LY3025876	0
Placebo + Liraglutide	0
5.0 mg LY3025876 + Liraglutide	0

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Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose

Least Squares Mean (LS) Mean change from baseline in fasting glucose was modeled using Mixed Effect Model Repeat Measurement (MMRM) analysis with fixed effects of baseline, treatment, day, treatment*day interaction, and participant as a random effect. (NCT01870297)
Timeframe: Baseline, Day 28

Intervention	milligram/deciliter (mg/dL) (Least Squares Mean)
Placebo Part A	3.52
0.5 mg LY3025876	18.08
1.5 mg LY3025876	0.12
5.0 mg LY3025876	-14.50
15 mg LY3025876	22.96
Placebo Part B	11.72
5.0 mg LY3025876 + Liraglutide	6.32

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PK: Maximum Concentration (Cmax) of LY3025876

(NCT01870297)
Timeframe: Days 1 and 28: Predose and 0.5 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose

,,,,

Intervention	nanogram/milliliter (ng/mL) (Geometric Mean)
	Day 1	Day 28
0.5 mg LY3025876	3.90	4.87
1.5 mg LY3025876	17.5	14.2
15 mg LY3025876	126	185
5.0 mg LY3025876	45.1	51.9
5.0 mg LY3025876 + Liraglutide	40.3	44.8

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Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies

(NCT01870297)
Timeframe: Predose on Day 7, 14, 28, 56, and 180

,,,,,,

Intervention	Participants (Count of Participants)
	Positive Antibodies Day 7	Positive Antibodies Day 14	Positive Antibodies Day 28	Positive Antibodies Day 56	Positive Antibodies Day 180
0.5 mg LY3025876	0	1	1	1	0
1.5 mg LY3025876	0	0	2	4	0
15 mg LY3025876	1	0	6	6	4
5.0 mg LY3025876	0	0	2	2	1
5.0 mg LY3025876 + Liraglutide	1	1	1	1	0
Placebo + Liraglutide	0	0	0	0	0
Placebo Part A	0	0	0	0	0

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Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876

AUC(0-24) of individual participants was calculated by equation Area Under Concentration (AUC)=Dose/CL, where the clearance (CL) was estimated using a population PK model. (NCT01870297)
Timeframe: Predose and 0.5 hour(hr), 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose

Intervention	nanogramshour/milliliter (nghr/mL) (Geometric Mean)
0.5 mg LY3025876	51.5
1.5 mg LY3025876	207
5.0 mg LY3025876	622
15 mg LY3025876	1930
LY3025876 + Liraglutide	525

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Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)

Number of subjects who achieve HbA1c <7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM. (NCT01907854)
Timeframe: After 26 weeks of treatment

Intervention	percentage (%) (Number)
	Yes	No
Liraglutide	50.6	49.4
Sitagliptin	26.9	73.1

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Change in Systolic Blood Pressure and Diastolic Blood Pressure

Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM. (NCT01907854)
Timeframe: From baseline to week 26

Intervention	mmHg (Mean)
	Systolic Blood Pressure	Diastolic Blood Pressure
Liraglutide	-3.6	-0.23
Sitagliptin	-2.57	-0.81

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Change in Fasting Blood Lipids

Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein [LDL], very low density lipoprotein [VLDL], high density lipoprotein [HDL], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data. (NCT01907854)
Timeframe: From baseline to week 26

Intervention	ratio (Mean)
	Total cholesterol	LDL cholesterol	VLDL cholesterol	HDL cholesterol	Triglycerides	Free Fatty acids
Liraglutide	1.011	1.049	1.062	1.004	1.089	1.086
Sitagliptin	1.045	1.121	1.075	0.997	1.099	1.104

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Change in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM). (NCT01907854)
Timeframe: From baseline to week 26

Intervention	percentage of glycosylated haemoglobin (Mean)
Liraglutide	-1.146
Sitagliptin	-0.529

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Number of Treatment Emergent Adverse Events (TEAEs)

A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus one week follow-up period. (NCT01907854)
Timeframe: During 26 weeks of treatment plus one week follow-up period.

Intervention	number of events (Number)
Liraglutide	455
Sitagliptin	318

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Change in Fasting Plasma Glucose

Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM. (NCT01907854)
Timeframe: From baseline to week 26

Intervention	nmol/L (Mean)
Liraglutide	-1.967
Sitagliptin	-0.588

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Change in Body Weight

Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM. (NCT01907854)
Timeframe: From baseline to week 26

Intervention	kg (Mean)
Liraglutide	-3.32
Sitagliptin	-1.80

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Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.

(NCT01917656)
Timeframe: Day -1 to day 29

Intervention	Events/1000 years of patient exposure (Number)
Liraglutide and Metformin	246
Sulfonylurea and Metformin	623

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Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)

Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target) (NCT01917656)
Timeframe: Visit 14 (4 weeks post Ramadan)

Intervention	percentage (%) of subjects (Number)
Liraglutide and Metformin	51.0
Sulfonylurea and Metformin	29.9

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Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes

Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target) (NCT01917656)
Timeframe: Visit 14 (4 weeks post Ramadan)

Intervention	percentage (%) of subjects (Number)
Liraglutide and Metformin	47.6
Sulfonylurea and Metformin	25.2

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Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.

"A serious AE was an experience that at any dose resulted in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, congenital anomaly or birth defect, important medical events.~Mild - no or transient symptoms, no interference with the subject's daily activities Moderate - marked symptoms, moderate interference with the subject's daily activities Severe - considerable interference with the subject's daily activities, unacceptable" (NCT01917656)
Timeframe: Day -1 to day 29

Intervention	Events/1000 years of patient exposure (Number)
	Adverse events	Serious adverse events	Severe adverse events	Moderate adverse event	Mild adverse event
Liraglutide and Metformin	5258	164	411	986	3861
Sulfonylurea and Metformin	3349	0	78	779	2492

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Change in Fructosamine From Start of Ramadan to End of Ramadan

The level of fructosamine in the blood was used to assess the glycaemic control in the patients during the time period described- from start of Ramadan (day -1, visit 8) to end of Ramadan (day 29, visit 12). (NCT01917656)
Timeframe: Day -1, day 29

Intervention	umol/L (Mean)
Liraglutide and Metformin	-13.2
Sulfonylurea and Metformin	-14.9

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Fructosamine at End of Ramadan

The fructosamine values at the end of Ramadan (visit 12) were presented (NCT01917656)
Timeframe: Day 29

Intervention	umol/L (Mean)
Liraglutide and Metformin	276.8
Sulfonylurea and Metformin	284.9

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Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)

The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described. (NCT01917656)
Timeframe: Day -1, day 29

Intervention	mmol/L (Mean)
Liraglutide and Metformin	-0.1
Sulfonylurea and Metformin	0.1

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Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)

The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described. (NCT01917656)
Timeframe: Baseline, day 29

Intervention	Percent (%) glycosylated haemoglobin (Mean)
Liraglutide and Metformin	-1.3
Sulfonylurea and Metformin	-0.7

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Change From Baseline to End of Ramadan in Fasting Plasma Glucose

The changes from baseline measured postbaseline (i.e., the changes measured on visit 8 and 12) entered as the dependent variables, and visit, treatment, country, and the stratification variables were included as fixed factors and the corresponding values for the specific endpoint measured at randomisation as covariate. (NCT01917656)
Timeframe: Baseline, day 29

Intervention	mmol/L (Mean)
Liraglutide and Metformin	-1.8
Sulfonylurea and Metformin	-0.6

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Change From Baseline to End of Ramadan in Body Weight

(NCT01917656)
Timeframe: Baseline, day 29

Intervention	kg (Least Squares Mean)
Liraglutide and Metformin	-5.40
Sulfonylurea and Metformin	-1.46

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Hypoglycemic Episodes

Number of participants who had at least one hypoglycemic event (<70 mg/dl) and severe hypoglycemic event (<40 mg/dl) (NCT01919489)
Timeframe: After discharge, average 6 months

Intervention	Participants (Count of Participants)
	Participants who had at least one hypoglycemic events (<70 mg/dl)	Participants who had at least one severe hypoglycemic event (<40 mg/dl)
Glargine + OADs	31	3
Liraglutide + OADs	18	2

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HbA1c <7.0% and no Weight Gain

Percent of patients with 26 week HbA1c <7.0% and no weight gain (NCT01919489)
Timeframe: After discharge, average 6 months

Intervention	Participants (Count of Participants)
Liraglutide + OADs	32
Glargine + OADs	21

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Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up

Number of participants that reported self-measured blood glucose (SMBG) 7-point profiles at 26 weeks follow up (NCT01919489)
Timeframe: 26 weeks post-intervention

Intervention	Participants (Count of Participants)
Liraglutide + OADs	34
Glargine + OADs	34

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Change in Body Weight From Baseline

Change in body weight from baseline after 6 months of follow up (26 weeks) (NCT01919489)
Timeframe: After discharge, average 6 months

Intervention	Kgs (Mean)
	Baseline weight at discharge	Weight at six months	Weight change from baseline (discharge) to 6 months after discharge
Glargine + OADs	98.2	98.3	0.6
Liraglutide + OADs	101.0	97.2	-4.77

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Total Daily Dose of Insulin

Evaluate the total daily dose of insulin needed in the group receiving glargine (NCT01919489)
Timeframe: After discharge, average 6 months

Intervention	IU per day (Mean)
Liraglutide + OADs	0
Glargine + OADs	20.9

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Cardiovascular Risk Factor: Heart Rate

Cardiovascular risk: heart rate at baseline and 26 weeks post-intervention (NCT01919489)
Timeframe: 26 weeks post-intervention

Intervention	beats/min (Mean)
	Heart rate at baseline (discharge)	Heart rate at 6 months post-discharge
Glargine + OADs	79	79
Liraglutide + OADs	79	83

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Change in BMI

Change in BMI after 6 months from baseline (NCT01919489)
Timeframe: Baseline, and follow up after discharge (average 6 months)

Intervention	kg/m2 (Mean)
	Baseline BMI	BMI at 26 weeks follow up
Glargine + OADs	33.3	33.3
Liraglutide + OADs	33.5	32.7

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HbA1c <7.0% and no Hypoglycemia

Percent of patients with 12 week HbA1c <7.0% and no hypoglycemia (NCT01919489)
Timeframe: After discharge, average 12 weeks

Intervention	Participants (Count of Participants)
Liraglutide + OADs	40
Glargine + OADs	31

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Cardiovascular Risk Factor: Lipid Profile

Lipid profile was measured with total cholesterol level results at 26 weeks post-intervention. This outcome was not part of standard of care. (NCT01919489)
Timeframe: 26 weeks post-intervention

Intervention	mg/dL (Mean)
Liraglutide + OADs	190
Glargine + OADs	130

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Acute Renal Failure

Acute renal failure during the 26-week follow-up defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (increment in creatinine > 0.5 mg/dL from baseline) (NCT01919489)
Timeframe: After discharge, average 6 months

Intervention	Participants (Count of Participants)
Liraglutide + OADs	1
Glargine + OADs	3

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HbA1c <7.0% and no Hypoglycemia

Percent of patients with 26 week HbA1c <7.0% and no hypoglycemia (NCT01919489)
Timeframe: After discharge, average 6 months

Intervention	Participants (Count of Participants)
Liraglutide + OADs	34
Glargine + OADs	29

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Change in Cardiovascular Risk Factors: Blood Pressure

Cardiovascular risk factors including changes in systolic and diastolic blood pressure from baseline to 26 weeks post-intervention (NCT01919489)
Timeframe: Baseline, 26 weeks post-intervention

Intervention	mmHg (Mean)
	Systolic blood pressure at baseline	Systolic blood pressure at 26 weeks follow up	Diastolic blood pressure at baseline	Diastolic blood pressure at 26 weeks follow up
Glargine + OADs	130	135	77	79
Liraglutide + OADs	134	136	79	80

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Emergency Room Visits and Readmissions

Number of participants who had at least one emergency room visit and hospital readmissions (NCT01919489)
Timeframe: After discharge, average 6 months

Intervention	Participants (Count of Participants)
	Number of participants with at least one ER visit	Number of participants with at least one hospital readmission
Glargine + OADs	23	43
Liraglutide + OADs	31	35

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Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks

To determine differences in BG concentration between liraglutide and glargine insulin therapy (NCT01919489)
Timeframe: After discharge, average at 3 months (12 week) and 6 months (26 weeks)

Intervention	mmol/L (Mean)
	Fasting blood glucose at 26 weeks follow up	Post-prandial blood glucose at 12 weeks	Postprandial blood glucose at 26 weeks follow up	Fasting blood glucose at 12 weeks
Glargine + OADs	8.56	9.32	8.72	7.70
Liraglutide + OADs	7.61	7.67	8.23	7.96

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Glycemic Control at Hospital Discharge and 6 Months Follow up

To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy (NCT01919489)
Timeframe: Hospital discharge, 6 months (26 weeks)

Intervention	% (mmol/mol) (Mean)
	HbA1C at hospital discharge	HbA1C at 6 months post-intervention
Glargine + OADs	8.4	7.68
Liraglutide + OADs	8.3	7.13

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AUC Total GIP

(NCT01937598)
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)

Intervention	pmol/l*min (Mean)
Sitagliptin	6242
Placebo	7523

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AUC Total GLP-1

(NCT01937598)
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)

Intervention	pmol/l*min (Mean)
Sitagliptin	748
Placebo	1143

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Incremental Area Under the Plasma Glucose (BG) Concentration-time Profile (AUC)

Incremental area under the plasma glucose (BG) concentration-time profile (AUC) immediately before to 300 min after a mixed meal test. In addition, the time course of BG values will be analysed with an ANCOVA model for repeated measurements with placebo baseline values as covariate. Time points to create the curce were 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 and 300 minutes post mixed meal test. (NCT01937598)
Timeframe: 0 to 300 min post mixed meal test

Intervention	[mg*min/dL] (Mean)
Sitagliptin	5678
Placebo	5557

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AUC Active GIP

(NCT01937598)
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)

Intervention	pmol/l*min (Mean)
Sitagliptin	6270
Placebo	3496

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AUC Active GLP-1

(NCT01937598)
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)

Intervention	pmol/l*min (Mean)
Sitagliptin	607.9
Placebo	418.4

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AUC C-peptide

(NCT01937598)
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)

Intervention	nmol/l*min (Mean)
Sitagliptin	171.5
Placebo	159.2

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AUC Glucagon

(NCT01937598)
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)

Intervention	pmol/l*min (Mean)
Sitagliptin	6933
Placebo	7004

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AUC Insulin

(NCT01937598)
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)

Intervention	nmol/l*min (Mean)
Sitagliptin	45.8
Placebo	42.6

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AUC Plasma Glucose

Incremental AUC from 0 to 300 min (NCT01937598)
Timeframe: Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)

Intervention	mmol/l*min (Mean)
Sitagliptin	315.4
Placebo	308.7

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Change From Baseline in Body Weight

Change from baseline in body weight after 26 weeks of treatment (NCT01952145)
Timeframe: Week 0, week 26

Intervention	Kg (Mean)
Insulin Degludec/Liraglutide (IDegLira)	-1.4
Insulin Glargine (IGlar)	1.8

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c after 26 weeks of treatment (NCT01952145)
Timeframe: Week 0, week 26

Intervention	Percentage (%) (Mean)
Insulin Degludec/Liraglutide (IDegLira)	-1.81
Insulin Glargine (IGlar)	-1.13

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Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia. (NCT01952145)
Timeframe: During 26 weeks of treatment

Intervention	Number of episodes (Number)
Insulin Degludec/Liraglutide (IDegLira)	289
Insulin Glargine (IGlar)	683

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Change in Short Form-36 (SF-36) Questionnaire Score

Quality of life questionnaires will be completed by the patient at the randomization and end-of study visits. SF-36 is scored on a 1-100 scale; a higher score represents a better self-assessed health - for all domains. (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 26

Intervention	score on a scale (Least Squares Mean)
	Physical Component Summary	Mental Component Summary
Control: Metformin, Insulin Detemir, Insulin Aspart	-0.1	0.04
Metformin, Insulin Determir, Liraglutide	0.007	0.09

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Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means

Diabetes Quality of Life (DQOL) questionnaires will be completed by the patient at the randomization and end-of study visits. ALL D-QOL domains are scored on a 1-5 scale, with a lower number representing better quality of life or treatment satisfaction. Outcome reported is difference between mean baseline and mean Week 26 score. (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 26

Intervention	score on a scale (Least Squares Mean)
	General Health Perception	Current Health Perception	Treatment Satisfaction	Diabetes Related Worry	Social or Vocational Worry	Hypoglycemia Fear	Glycemic Control Perception	Satisfaction with Insulin Treatment	Willingness to Continue Insulin Treatment	LifeStyle Flexibility	Social Stigma
Control: Metformin, Insulin Detemir, Insulin Aspart	-0.3	-0.5	-0.3	0.03	-0.02	0.3	-1.1	-1.3	-0.9	-0.09	0.1
Metformin, Insulin Determir, Liraglutide	-0.9	-1.1	-0.6	-0.2	-0.2	-0.2	-1.6	-1.7	-1.1	-0.2	0.01

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Percentage of Participants Reaching Target A1c of <7% at Week 26

(NCT01966978)
Timeframe: Week 26

Intervention	percentage of participants (Number)
Control: Metformin, Insulin Detemir, Insulin Aspart	20
Metformin, Insulin Determir, Liraglutide	44

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Mean Change From Randomization in Body Weight

Change in body weight from randomization to end of study. (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 26

Intervention	kilogram (Mean)
Control: Metformin, Insulin Detemir, Insulin Aspart	3.1
Metformin, Insulin Determir, Liraglutide	-0.6

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Mean Change From Randomization in A1c at Week 26

Change in glycosylated Hemoglobin A1c (A1c) from randomization to 26 weeks of therapy (NCT01966978)
Timeframe: Baseline and Week 26

Intervention	Percentage of glycosylated hemoglobin (Mean)
Control: Metformin, Insulin Detemir, Insulin Aspart	3.4
Metformin, Insulin Determir, Liraglutide	4.1

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Hypoglycemic Episodes

Percentage of participants experiencing any episodes of documented hypoglycemia defined as CBG reading of <70 mg/dl (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 2, week 4, week 13, Week 26

Intervention	percentage of participants (Number)
Control: Metformin, Insulin Detemir, Insulin Aspart	66.1
Metformin, Insulin Determir, Liraglutide	35.2

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"Percentage of Participants Reaching Pre-specified Treatment Failure Outcome"

Treatment Failure defined as A1c>10% at week 13 (visit 5) (NCT01966978)
Timeframe: week 13

Intervention	percentage of participants (Number)
Control: Metformin, Insulin Detemir, Insulin Aspart	16.1
Metformin, Insulin Determir, Liraglutide	7.4

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Composite End-point

Percentage of participants with glycosylated Hemoglobin A1c (A1c)<8% AND no documented severe hypoglycemia (<56 mg/dL) during the study AND no significant weight gain (>3% from baseline) (NCT01966978)
Timeframe: Week 0 (Randomization) , Week 26

Intervention	percentage of participants (Number)
Control: Metformin, Insulin Detemir, Insulin Aspart	16
Metformin, Insulin Determir, Liraglutide	34

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Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no)

Subjects who achieved HbA1c below equal to or below 6.5% (48 mmol/mol) after 26 weeks of treatment (yes/no). (NCT01973231)
Timeframe: After 26 weeks of treatment

Intervention	percentage (%) of subjects (Number)
	Yes	No
Liraglutide	54.6	45.4
Lixisenatide	26.2	73.8

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Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)

Subjects who achieved HbA1c below 7.0% (53 mmol/mol) and no weight gain after 26 weeks of treatment (yes/no). (NCT01973231)
Timeframe: After 26 weeks of treatment

Intervention	percentage (%) of subjects (Number)
	Yes	No
Liraglutide	66.5	33.5
Lixisenatide	41.9	58.1

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Change in Body Weight From Baseline

Change from baseline in body weight after 26 weeks of treatment. (NCT01973231)
Timeframe: Week 0, week 26

Intervention	kg (Mean)
Liraglutide	-4.24
Lixisenatide	-3.69

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Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)

Subjects who achieved HbA1c below 7.0% (53 mmol/mol) after 26 weeks of treatment (yes/no). (NCT01973231)
Timeframe: After 26 weeks of treatment

Intervention	percentage (%) of subjects (Number)
	Yes	No
Liraglutide	74.2	25.8
Lixisenatide	45.5	54.5

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Number of Treatment Emergent Adverse Events (TEAEs)

A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator. (NCT01973231)
Timeframe: Weeks 0-26

Intervention	events (Number)
	Events	Serious	Severe	Moderate	Mild
Liraglutide	540	13	10	109	421
Lixisenatide	435	7	3	84	348

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Change in Glycosylated Haemoglobin (HbA1c) From Baseline

Change from baseline in HbA1c after 26 weeks of treatment. (NCT01973231)
Timeframe: Week 0, week 26

Intervention	Percent (%) glycosylated haemoglobin (Mean)
Liraglutide	-1.809
Lixisenatide	-1.238

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Change in Fasting Plasma Glucose (FPG) From Baseline

Change from baseline in FPG after 26 weeks of treatment. (NCT01973231)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Liraglutide	-2.904
Lixisenatide	-1.644

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Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs) in Part 1

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Discontinuations are presented by individual dose received by participants during titration in an assigned study treatment sequence. (NCT01982630)
Timeframe: Up to approximately 14 days

Intervention	Participants (Count of Participants)
Part 1: MK-8521 64 μg/Day	2
Part 1: MK-8521 120 μg/Day	0
Part 1: MK-8521 34 μg/Day	0
Part 1: MK-8521 72 μg/Day	0
Part 1: Liraglutide 0.6 mg/Day	1
Part 1: Liraglutide 1.2 mg/Day	0
Part 1: Liraglutide 1.8 mg/Day	0
Part 1: Placebo for MK-8521	0

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Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs) in Part 2

Intervention	Participants (Count of Participants)
Part 2: MK-8521 64 μg/Day	0
Part 2: MK-8521 120 μg/Day	0
Part 2: MK-8521 180 μg/Day	0
Part 2: MK-8521 240 μg/Day	1
Part 2: MK-8521 300 μg/Day	0
Part 2: Liraglutide 0.6 mg/Day	0
Part 2: Liraglutide 1.2 mg/Day	1
Part 2: Liraglutide 1.8 mg/Day	1
Part 2: Placebo for MK-8521-T2DM	1
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese	0
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese	0

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Number of Participants Experiencing Adverse Events (AEs) in Part 1

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. AEs are presented by individual dose received by participants during titration in an assigned study treatment sequence. (NCT01982630)
Timeframe: Up to approximately 42 days

Intervention	Participants (Count of Participants)
Part 1: MK-8521 64 μg/Day	5
Part 1: MK-8521 120 μg/Day	5
Part 1: MK-8521 34 μg/Day	1
Part 1: MK-8521 72 μg/Day	4
Part 1: Liraglutide 0.6 mg/Day	2
Part 1: Liraglutide 1.2 mg/Day	7
Part 1: Liraglutide 1.8 mg/Day	2
Part 1: Placebo for MK-8521	5

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Number of Participants Experiencing Adverse Events (AEs) in Part 2

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. AEs are presented by individual dose received by participants during titration in an assigned study treatment sequence. (NCT01982630)
Timeframe: Up to approximately 57 days

Intervention	Participants (Count of Participants)
Part 2: MK-8521 64 μg/Day	8
Part 2: MK-8521 120 μg/Day	14
Part 2: MK-8521 180 μg/Day	6
Part 2: MK-8521 240 μg/Day	13
Part 2: MK-8521 300 μg/Day	8
Part 2: Liraglutide 0.6 mg/Day	8
Part 2: Liraglutide 1.2 mg/Day	8
Part 2: Liraglutide 1.8 mg/Day	12
Part 2: Placebo for MK-8521-T2DM	3
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese	2
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese	4

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Time to Maximum Concentration (Tmax) of MK-8521 on Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

Tmax was the time required to reach the maximum concentration of MK-8521 in plasma. Plasma samples were collected from predose to 120 hours postdose for determination of Tmax. Tmax is presented as median with a full range. (NCT01982630)
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, 24, 72, 96, and 120 hours post-dose on Day 14

Intervention	Hours (Median)
Part 1: MK-8521 64/120 μg/Day	8
Part 1: MK-8521 34/72 μg/Day	6

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Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2

AUC0-24hr was the area under the concentration-time curve of MK-8521 from time zero to 24 hours after administration. Plasma samples were collected from predose to 24 hours postdose for determination of AUC0-24hr. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. AUC0-24hr is presented as geometric mean and percent coefficient of variation of geometric mean. (NCT01982630)
Timeframe: Predose and 1, 2, 6, 10, 16, and 24 hours postdose on Days 1, 7, and 14

Intervention	nM•hour (Geometric Mean)
	Day 1	Day 7	Day 14
Part 2: MK-8521 64/120 µg/Day-Non-Diabetic Overweight/Obese	7.68	15.0	34.4
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	6.46	15.1	30.0

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Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

AUC0-24hr was the area under the concentration-time curve of MK-8521 from time zero to 24 hours after administration. Plasma samples were collected from predose to 24 hours postdose for determination of AUC0-24hr. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. AUC0-24hr is presented as geometric mean and percent coefficient of variation of geometric mean. (NCT01982630)
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1, 7, and 14

Intervention	nM•hour (Geometric Mean)
	Day 1	Day 7	Day 14
Part 1: MK-8521 34/72 μg/Day	2.25	5.63	12.6
Part 1: MK-8521 64/120 μg/Day	6.11	14.4	32.8

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Maximum Concentration (Cmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2

Cmax was the maximum observed concentration of MK-8521 in plasma after administration. Plasma samples were collected from predose to 120 hours postdose for determination of Cmax. Per protocol, Cmax in the non-diabetic overweight/obese participants was not measured on Days 19, 24, and 29 because they only received 14 days of treatment. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. Cmax is presented as geometric mean and percent coefficient of variation of geometric mean. (NCT01982630)
Timeframe: Predose and 1, 2, 6, 10, 16, 24 hours post dose on Days 1, 7, 14, 19, 24 (T2DM) and Days 1 and 7 (Non-Diabetic Overweight/Obese); predose and 1, 2, 6, 10, 16, 24, 72, 96. and 120 hours post dose on Day 14 (Non-Diabetic Overweight/Obese) and Day 29 (T2DM).

Intervention	nM (Geometric Mean)
	Day 1	Day 7	Day 14
Part 2: MK-8521 64/120 μg/Day-Non-Diabetic Overweight/Obese	0.411	0.742	1.72

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Maximum Concentration (Cmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2

Intervention	nM (Geometric Mean)
	Day 1	Day 7	Day 14	Day 19	Day 24	Day 29
Part 2: MK-8521 64/120/180/240/300 μg/Day-T2DM	0.35	0.719	1.43	2.27	2.85	3.14

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Maximum Concentration (Cmax) of MK-8521 on Days 1 and 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

Cmax was the maximum observed concentration of MK-8521 in plasma after administration. Plasma samples were collected from predose to 24 hours postdose for determination of Cmax. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. Cmax is presented as geometric mean and percent coefficient of variation of geometric mean. (NCT01982630)
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7

Intervention	nM (Geometric Mean)
	Day 1	Day 7
Part 1: MK-8521 34/72 μg/Day	0.128	0.275
Part 1: MK-8521 64/120 μg/Day	0.350	0.710

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Time to Maximum Concentration (Tmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2

Tmax was the time required to reach the maximum concentration of MK-8521 in plasma. Plasma samples were collected from predose to 120 hours postdose for determination of Tmax. Per protocol, Tmax in the non-diabetic overweight/obese participants was not measured on Days 19, 24, and 29 because they only received 14 days of treatment. Tmax is presented as median with a full range. (NCT01982630)
Timeframe: Predose and 1, 2, 6, 10, 16, 24 hours post dose on Days 1, 7, 14, 19, 24 (T2DM) and Days 1 and 7 (Non-Diabetic Overweight/Obese); predose and 1, 2, 6, 10, 16, 24, 72, 96. and 120 hours post dose on Day 14 (Non-Diabetic Overweight/Obese) and Day 29 (T2DM).

Intervention	Hours (Median)
	Day 1	Day 7	Day 14
Part 2: MK-8521 64/120 μg/Day-Non-Diabetic Overweight/Obese	16	10	6

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Time to Maximum Concentration (Tmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2

Intervention	Hours (Median)
	Day 1	Day 7	Day 14	Day 19	Day 24	Day 29
Part 2: MK-8521 64/120/180/240/300 μg/Day-T2DM	16	10	6	6	6	10

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Time to Maximum Concentration (Tmax) of MK-8521 on Days 1 and 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

Tmax was the time required to reach the maximum concentration of MK-8521 in plasma. Plasma samples were collected from predose to 24 hours postdose for determination of Tmax. Tmax is presented as median with a full range. (NCT01982630)
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7

Intervention	Hours (Median)
	Day 1	Day 7
Part 1: MK-8521 34/72 μg/Day	16	6
Part 1: MK-8521 64/120 μg/Day	16	7

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Trough Concentration (Ctrough) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2

Ctrough was the lowest observed concentration of MK-8521 in plasma. Plasma samples were collected predose on Day 2 (sampled after the Day 1 dose and prior to Day 2 dose), 7, 14, 19, 24, and 29 for determination of Ctrough. Per protocol, Ctrough in the non-diabetic overweight/obese participants was not measured on Days 19, 24, and 29 because they only received 14 days of treatment. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. Ctrough is presented as geometric mean and percent coefficient of variation of geometric mean. (NCT01982630)
Timeframe: Predose on Days 2 (sampled 24 hours after Day 1 dose) and 7, 14, 19, 24, and 29

Intervention	nM (Geometric Mean)
	Day 1	Day 7	Day 14
Part 2: MK-8521 64/120 μg/Day-Non-Diabetic Overweight/Obese	0.388	0.492	1.12

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Trough Concentration (Ctrough) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2

Intervention	nM (Geometric Mean)
	Day 1	Day 7	Day 14	Day 19	Day 24	Day 29
Part 2: MK-8521 64/120/180/240/300 μg/Day-T2DM	0.331	0.533	1.07	1.61	2.02	2.47

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Trough Concentration (Ctrough) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

Ctrough was the lowest observed concentration of MK-8521 in plasma. Plasma samples were collected predose on Day 2 (sampled after the Day 1 dose and prior to Day 2 dose), 7, and 14 for determination of Ctrough. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. Ctrough is presented as geometric mean and percent coefficient of variation of geometric mean. (NCT01982630)
Timeframe: Predose on Days 2, 7, and 14

Intervention	nM (Geometric Mean)
	Day 1	Day 7	Day 14
Part 1: MK-8521 34/72 μg/Day	0.119	0.207	0.506
Part 1: MK-8521 64/120 μg/Day	0.322	0.442	1.16

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Accumulation Ratio of the Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2

Plasma samples were collected from predose to 24 hours postdose for determination of the accumulation ratio of AUC0-24hr. The geometric mean accumulation ratio was calculated as Day 7 AUC0-24hr/Day 1 AUC0-24hr and presented as geometric mean ratio and percent geometric coefficient of variation. (NCT01982630)
Timeframe: Predose and 1, 2, 6, 10, 16, and 24 hours post-dose on Days 1 and 7

Intervention	Ratio (Geometric Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	2.33
Part 2: MK-8521 64/120 µg/Day-Non-Diabetic Overweight/Obese	1.95

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Accumulation Ratio of the Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

Plasma samples were collected from predose to 24 hours postdose for determination of the accumulation ratio of AUC0-24hr. The geometric mean accumulation ratio was calculated as Day 7 AUC0-24hr/Day 1 AUC0-24hr and presented as geometric mean ratio with a full range. (NCT01982630)
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7

Intervention	Ratio (Geometric Mean)
Part 1: MK-8521 64/120 μg/Day	2.31
Part 1: MK-8521 34/72 μg/Day	2.50

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Accumulation Ratio of the Maximum Concentration (Cmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

Plasma samples were collected from predose to 24 hours postdose for determination of the accumulation ratio of Cmax. The geometric mean accumulation ratio was calculated as Day 7 Cmax/Day 1 Cmax and presented as geometric mean ratio with a full range. (NCT01982630)
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7

Intervention	Ratio (Geometric Mean)
Part 1: MK-8521 64/120 μg/Day	2.00
Part 1: MK-8521 34/72 μg/Day	2.14

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Accumulation Ratio of the Trough Concentration (Ctrough) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

Plasma samples were collected predose on Days 2 (sampled after the Day 1 dose and prior to Day 2 dose) and 7 for determination of the accumulation ratio of Ctrough. The geometric mean accumulation ratio was calculated as Day 7 Ctrough/Day 1 Ctrough (sampled after the Day 1 dose and prior to Day 2 dose) and presented as geometric mean ratio with a full range. (NCT01982630)
Timeframe: Predose on Days 2 and 7

Intervention	Ratio (Geometric Mean)
Part 1: MK-8521 64/120 μg/Day	1.37
Part 1: MK-8521 34/72 μg/Day	1.73

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Apparent Terminal Half Life (t1/2) of MK-8521 on Day 14 for Non-Diabetic Overweight/Obese Participants in Part 2

t1/2 was the time required to divide the MK-8521 concentration by half after reaching pseudo-equilibrium. Plasma samples were collected from predose to 24 hours postdose for determination of t1/2. Per protocol, t1/2 was measured on Day 14 which is the longest time point for sampling for non-diabetic overweight/obese participants 1/2 is presented as geometric mean and percent coefficient of variation of geometric mean. (NCT01982630)
Timeframe: Predose and 1, 2, 6, 10, 16, and 24 hours post dose on Day 14

Intervention	Hours (Geometric Mean)
Part 2: MK-8521 64/120 μg/Day-Non-Diabetic Overweight/Obese	14.4

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Apparent Terminal Half Life (t1/2) of MK-8521 on Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

t1/2 was the time required to divide the MK-8521 concentration by half after reaching pseudo-equilibrium. Plasma samples were collected from predose to 120 hours postdose for determination of t1/2. t1/2 was measured on Day 14 which is the longest time point for sampling for T2DM participants in Part 1. t1/2 is presented as geometric mean and percent coefficient of variation of geometric mean. (NCT01982630)
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, 24, 72, 96, and 120 hours post-dose on Day 14

Intervention	Hours (Geometric Mean)
Part 1: MK-8521 64/120 μg/Day	15.6
Part 1: MK-8521 34/72 μg/Day	17.2

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Apparent Terminal Half Life (t1/2) of MK-8521 on Day 29 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

t1/2 was the time required to divide the MK-8521 concentration by half after reaching pseudo-equilibrium. Plasma samples were collected from predose to 120 hours postdose for determination of t1/2. Per protocol, t1/2 was measured on Day 29 which is the longest time point for sampling for T2DM participants 1/2 is presented as geometric mean and percent coefficient of variation of geometric mean. (NCT01982630)
Timeframe: Predose and 1, 2, 6, 10, 16, 24, 72, 96 and 120 hours post dose on Day 29

Intervention	Hours (Geometric Mean)
Part 2: MK-8521 64/120/180/240/300 μg/Day-T2DM	15.4

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Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC0-24hr) divided by 24 hours. Blood samples for glucose were collected immediately prior to and after each meal. The change from baseline value for 24-hour WMG was calculated where baseline was the WMG before food and prior to treatment on Day 1. Blood for plasma glucose concentrations was obtained on Day -1 at pre meal (breakfast), 0.5, 1, 2, 3, 4 (pre lunch), 4.5, 5, 6, 7, 10 (pre dinner), 10.5, 11, 12, 13, 15 and 23 hours post breakfast meal; and on Day 14 at 1 (pre breakfast), 1.5, 2, 3, 4, 5 (pre lunch), 5.5, 6, 7, 8, 11(pre dinner), 11.5, 12, 13, 14, 16, 24 hours post dose. Individual change from baseline 24-hour WMG was analyzed in a linear mixed effects model with fixed effects for treatment, day and treatment by day interaction, a random effect for participant, and baseline 24-hour WMG as a covariate. WMG is presented as least squares mean with a 95% confidence interval. (NCT01982630)
Timeframe: Baseline (predose and before food on Day 1) and up to 24 hours post Day 14 dose

Intervention	mg/dL (Least Squares Mean)
Part 1: MK-8521 64/120 μg/Day	-37.24
Part 1: MK-8521 34/72 μg/Day	-45.63
Part 1: Liraglutide 0.6/1.2/1.8 mg/Day	-52.20
Part 1: Placebo for MK-8521	-2.00

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Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC0-24hr) divided by 24 hours. Plasma glucose concentrations were obtained on Day -1 at pre meal (breakfast), 1, 3, 4 (pre lunch), 5, 7, 10 (pre dinner), 11, 13, 15 and 23 hours post breakfast meal and Day 14 at 1 (pre breakfast), 2, 4, 5 (pre lunch), 6, 8, 11 (pre dinner), 12, 14, 16, 24 hours post dose. The timing of samples on Day -1 are relative to the breakfast meal. Day 14 samples are relative to dosing. The change from baseline value for 24-hour WMG was calculated where baseline was the WMG before food and prior to treatment on Day 1. Individual change from baseline 24-hour WMG was analyzed in a linear mixed effects model with group, day and group by day interaction as fixed effects, baseline 24-hour WMG as a covariate, and participant as a random effect. WMG is presented as least squares mean with a 95% confidence interval. (NCT01982630)
Timeframe: Baseline (predose and before food on Day 1) and up to 24 hours post Day 14 dose

Intervention	mg/dL (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	-47.52
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	-51.24
Part 2: Placebo for MK-8521-T2DM	-3.84

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Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 19 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC0-24hr) divided by 24 hours. Plasma glucose concentrations were obtained on Day -1 at pre meal (breakfast), 1, 3, 4 (pre lunch), 5, 7, 10 (pre dinner), 11, 13, 15 and 23 hours post breakfast meal and Day 19 at 1 (pre breakfast), 2, 4, 5 (pre lunch), 6, 8, 11 (pre dinner), 12, 14, 16, 24 hours post dose. The timing of samples on Day -1 are relative to the breakfast meal. Day 19 samples are relative to dosing. The change from baseline value for 24-hour WMG was calculated where baseline was the WMG before food and prior to treatment on Day 1. Individual change from baseline 24-hour WMG was analyzed in a linear mixed effects model with group, day and group by day interaction as fixed effects, baseline 24-hour WMG as a covariate, and participant as a random effect. WMG is presented as least squares mean with a 95% confidence interval. (NCT01982630)
Timeframe: Baseline (predose and before food on Day 1) and up to 24 hours post Day 19 dose

Intervention	mg/dL (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	-52.23
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	-57.43
Part 2: Placebo for MK-8521-T2DM	-18.22

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Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 24 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC0-24hr) divided by 24 hours. Plasma glucose concentrations were obtained on Day -1 at pre meal (breakfast), 1, 3, 4 (pre lunch), 5, 7, 10 (pre dinner), 11, 13, 15 and 23 hours post breakfast meal and Day 24 at 1 (pre breakfast), 2, 4, 5 (pre lunch), 6, 8, 11 (pre dinner), 12, 14, 16, 24 hours post dose. The timing of samples on Day -1 are relative to the breakfast meal. Day 24 samples are relative to dosing. The change from baseline value for 24-hour WMG was calculated where baseline was the WMG before food and prior to treatment on Day 1. Individual change from baseline 24-hour WMG was analyzed in a linear mixed effects model with group, day and group by day interaction as fixed effects, baseline 24-hour WMG as a covariate, and participant as a random effect. WMG is presented as least squares mean with a 95% confidence interval. (NCT01982630)
Timeframe: Baseline (predose and before food on Day 1) and up to 24 hours post Day 24 dose

Intervention	mg/dL (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	-50.44
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	-60.66
Part 2: Placebo for MK-8521-T2DM	-26.71

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Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 29 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC0-24hr) divided by 24 hours. Plasma glucose concentrations were obtained on Day -1 at pre meal (breakfast), 1, 3, 4 (pre lunch), 5, 7, 10 (pre dinner), 11, 13, 15 and 23 hours post breakfast meal and Day 29 at 1 (pre breakfast), 2, 4, 5 (pre lunch), 6, 8, 11 (pre dinner), 12, 14, 16, 24 hours post dose. The timing of samples on Day -1 are relative to the breakfast meal. Day 29 samples are relative to dosing. The change from baseline value for 24-hour WMG was calculated where baseline was the WMG before food and prior to treatment on Day 1. Individual change from baseline 24-hour WMG was analyzed in a linear mixed effects model with group, day and group by day interaction as fixed effects, baseline 24-hour WMG as a covariate, and participant as a random effect. WMG is presented as least squares mean with a 95% confidence interval. (NCT01982630)
Timeframe: Baseline (predose and before food on Day 1) and up to 24 hours post Day 29 dose

Intervention	mg/dL (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	-53.44
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	-59.72
Part 2: Placebo for MK-8521-T2DM	-29.96

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Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC0-24hr) divided by 24 hours. Blood samples for glucose were collected immediately prior to, and after each meal. The change from baseline value for 24-hour WMG was calculated where baseline was the WMG before food and prior to treatment on Day 1. Blood for plasma glucose concentrations was obtained at predose Day 1 at pre meal (breakfast), 0.5, 1, 2, 3, 4 (pre lunch), 4.5, 5, 6, 7, 10 (pre dinner), 10.5, 11, 12, 13, 15 and 23 hours post breakfast meal; and on Day 7 at 1 (pre breakfast), 1.5, 2, 3, 4, 5 (pre lunch), 5.5, 6, 7, 8, 11 (pre dinner), 11.5, 12, 13, 14, 16, 24 hours post dose. Individual change from baseline 24-hour WMG was analyzed in a linear mixed effects model with fixed effects for treatment, day and treatment by day interaction, a random effect for participant, and baseline 24-hour WMG as a covariate. WMG is presented as least squares mean with a 95% confidence interval. (NCT01982630)
Timeframe: Baseline (predose and before food on Day 1) and up to 24 hours post Day 7 dose

Intervention	mg/dL (Least Squares Mean)
Part 1: MK-8521 64/120 μg/Day	-24.08
Part 1: MK-8521 34/72 μg/Day	-27.54
Part 1: Liraglutide 0.6/1.2/1.8 mg/Day	-53.64
Part 1: Placebo for MK-8521	2.36

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Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

FPG was measured predose on Days 1 and 14. The change from baseline of FPG was calculated as the difference between the predose measurement on Day 1 (baseline) and the measurement obtained predose on Day 14. FPG is presented as mean change from baseline with a standard error. (NCT01982630)
Timeframe: Predose on Days 1 (baseline) and 14

Intervention	mg/dL (Mean)
Part 1: MK-8521 64/120 μg/Day	-41.29
Part 1: MK-8521 34/72 μg/Day	-48.50
Part 1: Liraglutide 0.6/1.2/1.8 mg/Day	-59.25
Part 1: Placebo for MK-8521	-13.50

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Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

FPG was measured predose on Days 1 and 14. The change from baseline of FPG was calculated as the difference between the predose measurement on Day 1 (baseline) and the measurement obtained predose on Day 14. FPG is presented as least squares mean change from baseline with a 95% confidence interval. (NCT01982630)
Timeframe: Predose on Days 1 (baseline) and 14

Intervention	mg/dL (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	-45.89
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	-39.80
Part 2: Placebo for MK-8521-T2DM	-14.69

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Change From Baseline in Fasting Plasma Glucose (FPG) at Day 19 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

FPG was measured predose on Days 1 and 19. The change from baseline of FPG was calculated as the difference between the predose measurement on Day 1 (baseline) and the measurement obtained predose on Day 19. FPG is presented as least squares mean change from baseline with a 95% confidence interval. (NCT01982630)
Timeframe: Predose on Days 1 (baseline) and 19

Intervention	mg/dL (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	-44.22
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	-47.33
Part 2: Placebo for MK-8521-T2DM	-16.74

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Change From Baseline in Fasting Plasma Glucose (FPG) at Day 24 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

FPG was measured predose on Days 1 and 24. The change from baseline of FPG was calculated as the difference between the predose measurement on Day 1 (baseline) and the measurement obtained predose on Day 24. FPG is presented as least squares mean change from baseline with a 95% confidence interval. (NCT01982630)
Timeframe: Predose on Days 1 (baseline) and 24

Intervention	mg/dL (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	-40.14
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	-50.14
Part 2: Placebo for MK-8521-T2DM	-44.73

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Change From Baseline in Fasting Plasma Glucose (FPG) at Day 29 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

FPG was measured predose on Days 1 and 29. The change from baseline of FPG was calculated as the difference between the predose measurement on Day 1 (baseline) and the measurement obtained predose on Day 29. FPG is presented as least squares mean change from baseline with a 95% confidence interval. (NCT01982630)
Timeframe: Predose on Days 1 (baseline) and 29

Intervention	mg/dL (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	-52.54
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	-52.06
Part 2: Placebo for MK-8521-T2DM	-37.55

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Change From Baseline in Fasting Plasma Glucose (FPG) at Day 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

FPG was measured predose on Days 1 and 7. The change from baseline of FPG was calculated as the difference between the predose measurement on Day 1 (baseline) and the measurement obtained predose on Day 7. FPG is presented as mean change from baseline with a standard error. (NCT01982630)
Timeframe: Predose on Days 1 (baseline) and 7

Intervention	mg/dL (Mean)
Part 1: MK-8521 64/120 μg/Day	-23.57
Part 1: MK-8521 34/72 μg/Day	-39.00
Part 1: Liraglutide 0.6/1.2/1.8 mg/Day	-59.11
Part 1: Placebo for MK-8521	-11.13

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Change From Baseline in Peak Heart Rate (PHR) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

PHR was defined as the maximum time matched baseline adjusted heart rate over 24 hours. Semi-recumbent PHR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 14: predose, 2, 4, 6, 8, 12, and 16 hours postdose; and prior to dosing on Day 15. The repeated measurements were averaged before conducting the analysis. Change from baseline PHR was calculated as the peak heart rate at Day 14 minus baseline where baseline was defined as predose on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 14 dose

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	11.41
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	13.00
Part 2: Placebo for MK-8521-T2DM	8.90

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Change From Baseline in Peak Heart Rate (PHR) at Day 19 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

PHR was defined as the maximum time matched baseline adjusted heart rate over 24 hours. Semi-recumbent PHR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 19: predose, 2, 4, 6, 8, 12, and 16 hours postdose; and prior to dosing on Day 20. The repeated measurements were averaged before conducting the analysis. Change from baseline PHR was calculated as the peak heart rate at Day 19 minus baseline where baseline was defined as predose on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 19 dose

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	11.26
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	14.75
Part 2: Placebo for MK-8521-T2DM	7.30

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Change From Baseline in Peak Heart Rate (PHR) at Day 24 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

PHR was defined as the maximum time matched baseline adjusted heart rate over 24 hours. Semi-recumbent PHR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 24: predose, 2, 4, 6, 8, 12, and 16 hours postdose; and prior to dosing on Day 25. The repeated measurements were averaged before conducting the analysis. Change from baseline PHR was calculated as the peak heart rate at Day 24 minus baseline where baseline was defined as predose on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 24 dose

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	14.09
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	14.06
Part 2: Placebo for MK-8521-T2DM	9.39

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Change From Baseline in Peak Heart Rate (PHR) at Day 29 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

PHR was defined as the maximum time matched baseline adjusted heart rate over 24 hours. Semi-recumbent PHR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; and Day 29: predose 2, 4, 6, 8, 12, 16, and 24 hours post dose. The repeated measurements were averaged before conducting the analysis. Change from baseline PHR was calculated as the peak heart rate at Day 29 minus baseline where baseline was defined as predose on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 29 dose

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	16.01
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	12.66
Part 2: Placebo for MK-8521-T2DM	7.13

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Change From Baseline in Peak Heart Rate (PHR) at Day 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

PHR was defined as the maximum time matched baseline adjusted heart rate over 24 hours. Semi-recumbent PHR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 7: predose, 2, 4, 6, 8, 12, and 16 hours postdose; and prior to dosing on Day 8. The repeated measurements were averaged before conducting the analysis. Change from baseline PHR was calculated as the peak heart rate at Day 7 minus baseline where baseline was defined as predose on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 7 dose

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	7.94
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	11.91
Part 2: Placebo for MK-8521-T2DM	8.65

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Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 14 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

Semi-recumbent RMHR was measured in triplicate with at least a 1-2-minute interval between measurements. The repeated measurements were averaged for each time point. Change from baseline RMHR was calculated as the RMHR 24 hours after the Day 14 dose (predose Day 15) minus baseline. Baseline was an average of 2 readings prior to dosing on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and Day 15 (24 hours after Day 14)

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	4.22
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	5.38
Part 2: Placebo for MK-8521-T2DM	-4.42

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Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 19 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

Semi-recumbent RMHR was measured in triplicate with at least a 1-2-minute interval between measurements. The repeated measurements were averaged for each time point. Change from baseline RMHR was calculated as the RMHR 24 hours after the Day 19 dose (predose Day 20) minus baseline. Baseline was an average of 2 readings prior to dosing on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and Day 20 (24 hours after Day 19)

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	6.41
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	10.44
Part 2: Placebo for MK-8521-T2DM	-3.82

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Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 24 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

Semi-recumbent RMHR was measured in triplicate with at least a 1-2-minute interval between measurements. The repeated measurements were averaged for each time point. Change from baseline RMHR was calculated as the RMHR 24 hours after the Day 24 dose (predose Day 25) minus baseline. Baseline was an average of 2 readings prior to dosing on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and Day 25 (24 hours after Day 24)

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	7.51
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	9.63
Part 2: Placebo for MK-8521-T2DM	-5.82

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Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 29 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

Semi-recumbent RMHR was measured in triplicate with at least a 1-2-minute interval between measurements. The repeated measurements were averaged for each time point. Change from baseline RMHR was calculated as the RMHR 24 hours after the Day 29 dose minus baseline. Baseline was an average of 2 readings prior to dosing on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and Day 30 (24 hours after Day 29)

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	9.41
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	7.30
Part 2: Placebo for MK-8521-T2DM	-1.02

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Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 7 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

Semi-recumbent RMHR was measured in triplicate with at least a 1-2-minute interval between measurements. The repeated measurements were averaged for each time point. Change from baseline RMHR was calculated as the RMHR 24 hours after the Day 7 dose (predose Day 8) minus baseline. Baseline was an average of 2 readings prior to dosing on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and Day 8 (24 hours after Day 7)

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	1.65
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	5.20
Part 2: Placebo for MK-8521-T2DM	0.59

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Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 14 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 14: predose, 2, 4, 6, 8, 12, 13, 14, 15, 16, 22 hours postdose and prior to dosing on Day 15. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 14 minus baseline where baseline was defined as predose on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 14 dose

Intervention	Beats per minute (Least Squares Mean)
Part 1: MK-8521 64/120 μg/Day	9.67
Part 1: MK-8521 34/72 μg/Day	3.90
Part 1: Liraglutide 0.6/1.2/1.8 mg/Day	10.32
Part 1: Placebo for MK-8521	9.81

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Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 14 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 14: predose, 2, 4, 6, 8, 12, 16, hours postdose; and prior to dosing on Day 15. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 14 minus baseline where baseline was defined as predose on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 14 dose

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	5.05
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	5.93
Part 2: Placebo for MK-8521-T2DM	-0.20

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Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 19 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 19: predose, 2, 4, 6, 8, 12, 16, hours post dose; and prior to dosing on Day 20. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 19 minus baseline where baseline was defined as predose on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 19 dose

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	5.62
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	6.20
Part 2: Placebo for MK-8521-T2DM	-2.14

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Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 24 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 24: predose, 2, 4, 6, 8, 12, 16, hours postdose; and prior to dosing on Day 25. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 24 minus baseline where baseline was defined as predose on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 24 dose

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	7.30
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	5.95
Part 2: Placebo for MK-8521-T2DM	-0.99

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Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 29 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; and Day 29: predose, 2, 4, 6, 8, 12, 16 and 24 hours postdose. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 29 minus baseline where baseline was defined as predose on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 29 dose

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	8.30
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	5.84
Part 2: Placebo for MK-8521-T2DM	-1.31

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Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 7 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

Semi-recumbent heart rate was assessed at baseline on Day 1; Day 7 at predose, 2, 4, 6, 8, 12, 13, 14, 15, 16, 22 hours postdose; and prior to dosing on Day 8. Heart rate was measured in triplicate with at least a 1-2-minute interval between measurements. The repeated measurements were averaged before conducting the statistical analysis. TWA0-24hr was calculated as the area under the measurement-time curve (AUC) divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 7 minus baseline where baseline was defined as predose on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 7 dose

Intervention	Beats per minute (Least Squares Mean)
Part 1: MK-8521 64/120 μg/Day	7.19
Part 1: MK-8521 34/72 μg/Day	1.17
Part 1: Liraglutide 0.6/1.2/1.8 mg/Day	7.42
Part 1: Placebo for MK-8521	5.69

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Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 7 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2

Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 7: predose, 2, 4, 6, 8, 12, and 16 hours postdose; and prior to dosing on Day 8. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 7 minus baseline where baseline was defined as predose on Day 1. (NCT01982630)
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 7 dose

Intervention	Beats per minute (Least Squares Mean)
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM	1.99
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM	4.10
Part 2: Placebo for MK-8521-T2DM	-0.54

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Maximum Concentration (Cmax) of MK-8521 on Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1

Cmax was the maximum observed concentration of MK-8521 in plasma after administration on Day 14. Plasma samples were collected from predose to 120 hours postdose for determination of Cmax. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. Cmax is presented as geometric mean and percent coefficient of variation of geometric mean. (NCT01982630)
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, 24, 72, 96, and 120 hours post-dose on Day 14

Intervention	nM (Geometric Mean)
Part 1: MK-8521 64/120 μg/Day	1.70
Part 1: MK-8521 34/72 μg/Day	0.619

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Change From Baseline in Fasting Plasma Glucose

Mean change from baseline in fasting plasma glucose (FPG) at Week 26. (NCT02008682)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Liraglutide	-2.347
Sitagliptin	-1.205

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Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26. (NCT02008682)
Timeframe: Week 0, week 26

Intervention	Percent (%) glycosylated haemoglobin (Mean)
Liraglutide	-1.666
Sitagliptin	-0.969

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Number of Confirmed Hypoglycaemic Episodes

confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L (NCT02008682)
Timeframe: Weeks 0-26

Intervention	episodes (Number)
Liraglutide	2
Sitagliptin	1

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Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target)

Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26 (NCT02008682)
Timeframe: After 26 weeks of treatment

Intervention	percentage of subjects (Number)
Liraglutide	76.5
Sitagliptin	52.6

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Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)

Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26 (NCT02008682)
Timeframe: After 26 weeks of treatment

Intervention	percentage of subjects (Number)
Liraglutide	61.7
Sitagliptin	26.3

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Change From Baseline in 7-point Self-measured Plasma Glucose Profile

Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time. (NCT02008682)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Liraglutide	-2.25
Sitagliptin	-1.36

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Echocardiographic Epicardial Fat Thickness

Echocardiographic epicardial fat thickness is an non invasive, inexpensive, reproducible and direct measure of visceral fat. In fact, epicardial fat strongly reflects the intra-abdominal and intra-myocardial fat accumulation as measured by magnetic resonance imaging procedures. (NCT02014740)
Timeframe: 6 months

Intervention	mm (Mean)
	Baseline	3-month	6-month
Liraglutide	9.6	6.8	6.2
Metformin	7.4	7.5	6.9

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Change in HbA1c From Randomization to Approximately 16 Weeks

Absolute change in HbA1c from randomization to end of core phase (16 weeks) in incretin based therapy arm and insulin arm, and mean difference of change in HbA1c between the two treatment groups based on an ANOVA model using treatment (Incretin, Insulin) and the two randomization stratification factors (Disease: Cushing's disease vs Acromegaly; Baseline glycemic status: HbA1c <7% vs HbA1c ≥ 7%) as fixed effects. For Participants who discontinued the study or required rescue treatment before the time of assessing the primary endpoint, the last HbA1c assessment collected 8 weeks (56 days) after randomization (and prior to or on the date of start of rescue treatment) was carried forward. If the participant discontinued the study or used rescue treatment within 8 weeks after randomization, it was considered missing. (NCT02060383)
Timeframe: Randomization, 16 weeks

Intervention	Hba1c percentage (Mean)
	All Patients	Cushing's Disease	Acromegaly
Incretin Based Therapy (Randomized Group)	-0.12	0.33	-0.25
Insulin (Randomized Group)	0.26	0.45	0.19

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Change in HbA1c From Randomization (R) Over Time Per Randomized Arm

Absolute change in HbA1c overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm (NCT02060383)
Timeframe: Randomization (R), Week (W) 4 post R, W 8 post R, W 16 post R, end of Core phase (up to week 16 post R)

Intervention	HbA1c percentage (Mean)
	Randomization	Change at RW4 D29	Change at RW8 D57	Change at RW12 D85	Change at RW16 D113	End of Core Phase
Incretin Based Therapy (Randomized Group)	7.1	0.5	0.3	0.2	0.0	0.0
Insulin (Randomized Group)	7.1	0.5	0.5	0.4	0.3	0.3

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Percentage of Participants in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin

The percentage of participants who received anti-diabetic rescue therapy in incretin based therapy is summarized. (NCT02060383)
Timeframe: Randomization to up to 16 weeks

Intervention	Percentage of participants (Number)
Incretin Based Therapy (Randomized Group)	31.6

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Percentage of Participants With ≤ 0.3% HbA1c Increase to End of Core Phase

Percentage of participants with ≤ 0.3% HbA1c increase in the incretin based therapy arm and the insulin arm. (NCT02060383)
Timeframe: Randomization, up to 16 weeks

Intervention	Percentage of participants (Number)
Incretin Based Therapy (Randomized Group)	73.7
Insulin (Randomized Group)	65.1

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Absolute Change in FPG From Baseline to End of Core Phase

Absolute change in FPG from baseline to end of core phase in the incretin based therapy arm and the insulin arm. (NCT02060383)
Timeframe: Baseline, Up to 32 weeks (end of Core Phase)

,,,,

Intervention	mg/dL (Mean)
	Baseline: All Patients	Change at EOP: All Patients	Baseline: Cushing's	Change at EOP: Cushing's	Baseline: Acromegaly	Change at EOP: Acromegaly
Baseline Insulin (BL) (Non-randomized Group)	157.7	9.8	147.2	21.3	162.5	4.6
Incretin Based Therapy (Randomized Group)	111.1	22.2	117.9	13.4	107.9	26.5
Insulin (Randomized Group)	111.8	22.5	106.3	36.4	114.2	16.7
No OAD (Non-randomized Group)	92.2	16.3	85.5	11.7	93.4	17.0
Oral Antidiabetic Drugs (OAD) (Non-randomized Group)	97.2	22.9	93.3	15.8	98.8	25.8

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Absolute Change in HbA1c From Baseline to End of Core Phase

Absolute change in HbA1c from baseline to end of core phase in the incretin based therapy arm and the insulin arm (NCT02060383)
Timeframe: Baseline, up to 32 weeks (end of Core phase)

,,,,

Intervention	HbA1c percentage (Mean)
	Baseline: All Patients	Change at EOP: All Patients	Baseline: Cushing's	Change at EOP: Cushing's	Baseline: Acromegaly	Change at EOP: Acromegaly
Baseline Insulin (BL) (Non-randomized Group)	7.7	1.3	6.9	1.4	8.0	1.2
Incretin Based Therapy (Randomized Group)	6.3	0.8	6.6	1.3	6.1	0.6
Insulin (Randomized Group)	6.3	1.1	6.5	1.7	6.3	0.8
No OAD (Non-randomized Group)	5.4	0.4	5.5	0.5	5.4	0.4
Oral Antidiabetic Drugs (OAD) (Non-randomized Group)	5.7	0.8	5.9	0.9	5.6	0.7

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Change in FPG (Fasting Plasma Glucose) From Randomization Until End of Core Phase

Absolute change in fasting glucose overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm (NCT02060383)
Timeframe: Randomization, R(randomization) Week 2, R-Week 4, R-Week 6, R-Week 8, R-Week 10, R-Week 12, R-Week 14, R-Week 16, end of Core phase

Intervention	mg/dL (Mean)
	Randomization	Change at RW2 D15	Change at RW4 D29	Change at RW6 D43	Change at RW8 D57	Change at RW10 D71	Change at RW12 D85	Change at RW14 D99	Change at RW16 D113	End of Core Phase
Incretin Based Therapy (Randomized Group)	172.2	4.6	-15.0	-17.7	-25.7	-28.8	-33.4	-35.1	-38.8	-40.1
Insulin (Randomized Group)	167.9	-31.1	-28.3	-37.5	-38.3	-36.9	-41.1	-35.6	-33.4	-36.0

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Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)

The eGFR is used in addition to the Urinary Albumin to Creatinine Ratio to measure the incidence and progression of diabetic kidney disease. (NCT02072096)
Timeframe: Baseline, Week 72

Intervention	milliliter per minute/1.73 square meter (Mean)
Strategy A (Glucose-Dependent)	-5.00
Strategy B (Reference)	-5.88

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Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia

(NCT02072096)
Timeframe: Baseline to last participant visit (up to 72 weeks)

Intervention	Participants (Number)
	Total Hypoglycemia	Severe Hypoglycemia	Clinically Significant Hypoglycemia	Symptomatic Hypoglycemia	Asymptomatic Hypoglycemia	Probable Symptomatic Hypoglycemia	Unspecified Hypoglycemia	Relative Hypoglycemia	Nocturnal Hypoglycemia
Strategy A (Glucose-Dependent)	10	0	0	5	8	0	2	1	4
Strategy B (Reference)	50	0	1	34	30	7	7	6	10

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Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy

(NCT02072096)
Timeframe: Baseline to last participant visit (up to 72 weeks)

Intervention	percentage of participants (Number)
Strategy A (Glucose-Dependent)	21
Strategy B (Reference)	13

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Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia

Failed to reach and maintain HbA1c target, without clinically significant hypoglycemia, is defined as having 2 consecutive HbA1c > upper limit of HbA1c target over 12 weeks starting from Week 24 for participants with HbA1c data beyond Week 24, or Week 24 HbA1c > upper limit of HbA1c target for participants without HbA1c data beyond Week 24. Clinically significant hypoglycemia is defined as any severe hypoglycemia or repeated hypoglycemia interrupting participants activities or sleep and associated with blood glucose ≤3.9 millimole per liter (mmol/L), or repeated asymptomatic hypoglycemia associated with blood glucose <3.0 mmol/L. Success is defined as lacking of failure. (NCT02072096)
Timeframe: Baseline to last participant visit (up to 72 weeks)

Intervention	percentage of participants (Number)
Strategy A (Glucose-Dependent)	64.5
Strategy B (Reference)	54.9

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Change From Baseline of Urinary Albumin to Creatinine Ratio

The Urinary Albumin to Creatinine Ratio is used in addition to Estimated Glomerular Filtration Rate (eGFR) to measure the incidence and progression of diabetic kidney disease. (NCT02072096)
Timeframe: Baseline, Week 72

Intervention	milligram per millimole (mg/mmol) (Mean)
Strategy A (Glucose-Dependent)	1.85
Strategy B (Reference)	1.85

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Change From Baseline in Body Mass Index (BMI)

(NCT02072096)
Timeframe: Baseline, Week 72

Intervention	kilogram per square meter (kg/m^2) (Mean)
Strategy A (Glucose-Dependent)	-0.47
Strategy B (Reference)	0.20

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Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)

measured as ml (NCT02073929)
Timeframe: at time 0 and 26 weeks

Intervention	ml (Mean)
Liraglutide	-2
Placebo	0

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Change in Endogenous Thrombin Potential (ETP)

Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min (NCT02073929)
Timeframe: at time 0 and 26 weeks

Intervention	nMolar x minutes (Mean)
Liraglutide	-56.7
Placebo	-8.2

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Change in Body Composition (VAT)

cubic cm (NCT02073929)
Timeframe: at time 0 and 26 weeks

Intervention	cubic cm (Mean)
Liraglutide	-17
Placebo	5

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Change in Bleeding Pattern (Bleeding Ratio)

Ration between number of bleedings during 3 months before trial and last 3 months of trial (NCT02073929)
Timeframe: at time 0 and 26 weeks

Intervention	n of bleedings/n of expected bleedings (Median)
Liraglutide	0.28
Placebo	0.14

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Change in Plasma Level of Atrial Natriuretic Peptide (ANP)

measured in pmol/l (NCT02073929)
Timeframe: at time 0 and 26 weeks

Intervention	pmol/l (Median)
Liraglutide	-11.5
Placebo	1.4

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Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1

(NCT02073929)
Timeframe: at time 0 and 26 weeks

Intervention	percent change in plasma PAI-1 (Mean)
Liraglutide	-12
Placebo	4

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Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)

percent change from baseline (NCT02073929)
Timeframe: at time 0 and 26 weeks

Intervention	percent change in CRP levels (Mean)
Liraglutide	-15
Placebo	-25

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Change in Serum Levels of Anti-Müllerian Hormone

measured as pmol/l (NCT02073929)
Timeframe: at time 0 and 26 weeks

Intervention	pmol/ml (Mean)
Liraglutide	-8.7
Placebo	3.5

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Change in Plasma Level of Copeptin

(NCT02073929)
Timeframe: at time 0 and 26 weeks

Intervention	pmol/l (Median)
Liraglutide	0.48
Placebo	0.28

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Change in Plasma Level of Adrenomedullin

measured in nmol/l (NCT02073929)
Timeframe: at time 0 and 26 weeks

Intervention	nmol/l (Median)
Liraglutide	-0.02
Placebo	0.003

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Change in Percent Liver Fat Content

percent liver fat content (NCT02073929)
Timeframe: at time 0 and 26 weeks

Intervention	percentage of liver fat (Mean)
Liraglutide	-1.6
Placebo	-0.2

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Change From Baseline in Body Weight

Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data. (NCT02098395)
Timeframe: Week 0, Week 26

Intervention	kg (Mean)
Liraglutide 0.6 mg	-2.37
Liraglutide 1.2 mg	-4.03
Liraglutide 1.8 mg	-5.1
Liraglutide Placebo	-0.26

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Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes

Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. (NCT02098395)
Timeframe: Weeks 0-26

Intervention	episodes (Number)
Liraglutide 0.6 mg	1437
Liraglutide 1.2 mg	1943
Liraglutide 1.8 mg	1490
Liraglutide Placebo	1567

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Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data. (NCT02098395)
Timeframe: Week 0, Week 26

Intervention	Percent (%) glycosylated haemoglobin (Mean)
Liraglutide 0.6 mg	-0.23
Liraglutide 1.2 mg	-0.23
Liraglutide 1.8 mg	-0.32
Liraglutide Placebo	0.01

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Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c after 26 weeks of treatment. (NCT02100475)
Timeframe: Week 0, week 26

Intervention	Percentage of glycosylated haemoglobin (Mean)
IDegLira	-0.43
IDegLira + IAsp	-0.14

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Change From Baseline in Body Weight

Change from baseline in body weight after 26 weeks of treatment. (NCT02100475)
Timeframe: Week 0, week 26

Intervention	Kilograms (Mean)
IDegLira	0.9
IDegLira + IAsp	1.5

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Number of Treatment-emergent Confirmed Hypoglycaemic Episodes

Treatment-emergent hypoglycaemic episodes: if the onset of the episode occurred on or after the first day of investigational medicinal product administration, and no later than 7 days after the last day on investigational medicinal product. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded plasma glucose < 3.1 mmol/L (56 mg/dL). (NCT02100475)
Timeframe: Week 0 - 26

Intervention	Number of episodes (Number)
IDegLira	34
IDegLira + IAsp	4

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HbA1c Below or Equal to 6.5%

Responders to HbA1c below or equal to 6.5% after 32 weeks of treatment. (NCT02298192)
Timeframe: Week 0, week 32

Intervention	particpants (Number)
	yes	No
IDegLira	170	30
IDegLira (1WT)	158	31

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HbA1c Below 7.0%

Responders to HbA1c below 7% after 32 weeks of treatment. (NCT02298192)
Timeframe: Week 0, week 32

Intervention	participants (Number)
	yes	No
IDegLira	179	21
IDegLira (1WT)	170	19

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Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

An episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. (NCT02298192)
Timeframe: Week 0-32

Intervention	Number of episodes (Number)
IDegLira (1WT)	20
IDegLira	97

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Change From Baseline in HbA1c

Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment. (NCT02298192)
Timeframe: Week 0, week 32

Intervention	percentage (Mean)
IDegLira (1WT)	-2.01
IDegLira	-2.02

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Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.

"Change in mean arterial blood pressure and diastolic blood pressure from baseline to 8 weeks in the intent-to-treat (ITT) population.~Change in nocturnal BP: the absence of the nocturnal (between 23:00-06:00 hrs) decline in BP of >/= 10% (defined as non-dippers) and whether restoration occurs following Liraglutide therapy.~Change in pulse pressure: defined as the difference in systolic and diastolic BPs from baseline to week 8." (NCT02299388)
Timeframe: Baseline and 8 Weeks

Intervention	mm/Hg (Mean)
	Overall Systolic Pressure	Overall Diastolic Pressure	Overall Pulse Pressure	Mean Arterial Pressure	Nocturnal Systolic Pressure	Nocturnal Diastolic Pressure
Liraglutide	-4.4	-1.8	-2.7	-2.6	1.15	1.0
Placebo	-5.4	-3.3	0.4	-4	-2.3	-0.8

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Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors.

To determine whether Liraglutide lowers systolic BP through the day compared to placebo in patients with T2DM who are not on any anti-hypertensive medications or whose BP medications are unchanged over the study period of 8 weeks. (NCT02299388)
Timeframe: Baseline and 8 Weeks

Intervention	mm/Hg (Mean)
Liraglutide	-4.88
Placebo	-5.45

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Change in Matsuda Index of Insulin Sensitivity, Insulin Secretion, and Beta Cell Function During Oral Glucose Tolerance Test (OGTT)

Values will be presented as the mean + SD. The Matsuda Index is a novel assessment of insulin sensitivity that is simple to calculate and provides a reasonable approximation of whole-body insulin sensitivity from the OGTT. The index is calculated from plasma glucose (mg/dl) and insulin (mIU/l) concentrations in both fasting state and post-OGTT. The index value obtained is compared to normal physiologic values to assess insulin sensitivity or resistance. The higher the number, the more insulin sensitive and the lower the number the more insulin resistant the subjects are. Insulin secretion will be measured from plasma C-peptide concentration during the OGTT and the Mari Model will be used to measure beta cell glucose sensitivity (NCT02324842)
Timeframe: Change from Baseline to Approximately 4 months

Intervention	index value (Mean)
Canagliflozin	0.8
Liraglutide	-0.5
Canagliflozin Plus Liraglutide	0.1

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Change in Free Plasma Insulin at the End of the Study From Baseline Value

Intervention	mg/ml (Mean)
Canagliflozin	-2
Liraglutide	2
Canagliflozin Plus Liraglutide	0.7

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Change in 24-hour Blood Pressure at Study End Compared to Baseline.

Intervention	mmHg (Mean)
Canagliflozin	-5.2
Liraglutide	5.1
Canagliflozin Plus Liraglutide	-14.1

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Change in Plasma Glucagon Concentration at the End of the Study Compared to Baseline

Intervention	mg/ml (Mean)
Canagliflozin	12
Liraglutide	-7
Canagliflozin Plus Liraglutide	-5

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Change in Total Body Weight at Study End Compared to Baseline

Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA. The difference between baseline and study end will represent the change in body weight due to change in hepatic, visceral and abdominal subcutaneous fat. (NCT02324842)
Timeframe: Approximately 4 months

Intervention	kg (Mean)
Canagliflozin	-3.5
Liraglutide	-1.9
Canagliflozin Plus Liraglutide	-6.0

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Fasting Plasma Glucose (FPG) at 4 Months

Values will be presented as the mean + (Standard Deviation) SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA. (NCT02324842)
Timeframe: Baseline to Approximately 4 months

Intervention	mg/dl (Mean)
Canagliflozin	174
Liraglutide	177
Canagliflozin Plus Liraglutide	180

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HbA1c at 4 Months

Primary end point of the study is the HbA1c level in response to canagliflozin alone, liraglutide or canagliflozin with liraglutide. (NCT02324842)
Timeframe: Approximately 4 months

Intervention	percentage glycated hemoglobin (Mean)
Canagliflozin	8.2
Liraglutide	8.4
Canagliflozin Plus Liraglutide	8.1

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Body Mass Index (BMI) at 4 Months

A measure of BMI at 4 months to examine effects of combination therapy with liraglutide plus canagliflozin. (NCT02324842)
Timeframe: Approximately 4 months

Intervention	kg/m2 (Mean)
Canagliflozin	34.8
Liraglutide	35.1
Canagliflozin Plus Liraglutide	34.8

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Responder for HbA1c Below or Equal to 6.5 %

Number of subjects with HbA1c below 6.5% after 26 weeks of treatment. (NCT02420262)
Timeframe: After 26 weeks of treatment

Intervention	Participants (Count of Participants)
	Yes	No
IDegLira	118	120
IGlar + IAsp	104	129

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Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.

Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. (NCT02420262)
Timeframe: Weeks 0-26

Intervention	Number of episodes (Number)
IDegLira	129
IGlar + IAsp	975

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Change in HbA1c (Glycosylated Haemoglobin)

Change in HbA1c values after 26 weeks of treatment. (NCT02420262)
Timeframe: Week 0, Week 26

Intervention	Percentage of glycosylated haemoglobin (Least Squares Mean)
IDegLira	-1.48
IGlar + IAsp	-1.46

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Change in Body Weight

Change in body weight after 26 weeks of treatment. (NCT02420262)
Timeframe: Week 0, Week 26

Intervention	kg (Least Squares Mean)
IDegLira	-0.93
IGlar + IAsp	2.64

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Responder for HbA1c Below 7.0%

Number of subjects with HbA1c below 7% after 26 weeks of treatment. (NCT02420262)
Timeframe: After 26 weeks of treatment

Intervention	Participants (Count of Participants)
	Yes	No
IDegLira	157	81
IGlar + IAsp	156	77

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Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point SMPG postprandial glucose /prandial increment (breakfast, lunch and dinner) value are presented. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	mmol/L (Mean)
	Change from week 0 to week 54: Breakfast	Change from week 0 to week 80: Breakfast	Change from week 0 to week 54: Lunch	Change from week 0 to week 80: Lunch	Change from week 0 to week 54: Dinner	Change from week 0 to week 80: Dinner
Liraglutide (Experimental)	-0.1	-0.1	1.5	1.0	-0.8	-0.4
NNC0114-0006 (Experimental)	0.4	0.5	0.5	0.1	1.1	0.5
NNC0114-0006 + Liraglutide (Experimental)	1.3	1.9	0.9	0.0	0.1	0.5
Placebo (Placebo)	-0.6	-0.5	0.7	0.8	-0.3	-0.4

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Change in Biochemistry: Alanine Aminotransferase (ALAT)

Change in ALAT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of ALT (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.97	1.06
NNC0114-0006 (Experimental)	0.98	0.98
NNC0114-0006 + Liraglutide (Experimental)	0.96	0.95
Placebo (Placebo)	0.90	0.92

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Change in Biochemistry: Albumin

Change in albumin (measured in gram per deciliter [g/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of albumin (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.02	1.00
NNC0114-0006 (Experimental)	1.00	1.01
NNC0114-0006 + Liraglutide (Experimental)	0.99	1.00
Placebo (Placebo)	0.99	0.99

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Change in Biochemistry: Alkaline Phosphatase (ALP)

Change in ALP (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of ALP (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.99	1.04
NNC0114-0006 (Experimental)	0.99	1.05
NNC0114-0006 + Liraglutide (Experimental)	1.03	1.07
Placebo (Placebo)	1.03	1.04

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Change in Biochemistry: Amylase

Change in amylase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of Amylase (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.04	1.03
NNC0114-0006 (Experimental)	0.98	0.99
NNC0114-0006 + Liraglutide (Experimental)	1.07	1.04
Placebo (Placebo)	1.01	1.04

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Change in Biochemistry: Aspartate Aminotransferase (ASAT)

Change in ASAT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of AST (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.00	1.09
NNC0114-0006 (Experimental)	0.99	0.98
NNC0114-0006 + Liraglutide (Experimental)	0.99	0.98
Placebo (Placebo)	0.98	0.99

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Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006)

Clearance of NNC0114-0006 at steady state was calculated as dose/AUCtau, NNC0114-0006. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. (NCT02443155)
Timeframe: Pre-dose and 1 hour post-dose during week 48 to week 54

Intervention	(Milliliters/day)/kilogram ([mL/day]/kg) (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	3.02
NNC0114-0006 (Experimental)	2.92

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Change in Biochemistry: Blood Urea Nitrogen Serum

Change in blood urea nitrogen serum (measured in milligram per deciliter [mg/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of Blood Urea Nitrogen serum (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.98	0.98
NNC0114-0006 (Experimental)	1.05	0.97
NNC0114-0006 + Liraglutide (Experimental)	1.00	0.97
Placebo (Placebo)	0.94	0.97

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Change in Biochemistry: C-reactive Protein Serum

Change in C-reactive protein serum (measured in milligrams per liter [mg/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of C-reactive protein (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.89	1.25
NNC0114-0006 (Experimental)	1.04	0.94
NNC0114-0006 + Liraglutide (Experimental)	0.92	1.08
Placebo (Placebo)	1.06	1.06

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Change in Biochemistry: Calcium Corrected

Change in calcium corrected (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of calcium (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.98	0.98
NNC0114-0006 (Experimental)	0.98	0.97
NNC0114-0006 + Liraglutide (Experimental)	0.99	0.96
Placebo (Placebo)	0.99	0.98

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Change in Biochemistry: Chloride

Change in chloride (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of chloride (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.00	1.00
NNC0114-0006 (Experimental)	1.00	1.01
NNC0114-0006 + Liraglutide (Experimental)	1.01	1.00
Placebo (Placebo)	1.00	1.00

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Occurrence of Anti-NNC0114-0006 Antibodies

This outcome measure was applicable for NNC0114-0006 + Liraglutide treatment arm and NNC0114-0006 treatment arm. Participants was assessed for anti-NNC0114-0006 antibodies. Participant who reported anti-NNC0114-0006 antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-NNC0114-0006 antibodies at week 54 and week 80 are presented. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

Intervention	Participants (Count of Participants)
	Week 0: Anti-NNC0114-0006 antibodies71930274		Week 0: Anti-NNC0114-0006 antibodies71930275	Week 0: Cross-reactivity71930274	Week 0: Cross-reactivity71930275	Week 54: Anti-NNC0114-000671930274	Week 54: Anti-NNC0114-000671930275	Week 54: Cross-reactivity71930274	Week 54: Cross-reactivity71930275	Week 80: Anti-NNC0114-0006 antibodies71930274	Week 80: Anti-NNC0114-0006 antibodies71930275	Week 80: Cross-reactivity71930274	Week 80: Cross-reactivity71930275
	Negative	Positive
NNC0114-0006 + Liraglutide (Experimental)	68
NNC0114-0006 + Liraglutide (Experimental)	9
NNC0114-0006 (Experimental)	14
NNC0114-0006 + Liraglutide (Experimental)	4
NNC0114-0006 + Liraglutide (Experimental)	5
NNC0114-0006 (Experimental)	7
NNC0114-0006 (Experimental)	62
NNC0114-0006 + Liraglutide (Experimental)	0
NNC0114-0006 (Experimental)	3
NNC0114-0006 (Experimental)	0
NNC0114-0006 + Liraglutide (Experimental)	65
NNC0114-0006 (Experimental)	60
NNC0114-0006 + Liraglutide (Experimental)	2
NNC0114-0006 (Experimental)	4
NNC0114-0006 + Liraglutide (Experimental)	1
NNC0114-0006 (Experimental)	2

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Occurrence of Anti-liraglutide Antibodies

This outcome measure is applicable for NNC0114-0006 + Liraglutide treatment arm and Liraglutide treatment arm. Participants was assessed for anti-liraglutide antibodies. Participant who reported anti-liraglutide antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-liraglutide antibodies at week 54 and week 80 are presented. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

Intervention	Participants (Count of Participants)
	Week 0: Anti-Liraglutide antibodies71930274		Week 0: Anti-Liraglutide antibodies71930278	Week 0: Cross-reactivity to native GLP-171930274	Week 0: Cross-reactivity to native GLP-171930278	Week 54: Anti-Liraglutide antibodies71930274	Week 54: Anti-Liraglutide antibodies71930278	Week 54: Cross-reactivity to native GLP-171930274	Week 54: Cross-reactivity to native GLP-171930278	Week 80: Anti-Liraglutide antibodies71930274	Week 80: Anti-Liraglutide antibodies71930278	Week 80: Cross-reactivity to native GLP-171930274	Week 80: Cross-reactivity to native GLP-171930278
	Negative	Positive
NNC0114-0006 + Liraglutide (Experimental)	77
Liraglutide (Experimental)	75
Liraglutide (Experimental)	65
NNC0114-0006 + Liraglutide (Experimental)	1
Liraglutide (Experimental)	1
NNC0114-0006 + Liraglutide (Experimental)	67
Liraglutide (Experimental)	66
Liraglutide (Experimental)	2
NNC0114-0006 + Liraglutide (Experimental)	0
Liraglutide (Experimental)	0

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Diabetes Retinopathy

Number of participants evaluated for diabetic retinopathy at baseline (Day -28 to -14), week 54 and week 80 are presented as 'yes', 'no' or 'unknown'. (NCT02443155)
Timeframe: Baseline, week 54 and week 80

Intervention	Participants (Count of Participants)
	Baseline (Day:-28 to -14)71930275			Baseline (Day:-28 to -14)71930277	Baseline (Day:-28 to -14)71930276	Baseline (Day:-28 to -14)71930274	Week 5471930275	Week 5471930276	Week 5471930277	Week 5471930274	Week 8071930274	Week 8071930275	Week 8071930276	Week 8071930277
	Yes	No	Unknown
NNC0114-0006 + Liraglutide (Experimental)	4
NNC0114-0006 (Experimental)	2
Liraglutide (Experimental)	1
NNC0114-0006 + Liraglutide (Experimental)	73
NNC0114-0006 (Experimental)	75
Liraglutide (Experimental)	75
Placebo (Placebo)	76
NNC0114-0006 (Experimental)	0
Liraglutide (Experimental)	0
NNC0114-0006 + Liraglutide (Experimental)	3
NNC0114-0006 (Experimental)	63
Liraglutide (Experimental)	68
Placebo (Placebo)	68
NNC0114-0006 + Liraglutide (Experimental)	0
Placebo (Placebo)	0
NNC0114-0006 + Liraglutide (Experimental)	65
NNC0114-0006 (Experimental)	62
Liraglutide (Experimental)	67
Placebo (Placebo)	63
NNC0114-0006 + Liraglutide (Experimental)	1
NNC0114-0006 (Experimental)	1
Placebo (Placebo)	1

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Change in Urinalysis: Urine Dipsticks

Urinalysis was performed by urine dipsticks for protein, glucose, erythrocytes, ketones leukocytes, nitrite, pH and specific gravity and categorised as normal, abnormal not clinically significant (NCS) and abnormal clinially significant (CS). Number of participants in each category at baseline (week 0), week 54 and 80 are presented. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

Intervention	Participants (Count of Participants)
	Week 0: Glucose dipstick71930274			Week 0: Glucose dipstick71930275	Week 0: Glucose dipstick71930276	Week 0: Glucose dipstick71930277	Week 54: Glucose dipstick71930274	Week 54: Glucose dipstick71930275	Week 54: Glucose dipstick71930276	Week 54: Glucose dipstick71930277	Week 80: Glucose dipstick71930274	Week 80: Glucose dipstick71930275	Week 80: Glucose dipstick71930276	Week 80: Glucose dipstick71930277	Week 0: Ketone dipstick71930274	Week 0: Ketone dipstick71930275	Week 0: Ketone dipstick71930276	Week 0: Ketone dipstick71930277	Week 54: Ketone dipstick71930274	Week 54: Ketone dipstick71930277	Week 54: Ketone dipstick71930275	Week 54: Ketone dipstick71930276	Week 80: Ketone dipstick71930275	Week 80: Ketone dipstick71930277	Week 80: Ketone dipstick71930274	Week 80: Ketone dipstick71930276	Week 0: pH dipstick71930274	Week 0: pH dipstick71930277	Week 0: pH dipstick71930275	Week 0: pH dipstick71930276	Week 54: pH dipstick71930274	Week 54: pH dipstick71930277	Week 54: pH dipstick71930275	Week 54: pH dipstick71930276	Week 80: pH dipstick71930274	Week 80: pH dipstick71930276	Week 80: pH dipstick71930275	Week 80: pH dipstick71930277	Week 0: Erythrocytes in urine71930274	Week 0: Erythrocytes in urine71930275	Week 0: Erythrocytes in urine71930277	Week 0: Erythrocytes in urine71930276	Week 54: Erythrocytes in urine71930275	Week 54: Erythrocytes in urine71930277	Week 54: Erythrocytes in urine71930274	Week 54: Erythrocytes in urine71930276	Week 80: Erythrocytes in urine71930277	Week 80: Erythrocytes in urine71930274	Week 80: Erythrocytes in urine71930275	Week 80: Erythrocytes in urine71930276	Week 0: Leukocytes in urine71930275	Week 0: Leukocytes in urine71930277	Week 0: Leukocytes in urine71930274	Week 0: Leukocytes in urine71930276	Week 54: Leukocytes in urine71930277	Week 54: Leukocytes in urine71930274	Week 54: Leukocytes in urine71930275	Week 54: Leukocytes in urine71930276	Week 80: Leukocytes in urine71930275	Week 80: Leukocytes in urine71930277	Week 80: Leukocytes in urine71930274	Week 80: Leukocytes in urine71930276	Week 0: Nitrite71930275	Week 0: Nitrite71930274	Week 0: Nitrite71930276	Week 0: Nitrite71930277	Week 54: Nitrite71930277	Week 54: Nitrite71930274	Week 54: Nitrite71930275	Week 54: Nitrite71930276	Week 80: Nitrite71930277	Week 80: Nitrite71930274	Week 80: Nitrite71930275	Week 80: Nitrite71930276	Week 0: Protein urine71930274	Week 0: Protein urine71930277	Week 0: Protein urine71930275	Week 0: Protein urine71930276	Week 54: Protein urine71930277	Week 54: Protein urine71930274	Week 54: Protein urine71930275	Week 54: Protein urine71930276	Week 80: Protein urine71930277	Week 80: Protein urine71930274	Week 80: Protein urine71930275	Week 80: Protein urine71930276	Week 0: Specific Gravity71930274	Week 0: Specific Gravity71930275	Week 0: Specific Gravity71930276	Week 0: Specific Gravity71930277	Week 54: Specific Gravity71930274	Week 54: Specific Gravity71930275	Week 54: Specific Gravity71930276	Week 54: Specific Gravity71930277	Week 80: Specific Gravity71930277	Week 80: Specific Gravity71930274	Week 80: Specific Gravity71930275	Week 80: Specific Gravity71930276
	Normal	Abnormal, NCS	Abnormal, CS
NNC0114-0006 + Liraglutide (Experimental)	72
Placebo (Placebo)	71
NNC0114-0006 + Liraglutide (Experimental)	5
Liraglutide (Experimental)	9
Placebo (Placebo)	6
NNC0114-0006 + Liraglutide (Experimental)	57
NNC0114-0006 (Experimental)	56
Liraglutide (Experimental)	63
NNC0114-0006 + Liraglutide (Experimental)	9
NNC0114-0006 (Experimental)	9
Liraglutide (Experimental)	5
NNC0114-0006 + Liraglutide (Experimental)	2
NNC0114-0006 + Liraglutide (Experimental)	54
NNC0114-0006 (Experimental)	54
Liraglutide (Experimental)	54
Placebo (Placebo)	51
NNC0114-0006 + Liraglutide (Experimental)	12
NNC0114-0006 (Experimental)	10
Liraglutide (Experimental)	13
Placebo (Placebo)	11
Liraglutide (Experimental)	73
Placebo (Placebo)	76
Placebo (Placebo)	1
Placebo (Placebo)	64
Liraglutide (Experimental)	66
Placebo (Placebo)	61
NNC0114-0006 + Liraglutide (Experimental)	75
Placebo (Placebo)	75
Placebo (Placebo)	2
Placebo (Placebo)	0
NNC0114-0006 + Liraglutide (Experimental)	66
Placebo (Placebo)	62
NNC0114-0006 + Liraglutide (Experimental)	74
NNC0114-0006 (Experimental)	74
Liraglutide (Experimental)	74
Placebo (Placebo)	72
Placebo (Placebo)	4
NNC0114-0006 (Experimental)	63
Placebo (Placebo)	63
NNC0114-0006 (Experimental)	2
Liraglutide (Experimental)	2
NNC0114-0006 + Liraglutide (Experimental)	77
NNC0114-0006 (Experimental)	73
NNC0114-0006 (Experimental)	4
NNC0114-0006 + Liraglutide (Experimental)	64
NNC0114-0006 + Liraglutide (Experimental)	62
NNC0114-0006 (Experimental)	61
Liraglutide (Experimental)	67
Placebo (Placebo)	60
NNC0114-0006 + Liraglutide (Experimental)	4
NNC0114-0006 (Experimental)	3
Liraglutide (Experimental)	1
Placebo (Placebo)	77
NNC0114-0006 + Liraglutide (Experimental)	68
Placebo (Placebo)	65
NNC0114-0006 (Experimental)	71
Liraglutide (Experimental)	75
NNC0114-0006 (Experimental)	6
Liraglutide (Experimental)	62
Liraglutide (Experimental)	6
NNC0114-0006 + Liraglutide (Experimental)	63
NNC0114-0006 (Experimental)	62
Liraglutide (Experimental)	65
Placebo (Placebo)	59
NNC0114-0006 + Liraglutide (Experimental)	3
Liraglutide (Experimental)	3
NNC0114-0006 (Experimental)	1
NNC0114-0006 (Experimental)	77
Liraglutide (Experimental)	76
NNC0114-0006 + Liraglutide (Experimental)	67
NNC0114-0006 (Experimental)	65
NNC0114-0006 + Liraglutide (Experimental)	65
NNC0114-0006 (Experimental)	64
Liraglutide (Experimental)	68
NNC0114-0006 + Liraglutide (Experimental)	1
NNC0114-0006 + Liraglutide (Experimental)	0
NNC0114-0006 (Experimental)	0
Liraglutide (Experimental)	0

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Change in Physical Examination

Physical examination parameters are categorised as general appearance; head, ears, eyes, nose, throat, neck; respiratory system;cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; skin; lymph node palpation and thyroid gland. Investigator assessed the participants with normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) findings at week 0, week 54 and week 80 are presented. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

Intervention	Participants (Count of Participants)
	Week 0: General Appearance71930275			Week 0: General Appearance71930277	Week 0: General Appearance71930274	Week 0: General Appearance71930276	Week 54: General Appearance71930277	Week 54: General Appearance71930274	Week 54: General Appearance71930275	Week 54: General Appearance71930276	Week 80: General Appearance71930274	Week 80: General Appearance71930276	Week 80: General Appearance71930275	Week 80: General Appearance71930277	Week 0: Head, Ears, Eyes, Nose, Throat, Neck71930274	Week 0: Head, Ears, Eyes, Nose, Throat, Neck71930275	Week 0: Head, Ears, Eyes, Nose, Throat, Neck71930276	Week 0: Head, Ears, Eyes, Nose, Throat, Neck71930277	Week 54: Head, Ears, Eyes, Nose, Throat, Neck71930274	Week 54: Head, Ears, Eyes, Nose, Throat, Neck71930276	Week 54: Head, Ears, Eyes, Nose, Throat, Neck71930275	Week 54: Head, Ears, Eyes, Nose, Throat, Neck71930277	Week 80: Head, Ears, Eyes, Nose, Throat, Neck71930276	Week 80: Head, Ears, Eyes, Nose, Throat, Neck71930277	Week 80: Head, Ears, Eyes, Nose, Throat, Neck71930275	Week 80: Head, Ears, Eyes, Nose, Throat, Neck71930274	Week 0: Respiratory System71930276	Week 0: Respiratory System71930274	Week 0: Respiratory System71930275	Week 0: Respiratory System71930277	Week 54: Respiratory System71930274	Week 54: Respiratory System71930275	Week 54: Respiratory System71930276	Week 54: Respiratory System71930277	Week 80: Respiratory System71930277	Week 80: Respiratory System71930274	Week 80: Respiratory System71930275	Week 80: Respiratory System71930276	Week 0: Cardiovascular System71930274	Week 0: Cardiovascular System71930276	Week 0: Cardiovascular System71930277	Week 0: Cardiovascular System71930275	Week 54: Cardiovascular System71930277	Week 54: Cardiovascular System71930274	Week 54: Cardiovascular System71930275	Week 54: Cardiovascular System71930276	Week 80: Cardiovascular System71930276	Week 80: Cardiovascular System71930275	Week 80: Cardiovascular System71930277	Week 80: Cardiovascular System71930274	Week 0: Gastrointestinal System incl. Mouth71930275	Week 0: Gastrointestinal System incl. Mouth71930276	Week 0: Gastrointestinal System incl. Mouth71930277	Week 0: Gastrointestinal System incl. Mouth71930274	Week 54: Gastrointestinal System incl. Mouth71930276	Week 54: Gastrointestinal System incl. Mouth71930277	Week 54: Gastrointestinal System incl. Mouth71930275	Week 54: Gastrointestinal System incl. Mouth71930274	Week 80: Gastrointestinal System incl. Mouth71930276	Week 80: Gastrointestinal System incl. Mouth71930277	Week 80: Gastrointestinal System incl. Mouth71930274	Week 80: Gastrointestinal System incl. Mouth71930275	Week 0: Musculoskeletal System71930277	Week 0: Musculoskeletal System71930276	Week 0: Musculoskeletal System71930274	Week 0: Musculoskeletal System71930275	Week 54: Musculoskeletal System71930276	Week 54: Musculoskeletal System71930277	Week 54: Musculoskeletal System71930274	Week 54: Musculoskeletal System71930275	Week 80: Musculoskeletal System71930274	Week 80: Musculoskeletal System71930276	Week 80: Musculoskeletal System71930275	Week 80: Musculoskeletal System71930277	Week 0: Central and Peripheral Nervous System71930275	Week 0: Central and Peripheral Nervous System71930276	Week 0: Central and Peripheral Nervous System71930274	Week 0: Central and Peripheral Nervous System71930277	Week 54: Central and Peripheral Nervous System71930277	Week 54: Central and Peripheral Nervous System71930274	Week 54: Central and Peripheral Nervous System71930276	Week 54: Central and Peripheral Nervous System71930275	Week 80: Central and Peripheral Nervous System71930275	Week 80: Central and Peripheral Nervous System71930276	Week 80: Central and Peripheral Nervous System71930277	Week 80: Central and Peripheral Nervous System71930274	Week 0: Skin71930275	Week 0: Skin71930277	Week 0: Skin71930274	Week 0: Skin71930276	Week 54: Skin71930277	Week 54: Skin71930274	Week 54: Skin71930275	Week 54: Skin71930276	Week 80: Skin71930274	Week 80: Skin71930276	Week 80: Skin71930275	Week 80: Skin71930277	Week 0: Lymph Node Palpation71930274	Week 0: Lymph Node Palpation71930277	Week 0: Lymph Node Palpation71930275	Week 0: Lymph Node Palpation71930276	Week 54: Lymph Node Palpation71930275	Week 54: Lymph Node Palpation71930277	Week 54: Lymph Node Palpation71930274	Week 54: Lymph Node Palpation71930276	Week 80: Lymph Node Palpation71930274	Week 80: Lymph Node Palpation71930276	Week 80: Lymph Node Palpation71930275	Week 80: Lymph Node Palpation71930277	Week 0: Thyroid Gland71930274	Week 0: Thyroid Gland71930275	Week 0: Thyroid Gland71930276	Week 0: Thyroid Gland71930277	Week 54: Thyroid Gland71930274	Week 54: Thyroid Gland71930277	Week 54: Thyroid Gland71930276	Week 54: Thyroid Gland71930275	Week 80: Thyroid Gland71930274	Week 80: Thyroid Gland71930277	Week 80: Thyroid Gland71930276	Week 80: Thyroid Gland71930275
	Normal	Abnormal, CS	Abnormal, NCS
NNC0114-0006 + Liraglutide (Experimental)	76
Placebo (Placebo)	66
Placebo (Placebo)	0
NNC0114-0006 + Liraglutide (Experimental)	65
Placebo (Placebo)	60
Liraglutide (Experimental)	2
Placebo (Placebo)	2
NNC0114-0006 (Experimental)	77
NNC0114-0006 + Liraglutide (Experimental)	68
NNC0114-0006 (Experimental)	64
NNC0114-0006 + Liraglutide (Experimental)	74
Placebo (Placebo)	73
NNC0114-0006 + Liraglutide (Experimental)	3
Placebo (Placebo)	4
NNC0114-0006 + Liraglutide (Experimental)	67
NNC0114-0006 + Liraglutide (Experimental)	1
Liraglutide (Experimental)	67
Placebo (Placebo)	62
Liraglutide (Experimental)	1
NNC0114-0006 + Liraglutide (Experimental)	75
NNC0114-0006 + Liraglutide (Experimental)	2
Placebo (Placebo)	61
NNC0114-0006 (Experimental)	1
Liraglutide (Experimental)	74
Placebo (Placebo)	65
NNC0114-0006 + Liraglutide (Experimental)	66
Placebo (Placebo)	76
NNC0114-0006 + Liraglutide (Experimental)	0
Liraglutide (Experimental)	66
Liraglutide (Experimental)	68
NNC0114-0006 + Liraglutide (Experimental)	70
NNC0114-0006 (Experimental)	75
Liraglutide (Experimental)	69
Placebo (Placebo)	74
NNC0114-0006 + Liraglutide (Experimental)	6
Liraglutide (Experimental)	7
Placebo (Placebo)	3
Liraglutide (Experimental)	63
NNC0114-0006 + Liraglutide (Experimental)	5
Liraglutide (Experimental)	3
NNC0114-0006 + Liraglutide (Experimental)	61
NNC0114-0006 (Experimental)	62
Liraglutide (Experimental)	65
NNC0114-0006 (Experimental)	2
NNC0114-0006 (Experimental)	0
NNC0114-0006 + Liraglutide (Experimental)	77
Placebo (Placebo)	77
Placebo (Placebo)	64
Placebo (Placebo)	1
NNC0114-0006 (Experimental)	63
NNC0114-0006 (Experimental)	76
Liraglutide (Experimental)	76
Placebo (Placebo)	75
NNC0114-0006 (Experimental)	65
Liraglutide (Experimental)	0

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Change in Eye-examination

Dilated fundoscopy or fundus photography was performed by the investigator at week 0, week 54 and week 80. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week 0, week 54 and week 80 are presented. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

Intervention	Participants (Count of Participants)
	Week 0: Left eye ophthalmoscopy71930274			Week 0: Left eye ophthalmoscopy71930276	Week 0: Left eye ophthalmoscopy71930277	Week 0: Left eye ophthalmoscopy71930275	Week 54: Left eye ophthalmoscopy71930274	Week 54: Left eye ophthalmoscopy71930275	Week 54: Left eye ophthalmoscopy71930276	Week 54: Left eye ophthalmoscopy71930277	Week 80: Left eye ophthalmoscopy71930274	Week 80: Left eye ophthalmoscopy71930275	Week 80: Left eye ophthalmoscopy71930276	Week 80: Left eye ophthalmoscopy71930277	Week 0: Right eye ophthalmoscopy71930274	Week 0: Right eye ophthalmoscopy71930275	Week 0: Right eye ophthalmoscopy71930277	Week 0: Right eye ophthalmoscopy71930276	Week 54: Right eye ophthalmoscopy71930274	Week 54: Right eye ophthalmoscopy71930275	Week 54: Right eye ophthalmoscopy71930276	Week 54: Right eye ophthalmoscopy71930277	Week 80: Right eye ophthalmoscopy71930274	Week 80: Right eye ophthalmoscopy71930275	Week 80: Right eye ophthalmoscopy71930276	Week 80: Right eye ophthalmoscopy71930277
	Abnormal, CS	Normal	Abnormal, NCS
NNC0114-0006 + Liraglutide (Experimental)	64
NNC0114-0006 (Experimental)	68
Liraglutide (Experimental)	70
Placebo (Placebo)	66
NNC0114-0006 + Liraglutide (Experimental)	13
Liraglutide (Experimental)	6
Placebo (Placebo)	11
NNC0114-0006 + Liraglutide (Experimental)	0
NNC0114-0006 (Experimental)	0
Liraglutide (Experimental)	0
Placebo (Placebo)	0
NNC0114-0006 + Liraglutide (Experimental)	55
NNC0114-0006 (Experimental)	56
Liraglutide (Experimental)	60
Placebo (Placebo)	54
NNC0114-0006 + Liraglutide (Experimental)	12
NNC0114-0006 (Experimental)	7
Liraglutide (Experimental)	9
Placebo (Placebo)	9
Placebo (Placebo)	1
NNC0114-0006 + Liraglutide (Experimental)	52
NNC0114-0006 (Experimental)	54
Liraglutide (Experimental)	59
Placebo (Placebo)	51
NNC0114-0006 + Liraglutide (Experimental)	11
Placebo (Placebo)	8
NNC0114-0006 + Liraglutide (Experimental)	3
NNC0114-0006 + Liraglutide (Experimental)	58
NNC0114-0006 (Experimental)	66
Liraglutide (Experimental)	69
Placebo (Placebo)	67
NNC0114-0006 + Liraglutide (Experimental)	18
NNC0114-0006 (Experimental)	11
Liraglutide (Experimental)	7
Placebo (Placebo)	10
NNC0114-0006 + Liraglutide (Experimental)	1
NNC0114-0006 (Experimental)	55
Placebo (Placebo)	55
NNC0114-0006 (Experimental)	8
NNC0114-0006 (Experimental)	53
Liraglutide (Experimental)	58
NNC0114-0006 (Experimental)	9
NNC0114-0006 + Liraglutide (Experimental)	2

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Change in Electrocardiogram (ECG)

The ECG was assessed by the investigator at baseline (week 0), week 54 and week 80 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline, week 54 and week 80 are presented. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

Intervention	Participants (Count of Participants)
	Week 071930275			Week 071930276	Week 071930277	Week 071930274	Week 5471930274	Week 5471930275	Week 5471930276	Week 5471930277	Week 8071930274	Week 8071930275	Week 8071930276	Week 8071930277
	Abnormal, NCS	Abnormal, CS	Normal
NNC0114-0006 + Liraglutide (Experimental)	62
NNC0114-0006 (Experimental)	65
Liraglutide (Experimental)	60
Placebo (Placebo)	63
NNC0114-0006 + Liraglutide (Experimental)	15
NNC0114-0006 (Experimental)	12
Liraglutide (Experimental)	16
Placebo (Placebo)	13
NNC0114-0006 + Liraglutide (Experimental)	0
NNC0114-0006 (Experimental)	0
Liraglutide (Experimental)	0
Placebo (Placebo)	1
NNC0114-0006 + Liraglutide (Experimental)	54
NNC0114-0006 (Experimental)	48
Liraglutide (Experimental)	55
Placebo (Placebo)	46
NNC0114-0006 + Liraglutide (Experimental)	14
NNC0114-0006 (Experimental)	17
Liraglutide (Experimental)	12
Placebo (Placebo)	19
NNC0114-0006 + Liraglutide (Experimental)	51
Liraglutide (Experimental)	53
Placebo (Placebo)	50
NNC0114-0006 (Experimental)	16
Liraglutide (Experimental)	15
Placebo (Placebo)	12
Placebo (Placebo)	0

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Autoantibodies Against Zinc-transporter 8 (ZnT8)

Participants were analyzed for autoantibodies against Zinc-transporter 8 (ZnT8) and were categorized as negative and positive. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

Intervention	Participants (Count of Participants)
	Week 071930275		Week 071930276	Week 071930274	Week 071930277	Week 5471930274	Week 5471930275	Week 5471930276	Week 5471930277	Week 8071930274	Week 8071930275	Week 8071930276	Week 8071930277
	Positive	Negative
NNC0114-0006 + Liraglutide (Experimental)	29
NNC0114-0006 (Experimental)	30
Liraglutide (Experimental)	30
Placebo (Placebo)	36
NNC0114-0006 + Liraglutide (Experimental)	48
NNC0114-0006 (Experimental)	47
Liraglutide (Experimental)	46
Placebo (Placebo)	41
NNC0114-0006 + Liraglutide (Experimental)	26
NNC0114-0006 (Experimental)	28
Liraglutide (Experimental)	27
NNC0114-0006 + Liraglutide (Experimental)	42
NNC0114-0006 (Experimental)	37
Liraglutide (Experimental)	41
Placebo (Placebo)	33
NNC0114-0006 + Liraglutide (Experimental)	23
Liraglutide (Experimental)	31
NNC0114-0006 (Experimental)	34
Liraglutide (Experimental)	37
Placebo (Placebo)	29

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Autoantibodies Against Islet Antigen-2 (IA2)

Participants were analyzed for autoantibodies against Islet antigen-2 (IA2) and were categorized as negative and positive. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

Intervention	Participants (Count of Participants)
	Week 071930274		Week 071930275	Week 071930276	Week 071930277	Week 5471930274	Week 5471930275	Week 5471930276	Week 5471930277	Week 8071930274	Week 8071930275	Week 8071930277	Week 8071930276
	Negative	Positive
NNC0114-0006 + Liraglutide (Experimental)	38
NNC0114-0006 (Experimental)	37
Liraglutide (Experimental)	31
Placebo (Placebo)	45
NNC0114-0006 + Liraglutide (Experimental)	39
NNC0114-0006 (Experimental)	40
Liraglutide (Experimental)	45
Placebo (Placebo)	32
NNC0114-0006 + Liraglutide (Experimental)	35
NNC0114-0006 (Experimental)	33
Liraglutide (Experimental)	28
Placebo (Placebo)	38
NNC0114-0006 + Liraglutide (Experimental)	33
NNC0114-0006 (Experimental)	32
Liraglutide (Experimental)	40
Placebo (Placebo)	28
NNC0114-0006 + Liraglutide (Experimental)	32
NNC0114-0006 (Experimental)	38
Liraglutide (Experimental)	29
Placebo (Placebo)	35
NNC0114-0006 (Experimental)	26
Liraglutide (Experimental)	39
Placebo (Placebo)	27

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Autoantibodies Against Insulin Autoantibodies (IAA)

Participants were analyzed for autoantibodies against Insulin autoantibodies (IAA) and were categorized as negative and positive. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

Intervention	Participants (Count of Participants)
	Week 071930275		Week 071930274	Week 071930276	Week 071930277	Week 5471930274	Week 5471930275	Week 5471930276	Week 5471930277	Week 8071930276	Week 8071930274	Week 8071930275	Week 8071930277
	Positive	Negative
NNC0114-0006 + Liraglutide (Experimental)	35
NNC0114-0006 (Experimental)	28
Liraglutide (Experimental)	26
Placebo (Placebo)	36
NNC0114-0006 + Liraglutide (Experimental)	42
NNC0114-0006 (Experimental)	48
Liraglutide (Experimental)	49
Placebo (Placebo)	40
NNC0114-0006 + Liraglutide (Experimental)	30
Liraglutide (Experimental)	22
Placebo (Placebo)	11
NNC0114-0006 + Liraglutide (Experimental)	38
NNC0114-0006 (Experimental)	37
Liraglutide (Experimental)	46
Placebo (Placebo)	55
NNC0114-0006 + Liraglutide (Experimental)	18
NNC0114-0006 (Experimental)	24
Liraglutide (Experimental)	13
Placebo (Placebo)	15
NNC0114-0006 + Liraglutide (Experimental)	48
NNC0114-0006 (Experimental)	40
Liraglutide (Experimental)	55
Placebo (Placebo)	47

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Autoantibodies Against Glutamic Acid Decarboxylase (GAD)

Participants were analyzed for autoantibodies against Glutamic acid decarboxylase (GAD) and were categorized as negative and positive. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

Intervention	Participants (Count of Participants)
	Week 071930275		Week 071930276	Week 071930274	Week 071930277	Week 5471930276	Week 5471930274	Week 5471930275	Week 5471930277	Week 8071930275	Week 8071930276	Week 8071930277	Week 8071930274
	Negative	Positive
NNC0114-0006 + Liraglutide (Experimental)	3
NNC0114-0006 (Experimental)	1
Liraglutide (Experimental)	5
Placebo (Placebo)	3
NNC0114-0006 + Liraglutide (Experimental)	74
NNC0114-0006 (Experimental)	76
Liraglutide (Experimental)	71
Placebo (Placebo)	74
NNC0114-0006 + Liraglutide (Experimental)	5
NNC0114-0006 (Experimental)	4
Liraglutide (Experimental)	4
NNC0114-0006 + Liraglutide (Experimental)	62
NNC0114-0006 (Experimental)	61
Liraglutide (Experimental)	64
Placebo (Placebo)	63
NNC0114-0006 + Liraglutide (Experimental)	4
NNC0114-0006 (Experimental)	2
Placebo (Placebo)	1
NNC0114-0006 + Liraglutide (Experimental)	61
NNC0114-0006 (Experimental)	62
Liraglutide (Experimental)	63
Placebo (Placebo)	61

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Number of Weeks Off Bolus Insulin

The number of weeks off bolus insulin after 54 weeks of treatment and week 80 are presented. (NCT02443155)
Timeframe: (Week 0 to week 54) and (week 0 to week 80)

,,,

Intervention	Weeks (Mean)
	Week 0 to week 54	Week 0 to week 80
Liraglutide (Experimental)	9	12
NNC0114-0006 (Experimental)	5	9
NNC0114-0006 + Liraglutide (Experimental)	10	14
Placebo (Placebo)	4	6

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Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA)

"Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 1 day after the date of last contact. Number of treatment-emergent hypoglycaemic episodes according to American Diabetes Association (ADA) classification from first dose of trial product to week 54 and from week 54 to week 80 are presented.~Results presented hypoglycaemia episodes were recorded as per ADA definition: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Pseudo-hypoglycaemia." (NCT02443155)
Timeframe: Weeks 0-54; Weeks 54-80

,,,

Intervention	Episodes (Number)
	Severe hypoglycaemia (Week 0-54)	Asymptomatic hypoglycaemia (Week 0-54)	Documented symptomatic hypoglycaemia (Week 0-54)	Pseudo-hypoglycaemia (Week 0-54)	Probable symptomatic hypoglycaemia (Week 0-54)	Severe hypoglycaemia (Week 54-80)	Asymptomatic hypoglycaemia (Week 54-80)	Documented symptomatic hypoglycaemia (Week 54-80)	Pseudo-hypoglycaemia (Week 54-80)	Probable symptomatic hypoglycaemia (Week 54-80)
Liraglutide (Experimental)	0	2092	1114	14	4	0	670	651	1	0
NNC0114-0006 (Experimental)	2	1956	1461	1	0	1	522	362	0	0
NNC0114-0006 + Liraglutide (Experimental)	1	2038	1305	1	9	3	609	514	0	1
Placebo (Placebo)	0	1774	1625	2	10	1	449	527	2	2

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Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions

Hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. BG-confirmed: An episode that is BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Severe or BG-confirmed: An episode that is severe according to the International Society for Pediatric and Adolescent Diabetes (ISPAD) classification or BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. (NCT02443155)
Timeframe: Weeks 0-54; Weeks 54-80

,,,

Intervention	Episodes (Number)
	Severe or BG confirmed (Week 0-54)	Symptomatic BG confirmed (Week 0-54)	Severe or BG confirmed (Week 54-80)	Symptomatic BG confirmed (Week 54-80)
Liraglutide (Experimental)	315	479	244	332
NNC0114-0006 (Experimental)	394	616	130	207
NNC0114-0006 + Liraglutide (Experimental)	396	576	216	368
Placebo (Placebo)	503	646	240	292

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Number of Treatment Emergent Hyperglycaemic Episodes

"Hyperglycaemic episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period.~On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit." (NCT02443155)
Timeframe: Week 0-54; Week 54-80

,,,

Intervention	Episodes (Number)
	Week 0-54	Week 54-80
Liraglutide (Experimental)	217	352
NNC0114-0006 (Experimental)	256	74
NNC0114-0006 + Liraglutide (Experimental)	302	306
Placebo (Placebo)	291	112

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Number of Treatment Emergent Episodes of Diabetic Ketoacidosis

"Diabetic ketoacidosis episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period.~On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit." (NCT02443155)
Timeframe: Weeks 0-54; Weeks 54-80

,,,

Intervention	Episodes (Number)
	Week 0-54	Week 54-80
Liraglutide (Experimental)	0	1
NNC0114-0006 (Experimental)	0	0
NNC0114-0006 + Liraglutide (Experimental)	0	0
Placebo (Placebo)	0	1

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Number of Treatment Emergent Adverse Events

"An adverse event was any untoward medical occurrence in a participants administered a product, and which did not necessarily have a causal relationship with this treatment. An adverse event was defined as treatment emergent if the onset of the adverse event occurs on or after the first day of trial product administration. Number of treatment emergent adverse events from first dose of trial product to week 54 and week 80 are presented. Results are based on the on-treatment and on-observation period.~On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit." (NCT02443155)
Timeframe: Week 0-54; Week 54-80

,,,

Intervention	Adverse events (Number)
	Week 0-54	Week 54-80
Liraglutide (Experimental)	410	78
NNC0114-0006 (Experimental)	327	73
NNC0114-0006 + Liraglutide (Experimental)	434	70
Placebo (Placebo)	364	87

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Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline

The eGFR was measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Change in eGFR (measured in milliliters per minute per 1.73 square meters) from baseline (week 0) at week 54 and week 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of eGFR (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.97	0.96
NNC0114-0006 (Experimental)	0.95	0.94
NNC0114-0006 + Liraglutide (Experimental)	0.98	0.97
Placebo (Placebo)	1.00	0.99

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Change in Total Immunoglobulin E (IgE)

Change in IgE (measured in kilo international units per liter [kIU/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of IgE (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.08	1.16
NNC0114-0006 (Experimental)	1.05	1.18
NNC0114-0006 + Liraglutide (Experimental)	1.31	1.32
Placebo (Placebo)	1.02	0.94

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Change in Haematology: Eosinophil

Change in eosinophil (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of eosinophils (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	3.10	1.54
NNC0114-0006 (Experimental)	1.30	1.23
NNC0114-0006 + Liraglutide (Experimental)	1.15	1.31
Placebo (Placebo)	1.37	1.36

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Change in Systolic and Diastolic Blood Pressure

Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) are evaluated from baseline (week 0) to weeks 54 and 80. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Millimeters of mercury (mmHg) (Mean)
	Week 54: Systolic blood pressure	Week 80: Systolic blood pressure	Week 54: Diastolic blood pressure	Week 80: Diastolic blood pressure
Liraglutide (Experimental)	-2	1	-1	1
NNC0114-0006 (Experimental)	3	2	2	2
NNC0114-0006 + Liraglutide (Experimental)	-3	-1	-0	-0
Placebo (Placebo)	1	4	-1	1

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Change in Short Form 36 Health Survey (SF-36)

SF-36v2™ questionnaire measured the HRQoL on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. Change from baseline (week 0) to week 54 and week 80 in SF-36 score is presented.The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicate an improvement since baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Score on a scale (Mean)
	Week 54: Bodily pain	Week 80: Bodily Pain	Week 54: General Health Perception	Week 80: General Health Perception	Week 54: Mental Component Sum	Week 80: Mental Component Sum	week 54: Mental Health	Week 80: Mental Health	Week 54: Physical Component Sum	Week 80: Physical Component Sum	Week 54: Physical Functioning	Week 80: Physical Functioning	Week 54:Lim Emotion Prob	Week 80: Lim Emotion Prob	Week 54: Lim. Phy Health	Week 80: Lim. Phy Health	Week 54: Social Functioning	Week 80: Social Functioning	Week 54: Vitality	Week 80: Vitality
Liraglutide (Experimental)	0.1	-0.5	-1.6	-1.7	-2.1	-2.4	-1.5	-1.5	-0.1	0.0	0.0	-0.1	-1.4	-2.2	-0.6	-0.2	-1.4	-1.2	-2.2	-2.2
NNC0114-0006 (Experimental)	-2.2	-1.4	-0.3	0.6	0.6	-0.4	0.6	-0.2	-0.4	0.5	0.9	1.1	0.5	-0.1	0.7	0.9	0.1	1.0	0.5	-1.4
NNC0114-0006 + Liraglutide (Experimental)	-0.8	0.8	-1.1	-0.9	0.5	1.7	0.7	1.5	-0.4	-0.1	0.6	0.5	0.3	1.2	0.3	0.8	0.8	2.3	-0.5	0.5
Placebo (Placebo)	0.6	0.8	-1.0	-1.8	-1.3	-0.7	-1.3	-0.7	0.3	0.0	0.3	0.1	-0.1	0.0	-0.2	0.0	0.0	-0.4	-2.3	-0.7

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Change in Respiratory Rate

Change in respiratory rate is evaluated from baseline (week 0) to weeks 54 and 80. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Breaths per minute (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.1	0.1
NNC0114-0006 (Experimental)	0.1	-0.2
NNC0114-0006 + Liraglutide (Experimental)	-0.3	-0.3
Placebo (Placebo)	0.6	0.1

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Change in Pulse

Change in pulse is evaluated from baseline (week 0) to weeks 54 and 80 (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Beats/min (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	6	2
NNC0114-0006 (Experimental)	0	-1
NNC0114-0006 + Liraglutide (Experimental)	3	-1
Placebo (Placebo)	2	1

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Change in Number of Insulin Injections

The number of insulin injections was derived as the average of the reported number on the three days prior to the visit. The change in number of insulin injections per day (count) from baseline (week 0) after 54 weeks of treatment and week 80 are presented. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Injections per day (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	-0.5	-0.2
NNC0114-0006 (Experimental)	-0.1	-0.3
NNC0114-0006 + Liraglutide (Experimental)	-0.3	0.2
Placebo (Placebo)	0.2	0.2

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Change in Mean of 7-point Profiles

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in mean of 7-point profiles value is presented. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	mmol/L (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	-0.1	0.7
NNC0114-0006 (Experimental)	0.3	0.0
NNC0114-0006 + Liraglutide (Experimental)	0.5	0.1
Placebo (Placebo)	0.0	0.3

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Change in Lipids: Triglycerides (TG) (Ratio to Baseline)

Change in Triglycerides (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of TG (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.03	1.09
NNC0114-0006 (Experimental)	0.96	0.94
NNC0114-0006 + Liraglutide (Experimental)	1.03	1.08
Placebo (Placebo)	1.02	0.95

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Change in Lipids: Total Cholesterol (Ratio to Baseline)

Change in total cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of total cholesterol (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.03	1.07
NNC0114-0006 (Experimental)	1.02	1.03
NNC0114-0006 + Liraglutide (Experimental)	1.00	1.02
Placebo (Placebo)	1.04	1.03

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Change in Lipids: LDL Cholesterol (Ratio to Baseline)

Change in LDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of LDL cholesterol (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.98	1.02
NNC0114-0006 (Experimental)	0.97	1.02
NNC0114-0006 + Liraglutide (Experimental)	0.96	0.99
Placebo (Placebo)	1.01	1.03

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Change in Lipids: HDL Cholesterol (Ratio to Baseline)

Change in HDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of HDL cholesterol (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.12	1.14
NNC0114-0006 (Experimental)	1.08	1.06
NNC0114-0006 + Liraglutide (Experimental)	1.04	1.04
Placebo (Placebo)	1.10	1.07

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Change in Lipids: Free Fatty Acids (Ratio to Baseline)

Change in total free fatty acids (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of free fatty acids (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.18	1.19
NNC0114-0006 (Experimental)	1.01	1.06
NNC0114-0006 + Liraglutide (Experimental)	0.86	0.89
Placebo (Placebo)	0.97	0.94

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Change in International Normalised Ratio (INR)

Change in INR (measured in ratio]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of INR (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.95	0.96
NNC0114-0006 (Experimental)	0.96	0.99
NNC0114-0006 + Liraglutide (Experimental)	0.97	0.98
Placebo (Placebo)	0.96	0.97

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Change in Insulin Dose

The total daily insulin dose was derived as the average of the doses reported on the three days prior to the visit. Change in daily total insulin dose from baseline (week 0) after 54 weeks of treatment and week 80 are presented. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Units per kilograms (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.01	0.11
NNC0114-0006 (Experimental)	0.02	0.05
NNC0114-0006 + Liraglutide (Experimental)	-0.05	0.10
Placebo (Placebo)	0.09	0.12

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Change in Hormone Level: Thyroid Stimulating Hormone (TSH)

Change in TSH (measured in milli international units per liter [mIU/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of Thyroid Stimulating Hormone (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.89	0.99
NNC0114-0006 (Experimental)	1.12	0.99
NNC0114-0006 + Liraglutide (Experimental)	1.00	1.04
Placebo (Placebo)	0.91	0.93

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Change in Hormone Level: Calcitonin

Change in Calcitonin (measured in nanogram per liter [ng/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of Calcitonin (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.89	0.82
NNC0114-0006 (Experimental)	0.90	0.93
NNC0114-0006 + Liraglutide (Experimental)	1.00	0.85
Placebo (Placebo)	0.88	0.90

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Change in HbA1c

Change in glycosylated haemoglobin (HbA1c) is evaluated from baseline (week 0) to weeks 54 and 80. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Percentage point of HbA1c (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	-0.3	0.5
NNC0114-0006 (Experimental)	-0.5	-0.2
NNC0114-0006 + Liraglutide (Experimental)	-0.7	-0.1
Placebo (Placebo)	-0.3	-0.4

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Change in Haematology: Thrombocytes

Change in thrombocytes (measured in 10^9 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of thrombocytes (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.03	1.04
NNC0114-0006 (Experimental)	0.98	1.03
NNC0114-0006 + Liraglutide (Experimental)	0.98	1.00
Placebo (Placebo)	0.98	1.00

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Change in Haematology: Neutrophils

Change in neutrophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of neutrophils (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.97	0.98
NNC0114-0006 (Experimental)	0.99	0.99
NNC0114-0006 + Liraglutide (Experimental)	0.98	0.97
Placebo (Placebo)	1.04	1.04

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Change in Haematology: Monocytes

Change in monocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of monocytes (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.01	1.04
NNC0114-0006 (Experimental)	1.02	1.07
NNC0114-0006 + Liraglutide (Experimental)	1.05	1.12
Placebo (Placebo)	1.01	1.12

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Change in Haematology: Mean Corpuscular Volume

Change in Mean Corpuscular volume (measured in femtoliter 'fL') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of mean corpuscular volume (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.00	1.00
NNC0114-0006 (Experimental)	0.99	1.00
NNC0114-0006 + Liraglutide (Experimental)	1.00	1.00
Placebo (Placebo)	0.99	0.99

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Change in Haematology: Mean Corpuscular Hemoglobin Concentration

Change in mean corpuscular hemoglobin concentration (MCHC) (measured in gram per liter 'g/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of MCHC (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.02	1.02
NNC0114-0006 (Experimental)	1.01	1.02
NNC0114-0006 + Liraglutide (Experimental)	1.02	1.02
Placebo (Placebo)	1.02	1.02

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Change in Haematology: Mean Corpuscular Hemoglobin

Change in mean Corpuscular hemoglobin (measured in femtomole 'fmol') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of mean Corpuscular hemoglobin (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.01	1.01
NNC0114-0006 (Experimental)	1.01	1.01
NNC0114-0006 + Liraglutide (Experimental)	1.02	1.02
Placebo (Placebo)	1.01	1.02

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Change in Haematology: Lymphocytes

Change in lymphocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of lymphocytes (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.02	0.99
NNC0114-0006 (Experimental)	1.00	0.98
NNC0114-0006 + Liraglutide (Experimental)	1.00	1.01
Placebo (Placebo)	0.91	0.91

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Change in Haematology: Leukocytes

Change in leukocytes (measured in 10^9 cells/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of leukocytes (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.97	0.99
NNC0114-0006 (Experimental)	0.98	0.95
NNC0114-0006 + Liraglutide (Experimental)	0.96	0.99
Placebo (Placebo)	1.02	1.00

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Change in Haematology: Haemoglobin

Change in haemoglobin (measured in millimoles per liter 'mmol/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of haemoglobin (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.00	1.00
NNC0114-0006 (Experimental)	1.02	1.02
NNC0114-0006 + Liraglutide (Experimental)	1.01	1.00
Placebo (Placebo)	1.01	1.01

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Change in Haematology: Haematocrit

Change in haematocrit (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of haematocrit (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.99	0.98
NNC0114-0006 (Experimental)	1.00	1.00
NNC0114-0006 + Liraglutide (Experimental)	0.99	0.98
Placebo (Placebo)	1.00	0.99

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Change in Biochemistry: Creatinine

Change in creatinine (measured in micromole per liter [umol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of Creatinine (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.04	1.05
NNC0114-0006 (Experimental)	1.05	1.05
NNC0114-0006 + Liraglutide (Experimental)	1.01	1.02
Placebo (Placebo)	1.01	1.02

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Change in Biochemistry: Gamma-glutamyl Transferase (GGT)

Change in GGT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of GGT (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.03	1.10
NNC0114-0006 (Experimental)	1.08	1.13
NNC0114-0006 + Liraglutide (Experimental)	1.02	1.05
Placebo (Placebo)	1.02	1.00

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Change in Biochemistry: Lactate Dehydrogenase

Change in Lactate Dehydrogenase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of Lactate Dehydrogenase (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.04	1.09
NNC0114-0006 (Experimental)	1.03	1.04
NNC0114-0006 + Liraglutide (Experimental)	0.99	1.02
Placebo (Placebo)	1.03	1.03

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Change in Biochemistry: Lipase

Change in lipase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of lipase (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.34	1.02
NNC0114-0006 (Experimental)	1.00	0.94
NNC0114-0006 + Liraglutide (Experimental)	1.49	1.05
Placebo (Placebo)	1.01	0.96

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Change in Biochemistry: Magnesium

Change in magnesium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of magnesium (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.02	1.02
NNC0114-0006 (Experimental)	1.01	1.03
NNC0114-0006 + Liraglutide (Experimental)	1.02	1.01
Placebo (Placebo)	0.99	0.98

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Change in Biochemistry: Phosphate

Change in phosphate (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of phosphate (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.02	1.03
NNC0114-0006 (Experimental)	0.99	1.01
NNC0114-0006 + Liraglutide (Experimental)	0.99	1.02
Placebo (Placebo)	0.96	0.99

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Change in Biochemistry: Potassium

Change in potassium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of potassium (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.99	0.98
NNC0114-0006 (Experimental)	0.98	0.99
NNC0114-0006 + Liraglutide (Experimental)	1.01	0.99
Placebo (Placebo)	0.98	0.98

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Change in Biochemistry: Sodium

Change in sodium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of sodium (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.00	1.00
NNC0114-0006 (Experimental)	1.00	1.00
NNC0114-0006 + Liraglutide (Experimental)	1.00	0.99
Placebo (Placebo)	1.00	1.00

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Change in Biochemistry: Total Bilirubin

Change in Total bilirubin (measured in micromole per liter [umol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of total bilirubin (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.99	0.98
NNC0114-0006 (Experimental)	1.10	1.04
NNC0114-0006 + Liraglutide (Experimental)	0.81	0.91
Placebo (Placebo)	1.01	0.99

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Change in Biochemistry: Total Protein

Change in total protein (measured in gram per liter [g/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of total protein (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.01	1.00
NNC0114-0006 (Experimental)	1.00	1.00
NNC0114-0006 + Liraglutide (Experimental)	0.99	0.99
Placebo (Placebo)	1.00	1.00

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Change in Biochemistry: Uric Acid

Change in Uric Acid (measured in milligram per deciliter [mg/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of uric acid (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.98	0.96
NNC0114-0006 (Experimental)	0.98	0.94
NNC0114-0006 + Liraglutide (Experimental)	0.93	0.95
Placebo (Placebo)	0.96	0.95

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Change in Biomarker: Immune Phenotyping- B Cell Panel

"B cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.~In below table CD refer to Cluster of Differentiation; IgMNeg refers to Immunoglobulin M negative; IgDNeg refers to Immunoglobulin D negative." (NCT02443155)
Timeframe: Week 0, week 54 and week 80

,,,

Intervention	Percentage of B cells (%) (Mean)
	Week 0: Activated Memory B-Cells	Week 54: Activated Memory B-Cells	Week 80: Activated Memory B-Cells	Week 0: Mature Naive B-Cells	Week 54: Mature Naive B-Cells	Week 80: Mature Naive B-Cells	Week 0: Antibody-Secreting Cells	Week 54: Antibody-Secreting Cells	Week 80: Antibody-Secreting Cells	Week 0: B-Cells Positive For Both CD19 & CD20	Week 54: B-Cells Positive For Both CD19 & CD20	Week 80: B-Cells Positive For Both CD19 & CD20	Week 0: CD20Neg B-Cell	Week 54: CD20Neg B-Cell	Week 80: CD20Neg B-Cell	Week 0: CD24- B-Cells	Week 54: CD24- B-Cells	Week 80: CD24- B-Cells	Week 0: Class-Switched Memory B Cells	Week 54: Class-Switched Memory B Cells	Week 80: Class-Switched Memory B Cells	Week 0: IgMNeg IgDNeg Switched Memory B-cells	Week 54: IgMNeg IgDNeg Switched Memory B-cells	Week 80: IgMNeg IgDNeg Switched Memory B-cells	Week 0: Non-Class Switched Memory B-Cells	Week 54: Non-Class Switched Memory B-Cells	Week 80: Non-Class Switched Memory B-Cells	Week 0: Total B-Cell Population	Week 54: Total B-Cell Population	Week 80: Total B-Cell Population	Week 0: Transitional B-Cells	Week 54: Transitional B-Cells	Week 80: Transitional B-Cells
Liraglutide (Experimental)	1.6	1.5	1.5	13.6	13.6	12.0	0.6	0.5	0.4	72.1	72.1	72.8	0.6	0.5	0.6	31.5	31.3	33.4	4.8	4.6	4.6	0.1	0.1	0.1	9.6	8.7	8.0	72.7	72.6	73.5	9.5	9.5	8.1
NNC0114-0006 (Experimental)	1.4	1.1	1.1	14.0	14.3	14.2	0.5	0.4	0.4	71.1	70.8	69.8	0.6	0.5	0.5	31.0	30.6	31.6	4.6	4.2	3.6	0.1	0.1	0.2	9.6	9.0	7.2	71.7	71.3	70.3	9.9	10.7	10.5
NNC0114-0006 + Liraglutide (Experimental)	1.3	1.2	1.2	15.1	14.0	14.3	0.6	0.6	0.5	71.9	71.1	71.0	0.6	0.6	0.5	29.8	30.2	30.0	5.0	5.0	4.6	0.1	0.1	0.1	10.2	8.5	8.2	72.5	71.7	71.4	11.4	10.2	10.8
Placebo (Placebo)	1.5	1.3	1.5	13.3	13.5	12.8	0.6	0.6	0.6	72.2	65.9	69.6	0.6	0.6	0.7	32.0	28.3	30.7	4.9	4.8	4.5	0.1	0.1	0.1	10.1	8.9	8.9	72.8	66.5	70.4	9.6	9.8	8.9

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Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel

"Myeloid panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.~In below table HLA refers to Human Leukocyte Antigen; MDSC refers to myeloid-derived suppressor cell; DC refers to Dendritic cells; MYDC refers to Myeloid Dendritic Cells; IMMYE_MDSC refers to Immature myeloid cells & a subset of myeloid suppressor cells within the CD14-HLA class II- myeloid cell population." (NCT02443155)
Timeframe: Week 0, week 54 and week 80

,,,

Intervention	Percentage of Myeloid cells (%) (Mean)
	Week 0: CD14+ HLA low Myeloid Cells	Week 54: CD14+ HLA low Myeloid Cells	Week 80: CD14+ HLA low Myeloid Cells	Week 0: CD14+ MDSC	Week 54: CD14+ MDSC	Week 80: CD14+ MDSC	Week 0: CD14-HLA II- Myeloid Cells Total Myeloid	Week 54: CD14-HLA II- Myeloid Cells Total Myeloid	Week 80: CD14-HLA II- Myeloid Cells Total Myeloid	Week 0: CD16+ Dendritic Cells	Week 54: CD16+ Dendritic Cells	Week 80: CD16+ Dendritic Cells	Week 0: IMMYE_MDSC	Week 54: IMMYE_MDSC	Week 80: IMMYE_MDSC	Week 0: Intermediate Monocyte Subset	Week 54: Intermediate Monocyte Subset	Week 80: Intermediate Monocyte Subset	Week 0: Non-Classical Monocytes	Week 54: Non-Classical Monocytes	Week 80: Non-Classical Monocytes	Week 0: Total Classical Monocytes	Week 54: Total Classical Monocytes	Week 80: Total Classical Monocytes	Week 0: Total Monocytes in Myeloid Cells	Week 54: Total Monocytes in Myeloid Cells	Week 80: Total Monocytes in Myeloid Cells	Week 0: Total Myeloid DC	Week 54: Total Myeloid DC	Week 80: Total Myeloid DC	Week 0: Total MYDC	Week 54: Total MYDC	Week 80: Total MYDC	Week 0: Total Percent Of Myeloid Cells	Week 54: Total Percent Of Myeloid Cells	Week 80: Total Percent Of Myeloid Cells	Week 0: Total Plasmacytoid Dendritic Cells (PDC)	Week 54: Total Plasmacytoid Dendritic Cells (PDC)	Week 80: Total Plasmacytoid Dendritic Cells (PDC)
Liraglutide (Experimental)	0.9	0.7	0.9	73.5	69.3	64.1	80.8	80.8	80.9	12.9	11.2	9.2	0.2	0.2	0.2	8.3	6.3	5.7	1.2	1.1	1.0	87.6	88.0	88.6	14.1	14.3	13.6	3.8	3.8	4.1	32.7	31.7	31.6	94.6	95.0	94.6	12.0	12.0	11.6
NNC0114-0006 (Experimental)	1.0	0.7	0.6	69.1	67.0	62.7	82.2	80.0	81.0	11.3	10.3	9.4	0.2	0.2	0.1	9.0	7.3	6.6	1.3	1.3	1.2	86.7	88.1	88.5	12.6	14.9	13.8	3.6	3.9	4.1	31.4	31.3	30.5	94.7	95.9	95.6	12.5	13.5	12.8
NNC0114-0006 + Liraglutide (Experimental)	1.1	1.1	1.0	68.2	64.0	65.7	80.4	80.9	79.0	12.5	10.2	11.7	0.3	0.2	0.2	8.6	6.5	6.0	1.5	1.2	1.2	87.2	87.8	89.3	14.2	13.8	15.5	3.8	3.7	4.1	30.4	30.4	28.7	94.6	95.1	94.8	14.3	14.4	13.5
Placebo (Placebo)	1.0	0.6	0.8	70.3	65.9	63.9	81.8	83.5	81.3	11.5	12.0	12.1	0.2	0.1	0.2	7.7	5.8	5.8	1.3	1.2	1.3	88.0	89.3	89.7	13.4	12.2	13.5	3.4	3.2	3.9	31.0	27.2	31.9	94.6	95.6	94.1	12.9	11.8	12.5

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Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel

"NK cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.~In below table ADCC refer to Antibody-dependent cellular cytotoxicity; CD refer to Cluster of Differentiation." (NCT02443155)
Timeframe: Week 0, week 54 and week 80

,,,

Intervention	Percentage of NK cells (%) (Mean)
	Week 0: ADCC-Competent NK	Week 54: ADCC-Competent NK	Week 80: ADCC-Competent NK	Week 0: CD16+ Highly Functional NK Cells	Week 54: CD16+ Highly Functional NK Cells	Week 80: CD16+ Highly Functional NK Cells	Week 0: CD56- Cells	Week 54: CD56- Cells	Week 80: CD56- Cells	Week 0: CD56High NK Pool	Week 54: CD56High NK Pool	Week 80: CD56High NK Pool	Week 0: CD57+ MatNK Effectors	Week 54: CD57+ MatNK Effectors	Week 80: CD57+ MatNK Effectors	Week 0: Functional NK Cells; Efficient At ADCC	Week 54: Functional NK Cells; Efficient At ADCC	Week 80: Functional NK Cells; Efficient At ADCC	Week 0: Highly Cytolytic Subset Of NK Cells	Week 54: Highly Cytolytic Subset Of NK Cells	Week 80: Highly Cytolytic Subset Of NK Cells	Week 0: Mature CD16+ Highly Functional NK Cells	Week 54: Mature CD16+ Highly Functional NK Cells	Week 80: Mature CD16+ Highly Functional NK Cells	Week 0: Mature CD16+ Terminally Differentiated	Week 54: Mature CD16+ Terminally Differentiated	Week 80: Mature CD16+ Terminally Differentiated	Week 0: Mature CD16- Terminally Differentiate NK	Week 54: Mature CD16- Terminally Differentiate NK	Week 80: Mature CD16- Terminally Differentiate NK	Week 0: Mature Cytolytic NK Cells	Week 54: Mature Cytolytic NK Cells	Week 80: Mature Cytolytic NK Cells	Week 0: Mature Rapid Cytokine-Producing NK Cell	Week 54: Mature Rapid Cytokine-Producing NK Cell	Week 80: Mature Rapid Cytokine-Producing NK Cell	Week 0: Rapid Cytokine-Producing NK Cell Subset	Week 54: Rapid Cytokine-Producing NK Cell Subset	Week 80: Rapid Cytokine-Producing NK Cell Subset	Week 0: Senescent CD16+ CD56- NK cells	Week 54: Senescent CD16+ CD56- NK cells	Week 80: Senescent CD16+ CD56- NK cells	Week 0: Senescent CD16+CD56hi NK	Week 54: Week 0: Senescent CD16+CD56hi NK	Week 80: Week 0: Senescent CD16+CD56hi NK	Week 0: Senescent CD16- CD56- NK cells	Week 54: Senescent CD16- CD56- NK cells	Week 80: Senescent CD16- CD56- NK cells	Week 0: Senescent Cytolytic NK Cells	Week 54: Senescent Cytolytic NK Cells	Week 80: Senescent Cytolytic NK Cells	Week 0: Senescent Rapid Cytokine-Producing NK	Week 54: Senescent Rapid Cytokine-Producing NK	Week 80: Senescent Rapid Cytokine-Producing NK	Week 0: Total CD16+ CD56- NK	Week 54: Total CD16+ CD56- NK	Week 80: Total CD16+ CD56- NK	Week 0: Total CD16- CD56- NK	Week 54: Week 0: Total CD16- CD56- NK	Week 80: Week 0: Total CD16- CD56- NK	Week 0: Total Mature NK Cells; Highly Cytolytic	Week 54: Total Mature NK Cells; Highly Cytolytic	Week 80: Total Mature NK Cells; Highly Cytolytic
Liraglutide (Experimental)	36.0	33.9	31.9	0.7	0.7	0.6	38.0	38.1	37.1	4.5	4.2	4.3	21.0	18.9	17.5	13.1	12.1	10.9	20.6	22.8	25.5	0.6	0.6	0.5	1.1	1.0	0.8	0.4	0.3	0.4	2.4	2.5	2.6	3.3	3.0	3.0	3.8	3.5	3.7	1.0	0.9	0.9	0.1	0.1	0.1	1.3	1.6	1.9	9.8	10.9	11.5	0.0	0.0	0.0	6.4	6.0	6.2	31.4	31.9	30.7	56.8	56.9	57.7
NNC0114-0006 (Experimental)	36.3	32.5	33.2	0.8	0.7	0.6	36.8	36.6	37.6	5.1	5.3	5.1	20.4	18.0	18.3	13.3	11.1	11.3	20.9	24.5	23.0	0.7	0.6	0.6	1.1	0.8	1.0	0.3	0.3	0.3	2.2	2.7	2.9	3.8	3.9	3.7	4.4	4.5	4.4	1.2	1.2	1.4	0.1	0.0	0.0	1.5	1.8	2.4	9.9	11.3	11.1	0.0	0.0	0.0	7.4	6.2	6.6	29.2	30.1	30.7	57.4	57.3	56.5
NNC0114-0006 + Liraglutide (Experimental)	39.5	37.1	37.1	0.8	0.7	0.7	34.5	34.8	36.2	4.9	4.9	4.5	22.6	21.0	20.0	14.5	13.2	13.3	18.8	22.2	21.1	0.7	0.6	0.6	1.3	0.9	1.1	0.3	0.3	0.3	2.3	2.4	2.3	3.6	3.6	3.2	4.1	4.2	3.8	1.3	1.0	1.1	0.1	0.1	0.1	1.3	1.5	1.9	8.7	9.9	9.4	0.1	0.0	0.0	6.7	5.9	6.8	27.6	28.6	29.2	58.6	59.6	58.5
Placebo (Placebo)	34.7	31.5	34.1	0.7	0.6	0.8	38.0	41.1	37.6	4.9	4.4	5.4	19.0	16.6	17.3	12.1	11.0	12.6	21.4	22.1	21.9	0.7	0.6	0.7	1.3	1.1	1.3	0.4	0.4	1.0	2.3	2.4	2.5	3.6	3.3	3.9	4.1	3.8	4.6	1.2	1.1	1.2	0.1	0.0	0.1	1.5	2.0	2.2	9.9	9.6	9.8	0.0	0.0	0.0	7.3	6.8	7.3	30.5	34.0	30.0	56.3	53.7	56.2

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Change in Biomarker: Immune Phenotyping- T Cell Panel

"T cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.~In below table CD refer to Cluster of Differentiation; TEMRA refers to terminally differentiated effector memory cells re-expressing CD45RA; CCR refers to C-C chemokine receptor; TREG refers to Regulatory T cells." (NCT02443155)
Timeframe: Week 0, week 54 and week 80

,,,

Intervention	Percentage of T cells (%) (Mean)
	Week 0: Activated CD4 TEMRA	Week 54: Activated CD4 TEMRA	Week 80: Activated CD4 TEMRA	Week 0: Activated CD8 TEMRA	Week 54: Activated CD8 TEMRA	Week 80: Activated CD8 TEMRA	Week 0: Activated Central Memory CD4	Week 54: Activated Central Memory CD4	Week 80: Activated Central Memory CD4	Week 0: Activated Central Memory CD8	Week 54: Activated Central Memory CD8	Week 80: Activated Central Memory CD8	Week 0: Activated Effector Memory CD4	Week 54: Activated Effector Memory CD4	Week 80: Activated Effector Memory CD4	Week 0: Activated Effector Memory CD8	Week 54: Activated Effector Memory CD8	Week 80: Activated Effector Memory CD8	Week 0: Activated Mature Naive CD4 T-Cells	Week 54: Activated Mature Naive CD4 T-Cells	Week 80: Activated Mature Naive CD4 T-Cells	Week 0: Activated Mature Naive CD8 T-Cells	Week 54: Activated Mature Naive CD8 T-Cells	Week 80: Activated Mature Naive CD8 T-Cells	Week 0: CCR5+ CD4 TEMRA	Week 54: CCR5+ CD4 TEMRA	Week 80: CCR5+ CD4 TEMRA	Week 0: CCR5+ CD4 Treg TEMRA	Week 54: CCR5+ CD4 Treg TEMRA	Week 80: CCR5+ CD4 Treg TEMRA	Week 0: CCR5+ CD8 EM	Week 54: CCR5+ CD8 EM	Week 80: CCR5+ CD8 EM	Week 0: CCR5+ CD8 TEMRA	Week 54: CCR5+ CD8 TEMRA	Week 80: CCR5+ CD8 TEMRA	Week 0: CCR5+ Central Memory CD4 Cells	Week 54: CCR5+ Central Memory CD4 Cells	Week 80: CCR5+ Central Memory CD4 Cells	Week 0: CCR5+ Central Memory CD8 Cells	Week 54: CCR5+ Central Memory CD8 Cells	Week 80: CCR5+ Central Memory CD8 Cells	Week 0: CCR5+ Central Memory Regulatory T-Cells	Week 54: CCR5+ Central Memory Regulatory T-Cells	Week 80: CCR5+ Central Memory Regulatory T-Cells	Week 0: CCR5+ Effector Memory CD4	Week 54: CCR5+ Effector Memory CD4	Week 80: CCR5+ Effector Memory CD4	Week 0: CCR5+ Effector Memory Regulatory T-Cells	Week 54: CCR5+ Effector Memory Regulatory T-Cells	Week 80: CCR5+ Effector Memory Regulatory T-Cells	Week 0: CCR5+ Naive CD4 T-Cells	Week 54: CCR5+ Naive CD4 T-Cells	Week 80: CCR5+ Naive CD4 T-Cells	Week 0: CCR5+ Naive CD8 T-Cells	Week 54: CCR5+ Naive CD8 T-Cells	Week 80: CCR5+ Naive CD8 T-Cells	Week 0: CCR5+ Naive Regulatory T-Cells	Week 54: CCR5+ Naive Regulatory T-Cells	Week 80: CCR5+ Naive Regulatory T-Cells	Week 0: CD4 TEMRA	Week 54: CD4 TEMRA	Week 80: CD4 TEMRA	Week 0: CD8 Central Memory	Week 54: CD8 Central Memory	Week 80: CD8 Central Memory	Week 0: CD8 Effector Memory	Week 54: CD8 Effector Memory	Week 80: CD8 Effector Memory	Week 0: CD8 TEMRA	Week 54: CD8 TEMRA	Week 80: CD8 TEMRA	Week 0: Conventional Central Memory CD4 T-Cells	Week 54: Conventional Central Memory CD4 T-Cells	Week 80: Conventional Central Memory CD4 T-Cells	Week 0: Conventional Effector Memory CD4 T-Cells	Week 54: Conventional Effector Memory CD4 T-Cells	Week 80: Conventional Effector Memory CD4 T-Cells	Week 0: Naive CD4 T-Cells	Week 54: Naive CD4 T-Cells	Week 80: Naive CD4 T-Cells	Week 0: Naive CD8 T-Cells	Week 54: Naive CD8 T-Cells	Week 80: Naive CD8 T-Cells	Week 0: Senescent CD4 Central Memory Cells	Week 54: Senescent CD4 Central Memory Cells	Week 80: Senescent CD4 Central Memory Cells	Week 0: Senescent CD4 Effector Memory Cells	Week 54: Senescent CD4 Effector Memory Cells	Week 80: Senescent CD4 Effector Memory Cells	Week 0: Senescent CD8 Central Memory Cells	Week 54: Senescent CD8 Central Memory Cells	Week 80: Senescent CD8 Central Memory Cells	Week 0: Senescent CD8 Effector Memory Cells	Week 54: Senescent CD8 Effector Memory Cells	Week 80: Senescent CD8 Effector Memory Cells	Week 0: Senescent Naive CD4 T-Cells	Week 54: Senescent Naive CD4 T-Cells	Week 80: Senescent Naive CD4 T-Cells	Week 0: Senescent Naive CD8 T-Cells	Week 54: Senescent Naive CD8 T-Cells	Week 80: Senescent Naive CD8 T-Cells	Week 0: Senescent Naive TREG	Week 54: Senescent Naive TREG	Week 80: Senescent Naive TREG	Week 0: Senescent TEMRA CD4	Week 54: Senescent TEMRA CD4	Week 80: Senescent TEMRA CD4	Week 0: Senescent TEMRA CD8	Week 54: Senescent TEMRA CD8	Week 80: Senescent TEMRA CD8	Week 0: Senescent TEMRA TREG	Week 54: Senescent TEMRA TREG	Week 80: Senescent TEMRA TREG	Week 0: Senescent TREG CM	Week 54: Senescent TREG CM	Week 80: Senescent TREG CM	Week 0: Senescent TREG EM	Week 54: Senescent TREG EM	Week 80: Senescent TREG EM	Week 0: Total Naive TREG	Week 54: Total Naive TREG	Week 80: Total Naive TREG	Week 0: Total TREG	Week 54: Total TREG	Week 80: Total TREG	Week 0: Total TREG CM	Week 54: Total TREG CM	Week 80: Total TREG CM	Week 0: Total TREG EM	Week 54: Total TREG EM	Week 80: Total TREG EM	Week 0: Total TREG TEMRA	Week 54: Total TREG TEMRA	Week 80: Total TREG TEMRA	Week 0: Total Viable CD4 T-Cells	Week 54: Total Viable CD4 T-Cells	Week 80: Total Viable CD4 T-Cells	Week 0: Total Viable CD8 T-Cells	Week 54: Total Viable CD8 T-Cells	Week 80: Total Viable CD8 T-Cells	Week 0: Total Viable T-Cells	Week 54: Total Viable T-Cells	Week 80: Total Viable T-Cells
Liraglutide (Experimental)	10.8	9.7	8.1	0.6	0.6	0.6	7.1	6.3	6.0	1.6	1.5	1.6	11.3	10.0	9.5	1.2	1.2	1.4	4.7	4.5	4.0	3.3	2.6	2.5	16.9	18.8	18.6	2.7	4.6	3.2	38.2	38.0	37.5	25.9	26.3	26.8	4.5	4.1	5.1	16.9	15.8	15.8	1.8	1.7	1.9	15.5	14.9	16.4	4.5	4.4	5.4	2.1	2.1	2.8	4.1	3.5	4.3	6.5	4.8	5.7	3.1	3.3	3.6	1.8	1.7	1.8	13.4	11.3	13.9	29.0	30.3	30.4	20.3	19.9	19.9	19.5	20.5	20.9	57.0	56.3	55.6	55.8	54.7	53.9	2.4	2.2	2.1	6.9	6.6	6.4	12.9	12.0	11.3	27.7	26.1	26.5	2.6	2.8	3.1	3.5	3.7	3.8	7.1	5.0	6.0	21.9	23.1	21.7	37.7	38.3	38.7	2.8	4.6	3.2	0.1	0.1	0.1	0.4	0.3	0.5	50.3	49.4	48.7	4.1	4.0	3.4	14.4	13.8	13.8	28.8	28.3	30.2	6.7	8.6	7.5	54.6	54.6	53.1	25.8	24.6	23.5	55.3	57.4	56.2
NNC0114-0006 (Experimental)	9.7	8.7	8.1	0.8	0.6	0.6	6.7	6.1	6.0	1.7	1.6	1.4	10.9	9.6	8.9	1.7	1.6	1.5	4.0	3.8	3.8	2.8	2.6	2.6	16.4	17.7	19.5	1.7	4.2	4.4	35.5	36.4	34.7	22.9	25.0	24.4	4.3	4.1	4.9	14.4	14.2	15.5	1.8	1.5	1.8	14.5	15.7	16.8	5.1	4.6	5.2	2.0	2.1	2.9	3.5	3.5	4.0	5.0	6.3	6.5	2.6	2.9	3.2	2.0	2.1	1.9	14.7	14.8	16.5	30.9	31.0	33.5	22.1	22.2	21.7	22.8	22.9	24.4	52.4	51.8	50.6	52.5	52.1	48.1	2.2	2.1	2.3	6.3	6.7	7.0	11.5	10.4	12.7	27.2	25.1	28.6	2.9	3.0	3.3	3.6	3.8	4.3	5.5	6.8	7.0	21.7	22.8	24.2	40.3	40.7	44.8	1.8	4.2	4.4	0.1	0.1	0.2	0.4	0.3	0.5	42.4	44.3	44.1	3.8	3.5	3.5	15.8	15.6	15.0	36.4	32.6	33.5	5.5	7.7	7.4	53.2	52.1	50.3	28.2	26.7	25.4	55.2	55.9	55.3
NNC0114-0006 + Liraglutide (Experimental)	10.1	10.3	9.1	0.9	0.9	0.7	6.3	6.3	6.5	1.1	1.4	2.2	10.3	10.1	10.2	1.9	2.0	1.9	4.0	3.9	4.0	3.4	3.0	2.7	17.7	18.4	18.3	3.7	4.2	2.8	35.3	37.9	38.8	22.8	25.9	25.9	4.1	4.5	4.9	15.0	16.8	16.8	1.9	2.0	2.1	15.5	16.2	17.5	4.7	4.8	5.2	1.9	2.0	2.3	3.7	3.4	3.8	6.1	6.7	5.8	3.7	3.8	4.4	2.0	1.8	1.8	14.3	15.1	15.1	31.6	29.8	31.9	20.0	20.4	19.4	19.2	20.3	20.0	57.0	55.4	56.1	52.0	53.2	51.1	2.3	1.9	2.3	6.9	5.9	6.9	12.1	11.7	12.7	27.3	25.2	27.5	2.6	2.5	3.1	3.9	3.5	4.4	6.9	7.2	6.3	23.3	20.0	21.0	42.8	39.2	42.7	3.6	3.9	2.6	0.1	0.1	0.2	0.4	0.4	0.5	46.8	43.7	46.8	3.9	3.8	3.7	14.8	15.5	15.3	30.8	32.4	30.7	7.6	8.5	7.3	54.7	54.3	51.9	26.1	25.0	24.2	55.6	53.6	52.7
Placebo (Placebo)	9.7	9.3	8.7	1.0	0.7	1.1	6.1	6.2	6.5	1.1	3.1	1.9	9.4	9.2	9.1	0.9	1.1	1.1	3.9	3.7	3.9	3.5	3.1	3.1	18.9	21.0	21.4	3.9	4.6	4.4	37.7	38.8	40.0	24.3	25.4	26.9	4.5	4.9	5.7	16.7	18.5	19.3	1.5	1.7	2.2	15.3	16.9	18.4	4.1	4.5	5.2	2.0	2.3	3.5	4.2	4.1	4.9	6.5	5.3	7.1	2.7	3.1	3.5	1.9	2.1	2.2	15.7	16.4	17.4	32.3	30.4	33.4	21.6	21.1	21.1	20.7	21.3	23.2	54.9	54.5	52.1	50.1	51.1	46.9	2.3	2.4	2.6	6.7	7.5	7.6	12.4	12.2	12.2	29.1	25.8	26.6	2.5	2.7	3.9	4.2	4.2	4.5	7.3	5.6	7.4	22.0	23.5	25.4	42.0	40.4	43.5	4.0	4.6	4.4	0.2	0.2	0.3	0.4	0.5	0.5	47.7	45.1	43.4	3.5	3.5	3.4	14.2	15.0	15.9	30.7	31.9	32.9	7.5	8.2	7.8	54.6	52.7	52.2	26.6	24.0	23.9	55.0	55.5	55.8

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Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel

"TfH cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.~In below table CTFH refer to Circulating T follicular helper; ICOS refers to inducible T-cell co-stimulator; PD refers to Programmed cell death protein; CCR refers to C-C chemokine receptor; CXCR refers to C-X-C chemokine receptor; CD refer to Cluster of Differentiation; CM refers to central memory; EM refers to effector memory, TIGIT refers to T cell immunoreceptor with Ig and ITIM domains." (NCT02443155)
Timeframe: Week 0, week 54 and week 80

,,,

Intervention	Percentage of TfH cells (%) (Mean)
	Week 0: Activated cTfh17 Cells	Week 54: Activated cTfh17 Cells	Week 80: Activated cTfh17 Cells	Week 0: Activated cTfh2 Cells	Week 54: Activated cTfh2 Cells	Week 80: Activated cTfh2 Cells	Week 0:Activated PD1+ICOS+ cTfh1	Week 54: Activated PD1+ICOS+ cTfh1	Week 80: Activated PD1+ICOS+ cTfh1	Week 0: CCR7+ cTfh1 Cells	Week 54: CCR7+ cTfh1 Cells	Week 80: CCR7+ cTfh1 Cells	Week 0: CCR7+ cTfh17 Cells	Week 54: CCR7+ cTfh17 Cells	Week 80: CCR7+ cTfh17 Cells	Week 0: CCR7+ cTfh2 Cells	Week 54: CCR7+ cTfh2 Cells	Week 80: CCR7+ cTfh2 Cells	Week 0: CXCR4+ cTfh1 Cells	Week 54: CXCR4+ cTfh1 Cells	Week 80: CXCR4+ cTfh1 Cells	Week 0: CXCR4+ cTfh17 Cells	Week 54: CXCR4+ cTfh17 Cells	Week 80: CXCR4+ cTfh17 Cells	Week 0: CXCR4+ Ctfh2 Cells	Week 54: CXCR4+ Ctfh2 Cells	Week 80: CXCR4+ Ctfh2 Cells	Week 0: Circulating TFH-Cells (cTfh)	Week 54: Circulating TFH-Cells (cTfh)	Week 80: Circulating TFH-Cells (cTfh)	Week 0: ICOS+ CD4 CM	Week 54: ICOS+ CD4 CM	Week 80: ICOS+ CD4 CM	Week 0: ICOS+ CD4 EM	Week 54: ICOS+ CD4 EM	Week 80: ICOS+ CD4 EM	Week 0: ICOS+ CD4 TEMRA	Week 54: ICOS+ CD4 TEMRA	Week 80: ICOS+ CD4 TEMRA	Week 0: ICOS+ NAIVE CD4 T-Cells	Week 54: ICOS+ NAIVE CD4 T-Cells	Week 80: ICOS+ NAIVE CD4 T-Cells	Week 0: ICOS+ NAIVE TREG	Week 54: ICOS+ NAIVE TREG	Week 80: ICOS+ NAIVE TREG	Week 0: ICOS+ TREG CM	Week 54: ICOS+ TREG CM	Week 80: ICOS+ TREG CM	Week 0: ICOS+ TREG EM	Week 54: ICOS+ TREG EM	Week 80: ICOS+ TREG EM	Week 0: ICOS+ TREG TEMRA	Week 54: ICOS+ TREG TEMRA	Week 80: ICOS+ TREG TEMRA	Week 0: PD1+ CD4 Central Memory	Week 54: PD1+ CD4 Central Memory	Week 80: PD1+ CD4 Central Memory	Week 0: PD1+ CD4 Effector Memory	Week 54: PD1+ CD4 Effector Memory	Week 80: PD1+ CD4 Effector Memory	Week 0: PD1+ Naive CD4	Week 54: PD1+ Naive CD4	Week 80: PD1+ Naive CD4	Week 0: PD1+ Naive TREG	Week 54: PD1+ Naive TREG	Week 80: PD1+ Naive TREG	Week 0: PD1+ TEMRA TREG	Week 54: PD1+ TEMRA TREG	Week 80: PD1+ TEMRA TREG	Week 0: PD1+ TREG CM	Week 54: PD1+ TREG CM	Week 80: PD1+ TREG CM	Week 0: PD1+ TREG EM	Week 54: PD1+ TREG EM	Week 80: PD1+ TREG EM	Week 0: PD1+ICOSNeg cTfh1	Week 54: PD1+ICOSNeg cTfh1	Week 80: PD1+ICOSNeg cTfh1	Week 0: PD1+ICOSNeg cTfh17	Week 54: PD1+ICOSNeg cTfh17	Week 80: PD1+ICOSNeg cTfh17	Week 0: PD1+ICOSNeg cTfh2	Week 54: PD1+ICOSNeg cTfh2	Week 80: PD1+ICOSNeg cTfh2	Week 0: PD1- ICOS- cTfh1	Week 54: PD1- ICOS- cTfh1	Week 80: PD1- ICOS- cTfh1	Week 0: PD1- ICOS- cTfh17	Week 54: PD1- ICOS- cTfh17	Week 80: PD1- ICOS- cTfh17	Week 0: PD1- ICOS- cTfh2	Week 54: PD1- ICOS- cTfh2	Week 80: PD1- ICOS- cTfh2	Week 0: Potentially Anergic TEMRA CD4	Week 54: Potentially Anergic TEMRA CD4	Week 80: Potentially Anergic TEMRA CD4	Week 0: Regulatory T-Follicular Subset	Week 54: Regulatory T-Follicular Subset	Week 80: Regulatory T-Follicular Subset	Week 0: TH17-Like Circulating T-Follicular cells	Week 54: TH17-Like Circulating T-Follicular cells	Week 80: TH17-Like Circulating T-Follicular cells	Week 0: TH2-Like Circulating T-Follicular Cells	Week 54: TH2-Like Circulating T-Follicular Cells	Week 80: TH2-Like Circulating T-Follicular Cells	Week 0: TIGIT+ cTfh1	Week 54: TIGIT+ cTfh1	Week 80: TIGIT+ cTfh1	Week 0: TIGIT+ cTfh17	Week 54: TIGIT+ cTfh17	Week 80: TIGIT+ cTfh17	Week 0: TIGIT+ cTfh2	Week 54: TIGIT+ cTfh2	Week 80: TIGIT+ cTfh2	Week 0: TOTAL ICOS+ TREG	Week 54: TOTAL ICOS+ TREG	Week 80: TOTAL ICOS+ TREG	Week 0: Th1-Like Circulating T-Follicular Cells	Week 54: Th1-Like Circulating T-Follicular Cells	Week 80: Th1-Like Circulating T-Follicular Cells	Week 0: Total PD1+ TREG	Week 54: Total PD1+ TREG	Week 80: Total PD1+ TREG
Liraglutide (Experimental)	0.8	0.7	0.6	0.6	0.7	0.5	1.1	1.2	1.0	94.7	97.1	97.4	97.4	96.9	96.8	98.2	98.3	98.4	54.9	64.4	63.5	43.7	53.1	54.6	54.0	63.7	62.7	6.2	6.2	6.1	0.4	0.4	0.3	0.2	0.2	0.2	0.0	0.0	0.0	0.1	0.0	0.0	1.9	1.9	1.9	10.4	9.7	8.8	13.0	12.8	10.5	10.5	11.0	8.2	7.2	7.2	6.8	4.0	3.6	3.6	4.2	4.4	4.2	8.4	9.1	9.3	19.8	18.6	22.4	17.3	16.8	16.6	21.6	21.1	19.4	32.4	34.2	31.3	23.7	26.2	23.6	20.8	20.2	18.9	64.6	64.1	67.4	73.4	70.9	73.6	78.3	78.8	80.4	0.4	0.5	0.5	0.2	0.2	0.2	0.5	0.4	0.3	4.0	4.0	3.9	53.4	52.2	49.6	39.3	40.7	35.3	44.8	42.0	40.5	8.0	7.6	6.6	1.6	1.8	1.9	14.7	14.5	14.2
NNC0114-0006 (Experimental)	1.0	0.4	1.1	0.6	0.4	0.5	1.9	1.0	0.9	97.1	95.8	96.8	97.4	93.9	97.3	98.2	98.5	98.3	58.0	64.5	66.4	45.8	54.0	57.2	56.3	65.2	65.8	5.4	5.6	5.9	0.5	0.3	0.3	0.3	0.2	0.2	0.0	0.0	0.0	0.1	0.0	0.0	2.7	2.0	2.1	11.3	9.2	9.0	13.3	11.6	11.3	13.0	9.7	9.6	6.7	6.8	7.5	4.2	3.9	4.3	3.0	2.9	3.3	8.7	9.4	10.1	23.5	19.7	25.7	17.5	16.7	18.7	21.1	19.8	21.1	28.8	29.1	30.7	22.5	21.1	24.7	18.4	18.1	19.6	69.0	68.0	68.1	74.7	72.9	74.0	80.8	81.3	79.8	0.2	0.2	0.2	0.2	0.2	0.2	0.4	0.4	0.4	3.6	3.6	3.7	48.5	47.6	48.1	36.2	31.4	35.9	40.9	37.9	38.4	9.6	7.5	7.4	1.3	1.6	1.8	15.1	14.3	15.9
NNC0114-0006 + Liraglutide (Experimental)	0.8	0.6	0.8	0.6	0.4	0.6	1.3	0.7	0.7	96.9	97.1	97.0	97.4	98.1	98.7	98.1	98.1	98.3	59.4	64.5	70.8	50.9	56.1	60.0	58.8	63.3	69.3	5.5	5.7	5.8	0.5	0.3	0.3	0.2	0.2	0.2	0.0	0.0	0.0	0.1	0.0	0.0	2.3	2.1	2.2	10.9	10.0	10.1	12.8	11.9	12.0	10.2	8.8	9.9	6.2	6.4	6.7	4.0	3.7	3.9	3.8	4.2	5.0	8.4	9.8	11.0	22.5	20.5	22.5	16.8	16.5	18.1	20.1	19.3	20.6	30.0	30.5	32.4	21.8	21.8	26.8	19.1	18.4	20.2	68.4	68.6	66.7	75.6	77.4	72.1	80.1	81.0	79.1	0.7	0.8	0.8	0.2	0.2	0.2	0.5	0.4	0.4	3.6	3.9	3.8	53.0	51.1	51.4	40.5	37.0	39.4	44.4	41.1	40.7	8.6	8.3	8.3	1.3	1.4	1.5	14.5	14.8	16.0
Placebo (Placebo)	0.6	0.9	0.9	0.6	0.6	0.6	1.0	1.2	1.1	97.2	97.3	97.0	97.3	95.3	98.7	98.3	98.1	98.3	55.6	69.4	66.8	45.1	56.4	57.6	54.5	67.7	66.7	6.1	6.2	5.8	0.5	0.4	0.3	0.2	0.2	0.2	0.0	0.0	0.0	0.1	0.1	0.0	2.5	2.4	2.7	11.0	10.6	10.5	12.8	12.7	12.0	9.3	12.8	11.0	6.6	6.7	7.2	4.1	4.0	4.3	3.2	3.5	3.8	8.5	9.4	10.7	19.5	21.4	22.7	17.2	18.0	18.8	20.9	21.6	21.9	29.7	31.0	32.8	22.3	21.7	24.3	18.5	18.8	20.2	68.9	67.5	65.9	75.3	73.5	74.6	80.7	80.3	79.0	0.3	0.3	0.3	0.2	0.3	0.3	0.5	0.4	0.4	4.1	3.9	3.8	51.6	50.2	52.7	38.7	35.8	36.8	43.4	41.0	41.9	8.9	8.6	8.6	1.5	1.8	1.6	14.4	15.0	16.1

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Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol)

Serum vitamin D is evaluated at baseline (week 0), week 54 and week 80. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

,,,

Intervention	picomole per liter (Mean)
	Week 0	Week 54	Week 80
Liraglutide (Experimental)	122	113	121
NNC0114-0006 (Experimental)	122	125	124
NNC0114-0006 + Liraglutide (Experimental)	123	117	119
Placebo (Placebo)	120	119	115

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Change in Biomarker: Total Interleukin-21 (IL-21)

IL-21 is evaluated at baseline (week 0), week 54 and week 80. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

,,,

Intervention	picogram per milliliter (Mean)
	Week 0	Week 54	Week 80
Liraglutide (Experimental)	30.9	25.0	28.0
NNC0114-0006 (Experimental)	31.1	4368.2	674.1
NNC0114-0006 + Liraglutide (Experimental)	28.8	3993.5	540.9
Placebo (Placebo)	30.2	34.1	30.7

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Change in Body Temperature

Change in body temperature is evaluated from baseline (week 0) to weeks 54 and 80. (NCT02443155)
Timeframe: Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Degree celsius (C) (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	-0.1	0.0
NNC0114-0006 (Experimental)	0.0	0.1
NNC0114-0006 + Liraglutide (Experimental)	-0.1	-0.0
Placebo (Placebo)	-0.0	0.0

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Change in Body Weight (kg)

Change in body weight is measured at week 54 and week 80 respective to baseline. Body weight was measured in unit 'Kg'. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Kilogram (Kg) (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	-2.5	0.4
NNC0114-0006 (Experimental)	1.2	1.6
NNC0114-0006 + Liraglutide (Experimental)	-1.8	1.9
Placebo (Placebo)	1.1	2.8

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Change in Cytokines- Interleukin (IL)-10

IL-10 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

,,,

Intervention	pg/mL (Mean)
	Week 0	Week 54	Week 80
Liraglutide (Experimental)	0.4	0.4	0.5
NNC0114-0006 (Experimental)	0.5	0.4	0.4
NNC0114-0006 + Liraglutide (Experimental)	0.7	0.4	0.4
Placebo (Placebo)	0.4	0.4	0.4

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Change in Cytokines: Interferon (IFN) Gamma

IFN gamma levels at baseline (week 0), weeks 54 and 80 are evaluated and presented. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

,,,

Intervention	pg/mL (Mean)
	Week 0	Week 54	Week 80
Liraglutide (Experimental)	5.8	5.0	13.0
NNC0114-0006 (Experimental)	7.8	7.5	4.9
NNC0114-0006 + Liraglutide (Experimental)	7.3	4.6	4.4
Placebo (Placebo)	4.3	5.8	4.5

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Change in Cytokines: Interleukin (IL)-17

IL-17 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

,,,

Intervention	pg/mL (Mean)
	Week 0	Week 54	Week 80
Liraglutide (Experimental)	4.7	5.1	4.8
NNC0114-0006 (Experimental)	4.7	4.8	4.7
NNC0114-0006 + Liraglutide (Experimental)	4.9	4.9	4.9
Placebo (Placebo)	4.8	5.4	4.8

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Change in Cytokines: Interleukin (IL)-6

IL-6 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

,,,

Intervention	picogram per milliliter (pg/mL) (Mean)
	Week 0	Week 54	Week 80
Liraglutide (Experimental)	1.2	1.0	0.9
NNC0114-0006 (Experimental)	0.8	0.8	0.8
NNC0114-0006 + Liraglutide (Experimental)	0.9	0.8	0.9
Placebo (Placebo)	0.8	0.8	0.9

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Change in Cytokines: TNF-alpha

TNF-alpha levels at baseline (week 0), weeks 54 and 80 are evaluated and presented. (NCT02443155)
Timeframe: Week 0, week 54 and week 80

,,,

Intervention	pg/mL (Mean)
	Week 0	Week 54	Week 80
Liraglutide (Experimental)	2.70	2.56	2.96
NNC0114-0006 (Experimental)	2.32	2.33	2.36
NNC0114-0006 + Liraglutide (Experimental)	2.60	2.36	2.43
Placebo (Placebo)	3.06	2.43	2.75

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Change in D-Dimer

Change in D-Dimer (measured in mg/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of D-dimer (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.98	1.05
NNC0114-0006 (Experimental)	0.98	0.92
NNC0114-0006 + Liraglutide (Experimental)	0.96	0.96
Placebo (Placebo)	1.15	1.10

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Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)

Change from baseline (week 0) in DTSQ is evaluated at week 54 and 80. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher score indicates a higher level of glycaemia/treatment satisfaction. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Score on a scale (Mean)
	Week 54: Perceived frequency of hyperglycaemia	Week 80: Perceived frequency of hyperglycaemia	Week 54: Perceived frequency of hypoglycaemia	Week 80: Perceived frequency of hypoglycaemia	Week 54: Treatment satisfaction	Week 80: Treatment satisfaction
Liraglutide (Experimental)	0.0	0.6	-0.4	-0.4	1.3	0.0
NNC0114-0006 (Experimental)	0.0	0.5	-0.6	-0.3	0.9	1.2
NNC0114-0006 + Liraglutide (Experimental)	0.6	0.9	-0.7	-0.9	1.5	1.3
Placebo (Placebo)	0.5	0.7	-0.2	-0.1	0.2	0.2

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Change in Experience of Treatment Benefits and Barriers (ETBB)

Treatment Benefits and Barriers (ETBB) questionnaire measured diabetes-specific health beliefs on 2 categories: Total Score for Perceived Barriers and Perceived Benefits. The measurement of perceived benefits of, and barriers to, treatment was achieved by creating a pool 28 statements each with a 7-point scale ranging from strongly agree (6) to strongly disagree (0). ETBB benefits score was calculated using the responses from questions 1, 4, 7, 8, 10, and 12 and ETBB barriers score was calculated using the responses from questions 2, 3, 5, 6, 9, and 11. Both was calculated as the sum of responses divided by number of responses received multiplied by the maximum number of responses. Based on the responses used the maximum responses available was 6. The higher score indicates more perceived benefits or more perceived barrier. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	score on a scale (Median)
	Week 54: Total Score for Perceived Barriers	Week 80: Total Score for Perceived Barriers	Week 54: Total Score for Perceived Benefits	Week 80: Total Score for Perceived Benefits
Liraglutide (Experimental)	-0.2	-0.1	0.2	1.3
NNC0114-0006 (Experimental)	-1.8	-2.0	1.1	1.1
NNC0114-0006 + Liraglutide (Experimental)	-1.2	-2.0	0.6	0.1
Placebo (Placebo)	-0.3	0.1	-0.5	-0.4

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Change in Fasting C-peptide- Ratio to Baseline

Change in fasting C-peptide (measured in nanomole per liter [nmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of C-peptide (Geometric Mean)
	Ratio from week 0 to week 54	Ratio from week 0 to week 80
Liraglutide (Experimental)	0.65	0.42
NNC0114-0006 (Experimental)	0.70	0.53
NNC0114-0006 + Liraglutide (Experimental)	1.01	0.58
Placebo (Placebo)	0.66	0.54

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Change in Fasting Glucagon- Ratio to Baseline

Change in fasting glucagon (measured in picogram per milliliter [pg/mL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of glucagon (Geometric Mean)
	Ratio from week 0 to week 54	Ratio from week 0 to week 80
Liraglutide (Experimental)	0.96	0.96
NNC0114-0006 (Experimental)	0.95	0.85
NNC0114-0006 + Liraglutide (Experimental)	1.01	0.89
Placebo (Placebo)	1.00	0.93

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Change in Fasting Plasma Glucose

Change in fasting plasma glucose is evaluated from baseline (week 0) to weeks 54 and 80. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	mmol/L (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	-0.3	0.2
NNC0114-0006 (Experimental)	0.2	0.3
NNC0114-0006 + Liraglutide (Experimental)	0.5	1.1
Placebo (Placebo)	0.5	1.0

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Change in Haematology: Basophils

Change in basophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of basophils (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.52	2.09
NNC0114-0006 (Experimental)	1.58	1.73
NNC0114-0006 + Liraglutide (Experimental)	1.73	2.17
Placebo (Placebo)	1.43	1.96

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Change in Haematology: Erythrocytes

Change in erythrocytes (measured in 10^12 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	ratio of erythrocytes (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.99	0.99
NNC0114-0006 (Experimental)	1.01	1.00
NNC0114-0006 + Liraglutide (Experimental)	0.99	0.99
Placebo (Placebo)	1.00	1.00

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Cmax of C-peptide at Week 54 Relative to Baseline

Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L). (NCT02443155)
Timeframe: 0-4 hours post-dose on week 0 and week 54

Intervention	Ratio of Cmax (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	0.978
NNC0114-0006 (Experimental)	0.779
Liraglutide (Experimental)	0.733
Placebo (Placebo)	0.644

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Cmax of C-peptide at Week 80 Relative to Baseline

Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L). (NCT02443155)
Timeframe: 0-4 hours post-dose on week 0 and week 80

Intervention	Ratio of Cmax (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	0.580
NNC0114-0006 (Experimental)	0.592
Liraglutide (Experimental)	0.389
Placebo (Placebo)	0.568

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Cmax of Glucose at Week 54 Relative to Baseline

Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'. (NCT02443155)
Timeframe: 0-4 hours post-dose on week 0 and week 54

Intervention	Ratio of Cmax (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	0.937
NNC0114-0006 (Experimental)	1.068
Liraglutide (Experimental)	1.004
Placebo (Placebo)	1.057

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Cmax of Glucose at Week 80 Relative to Baseline

Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'. (NCT02443155)
Timeframe: 0-4 hours post-dose on week 0 and week 80

Intervention	Ratio of Cmax (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	1.114
NNC0114-0006 (Experimental)	1.074
Liraglutide (Experimental)	1.104
Placebo (Placebo)	1.155

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Liraglutide Concentration at Steady State (C Liraglutide)

C liraglutide was defined as the liraglutide concentration at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and Liraglutide treatment arms. (NCT02443155)
Timeframe: Week 54 (post-dose)

Intervention	picomole per liter (pmol/L) (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	16287
Liraglutide (Experimental)	15920

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Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006)

This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. Mean residence time of NNC0114-0006 is presented. (NCT02443155)
Timeframe: Pre-dose and 1 hour post-dose during week 48 to week 80

Intervention	Days (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	27.7
NNC0114-0006 (Experimental)	27.2

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Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion

Injection/infusion site reactions episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of participants experiencing treatment emergent episodes of injection/infusion site reactions episodes from first dose of trial product to week 54 (treatment period) is presented. (NCT02443155)
Timeframe: Week 0-54

Intervention	Participants (Count of Participants)
NNC0114-0006 + Liraglutide (Experimental)	2
NNC0114-0006 (Experimental)	0
Liraglutide (Experimental)	0
Placebo (Placebo)	1

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Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006)

C1h, NNC0114-0006 was defined as concentration of NNC0114-0006 at 1 hour after dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. (NCT02443155)
Timeframe: Week 48 (1 hour post-dose)

Intervention	ug/mL (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	298.6
NNC0114-0006 (Experimental)	282.6

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Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006)

Ctrough of NNC0114-0006 was defined as concentration prior to dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. (NCT02443155)
Timeframe: Week 48 (predose)

Intervention	microgram/milliliter (ug/mL) (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	34.7
NNC0114-0006 (Experimental)	36.7

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Change in Biochemistry: Creatine Kinase

Change in creatine kinase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	Ratio of Creatine Kinase (Geometric Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	1.08	1.24
NNC0114-0006 (Experimental)	1.17	1.09
NNC0114-0006 + Liraglutide (Experimental)	1.16	1.11
Placebo (Placebo)	1.02	1.13

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Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006)

Accumulation ratio of NNC114-0006 was defined as AUC48-54 weeks/AUC0-6 weeks. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. (NCT02443155)
Timeframe: Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54)

Intervention	Ratio of AUC (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	1.24
NNC0114-0006 (Experimental)	1.26

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Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006)

The apparent volume of distribution of NNC0114-0006 at steady-state was calculated as mean residence time of (MRT) of NNC0114-0006 multiplied by clearance of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. (NCT02443155)
Timeframe: Pre-dose and 1 hour post-dose during week 48 to week 80

Intervention	Milliliters per kilogram (mL/kg) (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	83.7
NNC0114-0006 (Experimental)	79.3

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Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline

Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles*hour per liter (nmol*h/L). (NCT02443155)
Timeframe: 0 - 4 hours post-dose on week 0 and week 54

Intervention	Ratio of AUC (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	0.934
NNC0114-0006 (Experimental)	0.783
Liraglutide (Experimental)	0.709
Placebo (Placebo)	0.660

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Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline

Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles*hour per liter (nmol*h/L). (NCT02443155)
Timeframe: 0 - 4 hours post-dose on week 0 and week 80

Intervention	Ratio of AUC (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	0.566
NNC0114-0006 (Experimental)	0.598
Liraglutide (Experimental)	0.373
Placebo (Placebo)	0.571

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Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006)

AUCtau, NNC0114-0006 was derived as the area under the concentration-time curve using the linear trapezoidal technique based on observed values and actual measurement times between 0 and 6 weeks (after the last dose). This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. (NCT02443155)
Timeframe: Pre-dose and 1 hour post-dose during week 48 to week 54

Intervention	daymicrogram per milliliter (dayug/mL) (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	3969
NNC0114-0006 (Experimental)	4115

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AUC0-2h of C-peptide at Week 54 Relative to Baseline

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol*h/L'. (NCT02443155)
Timeframe: 0-2 hours post-dose on week 0 and week 54

Intervention	Ratio of AUC (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	0.961
NNC0114-0006 (Experimental)	0.824
Liraglutide (Experimental)	0.646
Placebo (Placebo)	0.655

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AUC0-2h of C-peptide at Week 80 Relative to Baseline

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol*h/L'. (NCT02443155)
Timeframe: 0-2 hours post-dose on week 0 and week 80

Intervention	Ratio of AUC (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	0.590
NNC0114-0006 (Experimental)	0.619
Liraglutide (Experimental)	0.370
Placebo (Placebo)	0.540

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AUC0-2h of Glucose at Week 54 Relative to Baseline

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose is measured as 'mmol*h/L'. (NCT02443155)
Timeframe: 0-2 hours post-dose on week 0 and week 54

Intervention	Ratio of AUC (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	0.939
NNC0114-0006 (Experimental)	1.066
Liraglutide (Experimental)	0.978
Placebo (Placebo)	1.057

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AUC0-2h of Glucose at Week 80 Relative to Baseline

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as 'mmol*h/L'. (NCT02443155)
Timeframe: 0-2 hours post-dose on week 0 and week 80

Intervention	Ratio of AUC (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	1.119
NNC0114-0006 (Experimental)	1.086
Liraglutide (Experimental)	1.070
Placebo (Placebo)	1.166

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AUC0-4h of Glucose at Week 80 Relative to Baseline

Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as Milli moles*hour per liter (mmol*h/L). (NCT02443155)
Timeframe: 0 - 4 hours post-dose on week 0 and week 80

Intervention	Ratio of AUC (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	1.129
NNC0114-0006 (Experimental)	1.115
Liraglutide (Experimental)	1.136
Placebo (Placebo)	1.221

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Terminal Half-life (t½) After Last Dose of NNC0114-0006

Terminal half life was calculated as log(2)/λz. The terminal rate constant λz was determined through linear regression with the logarithm to concentration as the response variable and actual measurement time as the explanatory variable. Valid observations from the terminal part of the curve, which is approximately linear, were used for the determination. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. (NCT02443155)
Timeframe: Pre-dose and 1 hour post-dose during week 48 to week 80

Intervention	Days (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	22.3
NNC0114-0006 (Experimental)	22.2

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7-point SMPG Profiles

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. 7-point SMPG profile values are presented for week 54 and week 80. (NCT02443155)
Timeframe: Week 54 and Week 80

,,,

Intervention	mmol/L (Mean)
	Week 54: Before breakfast	Week 54: 90 minutes after start of breakfast	Week 54: Before lunch	Week 54: 90 minutes after start of lunch	Week 54: Before dinner	Week 54: 90 minutes after start of dinner	Week 54: Bedtime	Week 80: Before breakfast	Week 80: 90 minutes after start of breakfast	Week 80: Before lunch	Week 80: 90 minutes after start of lunch	Week 80: Before dinner	Week 80: 90 minutes after start of dinner	Week 80: Bedtime
Liraglutide (Experimental)	6.4	7.4	6.1	7.8	6.6	7.2	7.5	7.2	8.3	6.9	8.5	7.6	9.0	7.8
NNC0114-0006 (Experimental)	6.8	7.5	6.4	7.5	6.5	7.0	7.4	6.4	7.2	6.2	7.6	6.7	7.0	6.6
NNC0114-0006 + Liraglutide (Experimental)	6.8	8.9	5.5	8.2	6.5	8.2	7.8	6.5	8.5	6.2	7.8	6.5	7.6	7.8
Placebo (Placebo)	6.3	7.6	6.0	7.7	6.1	6.8	7.2	6.8	7.5	6.1	8.0	6.5	7.6	7.4

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Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG)

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Before breakfast 7-point self-measured plasma glucose (SMPG) profile values are presented at week 54 and week 80. (NCT02443155)
Timeframe: Week 54 and week 80

,,,

Intervention	mmol/L (Mean)
	Week 54	Week 80
Liraglutide (Experimental)	6.4	7.2
NNC0114-0006 (Experimental)	6.8	6.4
NNC0114-0006 + Liraglutide (Experimental)	6.8	6.5
Placebo (Placebo)	6.3	6.8

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Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals)

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point self-measured plasma glucose (SMPG) postprandial glucose /prandial increment (average over the three meals) value is presented. (NCT02443155)
Timeframe: (Week 0, week 54) and (week 0, week 80)

,,,

Intervention	mmol/L (Mean)
	Change from week 0 to week 54	Change from week 0 to week 80
Liraglutide (Experimental)	0.2	0.0
NNC0114-0006 (Experimental)	0.6	0.4
NNC0114-0006 + Liraglutide (Experimental)	0.9	0.8
Placebo (Placebo)	-0.1	-0.0

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AUC0-4h of Glucose at Week 54 Relative to Baseline

Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose was measured as Milli moles*hour per liter (mmol*h/L). (NCT02443155)
Timeframe: 0 - 4 hours post-dose on week 0 and week 54

Intervention	Ratio of AUC (Geometric Mean)
NNC0114-0006 + Liraglutide (Experimental)	0.904
NNC0114-0006 (Experimental)	1.078
Liraglutide (Experimental)	0.993
Placebo (Placebo)	1.089

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Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week

Presented results are the number of nausea, vomiting, diarrhoea, and constipation events recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 0-59

,,,,,,,,

Intervention	Events (Number)
	Nausea	Vomiting	Diarrhoea	Constipation
Liraglutide 3.0 mg	89	17	46	30
Placebo Pool	30	6	23	7
Semaglutide 0.05 mg	41	10	29	15
Semaglutide 0.1 mg	80	29	37	27
Semaglutide 0.2 mg	74	41	61	33
Semaglutide 0.3 mg	69	18	54	25
Semaglutide 0.3 mg (Fast Escalation)	106	32	54	23
Semaglutide 0.4 mg	94	35	63	35
Semaglutide 0.4 mg (Fast Escalation)	97	47	49	34

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Change in Haematology: Haematocrit

Change from baseline (week 0) in haematocrit was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration. (NCT02453711)
Timeframe: Week 0, week 52

Intervention	Percentage of red blood cells (Mean)
Semaglutide 0.05 mg	-0.25
Semaglutide 0.1 mg	-0.58
Semaglutide 0.2 mg	-0.42
Semaglutide 0.3 mg	-0.49
Semaglutide 0.4 mg	-0.31
Semaglutide 0.3 mg (Fast Escalation)	-0.68
Semaglutide 0.4 mg (Fast Escalation)	-0.15
Liraglutide 3.0 mg	0.26
Placebo Pool	0.26

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Change in Haematology: Erythrocytes

Change from baseline (week 0) in erythrocytes was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration. (NCT02453711)
Timeframe: Week 0, week 52

Intervention	10^12 cells/litre (L) (Mean)
Semaglutide 0.05 mg	-0.01
Semaglutide 0.1 mg	-0.06
Semaglutide 0.2 mg	-0.03
Semaglutide 0.3 mg	-0.04
Semaglutide 0.4 mg	-0.01
Semaglutide 0.3 mg (Fast Escalation)	-0.04
Semaglutide 0.4 mg (Fast Escalation)	-0.01
Liraglutide 3.0 mg	0.05
Placebo Pool	0.04

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Change in FPG

Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline FPG as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 0, Week 52

Intervention	Millimoles per litre (mmol/L) (Least Squares Mean)
Semaglutide 0.05 mg	-0.29
Semaglutide 0.1 mg	-0.35
Semaglutide 0.2 mg	-0.40
Semaglutide 0.3 mg	-0.39
Semaglutide 0.4 mg	-0.43
Semaglutide 0.3 mg (Fast Escalation)	-0.38
Semaglutide 0.4 mg (Fast Escalation)	-0.51
Liraglutide 3.0 mg	-0.35
Placebo Pool	0.01

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Change in DBP

Change from baseline (week 0) in diastolic blood pressure (DBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline DBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 0, Week 52

Intervention	Millimeters of mercury (mmHg) (Least Squares Mean)
Semaglutide 0.05 mg	-2.55
Semaglutide 0.1 mg	-2.65
Semaglutide 0.2 mg	-4.09
Semaglutide 0.3 mg	-2.98
Semaglutide 0.4 mg	-3.61
Semaglutide 0.3 mg (Fast Escalation)	-2.20
Semaglutide 0.4 mg (Fast Escalation)	-5.52
Liraglutide 3.0 mg	-2.70
Placebo Pool	-1.50

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Change in Body Weight (kg)

Change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 0, Week 52

Intervention	Kilogram (kg) (Least Squares Mean)
Semaglutide 0.05 mg	-6.66
Semaglutide 0.1 mg	-9.34
Semaglutide 0.2 mg	-12.30
Semaglutide 0.3 mg	-12.45
Semaglutide 0.4 mg	-15.15
Semaglutide 0.3 mg (Fast Escalation)	-12.54
Semaglutide 0.4 mg (Fast Escalation)	-17.36
Liraglutide 3.0 mg	-8.47
Placebo Pool	-2.48

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Participants With Weight Loss of ≥10% of Baseline Body Weight

Presented results are percentage of participants who lost more than or equal to 10% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 52

Intervention	Percentage (%) of participants (Number)
Semaglutide 0.05 mg	18.94
Semaglutide 0.1 mg	36.57
Semaglutide 0.2 mg	55.95
Semaglutide 0.3 mg	57.76
Semaglutide 0.4 mg	64.61
Semaglutide 0.3 mg (Fast Escalation)	58.45
Semaglutide 0.4 mg (Fast Escalation)	71.91
Liraglutide 3.0 mg	33.98
Placebo Pool	10.08

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Change in BMI

Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline BMI as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 0, Week 52

Intervention	Kilogram per square meter (kg/m^2) (Least Squares Mean)
Semaglutide 0.05 mg	-2.37
Semaglutide 0.1 mg	-3.36
Semaglutide 0.2 mg	-4.38
Semaglutide 0.3 mg	-4.40
Semaglutide 0.4 mg	-5.40
Semaglutide 0.3 mg (Fast Escalation)	-4.48
Semaglutide 0.4 mg (Fast Escalation)	-6.21
Liraglutide 3.0 mg	-3.03
Placebo Pool	-0.88

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Change in Biochemistry: TSH

Change from baseline (week 0) in thyroid stimulating hormone (TSH) was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration. (NCT02453711)
Timeframe: Week 0, week 52

Intervention	Milli-international units/litre (mIU/L) (Mean)
Semaglutide 0.05 mg	-0.31
Semaglutide 0.1 mg	-0.10
Semaglutide 0.2 mg	-0.22
Semaglutide 0.3 mg	-0.18
Semaglutide 0.4 mg	-0.10
Semaglutide 0.3 mg (Fast Escalation)	-0.12
Semaglutide 0.4 mg (Fast Escalation)	-0.43
Liraglutide 3.0 mg	0.02
Placebo Pool	-0.07

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Change in Biochemistry: Calcitonin

Change from baseline (week 0) in calcitonin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration. (NCT02453711)
Timeframe: Week 0, week 52

Intervention	Nanogram/litre (ng/L) (Mean)
Semaglutide 0.05 mg	0.08
Semaglutide 0.1 mg	0.03
Semaglutide 0.2 mg	0.04
Semaglutide 0.3 mg	0.04
Semaglutide 0.4 mg	0.17
Semaglutide 0.3 mg (Fast Escalation)	-0.01
Semaglutide 0.4 mg (Fast Escalation)	0.20
Liraglutide 3.0 mg	0.29
Placebo Pool	-0.12

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Change in ECG

"Number of participants with electrocardiogram (ECG) results, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) was recorded at baseline (week 0) and week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration." (NCT02453711)
Timeframe: Week 0, week 52

Intervention	Participants (Count of Participants)
	Week: 071951141			Week: 071951142	Week: 071951143	Week: 071951146	Week: 071951147	Week: 071951145	Week: 071951144	Week: 071951148	Week: 071951149	Week: 5271951141	Week: 5271951142	Week: 5271951144	Week: 5271951145	Week: 5271951146	Week: 5271951148	Week: 5271951143	Week: 5271951147	Week: 5271951149
	Normal	Abnormal, NCS	Abnormal, CS
Semaglutide 0.05 mg	70
Semaglutide 0.1 mg	69
Semaglutide 0.2 mg	74
Semaglutide 0.3 mg	62
Semaglutide 0.4 mg	62
Semaglutide 0.3 mg (Fast Escalation)	70
Semaglutide 0.4 mg (Fast Escalation)	74
Liraglutide 3.0 mg	68
Placebo Pool	85
Semaglutide 0.05 mg	33
Semaglutide 0.1 mg	31
Semaglutide 0.2 mg	29
Semaglutide 0.3 mg	41
Semaglutide 0.4 mg	38
Semaglutide 0.3 mg (Fast Escalation)	32
Semaglutide 0.4 mg (Fast Escalation)	27
Liraglutide 3.0 mg	35
Placebo Pool	51
Semaglutide 0.05 mg	0
Semaglutide 0.1 mg	2
Semaglutide 0.2 mg	0
Semaglutide 0.3 mg	0
Semaglutide 0.4 mg	2
Semaglutide 0.3 mg (Fast Escalation)	0
Semaglutide 0.4 mg (Fast Escalation)	2
Liraglutide 3.0 mg	0
Semaglutide 0.05 mg	57
Semaglutide 0.1 mg	73
Semaglutide 0.2 mg	67
Semaglutide 0.3 mg	58
Semaglutide 0.4 mg	57
Semaglutide 0.3 mg (Fast Escalation)	55
Semaglutide 0.4 mg (Fast Escalation)	64
Liraglutide 3.0 mg	59
Placebo Pool	66
Semaglutide 0.05 mg	25
Semaglutide 0.1 mg	18
Semaglutide 0.2 mg	18
Semaglutide 0.3 mg	31
Semaglutide 0.4 mg	29
Semaglutide 0.3 mg (Fast Escalation)	21
Semaglutide 0.4 mg (Fast Escalation)	28
Liraglutide 3.0 mg	26
Placebo Pool	40
Semaglutide 0.1 mg	0
Semaglutide 0.2 mg	2
Semaglutide 0.4 mg	1
Semaglutide 0.3 mg (Fast Escalation)	1
Semaglutide 0.4 mg (Fast Escalation)	0
Liraglutide 3.0 mg	1
Placebo Pool	0

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Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)

Participants' status on receiving concomitant medication (antihypertensive and lipid-lowering medications) at week 0 (yes/no) and week 52 (decreased, no change, increased or missing) are presented. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration. (NCT02453711)
Timeframe: Week 0, Week 52

,,,,,,,,

Intervention	Participants (Count of Participants)
	Week 0: Antihypertensive medication (Yes)	Week 0: Antihypertensive medication (No)	Week 52: Antihypertensive medication (Decreased)	Week 52: Antihypertensive medication (No change)	Week 52: Antihypertensive medication (Increased)	Week 52: Antihypertensive medication (Missing)	Week 0: Lipid-lowering medication (Yes)	Week 0: Lipid-lowering medication (No)	Week 52: Lipid-lowering medication (Decreased)	Week 52: Lipid-lowering medication (No change)	Week 52: Lipid-lowering medication (Increased)	Week 52: Lipid-lowering medication (Missing)
Liraglutide 3.0 mg	36	67	3	74	8	1	25	78	1	83	1	1
Placebo Pool	50	86	6	89	6	2	28	108	2	94	5	2
Semaglutide 0.05 mg	37	66	3	68	4	2	20	83	0	73	2	2
Semaglutide 0.1 mg	31	71	3	74	9	2	17	85	1	83	2	2
Semaglutide 0.2 mg	28	75	8	76	2	1	13	90	3	81	2	1
Semaglutide 0.3 mg	31	72	6	75	6	1	15	88	1	84	2	1
Semaglutide 0.3 mg (Fast Escalation)	32	70	6	64	5	0	20	82	3	71	1	0
Semaglutide 0.4 mg	36	66	10	70	2	0	22	80	1	79	2	0
Semaglutide 0.4 mg (Fast Escalation)	29	74	7	80	4	0	13	90	3	87	1	0

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Change in Biochemistry: Albumin

Change from baseline (week 0) in albumin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration. (NCT02453711)
Timeframe: Week 0, week 52

Intervention	Gram/decilitre (g/dL) (Mean)
Semaglutide 0.05 mg	0.03
Semaglutide 0.1 mg	0.01
Semaglutide 0.2 mg	0.07
Semaglutide 0.3 mg	0.05
Semaglutide 0.4 mg	0.03
Semaglutide 0.3 mg (Fast Escalation)	0.01
Semaglutide 0.4 mg (Fast Escalation)	0.02
Liraglutide 3.0 mg	0.06
Placebo Pool	0.04

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Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score

This outcome measure presents results recorded at week 52. If a participant experienced an event of nausea within 24 hours prior to a site visit, a nausea questionnaire had to be completed. Participants experiencing such events were to answer 5 different categories in the questionnaire ('duration of nausea', 'time from the latest injection of trial product to the onset of nausea', 'time from last food intake to the onset of nausea', 'nausea accompanied by vomiting (yes/no)' and 'severity of nausea (worst during episode)'). Severity of nausea was recorded on a 0 to 10 numeric rating scale (NRS), where 0 = 'No nausea' and 10 = 'Nausea as bad as it could be'. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 52

Intervention	Events (Number)
	Duration of nausea:<30 min	Duration of nausea: 30 min-2 hr	Duration of nausea: 2-4 hr	Duration of nausea: 4-8 hr	Duration of nausea: >8 hr	Latest injection to onset time: 0-3 hr	Latest injection to onset time: 3-6 hr	Latest injection to onset time: 6-12 hr	Latest injection to onset time: 12-18 hr	Latest injection to onset time: >18 hr	Last food intake to onset time: 0-1 hr	Last food intake to onset time: 1-2 hr	Last food intake to onset time: 2-3 hr	Last food intake to onset time: 3-6 hr	Last food intake to onset time: >6 hr	Nausea accompanied by vomiting (Yes)	Nausea accompanied by vomiting (No)	Severity of nausea: 0	Severity of nausea: 1	Severity of nausea: 2	Severity of nausea: 3	Severity of nausea: 4	Severity of nausea: 5	Severity of nausea: 6	Severity of nausea: 7	Severity of nausea: 8	Severity of nausea: 9	Severity of nausea: 10
Semaglutide 0.1 mg	0	0	0	1	0	0	0	1	0	0	0	1	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0
Semaglutide 0.2 mg	1	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0

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Compliance With Nutritional Counselling

"This outcome measure presents nutritional compliance results recorded at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52. Nutritional compliance was recorded on a 0 to 10 numeric rating scale (NRS), with higher scores representing better compliance." (NCT02453711)
Timeframe: Week 4-52

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Intervention	Score on a scale (Mean)
	Week-4	Week-8	Week-12	Week-16	Week-20	Week-24	Week-28	Week-32	Week-36	Week-40	Week-44	Week-48	Week-52
Liraglutide 3.0 mg	7.21	6.92	7.01	6.98	6.85	6.69	6.69	6.94	6.63	6.52	6.60	6.01	6.87
Placebo Pool	6.08	5.85	6.14	6.31	6.24	6.06	6.34	5.86	6.10	5.90	5.99	6.16	6.09
Semaglutide 0.05 mg	6.85	6.53	6.70	6.85	6.92	6.49	6.94	6.83	6.87	6.86	6.83	6.82	7.23
Semaglutide 0.1 mg	7.30	7.24	7.26	7.22	7.20	7.14	7.54	6.97	7.12	6.88	6.95	7.05	7.22
Semaglutide 0.2 mg	7.17	6.82	7.22	7.36	6.87	7.07	7.10	7.12	7.03	7.07	6.96	6.88	7.05
Semaglutide 0.3 mg	7.07	7.13	7.04	7.04	7.14	7.17	7.11	7.07	6.86	7.03	6.96	6.92	6.85
Semaglutide 0.3 mg (Fast Escalation)	7.05	7.25	7.35	7.27	7.24	7.05	7.53	7.13	7.33	7.01	6.87	7.01	7.36
Semaglutide 0.4 mg	7.20	7.00	7.11	7.61	7.64	7.63	7.46	7.72	7.20	7.40	7.30	7.12	7.36
Semaglutide 0.4 mg (Fast Escalation)	7.30	7.65	7.64	7.71	7.74	7.55	7.47	7.29	7.34	7.26	7.30	7.23	7.31

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Change in SF-36

Short Form-36 (SF-36) is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 52. A positive change score indicates an improvement since baseline. Results are based on the in-trial observation period. (NCT02453711)
Timeframe: Week 0, Week 52

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Intervention	Score on a scale (Mean)
	Bodily pain	General health	Mental health	Physical functioning	Role-emotional	Role-physical	Social functioning	Vitality	Physical component summary	Mental component summary
Liraglutide 3.0 mg	2.48	3.95	1.91	6.79	0.25	5.37	0.35	4.83	6.21	-0.26
Placebo Pool	1.21	1.39	-0.38	2.28	0.63	1.52	-0.29	3.38	2.29	-0.05
Semaglutide 0.05 mg	1.85	2.03	0.42	6.00	3.31	3.45	0.81	1.73	4.16	0.25
Semaglutide 0.1 mg	3.01	2.51	0.24	4.67	-1.69	4.37	0.71	5.16	5.51	-1.15
Semaglutide 0.2 mg	4.27	4.17	2.82	6.52	1.17	7.35	1.36	8.90	7.14	1.45
Semaglutide 0.3 mg	3.82	1.20	-0.55	4.75	1.25	3.40	-0.88	3.22	4.70	-1.10
Semaglutide 0.3 mg (Fast Escalation)	1.88	5.85	1.02	7.27	0.18	7.12	2.23	5.96	7.54	-0.25
Semaglutide 0.4 mg	5.16	5.85	2.47	8.74	2.24	4.53	2.81	9.37	7.67	1.97
Semaglutide 0.4 mg (Fast Escalation)	5.11	4.81	1.64	7.28	2.11	5.51	-0.91	7.02	7.28	0.20

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Change in Mental Health Assessed by PHQ-9

Patient health questionnaire-9 (PHQ-9) was recorded at baseline (week 0) and week 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. On the PHQ-9, the participant rates the frequency of 9 items on a scale from 0 (not at all) to 3 (nearly every day). The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration. (NCT02453711)
Timeframe: Week 0, week 52

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Intervention	Score on a scale (Mean)
	Week 0	Week 52
Liraglutide 3.0 mg	2.0	1.3
Placebo Pool	2.5	1.7
Semaglutide 0.05 mg	2.5	1.5
Semaglutide 0.1 mg	1.7	1.1
Semaglutide 0.2 mg	2.1	1.3
Semaglutide 0.3 mg	1.5	1.1
Semaglutide 0.3 mg (Fast Escalation)	1.7	1.1
Semaglutide 0.4 mg	2.5	1.0
Semaglutide 0.4 mg (Fast Escalation)	2.0	0.9

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Change in Mental Health Assessed by C-SSRS

Presented results are the number of participants with Columbia Suicidality Severity Rating Scale (C-SSRS) results recorded during baseline (week 0) and post baseline (week 4-52) visits. For classification of the events reported on the C-SSRS, the following categories were used: 1) Suicidal ideation, 2) Suicidal behaviour and 3) Non-suicidal self-injurious behaviour. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration. (NCT02453711)
Timeframe: Week 0 and Week 4-59

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Intervention	Participants (Count of Participants)
	Wk 0: Suicidal ideation	Wk 0: Suicidal behaviour	Wk 0: Non-suicidal self-injurious behaviour	Wk 4-59: Suicidal ideation	Wk 4-59: Suicidal behaviour	Wk 4-59: Non-suicidal self-injurious behaviour
Liraglutide 3.0 mg	0	0	0	2	0	0
Placebo Pool	0	0	0	1	0	0
Semaglutide 0.05 mg	0	0	0	1	0	0
Semaglutide 0.1 mg	0	0	0	0	0	0
Semaglutide 0.2 mg	1	0	0	1	0	0
Semaglutide 0.3 mg	2	1	0	2	0	0
Semaglutide 0.3 mg (Fast Escalation)	0	0	0	0	0	0
Semaglutide 0.4 mg	1	0	0	0	0	0
Semaglutide 0.4 mg (Fast Escalation)	0	0	0	0	0	0

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Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)

Change from baseline (week 0) in lipids (total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, very low density lipoprotein (VLDL) cholesterol and triglycerides) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and respective baseline lipid value as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. Free fatty acid (FFA) results are not presented as the values were considered invalid. The shipment of the samples to be tested for FFA was not as per the requirement. (NCT02453711)
Timeframe: Week 0, Week 52

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Intervention	Millimoles per litre (mmol/L) (Least Squares Mean)
	Total cholesterol	LDL cholesterol	HDL cholesterol	VLDL cholesterol	Triglycerides
Liraglutide 3.0 mg	0.96	0.95	1.00	0.91	0.90
Placebo Pool	0.97	0.97	1.00	0.95	0.95
Semaglutide 0.05 mg	0.96	0.97	0.99	0.90	0.89
Semaglutide 0.1 mg	0.95	0.93	1.02	0.89	0.88
Semaglutide 0.2 mg	0.93	0.93	1.02	0.81	0.81
Semaglutide 0.3 mg	0.93	0.92	1.02	0.85	0.85
Semaglutide 0.3 mg (Fast Escalation)	0.93	0.92	1.00	0.87	0.87
Semaglutide 0.4 mg	0.93	0.93	1.00	0.81	0.80
Semaglutide 0.4 mg (Fast Escalation)	0.92	0.91	1.01	0.81	0.80

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Change in Haematology: Thrombocytes, Leucocytes and Differential Count

"Change from baseline (week 0) in haematological parameters, thrombocytes, leucocytes and differential cell count (eosinophils, neutrophils, basophils, monocytes and lymphocytes) were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration." (NCT02453711)
Timeframe: Week 0, week 52

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Intervention	10^9 cells/litre (L) (Mean)
	Thrombocytes	Leucocytes	Eosinophils	Neutrophils	Basophils	Monocytes	Lymphocytes
Liraglutide 3.0 mg	4.83	-0.17	0.01	-0.12	-0.00	-0.01	-0.06
Placebo Pool	-6.11	-0.44	0.00	-0.33	0.00	-0.02	-0.09
Semaglutide 0.05 mg	-2.08	-0.47	0.02	-0.36	0.00	-0.04	-0.10
Semaglutide 0.1 mg	2.95	-0.24	0.02	-0.07	-0.00	-0.04	-0.16
Semaglutide 0.2 mg	-8.17	-0.23	-0.01	-0.05	-0.00	0.01	-0.17
Semaglutide 0.3 mg	2.79	-0.50	-0.02	-0.22	-0.01	-0.02	-0.24
Semaglutide 0.3 mg (Fast Escalation)	-5.76	-0.66	0.01	-0.57	-0.01	-0.01	-0.08
Semaglutide 0.4 mg	-0.52	-0.68	0.00	-0.51	-0.00	-0.02	-0.15
Semaglutide 0.4 mg (Fast Escalation)	-3.32	-0.40	-0.01	-0.23	0.00	-0.03	-0.14

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Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)

"Change from baseline (week 0) in biochemistry parameters, urea, sodium, potassium and calcium (total) were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration." (NCT02453711)
Timeframe: Week 0, week 52

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Intervention	Millimole/litre (mmol/L) (Mean)
	Urea	Sodium	Potassium	Calcium (total)
Liraglutide 3.0 mg	0.03	-0.37	-0.02	0.02
Placebo Pool	0.21	-0.35	-0.04	-0.00
Semaglutide 0.05 mg	-0.04	-0.18	0.01	0.01
Semaglutide 0.1 mg	0.16	-0.27	0.01	-0.01
Semaglutide 0.2 mg	-0.01	-0.40	-0.00	0.01
Semaglutide 0.3 mg	-0.10	-0.82	-0.04	0.01
Semaglutide 0.3 mg (Fast Escalation)	-0.06	-0.76	0.00	-0.00
Semaglutide 0.4 mg	-0.00	-0.92	-0.10	0.00
Semaglutide 0.4 mg (Fast Escalation)	-0.33	-0.74	-0.11	0.00

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Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP

"Change from baseline (week 0) in biochemistry parameters, creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration." (NCT02453711)
Timeframe: Week 0, week 52

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Intervention	Unit/litre (U/L) (Mean)
	Creatinine kinase	Amylase	Lipase	ALT	AST	ALP
Liraglutide 3.0 mg	-3.09	7.12	11.86	-2.95	-1.48	-0.52
Placebo Pool	53.36	3.41	1.63	-3.03	0.00	-1.46
Semaglutide 0.05 mg	0.53	3.35	5.62	-5.82	-1.08	-3.42
Semaglutide 0.1 mg	-44.75	4.84	8.83	-5.45	-1.99	-3.44
Semaglutide 0.2 mg	-13.20	9.20	17.55	-7.44	-2.33	-6.21
Semaglutide 0.3 mg	-46.34	7.53	13.28	-9.15	-3.32	-6.70
Semaglutide 0.3 mg (Fast Escalation)	-8.86	8.39	14.92	-9.07	-1.62	-3.50
Semaglutide 0.4 mg	-29.91	7.67	13.33	-3.64	-2.07	-4.25
Semaglutide 0.4 mg (Fast Escalation)	-28.08	7.78	15.09	-7.17	-2.73	-8.20

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Change in Biochemistry: Creatinine and Bilirubin (Total)

"Change from baseline (week 0) in biochemistry parameters, creatinine and bilirubin (total) were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration." (NCT02453711)
Timeframe: Week 0, week 52

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Intervention	Micromole/litre (umol/L) (Mean)
	Creatinine	Bilirubin (total)
Liraglutide 3.0 mg	-0.81	1.02
Placebo Pool	0.28	1.09
Semaglutide 0.05 mg	-1.14	0.30
Semaglutide 0.1 mg	-0.85	1.12
Semaglutide 0.2 mg	-1.09	1.59
Semaglutide 0.3 mg	0.76	1.33
Semaglutide 0.3 mg (Fast Escalation)	1.05	1.02
Semaglutide 0.4 mg	1.48	1.23
Semaglutide 0.4 mg (Fast Escalation)	-2.10	1.67

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Relative Change in Body Weight (%)

Relative change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 0, Week 52

Intervention	Percentage (%) of body weight (Least Squares Mean)
Semaglutide 0.05 mg	-5.99
Semaglutide 0.1 mg	-8.62
Semaglutide 0.2 mg	-11.60
Semaglutide 0.3 mg	-11.17
Semaglutide 0.4 mg	-13.84
Semaglutide 0.3 mg (Fast Escalation)	-11.38
Semaglutide 0.4 mg (Fast Escalation)	-16.29
Liraglutide 3.0 mg	-7.76
Placebo Pool	-2.29

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Participants With Weight Loss of ≥5% of Baseline Body Weight

Presented results are percentage of participants who lost more than or equal to 5% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 52

Intervention	Percentage (%) of participants (Number)
Semaglutide 0.05 mg	53.50
Semaglutide 0.1 mg	67.49
Semaglutide 0.2 mg	74.91
Semaglutide 0.3 mg	80.52
Semaglutide 0.4 mg	82.52
Semaglutide 0.3 mg (Fast Escalation)	72.19
Semaglutide 0.4 mg (Fast Escalation)	89.58
Liraglutide 3.0 mg	66.12
Placebo Pool	22.87

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Anti-semaglutide Antibodies During and After Treatment

Participants were tested for anti-semaglutide antibodies from week 0 (post treatment) to week 52 (at weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52). This outcome measure is applicable only for the semaglutide treatment arms. (NCT02453711)
Timeframe: Week 0-52

Intervention	Participants (Count of Participants)
Semaglutide 0.05 mg	0
Semaglutide 0.1 mg	0
Semaglutide 0.2 mg	0
Semaglutide 0.3 mg	0
Semaglutide 0.4 mg	0
Semaglutide 0.3 mg (Fast Escalation)	0
Semaglutide 0.4 mg (Fast Escalation)	0

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Number of Hypoglycaemic Episodes During the Trial

Hypoglycaemic episodes were identified by either: 1) Subject reporting of symptoms of hypoglycaemia (low blood sugar) or 2) fasting plasma glucose (FPG) values ≤3.9 mmol/L (70 mg/dL) from blood sampling at site visits. Hypoglycaemic episodes were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 0-59

Intervention	Episodes (Number)
Semaglutide 0.05 mg	1
Semaglutide 0.1 mg	6
Semaglutide 0.2 mg	4
Semaglutide 0.3 mg	8
Semaglutide 0.4 mg	10
Semaglutide 0.3 mg (Fast Escalation)	20
Semaglutide 0.4 mg (Fast Escalation)	16
Liraglutide 3.0 mg	4
Placebo Pool	18

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Number of AEs During the Trial

Adverse events (AEs) were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 0-59

Intervention	Events (Number)
Semaglutide 0.05 mg	547
Semaglutide 0.1 mg	730
Semaglutide 0.2 mg	738
Semaglutide 0.3 mg	587
Semaglutide 0.4 mg	775
Semaglutide 0.3 mg (Fast Escalation)	737
Semaglutide 0.4 mg (Fast Escalation)	681
Liraglutide 3.0 mg	612
Placebo Pool	650

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Change in Waist to Hip Circumference Ratio

Change from baseline (week 0) in waist to hip circumference ratio was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist to hip circumference ratio as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 0, Week 52

Intervention	Waist to hip circumference ratio (Least Squares Mean)
Semaglutide 0.05 mg	-0.01
Semaglutide 0.1 mg	-0.02
Semaglutide 0.2 mg	-0.02
Semaglutide 0.3 mg	-0.03
Semaglutide 0.4 mg	-0.02
Semaglutide 0.3 mg (Fast Escalation)	-0.02
Semaglutide 0.4 mg (Fast Escalation)	-0.03
Liraglutide 3.0 mg	-0.02
Placebo Pool	-0.01

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Change in Waist Circumference

Change from baseline (week 0) in waist circumference was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist circumference as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 0, Week 52

Intervention	Centimetre (cm) (Least Squares Mean)
Semaglutide 0.05 mg	-6.11
Semaglutide 0.1 mg	-8.75
Semaglutide 0.2 mg	-11.02
Semaglutide 0.3 mg	-10.91
Semaglutide 0.4 mg	-12.31
Semaglutide 0.3 mg (Fast Escalation)	-11.06
Semaglutide 0.4 mg (Fast Escalation)	-14.88
Liraglutide 3.0 mg	-8.35
Placebo Pool	-3.47

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Change in SBP

Change from baseline (week 0) in systolic blood pressure (SBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline SBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 0, Week 52

Intervention	Millimeters of mercury (mmHg) (Least Squares Mean)
Semaglutide 0.05 mg	-4.46
Semaglutide 0.1 mg	-5.76
Semaglutide 0.2 mg	-6.26
Semaglutide 0.3 mg	-6.41
Semaglutide 0.4 mg	-5.81
Semaglutide 0.3 mg (Fast Escalation)	-6.07
Semaglutide 0.4 mg (Fast Escalation)	-10.26
Liraglutide 3.0 mg	-5.45
Placebo Pool	-1.58

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Change in Pulse

Change from baseline (week 0) in pulse rate was evaluated at week 52. Analysis of observed data using a mixed model for repeated measurements (MMRM) with treatment, region and sex as factors and baseline pulse as covariate, all nested within visit. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration. (NCT02453711)
Timeframe: Week 0, week 52

Intervention	Beats per minute (Least Squares Mean)
Semaglutide 0.05 mg	-0.33
Semaglutide 0.1 mg	3.46
Semaglutide 0.2 mg	1.88
Semaglutide 0.3 mg	2.38
Semaglutide 0.4 mg	2.54
Semaglutide 0.3 mg (Fast Escalation)	2.34
Semaglutide 0.4 mg (Fast Escalation)	2.15
Liraglutide 3.0 mg	2.63
Placebo Pool	-0.86

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Change in hsCRP

Change from baseline (week 0) in high-sensitivity C-reactive protein (hsCRP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline hsCRP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 0, Week 52

Intervention	Milligrams per decilitre (mg/dL) (Least Squares Mean)
Semaglutide 0.05 mg	0.71
Semaglutide 0.1 mg	0.65
Semaglutide 0.2 mg	0.57
Semaglutide 0.3 mg	0.66
Semaglutide 0.4 mg	0.54
Semaglutide 0.3 mg (Fast Escalation)	0.58
Semaglutide 0.4 mg (Fast Escalation)	0.44
Liraglutide 3.0 mg	0.72
Placebo Pool	0.82

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Change in HbA1c

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline HbA1c as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. (NCT02453711)
Timeframe: Week 0, Week 52

Intervention	Percentage of HbA1c (Least Squares Mean)
Semaglutide 0.05 mg	-0.13
Semaglutide 0.1 mg	-0.21
Semaglutide 0.2 mg	-0.28
Semaglutide 0.3 mg	-0.23
Semaglutide 0.4 mg	-0.29
Semaglutide 0.3 mg (Fast Escalation)	-0.25
Semaglutide 0.4 mg (Fast Escalation)	-0.34
Liraglutide 3.0 mg	-0.21
Placebo Pool	-0.01

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Change in Haematology: Haemoglobin

Change from baseline (week 0) in haemoglobin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration. (NCT02453711)
Timeframe: Week 0, week 52

Intervention	Millimoles per litre (mmol/L) (Mean)
Semaglutide 0.05 mg	0.01
Semaglutide 0.1 mg	-0.08
Semaglutide 0.2 mg	-0.02
Semaglutide 0.3 mg	-0.07
Semaglutide 0.4 mg	0.00
Semaglutide 0.3 mg (Fast Escalation)	-0.07
Semaglutide 0.4 mg (Fast Escalation)	0.02
Liraglutide 3.0 mg	0.11
Placebo Pool	-0.01

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Body Weight Change

"The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy." (NCT02461589)
Timeframe: Week 0, Week 26

Intervention	kg (Mean)
Semaglutide 0.05 mg/Day	-2.75
Semaglutide 0.1 mg/Day	-4.36
Semaglutide 0.2 mg/Day	-6.70
Semaglutide 0.3 mg/Day	-8.23
Liraglutide 0.3 mg/Day	-1.48
Liraglutide 0.6 mg/Day	-1.81
Liraglutide 1.2 mg/Day	-1.78
Liraglutide 1.8 mg/Day	-3.68
Placebo	-1.22
Semaglutide Flexible	-6.60

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Change in Fasting Plasma Glucose (FPG)

"Estimated mean change from baseline in FPG at week 26. The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy." (NCT02461589)
Timeframe: Week 0, Week 26

Intervention	mmol/L (Mean)
Semaglutide 0.05 mg/Day	-2.09
Semaglutide 0.1 mg/Day	-2.08
Semaglutide 0.2 mg/Day	-2.64
Semaglutide 0.3 mg/Day	-3.53
Liraglutide 0.3 mg/Day	-1.33
Liraglutide 0.6 mg/Day	-1.56
Liraglutide 1.2 mg/Day	-1.51
Liraglutide 1.8 mg/Day	-1.92
Placebo	-0.54
Semaglutide Flexible	-3.40

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Change in HbA1c (Glycosylated Haemoglobin)

"Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy." (NCT02461589)
Timeframe: Week 0, week 26

Intervention	percentage of glycosylated haemoglobin (Mean)
Semaglutide 0.05 mg/Day	-0.97
Semaglutide 0.1 mg/Day	-1.30
Semaglutide 0.2 mg/Day	-1.65
Semaglutide 0.3 mg/Day	-1.96
Liraglutide 0.3 mg/Day	-0.50
Liraglutide 0.6 mg/Day	-0.88
Liraglutide 1.2 mg/Day	-0.86
Liraglutide 1.8 mg/Day	-1.32
Placebo	-0.05
Semaglutide Flexible	-1.72

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Change in Systolic and Diastolic Blood Pressure

,,,,,,,,,

Intervention	mmHg (Mean)
	Systolicblood pressure	Diastolic blood pressure
Liraglutide 0.3 mg/Day	-3.77	-1.77
Liraglutide 0.6 mg/Day	-3.20	-1.89
Liraglutide 1.2 mg/Day	-4.69	-0.60
Liraglutide 1.8 mg/Day	-2.99	0.63
Placebo	-2.34	-0.61
Semaglutide 0.05 mg/Day	-5.74	-0.60
Semaglutide 0.1 mg/Day	-2.77	0.66
Semaglutide 0.2 mg/Day	-4.25	-1.62
Semaglutide 0.3 mg/Day	-9.85	-4.02
Semaglutide Flexible	-6.62	-1.69

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Number of Participants With an Adverse Event (AE)

Intervention	Participants (Count of Participants)
MK-8521 180 μg	24
MK-8521 300 μg	29
Placebo	25
Liraglutide 1.8 mg	22

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Number of Participants With an AE of Symptomatic Hypoglycemia

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Hypoglycemia episodes are those with glucose values ≤70 mg/dL (3.9 mmol/L). Symptomatic hypoglycemia episodes were episodes with clinical symptoms reported by the investigator as hypoglycemia and classified as adverse events. (NCT02492763)
Timeframe: Up to Week 14

Intervention	Participants (Count of Participants)
MK-8521 180 μg	0
MK-8521 300 μg	2
Placebo	1
Liraglutide 1.8 mg	1

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Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12

This change from baseline reflects the Week 12 DBP minus the Week 0 DBP. (NCT02492763)
Timeframe: Baseline and Week 12

Intervention	mmHg (Least Squares Mean)
MK-8521 180 μg	0.5
MK-8521 300 μg	0.4
Placebo	-1.0
Liraglutide 1.8 mg	0.6

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Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12

This change from baseline reflects the Week 12 fasting HDL cholesterol minus the Week 0 fasting HDL cholesterol. (NCT02492763)
Timeframe: Baseline and Week 12

Intervention	mg/dL (Mean)
MK-8521 180 μg	-0.4
MK-8521 300 μg	-0.5
Placebo	3.8
Liraglutide 1.8 mg	0.4

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Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12

This change from baseline reflects the Week 12 fasting LDL cholesterol minus the Week 0 fasting LDL cholesterol. (NCT02492763)
Timeframe: Baseline and Week 12

Intervention	mg/dL (Mean)
MK-8521 180 μg	-9.3
MK-8521 300 μg	8.8
Placebo	4.5
Liraglutide 1.8 mg	0.3

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Number of Participants Who Discontinued Study Treatment Due to an AE

Intervention	Participants (Count of Participants)
MK-8521 180 μg	3
MK-8521 300 μg	1
Placebo	2
Liraglutide 1.8 mg	2

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Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

This change from baseline reflects the Week 12 FPG minus the Week 0 FPG. (NCT02492763)
Timeframe: Baseline and Week 12

Intervention	mg/dL (Least Squares Mean)
MK-8521 180 μg	-13.7
MK-8521 300 μg	-34.6
Placebo	-5.1
Liraglutide 1.8 mg	-42.9

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Change From Baseline in Fasting Triglycerides at Week 12

This change from baseline reflects the Week 12 fasting triglycerides minus the Week 0 fasting triglycerides. (NCT02492763)
Timeframe: Baseline and Week 12

Intervention	mg/dL (Mean)
MK-8521 180 μg	-2.9
MK-8521 300 μg	-26.6
Placebo	-15.6
Liraglutide 1.8 mg	-20.5

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Change From Baseline in Heart Rate at Week 12

This change from baseline reflects the Week 12 heart rate minus the Week 0 heart rate. (NCT02492763)
Timeframe: Baseline and Week 12

Intervention	Beats/minute (Least Squares Mean)
MK-8521 180 μg	5.47
MK-8521 300 μg	6.28
Placebo	-1.42
Liraglutide 1.8 mg	1.63

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Change From Baseline in Body Weight at Week 12

This change from baseline reflects the Week 12 body weight minus the Week 0 body weight. (NCT02492763)
Timeframe: Baseline and Week 12

Intervention	Kilograms (Least Squares Mean)
MK-8521 180 μg	-2.0
MK-8521 300 μg	-3.0
Placebo	-1.3
Liraglutide 1.8 mg	-2.9

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Change From Baseline in Hemoglobin A1C (A1C) at Week 12

A1C is the percentage of hemoglobin that has glucose bound to it and is a blood marker used to report average blood glucose levels over prolonged periods of time. A1C is reported as a percentage (%). This change from baseline reflects the Week 12 A1C minus the Week 0 A1C. (NCT02492763)
Timeframe: Baseline and Week 12

Intervention	Percent (Least Squares Mean)
MK-8521 180 μg	-0.82
MK-8521 300 μg	-1.05
Placebo	-0.44
Liraglutide 1.8 mg	-1.42

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Change From Baseline in Systolic Blood Pressure (SBP) at Week 12

This change from baseline reflects the Week 12 SBP minus the Week 0 SBP. (NCT02492763)
Timeframe: Baseline and Week 12

Intervention	mmHg (Least Squares Mean)
MK-8521 180 μg	-2.7
MK-8521 300 μg	-1.5
Placebo	1.0
Liraglutide 1.8 mg	-1.7

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Change in Fasting Human Insulin

Change in fasting human insulin (measured in picomoles per liter [pmol/L]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Ratio of insulin (Geometric Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	0.67	0.60
Insulin Glargine	0.68	0.62

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Change in Fasting Free Fatty Acids

Change in fasting free fatty acids (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Ratio of free fatty acids (Geometric Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	0.68	0.70
Insulin Glargine	0.75	0.78

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Change in Fasting C-peptide

Change in fasting C-peptide (measured in nanomoles per liter [nmol/L]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Ratio of C-peptide (Geometric Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	0.63	0.58
Insulin Glargine	0.57	0.54

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Change in Calcitonin

The number of participants who reported low, normal and high levels of calcitonin in relation to reference ranges at baseline (week 0), week 26 and week 104 are presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Participants (Count of Participants)
	Week 0: Low	Week 0: Normal	Week 0: High	Week 26: Low	Week 26: Normal	Week 26: High	Week 104: Low	Week 104: Normal	Week 104: High
Insulin Degludec/Liraglutide	0	481	25	0	437	40	0	301	31
Insulin Glargine	0	472	32	0	431	30	0	169	17

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Change in Body Weight

Change in body weight from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Kilogram (kg) (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	0.5	1.2
Insulin Glargine	2.2	3.0

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Change in Blood Pressure (Systolic and Diastolic)

Change in blood pressure (systolic and diastolic) from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Millimeters of mercury (mmHg) (Mean)
	Week 26: Systolic blood pressure	Week 26: Diastolic blood pressure	Week 104: Systolic blood pressure	Week 104: Diastolic blood pressure
Insulin Degludec/Liraglutide	-1.2	0.1	0.5	-0.1
Insulin Glargine	0.5	-0.3	0.9	-0.2

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Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase

Change in biochemistry parameters- alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lipase and amylase from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Units per liter (U/L) (Mean)
	Week 26: ALP	Week 104: ALP	Week 26: ALT	Week 104: ALT	Week 26: AST	Week 104: AST	Week 26: lipase	Week 104: lipase	Week 26: amylase	Week 104: amylase
Insulin Degludec/Liraglutide	-4.16	-1.35	-5.45	-5.39	-1.62	-1.84	9.26	5.41	9.72	7.23
Insulin Glargine	-4.33	-1.34	-3.33	-3.45	-0.39	-0.67	-7.97	-13.33	2.79	-0.13

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Change in Biochemistry Parameter- Sodium, Potassium and Calcium

Change in sodium, potassium and calcium from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	mmol/L (Mean)
	Week 26: sodium	Week 104: sodium	Week 26: potassium	Week 104: potassium	Week 26: calcium	Week 104: calcium
Insulin Degludec/Liraglutide	0.89	1.22	-0.05	-0.06	-0.01	-0.07
Insulin Glargine	1.03	1.47	-0.08	-0.07	-0.00	-0.06

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Change in Biochemistry Parameter- Creatinine, Total Bilirubin

Change in biochemistry parameter- creatinine, total bilirubin from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Micromoles per liter (umol/L) (Mean)
	Week 26: creatinine	Week 104: creatinine	Week 26: total bilirubin	Week 104: total bilirubin
Insulin Degludec/Liraglutide	-0.50	0.75	-0.30	-0.33
Insulin Glargine	0.25	2.20	-0.32	-0.59

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Change in Biochemistry Parameter- Albumin

Change in biochemistry parameter- albumin from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Grams per deciliter (g/dL) (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	-0.03	0.01
Insulin Glargine	-0.03	0.03

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Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment

Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-26

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	143
Insulin Glargine	261

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Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment

Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-104

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	319
Insulin Glargine	642

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Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment

Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-26

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	27
Insulin Glargine	60

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Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment

Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-104

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	61
Insulin Glargine	164

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Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment

Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent hypoglycaemic episodes according to ADA during 26 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-26

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	3190
Insulin Glargine	3806

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Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment

Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment emergent hypoglycaemic episodes according to ADA during 104 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-104

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	8934
Insulin Glargine	10658

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Number of TEAEs During 26 Weeks of Treatment

An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 26 weeks of treatment is presented. (NCT02501161)
Timeframe: Weeks 0-26

Intervention	Adverse events (Number)
Insulin Degludec/Liraglutide	718
Insulin Glargine	624

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Number of TEAEs During 104 Weeks of Treatment

An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 104 weeks of treatment is presented. (NCT02501161)
Timeframe: Week 0 to week 104

Intervention	Adverse events (Number)
Insulin Degludec/Liraglutide	1788
Insulin Glargine	1368

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Change in Urine Albumin/Creatinine Ratio

Change in urine albumin/creatinine ratio from baseline (week 0) to week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 104

Intervention	Milligrams per millimole (mg/mmol) (Mean)
Insulin Degludec/Liraglutide	-1.09
Insulin Glargine	-0.74

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Change in HbA1c

Change in HbA1c from baseline (week 0) to week 26 is presented. (NCT02501161)
Timeframe: Week 0, week 26

Intervention	Percentage of HbA1c (Mean)
Insulin Degludec/Liraglutide	-1.99
Insulin Glargine	-1.69

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Change in Fasting LDL-cholesterol

Change in fasting low density lipoprotein (LDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Ratio of LDL-cholesterol (Geometric Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	1.05	0.96
Insulin Glargine	1.02	0.98

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Change in Fasting Total Cholesterol

Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Ratio of total cholesterol (Geometric Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	0.99	0.97
Insulin Glargine	0.99	0.97

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Change in Fasting Triglycerides

Change in fasting triglycerides (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Ratio of triglycerides (Geometric Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	0.84	0.89
Insulin Glargine	0.85	0.89

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Change in Fasting VLDL-cholesterol

Change in fasting very low density lipoprotein (VLDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Ratio of VLDL-cholesterol (Geometric Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	0.85	0.90
Insulin Glargine	0.85	0.88

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Change in FPG

Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	mmol/L (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	-3.97	-3.93
Insulin Glargine	-3.79	-3.73

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Change in Haematological Parameter- Basophils

Change in basophils from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Percentage of basophils (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	0.00	0.20
Insulin Glargine	-0.00	0.16

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Change in Haematological Parameter- Eosinophils

Change in eosinophils from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Percentage of eosinophils (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	0.10	0.32
Insulin Glargine	0.06	0.43

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Change in Haematological Parameter- Erythrocytes

Change in erythrocytes from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	10^12 cells/L (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	-0.02	-0.12
Insulin Glargine	-0.03	-0.11

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Change in Haematological Parameter- Haematocrit

Change in haematocrit from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Percentage of red blood cells (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	-0.33	-0.71
Insulin Glargine	-0.36	-0.95

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Change in Haematological Parameter- Haemoglobin

Change in haemoglobin from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	g/dL (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	0.08	-0.00
Insulin Glargine	0.08	-0.03

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Change in Haematological Parameter- Lymphocytes

Change in lymphocytes from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Percentage of lymphocytes (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	-1.87	-2.25
Insulin Glargine	-0.84	-2.38

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Change in Haematological Parameter- Monocytes

Change in monocytes from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Percentage of monocytes (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	-0.10	0.49
Insulin Glargine	0.01	0.59

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Change in Haematological Parameter- Neutrophils

Change in neutrophils from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Percentage of neutrophils (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	1.86	1.25
Insulin Glargine	0.78	1.21

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Change in Haematological Parameter- Thrombocytes and Leukocytes

Change in thrombocytes and leukocytes from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	10^9 cells/L (Mean)
	Week 26: Thrombocytes	Week 104: Thrombocytes	Week 26: Leukocytes	Week 104: Leukocytes
Insulin Degludec/Liraglutide	8.77	16.87	0.49	0.07
Insulin Glargine	7.05	18.73	0.39	0.32

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Change in Pulse Rate

Change in pulse rate from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Beats per minute (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	2.0	1.7
Insulin Glargine	-0.4	-0.5

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Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores and component summary (PCS and MCS) scores are presented. A positive change score indicates an improvement since baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Score on a scale (Mean)
	Week 26: Physical functioning	Week 104: Physical functioning	Week 26: Role-physical	Week 104: Role-physical	Week 26: Bodily pain	Week 104: Bodily pain	Week 26: General health	Week 104: General health	Week 26: Vitality	Week 104: Vitality	Week 26: Social functioning	Week 104: Social functioning	Week 26: Role-emotional	Week 104: Role-emotional	Week 26: Mental health	Week 104: Mental health	Week 26: PCS	Week 104: PCS	Week 26: MCS	Week 104: MCS
Insulin Degludec/Liraglutide	1.2	0.7	1.4	1.4	1.5	1.6	2.5	2.3	1.4	1.5	1.8	0.9	0.6	1.6	1.7	2.5	1.6	1.0	1.3	2.0
Insulin Glargine	1.1	0.6	0.5	0.7	0.4	0.1	2.1	2.1	1.4	1.5	0.9	1.1	0.7	1.2	1.3	0.3	0.9	0.8	1.2	1.0

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Change in SMPG-mean 9-point Profile

Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean 9-point profile from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	mmol/L (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	-3.34	-3.27
Insulin Glargine	-3.32	-2.76

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Change in SMPG-mean Postprandial Increment Over All Meals

Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	mmol/L (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	-0.28	-0.47
Insulin Glargine	0.20	0.12

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Change in TRIM-D

Treatment related impact measures-diabetes (TRIM-D) was developed according to the FDA guidance from 2009 on development of new PRO measures. The questionnaire consists of 5 sub-domains, which are scored according to a 1-5 point scale with a higher score indicating a better health state (less negative impact). Sub-domain scores are calculated by summing across items in the same sub-domain, and the total score is calculated by summing scores from all the sub-domains. The highest possible summed score within a sub-domain ranges from 20 (compliance sub-domain) to 40 (psychological health sub-domain) points and the highest possible total score is 140 points. Change in TRIM-D total score from baseline (week 0) to week 26 and week 104 is presented. A positive change score indicates an improvement since baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Score on a scale (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	9.6	11.4
Insulin Glargine	7.3	9.5

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ECG Evaluation

The electrocardiogram (ECG) was assessed at baseline (within 2 weeks prior to week 0) and week 104. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 104 are presented. (NCT02501161)
Timeframe: Baseline (within 2 weeks prior to week 0), week 104

Intervention	Participants (Count of Participants)
	Normal (Baseline)	Abnormal NCS (Baseline)	Abnormal CS (Baseline)	Normal (week 104)	Abnormal NCS (week 104)	Abnormal CS (week 104)
Insulin Degludec/Liraglutide	335	162	9	227	97	7
Insulin Glargine	335	165	4	122	65	2

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Eye Examination Category

Fundus photography or a dilated fundoscopy was performed at baseline (within 12 weeks prior to week 0) and week 104. The investigator interpreted each eye's (left and right) results and categorised them as: normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline and week 104 were presented. (NCT02501161)
Timeframe: Baseline (within 12 weeks prior to week 0), week 104

Intervention	Participants (Count of Participants)
	Left eye: Normal (baseline)	Left eye: Abnormal NCS (baseline)	Left eye: Abnormal CS (baseline)	Left eye: Normal (week 104)	Left eye: Abnormal NCS (week 104)	Left eye: Abnormal CS (week 104)	Right eye: Normal (baseline)	Right eye: Abnormal NCS (baseline)	Right eye: Abnormal CS (baseline)	Right eye: Normal (week 104)	Right eye: Abnormal NCS (week 104)	Right eye: Abnormal CS (week 104)
Insulin Degludec/Liraglutide	345	151	10	204	97	17	344	151	11	200	99	19
Insulin Glargine	341	155	8	129	50	6	355	143	6	132	48	5

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Insulin Dose

Insulin dose after 26 and 104 weeks of treatment is presented. (NCT02501161)
Timeframe: Week 26, week 104

Intervention	Units (Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	34.6	36.1
Insulin Glargine	48.6	50.6

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Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain

Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

Intervention	Percentage of participants (Number)
	Week 26: Yes	Week 26: No	Week 104: Yes	Week 104: No
Insulin Degludec/Liraglutide	35.2	64.8	20.0	80.0
Insulin Glargine	13.6	86.4	6.1	93.9

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Participants Who Achieved (Yes/no): HbA1c <7.0%

Percentage of participants who achieved (yes/no) HbA1c <7.0% at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

Intervention	Percentage of participants (Number)
	Week 26: Yes	Week 26: No	Week 104: Yes	Week 104: No
Insulin Degludec/Liraglutide	78.7	21.3	55.5	44.5
Insulin Glargine	55.7	44.3	28.5	71.5

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Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

Intervention	Percentage of participants (Number)
	Week 26: Yes	Week 26: No	Week 104: Yes	Week 104: No
Insulin Degludec/Liraglutide	71.3	28.7	51.8	48.2
Insulin Glargine	44.9	55.1	25.5	74.5

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Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain

Percentage of participants who achieved (yes/no) HbA1c <7.0% without weight gain at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

Intervention	Percentage of participants (Number)
	Week 26: Yes	Week 26: No	Week 104: Yes	Week 104: No
Insulin Degludec/Liraglutide	38.5	61.5	20.9	79.1
Insulin Glargine	15.4	84.6	6.3	93.7

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Participants Who Achieved (Yes/no): HbA1c ≤6.5%

Percentage of participants who achieved (yes/no) HbA1c ≤6.5% at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

Intervention	Percentage of participants (Number)
	Week 26: Yes	Week 26: No	Week 104: Yes	Week 104: No
Insulin Degludec/Liraglutide	63.6	36.4	43.3	56.7
Insulin Glargine	35.4	64.6	21.7	78.3

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Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

Intervention	Percentage of participants (Number)
	Week 26: Yes	Week 26: No	Week 104: Yes	Week 104: No
Insulin Degludec/Liraglutide	57.9	42.1	40.1	59.9
Insulin Glargine	27.9	72.1	19.2	80.8

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Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain

Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

Intervention	Percentage of participants (Number)
	Week 26: Yes	Week 26: No	Week 104: Yes	Week 104: No
Insulin Degludec/Liraglutide	30.2	69.8	16.6	83.4
Insulin Glargine	8.7	91.3	5.5	94.5

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Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain

Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without weight gain at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

Intervention	Percentage of participants (Number)
	Week 26: Yes	Week 26: No	Week 104: Yes	Week 104: No
Insulin Degludec/Liraglutide	33.2	66.8	17.6	82.4
Insulin Glargine	9.9	90.1	5.7	94.3

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SMPG-9-point Profile (Individual Points in the Profile)

Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Self-measured plasma glucose (SMPG)-9-point profile (individual points in the profile) at week 26 and week 104 is presented. (NCT02501161)
Timeframe: Week 26, week 104

Intervention	mmol/L (Mean)
	Week 26: Before breakfast	Week 26: 90 minutes after breakfast	Week 26: Before lunch	Week 26: 90 minutes after lunch	Week 26: Before dinner	Week 26: 90 minutes after dinner	Week 26: Bedtime	Week 26: At 4:00 a.m.	Week 26: Before breakfast the following day	Week 104: Before breakfast	Week 104: 90 minutes after breakfast	Week 104: Before lunch	Week 104: 90 minutes after lunch	Week 104: Before dinner	Week 104: 90 minutes after dinner	Week 104: Bedtime	Week 104: At 4:00 a.m.	Week 104: Before breakfast the following day
Insulin Degludec/Liraglutide	5.59	8.34	6.03	8.02	6.67	8.31	7.48	5.72	5.53	5.58	7.99	6.06	7.80	6.58	8.20	7.47	5.67	5.44
Insulin Glargine	5.58	8.76	6.43	8.79	6.91	9.10	8.13	5.91	5.56	5.57	8.64	6.37	8.87	7.02	9.10	7.90	5.96	5.47

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Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits

"Time to HbA1c > 6.5% at 2 consecutive visits is defined as time from randomization to HbA1c > 6.5% at 2 consecutive planned scheduled visits from week 26 (including week 26 if HbA1c was > 6.5% at week 12). Time from randomisation to HbA1c >6.5% at 2 consecutive visits was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable baseline HbA1c group was a dichotomised baseline HbA1c variable with 2 categories: HbA1c < 8.5% or HbA1c ≥ 8.5% and the variable previous OAD treatment was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function." (NCT02501161)
Timeframe: Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2

Intervention	Weeks (Median)
	Baseline HbA1c <8.5% + Non-SU users	Baseline HbA1c <8.5% + SU users	Baseline HbA1c >=8.5% + Non-SU users	Baseline HbA1c >=8.5% + SU users
Insulin Degludec/Liraglutide	NA	90.1	64.1	52.1
Insulin Glargine	64.1	26.6	26.6	26.1

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Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification

"Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable baseline HbA1c group was a dichotomised baseline HbA1c variable with 2 categories: HbA1c < 8.5% or HbA1c ≥ 8.5% and the variable previous OAD treatment was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function." (NCT02501161)
Timeframe: Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2

Intervention	Weeks (Median)
	Baseline HbA1c <8.5% + Non-SU users	Baseline HbA1c <8.5% + SU users	Baseline HbA1c >=8.5% + Non-SU users	Baseline HbA1c >=8.5% + SU users
Insulin Degludec/Liraglutide	NA	106.7	NA	104.0
Insulin Glargine	104.3	90.3	64.6	26.6

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Change in Fasting HDL-cholesterol

Change in fasting high density lipoprotein (HDL)- cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. (NCT02501161)
Timeframe: Week 0, week 26, week 104

Intervention	Ratio of HDL-cholesterol (Geometric Mean)
	Week 26	Week 104
Insulin Degludec/Liraglutide	1.03	1.02
Insulin Glargine	1.02	1.03

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Triglycerides

Triglycerides were evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	mg/dL (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	135.4	130.4

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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the 26-week and 52-week treatment period, respectively. Severe or BG confirmed symptomatic hypoglycaemia (hypo):An episode that was severe according to the ADA classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypo. ADA definition of severe hypo:episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk) 0) and no later than 7 days after the last day on liraglutide (maximum till wk 26 and wk 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'wk 0-26+7 days and wk 0-52+7 days'. (NCT02505334)
Timeframe: Weeks 0-26 and Weeks 0-52

Intervention	Episodes (Number)
	Weeks 0-26
Liraglutide 0.9 mg	0

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Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Treatment emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the26-week and 52-week treatment period, respectively. Nocturnal hypoglycaemic episodes: Those occurring between 00:01 and 05:59 hours, both inclusive. Severe or BG confirmed symptomatic hypoglycaemia: episode that was severe according to the ADA classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Treatment emergent: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'. (NCT02505334)
Timeframe: Weeks 0-26 and Weeks 0-52

Intervention	Episodes (Number)
	Weeks 0-26	Weeks 0-52
Liraglutide 1.8 mg	0	0

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Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Intervention	Episodes (Number)
	Weeks 0-26
Liraglutide 0.9 mg	0

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Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition

"American Diabetes Association (ADA) classification of hypoglycaemia:~Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.~Documented symptomatic: PG level ≤3.9 mmol/L with symptoms.~Asymptomatic: PG level ≤3.9 mmol/L without symptoms.~Probable symptomatic: No measurement with symptoms.~Pseudo: PG level >3.9 mmol/L with symptoms. Treatment emergent hypoglycaemic episode: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'." (NCT02505334)
Timeframe: Weeks 0-26 and Weeks 0-52

Intervention	Episodes (Number)
	Weeks 0-26: Severe hypoglycaemia	Weeks 0-26: Documented symptomatic hypoglycaemia	Weeks 0-26: Asymptomatic hypoglycaemia	Weeks 0-26: Probable symptomatic hypoglycaemia	Weeks 0-26: Pseudo-hypoglycaemia
Liraglutide 0.9 mg	0	0	1	1	1

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Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition

Intervention	Episodes (Number)
	Weeks 0-26: Severe hypoglycaemia	Weeks 0-26: Documented symptomatic hypoglycaemia	Weeks 0-26: Asymptomatic hypoglycaemia	Weeks 0-26: Probable symptomatic hypoglycaemia	Weeks 0-26: Pseudo-hypoglycaemia	Weeks 0-52: Severe hypoglycaemia	Weeks 0-52: Documented symptomatic hypoglycaemia	Weeks 0-52: Asymptomatic hypoglycaemia	Weeks 0-52: Probable symptomatic hypoglycaemia	Weeks 0-52: Pseudo-hypoglycaemia
Liraglutide 1.8 mg	0	0	2	3	2	0	0	3	4	2

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Number of Treatment Emergent Adverse Events

Treatment emergent adverse events (TEAEs) were evaluated during the 26-week and 52-week treatment period, respectively. TEAE for weeks 0-26: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 + 7 days). TEAE for weeks 0-52: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 52 + 7 days). Hence, the following shown 'Time Frame' should be read as 'Weeks 0-26 + 7 days and Weeks 0-52 + 7 days'. (NCT02505334)
Timeframe: Weeks 0-26 and Weeks 0-52

Intervention	Events (Number)
	Weeks 0-26	Weeks 0-52
Liraglutide 1.8 mg	365	588

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Number of Treatment Emergent Adverse Events

Intervention	Events (Number)
	Weeks 0-26
Liraglutide 0.9 mg	266

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Change in Biochemistry: Albumin Corrected Calcium

Change from baseline (week 0) in albumin corrected calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	9.28	0.00	0.02

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Low Density Lipoprotein (LDL) Cholesterol

LDL was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	mg/dL (Geometric Mean)
	Week 26
Liraglutide 0.9 mg	107.1

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Homeostasis Model Assessment of Beta-cell Function (HOMA-B)

HOMA-B was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B=[(20 x fasting insulin in µU/mL)/(FPG in mmol/L-3.5)]. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	Percentage (%) of beta-cell function (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	42.06	40.03

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Homeostasis Model Assessment of Beta-cell Function (HOMA-B)

Intervention	Percentage (%) of beta-cell function (Geometric Mean)
	Week 26
Liraglutide 0.9 mg	35.54

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Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)

HOMA-IR was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-IR is an index of insulin resistance and was calculated as: HOMA-IR= fasting insulin (μU/mL) x FPG (mmol/L)/22.5. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	HOMA-IR score (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	4.388	4.567

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Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)

Intervention	HOMA-IR score (Geometric Mean)
	Week 26
Liraglutide 0.9 mg	4.262

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High Density Lipoprotein (HDL) Cholesterol

HDL was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	mg/dL (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	52.7	53.3

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High Density Lipoprotein (HDL) Cholesterol

HDL was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	mg/dL (Geometric Mean)
	Week 26
Liraglutide 0.9 mg	52.9

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Free Fatty Acids

Free fatty acids were evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	mg/dL (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	12.56	12.19

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Free Fatty Acids

Free fatty acids were evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	mg/dL (Geometric Mean)
	Week 26
Liraglutide 0.9 mg	12.99

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Fasting Insulin

Fasting insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	pmol/L (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	77.00	77.31

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Fasting Insulin

Fasting insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	pmol/L (Geometric Mean)
	Week 26
Liraglutide 0.9 mg	70.91

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Fasting Glucagon

Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	pmol/L (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	22.5	23.4

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Fasting Glucagon

Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	pmol/L (Geometric Mean)
	Week 26
Liraglutide 0.9 mg	23.4

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Fasting C-peptide

Fasting C-peptide was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	ng/mL (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	1.946	1.906

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Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Reported results are subjects with HbA1c <7.0% after 26 weeks and 52 weeks of treatment, respectively without treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. Severe or BG confirmed symptomatic hypoglycaemia: severe as per ADA classification or BG confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA: episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk)0) and no later than 7 days after the last day on liraglutide (maximum till wk26+7days and wk52+7days). Hence, the following shown 'Time Frame' should be read as 'Wk26+7days and Wk52+7days' (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	Participants (Count of Participants)
	Week 26	Week 52
Liraglutide 1.8 mg	53	45

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Change in Glycosylated Haemoglobin (HbA1c) (Week 26)

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment. The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate. (NCT02505334)
Timeframe: Week 0, Week 26

Intervention	Percentage (%) of HbA1c (Least Squares Mean)
Liraglutide 1.8 mg	-0.23
Liraglutide 0.9 mg	0.17

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Fasting C-peptide

Fasting C-peptide was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	ng/mL (Geometric Mean)
	Week 26
Liraglutide 0.9 mg	1.853

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Change in Waist Circumference

Change from baseline (week 0) in waist circumference was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	Centimeter (cm) (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	93.68	-0.44	-1.07

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Change in Waist Circumference

Change from baseline (week 0) in waist circumference was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	Centimeter (cm) (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	93.82	-0.73

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Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)

Change from baseline (week 0) in mean of postprandial increments (from before meal to 90 minutes after for breakfast, lunch and dinner) of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	81.7	-8.4	-6.3

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Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	81.6	-1.5

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Change in SMBG 7-point Profile: Mean of 7-point Profile

Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Baseline (week 0)	Change from baseline: week 26	Change from baseline: week 52
Liraglutide 1.8 mg	217.9	-14.5	-8.9

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Change in SMBG 7-point Profile: Mean of 7-point Profile

Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Baseline (week 0)	Change from baseline: week 26
Liraglutide 0.9 mg	217.7	-0.6

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Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)

"Reported results are 7-point SMBG values at week 0, week 26 and week 52. The 7-point profile blood glucose levels were measured at the following time points always starting with the first:~Before breakfast.~90 minutes after start of breakfast.~Before lunch.~90 minutes after start of lunch.~Before dinner.~90 minutes after start of dinner.~At bedtime." (NCT02505334)
Timeframe: Week 0 and Week 26 and Week 52

Intervention	mg/dL (Mean)
	Week 0: Before breakfast	Week 0: 90 minutes after start of breakfast	Week 0: Before lunch	Week 0: 90 minutes after start of lunch	Week 0: Before dinner	Week 0: 90 minutes after start of dinner	Week 0: At bedtime	Week 26: Before breakfast	Week 26: 90 minutes after start of breakfast	Week 26: Before lunch	Week 26: 90 minutes after start of lunch	Week 26: Before dinner	Week 26: 90 minutes after start of dinner	Week 26: At bedtime	Week 52: Before breakfast	Week 52: 90 minutes after start of breakfast	Week 52: Before lunch	Week 52: 90 minutes after start of lunch	Week 52: Before dinner	Week 52: 90 minutes after start of dinner	Week 52: At bedtime
Liraglutide 1.8 mg	181.8	262.6	169.5	253.1	173.4	254.3	226.1	171.7	247.2	161.2	234.7	162.3	233.3	205.6	176.1	251.1	169.6	243.3	164.3	240.5	207.9

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Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)

Intervention	mg/dL (Mean)
	Week 0: Before breakfast	Week 0: 90 minutes after start of breakfast	Week 0: Before lunch	Week 0: 90 minutes after start of lunch	Week 0: Before dinner	Week 0: 90 minutes after start of dinner	Week 0: At bedtime	Week 26: Before breakfast	Week 26: 90 minutes after start of breakfast	Week 26: Before lunch	Week 26: 90 minutes after start of lunch	Week 26: Before dinner	Week 26: 90 minutes after start of dinner	Week 26: At bedtime
Liraglutide 0.9 mg	177.1	266.5	177.6	252.2	169.7	249.5	217.8	178.2	258.2	177.0	255.3	168.6	251.5	220.5

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Change in Pulse

Change from baseline (week 0) in pulse was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	Beats/minute (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	80.2	0.8	0.2

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Change in Pulse

Change from baseline (week 0) in pulse was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	Beats/minute (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	80.8	0.2

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Change in Physical Examination

"Reported results are physical examination outcomes at week (wk) 0, wk 26 and wk 52. Physical examination consisted of the following listed examinations and the outcome of each examination was evaluated as: 1) normal, 2) abnormal, not clinically significant (NCS) or 3) abnormal, clinically significant (CS).~Cardiovascular system~Central and peripheral nervous system (PNS)~Gastrointestinal (GI) system including mouth~General appearance~Head, ears, eyes, nose, throat, neck~Lymph node palpation~Musculoskeletal system~Respiratory system~Skin~Thyroid gland" (NCT02505334)
Timeframe: Week 0 and Week 26 and Week 52

Intervention	Participants (Count of Participants)
	Cardiovascular system: Wk 0: Normal	Cardiovascular system: Wk 0: Abnormal, NCS	Cardiovascular system: Wk 0: Abnormal, CS	Cardiovascular system: Wk 26: Normal	Cardiovascular system: Wk 26: Abnormal, NCS	Cardiovascular system: Week 26: Abnormal, CS	Cardiovascular system: Wk 52: Normal	Cardiovascular system: Wk 52: Abnormal, NCS	Cardiovascular system: Wk 52: Abnormal, CS	Central and PNS: Wk 0: Normal	Central and PNS: Wk 0: Abnormal, NCS	Central and PNS: Wk 0: Abnormal, CS	Central and PNS: Wk 26: Normal	Central and PNS: Wk 26: Abnormal, NCS	Central and PNS: Wk 26: Abnormal, CS	Central and PNS: Wk 52: Normal	Central and PNS: Wk 52: Abnormal, NCS	Central and PNS: Wk 52: Abnormal, CS	GI system including mouth: Wk 0: Normal	GI system including mouth: Wk 0: Abnormal, NCS	GI system including mouth: Wk 0: Abnormal, CS	GI system including mouth: Wk 26: Normal	GI system including mouth: Wk 26: Abnormal, NCS	GI system including mouth: Wk 26: Abnormal, CS	GI system including mouth: Wk 52: Normal	GI system including mouth: Wk 52: Abnormal, NCS	GI system including mouth: Wk 52: Abnormal, CS	General appearance: Wk 0: Normal	General appearance: Wk 0: Abnormal, NCS	General appearance: Wk 0: Abnormal, CS	General appearance: Wk 26: Normal	General appearance: Wk 26: Abnormal, NCS	General appearance: Wk 26: Abnormal, CS	General appearance: Wk 52: Normal	General appearance: Wk 52: Abnormal, NCS	General appearance: Wk 52: Abnormal, CS	Head,ears,eyes,nose,throat,neck: Wk0:Normal	Head,ears,eyes,nose,throat,neck: Wk0:Abnormal,NCS	Head,ears,eyes,nose,throat,neck: Wk0:Abnormal,CS	Head,ears,eyes,nose,throat,neck: Wk26:Normal	Head,ears,eyes,nose,throat,neck: Wk26:Abnormal,NCS	Head,ears,eyes,nose,throat,neck: Wk26:Abnormal,CS	Head,ears,eyes,nose,throat,neck: Wk52:Normal	Head,ears,eyes,nose,throat,neck: Wk52:Abnormal,NCS	Head,ears,eyes,nose,throat,neck: Wk52:Abnormal,CS	Lymph node palpation: Wk 0: Normal	Lymph node palpation: Wk 0: Abnormal, NCS	Lymph node palpation: Wk 0: Abnormal, CS	Lymph node palpation: Wk 26: Normal	Lymph node palpation: Wk 26: Abnormal, NCS	Lymph node palpation: Wk 26: Abnormal, CS	Lymph node palpation: Wk 52: Normal	Lymph node palpation: Wk 52: Abnormal, NCS	Lymph node palpation: Wk 52: Abnormal, CS	Musculoskeletal system: Wk 0: Normal	Musculoskeletal system: Wk 0: Abnormal, NCS	Musculoskeletal system: Wk 0: Abnormal, CS	Musculoskeletal system: Wk 26: Normal	Musculoskeletal system: Wk 26: Abnormal, NCS	Musculoskeletal system: Wk 26: Abnormal, CS	Musculoskeletal system: Wk 52: Normal	Musculoskeletal system: Wk 52: Abnormal, NCS	Musculoskeletal system: Wk 52: Abnormal, CS	Respiratory system: Wk 0: Normal	Respiratory system: Wk 0: Abnormal, NCS	Respiratory system: Wk 0: Abnormal, CS	Respiratory system: Wk 26: Normal	Respiratory system: Wk 26: Abnormal, NCS	Respiratory system: Wk 26: Abnormal, CS	Respiratory system: Wk 52: Normal	Respiratory system: Wk 52: Abnormal, NCS	Respiratory system: Wk 52: Abnormal, CS	Skin: Wk 0: Normal	Skin: Wk 0: Abnormal, NCS	Skin: Wk 0: Abnormal, CS	Skin: Wk 26: Normal	Skin: Wk 26: Abnormal, NCS	Skin: Wk 26: Abnormal, CS	Skin: Wk 52: Normal	Skin: Wk 52: Abnormal, NCS	Skin: Wk 52: Abnormal, CS	Thyroid gland: Wk 0: Normal	Thyroid gland: Wk 0: Abnormal, NCS	Thyroid gland: Wk 0: Abnormal, CS	Thyroid gland: Wk 26: Normal	Thyroid gland: Wk 26: Abnormal, NCS	Thyroid gland: Wk 26: Abnormal, CS	Thyroid gland: Wk 52: Normal	Thyroid gland: Wk 52: Abnormal, NCS	Thyroid gland: Wk 52: Abnormal, CS
Liraglutide 1.8 mg	229	3	1	230	2	1	227	4	2	232	0	1	231	0	2	232	0	1	227	0	6	227	0	6	226	2	5	229	4	0	229	4	0	229	4	0	225	3	5	225	4	4	223	5	5	233	0	0	233	0	0	233	0	0	226	4	3	224	5	4	224	5	4	233	0	0	232	0	1	232	0	1	225	4	4	218	4	11	224	4	5	232	0	1	232	0	1	232	0	1

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Change in Electrocardiogram (ECG)

Reported results are ECG outcomes at week 0, week 26 and week 52. ECG outcomes were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS. (NCT02505334)
Timeframe: Week 0 and Week 26 and Week 52

Intervention	Participants (Count of Participants)
	Week 0: Normal	Week 0: Abnormal, NCS	Week 0: Abnormal, CS	Week 26: Normal	Week 26: Abnormal, NCS	Week 26: Abnormal, CS	Week 52: Normal	Week 52: Abnormal, NCS	Week 52: Abnormal, CS
Liraglutide 1.8 mg	202	31	0	205	26	2	203	28	2

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Change in Electrocardiogram (ECG)

Intervention	Participants (Count of Participants)
	Week 0: Normal	Week 0: Abnormal, NCS	Week 0: Abnormal, CS	Week 26: Normal	Week 26: Abnormal, NCS	Week 26: Abnormal, CS
Liraglutide 0.9 mg	196	35	2	204	26	3

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Change in Calcitonin

Reported results are number of subjects with low, normal or high calcitonin values at week 0, week 26 and week 52. Number of subjects analyzed = number of subjects contributed to the analysis for individual time point. Calcitonin values were categorised as low, normal or high. (NCT02505334)
Timeframe: Week 0 and Week 26 and Week 52

Intervention	Participants (Count of Participants)
	Week 0: Low	Week 0: Normal	Week 0: High	Week 26: Low	Week 26: Normal	Week 26: High	Week 52: Low	Week 52: Normal	Week 52: High
Liraglutide 1.8 mg	0	229	4	0	228	5	0	230	3

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Change in Calcitonin

Intervention	Participants (Count of Participants)
	Week 0: Low	Week 0: Normal	Week 0: High	Week 26: Low	Week 26: Normal	Week 26: High
Liraglutide 0.9 mg	0	229	3	0	231	2

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Change in Body Weight

Change from baseline (week 0) in body weight was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	Kilogram (kg) (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	74.67	-0.77	-1.05

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Change in Body Weight

Change from baseline (week 0) in body weight was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	Kilogram (kg) (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	75.13	-0.95

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Change in Body Mass Index (BMI)

Change from baseline (week 0) in BMI was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	kg/m^2 (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	27.34	-0.28	-0.39

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Change in Body Mass Index (BMI)

Change from baseline (week 0) in BMI was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	kg/m^2 (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	27.20	-0.33

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Change in Blood Pressure (Systolic and Diastolic)

Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mmHg (Mean)
	Week 0: SBP, Baseline	Week 26: SBP, change from baseline	Week 52: SBP, change from baseline	Week 0: DBP, Baseline	Week 26: DBP, change from baseline	Week 52: DBP, change from baseline
Liraglutide 1.8 mg	128.0	-1.7	-0.9	79.6	-0.9	-0.6

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Change in Blood Pressure (Systolic and Diastolic)

Intervention	mmHg (Mean)
	Week 0: SBP, Baseline	Week 26: SBP, change from baseline	Week 0: DBP, Baseline	Week 26: DBP, change from baseline
Liraglutide 0.9 mg	128.8	0.4	80.3	0.1

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Change in Biochemistry: Urea

Change from baseline (week 0) in urea was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	13.5	0.3	0.7

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Change in Biochemistry: Urea

Change from baseline (week 0) in urea was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	14.0	-0.0

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Change in Biochemistry: Total Bilirubin

Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	0.52	0.04	0.06

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Change in Biochemistry: Total Bilirubin

Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	0.53	0.04

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Low Density Lipoprotein (LDL) Cholesterol

LDL was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	mg/dL (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	103.4	104.5

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Change in Biochemistry: Sodium

Change from baseline (week 0) in sodium was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mmol/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	140.2	0.1	0.3

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Change in Biochemistry: Sodium

Change from baseline (week 0) in sodium was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mmol/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	140.2	0.2

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Change in Biochemistry: Potassium

Change from baseline (week 0) in potassium was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mmol/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	4.40	-0.01	0.00

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Change in Biochemistry: Potassium

Change from baseline (week 0) in potassium was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mmol/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	4.38	-0.02

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Change in Biochemistry: Lipase

Change from baseline (week 0) in lipase was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	U/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	55.4	-1.4	-1.0

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Change in Biochemistry: Lipase

Change from baseline (week 0) in lipase was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	U/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	57.3	-3.3

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Change in Biochemistry: eGFR

Change from baseline (week 0) in estimated glomerular filtration rate (eGFR) was evaluated after 26 weeks and 52 weeks of treatment, respectively. eGFR was evaluated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, mL/min/1.73m^2. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mL/min/1.73m^2 (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	78.6	-1.5	-2.3

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Change in Biochemistry: eGFR

Intervention	mL/min/1.73m^2 (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	77.6	-1.0

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Change in Biochemistry: Creatinine

Change from baseline (week 0) in creatinine was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	0.802	0.018	0.025

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Change in Biochemistry: Creatinine

Change from baseline (week 0) in creatinine was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	0.822	0.011

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Change in Biochemistry: Creatine Kinase

Change from baseline (week 0) in creatine kinase was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	U/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	117.3	5.2	7.5

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Change in Biochemistry: Creatine Kinase

Change from baseline (week 0) in creatine kinase was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	U/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	129.3	-5.2

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Change in Biochemistry: Calcium

Change from baseline (week 0) in calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	9.66	-0.01	0.01

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Change in Biochemistry: Calcium

Change from baseline (week 0) in calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	9.66	0.01

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Change in Biochemistry: Aspartate Aminotransferase

Change from baseline (week 0) in aspartate aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	U/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	26.5	0.2	-1.2

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Change in Biochemistry: Aspartate Aminotransferase

Change from baseline (week 0) in aspartate aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	U/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	26.9	-1.0

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Change in Biochemistry: Amylase

Change from baseline (week 0) in amylase was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	U/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	62.3	-0.9	-0.7

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Change in Biochemistry: Amylase

Change from baseline (week 0) in amylase was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	U/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	61.1	-2.3

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Change in Biochemistry: Alkaline Phosphatase

Change from baseline (week 0) in alkaline phosphatase was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	U/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	72.5	0.6	2.1

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Change in Biochemistry: Alkaline Phosphatase

Change from baseline (week 0) in alkaline phosphatase was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	U/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	74.1	2.0

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Change in Biochemistry: Albumin Corrected Calcium

Change from baseline (week 0) in albumin corrected calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	9.26	0.02

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Change in Eye Examination

Reported results are eye examination (ophthalmoscopy) outcomes at week 0, week 26 and week 52. Ophthalmoscopy outcomes for both left and right eye were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS. (NCT02505334)
Timeframe: Week 0 and Week 26 and Week 52

Intervention	Participants (Count of Participants)
	Week 0: Left eye - Normal	Week 0: Left eye - Abnormal, NCS	Week 0: Left eye - Abnormal, CS	Week 26: Left eye - Normal	Week 26: Left eye - Abnormal, NCS	Week 26: Left eye - Abnormal, CS	Week 0: Right eye - Normal	Week 0: Right eye - Abnormal, NCS	Week 0: Right eye - Abnormal, CS	Week 26: Right eye - Normal	Week 26: Right eye - Abnormal, NCS	Week 26: Right eye - Abnormal, CS
Liraglutide 0.9 mg	176	13	44	178	15	40	180	11	42	180	14	39

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Change in Eye Examination

Intervention	Participants (Count of Participants)
	Week 0: Left eye - Normal	Week 0: Left eye - Abnormal, NCS	Week 0: Left eye - Abnormal, CS	Week 26: Left eye - Normal	Week 26: Left eye - Abnormal, NCS	Week 26: Left eye - Abnormal, CS	Week 52: Left eye - Normal	Week 52: Left eye - Abnormal, NCS	Week 52: Left eye - Abnormal, CS	Week 0: Right eye - Normal	Week 0: Right eye - Abnormal, NCS	Week 0: Right eye - Abnormal, CS	Week 26: Right eye - Normal	Week 26: Right eye - Abnormal, NCS	Week 26: Right eye - Abnormal, CS	Week 52: Right eye - Normal	Week 52: Right eye - Abnormal, NCS	Week 52: Right eye - Abnormal, CS
Liraglutide 1.8 mg	183	15	35	178	18	37	181	16	36	183	14	36	176	19	38	177	18	38

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Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	172.0	1.0

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Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	mg/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	172.5	-8.4	-1.2

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Change in Haematology: Basophils

Change from baseline (week 0) in basophils was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	0.026	0.000

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Change in Haematology: Basophils

Change from baseline (week 0) in basophils was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	0.024	0.004	0.000

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Change in Haematology: Eosinophils

Change from baseline (week 0) in eosinophils was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	0.167	-0.016

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Change in Haematology: Eosinophils

Change from baseline (week 0) in eosinophils was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	0.182	0.001	-0.008

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Change in Haematology: Erythrocytes

Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^12 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	4.89	-0.00

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Change in Haematology: Erythrocytes

Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^12 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	4.87	-0.02	-0.04

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Change in Haematology: Haematocrit

Change from baseline (week 0) in haematocrit was evaluated after 26 weeks and 52 weeks of treatment, respectively. Haematocrit is the ratio of the volume of red blood cells to the total volume of blood. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	% of red blood cell (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	44.65	-0.06

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Change in Haematology: Haematocrit

Intervention	% of red blood cell (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	44.86	-0.22	-0.49

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Change in Haematology: Haemoglobin

Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	g/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	14.56	0.04

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Change in Haematology: Haemoglobin

Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	g/dL (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	14.65	-0.00	-0.00

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Change in Haematology: Leukocytes

Change from baseline (week 0) in leukocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	6.53	-0.08

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Change in Haematology: Leukocytes

Change from baseline (week 0) in leukocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	6.55	0.09	0.09

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Change in Physical Examination

Intervention	Participants (Count of Participants)
	Cardiovascular system: Wk 0: Normal	Cardiovascular system: Wk 0: Abnormal, NCS	Cardiovascular system: Wk 0: Abnormal, CS	Cardiovascular system: Wk 26: Normal	Cardiovascular system: Wk 26: Abnormal, NCS	Cardiovascular system: Week 26: Abnormal, CS	Central and PNS: Wk 0: Normal	Central and PNS: Wk 0: Abnormal, NCS	Central and PNS: Wk 0: Abnormal, CS	Central and PNS: Wk 26: Normal	Central and PNS: Wk 26: Abnormal, NCS	Central and PNS: Wk 26: Abnormal, CS	GI system including mouth: Wk 0: Normal	GI system including mouth: Wk 0: Abnormal, NCS	GI system including mouth: Wk 0: Abnormal, CS	GI system including mouth: Wk 26: Normal	GI system including mouth: Wk 26: Abnormal, NCS	GI system including mouth: Wk 26: Abnormal, CS	General appearance: Wk 0: Normal	General appearance: Wk 0: Abnormal, NCS	General appearance: Wk 0: Abnormal, CS	General appearance: Wk 26: Normal	General appearance: Wk 26: Abnormal, NCS	General appearance: Wk 26: Abnormal, CS	Head,ears,eyes,nose,throat,neck: Wk0:Normal	Head,ears,eyes,nose,throat,neck: Wk0:Abnormal,NCS	Head,ears,eyes,nose,throat,neck: Wk0:Abnormal,CS	Head,ears,eyes,nose,throat,neck: Wk26:Normal	Head,ears,eyes,nose,throat,neck: Wk26:Abnormal,NCS	Head,ears,eyes,nose,throat,neck: Wk26:Abnormal,CS	Lymph node palpation: Wk 0: Normal	Lymph node palpation: Wk 0: Abnormal, NCS	Lymph node palpation: Wk 0: Abnormal, CS	Lymph node palpation: Wk 26: Normal	Lymph node palpation: Wk 26: Abnormal, NCS	Lymph node palpation: Wk 26: Abnormal, CS	Musculoskeletal system: Wk 0: Normal	Musculoskeletal system: Wk 0: Abnormal, NCS	Musculoskeletal system: Wk 0: Abnormal, CS	Musculoskeletal system: Wk 26: Normal	Musculoskeletal system: Wk 26: Abnormal, NCS	Musculoskeletal system: Wk 26: Abnormal, CS	Respiratory system: Wk 0: Normal	Respiratory system: Wk 0: Abnormal, NCS	Respiratory system: Wk 0: Abnormal, CS	Respiratory system: Wk 26: Normal	Respiratory system: Wk 26: Abnormal, NCS	Respiratory system: Wk 26: Abnormal, CS	Skin: Wk 0: Normal	Skin: Wk 0: Abnormal, NCS	Skin: Wk 0: Abnormal, CS	Skin: Wk 26: Normal	Skin: Wk 26: Abnormal, NCS	Skin: Wk 26: Abnormal, CS	Thyroid gland: Wk 0: Normal	Thyroid gland: Wk 0: Abnormal, NCS	Thyroid gland: Wk 0: Abnormal, CS	Thyroid gland: Wk 26: Normal	Thyroid gland: Wk 26: Abnormal, NCS	Thyroid gland: Wk 26: Abnormal, CS
Liraglutide 0.9 mg	230	0	3	229	0	4	229	1	3	229	1	3	226	4	3	226	3	4	232	1	0	233	0	0	226	2	5	228	1	4	233	0	0	233	0	0	231	0	2	230	0	3	232	1	0	232	1	0	223	3	7	222	4	7	232	0	1	232	0	1

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Change in HbA1c (Week 52)

Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment. (NCT02505334)
Timeframe: Week 0, Week 52

Intervention	Percentage (%) of HbA1c (Mean)
	Week 0: Baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	8.14	-0.09

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Change in Haematology: Thrombocytes

Change from baseline (week 0) in thrombocytes (platelets) was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	229.1	0.8	3.4

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Change in Haematology: Thrombocytes

Change from baseline (week 0) in thrombocytes (platelets) was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	231.0	-1.5

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Change in Haematology: Neutrophils

Change from baseline (week 0) in neutrophils was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	3.967	0.054	0.062

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Change in Haematology: Neutrophils

Change from baseline (week 0) in neutrophils was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	3.975	-0.088

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Change in Haematology: Monocytes

Change from baseline (week 0) in monocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	0.341	0.001	0.019

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Change in Haematology: Monocytes

Change from baseline (week 0) in monocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	0.326	-0.000

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Change in Haematology: Lymphocytes

Change from baseline (week 0) in lymphocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	2.034	0.032	0.014

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Change in Haematology: Lymphocytes

Change from baseline (week 0) in lymphocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26 and Week 52

Intervention	10^9 cells/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	2.037	0.022

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Change in Biochemistry: Alanine Aminotransferase

Change from baseline (week 0) in alanine aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	U/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	34.2	-2.2

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Change in Biochemistry: Alanine Aminotransferase

Change from baseline (week 0) in alanine aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	U/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	32.7	-0.4	-2.4

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Change in Biochemistry: Albumin

Change from baseline (week 0) in albumin was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	g/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline
Liraglutide 0.9 mg	45.1	-0.2

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Change in Biochemistry: Albumin

Change from baseline (week 0) in albumin was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 0, Week 26, Week 52

Intervention	g/L (Mean)
	Week 0: Baseline	Week 26: Change from baseline	Week 52: Change from baseline
Liraglutide 1.8 mg	44.7	-0.2	-0.2

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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Intervention	Episodes (Number)
	Weeks 0-26	Weeks 0-52
Liraglutide 1.8 mg	0	0

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Proinsulin

Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	pmol/L (Geometric Mean)
	Week 26
Liraglutide 0.9 mg	16.054

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Proinsulin

Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	pmol/L (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	15.638	16.217

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Proinsulin/Insulin

Proinsulin/insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	Percentage (%) of proinsulin/insulin (Geometric Mean)
	Week 26
Liraglutide 0.9 mg	22.64

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Proinsulin/Insulin

Proinsulin/insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	Percentage (%) of proinsulin/insulin (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	20.31	20.98

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Responder for HbA1c Below 7.0% (53 mmol/Mol)

Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	Participants (Count of Participants)
	Week 26
Liraglutide 0.9 mg	18

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Responder for HbA1c Below 7.0% (53 mmol/Mol)

Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	Participants (Count of Participants)
	Week 26	Week 52
Liraglutide 1.8 mg	53	45

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Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Intervention	Participants (Count of Participants)
	Week 26
Liraglutide 0.9 mg	18

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Responder for HbA1c Below 7.0% Without Weight Gain

Reported results are number of subjects who achieved HbA1c target below 7.0% without weight gain after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	Participants (Count of Participants)
	Week 26
Liraglutide 0.9 mg	13

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Responder for HbA1c Below 7.0% Without Weight Gain

Reported results are number of subjects who achieved HbA1c target below 7.0% without weight gain after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	Participants (Count of Participants)
	Week 26	Week 52
Liraglutide 1.8 mg	36	35

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Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)

Reported results are number of subjects who achieved HbA1c target below or equal to 6.5% after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	Participants (Count of Participants)
	Week 26
Liraglutide 0.9 mg	5

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Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)

Reported results are number of subjects who achieved HbA1c target below or equal to 6.5% after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	Participants (Count of Participants)
	Week 26	Week 52
Liraglutide 1.8 mg	18	16

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Total Cholesterol

Total cholesterol was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	mg/dL (Geometric Mean)
	Week 26
Liraglutide 0.9 mg	194.5

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Total Cholesterol

Total cholesterol was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	mg/dL (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	191.2	190.6

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Triglycerides

Triglycerides were evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	mg/dL (Geometric Mean)
	Week 26
Liraglutide 0.9 mg	142.3

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Very Low Density Lipoprotein (VLDL) Cholesterol

VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	mg/dL (Geometric Mean)
	Week 26
Liraglutide 0.9 mg	27.8

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Very Low Density Lipoprotein (VLDL) Cholesterol

VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively. (NCT02505334)
Timeframe: Week 26 and Week 52

Intervention	mg/dL (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	26.8	25.9

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Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16

Change in free fatty acids (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Ratio of FFA (Mean)
Part A: Liraglutide	1.52
Part A: Placebo	1.31
Part B: Liraglutide	1.04
Part B: Placebo	0.99
Part A+B: Liraglutide	1.31
Part A+B: Placebo	1.21

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Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52

Change in free fatty acids (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Ratio of FFA (Mean)
Part A: Liraglutide	1.15
Part A: Placebo	1.45
Part B: Liraglutide	0.85
Part B: Placebo	1.05
Part A+B: Liraglutide	1.01
Part A+B: Placebo	1.32

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Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16

Change in FPG from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	mmol/L (Mean)
Part A: Liraglutide	-0.2
Part A: Placebo	0.1
Part B: Liraglutide	-0.1
Part B: Placebo	0.2
Part A+B: Liraglutide	-0.2
Part A+B: Placebo	0.1

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Change in FPG From Baseline at Week 52

Change in FPG from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	mmol/L (Mean)
Part A: Liraglutide	0
Part A: Placebo	0.3
Part B: Liraglutide	0
Part B: Placebo	0
Part A+B: Liraglutide	0
Part A+B: Placebo	0.2

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Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16

Change in HbA1c from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Percentage point of HbA1c (Mean)
Part A: Liraglutide	-0.2
Part A: Placebo	0
Part B: Liraglutide	-0.2
Part B: Placebo	-0.2
Part A+B: Liraglutide	-0.2
Part A+B: Placebo	-0.1

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Change in Haematology: Erythrocytes From Baseline at Week 16

Change in erythrocytes from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	10^12 cells per liter (10^12/L) (Mean)
Part A: Liraglutide	-0.1
Part A: Placebo	0
Part B: Liraglutide	0.1
Part B: Placebo	0
Part A+B: Liraglutide	-0.1
Part A+B: Placebo	0

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Change in Haematology: Erythrocytes From Baseline at Week 52

Change in erythrocytes from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	10^12 cells per liter (10^12/L) (Mean)
Part A: Liraglutide	-0.1
Part A: Placebo	0
Part B: Liraglutide	-0.1
Part B: Placebo	0
Part A+B: Liraglutide	-0.1
Part A+B: Placebo	0

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Change in Haematology: Haematocrit From Baseline at Week 16

Change in haematocrit from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Percentage of haematocrit in blood (Mean)
Part A: Liraglutide	-1.8
Part A: Placebo	-0.5
Part B: Liraglutide	0.4
Part B: Placebo	-0.6
Part A+B: Liraglutide	-0.9
Part A+B: Placebo	-0.5

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Change in Haematology: Haematocrit From Baseline at Week 52

Change in haematocrit from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Percentage of haematocrit in blood (Mean)
Part A: Liraglutide	-1.4
Part A: Placebo	0
Part B: Liraglutide	-0.2
Part B: Placebo	-0.8
Part A+B: Liraglutide	-0.9
Part A+B: Placebo	-0.3

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Change in Haematology: Haemoglobin From Baseline at Week 16

Change in haemoglobin from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	millimoles per liter (mmol/L) (Mean)
Part A: Liraglutide	-0.18
Part A: Placebo	0.06
Part B: Liraglutide	-0.20
Part B: Placebo	-0.07
Part A+B: Liraglutide	-0.19
Part A+B: Placebo	0.01

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Change in Haematology: Haemoglobin From Baseline at Week 52

Change in haemoglobin from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	mmol/L (Mean)
Part A: Liraglutide	-0.14
Part A: Placebo	-0.01
Part B: Liraglutide	-0.02
Part B: Placebo	-0.02
Part A+B: Liraglutide	-0.09
Part A+B: Placebo	-0.01

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Change in HbA1c From Baseline at Week 52

Change in HbA1c from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Percentage point of HbA1c (Mean)
Part A: Liraglutide	-0.2
Part A: Placebo	0.1
Part B: Liraglutide	-0.2
Part B: Placebo	-0.1
Part A+B: Liraglutide	-0.2
Part A+B: Placebo	0.1

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Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16

Change in HDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Ratio of HDL-cholesterol (Mean)
Part A: Liraglutide	0.96
Part A: Placebo	1.00
Part B: Liraglutide	1.01
Part B: Placebo	1.12
Part A+B: Liraglutide	0.98
Part A+B: Placebo	1.04

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Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52

Change in HDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Ratio of HDL-cholesterol (Mean)
Part A: Liraglutide	0.99
Part A: Placebo	1.02
Part B: Liraglutide	1.06
Part B: Placebo	1.08
Part A+B: Liraglutide	1.02
Part A+B: Placebo	1.04

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Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16

Change in hsCRP from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Milligram per liter (mg/L) (Mean)
Part A: Liraglutide	0.79
Part A: Placebo	-0.57
Part B: Liraglutide	-2.79
Part B: Placebo	1.87
Part A+B: Liraglutide	-0.61
Part A+B: Placebo	0.24

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Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52

Change in hsCRP from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	mg/L (Mean)
Part A: Liraglutide	0.25
Part A: Placebo	0.14
Part B: Liraglutide	-2.42
Part B: Placebo	-0.37
Part A+B: Liraglutide	-0.89
Part A+B: Placebo	-0.03

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Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16

Change in HOMA-B from baseline to week 16 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5). (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Ratio of HOMA-B (Mean)
Part A: Liraglutide	1.69
Part A: Placebo	0.70
Part B: Liraglutide	1.55
Part B: Placebo	1.07
Part A+B: Liraglutide	1.63
Part A+B: Placebo	0.82

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Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52

Change in HOMA-B from baseline to week 52 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5). (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Ratio of HOMA-B (Mean)
Part A: Liraglutide	2.24
Part A: Placebo	0.65
Part B: Liraglutide	1.50
Part B: Placebo	1.25
Part A+B: Liraglutide	1.91
Part A+B: Placebo	0.88

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Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16

Change in HOMA-IR from baseline to week 16 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Ratio of HOMA-IR (Mean)
Part A: Liraglutide	1.57
Part A: Placebo	0.80
Part B: Liraglutide	1.43
Part B: Placebo	1.33
Part A+B: Liraglutide	1.51
Part A+B: Placebo	0.97

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Change in Hormone Level: Calcitonin From Baseline at Week 16

Change in calcitonin from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	nanogram per liter (ng/L) (Mean)
Part A: Liraglutide	0
Part A: Placebo	0
Part B: Liraglutide	0.3
Part B: Placebo	0
Part A+B: Liraglutide	0.1
Part A+B: Placebo	0

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Change in Hormone Level: Calcitonin From Baseline at Week 52

Change in calcitonin from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	ng/L (Mean)
Part A: Liraglutide	0.1
Part A: Placebo	0
Part B: Liraglutide	0.5
Part B: Placebo	0
Part A+B: Liraglutide	0.3
Part A+B: Placebo	0

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Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16

Change in CEA serum from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	nanogram per milliliter (ng/mL) (Mean)
Part A: Liraglutide	-0.01
Part A: Placebo	-0.17
Part B: Liraglutide	0.17
Part B: Placebo	-0.04
Part A+B: Liraglutide	0.07
Part A+B: Placebo	-0.12

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Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52

Change in CEA serum from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	ng/mL (Mean)
Part A: Liraglutide	0.03
Part A: Placebo	-0.14
Part B: Liraglutide	-0.01
Part B: Placebo	0.17
Part A+B: Liraglutide	0.01
Part A+B: Placebo	-0.01

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Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16

Change in DHEAS from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	umol/L (Mean)
Part A: Liraglutide	0.16
Part A: Placebo	0.21
Part B: Liraglutide	0.25
Part B: Placebo	1.00
Part A+B: Liraglutide	0.20
Part A+B: Placebo	0.46

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Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52

Change in DHEAS from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	umol/L (Mean)
Part A: Liraglutide	0.77
Part A: Placebo	0.76
Part B: Liraglutide	0.25
Part B: Placebo	0.74
Part A+B: Liraglutide	0.55
Part A+B: Placebo	0.76

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Change in Hormone Level: Estradiol (Females) From Baseline at Week 16

Change in estradiol (only for females) from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	picograms per milliliter (pg/mL) (Mean)
Part A: Liraglutide	0.9
Part A: Placebo	9.2
Part B: Liraglutide	1.6
Part B: Placebo	0
Part A+B: Liraglutide	1.2
Part A+B: Placebo	6.1

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Change in Hormone Level: Estradiol (Females) From Baseline at Week 52

Change in estradiol (only for females) from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	pg/mL (Mean)
Part A: Liraglutide	7.0
Part A: Placebo	13.7
Part B: Liraglutide	1.6
Part B: Placebo	0
Part A+B: Liraglutide	4.1
Part A+B: Placebo	11.0

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Change in Hormone Level: Testosterone (Males) From Baseline at Week 16

Change in testosterone (only for males) from baseline to week 16 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	nanomoles per liter (nmol/L) (Mean)
Part A: Liraglutide	1.55
Part A: Placebo	0.61

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Change in Hormone Level: Testosterone (Males) From Baseline at Week 52

Change in testosterone (only for males) from baseline to week 52 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	nmol/L (Mean)
Part A: Liraglutide	0.62
Part A: Placebo	-0.34

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Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16

Change in LDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Ratio of LDL-cholesterol (Mean)
Part A: Liraglutide	1.01
Part A: Placebo	1.13
Part B: Liraglutide	1.04
Part B: Placebo	0.96
Part A+B: Liraglutide	1.02
Part A+B: Placebo	1.07

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Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52

Change in LDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Ratio of LDL-cholesterol (Mean)
Part A: Liraglutide	1.02
Part A: Placebo	1.12
Part B: Liraglutide	0.99
Part B: Placebo	1.06
Part A+B: Liraglutide	1.01
Part A+B: Placebo	1.10

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Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16

Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Ratio of non-HDL cholesterol (Mean)
Part A: Liraglutide	1.02
Part A: Placebo	1.09
Part B: Liraglutide	1.03
Part B: Placebo	0.93
Part A+B: Liraglutide	1.02
Part A+B: Placebo	1.04

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Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52

Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Ratio of non-HDL cholesterol (Mean)
Part A: Liraglutide	1.02
Part A: Placebo	1.07
Part B: Liraglutide	1.00
Part B: Placebo	1.07
Part A+B: Liraglutide	1.01
Part A+B: Placebo	1.07

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Change in Pulse From Baseline at Week 16

Change in pulse from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Beats/minute (Mean)
Part A: Liraglutide	2
Part A: Placebo	-2
Part B: Liraglutide	1
Part B: Placebo	-9
Part A+B: Liraglutide	2
Part A+B: Placebo	-4

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Change in Total Cholesterol From Baseline at Week 16

Change in Total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 16 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Ratio of total cholesterol (Mean)
Part A: Liraglutide	0.99
Part A: Placebo	1.06
Part B: Liraglutide	1.02
Part B: Placebo	0.97
Part A+B: Liraglutide	1.00
Part A+B: Placebo	1.03

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Change in Total Cholesterol From Baseline at Week 52

Change in total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 52 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Ratio of total cholesterol (Mean)
Part A: Liraglutide	1.00
Part A: Placebo	1.06
Part B: Liraglutide	1.01
Part B: Placebo	1.07
Part A+B: Liraglutide	1.01
Part A+B: Placebo	1.06

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Change in Triglycerides From Baseline at Week 16

Change in triglycerides (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Ratio of triglycerides (Mean)
Part A: Liraglutide	1.04
Part A: Placebo	0.99
Part B: Liraglutide	1.05
Part B: Placebo	0.80
Part A+B: Liraglutide	1.05
Part A+B: Placebo	0.93

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Change in Triglycerides From Baseline at Week 52

Change in triglycerides (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Ratio of triglycerides (Mean)
Part A: Liraglutide	1.07
Part A: Placebo	0.94
Part B: Liraglutide	1.04
Part B: Placebo	1.12
Part A+B: Liraglutide	1.06
Part A+B: Placebo	1.00

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Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16

Change in VLDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Ratio of VLDL cholesterol (Mean)
Part A: Liraglutide	1.05
Part A: Placebo	0.98
Part B: Liraglutide	1.05
Part B: Placebo	0.80
Part A+B: Liraglutide	1.05
Part A+B: Placebo	0.93

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Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52

Change in VLDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Ratio of VLDL cholesterol (Mean)
Part A: Liraglutide	1.06
Part A: Placebo	0.95
Part B: Liraglutide	1.03
Part B: Placebo	1.13
Part A+B: Liraglutide	1.04
Part A+B: Placebo	1.01

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Change in Waist Circumference From Baseline at Week 16

Change in waist circumference from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	centimeters (cm) (Mean)
Part A: Liraglutide	-2.50
Part A: Placebo	-2.44
Part B: Liraglutide	-0.73
Part B: Placebo	-1.04
Part A+B: Liraglutide	-1.70
Part A+B: Placebo	-1.92

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Change in Waist Circumference From Baseline at Week 52

Change in waist circumference from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	centimeter (Mean)
Part A: Liraglutide	-2.98
Part A: Placebo	-3.48
Part B: Liraglutide	0.45
Part B: Placebo	0.97
Part A+B: Liraglutide	-1.49
Part A+B: Placebo	-2.09

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Change in Waist-to-hip Circumference Ratio From Baseline at Week 16

Change in waist-to-hip circumference ratio from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Waist-to-hip circumference ratio (Mean)
Part A: Liraglutide	-0.01
Part A: Placebo	-0.02
Part B: Liraglutide	0.00
Part B: Placebo	0.01
Part A+B: Liraglutide	-0.01
Part A+B: Placebo	-0.01

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Change in Waist-to-hip Circumference Ratio From Baseline at Week 52

Change in waist-to-hip circumference ratio from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	waist-to-hip circumference ratio (Mean)
Part A: Liraglutide	-0.01
Part A: Placebo	-0.04
Part B: Liraglutide	-0.02
Part B: Placebo	-0.01
Part A+B: Liraglutide	-0.02
Part A+B: Placebo	-0.03

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Height Velocity at Week 16

Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Weeks 16 is presented. (NCT02527200)
Timeframe: Week 16

Intervention	Centimeters/year (cm/yr) (Mean)
Part A: Liraglutide	2.113
Part A: Placebo	2.718
Part B: Liraglutide	4.190
Part B: Placebo	6.898
Part A+B: Liraglutide	3.090
Part A+B: Placebo	4.258

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Height Velocity at Week 52

Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Week 52 are presented. (NCT02527200)
Timeframe: week 52

Intervention	Centimeters/year (cm/yr) (Mean)
Part A: Liraglutide	1.564
Part A: Placebo	1.839
Part B: Liraglutide	4.752
Part B: Placebo	5.620
Part A+B: Liraglutide	3.004
Part A+B: Placebo	3.173

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Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia

Symptomatic blood glucose confirmed hypoglycaemia: An episode that is blood glucose confirmed by plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54). (NCT02527200)
Timeframe: From week 0 to week 54

Intervention	Episodes (Number)
Part A: Liraglutide	0
Part A: Placebo	0
Part B: Liraglutide	0
Part B: Placebo	0
Part A+B: Liraglutide	0
Part A+B: Placebo	0

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Number of Severe Treatment Emergent Episodes of Hypoglycaemia

Hypoglycaemic episode (blood glucose less than or equal to (<=) 3.9 mmol/L (70 mg/dL) Or greater than (>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Severe hypoglycaemia defined by American Diabetes Association (ADA) 2013 and International Society for Paediatric and Adolescent Diabetes (ISPAD) 2018: hypoglycaemic episode associated with severe cognitive impairment requiring external assistance for recovery. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54). (NCT02527200)
Timeframe: From week 0 to week 54

Intervention	Episodes (Number)
Part A: Liraglutide	0
Part A: Placebo	0
Part B: Liraglutide	1
Part B: Placebo	0
Part A+B: Liraglutide	1
Part A+B: Placebo	0

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Number of Treatment Emergent Adverse Events

An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period included AEs are with an onset date on or after the first day of trial product administration and any of the following dates, whichever came first: a) 14 days after the last day on trial product, or b) Follow-up visit (week 54) for participants with trial product discontinuation, or c) Last study visit (participants withdrawn without follow-up visit (week 54)). (NCT02527200)
Timeframe: From week 0 to week 54

Intervention	Events (Number)
Part A: Liraglutide	134
Part A: Placebo	37
Part B: Liraglutide	159
Part B: Placebo	8
Part A+B: Liraglutide	293
Part A+B: Placebo	45

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Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 16

Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 16. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Score on a scale (Mean)
Part A: Liraglutide	-2
Part A: Placebo	1

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Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 52

Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Score on a scale (Mean)
Part A: Liraglutide	-2
Part A: Placebo	0

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Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16

Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

,,,,,

Intervention	Units per liter (U/L) (Mean)
	Creatinine kinase: Change from week 0 to week 16	Amylase: Change from week 0 to week 16	Lipase: Change from week 0 to week 16	ALT: Change from week 0 to week 16	AST: Change from week 0 to week 16	ALP: Change from week 0 to week 16
Part A: Liraglutide	-3	5	10	-9	-6	-10
Part A: Placebo	16	-2	0	-4	0	-7
Part A+B: Liraglutide	-1	6	9	-6	-4	-14
Part A+B: Placebo	10	1	0	-10	-6	-19
Part B: Liraglutide	3	8	8	-2	-2	-21
Part B: Placebo	-5	8	1	-25	-18	-47

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Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52

Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

,,,,,

Intervention	Units per liter (U/L) (Mean)
	Creatinine kinase: Change from week 0 to week 52	Amylase: Change from week 0 to week 52	Lipase: Change from week 0 to week 52	ALT: Change from week 0 to week 52	AST: Change from week 0 to week 52	ALP: Change from week 0 to week 52
Part A: Liraglutide	30	4	9	1	-2	-24
Part A: Placebo	-4	2	-1	4	9	-35
Part A+B: Liraglutide	28	5	8	1	-1	-24
Part A+B: Placebo	-5	4	0	-6	0	-32
Part B: Liraglutide	25	7	7	0	1	-25
Part B: Placebo	-8	8	3	-24	-21	-26

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Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16

Change in creatinine and bilirubin (total) from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

,,,,,

Intervention	micro mole per liter (umol/L) (Mean)
	Creatinine: Change from week 0 to week 16	Bilirubin (total): Change from week 0 to week 16
Part A: Liraglutide	1	0
Part A: Placebo	0	0
Part A+B: Liraglutide	1	0
Part A+B: Placebo	0	0
Part B: Liraglutide	2	0
Part B: Placebo	0	1

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Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52

Change in creatinine and bilirubin (total) from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

,,,,,

Intervention	umol/L (Mean)
	Creatinine: Change from week 0 to week 52	Bilirubin (total): Change from week 0 to week 52
Part A: Liraglutide	3	0
Part A: Placebo	-4	2
Part A+B: Liraglutide	3	0
Part A+B: Placebo	-1	2
Part B: Liraglutide	3	0
Part B: Placebo	5	2

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Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16

Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

,,,,,

Intervention	mmol/L (Mean)
	Urea: Change from week 0 to week 16	Sodium: Change from week 0 to week 16	Potassium: Change from week 0 to week 16	Calcium: Change from week 0 to week 16
Part A: Liraglutide	0.03	0	0.1	0
Part A: Placebo	-0.51	2	-0.1	0
Part A+B: Liraglutide	0.02	0	0	0.03
Part A+B: Placebo	-0.31	1	-0.1	0.01
Part B: Liraglutide	0	1	-0.2	0.08
Part B: Placebo	0.09	0	-0.1	0.02

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Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52

Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

,,,,,

Intervention	mmol/L (Mean)
	Urea: Change from week 0 to week 52	Sodium: Change from week 0 to week 52	Potassium: Change from week 0 to week 52	Calcium: Change from week 0 to week 52
Part A: Liraglutide	-0.38	-1	-0.2	-0.05
Part A: Placebo	-0.34	-2	-0.1	-0.11
Part A+B: Liraglutide	-0.31	0	-0.2	0.01
Part A+B: Placebo	-0.24	-1	-0.1	-0.08
Part B: Liraglutide	-0.21	1	-0.2	0.09
Part B: Placebo	-0.04	2	0	0

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Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16

Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

,,,,,

Intervention	10^9 cells per liter (10^9/L) (Mean)
	Thrombocytes: Change from week 0 to week 16	Leukocytes: Change from week 0 to week 16	Eosinophils: Change from week 0 to week 16	Neutrophils: Change from week 0 to week 16	Basophils: Change from week 0 to week 16	Lymphocytes: Change from week 0 to week 16	Monocytes: Change from week 0 to week 16
Part A: Liraglutide	6	-0.1	-0.03	0.11	-0.01	-0.24	0.06
Part A: Placebo	-21	-0.3	0.04	-0.22	0	-0.09	-0.04
Part A+B: Liraglutide	7	-0.4	-0.07	-0.06	-0.01	-0.29	0.01
Part A+B: Placebo	-8	-0.6	0.05	-0.62	0	-0.02	-0.01
Part B: Liraglutide	8	-0.8	-0.14	-0.28	-0.01	-0.36	-0.05
Part B: Placebo	19	-1.1	0.07	-1.35	-0.01	0.09	0.05

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Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52

Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

,,,,,

Intervention	10^9 cells per liter (10^9/L) (Mean)
	Thrombocytes: Change from week 0 to week 52	Leukocytes: Change from week 0 to week 52	Eosinophils: Change from week 0 to week 52	Neutrophils: Change from week 0 to week 52	Basophils: Change from week 0 to week 52	Lymphocytes: Change from week 0 to week 52	Monocytes: Change from week 0 to week 52
Part A: Liraglutide	18	-0.2	0.01	0.11	0	-0.28	-0.04
Part A: Placebo	-7	-0.6	0.03	-0.76	0	0.19	-0.06
Part A+B: Liraglutide	10	-0.4	-0.05	0.05	-0.01	-0.36	-0.04
Part A+B: Placebo	5	-0.3	-0.03	-0.55	0.01	0.25	0
Part B: Liraglutide	-2	-0.7	-0.13	-0.03	-0.01	-0.47	-0.05
Part B: Placebo	37	0.3	-0.17	-0.07	0.02	0.39	0.14

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Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16

Change in free T4 and ACTH from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

,,,,,

Intervention	picomole per liter (pmol/L) (Mean)
	T4: Change from week 0 to week 16	ACTH: Change from week 0 to week 16
Part A: Liraglutide	-0.6	0.99
Part A: Placebo	0.3	-0.85
Part A+B: Liraglutide	-0.1	0.42
Part A+B: Placebo	0.2	-1.02
Part B: Liraglutide	0.7	-0.37
Part B: Placebo	0.1	-1.32

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Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52

Change in free T4 and ACTH from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

,,,,,

Intervention	pmol/L (Mean)
	T4: Change from week 0 to week 52	ACTH: Change from week 0 to week 52
Part A: Liraglutide	-0.4	-0.02
Part A: Placebo	1.9	1.29
Part A+B: Liraglutide	-0.3	0.42
Part A+B: Placebo	1.5	0.89
Part B: Liraglutide	-0.1	0.98
Part B: Placebo	0.8	0.20

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Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16

Change in IGF-1 and cortisol from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

,,,,,

Intervention	nanogram per milliliter (ng/mL) (Mean)
	IGF-1: Change from week 0 to week 16	Cortisol: Change from week 0 to week 16
Part A: Liraglutide	-56.89	-22.94
Part A: Placebo	-28.23	6.75
Part A+B: Liraglutide	-30.31	-16.71
Part A+B: Placebo	-23.86	-4.85
Part B: Liraglutide	2.41	-8.09
Part B: Placebo	-14.23	-23.08

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Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52

Change in IGF-1 and cortisol from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

,,,,,

Intervention	ng/mL (Mean)
	IGF-1: Change from week 0 to week 52	Cortisol: Change from week 0 to week 52
Part A: Liraglutide	-25.90	3.60
Part A: Placebo	-103.45	7.54
Part A+B: Liraglutide	-15.04	-4.01
Part A+B: Placebo	-59.66	12.59
Part B: Liraglutide	-1.47	-14.15
Part B: Placebo	10.40	21.67

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Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16

Change in LH and FSH from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

,,,,,

Intervention	IU/L (Mean)
	LH: Change from week 0 to week 16	FSH: Change from week 0 to week 16
Part A: Liraglutide	-0.04	-0.2
Part A: Placebo	0.06	0.2
Part A+B: Liraglutide	-0.05	-0.2
Part A+B: Placebo	0.12	0.5
Part B: Liraglutide	-0.07	-0.1
Part B: Placebo	0.22	1.0

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Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52

Change in LH and FSH from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

,,,,,

Intervention	IU/L (Mean)
	LH: Change from week 0 to week 52	FSH: Change from week 0 to week 52
Part A: Liraglutide	0.16	1.1
Part A: Placebo	0.06	0.4
Part A+B: Liraglutide	0.24	0.8
Part A+B: Placebo	0.14	0.6
Part B: Liraglutide	0.37	0.4
Part B: Placebo	0.30	0.7

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Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16

Change in TSH and prolactin from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

,,,,,

Intervention	Milli-international units/liter (mIU/L) (Mean)
	TSH: Change from week 0 to week 16	Prolactin: Change from week 0 to week 16
Part A: Liraglutide	-0.34	7
Part A: Placebo	-0.01	-6
Part A+B: Liraglutide	-0.23	4
Part A+B: Placebo	-0.23	-12
Part B: Liraglutide	-0.09	0
Part B: Placebo	-0.59	-22

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Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52

Change in TSH and prolactin from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

,,,,,

Intervention	mIU/L (Mean)
	TSH: Change from week 0 to week 52	Prolactin: Change from week 0 to week 52
Part A: Liraglutide	0.02	10
Part A: Placebo	-0.48	8
Part A+B: Liraglutide	-0.30	5
Part A+B: Placebo	-0.38	15
Part B: Liraglutide	-0.75	-3
Part B: Placebo	-0.17	29

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Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16

Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 16 is presented. The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity. (NCT02527200)
Timeframe: Week 0, week 16

,,,,,

Intervention	Score on a scale (Mean)
	Hyperphagia behaviour score	Hyperphagia drive score	Hyperphagia severity score	Hyperphagia total score
Part A: Liraglutide	-0.8	-0.9	-0.6	-2.4
Part A: Placebo	-1.7	-0.9	-0.3	-2.9
Part A+B: Liraglutide	-1.0	-1.3	-0.4	-2.7
Part A+B: Placebo	-2.0	-1.3	-0.2	-3.5
Part B: Liraglutide	-1.2	-1.8	-0.1	-3.1
Part B: Placebo	-2.6	-2.0	0.1	-4.4

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Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52

Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 52 is presented.The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity. (NCT02527200)
Timeframe: Week 0, week 52

,,,,,

Intervention	Score on a scale (Mean)
	Hyperphagia behaviour score	Hyperphagia drive score	Hyperphagia severity score	Hyperphagia total score
Part A: Liraglutide	-0.9	-2.2	-1.3	-4.4
Part A: Placebo	-0.6	-0.5	-0.9	-2.1
Part A+B: Liraglutide	-0.8	-1.7	-0.9	-3.4
Part A+B: Placebo	-1.3	-0.8	-1.1	-3.1
Part B: Liraglutide	-0.7	-1.1	-0.4	-2.1
Part B: Placebo	-2.6	-1.4	-1.4	-5.4

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Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16

Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

,,,,,

Intervention	Millimeters of mercury (mmHg) (Mean)
	SBP: Change from week 0 to week 16	DBP: Change from week 0 to week 16
Part A: Liraglutide	-5	-1
Part A: Placebo	-2	0
Part A+B: Liraglutide	-1	0
Part A+B: Placebo	-1	0
Part B: Liraglutide	2	1
Part B: Placebo	2	-1

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Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52

Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

,,,,,

Intervention	Millimeters of mercury (mmHg) (Mean)
	SBP: Change from week 0 to week 52	DBP: Change from week 0 to week 52
Part A: Liraglutide	-5	-3
Part A: Placebo	4	5
Part A+B: Liraglutide	-1	0
Part A+B: Placebo	5	4
Part B: Liraglutide	4	4
Part B: Placebo	7	1

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Number of Participants in Glycaemic Category at Week 16

"Number of participants in glycaemic categories, normoglycaemia, pre-diabetes and type 2 diabetes at Week 16 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%." (NCT02527200)
Timeframe: week 16

,,,,,

Intervention	Participants (Count of Participants)
	Normoglycaemia	Pre-diabetes	Type 2 diabetes
Part A: Liraglutide	16	2	0
Part A: Placebo	8	4	0
Part A+B: Liraglutide	27	4	0
Part A+B: Placebo	13	6	0
Part B: Liraglutide	11	2	0
Part B: Placebo	5	2	0

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Number of Participants in Glycaemic Category at Week 52

"Number of participants in glycaemic categories, normoglycaemia, pre-diabetes and type 2 diabetes at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%." (NCT02527200)
Timeframe: Week 52

,,,,,

Intervention	Participants (Count of Participants)
	Normoglycaemia	Pre-diabetes	Type 2 diabetes
Part A: Liraglutide	13	2	1
Part A: Placebo	4	4	1
Part A+B: Liraglutide	23	4	1
Part A+B: Placebo	6	7	1
Part B: Liraglutide	10	2	0
Part B: Placebo	2	3	0

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Number of Participants With Change in ECG From Baseline at Week 52

A 12-lead ECG was performed at baseline (week 0) and week 52 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and week 52 are presented. (NCT02527200)
Timeframe: Week 0, Week 52

,,,,,

Intervention	Participants (Count of Participants)
	Week 0: Normal	Week 0: Abnormal, NCS	Week 0: Abnormal, CS	Week 52: Normal	Week 52: Abnormal, NCS	Week 52: Abnormal, CS
Part A: Liraglutide	20	0	0	17	1	0
Part A: Placebo	12	0	0	9	1	0
Part A+B: Liraglutide	37	0	0	30	1	0
Part A+B: Placebo	18	1	0	13	1	0
Part B: Liraglutide	17	0	0	13	0	0
Part B: Placebo	6	1	0	4	0	0

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Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16

A 12-lead ECG was performed at baseline (week 0) and week 16 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and weeks 16 are presented. (NCT02527200)
Timeframe: Week 0, Week 16

,,,,,

Intervention	Participants (Count of Participants)
	Week 0: Normal	Week 0: Abnormal, NCS	Week 0: Abnormal, CS	Week 16: Normal	Week 16: Abnormal, NCS	Week 16: Abnormal, CS
Part A: Liraglutide	20	0	0	17	0	0
Part A: Placebo	12	0	0	12	0	0
Part A+B: Liraglutide	37	0	0	30	1	0
Part A+B: Placebo	18	1	0	19	0	0
Part B: Liraglutide	17	0	0	13	1	0
Part B: Placebo	6	1	0	7	0	0

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Number of Participants With Occurrence of Anti-liraglutide Antibodies

Number of participants with occurrence of anti-liraglutide antibodies is presented. In the below table, 'Yes' infers number of participants with occurrence of anti- liraglutide antibodies and 'No' infers number of participants without anti- liraglutide antibodies. (NCT02527200)
Timeframe: From week 0 to week 54

Intervention	Participants (Count of Participants)
	Yes	No
Part A: Liraglutide	2	14
Part A+B: Liraglutide	3	22
Part B: Liraglutide	1	8

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Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16

"C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is yes for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is yes for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with suicidal ideation or suicidal behaviour on C-SSRS assessed at baseline (week 0), week 16. The questionnaire was not used in Part B due to the young age of the participants in Part B." (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Participants (Count of Participants)
	Week 0: Suicidal ideation	Week 0: Suicidal behaviour	Week 16: Suicidal ideation	Week 16: Suicidal behaviour
Part A: Liraglutide	1	0	1	0
Part A: Placebo	3	0	1	0

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Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52

"C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is yes for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is yes for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with suicidal ideation or suicidal behaviour on C-SSRS assessed at baseline (week 0), week 52. The questionnaire was not used in Part B due to the young age of the participants in Part B." (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Participants (Count of Participants)
	Week 0: Suicidal ideation	Week 0: Suicidal behaviour	Week 52: Suicidal ideation	Week 52: Suicidal behaviour
Part A: Liraglutide	1	0	1	0
Part A: Placebo	3	0	0	0

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Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16

Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 16. (NCT02527200)
Timeframe: At week 16

,,,,,

Intervention	Percentage of participants (Number)
	Yes	No
Part A: Liraglutide	0	100
Part A: Placebo	0	100
Part A+B: Liraglutide	2.9	97.1
Part A+B: Placebo	5.3	94.7
Part B: Liraglutide	6.3	93.8
Part B: Placebo	14.3	85.7

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Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52

Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 52. (NCT02527200)
Timeframe: At week 52

,,,,,

Intervention	Percentage of participants (Number)
	Yes	No
Part A: Liraglutide	11.8	88.2
Part A: Placebo	0	100
Part A+B: Liraglutide	12.9	87.1
Part A+B: Placebo	11.1	88.9
Part B: Liraglutide	14.3	85.7
Part B: Placebo	28.6	71.4

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Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16

Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 16. (NCT02527200)
Timeframe: At week 16

,,,,,

Intervention	Percentage of participants (Number)
	Yes	No
Part A: Liraglutide	27.8	72.2
Part A: Placebo	8.3	91.7
Part A+B: Liraglutide	32.4	67.6
Part A+B: Placebo	26.3	73.7
Part B: Liraglutide	37.5	62.5
Part B: Placebo	57.1	42.9

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Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52

Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 52. (NCT02527200)
Timeframe: At week 52

,,,,,

Intervention	Percentage of participants (Number)
	Yes	No
Part A: Liraglutide	29.4	70.6
Part A: Placebo	18.2	81.8
Part A+B: Liraglutide	32.3	67.7
Part A+B: Placebo	27.8	72.2
Part B: Liraglutide	35.7	64.3
Part B: Placebo	42.9	57.1

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Percentage of Participants With no Increase in BMI SDS at Week 16

Percentage of participants with no increase in BMI SDS at week 16 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 16 and 'No' infers percentage of participants with increase in BMI SDS at week 16. (NCT02527200)
Timeframe: At week 16

,,,,,

Intervention	Percentage of participants (Number)
	Yes	No
Part A: Liraglutide	66.7	33.3
Part A: Placebo	75.0	25.0
Part A+B: Liraglutide	76.5	23.5
Part A+B: Placebo	84.2	15.8
Part B: Liraglutide	87.5	12.5
Part B: Placebo	100	0

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Percentage of Participants With no Increase in BMI SDS at Week 52

Percentage of participants with no increase in BMI SDS at week 52 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 52 and 'No' infers percentage of participants with increase in BMI SDS at week 52. (NCT02527200)
Timeframe: At week 52

,,,,,

Intervention	Percentage of participants (Number)
	Yes	No
Part A: Liraglutide	70.6	29.4
Part A: Placebo	72.7	27.3
Part A+B: Liraglutide	73.3	26.7
Part A+B: Placebo	81.3	18.8
Part B: Liraglutide	78.6	21.4
Part B: Placebo	100	0

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Number of Participants With Change in Physical Examination From Baseline at Week 16

"This outcome measure presents number of participants with physical examination findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) at baseline (week 0), week 16. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation." (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Participants (Count of Participants)
	General Appearance: Week 072474036			General Appearance: Week 072474037	General Appearance: Week 072474038	General Appearance: Week 072474040	General Appearance: Week 072474041	General Appearance: Week 072474039	General Appearance: Week 1672474036	General Appearance: Week 1672474037	General Appearance: Week 1672474038	General Appearance: Week 1672474039	General Appearance: Week 1672474040	General Appearance: Week 1672474041	Head, ears, eyes, nose, throat, neck: Week 072474036	Head, ears, eyes, nose, throat, neck: Week 072474037	Head, ears, eyes, nose, throat, neck: Week 072474041	Head, ears, eyes, nose, throat, neck: Week 072474038	Head, ears, eyes, nose, throat, neck: Week 072474039	Head, ears, eyes, nose, throat, neck: Week 072474040	Head, ears, eyes, nose, throat, neck: Week 1672474036	Head, ears, eyes, nose, throat, neck: Week 1672474037	Head, ears, eyes, nose, throat, neck: Week 1672474038	Head, ears, eyes, nose, throat, neck: Week 1672474041	Head, ears, eyes, nose, throat, neck: Week 1672474039	Head, ears, eyes, nose, throat, neck: Week 1672474040	Respiratory system: Week 072474038	Respiratory system: Week 072474039	Respiratory system: Week 072474040	Respiratory system: Week 072474041	Respiratory system: Week 072474036	Respiratory system: Week 072474037	Respiratory system: Week 1672474036	Respiratory system: Week 1672474038	Respiratory system: Week 1672474041	Respiratory system: Week 1672474039	Respiratory system: Week 1672474037	Respiratory system: Week 1672474040	Cardiovascular system: Week 072474036	Cardiovascular system: Week 072474037	Cardiovascular system: Week 072474038	Cardiovascular system: Week 072474041	Cardiovascular system: Week 072474040	Cardiovascular system: Week 072474039	Cardiovascular system: Week 1672474037	Cardiovascular system: Week 1672474038	Cardiovascular system: Week 1672474041	Cardiovascular system: Week 1672474036	Cardiovascular system: Week 1672474039	Cardiovascular system: Week 1672474040	GI system including mouth: Week 072474036	GI system including mouth: Week 072474037	GI system including mouth: Week 072474038	GI system including mouth: Week 072474039	GI system including mouth: Week 072474040	GI system including mouth: Week 072474041	GI system including mouth: Week 1672474036	GI system including mouth: Week 1672474039	GI system including mouth: Week 1672474041	GI system including mouth: Week 1672474037	GI system including mouth: Week 1672474038	GI system including mouth: Week 1672474040	Musculoskeletal system: Week 072474036	Musculoskeletal system: Week 072474040	Musculoskeletal system: Week 072474041	Musculoskeletal system: Week 072474038	Musculoskeletal system: Week 072474039	Musculoskeletal system: Week 072474037	Musculoskeletal system: Week 1672474038	Musculoskeletal system: Week 1672474039	Musculoskeletal system: Week 1672474040	Musculoskeletal system: Week 1672474041	Musculoskeletal system: Week 1672474037	Musculoskeletal system: Week 1672474036	CNS and PNS: Week 072474036	CNS and PNS: Week 072474037	CNS and PNS: Week 072474038	CNS and PNS: Week 072474041	CNS and PNS: Week 072474039	CNS and PNS: Week 072474040	CNS and PNS: Week 1672474040	CNS and PNS: Week 1672474041	CNS and PNS: Week 1672474039	CNS and PNS: Week 1672474036	CNS and PNS: Week 1672474037	CNS and PNS: Week 1672474038	Skin: Week 072474036	Skin: Week 072474037	Skin: Week 072474038	Skin: Week 072474039	Skin: Week 072474040	Skin: Week 072474041	Skin: Week 1672474036	Skin: Week 1672474037	Skin: Week 1672474038	Skin: Week 1672474039	Skin: Week 1672474040	Skin: Week 1672474041	Thyroid gland: Week 072474037	Thyroid gland: Week 072474038	Thyroid gland: Week 072474039	Thyroid gland: Week 072474040	Thyroid gland: Week 072474036	Thyroid gland: Week 072474041	Thyroid gland: Week 1672474036	Thyroid gland: Week 1672474038	Thyroid gland: Week 1672474040	Thyroid gland: Week 1672474037	Thyroid gland: Week 1672474039	Thyroid gland: Week 1672474041	Lymph node palpation: Week 072474036	Lymph node palpation: Week 072474038	Lymph node palpation: Week 072474040	Lymph node palpation: Week 072474041	Lymph node palpation: Week 072474037	Lymph node palpation: Week 072474039	Lymph node palpation: Week 1672474037	Lymph node palpation: Week 1672474040	Lymph node palpation: Week 1672474036	Lymph node palpation: Week 1672474038	Lymph node palpation: Week 1672474039	Lymph node palpation: Week 1672474041
	Normal	Abnormal, NCS	Abnormal, CS
Part A: Liraglutide	14
Part B: Liraglutide	12
Part B: Placebo	5
Part A+B: Liraglutide	26
Part A+B: Placebo	15
Part B: Liraglutide	3
Part A+B: Liraglutide	5
Part A: Liraglutide	4
Part B: Liraglutide	2
Part A+B: Liraglutide	6
Part B: Liraglutide	11
Part A+B: Liraglutide	25
Part B: Liraglutide	4
Part A+B: Liraglutide	4
Part A+B: Liraglutide	34
Part A+B: Placebo	3
Part A: Liraglutide	20
Part B: Liraglutide	16
Part A: Liraglutide	19
Part A: Placebo	12
Part B: Liraglutide	17
Part B: Placebo	7
Part A+B: Liraglutide	36
Part A+B: Placebo	19
Part A: Liraglutide	1
Part A: Placebo	0
Part B: Liraglutide	0
Part A+B: Liraglutide	1
Part A+B: Placebo	0
Part A: Liraglutide	0
Part A+B: Liraglutide	0
Part A: Liraglutide	18
Part B: Liraglutide	15
Part A+B: Liraglutide	33
Part A: Liraglutide	17
Part A+B: Liraglutide	32
Part A: Placebo	9
Part A: Liraglutide	3
Part A+B: Liraglutide	27
Part A: Liraglutide	16
Part A: Placebo	10
Part B: Placebo	6
Part A+B: Liraglutide	31
Part A+B: Placebo	16
Part B: Liraglutide	1
Part B: Placebo	1
Part A+B: Placebo	1
Part A: Liraglutide	2
Part A: Placebo	2
Part A+B: Liraglutide	3
Part A+B: Placebo	2
Part A: Liraglutide	15
Part A: Placebo	11
Part B: Liraglutide	14
Part A+B: Liraglutide	29
Part A+B: Placebo	18
Part A: Placebo	1
Part A+B: Liraglutide	2
Part A: Liraglutide	11
Part A: Placebo	7
Part B: Liraglutide	10
Part A+B: Liraglutide	21
Part A+B: Placebo	13
Part A: Liraglutide	6
Part A: Placebo	4
Part B: Liraglutide	6
Part A+B: Liraglutide	12
Part A+B: Placebo	5
Part A: Liraglutide	12
Part A: Placebo	8
Part A+B: Liraglutide	22
Part A+B: Placebo	14
Part A: Liraglutide	5
Part A: Placebo	3
Part B: Liraglutide	5
Part A+B: Liraglutide	10
Part A+B: Liraglutide	37
Part B: Placebo	0

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Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52

Change in HOMA-IR from baseline to week 52 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Ratio of HOMA-IR (Mean)
Part A: Liraglutide	2.26
Part A: Placebo	0.88
Part B: Liraglutide	1.45
Part B: Placebo	1.24
Part A+B: Liraglutide	1.90
Part A+B: Placebo	1.02

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Change in Pulse From Baseline at Week 52

Change in pulse from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Beats/minute (Mean)
Part A: Liraglutide	1
Part A: Placebo	-8
Part B: Liraglutide	10
Part B: Placebo	-6
Part A+B: Liraglutide	5
Part A+B: Placebo	-7

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Number of Participants With Change in Pubertal Status From Baseline at Week 52

"This outcome measure presents pubertal status results which is based on Tanner staging recorded at baseline (week 0) and week 52. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents early pubertal development and stage 5 represents pubertal development equivalent to that of an adult." (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Participants (Count of Participants)
	Week 0: Breast development (for female)72474040					Week 0: Breast development (for female)72474041	Week 0: Breast development (for female)72474039	Week 0: Breast development (for female)72474036	Week 0: Breast development (for female)72474037	Week 0: Breast development (for female)72474038	Week 52: Breast development (for female)72474039	Week 52: Breast development (for female)72474036	Week 52: Breast development (for female)72474041	Week 52: Breast development (for female)72474040	Week 52: Breast development (for female)72474037	Week 52: Breast development (for female)72474038	Week 0: Pubic hair development (for female)72474039	Week 0: Pubic hair development (for female)72474040	Week 0: Pubic hair development (for female)72474041	Week 0: Pubic hair development (for female)72474038	Week 0: Pubic hair development (for female)72474036	Week 0: Pubic hair development (for female)72474037	Week 52: Pubic hair development (for female)72474038	Week 52: Pubic hair development (for female)72474039	Week 52: Pubic hair development (for female)72474040	Week 52: Pubic hair development (for female)72474041	Week 52: Pubic hair development (for female)72474036	Week 52: Pubic hair development (for female)72474037	Week 0: Pubic hair development (for male)72474039	Week 0: Pubic hair development (for male)72474041	Week 0: Pubic hair development (for male)72474037	Week 0: Pubic hair development (for male)72474038	Week 0: Pubic hair development (for male)72474036	Week 0: Pubic hair development (for male)72474040	Week 52: Pubic hair development (for male)72474036	Week 52: Pubic hair development (for male)72474039	Week 52: Pubic hair development (for male)72474040	Week 52: Pubic hair development (for male)72474041	Week 52: Pubic hair development (for male)72474037	Week 52: Pubic hair development (for male)72474038	Week 0: Penis development (for male)72474040	Week 0: Penis development (for male)72474039	Week 0: Penis development (for male)72474036	Week 0: Penis development (for male)72474037	Week 0: Penis development (for male)72474038	Week 0: Penis development (for male)72474041	Week 52: Penis development (for male)72474039	Week 52: Penis development (for male)72474040	Week 52: Penis development (for male)72474036	Week 52: Penis development (for male)72474037	Week 52: Penis development (for male)72474038	Week 52: Penis development (for male)72474041
	Stage 3	Stage 4	Stage 5	Stage 1	Stage 2
Part B: Liraglutide	11
Part A+B: Liraglutide	11
Part A+B: Placebo	2
Part A+B: Liraglutide	1
Part A+B: Placebo	0
Part A: Liraglutide	8
Part B: Placebo	0
Part A+B: Liraglutide	8
Part A+B: Liraglutide	0
Part A+B: Placebo	1
Part A+B: Liraglutide	2
Part A: Liraglutide	5
Part B: Placebo	1
Part A+B: Liraglutide	7
Part A+B: Liraglutide	5
Part B: Liraglutide	1
Part A: Liraglutide	1
Part B: Liraglutide	2
Part A: Liraglutide	3
Part A: Liraglutide	2
Part B: Liraglutide	6
Part B: Placebo	3
Part A: Placebo	4
Part A+B: Placebo	5
Part A: Liraglutide	0
Part B: Liraglutide	4
Part A: Placebo	0
Part A: Placebo	2
Part A: Placebo	3
Part A+B: Placebo	4
Part A: Placebo	1
Part B: Liraglutide	0
Part B: Placebo	5
Part A+B: Liraglutide	6
Part A+B: Placebo	6
Part A: Liraglutide	4
Part A+B: Liraglutide	4
Part A+B: Placebo	3
Part A+B: Liraglutide	3
Part B: Liraglutide	3
Part B: Placebo	2

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Number of Participants With Change in Physical Examination From Baseline at Week 52

"This outcome measure presents number of participants with physical examination findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) at baseline (week 0) and week 52. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation." (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Participants (Count of Participants)
	General Appearance: Week 072474036			General Appearance: Week 072474037	General Appearance: Week 072474038	General Appearance: Week 072474039	General Appearance: Week 072474041	General Appearance: Week 072474040	General Appearance: Week 5272474036	General Appearance: Week 5272474037	General Appearance: Week 5272474038	General Appearance: Week 5272474039	General Appearance: Week 5272474040	General Appearance: Week 5272474041	Head, ears, eyes, nose, throat, neck: Week 072474040	Head, ears, eyes, nose, throat, neck: Week 072474041	Head, ears, eyes, nose, throat, neck: Week 072474037	Head, ears, eyes, nose, throat, neck: Week 072474036	Head, ears, eyes, nose, throat, neck: Week 072474038	Head, ears, eyes, nose, throat, neck: Week 072474039	Head, ears, eyes, nose, throat, neck: Week 5272474037	Head, ears, eyes, nose, throat, neck: Week 5272474039	Head, ears, eyes, nose, throat, neck: Week 5272474041	Head, ears, eyes, nose, throat, neck: Week 5272474036	Head, ears, eyes, nose, throat, neck: Week 5272474038	Head, ears, eyes, nose, throat, neck: Week 5272474040	Respiratory system: Week 072474037	Respiratory system: Week 072474038	Respiratory system: Week 072474040	Respiratory system: Week 072474041	Respiratory system: Week 072474036	Respiratory system: Week 072474039	Cardiovascular system: Week 072474036	Cardiovascular system: Week 072474038	Cardiovascular system: Week 072474040	Cardiovascular system: Week 072474039	Cardiovascular system: Week 072474037	Cardiovascular system: Week 072474041	Cardiovascular system: Week 5272474037	Cardiovascular system: Week 5272474038	Cardiovascular system: Week 5272474040	Cardiovascular system: Week 5272474041	Cardiovascular system: Week 5272474036	Cardiovascular system: Week 5272474039	GI system including mouth: Week 072474036	GI system including mouth: Week 072474037	GI system including mouth: Week 072474038	GI system including mouth: Week 072474040	GI system including mouth: Week 072474041	GI system including mouth: Week 072474039	GI system including mouth: Week 5272474036	GI system including mouth: Week 5272474037	GI system including mouth: Week 5272474038	GI system including mouth: Week 5272474039	GI system including mouth: Week 5272474041	GI system including mouth: Week 5272474040	Musculoskeletal system: Week 072474037	Musculoskeletal system: Week 072474038	Musculoskeletal system: Week 072474039	Musculoskeletal system: Week 072474036	Musculoskeletal system: Week 072474040	Musculoskeletal system: Week 072474041	Musculoskeletal system: Week 5272474036	Musculoskeletal system: Week 5272474037	Musculoskeletal system: Week 5272474038	Musculoskeletal system: Week 5272474040	Musculoskeletal system: Week 5272474039	Musculoskeletal system: Week 5272474041	CNS and PNS: Week 072474037	CNS and PNS: Week 072474041	CNS and PNS: Week 072474038	CNS and PNS: Week 072474036	CNS and PNS: Week 072474039	CNS and PNS: Week 072474040	CNS and PNS: Week 5272474036	CNS and PNS: Week 5272474041	CNS and PNS: Week 5272474039	CNS and PNS: Week 5272474040	CNS and PNS: Week 5272474037	CNS and PNS: Week 5272474038	Skin: Week 072474036	Skin: Week 072474040	Skin: Week 072474041	Skin: Week 072474037	Skin: Week 072474038	Skin: Week 072474039	Skin: Week 5272474036	Skin: Week 5272474037	Skin: Week 5272474038	Skin: Week 5272474039	Skin: Week 5272474040	Skin: Week 5272474041	Thyroid gland: Week 072474036	Thyroid gland: Week 072474037	Thyroid gland: Week 072474039	Thyroid gland: Week 072474040	Thyroid gland: Week 072474038	Thyroid gland: Week 072474041	Thyroid gland: Week 5272474036	Thyroid gland: Week 5272474037	Thyroid gland: Week 5272474038	Thyroid gland: Week 5272474039	Thyroid gland: Week 5272474040	Thyroid gland: Week 5272474041	Lymph node palpation: Week 072474036	Lymph node palpation: Week 072474038	Lymph node palpation: Week 072474039	Lymph node palpation: Week 072474040	Lymph node palpation: Week 072474041	Lymph node palpation: Week 072474037	Lymph node palpation: Week 5272474039	Lymph node palpation: Week 5272474036	Lymph node palpation: Week 5272474037	Lymph node palpation: Week 5272474038	Lymph node palpation: Week 5272474040	Lymph node palpation: Week 5272474041
	Normal	Abnormal, NCS	Abnormal, CS
Part A: Liraglutide	14
Part A+B: Liraglutide	26
Part B: Liraglutide	3
Part A+B: Liraglutide	5
Part A: Liraglutide	4
Part B: Liraglutide	2
Part A+B: Liraglutide	6
Part B: Liraglutide	9
Part A+B: Liraglutide	22
Part A: Liraglutide	3
Part A+B: Liraglutide	4
Part A+B: Liraglutide	34
Part A+B: Placebo	3
Part A: Liraglutide	15
Part A+B: Liraglutide	27
Part A+B: Liraglutide	2
Part A: Liraglutide	20
Part B: Liraglutide	16
Part A: Liraglutide	19
Part A: Placebo	12
Part B: Liraglutide	17
Part A+B: Liraglutide	36
Part A+B: Placebo	19
Part A: Liraglutide	1
Part B: Liraglutide	0
Part A+B: Liraglutide	1
Part A: Liraglutide	0
Part A: Placebo	0
Part A+B: Liraglutide	0
Part A+B: Placebo	0
Part A: Liraglutide	17
Part B: Liraglutide	12
Part A+B: Liraglutide	29
Part A+B: Placebo	15
Part A: Placebo	1
Part A+B: Placebo	1
Part A: Placebo	11
Part A+B: Liraglutide	28
Part A: Placebo	9
Part B: Liraglutide	14
Part A: Placebo	10
Part B: Liraglutide	10
Part A+B: Liraglutide	25
Part A: Liraglutide	16
Part B: Liraglutide	15
Part B: Placebo	6
Part A+B: Liraglutide	31
Part A+B: Placebo	16
Part B: Liraglutide	1
Part B: Placebo	1
Part A: Liraglutide	2
Part A: Placebo	2
Part A+B: Liraglutide	3
Part A+B: Placebo	2
Part A: Liraglutide	13
Part B: Liraglutide	11
Part B: Placebo	4
Part A+B: Liraglutide	24
Part A+B: Placebo	14
Part A: Liraglutide	11
Part A: Placebo	7
Part A+B: Liraglutide	21
Part A+B: Placebo	13
Part A: Liraglutide	6
Part A: Placebo	4
Part B: Liraglutide	6
Part A+B: Liraglutide	12
Part A+B: Placebo	5
Part A: Placebo	8
Part A+B: Placebo	12
Part B: Placebo	7
Part A+B: Liraglutide	37
Part B: Placebo	0
Part B: Placebo	5

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Change in Biochemistry: Albumin From Baseline at Week 16

Change in albumin from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	gram per deciliter (g/dL) (Mean)
Part A: Liraglutide	0
Part A: Placebo	0
Part B: Liraglutide	0
Part B: Placebo	0
Part A+B: Liraglutide	0
Part A+B: Placebo	0

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Change in Biochemistry: Albumin From Baseline at Week 52

Change in albumin from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	g/dL (Mean)
Part A: Liraglutide	-0.1
Part A: Placebo	-0.1
Part B: Liraglutide	0
Part B: Placebo	0
Part A+B: Liraglutide	0
Part A+B: Placebo	-0.1

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Change in BMI From Baseline at Week 16

Change in body mass index (BMI) from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	kilogram per meter square (kg/m^2) (Mean)
Part A: Liraglutide	-0.9
Part A: Placebo	-0.8
Part B: Liraglutide	-1.1
Part B: Placebo	-1.5
Part A+B: Liraglutide	-1.0
Part A+B: Placebo	-1.1

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Change in BMI From Baseline at Week 52

Change in body mass index (BMI) from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	kg/m^2 (Mean)
Part A: Liraglutide	0.8
Part A: Placebo	-0.1
Part B: Liraglutide	-0.6
Part B: Placebo	-0.7
Part A+B: Liraglutide	-0.7
Part A+B: Placebo	-0.4

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Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks

Change in BMI SDS from baseline to week 16 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=[(y / M)^L - 1] / S*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial. (NCT02527200)
Timeframe: Week 0, Week 16

Intervention	SDS score (Mean)
Part A: Liraglutide	-0.18
Part A: Placebo	-0.18
Part B: Liraglutide	-0.50
Part B: Placebo	-0.48
Part A+B: Liraglutide	-0.33
Part A+B: Placebo	-0.29

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Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks

Change in BMI SDS from baseline to week 52 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=[(y / M)^L - 1] / S*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial. (NCT02527200)
Timeframe: Week 0, Week 52

Intervention	SDS score (Mean)
Part A: Liraglutide	-0.27
Part A: Placebo	-0.13
Part B: Liraglutide	-0.79
Part B: Placebo	-0.71
Part A+B: Liraglutide	-0.50
Part A+B: Placebo	-0.36

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Change in Body Weight (%) From Baseline at Week 52

Change in body weight (%) from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Percent change in body weight (Mean)
Part A: Liraglutide	-0.4
Part A: Placebo	2.3
Part B: Liraglutide	6.3
Part B: Placebo	4.9
Part A+B: Liraglutide	2.6
Part A+B: Placebo	3.3

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Change in Body Weight (kg) From Baseline at Week 52

Change in body weight (kg) from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	kilogram (Mean)
Part A: Liraglutide	-0.4
Part A: Placebo	1.9
Part B: Liraglutide	3.0
Part B: Placebo	2.8
Part A+B: Liraglutide	1.1
Part A+B: Placebo	2.3

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Change in Body Weight (Kilogram (kg)) From Baseline at Week 16

Change in body weight (kg) from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	(kilogram (kg)) (Mean)
Part A: Liraglutide	-1.7
Part A: Placebo	-1.1
Part B: Liraglutide	-0.6
Part B: Placebo	-1.0
Part A+B: Liraglutide	-1.2
Part A+B: Placebo	-1.0

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Change in Body Weight (lb) From Baseline at Week 52

Change in body weight (lb) from baseline to week 52 is presented. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	pounds (Mean)
Part A: Liraglutide	-0.9
Part A: Placebo	4.3
Part B: Liraglutide	6.7
Part B: Placebo	6.2
Part A+B: Liraglutide	2.5
Part A+B: Placebo	5.0

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Change in Body Weight (Percentage [%]) From Baseline at Week 16

Change in body weight (%) from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Percent change in body weight (Mean)
Part A: Liraglutide	-1.7
Part A: Placebo	-0.7
Part B: Liraglutide	-1.1
Part B: Placebo	-2.2
Part A+B: Liraglutide	-1.4
Part A+B: Placebo	-1.2

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Change in Body Weight (Pounds (lb)) From Baseline at Week 16

Change in body weight (lb) from baseline to week 16 is presented. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	pounds (lb) (Mean)
Part A: Liraglutide	-3.7
Part A: Placebo	-2.4
Part B: Liraglutide	-1.4
Part B: Placebo	-2.1
Part A+B: Liraglutide	-2.6
Part A+B: Placebo	-2.3

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Change in Fasting C Peptide From Baseline at Week 16

Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 16 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Ratio of fasting C peptide (Mean)
Part A: Liraglutide	1.14
Part A: Placebo	0.86
Part B: Liraglutide	1.11
Part B: Placebo	1.08
Part A+B: Liraglutide	1.13
Part A+B: Placebo	0.94

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Change in Fasting C Peptide From Baseline at Week 52

Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 52 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Ratio of fasting C peptide (Mean)
Part A: Liraglutide	1.34
Part A: Placebo	0.91
Part B: Liraglutide	1.15
Part B: Placebo	1.09
Part A+B: Liraglutide	1.26
Part A+B: Placebo	0.98

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Change in Fasting Insulin From Baseline at Week 16

Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 16 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Ratio of fasting insulin (Mean)
Part A: Liraglutide	1.59
Part A: Placebo	0.78
Part B: Liraglutide	1.43
Part B: Placebo	1.32
Part A+B: Liraglutide	1.52
Part A+B: Placebo	0.97

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Change in Fasting Insulin From Baseline at Week 52

Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 52 is presented as ratio to baseline. (NCT02527200)
Timeframe: Week 0, week 52

Intervention	Ratio of fasting insulin (Mean)
Part A: Liraglutide	2.03
Part A: Placebo	0.79
Part B: Liraglutide	1.45
Part B: Placebo	1.22
Part A+B: Liraglutide	1.78
Part A+B: Placebo	0.96

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Number of Participants With Change in Pubertal Status From Baseline at Week 16

"This outcome measure presents pubertal status results which is based on Tanner staging recorded at baseline (week 0), week 16. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents early pubertal development and stage 5 represents pubertal development equivalent to that of an adult." (NCT02527200)
Timeframe: Week 0, week 16

Intervention	Participants (Count of Participants)
	Week 0: Breast development (for female)72474036					Week 0: Breast development (for female)72474037	Week 0: Breast development (for female)72474038	Week 0: Breast development (for female)72474039	Week 0: Breast development (for female)72474040	Week 0: Breast development (for female)72474041	Week 16: Breast development (for female)72474037	Week 16: Breast development (for female)72474036	Week 16: Breast development (for female)72474039	Week 16: Breast development (for female)72474038	Week 16: Breast development (for female)72474040	Week 16: Breast development (for female)72474041	Week 0: Pubic hair development (for female)72474036	Week 0: Pubic hair development (for female)72474037	Week 0: Pubic hair development (for female)72474038	Week 0: Pubic hair development (for female)72474039	Week 0: Pubic hair development (for female)72474040	Week 0: Pubic hair development (for female)72474041	Week 16: Pubic hair development (for female)72474036	Week 16: Pubic hair development (for female)72474041	Week 16: Pubic hair development (for female)72474037	Week 16: Pubic hair development (for female)72474038	Week 16: Pubic hair development (for female)72474039	Week 16: Pubic hair development (for female)72474040	Week 0: Pubic hair development (for male)72474037	Week 0: Pubic hair development (for male)72474038	Week 0: Pubic hair development (for male)72474039	Week 0: Pubic hair development (for male)72474036	Week 0: Pubic hair development (for male)72474040	Week 0: Pubic hair development (for male)72474041	Week 16: Pubic hair development (for male)72474036	Week 16: Pubic hair development (for male)72474041	Week 16: Pubic hair development (for male)72474037	Week 16: Pubic hair development (for male)72474040	Week 16: Pubic hair development (for male)72474038	Week 16: Pubic hair development (for male)72474039	Week 0: Penis development (for male)72474036	Week 0: Penis development (for male)72474037	Week 0: Penis development (for male)72474041	Week 0: Penis development (for male)72474040	Week 0: Penis development (for male)72474038	Week 0: Penis development (for male)72474039	Week 16: Penis development (for male)72474036	Week 16: Penis development (for male)72474037	Week 16: Penis development (for male)72474038	Week 16: Penis development (for male)72474039	Week 16: Penis development (for male)72474040	Week 16: Penis development (for male)72474041
	Stage 2	Stage 3	Stage 1	Stage 4	Stage 5
Part A: Liraglutide	0
Part A: Placebo	0
Part B: Liraglutide	11
Part A+B: Liraglutide	11
Part A: Liraglutide	1
Part A: Liraglutide	8
Part A: Placebo	2
Part A+B: Liraglutide	8
Part A: Placebo	1
Part A+B: Liraglutide	0
Part A: Liraglutide	2
Part B: Placebo	2
Part A+B: Liraglutide	4
Part A: Liraglutide	7
Part A+B: Liraglutide	7
Part B: Liraglutide	2
Part A+B: Liraglutide	5
Part B: Liraglutide	3
Part B: Liraglutide	5
Part A+B: Placebo	0
Part B: Liraglutide	1
Part A+B: Liraglutide	6
Part A+B: Liraglutide	3
Part A: Placebo	4
Part A+B: Placebo	5
Part A+B: Liraglutide	2
Part B: Liraglutide	6
Part A+B: Placebo	1
Part B: Placebo	3
Part A+B: Placebo	3
Part B: Placebo	1
Part A+B: Placebo	4
Part B: Liraglutide	0
Part B: Placebo	0
Part A+B: Placebo	2
Part A: Liraglutide	4
Part A: Placebo	3
Part A+B: Liraglutide	1
Part A: Liraglutide	3
Part B: Placebo	5
Part A+B: Placebo	6

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Change in SMBG 9-point Profile - Mean of the 9-point Profile

Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. Mean of the 9-point profile was defined as the area under the profile (calculated using the trapezoidal method) divided by the measurement time. (NCT02607306)
Timeframe: Week 0, week 52

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	-4.60
Insulin Degludec	-3.84
Liraglutide	-3.46

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Plasma Concentrations of Liraglutide

Samples from the IDegLira and liraglutide arms were assayed for plasma concentrations of liraglutide using validated ELISA assays. (NCT02607306)
Timeframe: Weeks 2, 8, 16, 26, 44, 52

Intervention	pmol/L (Geometric Mean)
	At week 2	At week 8	At week 16	At week 26	At week 44	At week 52
Insulin Degludec/Liraglutide	5681.3	9107.8	10038.1	9995.3	8791.7	7426.2
Liraglutide	6081.6	14539.5	14046.5	13904.2	12855.6	12127.4

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Responder (Yes/no): HbA1c Less Than 6.5%

Number of subjects with HbA1c less than 6.5% after 52 weeks of treatment. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	134	137
Insulin Degludec/Liraglutide	213	62
Liraglutide	171	102

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Proinsulin as a Ratio to Baseline at 52 Weeks

Proinsulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Ratio (Geometric Mean)
Insulin Degludec/Liraglutide	0.18
Insulin Degludec	0.17
Liraglutide	0.59

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Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

"Number of subjects with HbA1c less than 6.5% with no weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	17	248
Insulin Degludec/Liraglutide	35	235
Liraglutide	125	146

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Total Cholesterol as a Ratio to Baseline at 52 Weeks

Total cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Ratio (Geometric Mean)
Insulin Degludec/Liraglutide	0.92
Insulin Degludec	0.97
Liraglutide	0.94

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Responder (Yes/no): HbA1c Less Than 7.0%

Number of subjects with HbA1c less than 7.0% after 52 weeks of treatment. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	189	82
Insulin Degludec/Liraglutide	245	30
Liraglutide	208	65

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Change in Waist Circumference

Change from baseline (week 0) in waist circumference after 52 weeks of treatment. (NCT02607306)
Timeframe: Week 0, Week 52

Intervention	Cm (Mean)
Insulin Degludec/Liraglutide	2.5
Insulin Degludec	3.4
Liraglutide	-1.1

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Fasting C-peptide as a Ratio to Baseline at 52 Weeks

Fasting C-peptide after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Ratio (Geometric Mean)
Insulin Degludec/Liraglutide	0.61
Insulin Degludec	0.42
Liraglutide	1.12

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Fasting Glucagon as a Ratio to Baseline at 52 Weeks

Fasting glucagon after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Ratio (Geometric Mean)
Insulin Degludec/Liraglutide	0.95
Insulin Degludec	0.94
Liraglutide	0.96

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Fasting Human Insulin as a Ratio to Baseline at 52 Weeks

Fasting human insulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Ratio (Geometric Mean)
Insulin Degludec/Liraglutide	0.90
Insulin Degludec	0.61
Liraglutide	1.52

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Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.

"Number of subjects with HbA1c less than 6.5% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	123	142
Insulin Degludec/Liraglutide	198	72
Liraglutide	170	101

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Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero

Number of subjects with HbA1c less than 6.5% and without weight gain after 52 weeks of treatment. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	17	254
Insulin Degludec/Liraglutide	41	234
Liraglutide	126	147

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Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero

Number of subjects with HbA1c less than 7.0% and without weight gain after 52 weeks of treatment. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	22	249
Insulin Degludec/Liraglutide	44	231
Liraglutide	142	131

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Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

"Number of subjects with HbA1c less than 7.0% and without weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	22	243
Insulin Degludec/Liraglutide	37	233
Liraglutide	141	130

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Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.

"Number of subjects with HbA1c less than 7.0% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	169	96
Insulin Degludec/Liraglutide	227	43
Liraglutide	206	65

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Free Fatty Acids as a Ratio to Baseline at 52 Weeks

Free fatty acids after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Ratio (Geometric Mean)
Insulin Degludec/Liraglutide	0.74
Insulin Degludec	0.70
Liraglutide	0.93

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Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT02607306)
Timeframe: 0-52 weeks

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	135
Insulin Degludec	362
Liraglutide	136

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Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)

Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. (NCT02607306)
Timeframe: After 52 weeks of the treatment

Intervention	mmol/L (Mean)
	Before breakfast	90 minutes after start of breakfast	Before lunch	90 minutes after start of lunch	Before dinner	90 minutes after start of dinner	Bedtime	At 4:00 a.m.	Before breakfast the following day
Insulin Degludec	5.93	10.43	6.72	11.12	6.90	10.89	9.49	6.41	5.71
Insulin Degludec/Liraglutide	5.90	9.57	6.01	9.85	6.47	9.67	8.27	6.12	5.77
Liraglutide	7.35	10.59	6.87	10.59	7.03	10.14	8.73	7.27	7.13

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Serum Concentrations of Insulin Degludec

Samples from the IDegLira and IDeg arms were analysed for serum concentrations of insulin degludec using validated ELISA assays. (NCT02607306)
Timeframe: Weeks 2, 8, 16, 26, 44, 52

Intervention	pmol/L (Geometric Mean)
	At week 2	At week 8	At week 16	At week 26	At week 44	At week 52
Insulin Degludec	1477.1	2524.6	2856.4	2946.9	3238.8	3124.4
Insulin Degludec/Liraglutide	1468.7	2246.0	2511.0	2597.3	2766.6	2393.8

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Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)

Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. The mean increment over all meals was derived as the mean of all available meal increments. (NCT02607306)
Timeframe: Week 0, week 52

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	-0.74
Insulin Degludec	-0.27
Liraglutide	-1.01

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Change in Clinical Evaluation: Pulse

Change in pulse after 52 weeks of treatment. (NCT02607306)
Timeframe: Week 0, week 52

Intervention	beats per minute (Mean)
Insulin Degludec/Liraglutide	3.9
Insulin Degludec	0.8
Liraglutide	4.2

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High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks

High density lipoprotein (HDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Ratio (Geometric Mean)
Insulin Degludec/Liraglutide	0.94
Insulin Degludec	0.94
Liraglutide	0.99

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Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg

Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analysis was performed to test the hypothesis: superiority of IDegLira vs. IDeg. (NCT02607306)
Timeframe: Week 0, Week 52

Intervention	Percentage of HbA1c (Mean)
Insulin Degludec/Liraglutide	-2.42
Insulin Degludec	-1.80
Liraglutide	-1.80

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Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira

Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analyses were performed to test the hypotheses: non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Liraglutide (Lira). (NCT02607306)
Timeframe: Week 0, Week 52

Intervention	Percentage of HbA1c (Mean)
Insulin Degludec/Liraglutide	-2.42
Insulin Degludec	-1.80
Liraglutide	-1.80

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Insulin Dose

Actual daily total insulin dose after 52 weeks of treatment. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Insulin Units/Day (Mean)
Insulin Degludec/Liraglutide	27.7
Insulin Degludec	34.8

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Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks

Low density lipoprotein (LDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Ratio (Geometric Mean)
Insulin Degludec/Liraglutide	0.91
Insulin Degludec	0.99
Liraglutide	0.93

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Number of Treatment Emergent Adverse Events (TEAEs)

Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE. (NCT02607306)
Timeframe: 0-52 weeks

Intervention	Events (Number)
Insulin Degludec/Liraglutide	873
Insulin Degludec	829
Liraglutide	885

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Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition

"Results represent total number of treatment emergent hypoglycaemic episodes that fall under ADA's definition of hypoglycaemia. ADA's definition of hypoglycaemia includes following categories:~Severe hypoglycaemia~Documented symptomatic hypoglycaemia~Asymptomatic hypoglycaemia~Probable symptomatic hypoglycaemia~Pseudo-hypoglycaemia. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product." (NCT02607306)
Timeframe: 0-52 weeks

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	4830
Insulin Degludec	6340
Liraglutide	162

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Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Nocturnal period: The period between 00:01 and 05:59 a.m. (both inclusive).~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT02607306)
Timeframe: 0-52 weeks

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	16
Insulin Degludec	42
Liraglutide	0

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Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT02607306)
Timeframe: Weeks 0-52

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	467
Insulin Degludec	869
Liraglutide	13

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Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG after 52 weeks (NCT02607306)
Timeframe: Week 0, Week 52

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	-4.08
Insulin Degludec	-3.97
Liraglutide	-2.62

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Change From Baseline in Body Weight (kg)

Change from baseline (week 0) in body weight after 52 weeks of treatment. (NCT02607306)
Timeframe: Week 0, Week 52

Intervention	Kg (Mean)
Insulin Degludec/Liraglutide	2.9
Insulin Degludec	4.1
Liraglutide	-1.0

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Anti-drug Antibodies: Anti-insulin Degludec Antibodies

Insulin degludec (IDeg)-specific antibodies were measured at week 52, as %B/T (percentage of bound & precipitated radioactive drug/total added drug to the sample). A sample is measured in 2 different series. In series 1, the radioactive IDeg (tracer) and surplus unlabeled IDeg are added to the sample. In series 2, the tracer and surplus unlabeled human insulin are added to the sample. Series 1 represents unspecific background binding. Series 2 represents IDeg specific antibodies including unspecific background binding. The reported %B/T is calculated by subtracting the background %B/T in series 1 from the %B/T result in series 2. If the background result has higher values than the %B/T in series 2, the resulting value is negative %B/T. Here, a negative %B/T value means that the test samples do not have IDeg-specific antibodies. The reason for getting a negative value for %B/T is due to variation in the analytical background. Thus, the results presented are not a change from baseline. (NCT02607306)
Timeframe: at week 52

Intervention	Percentage B/T (Mean)
Insulin Degludec/Liraglutide	0.12
Insulin Degludec	-0.11

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Triglycerides as a Ratio to Baseline at 52 Weeks

Triglycerides after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Ratio (Geometric Mean)
Insulin Degludec/Liraglutide	0.91
Insulin Degludec	0.96
Liraglutide	0.91

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Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks

Very low density lipoprotein (VLDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values. (NCT02607306)
Timeframe: After 52 weeks of treatment

Intervention	Ratio (Geometric Mean)
Insulin Degludec/Liraglutide	0.92
Insulin Degludec	0.97
Liraglutide	0.91

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Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies

Anti-liraglutide antibodies were measured at week 52. Number of participants positive or negative for anti-liraglutide antibodies at week 52 were reported. (NCT02607306)
Timeframe: at week 52

Intervention	Participants (Count of Participants)
	Negative	Positive
Insulin Degludec/Liraglutide	247	28
Liraglutide	224	49

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Change in Blood Pressure (Systolic and Diastolic)

Change from baseline in blood pressure (systolic and diastolic) after 52 weeks of treatment. (NCT02607306)
Timeframe: Week 0, Week 52

Intervention	mmHg (Mean)
	Systolic blood pressure	Diastolic blood pressure
Insulin Degludec	3.4	0.6
Insulin Degludec/Liraglutide	1.7	0.5
Liraglutide	-1.8	-0.4

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Change in Clinical Evaluation: Electrocardiogram (ECG)

The result of the ECG was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' ECG results at screening (week -2 to week 0) and week 52. (NCT02607306)
Timeframe: at screening (week -2 to week 0), at week 52

Intervention	Participants (Count of Participants)
	At screening visit - normal	At screening visit - Abn, NCS	At screening visit - Abn, CS	Week 52 - normal	Week 52 - Abn, NCS	Week 52 - Abn, CS
Insulin Degludec	230	38	3	232	35	4
Insulin Degludec/Liraglutide	228	40	7	238	30	7
Liraglutide	222	41	10	233	34	6

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Change in Clinical Evaluation: Fundoscopy or Fundus Photography

The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at screening (week -2 to week 0) and week 52. (NCT02607306)
Timeframe: at screening (week -2 to week 0), at week 52

Intervention	Participants (Count of Participants)
	Left eye - at screening visit - normal	Left eye - at screening visit - Abn, NCS	Left eye - at screening visit - Abn, CS	Left eye - week 52 - normal	Left eye - week 52 - Abn, NCS	Left eye - week 52 - Abn, CS	Right eye - at screening visit - normal	Right eye - at screening visit - Abn, NCS	Right eye - at screening visit - Abn, CS	Right eye - week 52 - normal	Right eye - week 52 - Abn, NCS	Right eye - week 52 - Abn, CS
Insulin Degludec	213	16	42	214	16	41	212	14	45	217	14	40
Insulin Degludec/Liraglutide	225	10	39	217	17	40	224	10	41	220	14	41
Liraglutide	211	14	47	212	15	45	207	12	54	209	15	49

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Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks

Gastric emptying of solids was assessed by scintigraphy using a 320 Kcal 99mTc-radiolabeled egg, solid-liquid meal. Gastric Emptying Half-time was the linear interpretation of time to when 50% of radiolabeled meal emptied from the stomach. (NCT02647944)
Timeframe: 16 weeks

Intervention	minutes (Median)
Liraglutide	142
Placebo	113

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Gastric Accommodation Volume at 16 Weeks

Change between postprandial and fasting whole gastric volume by 99mTc-SPECT Imaging. A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. (NCT02647944)
Timeframe: 16 weeks (approximately 1 hour after 99mTC injection)

Intervention	mL (Median)
Liraglutide	453
Placebo	433

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Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks

Intervention	minutes (Median)
Liraglutide	180
Placebo	117

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Weight Change at 16 Weeks

Body weight in kg was measured at 16 weeks and compared to baseline. (NCT02647944)
Timeframe: baseline, 16 weeks

Intervention	kg (Median)
Liraglutide	5.30
Placebo	2.5

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Weight Change at 5 Weeks

Body weight in kg was measured at 5 weeks and compared to baseline. (NCT02647944)
Timeframe: baseline, 5 weeks

Intervention	kg (Median)
Liraglutide	3.70
Placebo	0.60

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Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks

"Satiety (a measure of appetite) was appraised by free feeding buffet meal consisting of standard foods of known nutrient composition. The total amount of food consumed was analyzed by the study dietitian." (NCT02647944)
Timeframe: 16 weeks

Intervention	kcal (Median)
Liraglutide	554.0
Placebo	680.5

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Gastric Fasting Volume at 16 Weeks

Gastric fasting volume was measured by single photon emission computed tomography (SPECT) imaging of the stomach after intravenous injection of 99mTC-pertechnetate, which is taken up by the gastric mucosa. (NCT02647944)
Timeframe: 16 weeks

Intervention	mL (Median)
Liraglutide	231
Placebo	192

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Satiation Volume to Fullness at 16 Weeks

After drinking Ensure, participants recorded their sensations every 5 minutes using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). (NCT02647944)
Timeframe: 16 weeks

Intervention	mL (Median)
Liraglutide	360
Placebo	600

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Satiation Maximum Tolerated Volume at 16 Weeks

Intervention	mL (Median)
Liraglutide	750
Placebo	1126

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Gastric Postprandial Volume at 16 Weeks

Intervention	mL (Median)
Liraglutide	705
Placebo	668

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Change in Pulse

Change from baseline (week 0) in pulse at week 104 or at premature treatment discontinuation is presented. (NCT02730377)
Timeframe: Week 0, week 104/premature treatment discontinuation

Intervention	Beats per minute (beats/min) (Mean)
	Change at week 104	Change at premature treatment discontinuation
Liraglutide 1.8 mg	1.0	0.7
Oral Antidiabetic Drug	-0.6	0.9

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Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control)

The time to premature treatment discontinuation (for any reason including inadequate glycaemic control) was analysed and presented using the generalised log rank test. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. (NCT02730377)
Timeframe: Weeks 0-104

Intervention	Weeks (Median)
Liraglutide 1.8 mg	80.4
Oral Antidiabetic Drug	52.3

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Number of AEs Leading to Permanent Discontinuation of Trial Product

An adverse event (AE) was any untoward medical occurrence in a participant who administered a product, and which did not necessarily had a causal relationship with this treatment. An AE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent AEs that led to permanent discontinuation of trial product are presented. (NCT02730377)
Timeframe: Weeks 0-105

Intervention	Events (Number)
Liraglutide 1.8 mg	188
Oral Antidiabetic Drug	98

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Number of Documented Symptomatic Hypoglycaemic Episodes (ADA)

Documented symptomatic hypoglycaemic were defined as episodes with typical symptoms of hypoglycaemia accompanied by measure plasma glucose concentration <= 3.9 mmol/L. Number of documented symptomatic hypoglycaemic episodes that occured during the weeks 0-104 are presented. (NCT02730377)
Timeframe: Weeks 0-104

Intervention	Episodes (Number)
Liraglutide 1.8 mg	98
Oral Antidiabetic Drug	155

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Number of Serious Adverse Events (SAEs)

A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or suspicion of transmission of infectious agents via the trial product. An SAE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent serious adverse events are presented. (NCT02730377)
Timeframe: Weeks 0-105

Intervention	Events (Number)
Liraglutide 1.8 mg	145
Oral Antidiabetic Drug	140

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Number of Severe Hypoglycaemic Episodes

Severe hypoglycaemic episodes were defined as episodes that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Number of severe hypoglycaemic episodes that occured during weeks 0-104 are presented. (NCT02730377)
Timeframe: Weeks 0-104

Intervention	Episodes (Number)
Liraglutide 1.8 mg	32
Oral Antidiabetic Drug	52

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Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Number of severe or BG confirmed symptomatic hypoglycaemic episodes that occured during weeks 0-104 are presented. (NCT02730377)
Timeframe: Weeks 0-104

Intervention	Episodes (Number)
Liraglutide 1.8 mg	24
Oral Antidiabetic Drug	44

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Time to Inadequate Glycaemic Control

Inadequate glycaemic control was defined as glycosylated haemoglobin (HbA1c) of 7.0% (53 mmol/mol) or greater at two consecutive visits after the first 26 weeks of treatment and up to 104 weeks. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. HbA1c was recorded at weeks 38, 52, 65, 78, 91 and 104. (NCT02730377)
Timeframe: Weeks 26-104

Intervention	Weeks (Median)
Liraglutide 1.8 mg	108.9
Oral Antidiabetic Drug	64.9

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Change in Biochemistry- Creatinine, Total Bilirubin

Change from baseline (week 0) in creatinine and total bilirubin (TB) at week 104 or at premature treatment discontinuation is presented. (NCT02730377)
Timeframe: Week 0, week 104/premature treatment discontinuation

Intervention	Micromoles per liter (umol/L) (Mean)
	Creatinine: week 104	Creatinine: premature treatment discontinuation	TB: week 104	TB: premature treatment discontinuation
Liraglutide 1.8 mg	3.3	2.9	0.4	-0.0
Oral Antidiabetic Drug	1.0	2.6	0.7	-0.6

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Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum

The estimated GFR was derived from serum creatinine using the MDRD (Modification of diet in renal disease) formula. eGFR was measured as milliliter per min per specific surface area (mL/min/SSA). (NCT02730377)
Timeframe: Week 0, week 104/premature treatment discontinuation

Intervention	mL/min/SSA (Mean)
	Change at week 104	Change at premature treatment discontinuation
Liraglutide 1.8 mg	-5.1	-3.0
Oral Antidiabetic Drug	-1.6	-1.7

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Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Change from baseline (week 0) in systolic and diastolic blood pressure at week 104 or at premature treatment discontinuation is presented. (NCT02730377)
Timeframe: Week 0, week 104/premature treatment discontinuation

Intervention	Millimeters of mercury (mmHg) (Mean)
	SBP: Change at week 104	SBP: Change at premature treatment discontinuation	DBP: Change at week 104	DBP: Change at premature treatment discontinuation
Liraglutide 1.8 mg	-2.4	-2.8	-1.3	-1.0
Oral Antidiabetic Drug	-1.1	-2.9	-0.6	0.2

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Change in Body Mass Index (BMI)

Change from baseline (week 0) in BMI at week 104 or at premature treatment discontinuation is presented. (NCT02730377)
Timeframe: Week 0, week 104/premature treatment discontinuation

Intervention	Kilograms per square meter (kg/m^2) (Mean)
	Change at week 104	Change at premature treatment discontinuation
Liraglutide 1.8 mg	-1.3	-1.1
Oral Antidiabetic Drug	-1.2	-0.8

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Change in Body Weight

Change from baseline (week 0) in body weight at week 104 or at premature treatment discontinuation is presented. (NCT02730377)
Timeframe: Week 0, week 104/premature treatment discontinuation

Intervention	Kilogram (Kg) (Mean)
	Change at week 104	Change at premature treatment discontinuation
Liraglutide 1.8 mg	-3.8	-2.9
Oral Antidiabetic Drug	-3.5	-2.2

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Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG at week 104 or at premature treatment discontinuation is presented. (NCT02730377)
Timeframe: Week 0, week 104/premature treatment discontinuation

Intervention	Millimoles per liter (mmol/L) (Mean)
	Change at week 104	Change at premature treatment discontinuation
Liraglutide 1.8 mg	-2.2	-0.6
Oral Antidiabetic Drug	-1.2	-0.6

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Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase

Change from baseline (week 0) in alanine aminotransferase (ALAT), amylase, aspartate aminotransferase (ASAT) and lipase at week 104 or at premature treatment discontinuation is presented. (NCT02730377)
Timeframe: Week 0, week 104/premature treatment discontinuation

Intervention	Units per liter (U/L) (Mean)
	ALAT: Week 104	ALAT: Premature treatment discontinuation	Amylase: Week 104	Amylase: Premature treatment discontinuation	ASAT: Week 104	ASAT: Premature treatment discontinuation	Lipase: Week 104	Lipase: Premature treatment discontinuation
Liraglutide 1.8 mg	-4.6	-3.2	8.9	0.6	-2.0	-1.9	15.1	10.4
Oral Antidiabetic Drug	-5.4	-3.3	5.1	2.1	-2.3	-0.4	-0.5	-2.2

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Change in Haemoglobin

Change from baseline (week 0) in haemoglobin at week 104 or at premature treatment discontinuation is presented. (NCT02730377)
Timeframe: Week 0, week 104/premature treatment discontinuation

Intervention	Grams per deciliter (g/dL) (Mean)
	Change at week 104	Change at premature treatment discontinuation
Liraglutide 1.8 mg	-0.4	-0.3
Oral Antidiabetic Drug	-0.0	-0.3

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Change in HbA1c

Change from baseline (week 0) in HbA1c at week 104 or at premature treatment discontinuation is presented. (NCT02730377)
Timeframe: Week 0, week 104/premature treatment discontinuation

Intervention	Percentage point of HbA1c (Mean)
	Change at week 104	Change at premature treatment discontinuation
Liraglutide 1.8 mg	-1.4	-0.6
Oral Antidiabetic Drug	-1.1	-0.2

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Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides

Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol (TC) and triglycerides (TG) at week 104 or at premature treatment discontinuation is presented. (NCT02730377)
Timeframe: Week 0, week 104/premature treatment discontinuation

Intervention	Millimoles per liter (mmol/L) (Mean)
	HDL: Change at week 104	HDL: Change at premature treatment discontinuation	LDL: Change at week 104	LDL: Change at premature treatment discontinuation	TC: Change at week 104	TC: Change at premature treatment discontinuation	TG: Change at week 104	TG: Change at premature treatment discontinuation
Liraglutide 1.8 mg	0.1	-0.0	-0.1	-0.1	-0.2	-0.0	-0.3	-0.0
Oral Antidiabetic Drug	0.1	0.0	0.0	-0.1	0.1	-0.1	-0.1	-0.0

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Change in Potassium

Change from baseline (week 0) in potassium at week 104 or at premature treatment discontinuation is presented. (NCT02730377)
Timeframe: Week 0, week 104/premature treatment discontinuation

Intervention	Millimoles per liter (mmol/L) (Mean)
	Change at week 104	Change at premature treatment discontinuation
Liraglutide 1.8 mg	-0.1	-0.0
Oral Antidiabetic Drug	-0.0	-0.2

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Mean apoB48 FTR to VLDL1 Particles

Before vs after intervention (Liraglutide or placebo): Change in apoB48 chylomicron fractional transfer rate to VLDL1 isolated from plasma by ultracentrifugation and by liquid chromatography/mass spectrometry and calculated with multicompartmental modeling assay. So far few studies have focused on the modelling of apo B48 and apo B100 after a meal that is more physiological than the fasting state (Björnson E et al. JIM 2019). Production rates for apo B48, apo B100 and triglycerides in chylomicrons, VLDL1 and VLDL2 were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90,120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. Analysis of tracer/ tracee curves of stable isotopes was used to derived the estimates of kinetic parameters using a new mathematical modeling per day. Results from Taskinen et al. 2021. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	pools/day (Mean)
	Baseline	16 weeks
Liraglutide	12	26
Placebo	34	30

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Change in fP-glucose Level

Before vs after intervention (Liraglutide or placebo): concentration of fasting plasma glucose measured using the hexokinase method. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	mmol/L (Mean)
	Baseline	16 weeks
Liraglutide	8.3	6.4
Placebo	6.5	6.4

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Change in Direct CM-apoB48 Clearance

Before vs after intervention (Liraglutide or placebo): Direct apoB48 clearance rates in isolated chylomicrons and measured by liquid chromatography - mass spectrometry and calculated by multicompartmental modeling assay. The power of mathematical modelling to describe the metabolic pathways of lipid and lipoprotein metabolism was demonstrated by Zech L et al (1979). So far few studies have focused on the modelling of apo B48 and apo B100 after a meal that is more physiological than the fasting state (Björnson E et al. 2019). Production rates for apo B48, apo B100 and triglycerides in chylomicrons, VLDL1 and VLDL2 were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90,120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. Analysis of tracer/ tracee curves of stable isotopes was used to derived the estimates of kinetic parameters using a new mathematical modeling per day. Results from Taskinen et al. 2021. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	mg/day (Mean)
	Baseline	16 weeks
Liraglutide	106	3.8
Placebo	20	17

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Change in ApoCIII Level

Before vs after intervention (Liraglutide or placebo): apolipoprotein CIII concentration in plasma measured by using turbidimetric immunoassay. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	mg/dL (Mean)
	Baseline	16 weeks
Liraglutide	12.0	9.9
Placebo	9.7	8.6

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Body Weight

Before vs after intervention (Liraglutide or placebo): Change in body weight. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	kg (Mean)
	Baseline	16 weeks
Liraglutide	98.6	96.1
Placebo	92.0	89.8

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Mean CM FDC of apoB48

Before vs after intervention (Liraglutide or placebo): Change in chylomicron fractional direct clearance rates of apoB48 measured from plasma by liquid chromatography - mass spectrometry with multicompartmental modeling assay. The power of mathematical modelling to describe the metabolic pathways of lipid and lipoprotein metabolism was demonstrated by Zech L et al (1979). So far few studies have focused on the modelling of apo B48 and apo B100 after a meal that is more physiological than the fasting state (Björnson E et al. 2019). Production rates for apo B48, apo B100 and triglycerides in chylomicrons, VLDL1 and VLDL2 were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90,120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. Analysis of tracer/ tracee curves of stable isotopes was used to derived the estimates of kinetic parameters using a new mathematical modeling per day. Results from Taskinen et al. 2021. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	pools/day (Mean)
	Baseline	16 weeks
Liraglutide	9	0.8
Placebo	4.4	3.2

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Change in HbA1c Level

Before vs after intervention (Liraglutide or placebo): Change in B -Hemoglobiini-A1c level in plasma. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	HbA1c % (Mean)
	Baseline	16 weeks
Liraglutide	7.0	6.4
Placebo	6.3	6.4

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Change in Hepatic de Novo Lipogenesis

Before vs after intervention (Liraglutide or placebo): Hepatic DNL is calculated from enrichment of deuterated water ingested during the kinetic study at specified time points (0, 4 and 8 hrs.). Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	μmol/L (Mean)
	Baseline	16 weeks
Liraglutide	15.4	19.1
Placebo	12.6	13.8

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Change in Insulin Level

Before vs after intervention (Liraglutide or placebo): Concentration of insulin level in plasma measured using electrochemiluminescence. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019. (NCT02765399)
Timeframe: Baseline and after16 weeks

Intervention	μU/mL (Mean)
	Baseline	16 weeks
Liraglutide	13.9	14.5
Placebo	13.8	14.1

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Change in Liver Fat Content

Before vs after intervention (Liraglutide or placebo): mean liver fat content was measured by magnetic resonance imaging. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	fat % (Mean)
	Baseline	16 weeks
Liraglutide	14.8	10.7
Placebo	16.1	13.9

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Change in Matsuda Index

Before vs after intervention (Liraglutide or placebo): Matsuda index was calculated for assessment of insulin sensitivity in plasma at time points 0, 30, 60 and 120 minutes using formula 10,000/square root of [fasting glucose x fasting insulin] x [mean glucose x mean insulin during oral glucose tolerance test]. The Matsuda index is considered to be the gold standard to determine insulin sensitivity without glucose clamp studies (Matsuda M, DeFronzo RA. Diabetes Care. 22:1462-70). Subjects who don't have insulin resistance have values of Matsuda Index of 2.5 or higher (Kerman WN et al. Stroke 34:1431;2003). Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	index (Mean)
	Baseline	16 weeks
Liraglutide	2.5	3.5
Placebo	3.1	3.1

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Change in SAT Area

Before vs after intervention (Liraglutide or placebo): subcutaneous adipose tissue area measured by magnetic resonance imaging (MRI). Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	cm3 (Mean)
	Baseline	16 weeks
Liraglutide	4043	3792
Placebo	5400	5161

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Plasma Triglyceride (TG) Area Under Curve (AUC)

Before vs after intervention (Liraglutide or placebo): postprandial plasma TG summary measured using the trapezoidal rule and expressed as AUC (at fasting and at 0.5, 1, 2, 3, 4, 6 and 8 hours) after oral fat tolerance test. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	mmol/l per h (Mean)
	Baseline	16 weeks
Liraglutide	22.0	17.1
Placebo	17.5	19.0

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Mean CM-apoB48 Transfer Rates to VLDL1

Before vs after intervention (Liraglutide or placebo): Change in chylomicron-apoB48 transfer rates to VLDL1 isolated from plasma by ultracentrifugation and measured using multicompartmental modeling. The power of mathematical modelling to describe the metabolic pathways of lipid and lipoprotein metabolism was demonstrated by Zech L et al (1979). So far few studies have focused on the modelling of apo B48 and apo B100 after a meal that is more physiological than the fasting state (Björnson E et al. 2019). Production rates for apo B48, apo B100 and triglycerides in chylomicrons, VLDL1 and VLDL2 were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90,120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. Analysis of tracer/ tracee curves of stable isotopes was used to derived the estimates of kinetic parameters using a new mathematical modeling per day. Results from Taskinen et al. 2021. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	mg/day (Mean)
	Baseline	16 weeks
Liraglutide	127	110
Placebo	170	150

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Mean TG Fractional Catabolic Rates in CM

Before vs after intervention (Liraglutide or placebo): Change in triglycerides fractional catabolic rates in isolated chylomicrons from plasma samples measured by multicompartmental modeling assay. The power of mathematical modelling to describe the metabolic pathways of lipid and lipoprotein metabolism was demonstrated by Zech L et al (JCI 1979). So far few studies have focused on the modelling of apo B48 and apo B100 after a meal that is more physiological than the fasting state (Björnson E et al. JIM 2019). Production rates for apo B48, apo B100 and triglycerides in chylomicrons, VLDL1 and VLDL2 were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90,120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. Analysis of tracer/ tracee curves of stable isotopes was used to derived the estimates of kinetic parameters using a new mathematical modeling per day. Results from Taskinen et al. DOM 2021. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	pools/day (Mean)
	Baseline	16 weeks
Liraglutide	33	46
Placebo	64	59

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Mean Fractional Catabolic Rate of VLDL2-apoB100

Before vs after intervention (Liraglutide or placebo): Change in VLDL2-apoB100 fractional catabolic rates measured from isolated VLDL2 from plasma by ultracentrifugation and measured using mathematical modeling. The power of mathematical modelling to describe the metabolic pathways of lipid and lipoprotein metabolism was demonstrated by Zech L et al (JCI 1979). So far few studies have focused on the modelling of apo B48 and apo B100 after a meal that is more physiological than the fasting state (Björnson E et al. JIM 2019). Production rates for apo B48, apo B100 and triglycerides in chylomicrons, VLDL1 and VLDL2 were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90,120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. Analysis of tracer/ tracee curves of stable isotopes was used to derived the estimates of kinetic parameters using a new mathematical modeling per day. Results from Taskinen et al. DOM 2021. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	pools/day (Mean)
	Baseline	16 weeks
Liraglutide	6.7	5.6
Placebo	4.5	5.1

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Mean Total Production of apoB48

Before vs after intervention (Liraglutide or placebo): ApoB48 total production in plasma measured by using multicompartmental modeling. The power of mathematical modelling to describe the metabolic pathways of lipid and lipoprotein metabolism was demonstrated by Zech L et al (JCI 63:1262;1979) and have been widely used over 30yrs. So far few studies have focused on the modelling of apo B48 and apo B100 after a meal that is more physiological than the fasting state (Björnson E et al. JIM 285:562;2019). Production rates for apo B48, apo B100 and triglycerides in chylomicrons, VLDL1 and VLDL2 were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90,120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. Analysis of tracer/ tracee curves of stable isotopes was used to derived the estimates of kinetic parameters using a new mathematical modeling per day. Results from Taskinen et al. Diabetes Obes Metab. 23:1191; 2021. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	mg/day (Mean)
	Baseline	16 weeks
Liraglutide	490	329
Placebo	570	530

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Mean VLDL1-TG Production Rates

Before vs after intervention (Liraglutide or placebo): Change in VLDL1 production rates measured from isolated VLDL from plasma samples by ultracentrifugation and measured using mathematical modeling. The power of mathematical modelling to describe the metabolic pathways of lipid and lipoprotein metabolism was demonstrated by Zech L et al (JCI 1979). So far few studies have focused on the modelling of apo B48 and apo B100 after a meal that is more physiological than the fasting state (Björnson E et al. JIM 2019). Production rates for apo B48, apo B100 and triglycerides in chylomicrons, VLDL1 and VLDL2 were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90,120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. Analysis of tracer/ tracee curves of stable isotopes was used to derived the estimates of kinetic parameters using a new mathematical modeling per day. Results from Taskinen et al. DOM 2021. (NCT02765399)
Timeframe: Baseline and after16 weeks

Intervention	g/day (Mean)
	Baseline	16 weeks
Liraglutide	51	35
Placebo	43	35

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Mean Production Rate of apoB48 in CM

Before vs after intervention (Liraglutide or placebo): Change in mean production rate of ApoB48 in chylomicrons isolated from plasma samples and measured by multicompartmental modeling assay. The power of mathematical modelling to describe the metabolic pathways of lipid and lipoprotein metabolism was demonstrated by Zech L et al (JCI 1979). So far few studies have focused on the modelling of apo B48 and apo B100 after a meal that is more physiological than the fasting state (Björnson E et al. JIM 2019). Production rates for apo B48, apo B100 and triglycerides in chylomicrons, VLDL1 and VLDL2 were derived from samples taken before and after the tracer injection and after the meal at 0, 30, 45, 60, 75, 90,120, 150 min and at 3, 4, 5, 6, 8, 10, 24 hrs and averages for 24 hrs. Analysis of tracer/ tracee curves of stable isotopes was used to derived the estimates of kinetic parameters using a new mathematical modeling per day. Results from Taskinen et al. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	mg/day (Mean)
	Baseline	16 weeks
Liraglutide	284	113
Placebo	190	160

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Change in Systolic RR

Before vs after intervention (Liraglutide or placebo): systolic blood pressure measurements. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	mm Hg (Mean)
	Baseline	16 weeks
Liraglutide	135	139
Placebo	145	137

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Change in VAT Area

Before vs after intervention (Liraglutide or placebo): visceral adipose tissue area measured by magnetic resonance imaging (MRI). Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019. (NCT02765399)
Timeframe: Baseline and after 16 weeks

Intervention	cm3 (Mean)
	Baseline	16 weeks
Liraglutide	3403	3185
Placebo	2710	2600

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Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile

Change in mean of the 9-point profile SMPG was evaluated after 26 weeks of randomised treatment. 9-point profile SMPG was measured at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day. (NCT02773368)
Timeframe: After 26 weeks

Intervention	mmol/L (Mean)
	Mean 9-point SMPG (mmol/L) at baseline	Mean 9-point SMPG change from baseline to week 26
IDegLira	9.98	-3.47
IGlar	10.06	-2.98

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Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile

Change in 9-point SMPG profile was evaluated after 26 weeks of randomised treatment. SMPG measurements at baseline and week 26 are presented here at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day. (NCT02773368)
Timeframe: After 26 weeks

Intervention	mmol/L (Mean)
	Before breakfast - Baseline	Ninety (90) minutes after breakfast - Baseline	Before lunch - Baseline	Ninety (90) minutes after lunch - Baseline	Before dinner - Baseline	Ninety (90) minutes after dinner - Baseline	At bedtime - Baseline	At 4.00 AM - Baseline	Before breakfast the following day - Baseline	Before breakfast - Week 26	Ninety (90) minutes after breakfast - Week 26	Before lunch - Week 26	Ninety (90) minutes after lunch - Week 26	Before dinner - Week 26:	Ninety (90) minutes after dinner - Week 26	At bedtime - Week 26	At 4.00 AM - Week 26	Before breakfast the following day - Week 26
IDegLira	9.01	11.79	8.93	11.24	9.33	11.40	10.38	8.80	8.60	5.40	7.20	5.83	7.25	6.43	7.85	7.05	5.58	5.23
IGlar	9.00	11.77	9.20	11.22	9.36	11.40	10.71	9.00	8.81	5.39	8.35	6.35	8.49	6.77	8.70	7.79	5.72	5.36

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Change in Body Weight

The mean change from baseline (week 0) in body weight evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: Week 0, Week 26

Intervention	kg (Mean)
	Body weight (kg) at baseline	Body weight (kg) change from baseline to week 26
IDegLira	89.3	-0.0
IGlar	87.2	2.0

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Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG was evaluated after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: Week 0, Week 26

Intervention	mmol/ L (Mean)
	FPG (mmol/L) at baseline	FPG (mmol/L) change from baseline to week 26
IDegLira	9.51	-3.72
IGlar	9.57	-3.50

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Change in HbA1c (Glycosylated Haemoglobin)

The mean change from baseline (week 0) in HbA1c values evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: Week 0, Week 26

Intervention	Percentage of glycosylated haemoglobin (Mean)
	HbA1c (%) at baseline	HbA1c (%) change from baseline to week 26
IDegLira	8.20	-1.94
IGlar	8.36	-1.68

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Change From Baseline in Diastolic Blood Pressure

Change from baseline (week 0) in diastolic blood pressure was evaluated after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

Intervention	mmHg (Mean)
	Diastolic (mmHg) at baseline	Diastolic (mmHg) change from baseline to week 26
IDegLira	79.4	-1.2
IGlar	78.9	-1.1

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Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks

American Diabetes Association (ADA) classification of hypoglycaemic episodes: 1)Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo: PG >3.9 mmol/L with symptoms. 6) Unclassifiable. (NCT02773368)
Timeframe: Week 0-26

Intervention	Number of episodes (Number)
	Severe - ADA	Documented symptomatic - ADA	Asymptomatic - ADA	Probably symptomatic - ADA	Pseudo - ADA	Unclassifiable hypoglycaemia - ADA
IDegLira	1	239	850	23	10	2
IGlar	0	419	902	5	14	0

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Responder (Yes/No) for HbA1c Below 7.0%

The proportion of subjects achieving pre-defined HbA1c targets <7.0% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Participants (Number)
	Yes	No
IDegLira	167	30
IGlar	144	58

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Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain

The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Participants (Number)
	Yes	No
IDegLira	83	114
IGlar	34	168

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Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain

The proportion of subjects achieving pre-defined HbA1c targets <7.0% without weight gain after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Participants (Number)
	Yes	No
IDegLira	91	106
IGlar	38	164

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Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Participants (Number)
	Yes	No
IDegLira	156	41
IGlar	114	88

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Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain

The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Partcipants (Number)
	Yes	No
IDegLira	77	120
IGlar	24	178

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Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Particpants (Number)
	Yes	No
IDegLira	137	60
IGlar	79	123

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Change From Baseline in Fasting Lipid Profile: Free Fatty Acids

The values of free fatty acids from fasting lipid profile after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

Intervention	mmol/L (Median)
	Free fatty acids (mmol/L) at baseline	Free fatty acids (mmol/L) at week 26
IDegLira	0.58	0.38
IGlar	0.61	0.42

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Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain

The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% without weight gain after 26 weeks of randomised treatment. The results are based on retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Participants (Number)
	Yes	No
IDegLira	84	113
IGlar	26	176

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Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments

Mean prandial plasma glucose increments for each meal (from before meal to 90 min after breakfast, lunch and dinner) was evaluated after 26 weeks of randomised treatment. The mean increment over all meals was derived as the mean of all available meal increments are presented here. (NCT02773368)
Timeframe: After 26 weeks

Intervention	mmol/L (Mean)
	Baseline	Change from baseline to week 26
IDegLira	2.38	-0.86
IGlar	2.28	-0.09

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Insulin Dose, Total Daily Dose (U)

Actual daily total insulin dose (Units) was evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Units (U) (Mean)
IDegLira	36.2
IGlar	53.5

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Number of Treatment-emergent Adverse Events

Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 26. TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. (NCT02773368)
Timeframe: Week 0-26

Intervention	Number of events (Number)
IDegLira	450
IGlar	386

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Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks

Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes (00:01-05:59 - inclusive) during 26 weeks of randomised treatment. (NCT02773368)
Timeframe: Week 0-26

Intervention	Number of episodes (Number)
IDegLira	6
IGlar	13

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Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe (subjects who were not able to self-treat) and/or BG confirmed by a plasma glucose values <3.1 mmol/L (56 mg/dL) with accompanied symptoms consistent with hypoglycaemia. (NCT02773368)
Timeframe: Week 0-26

Intervention	Number of episodes (Number)
IDegLira	38
IGlar	95

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Change From Baseline After 26 Weeks in Waist Circumference

Mean change from baseline in waist circumference after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

Intervention	cm (Mean)
	Waist circum. (cm) at baseline	Waist circum. (cm) change from baseline to week 26
IDegLira	105.9	-0.6
IGlar	104.7	0.7

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Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)

Reported results are ECG findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Number of subjects (Number)
	Screening, Normal	Screening, Abnormal NCS	Screening, Abnormal CS	Screening, Missing	Week 26, Normal	Week 26, Abnormal NCS	Week 26, Abnormal CS	Week 26, Missing
IDegLira	142	66	1	0	134	58	2	0
IGlar	141	69	0	0	136	64	0	0

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Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography

Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Number of subjects (Number)
	Screening, Left eye (Normal)	Screening, Left eye (Abnormal -NCS)	Screening, Left eye (Abnormal-CS)	Screening, Left eye (Missing)	Week 26, Left eye (Normal)	Week 26, Left eye (Abnormal -NCS)	Week 26, Left eye (Abnormal-CS)	Week 26, Left eye (Missing)	Screening, Right eye (Normal)	Screening, Right eye (Abnormal-NCS)	Screening, Right eye (Abnormal- CS)	Screening, Right eye (Missing)	Week 26, Right eye (Normal)	Week 26, Right eye (Abnormal-NCS)	Week 26, Right eye (Abnormal- CS)	Week 26, Right eye (Missing)
IDegLira	134	68	7	0	123	66	2	0	133	69	7	0	120	69	2	0
IGlar	131	74	4	0	125	68	4	0	133	72	4	0	127	66	4	0

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Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate

Change from baseline (week 0) in pulse rate was evaluated after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Beats/minute (Mean)
	Pulse (beats/min) at baseline	Pulse (beats/min) change from baseline to week 26
IDegLira	76.1	2.0
IGlar	75.0	-0.4

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Change From Baseline in Fasting Lipid Profile: Cholesterol

The values of total cholesterol from fasting lipid profile after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

Intervention	mmol/L (Median)
	Total cholesterol (mmol/L) at baseline	Total cholesterol (mmol/L) at week 26
IDegLira	4.42	4.27
IGlar	4.45	4.27

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Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)

The values of HDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

Intervention	mmol/L (Median)
	HDL cholesterol (mmol/L) at baseline	HDL cholesterol (mmol/L) at week 26
IDegLira	1.14	1.17
IGlar	1.14	1.17

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Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)

The values of LDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

Intervention	mmol/L (Median)
	LDL cholesterol (mmol/L) at baseline	LDL cholesterol (mmol/L) at week 26
IDegLira	2.28	2.20
IGlar	2.28	2.31

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Change From Baseline in Fasting Lipid Profile: Triglycerides

The values of triglycerides from fasting lipid profile after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

Intervention	mmol/L (Median)
	Triglycerides (mmol/L) at baseline	Triglycerides (mmol/L) at week 26
IDegLira	1.67	1.55
IGlar	1.73	1.47

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Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)

The values of VLDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

Intervention	mmol/L (Median)
	VLDL cholesterol (mmol/L) at baseline	VLDL cholesterol (mmol/L) at week 26
IDegLira	0.75	0.70
IGlar	0.80	0.67

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Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)

The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL). PRO questionnaire (SF-36v2™) measured the HRQoL which contains 36 items covering 8 domains of physical and mental health status. The raw scale scores from the SF-36 were transformed to a 0-100 scale scores (where higher scores indicated a better health status) which is further converted to norm-based scores using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 2009 reference population . The total/overall (SF-36v2™) scores for physical and mental health from baseline to week 26 are presented here. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Scores on a scale (Median)
	Overall physical - Baseline	Overall physical - Week 26	Overall mental - Baseline	Overall mental - Week 26
IDegLira	51.3	53.2	53.3	54.4
IGlar	51.5	54.6	53.3	54.4

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Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)

The patient reported outcomes are calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D domain scores and the total scores are later transformed to a 0-100 scale for analysis. Summary scores from baseline and week 26 for total/overall scores are presented here. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Scores on a scale (Median)
	TRIM-D scores at baseline	TRIM-D scores at week 26
IDegLira	75.9	84.4
IGlar	75.9	83.9

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Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%

The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. (NCT02773368)
Timeframe: After 26 weeks

Intervention	Participants (Number)
	Yes	No
IDegLira	147	50
IGlar	100	102

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Change From Baseline in Systolic Blood Pressure

Change from baseline (week 0) in systolic blood pressure (BP) was evaluated after 26 weeks of randomised treatment. (NCT02773368)
Timeframe: After 26 weeks

Intervention	mmHg (Mean)
	Systolic BP (mmHg) at baseline	Systolic BP (mmHg) change from baseline to week 26
IDegLira	130.5	-3.0
IGlar	128.9	0.6

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Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Core Period

Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of <3.0 mmol/L (54 mg/dL) were also analyzed. (NCT02787551)
Timeframe: From Baseline to Week 26

Intervention	events per participant-year (Number)
	Documented symptomatic hypoglycemia(<=3.9 mmol/L)	Documented symptomatic hypoglycemia (<3.0 mmol/L)
GLP-1 Receptor Agonist	0.08	0.01
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	1.54	0.25

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Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period

Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c >8%. (NCT02787551)
Timeframe: From Week 26 to Week 52

Intervention	percentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	1.5

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Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period

Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c >8%. (NCT02787551)
Timeframe: From Baseline to Week 26

Intervention	percentage of participants (Number)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	4.8
GLP-1 Receptor Agonist	15.0

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Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period

Intervention	mmol/L (Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	-1.68

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Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period

Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period. (NCT02787551)
Timeframe: Baseline, Week 26

Intervention	percentage of HbA1c (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	-1.02
GLP-1 Receptor Agonist	-0.38

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Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period

Change in FPG was calculated by subtracting baseline value from Week 52 value. (NCT02787551)
Timeframe: Baseline, Week 52

Intervention	mmol/L (Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	-2.27

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Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period

Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period. (NCT02787551)
Timeframe: Baseline, Week 26

Intervention	millimoles per litre (mmol/L) (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	-2.28
GLP-1 Receptor Agonist	-0.60

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Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period

Participants without any available HbA1c assessment at Week 52 were considered as non-responders. (NCT02787551)
Timeframe: Week 52

Intervention	percentage of participants (Number)
	HbA1c <7%	HbA1c <=6.5%
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	64.1	42.7

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Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period

Participants without any available HbA1c assessment at Week 26 were considered as non-responders. (NCT02787551)
Timeframe: Week 26

Intervention	percentage of participants (Number)
	HbA1c <7%	HbA1c <=6.5%
GLP-1 Receptor Agonist	25.7	9.9
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	61.9	40.5

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Change From Baseline in Body Weight to Week 52: Single Arm Extension Period

Change in body weight was calculated by subtracting baseline value from Week 52 value. (NCT02787551)
Timeframe: Baseline, Week 52

Intervention	kg (Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	2.78

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Change From Baseline in Body Weight at Week 26: Core Period

Change in body weight was calculated by subtracting baseline value from Week 26 value. (NCT02787551)
Timeframe: Baseline, Week 26

Intervention	kilogram (kg) (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	1.89
GLP-1 Receptor Agonist	-1.14

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Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period

The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF. (NCT02787551)
Timeframe: Baseline, Week 52

Intervention	mmol/L (Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	-4.30

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Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period

The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last observation carried forward (LOCF). (NCT02787551)
Timeframe: Baseline, Week 26

Intervention	mmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	-3.96
GLP-1 Receptor Agonist	-1.11

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Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period

2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before IMP administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF. (NCT02787551)
Timeframe: Baseline, Week 52

Intervention	mmol/L (Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	-1.85

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Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period

2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. (NCT02787551)
Timeframe: Baseline, Week 26

Intervention	mmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	-1.51
GLP-1 Receptor Agonist	-0.52

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Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period

Change in HbA1c was calculated by subtracting baseline value from Week 52 value. (NCT02787551)
Timeframe: Baseline, Week 52

Intervention	percentage of HbA1c (Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	-1.01

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Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Single Arm Extension Period

Intervention	events per participant-year (Number)
	Documented symptomatic hypoglycemia(<=3.9 mmol/L)	Documented symptomatic hypoglycemia (<3.0 mmol/L)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	1.59	0.24

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Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period

The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period. (NCT02787551)
Timeframe: Baseline, Week 26

Intervention	mmol/L (Least Squares Mean)
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)	-1.69
GLP-1 Receptor Agonist	-0.67

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Change in Body Mass Index

Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	kg/m^2 (Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	-1.1	-1.1
Oral Semaglutide 14 mg	-1.6	-1.6
Placebo	-0.2	-0.4

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Change in Amylase - Ratio to Baseline

Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	Ratio of amylase (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	1.11	1.10
Oral Semaglutide 14 mg	1.13	1.14
Placebo	0.99	0.98

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Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes

Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. (NCT02863419)
Timeframe: Weeks 0-57

Intervention	Participants (Count of Participants)
Oral Semaglutide 14 mg	2
Liraglutide 1.8 mg	7
Placebo	3

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Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Weeks 0-57

Intervention	Participants (Count of Participants)
Oral Semaglutide 14 mg	0

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Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0-57

Intervention	Participants (Count of Participants)
Oral Semaglutide 14 mg	0

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Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Weeks 0-57

Intervention	Participants (Count of Participants)
Oral Semaglutide 14 mg	0

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Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. (NCT02863419)
Timeframe: Weeks 0-57

Intervention	Episodes (Number)
Oral Semaglutide 14 mg	2
Liraglutide 1.8 mg	9
Placebo	3

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Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product

Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT02863419)
Timeframe: Weeks 0-57

Intervention	Events (Number)
Oral Semaglutide 14 mg	973
Liraglutide 1.8 mg	927
Placebo	300

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Change in HbA1c (Week 52)

Change from baseline (week 0) in HbA1c was evaluated at 52 weeks. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 52

Intervention	Percentage of HbA1c (Mean)
Oral Semaglutide 14 mg	-1.2
Liraglutide 1.8 mg	-0.9
Placebo	-0.1

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Change in Body Weight (Week 52)

Change from baseline (week 0) in body weight was evaluated at 52 weeks. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 52

Intervention	Kg (Mean)
Oral Semaglutide 14 mg	-4.4
Liraglutide 1.8 mg	-3.1
Placebo	-1.0

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Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Weeks 0-57

Intervention	Participants (Count of Participants)
Oral Semaglutide 14 mg	0

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Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline

Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	Ratio of LDL cholesterol (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	0.97	1.00
Oral Semaglutide 14 mg	0.95	0.99
Placebo	0.99	1.06

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Change in Lipase - Ratio to Baseline

Change from baseline (week 0) in lipase (U/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	Ratio of lipase (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	1.40	1.32
Oral Semaglutide 14 mg	1.33	1.28
Placebo	0.99	0.96

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Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline

Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	Ratio of HDL-cholesterol (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	1.02	1.01
Oral Semaglutide 14 mg	1.02	1.03
Placebo	1.02	1.00

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Change in HbA1c (Week 26)

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. (NCT02863419)
Timeframe: Week 0, week 26

Intervention	Percentage of HbA1c (Mean)
	In-trial	On-treatment without rescue medication
Liraglutide 1.8 mg	-1.1	-1.2
Oral Semaglutide 14 mg	-1.2	-1.4
Placebo	-0.1	-0.1

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Change in Triglycerides - Ratio to Baseline

Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	Ratio of triglycerides (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	0.91	0.89
Oral Semaglutide 14 mg	0.89	0.87
Placebo	1.01	0.97

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Change in Free Fatty Acids - Ratio to Baseline

Change from baseline (week 0) in free fatty acids (FFA) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	Ratio of FFA (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	0.95	0.87
Oral Semaglutide 14 mg	0.94	0.83
Placebo	1.06	0.89

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Change in Fasting Plasma Glucose

Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	mmol/L (Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	-1.91	-1.54
Oral Semaglutide 14 mg	-2.04	-1.91
Placebo	-0.33	-0.66

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Participants Who Achieve Weight Loss ≥5% (Yes/no)

Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 26, week 52

Intervention	Participants (Count of Participants)
	Week 2672562905		Week 2672562903	Week 2672562904	Week 5272562904	Week 5272562905	Week 5272562903
	Yes	No
Oral Semaglutide 14 mg	121
Liraglutide 1.8 mg	75
Placebo	10
Oral Semaglutide 14 mg	157
Liraglutide 1.8 mg	196
Placebo	124
Oral Semaglutide 14 mg	123
Liraglutide 1.8 mg	66
Placebo	16
Oral Semaglutide 14 mg	152
Liraglutide 1.8 mg	203
Placebo	117

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Participants Who Achieve Weight Loss ≥ 10% (Yes/no)

Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 26, week 52

Intervention	Participants (Count of Participants)
	Week 2672562903		Week 2672562904	Week 2672562905	Week 5272562904	Week 5272562903	Week 5272562905
	Yes	No
Oral Semaglutide 14 mg	39
Liraglutide 1.8 mg	16
Placebo	0
Oral Semaglutide 14 mg	239
Liraglutide 1.8 mg	255
Placebo	134
Oral Semaglutide 14 mg	45
Liraglutide 1.8 mg	20
Placebo	4
Oral Semaglutide 14 mg	230
Liraglutide 1.8 mg	249
Placebo	129

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Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)

Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 26, week 52

Intervention	Participants (Count of Participants)
	Week 2672562904		Week 2672562905	Week 2672562903	Week 5272562904	Week 5272562903	Week 5272562905
	Yes	No
Oral Semaglutide 14 mg	130
Liraglutide 1.8 mg	93
Placebo	5
Oral Semaglutide 14 mg	148
Liraglutide 1.8 mg	178
Placebo	129
Oral Semaglutide 14 mg	120
Liraglutide 1.8 mg	77
Placebo	9
Oral Semaglutide 14 mg	155
Liraglutide 1.8 mg	192
Placebo	124

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Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)

Participants who achieved HbA1c <7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 26, week 52

Intervention	Participants (Count of Participants)
	Week 2672562903		Week 2672562904	Week 2672562905	Week 5272562903	Week 5272562904	Week 5272562905
	Yes	No
Oral Semaglutide 14 mg	188
Liraglutide 1.8 mg	168
Placebo	19
Oral Semaglutide 14 mg	90
Liraglutide 1.8 mg	104
Placebo	115
Oral Semaglutide 14 mg	167
Liraglutide 1.8 mg	148
Placebo	20
Oral Semaglutide 14 mg	108
Liraglutide 1.8 mg	121
Placebo	113

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Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)

Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 26, week 52

Intervention	Participants (Count of Participants)
	Week 2672562903		Week 2672562904	Week 2672562905	Week 5272562903	Week 5272562905	Week 5272562904
	No	Yes
Oral Semaglutide 14 mg	169
Liraglutide 1.8 mg	145
Oral Semaglutide 14 mg	109
Liraglutide 1.8 mg	126
Placebo	119
Oral Semaglutide 14 mg	155
Liraglutide 1.8 mg	130
Placebo	15
Oral Semaglutide 14 mg	120
Liraglutide 1.8 mg	139
Placebo	118

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Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no)

Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 26, week 52

Intervention	Participants (Count of Participants)
	Week 2672562903		Week 2672562904	Week 2672562905	Week 5272562904	Week 5272562903	Week 5272562905
	No	Yes
Oral Semaglutide 14 mg	133
Liraglutide 1.8 mg	116
Placebo	7
Oral Semaglutide 14 mg	145
Liraglutide 1.8 mg	156
Placebo	127
Oral Semaglutide 14 mg	119
Liraglutide 1.8 mg	88
Placebo	5
Oral Semaglutide 14 mg	156
Liraglutide 1.8 mg	181
Placebo	128

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Change in Physical Examination

Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland. (NCT02863419)
Timeframe: Week -2, week 52

Intervention	Participants (Count of Participants)
	1) Cardiovascular system (Week -2)72562903			1) Cardiovascular system (Week -2)72562904	1) Cardiovascular system (Week -2)72562905	1) Cardiovascular system (Week 52)72562905	1) Cardiovascular system (Week 52)72562903	1) Cardiovascular system (Week 52)72562904	2) Central and peripheral nervous system (Week -2)72562903	2) Central and peripheral nervous system (Week -2)72562904	2) Central and peripheral nervous system (Week -2)72562905	2) Central and peripheral nervous system (Week 52)72562903	2) Central and peripheral nervous system (Week 52)72562904	2) Central and peripheral nervous system (Week 52)72562905	3) Gastrointestinal system, incl. mouth (Week -2)72562905	3) Gastrointestinal system, incl. mouth (Week -2)72562903	3) Gastrointestinal system, incl. mouth (Week -2)72562904	3) Gastrointestinal system, incl. mouth (Week 52)72562903	3) Gastrointestinal system, incl. mouth (Week 52)72562904	3) Gastrointestinal system, incl. mouth (Week 52)72562905	4) General appearance (Week -2)72562903	4) General appearance (Week -2)72562904	4) General appearance (Week -2)72562905	4) General appearance (Week 52)72562903	4) General appearance (Week 52)72562904	4) General appearance (Week 52)72562905	5) Head, ears, eyes, nose, throat, neck (Week -2)72562905	5) Head, ears, eyes, nose, throat, neck (Week -2)72562903	5) Head, ears, eyes, nose, throat, neck (Week -2)72562904	5) Head, ears, eyes, nose, throat, neck (Week 52)72562903	5) Head, ears, eyes, nose, throat, neck (Week 52)72562904	5) Head, ears, eyes, nose, throat, neck (Week 52)72562905	6) Lymph node palpation (Week -2)72562903	6) Lymph node palpation (Week -2)72562904	6) Lymph node palpation (Week -2)72562905	6) Lymph node palpation (Week 52)72562903	6) Lymph node palpation (Week 52)72562904	6) Lymph node palpation (Week 52)72562905	7) Musculoskeletal system (Week -2)72562903	7) Musculoskeletal system (Week -2)72562904	7) Musculoskeletal system (Week -2)72562905	7) Musculoskeletal system (Week 52)72562903	7) Musculoskeletal system (Week 52)72562904	7) Musculoskeletal system (Week 52)72562905	8) Respiratory system (Week -2)72562903	8) Respiratory system (Week -2)72562904	8) Respiratory system (Week -2)72562905	8) Respiratory system (Week 52)72562903	8) Respiratory system (Week 52)72562904	8) Respiratory system (Week 52)72562905	9) Skin (Week -2)72562903	9) Skin (Week -2)72562904	9) Skin (Week -2)72562905	9) Skin (Week 52)72562903	9) Skin (Week 52)72562904	9) Skin (Week 52)72562905	10) Thyroid gland (Week -2)72562903	10) Thyroid gland (Week -2)72562904	10) Thyroid gland (Week -2)72562905	10) Thyroid gland (Week 52)72562903	10) Thyroid gland (Week 52)72562904	10) Thyroid gland (Week 52)72562905
	Abnormal NCS	Abnormal CS	Normal
Oral Semaglutide 14 mg	260
Liraglutide 1.8 mg	249
Placebo	128
Oral Semaglutide 14 mg	23
Liraglutide 1.8 mg	26
Placebo	12
Oral Semaglutide 14 mg	255
Liraglutide 1.8 mg	236
Placebo	118
Oral Semaglutide 14 mg	19
Liraglutide 1.8 mg	24
Placebo	15
Oral Semaglutide 14 mg	258
Liraglutide 1.8 mg	254
Oral Semaglutide 14 mg	16
Liraglutide 1.8 mg	16
Placebo	13
Liraglutide 1.8 mg	14
Placebo	6
Oral Semaglutide 14 mg	247
Liraglutide 1.8 mg	239
Placebo	115
Oral Semaglutide 14 mg	20
Liraglutide 1.8 mg	20
Liraglutide 1.8 mg	271
Oral Semaglutide 14 mg	10
Placebo	9
Oral Semaglutide 14 mg	266
Liraglutide 1.8 mg	260
Placebo	123
Liraglutide 1.8 mg	9
Oral Semaglutide 14 mg	203
Liraglutide 1.8 mg	212
Placebo	109
Oral Semaglutide 14 mg	67
Liraglutide 1.8 mg	54
Placebo	22
Oral Semaglutide 14 mg	15
Liraglutide 1.8 mg	18
Placebo	11
Oral Semaglutide 14 mg	208
Liraglutide 1.8 mg	204
Placebo	105
Oral Semaglutide 14 mg	59
Liraglutide 1.8 mg	55
Placebo	20
Placebo	8
Liraglutide 1.8 mg	269
Placebo	138
Oral Semaglutide 14 mg	9
Liraglutide 1.8 mg	13
Oral Semaglutide 14 mg	1
Liraglutide 1.8 mg	2
Oral Semaglutide 14 mg	267
Liraglutide 1.8 mg	258
Placebo	129
Oral Semaglutide 14 mg	8
Oral Semaglutide 14 mg	285
Liraglutide 1.8 mg	283
Placebo	142
Oral Semaglutide 14 mg	275
Liraglutide 1.8 mg	268
Placebo	133
Oral Semaglutide 14 mg	0
Liraglutide 1.8 mg	0
Oral Semaglutide 14 mg	268
Liraglutide 1.8 mg	264
Oral Semaglutide 14 mg	14
Liraglutide 1.8 mg	17
Placebo	10
Oral Semaglutide 14 mg	3
Liraglutide 1.8 mg	3
Oral Semaglutide 14 mg	262
Liraglutide 1.8 mg	257
Placebo	124
Oral Semaglutide 14 mg	11
Liraglutide 1.8 mg	10
Placebo	7
Oral Semaglutide 14 mg	2
Placebo	1
Oral Semaglutide 14 mg	282
Liraglutide 1.8 mg	278
Placebo	140
Oral Semaglutide 14 mg	273
Liraglutide 1.8 mg	262
Placebo	131
Liraglutide 1.8 mg	6
Placebo	0
Liraglutide 1.8 mg	1
Liraglutide 1.8 mg	243
Placebo	122
Oral Semaglutide 14 mg	40
Liraglutide 1.8 mg	36
Liraglutide 1.8 mg	5
Placebo	3
Oral Semaglutide 14 mg	243
Liraglutide 1.8 mg	235
Placebo	114
Oral Semaglutide 14 mg	30
Liraglutide 1.8 mg	30
Placebo	17
Liraglutide 1.8 mg	4
Placebo	2
Oral Semaglutide 14 mg	276
Liraglutide 1.8 mg	277
Placebo	132
Oral Semaglutide 14 mg	4
Placebo	127
Oral Semaglutide 14 mg	5
Placebo	4

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Change in Eye Examination Category

Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week -2, Week 52

Intervention	Participants (Count of Participants)
	Left eye - Normal to Normal	Left eye - Normal to Abnormal NCS	Left eye - Normal to Abnormal CS	Left eye - Abnormal NCS to normal	Left eye - Abnormal NCS to abnormal NCS	Left eye - Abnormal NCS to abnormal CS	Left eye - Abnormal CS to normal	Left eye - Abnormal CS to abnormal NCS	Left eye - Abnormal CS to abnormal CS	Right eye - Normal to Normal	Right eye - Normal to Abnormal NCS	Right eye - Normal to Abnormal CS	Right eye - Abnormal NCS to Normal	Right eye - Abnormal NCS to Abnormal NCS	Right eye - Abnormal NCS to Abnormal CS	Right eye - Abnormal CS to Normal	Right eye - Abnormal CS to Abnormal NCS	Right eye - Abnormal CS to Abnormal CS
Liraglutide 1.8 mg	144	15	4	13	43	1	3	3	12	150	13	4	12	42	1	3	2	11
Oral Semaglutide 14 mg	130	10	4	15	63	1	1	5	7	127	10	3	16	64	2	2	5	7
Placebo	57	5	2	5	38	1	0	2	8	57	7	2	6	37	1	1	1	6

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Time to Rescue Medication

Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. (NCT02863419)
Timeframe: Weeks 0-52

Intervention	Participants (Count of Participants)
	Week 0 - week 26	Week 0 - week 52
Liraglutide 1.8 mg	9	18
Oral Semaglutide 14 mg	10	20
Placebo	11	43

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Time to Additional Anti-diabetic Medication

Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Weeks 0-52

Intervention	Participants (Count of Participants)
	Week 0 to week 26	Week 0 to week 52
Liraglutide 1.8 mg	16	29
Oral Semaglutide 14 mg	20	39
Placebo	12	46

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Change in Waist Circumference

Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	cm (Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	-3.0	-2.7
Oral Semaglutide 14 mg	-4.2	-4.4
Placebo	-1.2	-1.7

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Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline

Change from baseline (week 0) in VLDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	Ratio of VLDL cholesterol (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	0.91	0.90
Oral Semaglutide 14 mg	0.90	0.87
Placebo	1.02	0.98

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Change in ECG Evaluation

Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and week 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26 and week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	Participants (Count of Participants)
	Normal (week 0) to normal (week 26)	Normal (week 0) to abnormal NCS (week 26)	Normal (week 0) to abnormal CS (week 26)	Abnormal NCS (week 0) to normal (week 26)	Abnormal NCS (week 0) to abnormal NCS (week 26)	Abnormal NCS (week 0) to abnormal CS (week 26)	Abnormal CS (week 0) to normal (week 26)	Abnormal CS (week 0) to abnormal NCS (week 26)	Abnormal CS (week 0) to abnormal CS (week 26)	Normal (week 0) to Normal (week 52)	Normal (week 0) to Abnormal NCS (week 52)	Normal (week 0) to Abnormal CS (week 52)	Abnormal NCS (week 0) to Normal (week 52)	Abnormal NCS (week 0) to Abnormal NCS (week 52)	Abnormal NCS (week 0) to Abnormal CS (week 52)	Abnormal CS (week 0) to Normal (week 52)	Abnormal CS (week 0) to Abnormal NCS (week 52)	Abnormal CS (week 0) to Abnormal CS (week 52)
Liraglutide 1.8 mg	123	20	0	27	75	0	2	2	7	123	14	1	26	73	0	3	1	5
Oral Semaglutide 14 mg	130	19	0	15	81	0	0	2	3	113	31	1	19	73	0	0	1	3
Placebo	67	6	0	19	33	0	2	1	0	64	5	1	14	37	0	2	1	0

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Change in Total Cholesterol - Ratio to Baseline

Change from baseline (week 0) in total cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	Ratio of total cholesterol (Geometric Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	0.97	0.98
Oral Semaglutide 14 mg	0.96	0.98
Placebo	0.99	1.02

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Change in SMPG - Mean Postprandial Increment Over All Meals

Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	mmol/L (Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	-0.4	-0.5
Oral Semaglutide 14 mg	-0.7	-0.5
Placebo	-0.2	-0.4

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Change in SMPG - Mean 7-point Profile

Change from baseline (week 0) to week 26 and week 52 in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	mmol/L (Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	-2.0	-1.8
Oral Semaglutide 14 mg	-2.2	-2.2
Placebo	-0.7	-0.9

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Change in SBP and DBP

Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	mmHg (Mean)
	SBP: 26 weeks	SBP: 52 weeks	DBP: 26 weeks	DBP: 52 weeks
Liraglutide 1.8 mg	-4	-3	-0	-1
Oral Semaglutide 14 mg	-4	-3	-1	-1
Placebo	-2	-0	-1	0

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Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed)

"Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 (wk 26) and week 52 (wk 52). The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction." (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	Scores on a scale (Mean)
	Satisfaction with treatment: wk 26	Satisfaction with treatment: wk 52	Feeling of unacceptably high blood sugars: wk 26	Feeling of unacceptably high blood sugars: wk 52	Feeling of unacceptably low blood sugars: wk 26	Feeling of unacceptably low blood sugars: wk 52	Convenience of treatment: wk 26	Convenience of treatment: wk 52	Flexibility of treatment: wk 26	Flexibility of treatment: wk 52	Satisfaction with understanding of diabetes: wk 26	Satisfaction with understanding of diabetes: wk 52	Recommending treatment to others: wk 26	Recommending treatment to others: wk 52	Satisfaction to continue present treatment: wk 26	Satisfaction to continue present treatment: wk 52	Total treatment satisfaction: wk 26	Total treatment satisfaction: wk 52
Liraglutide 1.8 mg	0.73	0.70	-1.72	-1.71	0.03	-0.06	0.39	0.42	0.43	0.40	0.52	0.54	0.63	0.48	0.74	0.56	3.44	3.11
Oral Semaglutide 14 mg	0.72	0.67	-1.94	-1.97	-0.18	-0.17	0.55	0.50	0.45	0.38	0.66	0.65	0.57	0.60	0.64	0.60	3.59	3.41
Placebo	0.28	0.48	-0.87	-1.04	-0.07	-0.14	0.17	0.21	0.09	0.14	0.38	0.27	0.10	0.02	0.22	0.11	1.24	1.23

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Change in Body Weight (Week 26)

Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. (NCT02863419)
Timeframe: Week 0, week 26

Intervention	Kg (Mean)
	In-trial	On-treatment without rescue medication
Liraglutide 1.8 mg	-3.2	-3.3
Oral Semaglutide 14 mg	-4.4	-4.7
Placebo	-0.6	-0.7

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Change in Body Weight (%)

Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT02863419)
Timeframe: Week 0, Week 26, Week 52

Intervention	Percentage change (Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	-3.33	-3.25
Oral Semaglutide 14 mg	-4.89	-4.94
Placebo	-0.60	-0.99

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Change in Pulse Rate

Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT02863419)
Timeframe: Week 0, week 26, week 52

Intervention	Beats/min (Mean)
	Week 26	Week 52
Liraglutide 1.8 mg	3	3
Oral Semaglutide 14 mg	2	2
Placebo	0	0

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Changes From Baseline on Measurements of Respiratory Function Defined by Forced Vital Capacity (FVC)

"Changes from baseline on measurements of respiratory function defined by forced vital capacity (FVC).~Mean difference between 7 weeks after treatment visit and baseline visit is registered." (NCT02889510)
Timeframe: 7 weeks

Intervention	% (FVC) (Mean)
Liraglutide	5.4
Placebo	0.2

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Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC)

"Changes from baseline on measurements of respiratory function defined by forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC).~Mean difference between 7 weeks after treatment visit and baseline visit is registered." (NCT02889510)
Timeframe: 7 weeks

Intervention	% (FEV1/FVC) (Mean)
Liraglutide	-2.1
Placebo	1.7

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Changes From Baseline in Serum Levels of Surfactant A and D Protein

Changes from baseline in serum levels of surfactant A and D protein. Values for surfactant A or D protein after 7 treatment weeks (liraglutide or placebo) are registered. (NCT02889510)
Timeframe: 7 weeks

Intervention	ng/ml (Median)
	A protein	D protein
Liraglutide	40.9	169.6
Placebo	41.3	201.5

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Changes From Baseline on Measurements of Respiratory Function Defined by Total Lung Capacity (TLC)

Changes from baseline on measurements of respiratory function defined by Total lung capacity (TLC). (NCT02889510)
Timeframe: 7 weeks

Intervention	% (TLCO) (Mean)
Liraglutide	-2.6
Placebo	-3.1

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Changes From Baseline on Measurements of Respiratory Function Defined by Residual Volume (RV)

Changes from baseline on measurements of respiratory function defined by residual volume (RV). (NCT02889510)
Timeframe: 7 weeks

Intervention	% (RV) (Mean)
Liraglutide	3.2
Placebo	-1.1

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Changes From Baseline on Measurements of Respiratory Function Defined by Maximum Mid-expiratory Flow (FEF25-75)

"Changes from baseline on measurements of respiratory function defined by Maximum mid-expiratory flow (FEF25-75).~Mean difference between 7 weeks after treatment visit and baseline visit is registered." (NCT02889510)
Timeframe: 7 weeks

Intervention	% (FEF25-75) (Mean)
Liraglutide	8.0
Placebo	12.5

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Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second (FEV1)

"Changes from baseline on measurements of respiratory function defined by forced expiratory volume in 1 second (FEV1).~Mean difference between 7 weeks after treatment visit and baseline visit is registered." (NCT02889510)
Timeframe: 7 weeks

Intervention	% (FEV1) (Mean)
Liraglutide	4.1
Placebo	4.3

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Change in 36-Item Short Form Survey (SF-36) - Physical Component Summary

"All sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health.~Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10.~Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health." (NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	T scores (Mean)
CMS-Alone	4.4
CMS-Liraglutide	2.1
Multi-Component Intervention	3.4

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Change in C Reactive Protein

(NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	mg/L (Mean)
CMS-Alone	-0.4
CMS-Liraglutide	-2.0
Multi-Component Intervention	-3.0

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Change in Diastolic Blood Pressure

(NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	mm Hg (Mean)
CMS-Alone	-3.0
CMS-Liraglutide	-2.9
Multi-Component Intervention	-3.5

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Change in Fasting Glucose

(NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	mg/dL (Mean)
CMS-Alone	0.01
CMS-Liraglutide	-5.2
Multi-Component Intervention	-5.7

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Change in Fasting Insulin

(NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	uIU/mL (Mean)
CMS-Alone	-1.5
CMS-Liraglutide	-1.1
Multi-Component Intervention	-1.5

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Change in HbA1c

(NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	percentage (Mean)
CMS-Alone	-0.3
CMS-Liraglutide	-0.5
Multi-Component Intervention	-0.6

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Change in HDL Cholesterol

(NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	mg/dL (Mean)
CMS-Alone	-1.3
CMS-Liraglutide	3.0
Multi-Component Intervention	2.0

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Change in Heart Rate

(NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	Beats per minute (Mean)
CMS-Alone	-7.4
CMS-Liraglutide	-5.3
Multi-Component Intervention	9.7

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Change in HOMA-IR

HOMA-IR is a measurement for insulin resistance and is calculated from: fasting insulin (U/L) x fasting glucose (mg/dL)/405. A decrease from baseline to the end of treatment, a negative value, indicates an improvement (NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	mg/dL*µIU/mL/405 (Mean)
CMS-Alone	-0.4
CMS-Liraglutide	-0.3
Multi-Component Intervention	-0.4

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Change in LDL Cholesterol

(NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	mg/dL (Mean)
CMS-Alone	-3.3
CMS-Liraglutide	-9.6
Multi-Component Intervention	-9.4

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Change in Patient Health Questionnaire (PHQ-9)

PHQ-9 is scored based on a 0-27 scale in which higher scores indicate more severe depression. Values are summed to compute the total score. (NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	score on a scale (Mean)
CMS-Alone	-1.8
CMS-Liraglutide	-1.9
Multi-Component Intervention	-1.5

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Change in Systolic Blood Pressure

(NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	mm Hg (Mean)
CMS-Alone	-14.1
CMS-Liraglutide	-13.3
Multi-Component Intervention	-15.3

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Change in Total Cholesterol

(NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	mg/dL (Mean)
CMS-Alone	-7.0
CMS-Liraglutide	-9.7
Multi-Component Intervention	-10.0

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Change in Triglycerides

(NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	mg/dL (Mean)
CMS-Alone	-16.3
CMS-Liraglutide	-21.3
Multi-Component Intervention	-14.4

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Change in Waist Circumference

(NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	cm (Mean)
CMS-Alone	-6.5
CMS-Liraglutide	-11.1
Multi-Component Intervention	-12.6

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Extension Study Primary Outcome: Percent Change in Re-randomization Weight

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	percent change (Mean)
12-Week Extension Study: Phentermine Group	-1.6
12-Week Extension Study: Placebo Group	-0.1

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Extension Study Secondary Outcome: Change in c-Reactive Protein

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	mg/L (Mean)
12-Week Extension Study: Placebo Group	-0.8
12-Week Extension Study: Phentermine Group	-0.6

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Extension Study Secondary Outcome: Change in Diastolic Blood Pressure

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	mm Hg (Mean)
12-Week Extension Study: Phentermine Group	1.3
12-Week Extension Study: Placebo Group	0.2

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Extension Study Secondary Outcome: Change in Fasting Glucose

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	mg/dL (Mean)
12-Week Extension Study: Placebo Group	1.4
12-Week Extension Study: Phentermine Group	6.3

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Extension Study Secondary Outcome: Change in Fasting Insulin

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	uIU/mL (Mean)
12-Week Extension Study: Placebo Group	0.2
12-Week Extension Study: Phentermine Group	0.5

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Extension Study Secondary Outcome: Change in HbA1c

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	percentage (Mean)
12-Week Extension Study: Placebo Group	0.0
12-Week Extension Study: Phentermine Group	0.0

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Extension Study Secondary Outcome: Change in HDL Cholesterol

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	mg/dL (Mean)
12-Week Extension Study: Placebo Group	0.6
12-Week Extension Study: Phentermine Group	2.0

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Extension Study Secondary Outcome: Change in Heart Rate

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	Beats per minute (Mean)
12-Week Extension Study: Placebo Group	0
12-Week Extension Study: Phentermine Group	2.1

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Extension Study Secondary Outcome: Change in HOMA-IR

Intervention	mg/dL*µIU/mL/405 (Mean)
12-Week Extension Study: Placebo Group	0.1
12-Week Extension Study: Phentermine Group	0.3

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Extension Study Secondary Outcome: Change in LDL Cholesterol

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	mg/dL (Mean)
12-Week Extension Study: Placebo Group	2.3
12-Week Extension Study: Phentermine Group	-2.4

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Extension Study Secondary Outcome: Change in Systolic Blood Pressure

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	mm Hg (Mean)
12-Week Extension Study: Placebo Group	1.2
12-Week Extension Study: Phentermine Group	2.0

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Extension Study Secondary Outcome: Change in Total Cholesterol

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	mg/dL (Mean)
12-Week Extension Study: Placebo Group	3.4
12-Week Extension Study: Phentermine Group	0.4

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Extension Study Secondary Outcome: Change in Triglycerides

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	mg/dL (Mean)
12-Week Extension Study: Placebo Group	4.1
12-Week Extension Study: Phentermine Group	6.6

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Extension Study Secondary Outcome: Change in Waist Circumference

(NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	cm (Mean)
12-Week Extension Study: Placebo Group	-0.6
12-Week Extension Study: Phentermine Group	-0.4

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Extension Study Secondary Outcome: Patient Health Questionnaire (PHQ-9)

PHQ-9 is scored based on a 0-27 scale in which higher scores indicate more severe depression. Values are summed to compute the total score. (NCT02911818)
Timeframe: Re-randomization and 12 weeks

Intervention	score on a scale (Mean)
12-Week Extension Study: Placebo Group	0.2
12-Week Extension Study: Phentermine Group	0.0

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Extension Study Secondary Outcome: SF-36 - Mental Health Component

Intervention	T scores (Mean)
12-Week Extension Study: Placebo Group	-0.1
12-Week Extension Study: Phentermine Group	0.2

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Percent Change in Baseline Weight

(NCT02911818)
Timeframe: Randomization and 52 weeks

Intervention	percent change (Mean)
CMS-Alone	-6.1
CMS-Liraglutide	-11.5
Multi-Component Intervention	-11.8

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Extension Study Secondary Outcome: SF-36 - Physical Health Component

Intervention	T scores (Mean)
12-Week Extension Study: Placebo Group	0.3
12-Week Extension Study: Phentermine Group	-1.2

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Change 36-Item Short Form Survey (SF-36) - Mental Component Summary

Intervention	T scores (Mean)
CMS-Alone	0.8
CMS-Liraglutide	4.5
Multi-Component Intervention	6.4

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Fasting Lipid Profile

Lipid profile includes total cholesterol, low density lipoprotein cholesterol (LDL cholesterol), high density lipoprotein cholesterol (HDL cholesterol), very low density lipoprotein cholesterol (VLDL cholesterol), triglycerides and free fatty acids. Lipid profile parameters are represented as ratio to baseline values. (NCT02911948)
Timeframe: Week 0, week 26

Intervention	Ratio (Geometric Mean)
	Total cholesterol	HDL cholesterol	LDL cholesterol	VLDL cholesterol	Triglycerides	Free fatty acids
Insulin Degludec	0.96	0.95	0.95	0.97	0.97	0.77
Insulin Degludec/Liraglutide	0.90	0.90	0.86	1.02	1.02	0.86

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Number of Treatment Emergent Adverse Events (TEAE)

Intervention	Number of events (Number)
Insulin Degludec/Liraglutide	280
Insulin Degludec	210

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Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition

Intervention	Number of episodes (Number)
Insulin Degludec/Liraglutide	780
Insulin Degludec	717

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Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Nocturnal period: The period between 00:01 and 05:59 a.m. (both inclusive).~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT02911948)
Timeframe: During 26 weeks of treatment

Intervention	Number of episodes (Number)
Insulin Degludec/Liraglutide	4
Insulin Degludec	8

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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Intervention	Number of episodes (Number)
Insulin Degludec/Liraglutide	52
Insulin Degludec	43

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Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT02911948)
Timeframe: During 26 weeks of treatment

Intervention	Number of episodes (Number)
Insulin Degludec/Liraglutide	124
Insulin Degludec	109

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Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: Diabetes Therapy-Related Quality of Life (DTR-QOL)Questionnaire

"For the DTR-QOL questionnaire, change from baseline in the 'Total score' and the following four 'Domain scores' were analysed:~Burden on social activities and daily activities~Anxiety and dissatisfaction with treatment~Hypoglycaemia~Satisfaction with treatment. The scoring range of 'Total score' was converted to 0-100 (best case response = 100; worst case response = 0).~The scoring range for each of four domains was converted to 0-100 (best case response = 100; worst case response = 0)." (NCT02911948)
Timeframe: week 0, week 26

Intervention	Score on a scale (Mean)
	Total score	Burden on social activities and daily activities	Anxiety and dissatisfaction with treatment	Hypoglycaemia	Satisfaction with treatment
Insulin Degludec	0.1	0.6	0.4	-1.6	-0.4
Insulin Degludec/Liraglutide	7.9	5.7	12.9	-2.6	15.8

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Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: EuroQol-5D (EQ-5D-5L) Questionnaire

"Overall health state was rated by patients using the EQ-5D-5L visual analogue scale (VAS) and the EQ-5D-5L index score. The EQ-5D-5L VAS is a vertical scale where patients can rank their health from 0 (worst health imaginable) to 100 (best health imaginable).~The EQ-5D-5L index score was calculated based on the 5 dimensions, i.e., mobility, self-care, usual activities (e.g., work, study), pain/discomfort and anxiety/depression with five response levels for each dimension, i.e., no problems, slight problems, moderate problems, severe problems and extreme problems. The scores from 5 dimensions are then converted to the EQ-5D-5L index score scale: 0 - 1 (full health/best-case response = 1; death/worst-case response = 0)." (NCT02911948)
Timeframe: week 0, week 26

Intervention	Score on a scale (Mean)
	Change in VAS score	Index score
Insulin Degludec	-1.0	-0.01
Insulin Degludec/Liraglutide	6.3	0.02

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Change in Blood Pressure (Systolic and Diastolic)

Change from baseline in blood pressure (systolic and diastolic) after 26 weeks of treatment. (NCT02911948)
Timeframe: week 0, week 26

Intervention	mmHg (Mean)
	Systolic blood pressure	Diastolic blood pressure
Insulin Degludec	0.9	1.2
Insulin Degludec/Liraglutide	-0.6	0.9

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Change in Clinical Evaluation: Electrocardiogram (ECG)

The result of the ECG was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' ECG results at screening (week -2 to week 0) and week 26. (NCT02911948)
Timeframe: Screening (week -2 to week 0), week 26

Intervention	Participants (Count of Participants)
	At screening visit - normal	At screening visit - Abn, NCS	At screening visit - Abn, CS	Week 26 -normal	Week 26 - Abn, NCS	Week 26 - Abn, CS
Insulin Degludec	82	18	5	82	20	3
Insulin Degludec/Liraglutide	80	20	5	82	17	6

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Change in Clinical Evaluation: Fundoscopy or Fundus Photography

The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at screening (week -2 to week 0) and week 26. (NCT02911948)
Timeframe: Screening (week -2 to week 0), week 26

Intervention	Participants (Count of Participants)
	Left eye - at screening visit - normal	Left eye - at screening visit - Abn, NCS	Left eye - at screening visit - Abn, CS	Left eye - week 26 - normal	Left eye - week 26 - Abn, NCS	Left eye - week 26 - Abn, CS	Right eye - at screening visit - normal	Right eye - at screening visit - Abn, NCS	Right eye - at screening visit - Abn, CS	Right eye - week 26 - normal	Right eye - week 26 - Abn, NCS	Right eye - week 26 - Abn, CS
Insulin Degludec	70	5	30	64	7	34	72	6	27	69	6	30
Insulin Degludec/Liraglutide	53	6	46	54	7	44	55	7	43	52	8	45

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Daily Insulin Dose

Actual daily total insulin dose after 26 weeks. (NCT02911948)
Timeframe: After 26 weeks

Intervention	Units (Mean)
Insulin Degludec/Liraglutide	37.6
Insulin Degludec	41.2

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Responder (Yes/no): HbA1c Less Than 7.0%

Number of subjects with HbA1c less than 7.0% after 26 weeks. (NCT02911948)
Timeframe: After 26 weeks

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	23	82
Insulin Degludec/Liraglutide	75	30

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Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain

Number of subjects with HbA1c less than 7.0% and without weight gain after 26 weeks. (NCT02911948)
Timeframe: After 26 weeks

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	9	96
Insulin Degludec/Liraglutide	50	55

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Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

"Number of subjects with HbA1c less than 7.0% and no weight gain after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02911948)
Timeframe: After 26 weeks

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	7	94
Insulin Degludec/Liraglutide	49	56

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Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG after 26 weeks of treatment. (NCT02911948)
Timeframe: week 0, week 26

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	-2.81
Insulin Degludec	-2.29

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Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

"Number of subjects with HbA1c less than 7.0% after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02911948)
Timeframe: After 26 weeks

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	20	81
Insulin Degludec/Liraglutide	70	35

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Responder (Yes/no): HbA1c Less Than or Equal to 6.5%

Number of subjects with HbA1c less than or equal to 6.5% after 26 weeks. (NCT02911948)
Timeframe: After 26 weeks

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	9	96
Insulin Degludec/Liraglutide	57	48

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Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain

Number of subjects with HbA1c less than or equal to 6.5% and without weight gain (NCT02911948)
Timeframe: After 26 weeks

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	4	101
Insulin Degludec/Liraglutide	38	67

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Change in Body Weight

Change from baseline (week 0) in body weight after 26 weeks of treatment. (NCT02911948)
Timeframe: week 0, week 26

Intervention	Kg (Mean)
Insulin Degludec/Liraglutide	-0.7
Insulin Degludec	0.7

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Change in SMBG 9-point Profile: Mean of Postprandial Plasma Glucose Increments (From Before Meal to 90 Minutes After Breakfast, Lunch and Dinner)

Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. The mean increment over all meals was derived as the mean of all available meal increments. (NCT02911948)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	-0.76
Insulin Degludec	0.70

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Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline (week 0) in HbA1c after 26 weeks of treatment. (NCT02911948)
Timeframe: week 0, week 26

Intervention	Percentage of HbA1c (Mean)
Insulin Degludec/Liraglutide	-1.95
Insulin Degludec	-0.65

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Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

"Number of subjects with HbA1c less than or equal to 6.5% and no weight gain after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02911948)
Timeframe: After 26 weeks

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	3	98
Insulin Degludec/Liraglutide	37	68

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Responder (Yes/no): HbA1c Less Than or Equal to 6.5% Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

"Number of subjects with HbA1c less than or equal to 6.5% after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia." (NCT02911948)
Timeframe: After 26 weeks

Intervention	Participants (Count of Participants)
	Yes	No
Insulin Degludec	8	93
Insulin Degludec/Liraglutide	53	52

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Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile)

Intervention	mmol/L (Mean)
	Before breakfast	90 minutes after start of breakfast	Before lunch	90 minutes after start of lunch	Before dinner	90 minutes after start of dinner	At Bedtime	At 4:00 a.m.	Before breakfast the following day
Insulin Degludec	6.53	12.02	8.49	12.84	8.60	13.27	11.98	7.72	6.40
Insulin Degludec/Liraglutide	6.59	11.00	7.22	10.59	7.39	11.09	9.57	6.75	6.14

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Change in Waist Circumference

Change from baseline (week 0) in waist circumference after 26 weeks of treatment. (NCT02911948)
Timeframe: week 0, week 26

Intervention	cm (Mean)
Insulin Degludec/Liraglutide	-0.6
Insulin Degludec	0.1

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Change in SMBG 9-point Profile: Mean of the 9-point Profile

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	-2.90
Insulin Degludec	-1.11

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Change in Pulse

Change in pulse after 26 weeks of treatment. (NCT02911948)
Timeframe: Week 0, week 26

Intervention	beats per minute (Mean)
Insulin Degludec/Liraglutide	6.1
Insulin Degludec	-0.2

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Change in BMI

Change in BMI was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	kg/m^2 (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-1.8	-1.6	1.5
Placebo	-0.2	0.1	0.7

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Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))

Change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 82, and from week 56 to week 82. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the trial period, week 0-30 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30 or 82, respectively. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 82); (Week 56, week 82)

Intervention	SDS score (Mean)
	Change from week 0 to week 30	Change from week 0 to week 82	Change from week 56 to week 82
Liraglutide 3.0 mg	-0.26	-0.06	0.22
Placebo	-0.04	0.07	0.08

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Change in BMI SDS (%)

Relative change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 56. Results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56)

Intervention	Percentage change (Least Squares Mean)
	Change from week 0 to week 30	Change from week 0 to week 56
Liraglutide 3.0 mg	-8.73	-8.32
Placebo	-1.70	-0.68

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Change in Body Weight (%)

Relative change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Percentage change (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-4.3	-3.2	5.3
Placebo	0.4	2.2	2.3

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Change in Body Weight (kg)

Change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	kg (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-3.9	-2.7	4.7
Placebo	0.4	2.1	2.4

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Change in C-SSRS

"This outcome measure presents number of subjects with suicidal ideation or suicidal behaviour on the Columbia Suicidality Severity Rating Scale (C-SSRS) assessed at baseline (week 0), week 30, week 56 and week 82. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82." (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Participants (Count of Participants)
	Wk 0: Suicidal ideation	Wk 0: Suicidal behaviour	Wk0: Self-injurious behaviour, no suicidal intent	Wk 30: Suicidal ideation	Wk 30: Suicidal behaviour	Wk30: Self-injurious behaviour, no suicidal intent	Wk 56: Suicidal ideation	Wk 56: Suicidal behaviour	Wk56: Self-injurious behaviour, no suicidal intent	Wk 82: Suicidal ideation	Wk 82: Suicidal behaviour	Wk82: Self-injurious behaviour, no suicidal intent
Liraglutide 3.0 mg	2	0	0	0	0	0	0	0	0	0	0	0
Placebo	2	1	1	0	0	0	0	0	0	0	0	0

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Change in CTX1

Change in type I collagen C-telopeptide (CTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	pg/mL (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-7	-36	-107
Placebo	-84	-97	-162

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Change in Fasting C-peptide (Ratio to Baseline)

Change in fasting C-peptide from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Ratio of fasting C-peptide (Geometric Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	1.12	0.98	0.92
Placebo	1.04	0.97	0.94

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Change in Fasting Insulin (Ratio to Baseline)

Change in fasting insulin from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Ratio of fasting insulin (Geometric Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	1.13	1.06	1.00
Placebo	1.14	1.10	1.08

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Change in Fasting Lipid: FFA (Ratio to Baseline)

Change in free fatty acids (FFA) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Ratio of FFA (Geometric Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	0.96	1.00	0.99
Placebo	0.83	0.95	0.94

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Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)

Change in high density lipoprotein (HDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Ratio of HDL-cholesterol (Geometric Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	1.04	1.04	0.99
Placebo	1.01	1.02	1.00

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Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)

Change in low density lipoprotein (LDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Ratio of LDL-cholesterol (Geometric Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	1.00	0.99	1.03
Placebo	1.00	1.02	1.04

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Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline)

Change in non-HDL cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Ratio of non-HDL cholesterol (Geometric Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	0.98	0.98	1.03
Placebo	0.97	0.99	1.02

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Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)

Change in total cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Ratio of total cholesterol (Geometric Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	1.00	1.00	1.02
Placebo	0.98	1.00	1.02

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Change in Fasting Lipid: Triglycerides (Ratio to Baseline)

Change in triglycerides from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Ratio of triglycerides (Geometric Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	0.91	0.92	1.04
Placebo	0.91	0.93	0.97

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Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline)

Change in very low density lipoprotein (VLDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Ratio of VLDL cholesterol (Geometric Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	0.91	0.92	1.04
Placebo	0.90	0.93	0.97

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Change in FPG

Change in fasting plasma glucose (FPG) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed treatment for the corresponding treatment period (week 0-30, week 0-56 or week 0-82). (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	mmol/L (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-0.2	-0.1	0.1
Placebo	-0.0	-0.0	0.1

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Change in Haematology: Erythrocytes

Change in erythrocytes was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	10^12 cells/L (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	0.0	-0.0	-0.1
Placebo	-0.0	-0.1	0.0

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Change in Haematology: Haematocrit

Change in haematocrit was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	% of red blood cells (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	0.7	1.2	-0.4
Placebo	0.1	0.4	-0.4

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Change in Haematology: Haemoglobin

Change in haemoglobin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	mmol/L (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	0.2	0.3	-0.1
Placebo	0.0	0.1	-0.0

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Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes

"Change in haematological parameters, thrombocytes, leucocytes, eosinophils, neutrophils, basophils, lymphocytes and monocytes was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82." (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	10^9 cells/L (Mean)
	Thrombocytes: Change from week 0 to week 30	Thrombocytes: Change from week 0 to week 56	Thrombocytes: Change from week 56 to week 82	Leucocytes: Change from week 0 to week 30	Leucocytes: Change from week 0 to week 56	Leucocytes: Change from week 56 to week 82	Eosinophils: Change from week 0 to week 30	Eosinophils: Change from week 0 to week 56	Eosinophils: Change from week 56 to week 82	Neutrophils: Change from week 0 to week 30	Neutrophils: Change from week 0 to week 56	Neutrophils: Change from week 56 to week 82	Basophils: Change from week 0 to week 30	Basophils: Change from week 0 to week 56	Basophils: Change from week 56 to week 82	Lymphocytes: Change from week 0 to week 30	Lymphocytes: Change from week 0 to week 56	Lymphocytes: Change from week 56 to week 82	Monocytes: Change from week 0 to week 30	Monocytes: Change from week 0 to week 56	Monocytes: Change from week 56 to week 82
Liraglutide 3.0 mg	9	7	-2	0.1	-0.2	0.2	0.03	0.01	-0.01	0.18	-0.01	0.21	0.01	0.01	0.00	-0.18	-0.28	-0.03	0.04	0.06	-0.00
Placebo	14	7	3	-0.1	-0.4	0.0	0.04	0.00	0.00	-0.01	-0.13	-0.00	0.01	0.02	0.00	-0.14	-0.27	-0.00	0.00	0.01	0.04

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Change in HbA1c

Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Percentage of HbA1c (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-0.1	-0.1	0.1
Placebo	-0.0	-0.0	0.1

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Change in Height SDS

Change in height standard deviation score (SDS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	SDS (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	0.11	0.20	0.07
Placebo	0.13	0.24	0.06

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Change in HOMA-B (Ratio to Baseline)

Change in homeostasis model assessment of beta-cell function (HOMA-B) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5). Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Ratio of HOMA-B (Geometric Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	1.32	1.13	0.92
Placebo	1.17	1.11	1.02

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Change in HOMA-IR (Ratio to Baseline)

Change in homeostasis model assessment of insulin resistance (HOMA-IR) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting insulin [mU/L] x FPG [mmol/L]/ 22.5. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Ratio of HOMA-IR (Geometric Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	1.08	1.04	1.03
Placebo	1.14	1.09	1.11

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Change in Hormone Level: Calcitonin

Change in calcitonin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	ng/L (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	0.1	0.0	-0.1
Placebo	0.1	-0.0	0.2

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Change in Hormone Level: DHEAS

Change in dehydroepiandrosterone sulfate (DHEAS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	umol/L (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	0.94	0.95	-0.08
Placebo	0.57	0.89	-0.05

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Change in Hormone Level: Estradiol (Females)

Change in estradiol (only for female) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	pg/mL (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-5.0	11.6	-2.3
Placebo	20.2	14.1	-1.7

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Change in Hormone Level: Free T4 and ACTH

"Change in hormone levels, thyroxine (T4) and adrenocorticotropic hormone (ACTH) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82." (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	pmol/L (Mean)
	T4: Change from week 0 to week 30	T4: Change from week 0 to week 56	T4: Change from week 56 to week 82	ACTH: Change from week 0 to week 30	ACTH: Change from week 0 to week 56	ACTH: Change from week 56 to week 82
Liraglutide 3.0 mg	0.6	0.3	0.0	0.4	0.6	-0.8
Placebo	0.8	0.6	0.2	0.5	0.6	-0.4

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Change in Hormone Level: IGF-1 and Cortisol

"Change in hormone levels, insulin-like growth factor-1 (IGF-1) and cortisol was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82." (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	ng/mL (Mean)
	IGF-1: Change from week 0 to week 30	IGF-1: Change from week 0 to week 56	IGF-1: Change from week 56 to week 82	Cortisol: Change from week 0 to week 30	Cortisol: Change from week 0 to week 56	Cortisol: Change from week 56 to week 82
Liraglutide 3.0 mg	10.61	-4.60	-14.60	6.9	5.1	0.6
Placebo	3.79	3.69	-16.35	8.6	8.5	10.4

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Change in Hormone Level: LH and FSH

"Change in hormone levels, luteinising hormone (LH) and follicle stimulating hormone (FSH) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82." (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	IU/L (Mean)
	LH: Change from week 0 to week 30	LH: Change from week 0 to week 56	LH: Change from week 56 to week 82	FSH: Change from week 0 to week 30	FSH: Change from week 0 to week 56	FSH: Change from week 56 to week 82
Liraglutide 3.0 mg	0.4	0.2	0.4	0.2	0.6	-0.1
Placebo	0.7	0.6	-0.5	-0.2	0.1	-0.1

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Change in Hormone Level: Testosterone (Males)

"This outcome measure presents testosterone (only for males) results for baseline (week 0), week 30, week 56 and week 82. ADVIA Centaur Testosterone (TSTO) assay was used for the evaluation of testosterone hormone. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82." (NCT02918279)
Timeframe: Week 0, week 30, week 56 and week 82

Intervention	nmol/L (Mean)
	Week 0	Week 30	Week 56	Week 82
Liraglutide 3.0 mg	8.13	10.00	10.55	11.36
Placebo	8.06	9.33	9.51	6.16

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Change in Hormone Level: TSH and Prolactin

"Change in hormone levels, thyroid stimulating hormone (TSH) and prolactin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82." (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	mIU/L (Mean)
	TSH: Change from week 0 to week 30	TSH: Change from week 0 to week 56	TSH: Change from week 56 to week 82	Prolactin: Change from week 0 to week 30	Prolactin: Change from week 0 to week 56	Prolactin: Change from week 56 to week 82
Liraglutide 3.0 mg	-0.35	-0.42	0.38	23	63	-29
Placebo	-0.08	-0.14	0.13	-47	-63	13

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Change in hsCRP

Change in high sensitivity C reactive protein (hsCRP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	mg/L (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-0.22	-0.25	1.51
Placebo	-0.56	-0.14	1.00

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Number of Treatment Emergent Adverse Events

"A treatment emergent adverse event (TEAE) was defined as an event that occurred in the on-treatment period. 'On-treatment' period: Events with onset date between the first day of trial product administration and any of the following date, whichever came first: 1) 14 days after the last day on trial product, or 2) follow-up visit (week 58) for participants who discontinued trial product, or 3) last study visit (participants withdrawn without follow-up visit)." (NCT02918279)
Timeframe: Week 0-56 + 14 days

Intervention	Events (Number)
Liraglutide 3.0 mg	777
Placebo	627

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Change in NTX1

"Change in type I collagen N-telopeptide (NTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are presented in nmol bone collagen equivalents (BCE)/L. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82." (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	nmol BCE/L (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-2.4	-3.7	-2.8
Placebo	-3.2	-2.9	-4.6

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Change in Nutritional Compliance

"This outcome measure presents nutritional compliance results recorded at baseline (week 0), week 30 and week 56. Nutritional compliance was recorded on a 0 to 10 numeric rating scale, with higher scores representing better compliance. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56." (NCT02918279)
Timeframe: Week 0, week 30 and week 56

Intervention	Score on a scale (Mean)
	Week 0	Week 30	Week 56
Liraglutide 3.0 mg	7.10	6.74	6.87
Placebo	7.07	6.51	6.45

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Change in IWQOL-Kids

Change in Impact of Weight on Quality of Life-Kids (IWQOL-Kids) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. The IWQOL-Kids is a 27-item measure of weight-related quality of life. There are four domain scores (Physical Comfort, Body Esteem, Social Life and Family Life) and a total score. Scores for all domains and total score range from 0-100, with higher scores representing better health-related quality of life. IWQOL-kids data at week 82 was not collected, thus could not be evaluated. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Scores on a scale (Mean)
	Body Esteem: Change from week 0 to week 30	Body Esteem: Change from week 0 to week 56	Family Relation: Change from week 0 to week 30	Family Relation: Change from week 0 to week 56	Physical Function: Change from week 0 to week 30	Physical Function: Change from week 0 to week 56	Social Life: Change from week 0 to week 30	Social Life: Change from week 0 to week 56	Total: Change from week 0 to week 30	Total: Change from week 0 to week 56
Liraglutide 3.0 mg	10.62	13.33	2.53	1.44	3.94	6.17	5.32	5.97	6.16	7.46
Placebo	6.73	13.24	-2.19	0.97	0.43	3.32	1.76	6.06	2.24	6.72

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Change in PHQ-9

Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Score on a scale (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-1	-1	0
Placebo	-1	-2	-0

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Change in Pulse

Change in pulse was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Beats/minute (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	4	4	-3
Placebo	-1	-1	2

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Change in Systolic and Diastolic Blood Pressure

Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	mmHg (Mean)
	SBP: Change from week 0 to week 30	SBP: Change from week 0 to week 56	SBP: Change from week 56 to week 82	DBP: Change from week 0 to week 30	DBP: Change from week 0 to week 56	DBP: Change from week 56 to week 82
Liraglutide 3.0 mg	-2	-2	2	-0	1	2
Placebo	-1	1	1	-1	-1	2

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Change in Waist Circumference

Change in waist circumference was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	cm (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-4.63	-5.12	3.58
Placebo	-2.01	-1.51	1.24

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Change in Waist-to-hip Circumference Ratio

Change in waist-to-hip circumference ratio was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Ratio (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-0.015	-0.022	0.010
Placebo	-0.018	-0.023	0.003

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Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification)

A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Severe hypoglycaemia episodes were recorded as per international society for pediatric and adolescent diabetes (ISPAD) definition. And the following presented hypoglycaemia episodes were recorded as per American Diabetes Association (ADA) definition: asymptomatic hypoglycaemia, documented symptomatic hypoglycaemia, pseudo-hypoglycaemia and probable symptomatic hypoglycaemia. (NCT02918279)
Timeframe: Week 0-56 + 14 days

Intervention	Episodes (Number)
	Severe hypoglycaemia	Asymptomatic hypoglycaemia	Documented symptomatic hypoglycaemia	Probable symptomatic hypoglycaemia	Pseudo-hypoglycaemia	Unclassifiable
Liraglutide 3.0 mg	0	12	31	1	30	4
Placebo	0	17	6	2	3	0

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Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification)

Severe hypoglycaemia episodes were recorded as per the ISPAD definition. And the following presented hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG-confirmed: An episode that is BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG-confirmed: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. (NCT02918279)
Timeframe: Week 0-56 + 14 days

Intervention	Episodes (Number)
	Severe hypoglycaemia	Asymptomatic BG-confirmed hypoglycaemia	Symptomatic BG-confirmed hypoglycaemia	Unclassifiable
Liraglutide 3.0 mg	0	1	4	73
Placebo	0	1	0	27

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Occurrence of Anti-liraglutide Antibodies

This outcome measure is only applicable for the liraglutide 3.0 mg treatment arm. Number of participants who measured with anti-liraglutide binding antibodies at weeks 0, 30, 56, 58, 70 and 82 are presented. (NCT02918279)
Timeframe: Weeks 0, 30, 56, 58, 70 and 82

Intervention	Participants (Count of Participants)
	Weeks 0	Weeks 30	Weeks 56	Weeks 58	Weeks 70	Weeks 82
Liraglutide 3.0 mg	0	6	5	11	6	2

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Percent of Subjects Achieving ≥10% Reduction in Baseline BMI

Participants achieving more than or equal to 10% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively. (NCT02918279)
Timeframe: Weeks 30, 56 and 82

Intervention	Percentage of participants (Number)
	Week 30 (Yes)	Week 30 (No)	Week 56 (Yes)	Week 56 (No)	Week 82 (Yes)	Week 82 (No)
Liraglutide 3.0 mg	24.4	75.6	29.2	70.8	18.8	81.3
Placebo	5.2	94.8	8.6	91.4	10.8	89.2

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Percent of Subjects Achieving ≥5% Reduction in Baseline BMI

Participants achieving more than or equal to 5% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively. (NCT02918279)
Timeframe: Weeks 30, 56 and 82

Intervention	Percentage of participants (Number)
	Week 30 (Yes)	Week 30 (No)	Week 56 (Yes)	Week 56 (No)	Week 82 (Yes)	Week 82 (No)
Liraglutide 3.0 mg	46.2	53.8	45.1	54.9	29.5	70.5
Placebo	14.7	85.3	19.0	81.0	18.6	81.4

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Change in P1NP

Change in procollagen 1 N-terminal propeptide (P1NP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	ng/mL (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-35	-55	-30
Placebo	-30	-63	-47

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Change in Glycaemic Category

"Number of participants in glycaemic categories, normoglycaemia, pre-diabetes and type 2 diabetes (T2DM) at baseline (weeks -2), and weeks 30, 56 and 82 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes (T2DM): FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82." (NCT02918279)
Timeframe: Week -2, week 30, week 56 and week 82

Intervention	Participants (Count of Participants)
	Week -272582204			Week -272582205	Week 3072582204	Week 3072582205	Week 5672582204	Week 5672582205	Week 8272582204	Week 8272582205
	Normoglycaemia	Type 2 diabetes	Pre-diabetes
Liraglutide 3.0 mg	93
Placebo	93
Liraglutide 3.0 mg	31
Placebo	32
Liraglutide 3.0 mg	1
Placebo	1
Liraglutide 3.0 mg	95
Placebo	86
Liraglutide 3.0 mg	19
Placebo	29
Liraglutide 3.0 mg	2
Liraglutide 3.0 mg	86
Placebo	75
Liraglutide 3.0 mg	17
Placebo	24
Placebo	2
Liraglutide 3.0 mg	79
Placebo	65
Liraglutide 3.0 mg	20
Placebo	30
Placebo	4

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Change in Physical Examination

"This outcome measure presents number of subjects with physical examination findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) at baseline (week 0), week 30, week 56 and week 82. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82." (NCT02918279)
Timeframe: Week 0, week 30, week 56 and week 82

Intervention	Participants (Count of Participants)
	General Appearance: Week 072582204			General Appearance: Week 072582205	General Appearance: Week 3072582205	General Appearance: Week 3072582204	General Appearance: Week 5672582204	General Appearance: Week 5672582205	General Appearance: Week 8272582204	General Appearance: Week 8272582205	Head, ears, eyes, nose, throat, neck: Week 072582204	Head, ears, eyes, nose, throat, neck: Week 072582205	Head, ears, eyes, nose, throat, neck: Week 3072582204	Head, ears, eyes, nose, throat, neck: Week 3072582205	Head, ears, eyes, nose, throat, neck: Week 5672582205	Head, ears, eyes, nose, throat, neck: Week 5672582204	Head, ears, eyes, nose, throat, neck: Week 8272582204	Head, ears, eyes, nose, throat, neck: Week 8272582205	Respiratory system: Week 072582204	Respiratory system: Week 072582205	Respiratory system: Week 3072582205	Respiratory system: Week 3072582204	Respiratory system: Week 5672582205	Respiratory system: Week 5672582204	Respiratory system: Week 8272582204	Respiratory system: Week 8272582205	Cardiovascular system: Week 072582204	Cardiovascular system: Week 072582205	Cardiovascular system: Week 3072582204	Cardiovascular system: Week 3072582205	Cardiovascular system: Week 5672582204	Cardiovascular system: Week 5672582205	Cardiovascular system: Week 8272582205	Cardiovascular system: Week 8272582204	GI system including mouth: Week 072582204	GI system including mouth: Week 072582205	GI system including mouth: Week 3072582204	GI system including mouth: Week 3072582205	GI system including mouth: Week 5672582204	GI system including mouth: Week 5672582205	GI system including mouth: Week 8272582205	GI system including mouth: Week 8272582204	Musculoskeletal system: Week 072582205	Musculoskeletal system: Week 072582204	Musculoskeletal system: Week 3072582204	Musculoskeletal system: Week 3072582205	Musculoskeletal system: Week 5672582205	Musculoskeletal system: Week 5672582204	Musculoskeletal system: Week 8272582205	Musculoskeletal system: Week 8272582204	CNS and PNS: Week 072582204	CNS and PNS: Week 072582205	CNS and PNS: Week 3072582204	CNS and PNS: Week 3072582205	CNS and PNS: Week 5672582204	CNS and PNS: Week 5672582205	CNS and PNS: Week 8272582205	CNS and PNS: Week 8272582204	Skin: Week 072582204	Skin: Week 072582205	Skin: Week 3072582204	Skin: Week 3072582205	Skin: Week 5672582204	Skin: Week 5672582205	Skin: Week 8272582204	Skin: Week 8272582205	Thyroid gland: Week 072582204	Thyroid gland: Week 072582205	Thyroid gland: Week 3072582205	Thyroid gland: Week 3072582204	Thyroid gland: Week 5672582204	Thyroid gland: Week 5672582205	Thyroid gland: Week 8272582205	Thyroid gland: Week 8272582204	Lymph node palpation: Week 072582204	Lymph node palpation: Week 072582205	Lymph node palpation: Week 3072582204	Lymph node palpation: Week 3072582205	Lymph node palpation: Week 5672582204	Lymph node palpation: Week 5672582205	Lymph node palpation: Week 8272582204	Lymph node palpation: Week 8272582205
	Abnormal, CS	Normal	Abnormal, NCS
Liraglutide 3.0 mg	93
Liraglutide 3.0 mg	30
Placebo	23
Liraglutide 3.0 mg	94
Placebo	95
Liraglutide 3.0 mg	21
Placebo	20
Liraglutide 3.0 mg	84
Placebo	85
Placebo	16
Liraglutide 3.0 mg	80
Placebo	81
Liraglutide 3.0 mg	18
Placebo	17
Liraglutide 3.0 mg	120
Placebo	116
Liraglutide 3.0 mg	5
Liraglutide 3.0 mg	114
Placebo	107
Liraglutide 3.0 mg	2
Placebo	9
Liraglutide 3.0 mg	101
Liraglutide 3.0 mg	125
Placebo	123
Liraglutide 3.0 mg	116
Placebo	115
Placebo	96
Placebo	3
Placebo	112
Placebo	100
Liraglutide 3.0 mg	119
Placebo	6
Liraglutide 3.0 mg	111
Placebo	109
Liraglutide 3.0 mg	96
Placebo	94
Liraglutide 3.0 mg	121
Placebo	119
Liraglutide 3.0 mg	4
Liraglutide 3.0 mg	113
Placebo	106
Liraglutide 3.0 mg	3
Placebo	10
Liraglutide 3.0 mg	0
Liraglutide 3.0 mg	102
Placebo	97
Placebo	5
Liraglutide 3.0 mg	97
Placebo	92
Placebo	7
Liraglutide 3.0 mg	1
Liraglutide 3.0 mg	104
Liraglutide 3.0 mg	99
Liraglutide 3.0 mg	76
Placebo	58
Liraglutide 3.0 mg	47
Placebo	64
Liraglutide 3.0 mg	71
Liraglutide 3.0 mg	44
Placebo	56
Placebo	4
Liraglutide 3.0 mg	65
Liraglutide 3.0 mg	35
Placebo	53
Liraglutide 3.0 mg	57
Placebo	50
Liraglutide 3.0 mg	40
Placebo	48
Placebo	124
Placebo	114
Placebo	2
Placebo	101
Placebo	0
Placebo	98
Placebo	1
Liraglutide 3.0 mg	124
Placebo	125
Liraglutide 3.0 mg	115
Liraglutide 3.0 mg	103
Placebo	102
Liraglutide 3.0 mg	98

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Change in Pubertal Status

"This outcome measure presents pubertal status results which is based on Tanner staging (Tanner stage 2-5), recorded at baseline (week 0), week 30, week 56 and week 82. Results are presented for the following categories: 1) For female: breast development and pubic hair development (by Tanner staging). 2) For male: penis development and pubic hair development (by Tanner staging). Each category shows number of participants in stages 2 to 5, where stage 2 represents early pubertal development and stage 5 represents pubertal development equivalent to that of an adult. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82." (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	Participants (Count of Participants)
	Week 0: Breast development (for female)72582204				Week 0: Breast development (for female)72582205	Week 30: Breast development (for female)72582204	Week 30: Breast development (for female)72582205	Week 56: Breast development (for female)72582204	Week 56: Breast development (for female)72582205	Week 82: Breast development (for female)72582204	Week 82: Breast development (for female)72582205	Week 0: Pubic hair development (for female)72582204	Week 0: Pubic hair development (for female)72582205	Week 30: Pubic hair development (for female)72582204	Week 30: Pubic hair development (for female)72582205	Week 56: Pubic hair development (for female)72582204	Week 56: Pubic hair development (for female)72582205	Week 82: Pubic hair development (for female)72582204	Week 82: Pubic hair development (for female)72582205	Week 0: penis development (male)72582204	Week 0: penis development (male)72582205	Week 30: penis development (male)72582204	Week 30: penis development (male)72582205	Week 56: penis development (male)72582204	Week 56: penis development (male)72582205	Week 82: penis development (male)72582205	Week 82: penis development (male)72582204	Week 0: Pubic hair development (male)72582204	Week 0: Pubic hair development (male)72582205	Week 30: Pubic hair development (male)72582205	Week 30: Pubic hair development (male)72582204	Week 56: Pubic hair development (male)72582205	Week 56: Pubic hair development (male)72582204	Week 82: Pubic hair development (male)72582204	Week 82: Pubic hair development (male)72582205
	Stage 2	Stage 3	Stage 4	Stage 5
Liraglutide 3.0 mg	2
Placebo	1
Liraglutide 3.0 mg	6
Liraglutide 3.0 mg	23
Placebo	30
Liraglutide 3.0 mg	40
Placebo	39
Liraglutide 3.0 mg	1
Placebo	0
Placebo	6
Placebo	25
Liraglutide 3.0 mg	39
Placebo	43
Liraglutide 3.0 mg	0
Placebo	20
Placebo	41
Liraglutide 3.0 mg	46
Placebo	46
Placebo	3
Liraglutide 3.0 mg	22
Placebo	26
Liraglutide 3.0 mg	41
Placebo	44
Placebo	4
Liraglutide 3.0 mg	20
Placebo	45
Liraglutide 3.0 mg	13
Placebo	40
Liraglutide 3.0 mg	7
Liraglutide 3.0 mg	45
Liraglutide 3.0 mg	4
Placebo	7
Liraglutide 3.0 mg	11
Placebo	8
Liraglutide 3.0 mg	16
Placebo	14
Placebo	19
Placebo	2
Liraglutide 3.0 mg	14
Placebo	11
Liraglutide 3.0 mg	25
Liraglutide 3.0 mg	26
Placebo	29
Liraglutide 3.0 mg	31
Placebo	9
Liraglutide 3.0 mg	8
Placebo	5
Liraglutide 3.0 mg	19
Placebo	13
Liraglutide 3.0 mg	21
Placebo	21
Liraglutide 3.0 mg	10
Liraglutide 3.0 mg	15
Liraglutide 3.0 mg	24
Liraglutide 3.0 mg	3
Liraglutide 3.0 mg	30
Placebo	28

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Change in Alkaline Phosphatase (Bone)

Change in alkaline phosphatase (bone specific) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	U/L (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-15	-17	-1
Placebo	-12	-17	-4

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Change in BMI SDS (Week 0, Week 56)

Change from baseline (week 0) in BMI SDS was evaluated at week 56. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the week 0-56 trial period and participants who prematurely discontinued the trial product but attended the follow-up visit at 56. (NCT02918279)
Timeframe: Week 0, week 56

Intervention	SDS score (Mean)
Liraglutide 3.0 mg	-0.25
Placebo	-0.02

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Change in Biochemistry: Albumin

Change in albumin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	g/dL (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	0.1	0.1	-0.0
Placebo	0.0	0.1	-0.0

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Change in Biochemistry: CEA

Change in carcinoembryonic antigen (CEA) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	ng/mL (Mean)
	Change from week 0 to week 30	Change from week 0 to week 56	Change from week 56 to week 82
Liraglutide 3.0 mg	-0.0	0.0	0.0
Placebo	-0.1	-0.0	0.0

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Change in Biochemistry: Creatinine and Bilirubin (Total)

Change in creatinine and bilirubin (total) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	umol/L (Mean)
	Creatinine: Change from week 0 to week 30	Creatinine: Change from week 0 to week 56	Creatinine: Change from week 56 to week 82	Bilirubin (total): Change from week 0 to week 30	Bilirubin (total): Change from week 0 to week 56	Bilirubin (total): Change from week 56 to week 82
Liraglutide 3.0 mg	1	2	2	1	1	0
Placebo	0	4	1	1	1	-0

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Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP

"Change in biochemistry parameters, creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82." (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	U/L (Mean)
	Creatinine kinase: Change from week 0 to week 30	Creatinine kinase: Change from week 0 to week 56	Creatinine kinase: Change from week 56 to week 82	Amylase: Change from week 0 to week 30	Amylase: Change from week 0 to week 56	Amylase: Change from week 56 to week 82	Lipase: Change from week 0 to week 30	Lipase: Change from week 0 to week 56	Lipase: Change from week 56 to week 82	ALT: Change from week 0 to week 30	ALT: Change from week 0 to week 56	ALT: Change from week 56 to week 82	AST: Change from week 0 to week 30	AST: Change from week 0 to week 56	AST: Change from week 56 to week 82	ALP: Change from week 0 to week 30	ALP: Change from week 0 to week 56	ALP: Change from week 56 to week 82
Liraglutide 3.0 mg	13	32	28	4	2	-1	6	3	-4	-2	-2	1	-1	-1	1	-16	-23	-2
Placebo	0	0	4	3	-0	1	1	-2	-0	-1	-0	2	-1	-1	1	-8	-19	-10

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Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected

"Change in biochemistry parameters, urea (blood urea nitrogen [BUN]), sodium, potassium, calcium total and calcium (Ca) albumin-corrected was evaluated from baseline (week [Wk] 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82." (NCT02918279)
Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Intervention	mmol/L (Mean)
	Urea (BUN): Change from week 0 to week 30	Urea (BUN): Change from week 0 to week 56	Urea (BUN): Change from week 56 to week 82	Sodium: Change from week 0 to week 30	Sodium: Change from week 0 to week 56	Sodium: Change from week 56 to week 82	Potassium: Change from week 0 to week 30	Potassium: Change from week 0 to week 56	Potassium: Change from week 56 to week 82	Calcium total: Change from week 0 to week 30	Calcium total: Change from week 0 to week 56	Calcium total: Change from week 56 to week 82	Ca albumin-corrected:Change from week 0 to week 30	Ca albumin-corrected:Change from week 0 to week 56	Ca albumin-corrected: Change from Wk 56 to Wk 82
Liraglutide 3.0 mg	-0.06	-0.26	0.23	0	0	-1	-0.0	-0.1	0.0	-0.01	-0.04	-0.00	-0.04	-0.07	0.01
Placebo	0.00	-0.05	0.00	0	0	-1	0.0	-0.0	-0.0	-0.03	-0.04	-0.01	-0.03	-0.07	-0.00

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Change in ECG

"This outcome measure presents number of subjects with electrocardiogram findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) recorded at baseline (week -14), week 30 and week 56. These findings were categorised by the investigator. Electrocardiogram (ECG) data at week 82 was not collected, thus could not be evaluated. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56." (NCT02918279)
Timeframe: Week -14, week 30, week 56 and week 82

Intervention	Participants (Count of Participants)
	Week -1472582204			Week -1472582205	Week 3072582204	Week 3072582205	Week 5672582204	Week 5672582205
	Normal	Abnormal, CS	Abnormal, NCS
Liraglutide 3.0 mg	102
Placebo	100
Liraglutide 3.0 mg	23
Placebo	26
Placebo	0
Liraglutide 3.0 mg	97
Placebo	95
Liraglutide 3.0 mg	20
Placebo	21
Liraglutide 3.0 mg	83
Placebo	80
Liraglutide 3.0 mg	21
Placebo	23
Liraglutide 3.0 mg	0

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Change in Palmitate Turnover From Baseline to 12 Weeks

Palmitate turnover is measured using stable isotope tracers and is reported as mg/kg LBM per minute. (NCT02960659)
Timeframe: Baseline to 12 weeks

Intervention	mg/kg LBM/min (Mean)
Metformin	0.003
Metformin and Liraglutide	-0.18

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Change in Whole Body Insulin Sensitivity From Baseline to 12 Weeks

Whole body insulin sensitivity is estimated from a model of glucose and insulin values obtained during the OGTT and is measured in 10^-4 mU/ml/min (NCT02960659)
Timeframe: Baseline to 12 weeks

Intervention	10^-4 mU/ml/min (Mean)
Metformin	0.023
Metformin and Liraglutide	0.020

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Change in Glycerol Turnover From Baseline to 12 Weeks

Glycerol turnover is measured using stable isotope tracers and is reported as mg/kg LBM per minute. (NCT02960659)
Timeframe: Baseline to 12 weeks

Intervention	mg/kg LBM/min (Mean)
Metformin	-0.057
Metformin and Liraglutide	-0.030

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Change in Absolute Gluconeogenesis From Baseline to 12 Weeks

Gluconeogenesis is measured using stable isotope tracers and is reported as mg/kg lean body mass (LBM) per minute (NCT02960659)
Timeframe: Baseline to 12 weeks

Intervention	mg/kg LBM/min (Mean)
Metformin	0.018
Metformin and Liraglutide	-0.050

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Change in GIP AUC During OGTT and Meal Absorption

Change in glucose-dependent insulinotropic polypeptide (GIP) AUC during OGTT and meal absorption (NCT02960659)
Timeframe: Baseline to 12 weeks

Intervention	pg*ml/min (Mean)
Metformin	-4432
Metformin and Liraglutide	-1476

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Change in Glucose Production Rate From Baseline to 12 Weeks

Glucose production rate is measured using stable isotope tracers and is reported as mg/kg LBM per minute. (NCT02960659)
Timeframe: Baseline to 12 weeks

Intervention	mg/kg LBM/min (Mean)
Metformin	0.089
Metformin and Liraglutide	-0.101

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Change in Hepatic Insulin Sensitivity Index From Baseline to 12 Weeks

The Hepatic Insulin Sensitivity Index(HISI) is the reciprocal of glucose rate of appearance [1000/(μmol/min)] X insulin concentration [mU/L] (NCT02960659)
Timeframe: Baseline to 12 weeks

Intervention	1000mU/L/(μmol/min) (Mean)
Metformin	0.86
Metformin and Liraglutide	0.46

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Change in Insulin AUC Concentrations During an OGTT and Meal Absorption

Change in insulin AUC as derived from 2-hour oral glucose tolerance test (OGTT). AUC is calculated using a trapezoidal rule. Higher AUC indicates higher insulin secretion (NCT02960659)
Timeframe: Baseline to 12 weeks

Intervention	min*pmol/L (Mean)
Metformin	-6381
Metformin and Liraglutide	47831

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Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U)

Change in total daily basal insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Percentage change (Mean)
Liraglutide 3.0 mg	19
Placebo	64

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Change in Body Weight (%)

Change in body weight from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events [AEs]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Percentage change (Mean)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	-6.0	-6.5
Placebo	-1.5	-1.7

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Change in SF-36: Physical Component Summary (PCS)

Change in short form 36 v2.0 acute domain physical component summary (PCS) from baseline (week 0) to week 56 was presented based on in-trial data. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Score on a scale (Mean)
Liraglutide 3.0 mg	2.7
Placebo	2.2

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Change in SF-36: Mental Component Summary (MCS)

Change in short form 36 v2.0 acute domain mental component summary (MCS) from baseline (week 0) to week 56 was presented based on in-trial data. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Score on a scale (Mean)
Liraglutide 3.0 mg	-1.9
Placebo	-1.7

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Change in Resting Pulse

Change from baseline (week -1) to week 56 in resting pulse was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week -1, week 56

Intervention	Beats/minute (Mean)
Liraglutide 3.0 mg	2
Placebo	-0

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Change in Electrocardiogram (ECG)

The ECGs were interpreted by the investigator at baseline (week -1) and week 56 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 56 were presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week -1, week 56

Intervention	Participants (Count of Participants)
	Normal (week -1)	Abnormal NCS (week -1)	Abnormal CS (week -1)	Normal (week 56)	Abnormal NCS (week 56)	Abnormal CS (week 56)
Liraglutide 3.0 mg	113	78	4	118	62	5
Placebo	133	60	4	126	57	3

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Change in Laboratory Parameters (Biochemistry) - Uric Acid

Change from baseline (week 0) to week 56 in uric acid was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	mg/dL (Mean)
Liraglutide 3.0 mg	-0.2
Placebo	-0.0

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Change in Laboratory Parameters (Biochemistry) - Thyroid Stimulating Hormone

Change from baseline (week 0) to week 56 in thyroid stimulating hormone was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Milli-international units per liter (Mean)
Liraglutide 3.0 mg	-0.0842
Placebo	0.1002

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Change in Laboratory Parameters (Biochemistry) - High Sensitive C-reactive Protein

Change from baseline (week 0) to week 56 in high sensitive C-reactive protein was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Milligrams per liter (mg/L) (Mean)
Liraglutide 3.0 mg	-1.40
Placebo	-1.29

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Change in Laboratory Parameters (Biochemistry) - eGFR

Change from baseline (week 0) to week 56 in estimated GFR serum using Modification of Diet in Renal Disease (MDRD) formula was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Milliliters per minute per 1.73m^2 (Mean)
Liraglutide 3.0 mg	0
Placebo	1

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Change in Laboratory Parameters (Biochemistry) - Calcitonin

Change from baseline (week 0) to week 56 in calcitonin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Nanograms per liter (ng/L) (Mean)
Liraglutide 3.0 mg	0.0
Placebo	0.0

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Change in Laboratory Parameters (Biochemistry) - Albumin

Change from baseline (week 0) to week 56 in albumin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Grams per deciliter (g/dL) (Mean)
Liraglutide 3.0 mg	-0.1
Placebo	-0.1

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Change in Laboratory Measurements (Haematology) - Haemoglobin

Change from baseline (week 0) to week 56 in haemoglobin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	mmol/L (Mean)
Liraglutide 3.0 mg	-0.1
Placebo	-0.1

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Change in Laboratory Measurements (Haematology) - Haematocrit

Change from baseline (week 0) to week 56 in Haematocrit was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Percentage of red blood cells (Mean)
Liraglutide 3.0 mg	-0.4
Placebo	-0.2

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Change in IWQoL-Lite for CT: Total Score

Change in IWQoL-Lite for CT total score from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Score on a scale (Mean)
Liraglutide 3.0 mg	5.7
Placebo	4.8

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Change in IWQoL-Lite for CT: Psychosocial Domain Score

Change in IWQoL-Lite for CT psychosocial domain from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Score on a scale (Mean)
Liraglutide 3.0 mg	5.4
Placebo	4.0

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Change in FPG

Change in fasting plasma glucose (FPG) from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Millimoles per liter (mmol/L) (Mean)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	-0.91	-1.05
Placebo	-0.68	-0.96

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Change in HbA1c

Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Percentage of HbA1c (Mean)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	-1.1	-1.2
Placebo	-0.5	-0.7

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Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score

Change in IWQoL-Lite for CT physical function domain (5-items) score. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. The endpoint was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Score on a scale (Mean)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	7.3	8.2
Placebo	6.8	6.5

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Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes

Change from baseline (week 0) to week 56 in thrombocytes and leukocytes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	10^9 cells/L (Mean)
	Thrombocytes	Leukocytes
Liraglutide 3.0 mg	7	-0.22
Placebo	7	-0.24

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Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase

Change from baseline (week 0) to week 56 in alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase and lipase was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Units per liter (U/L) (Mean)
	Alkaline Phosphatase	Alanine Aminotransferase	Amylase	Aspartate aminotransferase	Lipase
Liraglutide 3.0 mg	-1	-5	13	-3	30
Placebo	-0	-6	-1	-3	-8

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Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea

Change from baseline (week 0) to week 56 in bicarbonate, total calcium, potassium, sodium and urea was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	mmol/L (Mean)
	Bicarbonate serum	Total Calcium	Potassium	Sodium	Urea
Liraglutide 3.0 mg	0	-0.00	-0.0	-1	0.1
Placebo	-0	-0.02	-0.0	-0	0.1

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Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine

Change from baseline (week 0) to week 56 in total bilirubin and creatinine was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Micromoles per liter (umol/L) (Mean)
	Total Bilirubin	Creatinine
Liraglutide 3.0 mg	1.0	-0.1
Placebo	0.6	-0.2

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Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA

Change in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, triglycerides and free fatty acids (FFA) from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	mmol/L (Mean)
	Total cholesterol	HDL cholesterol	LDL cholesterol	VLDL cholesterol	Triglycerides	Free fatty acids
Liraglutide 3.0 mg	-0.12	0.05	-0.08	-0.09	-0.21	-0.10
Placebo	0.04	0.03	0.05	-0.04	-0.08	-0.06

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Change in Physical Examination

Physical examination parameters are categorised as abdomen; gastrointestinal system; cardiovascular system; central and peripheral nervous system; general appearance; head, eyes, ears, nose, throat (ENT) and neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -1) and week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week -1, week 56

Intervention	Participants (Count of Participants)
	Abdomen (week -1) Normal	Abdomen (week -1) Abnormal, NCS	Abdomen (week -1) Abnormal CS	Abdomen (week 56) Normal	Abdomen (week 56) Abnormal, NCS	Abdomen (week 56) Abnormal, CS	Gastrointestinal System (week -1) Normal	Gastrointestinal System (week -1) Abnormal NCS	Gastrointestinal System (week -1) Abnormal CS	Gastrointestinal System (week 56) Normal	Gastrointestinal System (week 56) Abnormal NCS	Gastrointestinal System (week 56) Abnormal CS	Cardiovascular System (week-1) Normal	Cardiovascular System (week-1) Abnormal NCS	Cardiovascular System (week-1) Abnormal CS	Cardiovascular System (week 56) Normal	Cardiovascular System (week 56) Abnormal NCS	Cardiovascular System (week 56) Abnormal CS	Nervous System (week -1) Normal	Nervous System (week -1) Abnormal NCS	Nervous System (week -1) Abnormal CS	Nervous System (week 56) Normal	Nervous System (week 56) Abnormal NCS	Nervous System (week 56) Abnormal CS	General Appearance (week -1) Normal	General Appearance (week -1) Abnormal NCS	General Appearance (week -1) Abnormal CS	General Appearance (week 56) Normal	General Appearance (week 56) Abnormal NCS	General Appearance (week 56) Abnormal CS	Head, eyes, ENTand Neck (week -1) Normal	Head, eyes, ENTand Neck (week -1) Abnormal NCS	Head, eyes, ENTand Neck (week -1) Abnormal CS	Head, eyes, ENTand Neck (week 56) Normal	Head, eyes, ENTand Neck (week 56) Abnormal NCS	Head, eyes, ENTand Neck (week 56) Abnormal CS	Lymph Node Palpation (week -1) Normal	Lymph Node Palpation (week -1) Abnormal NCS	Lymph Node Palpation (week -1) Abnormal CS	Lymph Node Palpation (week 56) Normal	Lymph Node Palpation (week 56) Abnormal NCS	Lymph Node Palpation (week 56) Abnormal CS	Musculoskeletal System (week -1) Normal	Musculoskeletal System (week -1) Abnormal NCS	Musculoskeletal System (week -1) Abnormal CS	Musculoskeletal System (week 56) Normal	Musculoskeletal System (week 56) Abnormal NCS	Musculoskeletal System (week 56) Abnormal CS	Respiratory System (week -1) Normal	Respiratory System (week -1) Abnormal NCS	Respiratory System (week -1) Abnormal CS	Respiratory System (week 56) Normal	Respiratory System (week 56) Abnormal NCS	Respiratory System (week 56) Abnormal CS	Skin (week -1) Normal	Skin (week -1) Abnormal NCS	Skin (week -1) Abnormal CS	Skin (week 56) Normal	Skin (week 56) Abnormal NCS	Skin (week 56) Abnormal CS	Thyroid Gland (week -1) Normal	Thyroid Gland (week -1) Abnormal NCS	Thyroid Gland (week -1) Abnormal CS	Thyroid Gland (week 56) Normal	Thyroid Gland (week 56) Abnormal NCS	Thyroid Gland (week 56) Abnormal CS
Liraglutide 3.0 mg	165	25	5	167	15	3	185	10	0	175	10	0	183	10	2	178	6	1	158	26	11	150	22	13	150	39	6	156	23	6	176	17	2	168	15	2	195	0	0	185	0	0	180	13	2	171	13	1	192	3	0	183	2	0	155	36	4	150	28	7	183	10	2	180	5	0
Placebo	169	25	3	160	24	3	187	10	0	177	8	0	182	15	0	175	12	0	159	25	13	149	24	14	150	36	11	151	27	9	182	13	2	173	12	2	197	0	0	186	0	0	180	16	1	171	14	2	192	3	2	185	0	2	156	33	8	149	29	9	187	7	3	178	6	3

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Change in sBP and dBP

Change in systolic blood pressure (sBP) and diastolic blood pressure (dBP) from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Millimeters of mercury (mmHg) (Mean)
	sBP	dBP
Liraglutide 3.0 mg	-6	-3
Placebo	-2	-1

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Change in IWQoL-Lite for CT: Pain/Discomfort Domain Score

Change in IWQoL-Lite for CT pain and discomfort domain from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Score on a scale (Mean)
Liraglutide 3.0 mg	4.0
Placebo	4.6

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Change in 7-point SMPG Profile Mean Daytime Glucose Value

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner and at bedtime. Change from baseline (week 0) to week 56 in 7-point self-measured plasma glucose (SMPG) profile mean daytime glucose value was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	mmol/L (Mean)
Liraglutide 3.0 mg	-2.2
Placebo	-1.6

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Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. Number of AEs from randomisation to until the end of the post-treatment follow-up period (30 days). Results based on in-trial data was presented. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0 to week 56 + 30 days

Intervention	Adverse events (Number)
Liraglutide 3.0 mg	1223
Placebo	1148

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Participants Losing More Than 10% of Baseline Body Weight at Week 56

The estimated percentage of participants losing more than 10% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events [AEs]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). (NCT02963922)
Timeframe: Week 56

Intervention	Percentage of participants (Number)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	22.77	22.56
Placebo	6.55	5.58

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Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses

The WRSS measure is a questionnaire under development. The version applied in this study has 10 items that measure the presence and bothersomeness of 10 weight-related symptoms. Each item has a categorical part with answers on the following 5 possible levels: 'Never/Almost never', 'Rarely', 'Sometimes', 'Often' and 'Almost always/Always'. Number of participants in each category at baseline (week 0) and week 56 was presented. Scoring algorithm was not available prior to database lock and therefore it was decided and documented in the statistical analysis plan that WRSS total score was not to be calculated and analyzed. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Participants (Count of Participants)
	Week 0: Joint pain72549445					Week 0: Joint pain72549446	Week 56: Joint pain72549445	Week 56: Joint pain72549446	Week 0: Shortness of breath72549446	Week 0: Shortness of breath72549445	Week 56: Shortness of breath72549445	Week 56: Shortness of breath72549446	Week 0: Heat sensitivity72549445	Week 0: Heat sensitivity72549446	Week 56: Heat sensitivity72549445	Week 56: Heat sensitivity72549446	Week 0: Sexual desire72549445	Week 0: Sexual desire72549446	Week 56: Sexual desire72549445	Week 56: Sexual desire72549446	Week 0: Heavy sweating72549446	Week 0: Heavy sweating72549445	Week 56: Heavy sweating72549445	Week 56: Heavy sweating72549446	Week 0: Low physical stamina72549445	Week 0: Low physical stamina72549446	Week 56: Low physical stamina72549445	Week 56: Low physical stamina72549446	Week 0: Foot pain72549445	Week 0: Foot pain72549446	Week 56: Foot pain72549445	Week 56: Foot pain72549446	Week 0: Trouble sleeping72549445	Week 0: Trouble sleeping72549446	Week 56: Trouble sleeping72549445	Week 56: Trouble sleeping72549446	Week 0: Back pain72549445	Week 0: Back pain72549446	Week 56: Back pain72549446	Week 56: Back pain72549445	Week 0: Low energy72549445	Week 0: Low energy72549446	Week 56: Low energy72549446	Week 56: Low energy72549445
	Rarely	Sometimes	Never/Almost never	Almost always/Always	Often
Liraglutide 3.0 mg	74
Placebo	85
Liraglutide 3.0 mg	17
Placebo	18
Liraglutide 3.0 mg	95
Placebo	75
Liraglutide 3.0 mg	12
Placebo	17
Liraglutide 3.0 mg	39
Placebo	52
Placebo	0
Liraglutide 3.0 mg	131
Placebo	140
Placebo	3
Liraglutide 3.0 mg	45
Liraglutide 3.0 mg	19
Placebo	21
Liraglutide 3.0 mg	1
Placebo	1
Liraglutide 3.0 mg	137
Liraglutide 3.0 mg	5
Liraglutide 3.0 mg	28
Placebo	46
Liraglutide 3.0 mg	16
Placebo	9
Liraglutide 3.0 mg	37
Placebo	31
Liraglutide 3.0 mg	2
Liraglutide 3.0 mg	92
Placebo	87
Liraglutide 3.0 mg	42
Placebo	47
Placebo	33
Liraglutide 3.0 mg	8
Placebo	8
Placebo	121
Placebo	13
Placebo	32
Liraglutide 3.0 mg	23
Placebo	22
Liraglutide 3.0 mg	105
Placebo	109
Liraglutide 3.0 mg	18
Liraglutide 3.0 mg	34
Liraglutide 3.0 mg	24
Placebo	25
Liraglutide 3.0 mg	101
Placebo	104
Placebo	38
Placebo	35
Placebo	5
Liraglutide 3.0 mg	98
Placebo	92
Liraglutide 3.0 mg	7
Placebo	16
Liraglutide 3.0 mg	51
Placebo	48
Liraglutide 3.0 mg	30
Placebo	27
Liraglutide 3.0 mg	73
Placebo	78
Liraglutide 3.0 mg	22
Liraglutide 3.0 mg	56
Placebo	49
Liraglutide 3.0 mg	3
Liraglutide 3.0 mg	77
Placebo	65
Placebo	19
Liraglutide 3.0 mg	57
Placebo	56
Liraglutide 3.0 mg	35
Placebo	44
Liraglutide 3.0 mg	114
Placebo	108
Placebo	12
Placebo	7
Liraglutide 3.0 mg	106
Placebo	88
Placebo	14
Liraglutide 3.0 mg	29
Placebo	39
Placebo	40
Placebo	4
Liraglutide 3.0 mg	119
Placebo	111
Liraglutide 3.0 mg	11
Placebo	10
Placebo	42
Liraglutide 3.0 mg	32
Placebo	29
Liraglutide 3.0 mg	6
Liraglutide 3.0 mg	104
Placebo	98
Liraglutide 3.0 mg	15
Liraglutide 3.0 mg	38
Placebo	6
Liraglutide 3.0 mg	96
Liraglutide 3.0 mg	93
Placebo	86
Liraglutide 3.0 mg	13
Placebo	11
Liraglutide 3.0 mg	47
Placebo	45
Placebo	2
Liraglutide 3.0 mg	102
Placebo	90
Liraglutide 3.0 mg	46
Liraglutide 3.0 mg	31
Placebo	50
Liraglutide 3.0 mg	0
Liraglutide 3.0 mg	82
Placebo	77
Liraglutide 3.0 mg	49
Liraglutide 3.0 mg	40
Placebo	41

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Responder Definition Value for IWQoL-Lite for CT Physical Function Domain Score

Percentage of participants who achieve responder definition value for IWQoL-Lite for CT physical function domain score was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 56

Intervention	Percentage of participants (Number)
Liraglutide 3.0 mg	25.3
Placebo	24.2

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Change in Total Daily Basal Insulin Dose (U/kg)

Intervention	Units of insulin dose per kilogram(U/kg) (Mean)
Liraglutide 3.0 mg	0.05
Placebo	0.15

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Change in Laboratory Measurements (Haematology) - Erythrocytes

Change from baseline (week 0) to week 56 in erythrocytes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	10^12 cells per liter (10^12 cells/L) (Mean)
Liraglutide 3.0 mg	-0.07
Placebo	-0.04

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Change in SF-36: Sub-domains

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores was presented based on in-trial data. A positive change score indicates an improvement since baseline. Results are presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Score on a scale (Mean)
	Bodily Pain	General Health	Physical Functioning	Role-physical	Role Lim Emotion Prob	Mental Health	Social Functioning	Vitality
Liraglutide 3.0 mg	1.2	1.9	2.5	0.8	-1.2	-1.1	-0.7	1.0
Placebo	1.2	0.3	2.6	0.9	-0.3	-1.1	-0.6	-0.0

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Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline (week 0) in SF-36 physical functioning score was presented based on in-trial data and on-drug data. A positive change score indicates an improvement since baseline. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Score on a scale (Mean)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	2.5	2.9
Placebo	2.6	2.5

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Change in Waist Circumference

Change in waist circumference from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). (NCT02963922)
Timeframe: Week 0, week 56

Intervention	Centimeters (cm) (Mean)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	-5.40	-5.71
Placebo	-2.60	-2.78

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Participants Losing at Least 5% of Baseline Body Weight

The estimated percentage of participants losing at least 5% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events [AEs]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). (NCT02963922)
Timeframe: Week 56

Intervention	Percentage of participants (Number)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	51.80	56.92
Placebo	23.98	21.83

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Participants Who Achieved (Yes/no): HbA1c <7%, Weight Loss ≥5% and no Documented Symptomatic Hypoglycaemia

Percentage of participants who achieved HbA1c <7%, weight loss ≥5% from baseline and no documented symptomatic hypoglycaemia at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 56

Intervention	Percentage of participants (Number)
Liraglutide 3.0 mg	10.1
Placebo	3.5

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Participants Who Achieved (Yes/no): HbA1c <7% and Weight Loss ≥5%

Percentage of participants who achieved HbA1c <7% and weight loss ≥5% from baseline at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 56

Intervention	Percentage of participants (Number)
Liraglutide 3.0 mg	39.9
Placebo	13.6

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Participants Who Achieved (Yes/no): ≥4.6 T-score Points Increase From Baseline in SF-36 Acute MCS

Percentage of participants who achieved ≥4.6 T-score points increase from baseline in SF-36 acute MCS at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 56

Intervention	Percentage of participants (Number)
Liraglutide 3.0 mg	14.6
Placebo	11.6

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Participants Who Achieved (Yes/no): ≥4.3 T-score Points Increase From Baseline in SF-36 Acute Physical Functioning Score

Percentage of participants who achieved ≥4.3 T-score points increase from baseline in SF-36 acute physical functioning score at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 56

Intervention	Percentage of participants (Number)
Liraglutide 3.0 mg	28.8
Placebo	26.3

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Participants Who Achieved (Yes/no): ≥3.8 T-score Points Increase From Baseline in SF-36 Acute PCS

Percentage of participants who achieved ≥3.8 T-score points increase from baseline in SF-36 acute PCS at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 56

Intervention	Percentage of participants (Number)
Liraglutide 3.0 mg	37.9
Placebo	31.3

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Number of Hypoglycaemic Episodes

Number of hypoglycaemic episodes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0 to week 56 + 30 days

Intervention	Hypoglycaemic episodes (Number)
Liraglutide 3.0 mg	1538
Placebo	1973

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Change in Total Daily Insulin Dose (U/kg)

Change in total daily insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. (NCT02963922)
Timeframe: Week 0, week 56

Intervention	U/kg (Mean)
Liraglutide 3.0 mg	0.05
Placebo	0.18

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Change in Total Daily Insulin Dose (U)

Intervention	Units of insulin dose (U) (Mean)
Liraglutide 3.0 mg	3
Placebo	18

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Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score

Observed mean change from baseline (week 0) to week 56 in IWQoL-Lite for CT total score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	scores on a scale (Mean)
Liraglutide 3.0 mg	13.2
Placebo	12.8

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AEs From Randomisation Until and Including the Follow-up Period

Number of adverse events from randomisation to until the end of the post-treatment follow-up period (30 days). Results based on SAS on-drug data is presented. (NCT02963935)
Timeframe: Week 0 to week 56+30 days

Intervention	events (Number)
Liraglutide 3.0 mg	867
Placebo	601

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Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score

"Observed mean change from baseline (week 0) to week 56 in WRSS measure, total score. The WRSS measures the presence and bothersome associated with weight-related symptoms.~The WRSS questionnaire was not validated until after database lock. Therefore the total score couldn't be calculated and the supportive secondary endpoint Weight related sign and symptom (WRSS) measure, total score couldn't be analysed." (NCT02963935)
Timeframe: Week 0, week 56

Intervention	Score on a scale (Mean)
Liraglutide 3.0 mg	NA
Placebo	NA

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Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score

Percentage of subjects who achieved ≥ 3.8 T-score points increase from baseline in SF-36 physical component score at week 56 is presented. Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 56

Intervention	Percentage of participants (Number)
Liraglutide 3.0 mg	43.7
Placebo	41.4

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Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score

Responder definition value for IWQoL-Lite for CT physical function domain (5-items) score' was defined as '≥ 20 responder definition value for IWQoL-Lite for CT physical function domain (5-items) score. Percentage of subjects considered IWQoL-Lite for CT physical function domain score responders (increase of ≥20 points) at week 56 is presented. Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 56

Intervention	Percentage of participants (Number)
Liraglutide 3.0 mg	37.3
Placebo	34.3

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Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score

Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) psychosocial domain. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	score (Mean)
Liraglutide 3.0 mg	13.5
Placebo	12.4

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Proportion of Subjects Losing 4% or More of Baseline Body Weight

The estimated mean percentage of subjects losing 4% or more of baseline body weight at week 16 is presented. The endpoint was evaluated for treatment policy estimand (in-trial data). (NCT02963935)
Timeframe: Week 16

Intervention	percentage of participants (Number)
Liraglutide 3.0 mg	78.73
Placebo	52.70

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Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product

Adherence to trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to trial product is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	weeks (Mean)
Liraglutide 3.0 mg	49.5
Placebo	46.8

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Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity

Adherence to physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to physical activity is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	weeks (Mean)
Liraglutide 3.0 mg	29.0
Placebo	30.0

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Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product

Adherence to caloric diet, physical activity and trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet, physical activity and trial product is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	weeks (Mean)
Liraglutide 3.0 mg	22.9
Placebo	24.0

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Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56

The estimated mean percentage of subjects losing more than 15% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data. (NCT02963935)
Timeframe: Week 56

Intervention	percentage of participants (Number)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	18.11	20.42
Placebo	8.92	8.57

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Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity

Adherence to caloric diet and physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet and physical activity is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	weeks (Mean)
Liraglutide 3.0 mg	24.0
Placebo	24.5

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Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet

Adherence to caloric diet is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	weeks (Mean)
Liraglutide 3.0 mg	38.4
Placebo	36.1

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Change in Laboratory Measurements: Biochemistry (Albumin)

Observed mean change from baseline in biochemical parameter - albumin. Results based on SAS on-drug data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	g/L (Mean)
Liraglutide 3.0 mg	-0.1
Placebo	-0.1

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Change in Laboratory Measurements: Biochemistry (Calcitonin)

Observed mean change from baseline in biochemical parameter - calcitonin. Results based on SAS on-drug data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	ng/L (Mean)
Liraglutide 3.0 mg	0.2
Placebo	0.1

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Change in Laboratory Measurements: Biochemistry (Glomerular Filtration Rate, Serum)

Observed mean change from baseline in biochemical parameters - estimated glomerular filtration rate. Serum GFR is estimated using MDRD formula . Results based on SAS on-drug data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mL/min/1.73m^2 (Mean)
Liraglutide 3.0 mg	2
Placebo	2

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Change in Laboratory Measurements: Biochemistry (Thyroid Stimulating Hormone)

Observed mean change from baseline in biochemical parameters - thyroid stimulating hormone. Results based on SAS on-drug data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mIU/L (Mean)
Liraglutide 3.0 mg	-0.2313
Placebo	0.2685

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Change in Laboratory Measurements: Haematology (Erythrocytes)

Observed mean change from baseline in haematological parameter - erythrocytes. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	10^12 cells/L (Mean)
Liraglutide 3.0 mg	-0.11
Placebo	-0.08

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Change in Laboratory Measurements: Haematology (Haematocrit Blood)

Observed mean change from baseline in haematological parameter blood haematocrit. Haematocrit is presented as the percentage of red blood cells in total blood. Results based on SAS on-drug data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	percentage of red blood cells (Mean)
Liraglutide 3.0 mg	-1.5
Placebo	-0.9

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Change in Laboratory Measurements: Haematology (Haemoglobin Blood)

Observed mean change from baseline in haematological parameter blood haemoglobin. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mmol/L (Mean)
Liraglutide 3.0 mg	-0.2
Placebo	-0.1

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Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS))

Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain physical component summary (PCS). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 physical component summary (PCS) score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	scores on a scale (Mean)
Liraglutide 3.0 mg	3.41
Placebo	3.83

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Change From Baseline dBP (mmHg)

Observed mean change from baseline (week 0) to week 56 in diastolic blood pressure (dBP). Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mmHg (Mean)
Liraglutide 3.0 mg	-1
Placebo	-1

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Change From Baseline in FPG (mg/dL)

Observed mean change from baseline (week 0) in fasting plasma glucose (FPG). Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mg/dL (Mean)
Liraglutide 3.0 mg	-4.04
Placebo	-0.28

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Change From Baseline in HbA1c (%)

Observed mean change from baseline to week 56 in glycosylated haemoglobin (HbA1c). Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	percentage (Mean)
Liraglutide 3.0 mg	-0.2
Placebo	-0.1

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Change From Baseline in Lipids - FFA

Observed mean change from baseline in free fatty acids (FFA) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mmol/L (Mean)
Liraglutide 3.0 mg	-0.07
Placebo	-0.06

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Change From Baseline in Lipids - HDL Cholesterol

Observed mean change from baseline in high density (HDL) cholesterol from baseline (week 0) to week 56. Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mmol/L (Mean)
Liraglutide 3.0 mg	0.06
Placebo	0.02

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Change in Resting Pulse

Observed mean change in pulse rate measured at resting position is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	beats/min (Mean)
Liraglutide 3.0 mg	2
Placebo	1

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Change From Baseline in Lipids - LDL Cholesterol

Observed mean change from baseline in low density cholesterol (LDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mmol/L (Mean)
Liraglutide 3.0 mg	-0.01
Placebo	-0.01

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Change From Baseline in Lipids - TG

Observed mean change from baseline in triglyceride (TG) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mmol/L (Mean)
Liraglutide 3.0 mg	-0.19
Placebo	-0.01

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Change From Baseline in Lipids - VLDL Cholesterol

Observed mean change from baseline in very low density cholesterol (VLDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mmol/L (Mean)
Liraglutide 3.0 mg	-0.06
Placebo	-0.01

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Change From Baseline in Lipids -Total Cholesterol

Observed mean change from baseline (week 0) to week 56 in total cholesterol (TC). Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mmol/L (Mean)
Liraglutide 3.0 mg	-0.01
Placebo	0.00

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Change From Baseline sBP (mmHg)

Observed mean change in systolic blood pressure from baseline to week 56. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mmHg (Mean)
Liraglutide 3.0 mg	-2
Placebo	-1

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Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score

Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) domain pain and discomfort. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	scores on a scale (Mean)
Liraglutide 3.0 mg	10.1
Placebo	8.6

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Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS)

Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain mental component summary (MCS). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 mental component summary is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	scores on a scale (Mean)
Liraglutide 3.0 mg	-1.22
Placebo	-2.20

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Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score

"Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trials Version (IWQoL-Lite for CT ) score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life.~The endpoint was evaluated based on in-trial data and on-drug data." (NCT02963935)
Timeframe: Week 0, week 56

Intervention	Scores on a scale (Mean)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	13.5	15.2
Placebo	15.5	17.5

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Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase)

Observed mean change from baseline in biochemical parameters - alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase and lipase. Results based on SAS on-drug data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	U/L (Mean)
	Alkaline Phosphatase	Alanine Aminotransferase	Amylase	Aspartate aminotransferase	Lipase
Liraglutide 3.0 mg	-2	-5	4	-3	7
Placebo	-1	-4	1	-2	2

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Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine)

Observed mean change from baseline in biochemical parameters - bilirubin and creatinine. Results based on SAS on-drug data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	umol/L (Mean)
	Bilirubin	Creatinine
Liraglutide 3.0 mg	1.1	-1.8
Placebo	1.0	-1.4

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Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid)

Observed mean change from baseline in biochemical parameters - high sensitive c-reactive protein and uric acid. Results based on SAS on-drug data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mg/dL (Mean)
	High sensitive c-reactive protein	Uric acid
Liraglutide 3.0 mg	-2.51	-0.6
Placebo	-0.85	-0.3

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Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea)

Observed mean change from baseline in biochemical parameters - total calcium, pottassium, sodium and urea. Results based on SAS on-drug data is presented. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	mmol/L (Mean)
	Total Calcium	Potassium	Sodium	Urea
Liraglutide 3.0 mg	0.01	-0.0	-0.0	0.0
Placebo	0.01	-0.0	-0	0.2

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Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes)

Observed mean change from baseline in haematological parameters - thrombocytss and leukocytes. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	10^9 cells/L (Mean)
	Thrombocytes	Leukocytes
Liraglutide 3.0 mg	4	-0.14
Placebo	0	-0.11

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Change in Physical Examination

Observed change from baseline to week 56 in physical examination are categorised under parameters namely abdomen, gastrointestinal system, cardiovascular system, central and peripheral nervous system, general appearence, head, ears, eyes, nose, throat and neck, lymph node palpation, musculoskeletal system, respiratory system, skin and thyroid gland. The percentage of subjects assessed as normal, abnormal not clinically significant and abnormal clinically significant at baseline and week 56 is presented. (NCT02963935)
Timeframe: Week 1, week 56

Intervention	participants (Number)
	Abdomen (week -1) Normal	Abdomen (week -1) Abnormal, NCS	Abdomen (week -1) Abnormal CS	Abdomen (week 56) Normal	Abdomen (week 56) Abnormal, NCS	Abdomen (week 56) Abnormal, CS	Gastrointestinal System (week -1) Normal	Gastrointestinal System (week -1) Abnormal NCS	Gastrointestinal System (week -1) Abnormal CS	Gastrointestinal System (week 56) Normal	Gastrointestinal System (week 56) Abnormal NCS	Gastrointestinal System (week 56) Abnormal CS	Cardiovascular System (week-1) Normal	Cardiovascular System (week-1) Abnormal NCS	Cardiovascular System (week-1) Abnormal CS	Cardiovascular System (week 56) Normal	Cardiovascular System (week 56) Abnormal NCS	Cardiovascular System (week 56) Abnormal CS	Nervous System (week -1) Normal	Nervous System (week -1) Abnormal NCS	Nervous System (week -1) Abnormal CS	Nervous System (week 56) Normal	Nervous System (week 56) Abnormal NCS	Nervous System (week 56) Abnormal CS	General Appearance (week -1) Normal	General Appearance (week -1) Abnormal NCS	General Appearance (week -1) Abnormal CS	General Appearance (week 56) Normal	General Appearance (week 56) Abnormal NCS	General Appearance (week 56) Abnormal CS	Head, ENTand Neck (week -1) Normal	Head, ENTand Neck (week -1) Abnormal NCS	Head, ENTand Neck (week -1) Abnormal CS	Head, ENTand Neck (week 56) Normal	Head, ENTand Neck (week 56) Abnormal NCS	Head, ENTand Neck (week 56) Abnormal CS	Lymph Node Palpation (week -1) Normal	Lymph Node Palpation (week -1) Abnormal NCS	Lymph Node Palpation (week -1) Abnormal CS	Lymph Node Palpation (week 56) Normal	Lymph Node Palpation (week 56) Abnormal NCS	Lymph Node Palpation (week 56) Abnormal CS	Musculoskeletal System (week -1) Normal	Musculoskeletal System (week -1) Abnormal NCS	Musculoskeletal System (week -1) Abnormal CS	Musculoskeletal System (week 56) Normal	Musculoskeletal System (week 56) Abnormal NCS	Musculoskeletal System (week 56) Abnormal CS	Respiratory System (week -1) Normal	Respiratory System (week -1) Abnormal NCS	Respiratory System (week -1) Abnormal CS	Respiratory System (week 56) Normal	Respiratory System (week 56) Abnormal NCS	Respiratory System (week 56) Abnormal CS	Skin (week -1) Normal	Skin (week -1) Abnormal NCS	Skin (week -1) Abnormal CS	Skin (week 56) Normal	Skin (week 56) Abnormal NCS	Skin (week 56) Abnormal CS	Thyroid Gland (week -1) Normal	Thyroid Gland (week -1) Abnormal NCS	Thyroid Gland (week -1) Abnormal CS	Thyroid Gland (week 56) Normal	Thyroid Gland (week 56) Abnormal NCS	Thyroid Gland (week 56) Abnormal CS
Liraglutide 3.0 mg	108	34	0	114	25	0	130	12	0	132	7	0	136	6	0	138	1	0	135	5	2	132	6	1	118	24	0	122	17	0	129	13	0	126	13	0	142	0	0	139	0	0	131	11	0	130	9	0	140	2	0	138	1	0	116	26	1	117	21	1	138	4	0	136	3	0
Placebo	121	19	0	108	12	2	129	11	0	116	6	0	127	13	0	116	5	1	127	6	7	112	9	1	123	17	0	112	10	0	128	12	0	115	7	0	140	0	0	121	0	1	128	12	0	112	9	1	138	2	0	120	2	0	114	24	0	98	24	0	138	2	0	120	2	0

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Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score

"SF-36 is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL).~SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 physical functioning score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data." (NCT02963935)
Timeframe: Week 0, week 56

Intervention	Scores on a scale (Mean)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	3.55	4.03
Placebo	4.21	4.77

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Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains)

"SF-36 is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL).~SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in in the sub-domain scores is presented. A positive change score indicates an improvement since baseline. Results are evaluated based on in-trial data." (NCT02963935)
Timeframe: Week 0, week 56

Intervention	scores on a scale (Mean)
	Bodily Pain	General Health Perception	Mental Health	Role Lim Emotion Prob	Role Lim. Phy Health	Social Functioning	Vitality
Liraglutide 3.0 mg	0.67	1.89	-0.93	-1.27	2.01	1.22	2.64
Placebo	1.21	1.08	-0.68	-2.21	2.11	-0.45	2.43

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Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score

Percentage of subjects who achieved ≥ 4.6 T-score points increase from baseline in SF-36 mental component score at week 56 is presented. Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 56

Intervention	Percentage of participants (Number)
Liraglutide 3.0 mg	20.4
Placebo	9.3

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Change in Six Minutes Walking Distance Test (6MWT)

Observed mean change from baseline in 6 minutes walking distance test. The 6MWT is a common test of functional exercise capacity that assesses the distance a subject can walk in 6 minutes. The endpoint was evaluated based on in-trial data and on-drug data. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	meter (Mean)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	47	53
Placebo	49	51

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Change in Waist Circumference (cm)

Observed mean change from baseline in waist circumference. The endpoint was evaluated based on in-trial data and on-drug data. (NCT02963935)
Timeframe: Week 0, week 56

Intervention	cm (Mean)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	-9.27	-10.46
Placebo	-6.91	-7.24

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Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56

The estimated mean percentage of subjects losing at least 5% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data. (NCT02963935)
Timeframe: Week 56

Intervention	percentage of participants (Number)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	61.47	64.08
Placebo	38.82	38.57

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Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56

The estimated mean percentage of subjects losing more than 10% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data. (NCT02963935)
Timeframe: Week 56

Intervention	percentage of participants (Number)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	30.45	33.80
Placebo	19.75	19.29

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Change in Body Weight (%)

"Observed mean change in body weight from baseline (week 0) to week 56 was evaluated for two different observation periods. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which subjects are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).~The test of superiority of liraglutide to placebo for the treatment policy estimand was tested in a hierarchical manner for the two primary and the consequent 7 confirmatory secondary endpoints presented." (NCT02963935)
Timeframe: Week 0, week 56

Intervention	percent change (Mean)
	In-trial observation period	On-drug observation period
Liraglutide 3.0 mg	-7.4	-9.1
Placebo	-4.0	-4.8

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Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score

Percentage of subjects who achieved ≥ 4.3 T-score points increase from baseline in SF-36 physical functioning score at week 56 is presented. Results based on FAS in-trial data is presented. (NCT02963935)
Timeframe: Week 56

Intervention	percentage of participants (Number)
Liraglutide 3.0 mg	38.7
Placebo	37.9

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Change in ECG

The ECGs were interpreted by the investigator at baseline (week -1) and week 56 and categorised as normal, abnormal NCS or abnormal CS. Number of subjects in each ECG category at baseline and week 56 are presented. (NCT02963935)
Timeframe: Week -1, week 56

Intervention	participants (Number)
	Normal (week -1)	Abnormal NCS (week -1)	Abnormal CS (week -1)	Normal (week 56)	Abnormal NCS (week 56)	Abnormal CS (week 56)
Liraglutide 3.0 mg	100	41	1	102	36	0
Placebo	91	49	0	81	42	1

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Change in Body Mass Index (BMI)

Observed mean change from baseline (week 0) to week 26 in body mass index (BMI). BMI was calculated based on body weight and height ('in-trial' observation period) (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	kg/m^2 (Mean)
Liraglutide	-1.02
Placebo	-0.72

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Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association Target

Percentage of subjects who achieve HbA1c below 7.0% (53 mmol/mol), American Diabetes Association target, after 26 weeks ('in-trial' observation period) (NCT02964247)
Timeframe: Week 26

Intervention	Percentage of Participants (Number)
	Yes	No
Liraglutide	51.79	48.21
Placebo	23.16	76.84

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Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), no Weight Gain and Systolic Blood Pressure Below 140 mmHg.

Percentage of subjects who achieve HbA1c below 7.0% (53 mmol/mol), no weight gain and systolic blood pressure below 140 mmHg, after 26 weeks ('in-trial' observation period) (NCT02964247)
Timeframe: Week 26

Intervention	Percentage of Participants (Number)
	Yes	No
Liraglutide	42.05	57.95
Placebo	18.09	81.91

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Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target

Percentage of subjects who achieve HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists target, after 26 weeks ('in-trial' observation period) (NCT02964247)
Timeframe: Week 26

Intervention	Percentage of Participants (Number)
	Yes	No
Liraglutide	34.36	65.64
Placebo	9.47	90.53

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Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol)

Percentage of subjects who achieve HbA1c reduction above or equal to 1% (11mmol/mol), after 26 weeks ('in-trial' observation period) (NCT02964247)
Timeframe: Week 26

Intervention	Percentage of Participants (Number)
	Yes	No
Liraglutide	52.31	47.69
Placebo	16.84	83.16

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Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and no Weight Gain

Percentage of subjects who achieve HbA1c reduction above or equal to 1% (11mmol/mol) and no weight gain, after 26 weeks. (NCT02964247)
Timeframe: Week 26

Intervention	Percentage of Participants (Number)
	Yes	No
Liraglutide	45.13	54.87
Placebo	14.89	85.11

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Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and Weight Loss Above or Equal to 3%.

Percentage of subjects who achieve HbA1c reduction above or equal to 1% (11mmol/mol) and weight loss above or equal to 3%, after 26 weeks ('in-trial' observation period) (NCT02964247)
Timeframe: Week 26

Intervention	Percentage of Participants (Number)
	Yes	No
Liraglutide	29.74	70.26
Placebo	7.45	92.55

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Subjects Who Achieve Weight Loss by 3% or More

Percentage of subjects who achieve HbA1c reduction above or equal to 1% (11mmol/mol) and weight loss above or equal to 3%, after 26 weeks ('in-trial' observation period). (NCT02964247)
Timeframe: Week 26

Intervention	Percentage of participants (Number)
	Yes	No
Liraglutide	46.43	53.57
Placebo	41.24	58.76

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Change in Self-measured Plasma Glucose 7-point Profile - Mean 7-point Profile

Change in self-measured plasma glucose 7-point profile - mean 7-point profile after 26 weeks. Subjects were instructed to measure their plasma glucose at following 7 timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime. Mean of the 7-point profile was calculated ('in-trial' observation period). (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	milligram/dL (Mean)
Liraglutide	-33.93
Placebo	-18.85

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Change in Self-measured Plasma Glucose 7-point Profile - Mean Post Prandial Increments (Over All Meals)

Subjects were instructed to measure their plasma glucose at following 7 timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime. The mean increment over all meals was derived as the mean of all available meal increments ('in-trial' observation period) (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	milligram/dL (Mean)
Liraglutide	-11.06
Placebo	-4.44

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Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes

Treatment emergent hypoglycaemic episode is defined episode with onset on or after the first day of exposure to randomised treatment and no later than the minimum of the date of the follow-up visit or the last day of randomised treatment + 1 days or the date of last subject-investigator contact. Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to American Diabetes Association's (ADA) classification or blood glucose confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. (NCT02964247)
Timeframe: Week 0 - 26

Intervention	Episodes (Number)
Liraglutide	0
Placebo	3

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Change in Fasting Plasma Glucose

Change from baseline (week 0) to week 26 in fasting plasma glucose ('in-trial' observation period) (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	milligram/dL (Mean)
Liraglutide	-27.00
Placebo	-11.97

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Change in Fasting Blood Lipids-triglycerides

Fasting triglycerides measured in mg/dL. Observed mean change in fasting triglycerides from baseline (week 0) to week 26 is presented as ratio to baseline value. (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	Ratio (Geometric Mean)
Liraglutide	0.81
Placebo	0.93

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Change in Body Weight

"Change from baseline (week 0) to week 26 in body weight was evaluated for 2 different observation period 'in-trial' observation period and 'on-treatment without rescue medication observation period. The 'in-trial' observation period represents the time-period where subjects were considered to be in the trial, regardless of whether or not the subjects had initiated rescue medication or prematurely discontinued trial product. The 'on-treatment' observation period is the part of the in-trial observation period during which subjects were treated with the trial product, that is the time from the first dose to the last dose of trial product. The 'on-treatment without rescue medication' observation period is a part of 'on-treatment' observation period during which subjects were considered treated with trial product and had not initiated any rescue medications." (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	Kg (Mean)
	in-trial obs. period	on-treatment without rescue medication obs. period
Liraglutide	-2.84	-2.89
Placebo	-2.02	-2.09

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Change in HbA1c

"Change from baseline (week 0) to week 26 in glycosylated haemoglobin was evaluated for 2 different observation period 'in-trial' observation period and 'on-treatment without rescue medication observation period. The 'in-trial' observation period represents the time-period where subjects were considered to be in the trial, regardless of whether or not the subjects had initiated rescue medication or prematurely discontinued trial product. The 'on-treatment' observation period is the part of the in-trial observation period during which subjects were treated with the trial product, that is the time from the first dose to the last dose of trial product. The 'on-treatment without rescue medication' observation period is a part of 'on-treatment' observation period during which subjects were considered treated with trial product and had not initiated any rescue medications." (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	Percentage of HbA1c (Mean)
	in-trial obs. period	on-treatment without rescue medication obs. period
Liraglutide	-1.00	-1.05
Placebo	-0.32	-0.35

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Number of Treatment Emergent Adverse Events

The on-treatment summary of adverse events includes treatment-emergent events with onset on or after the first day of exposure to randomised treatment and no later than the minimum of the date of the follow-up visit or the last day of randomised treatment + 7 days or the date of last subject-investigator contact. (NCT02964247)
Timeframe: Week 0 - 26 + 7 days

Intervention	Events (Number)
Liraglutide	426
Placebo	106

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Change in Systolic Blood Pressure

Change from baseline (week 0) in systolic blood pressure after 26 weeks ('in-trial' observation period). (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	mmHg (Mean)
Liraglutide	-1.95
Placebo	-3.35

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Change in Waist Circumference

Change from baseline (week 0) to week 26 in waist circumference ('in-trial' observation period). (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	cm (Mean)
Liraglutide	-4.28
Placebo	-1.77

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Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain

Percentage of subjects who achieve HbA1c below 7.0% (53 mmol/mol) and no weight gain, after 26 week ('in-trial' observation period). (NCT02964247)
Timeframe: Week 26

Intervention	Percentage of Participants (Number)
	Yes	No
Liraglutide	47.69	52.31
Placebo	19.15	80.85

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Change in Fasting Blood Lipids- Free Fatty Acids (FFA)

Free fatty acids measured in mg/dL. Observed mean change in fasting free fatty acids from baseline (week 0) to week 26 is presented as ratio to baseline value. (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	Ratio (Geometric Mean)
Liraglutide	0.80
Placebo	0.86

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Change in Fasting Blood Lipids - Very Low Density Lipoprotein (VLDL) Cholesterol

Very low density lipoprotein (VLDL) cholesterol measured in mg/dL. Observed mean change in fasting very low density lipoprotein cholesterol from baseline (week 0) to week 26 is presented as ratio to baseline value. (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	Ratio (Geometric Mean)
Liraglutide	0.83
Placebo	0.94

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Change in Fasting Blood Lipids - Total Cholesterol

Fasting total cholesterol measured in mg/dL. Observed mean change in fasting total cholesterol from baseline (week 0) to week 26 is presented as ratio to baseline value. (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	Ratio (Geometric Mean)
Liraglutide	0.95
Placebo	0.99

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Change in Fasting Blood Lipids - Low Density Lipoprotein (LDL) Cholesterol

Low density lipoprotein (LDL) cholesterol measured in mg/dL. Observed mean change in fasting low density lipoprotein cholesterol from baseline (week 0) to week 26 is presented as ratio to baseline value. (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	Ratio (Geometric Mean)
Liraglutide	0.97
Placebo	1.01

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Change in Fasting Blood Lipids - High Density Lipoprotein (HDL) Cholesterol

High density lipoprotein (HDL) cholesterol measured in mg/dL. Observed mean change in fasting high density lipoprotein cholesterol from baseline (week 0) to week 26 is presented as ratio to baseline value. (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	Ratio (Geometric Mean)
Liraglutide	1.05
Placebo	1.01

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Change in Diastolic Blood Pressure

Change from baseline (week 0) in diastolic blood pressure after 26 weeks ('in-trial' observation period). (NCT02964247)
Timeframe: Week 0, Week 26

Intervention	mmHg (Mean)
Liraglutide	-0.72
Placebo	-1.12

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Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain.

Percentage of subjects who achieve HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain, after 26 weeks ('in-trial' observation period) (NCT02964247)
Timeframe: Week 26

Intervention	Percentage of Participants (Number)
	Yes	No
Liraglutide	47.69	52.31
Placebo	19.15	80.85

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Change From Baseline in HbA1c to Week 26

Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based multiple imputation (MI) method under the missing not at random framework. (NCT02973321)
Timeframe: Baseline, Week 26

Intervention	percentage of HbA1c (Least Squares Mean)
Placebo	-0.663
SAR425899 0.12 mg	-1.517
SAR425899 0.16 mg	-1.618
SAR425899 0.20 mg	-1.562
Liraglutide	-1.312

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Change From Baseline in Insulin Resistance to Week 26

Insulin Resistance was assessed by homeostasis model assessment for insulin resistance (HOMA-IR), derived from FPG and FPI. HOMA-IR was derived from FPG and FPI as (FPI [micro units per milliliter] * FPG [mmol/L]) divided by 22.5. Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value. (NCT02973321)
Timeframe: Baseline, Week 26

Intervention	HOMA-IR Index (Least Squares Mean)
Placebo	-1.315
SAR425899 0.12 mg	-1.244
SAR425899 0.16 mg	-2.233
SAR425899 0.20 mg	-2.324
Liraglutide	-1.405

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Mean Change From Baseline in Body Weight to Week 26

Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing post- baseline values were imputed by placebo control-based MI method under the missing not at random framework. (NCT02973321)
Timeframe: Baseline, Week 26

Intervention	Kg (Least Squares Mean)
Placebo	-1.759
SAR425899 0.12 mg	-4.276
SAR425899 0.16 mg	-5.330
SAR425899 0.20 mg	-4.407
Liraglutide	-4.590

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Percentage of Participants Requiring Rescue Therapy

Rescue medication was introduced in case FPG or HbA1c values were above pre-defined thresholds, and if no reasons were found for insufficient glucose control, and appropriate action failed to decrease FPG / HbA1c under the threshold values (from baseline to Week 8: FPG >270 mg/dL 15.0 mmol/L, from Week 8 to Week 14: FPG >13.3 mmol/L, and from Week 14 to Week 26: FPG >11.1 mmol/L or HbA1c>8%). The choice of rescue therapy was at the Investigator's discretion with the exception of using glucagon-like peptide-1 receptor (GLP-1R) agonists or dipeptidyl peptidase 4 (DPP4) inhibitors. (NCT02973321)
Timeframe: Baseline up to 26 weeks

Intervention	percentage of participants (Number)
Placebo	18.2
SAR425899 0.12 mg	0.0
SAR425899 0.16 mg	1.5
SAR425899 0.20 mg	3.1
Liraglutide	6.0

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Percentage of Participants Achieving >=5% or >=10% Body Weight Loss at Week 26

The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders. (NCT02973321)
Timeframe: Week 26

,,,,

Intervention	percentage of participants (Number)
	Participants Achieving >=5% Body Weight Loss	Participants Achieving >=10% Body Weight Loss
Liraglutide	40.3	9.0
Placebo	3.0	0.0
SAR425899 0.12 mg	33.3	12.1
SAR425899 0.16 mg	45.5	13.6
SAR425899 0.20 mg	35.9	15.6

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Percentage of Participants Reached HbA1c Target of <6.5% or <7% at Week 26

,,,,

Intervention	percentage of participants (Number)
	Participants with HbA1c Target of <6.5%	Participants with HbA1c Target of <7%
Liraglutide	44.8	67.2
Placebo	12.1	36.4
SAR425899 0.12 mg	47.0	66.7
SAR425899 0.16 mg	51.5	68.2
SAR425899 0.20 mg	48.4	65.6

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Change From Baseline in Pharmacodynamic Biomarkers to Week 26 - Waist and Hip Circumferences

Waist circumference was measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest, using a stretch-resistant tape providing a constant 100 gm tension. Hip circumference was measured around the widest portion of the buttocks, with the tape parallel to the floor. Each measurement was repeated twice; if the measurements were within 1 cm of one another, the average was calculated, and if the difference exceeded 1 cm, the measurements were repeated. (NCT02973321)
Timeframe: Baseline,Week 26

,,,,

Intervention	cm (Mean)
	Waist Circumference	Hip Circumference
Liraglutide	-4.0	-2.56
Placebo	-2.0	-1.42
SAR425899 0.12 mg	-5.3	-4.46
SAR425899 0.16 mg	-2.3	-1.97
SAR425899 0.20 mg	-3.2	-4.09

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Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26

Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based MI method under the missing not at random framework. (NCT02973321)
Timeframe: Baseline, Week 26

Intervention	mmol/L (Least Squares Mean)
Placebo	-0.931
SAR425899 0.12 mg	-2.408
SAR425899 0.16 mg	-2.548
SAR425899 0.20 mg	-2.318
Liraglutide	-2.124

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Change From Baseline in Average 7 Point Self-Monitoring Plasma Glucose (SMPG) to Week 26

Change in 7-point SMPG profile from baseline to Week 26 was assessed by summary statistics. 7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, and Week 26): pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) is defined as 2 hours after the start of the meal. (NCT02973321)
Timeframe: Baseline, Week 26

Intervention	mmol/L (Mean)
Placebo	-1.82
SAR425899 0.12 mg	-2.86
SAR425899 0.16 mg	-2.63
SAR425899 0.20 mg	-2.49
Liraglutide	-2.21

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Change From Baseline in Beta-Cell Function to Week 26

Beta-cell function was assessed by homeostatic model assessment (HOMA)-beta, derived from FPG and fasting plasma insulin (FPI). HOMA-beta was derived from FPG and FPI as (20*FPI [micro units/milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value*100. (NCT02973321)
Timeframe: Baseline, Week 26

Intervention	percentage of normal beta cells function (Least Squares Mean)
Placebo	15.025
SAR425899 0.12 mg	26.768
SAR425899 0.16 mg	31.122
SAR425899 0.20 mg	17.932
Liraglutide	27.263

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Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.

Differences in augmentation index (AI, %) using oscillometry at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. (NCT03010683)
Timeframe: Baseline, 3 months, 6 months, and 12 months.

Intervention	percentage of the central pulse pressure (Mean)
	Baseline	3 months	6 months	12 months
Liraglutide	18	15.8	13	13.9
Metformin	14	13.6	15	15.3

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Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.

Differences in carotid-femoral pulse wave velocity (PWV, m/sec) using tonometry at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. (NCT03010683)
Timeframe: Baseline, 3 months, 6 months and 12 months

Intervention	m/s (Mean)
	Baseline	3 months	6 months	12 months
Liraglutide	11.8	11.6	10.3	10.5
Metformin	11.2	11.5	11	10.8

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Endothelial Glycocalyx and Pulse Wave Velocity.

Association of endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels with pulse wave velocity (PWV, m/sec) at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. (NCT03010683)
Timeframe: Baseline, 3 months, 6 months, and 12 months.

Intervention	Pearson correlation coefficient (r) (Number)
	Baseline	3 months	6 months	12 months
Liraglutide	0.39	0.36	0.32	0.44
Metformin	0.35	0.32	0.29	0.37

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Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.

Differences in endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. High PBR values represent reduced glycocalyx thickness. (NCT03010683)
Timeframe: Baseline, 3 months, 6 months, and 12 months.

Intervention	micrometers (Mean)
	Baseline	3 months	6 months	12 months
Liraglutide	2.1	2.07	2.5	2.04
Metformin	2.13	2.15	2.13	2.10

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Change in HbA1c (Week 26)

Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. The endpoint was also evaluated based on data from the in-trial observation period. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. (NCT03018028)
Timeframe: Week 0, week 26

,,,,

Intervention	Percentage point of HbA1c (Mean)
	On-treatment without rescue medication	In-trial observation period
Liraglutide 0.9 mg	-1.4	-1.4
Oral Semaglutide 14 mg	-1.7	-1.7
Oral Semaglutide 3 mg	-1.1	-1.1
Oral Semaglutide 7 mg	-1.7	-1.6
Placebo	-0.2	-0.4

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Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No)

Participants losing 10% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 26 and week 52

Intervention	Participants (Count of Participants)
	Week 2672495962		Week 2672495964	Week 2672495965	Week 2672495966	Week 2672495963	Week 5272495962	Week 5272495963	Week 5272495964	Week 5272495965	Week 5272495966
	Yes	No
Oral Semaglutide 7 mg	0
Oral Semaglutide 14 mg	3
Liraglutide 0.9 mg	0
Placebo	0
Oral Semaglutide 3 mg	43
Oral Semaglutide 7 mg	45
Oral Semaglutide 14 mg	41
Liraglutide 0.9 mg	45
Placebo	41
Oral Semaglutide 3 mg	0
Oral Semaglutide 7 mg	1
Oral Semaglutide 14 mg	6
Oral Semaglutide 3 mg	38
Oral Semaglutide 7 mg	42
Oral Semaglutide 14 mg	35
Liraglutide 0.9 mg	41
Placebo	34

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Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No)

Participants losing 5% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 26 and week 52

Intervention	Participants (Count of Participants)
	Week 2672495962		Week 2672495963	Week 2672495964	Week 2672495965	Week 2672495966	Week 5272495962	Week 5272495963	Week 5272495964	Week 5272495965	Week 5272495966
	Yes	No
Oral Semaglutide 3 mg	1
Oral Semaglutide 14 mg	16
Liraglutide 0.9 mg	0
Placebo	3
Oral Semaglutide 3 mg	42
Oral Semaglutide 7 mg	40
Oral Semaglutide 14 mg	28
Liraglutide 0.9 mg	45
Placebo	38
Oral Semaglutide 7 mg	5
Oral Semaglutide 14 mg	17
Liraglutide 0.9 mg	2
Placebo	2
Oral Semaglutide 3 mg	37
Oral Semaglutide 7 mg	38
Oral Semaglutide 14 mg	24
Liraglutide 0.9 mg	39
Placebo	32

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Change in HbA1c (Week 52)

Change from baseline (week 0) to week 52 in HbA1c. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 52

Intervention	Percentage of HbA1c (Mean)
Oral Semaglutide 3 mg	-1.0
Oral Semaglutide 7 mg	-1.4
Oral Semaglutide 14 mg	-1.5
Liraglutide 0.9 mg	-1.3
Placebo	0.1

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Number of Treatment-emergent Adverse Events (TEAEs)

A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) with onset in the on-treatment observation period (time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any, and excluding any period after premature trial product discontinuation) assessed up to approximately 57 weeks (52 weeks treatment period + 5 weeks follow-up period). (NCT03018028)
Timeframe: Weeks 0 - 57

Intervention	Adverse events (Number)
Oral Semaglutide 3 mg	119
Oral Semaglutide 7 mg	111
Oral Semaglutide 14 mg	96
Liraglutide 0.9 mg	116
Placebo	106

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Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. (NCT03018028)
Timeframe: Week 0 - 57

Intervention	Episodes (Number)
Oral Semaglutide 3 mg	0
Oral Semaglutide 7 mg	0
Oral Semaglutide 14 mg	0
Liraglutide 0.9 mg	2
Placebo	0

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Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. (NCT03018028)
Timeframe: Weeks 0 - 57

Intervention	Participants (Count of Participants)
Oral Semaglutide 3 mg	0
Oral Semaglutide 7 mg	0
Oral Semaglutide 14 mg	0
Liraglutide 0.9 mg	2
Placebo	0

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Anti-semaglutide Binding Antibodies (Yes/no)

"Number of participants with the presence or absence (yes/no) of anti-semaglutide binding antibodies in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product." (NCT03018028)
Timeframe: Week 0 - 57

Intervention	Participants (Count of Participants)
	Yes	No
Oral Semaglutide 14 mg	1	47
Oral Semaglutide 3 mg	0	49
Oral Semaglutide 7 mg	1	48

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Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)

"Number of participants with the presence or absence (yes/no) of anti-semaglutide binding antibodies cross reacting with native GLP-1 in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product." (NCT03018028)
Timeframe: Week 0 - 57

Intervention	Participants (Count of Participants)
	Yes	No
Oral Semaglutide 14 mg	1	47
Oral Semaglutide 3 mg	0	49
Oral Semaglutide 7 mg	0	49

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Anti-semaglutide Binding Antibody Levels

This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. (NCT03018028)
Timeframe: Weeks 0-57

Intervention	%B/T (Mean)
	Week 38
Oral Semaglutide 14 mg	2.40

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Anti-semaglutide Binding Antibody Levels

Intervention	%B/T (Mean)
	Week 8
Oral Semaglutide 7 mg	1.58

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Anti-semaglutide Neutralising Antibodies (Yes/no)

"Number of participants with the presence or absence (yes/no) of anti-semaglutide neutralising antibodies in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period is presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product." (NCT03018028)
Timeframe: Week 0 - 57

Intervention	Participants (Count of Participants)
	Yes	No
Oral Semaglutide 14 mg	0	48
Oral Semaglutide 3 mg	0	49
Oral Semaglutide 7 mg	0	49

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Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)

"Number of participants with the presence or absence (yes/no) of anti-semaglutide neutralising antibodies cross reacting with native GLP-1 in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product." (NCT03018028)
Timeframe: Week 0 - 57

Intervention	Participants (Count of Participants)
	Yes	No
Oral Semaglutide 14 mg	0	48
Oral Semaglutide 3 mg	0	49
Oral Semaglutide 7 mg	0	49

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Change From Baseline in DTR-QOL: Sub-domains

"DTR-QOL questionnaire is a 29-item patient-reported survey of patient health that measures the the influence of diabetes treatment on HRQoL. DTR-QOL questionnaire measured the HRQoL on 4 domains on individual scale ranges: Burden on social activities and daily activities, Anxiety and dissatisfaction with treatment, Hypoglycemia and Satisfaction with treatment on a 7-point graded response scale. Higher item scores indicate a higher level of HRQoL for items 1-25. For items 26-29 a higher score indicates a lower level of HRQoL. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100. W26 and W52 refer to week 26 and week 52 respectively. Data based on on-treatment without rescue medication observation period was presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication." (NCT03018028)
Timeframe: Week 0, week 26, week 52

,,,,

Intervention	Score on a scale (Mean)
	W26: Burden on social and daily activities	W52: Burden on social and daily activities	W26: Anxiety and dissatisfaction with treatment	W52: Anxiety and dissatisfaction with treatment	Week 26: Hypoglycemia	Week 52: Hypoglycemia	Week 26: Satisfaction with treatment	Week 52: Satisfaction with treatment
Liraglutide 0.9 mg	10.11	7.60	13.52	7.01	3.80	4.47	7.13	8.43
Oral Semaglutide 14 mg	7.90	3.94	14.68	10.52	9.19	8.13	17.14	16.16
Oral Semaglutide 3 mg	5.75	9.31	6.49	4.93	8.33	5.81	8.33	4.61
Oral Semaglutide 7 mg	5.87	5.49	10.46	5.04	3.15	1.26	14.72	10.85
Placebo	6.91	2.90	1.83	-2.94	7.42	6.00	-3.25	-5.39

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Change From Baseline in DTR-QOL: Total Score

"Diabetes Therapy-Related QOL (DTR-QOL) questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on HRQoL on 4 domains on individual scale ranges: Burden on social activities and daily activities, Anxiety and dissatisfaction with treatment, Hypoglycemia and Satisfaction with treatment on a 7-point graded response scale. Higher item scores indicate a higher level of HRQoL for items 1-25. For items 26-29 a higher score indicates a lower level of HRQoL. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100. The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worstcase response = 0). Data based on on-treatment without rescue medication observation period is presented." (NCT03018028)
Timeframe: Week 0, week 26, week 52

,,,,

Intervention	Score on a scale (Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	9.77	7.12
Oral Semaglutide 14 mg	11.22	8.02
Oral Semaglutide 3 mg	6.67	6.97
Oral Semaglutide 7 mg	7.98	5.52
Placebo	4.18	0.57

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Change in Amylase (Ratio to Baseine)

Change in amylase (measured as units per liter [U/L]) is presented as ratio to baseline. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. (NCT03018028)
Timeframe: Week 0, week 26, week 52

,,,,

Intervention	Ratio of amylase (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	1.07	1.06
Oral Semaglutide 14 mg	1.16	1.12
Oral Semaglutide 3 mg	1.03	1.06
Oral Semaglutide 7 mg	1.10	1.10
Placebo	1.02	1.02

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Change in Beta-cell Function (HOMA-B) (Ratio to Baseline)

Change from baseline (week 0) in beta-cell function (measured as percentage of beta-cell function) by homeostatic model assessment index of beta-cell function is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

,,,,

Intervention	Ratio of beta-cell function (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	1.89	1.69
Oral Semaglutide 14 mg	1.95	1.86
Oral Semaglutide 3 mg	1.71	1.36
Oral Semaglutide 7 mg	1.93	1.75
Placebo	1.00	0.89

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Change in Blood Pressure

Change from baseline in blood pressure (systolic [sBP] and diastolic [dBP]). Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. (NCT03018028)
Timeframe: Week 0, week 26, week 52

,,,,

Intervention	Millimeters of mercury (mmHg) (Mean)
	Week 26: sBP	Week 52: sBP	Week 26: dBP	Week 52: dBP
Liraglutide 0.9 mg	-1	1	-1	-0
Oral Semaglutide 14 mg	-2	-1	1	-0
Oral Semaglutide 3 mg	-3	-0	-0	-1
Oral Semaglutide 7 mg	-5	-1	-2	-0
Placebo	-4	-3	-3	-2

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Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no)

Participants who achieved HbA1c <7.0% (53 millimoles per mole [mmol/mol]) according to American Diabetes Association (ADA) target, at week 26 and week 52. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 26 and week 52

Intervention	Participants (Count of Participants)
	Week 2672495962		Week 2672495963	Week 2672495965	Week 2672495966	Week 2672495964	Week 5272495962	Week 5272495963	Week 5272495964	Week 5272495965	Week 5272495966
	No	Yes
Oral Semaglutide 3 mg	24
Oral Semaglutide 7 mg	33
Oral Semaglutide 14 mg	35
Liraglutide 0.9 mg	24
Placebo	6
Oral Semaglutide 7 mg	12
Oral Semaglutide 14 mg	9
Placebo	35
Oral Semaglutide 3 mg	19
Oral Semaglutide 7 mg	29
Oral Semaglutide 14 mg	33
Liraglutide 0.9 mg	20
Placebo	4
Oral Semaglutide 7 mg	14
Oral Semaglutide 14 mg	8
Liraglutide 0.9 mg	21
Placebo	30

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Time to Rescue Medication

Presented results are the number of participants who had taken rescue medication anytime from week 0 to week 52. 'Rescue medication': use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation and before last day on trial product. Time to rescue medication was estimated based on data from on-treatment without rescue medication observation period. (NCT03018028)
Timeframe: Weeks 0 - 52

,,,,

Intervention	Participants (Count of Participants)
	Up to Week 26	Up to Week 52
Liraglutide 0.9 mg	0	3
Oral Semaglutide 14 mg	1	4
Oral Semaglutide 3 mg	2	7
Oral Semaglutide 7 mg	2	5
Placebo	7	15

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Change in Pulse Rate

Change from baseline in pulse rate. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. (NCT03018028)
Timeframe: Week 0, week 26, week 52

,,,,

Intervention	Beats per minute (beats/min) (Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	2	2
Oral Semaglutide 14 mg	2	4
Oral Semaglutide 3 mg	1	1
Oral Semaglutide 7 mg	2	3
Placebo	0	0

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Time to Additional Anti-diabetic Medication

Presented results are the number of participants who had taken additional anti-diabetic medication anytime from week 0 to week 52. 'Additional anti-diabetic medication': use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. (NCT03018028)
Timeframe: Weeks 0 - 52

,,,,

Intervention	Participants (Count of Participants)
	Up to Week 26	Up to Week 52
Liraglutide 0.9 mg	0	4
Oral Semaglutide 14 mg	1	4
Oral Semaglutide 3 mg	3	8
Oral Semaglutide 7 mg	3	6
Placebo	7	15

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Change in Body Weight (%)

Relative change (%) from baseline (week 0) in body weight (kg). Data based on on-treatment without resue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

,,,,

Intervention	Percentage change (Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.08	0.68
Oral Semaglutide 14 mg	-3.54	-4.42
Oral Semaglutide 3 mg	-0.64	-0.03
Oral Semaglutide 7 mg	-1.63	-1.23
Placebo	-1.58	-1.42

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Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile

Change from baseline (week 0) in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26, week 52

,,,,

Intervention	mmol/L (Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	-2.8	-2.3
Oral Semaglutide 14 mg	-3.1	-3.1
Oral Semaglutide 3 mg	-2.2	-1.7
Oral Semaglutide 7 mg	-2.6	-2.2
Placebo	-0.8	-0.0

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Change in Body Weight (kg)

Change from baseline (week 0) in body weight. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26, week 52

,,,,

Intervention	Kilogram (kg) (Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.1	0.5
Oral Semaglutide 14 mg	-2.4	-2.9
Oral Semaglutide 3 mg	-0.4	0.0
Oral Semaglutide 7 mg	-1.2	-0.8
Placebo	-1.1	-1.0

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Change in ECG Evaluation

Electrocardiogram (ECG) was evaluated and interpreted by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). The number of participants who had shifted from normal, abnormal NCS or abnormal CS ECG results from baseline (week 0) to week 26, week 52 is presented. Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. (NCT03018028)
Timeframe: Week 0, week 26, week 52

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Intervention	Participants (Count of Participants)
	Normal (week 0) to normal (week 26)	Normal (week 0) to abnormal NCS (week 26)	Normal (week 0) to abnormal CS (week 26)	Abnormal NCS (week 0) to normal (week 26)	Abnormal NCS (week 0) to abnormal NCS (week 26)	Abnormal NCS (week 0) to abnormal CS (week 26)	Abnormal CS (week 0) to normal (week 26)	Abnormal CS (week 0) to abnormal NCS (week 26)	Abnormal CS (week 0) to abnormal CS (week 26)	Normal (week 0) to normal (week 52)	Normal (week 0) to abnormal NCS (week 52)	Normal (week 0) to abnormal CS (week 52)	Abnormal NCS (week 0) to normal (week 52)	Abnormal NCS (week 0) to abnormal NCS (week 52)	Abnormal NCS (week 0) to abnormal CS (week 52)	Abnormal CS (week 0) to normal (week 52)	Abnormal CS (week 0) to abnormal NCS (week 52)	Abnormal CS (week 0) to abnormal CS (week 52)
Liraglutide 0.9 mg	38	2	0	1	4	0	0	0	1	37	2	0	2	3	0	0	0	1
Oral Semaglutide 14 mg	39	0	0	3	4	0	0	0	1	36	3	0	2	5	0	1	0	0
Oral Semaglutide 3 mg	34	4	0	3	3	0	2	0	0	37	1	0	3	3	0	2	0	0
Oral Semaglutide 7 mg	41	0	0	1	5	0	0	0	2	40	1	0	2	4	0	0	0	2
Placebo	39	2	0	1	6	0	0	1	0	39	2	0	3	4	0	0	1	0

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Change in Eye Examination Category

Eye examination was performed by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. (NCT03018028)
Timeframe: Week -8, Week 52

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Intervention	Participants (Count of Participants)
	Week -8: Left eye- Normal	Week -8: Left eye- Abnormal NCS	Week -8: Left eye- Abnormal CS	Week 52: Left eye- Normal	Week 52: Left eye- Abnormal NCS	Week 52: Left eye- Abnormal CS	Week -8: Right eye- Normal	Week -8: Right eye- Abnormal NCS	Week -8: Right eye- Abnormal CS	Week 52: Right eye- Normal	Week 52: Right eye- Abnormal NCS	Week 52: Right eye- Abnormal CS
Liraglutide 0.9 mg	37	6	5	37	5	3	38	7	3	39	5	1
Oral Semaglutide 14 mg	37	4	7	38	5	4	36	5	7	36	7	4
Oral Semaglutide 3 mg	39	4	6	36	4	6	42	2	5	39	2	5
Oral Semaglutide 7 mg	45	2	2	46	2	1	46	2	1	44	2	3
Placebo	39	5	5	41	3	5	39	4	6	44	3	2

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Change in Fasting C-peptide (Ratio to Baseline)

Change from baseline (week 0) in fasting C-peptide (measured as nanomoles per liter [nmol/L]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

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Intervention	Ratio of C-peptide (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	1.18	1.11
Oral Semaglutide 14 mg	1.17	1.10
Oral Semaglutide 3 mg	1.15	1.12
Oral Semaglutide 7 mg	1.24	1.19
Placebo	0.98	0.99

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Change in Fasting Glucagon (Ratio to Baseline)

Change from baseline (week 0) in fasting glucagon (measured as picograms per milliliter [pg/mL]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

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Intervention	Ratio of glucagon (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.91	0.93
Oral Semaglutide 14 mg	0.85	0.92
Oral Semaglutide 3 mg	0.95	0.97
Oral Semaglutide 7 mg	0.89	0.95
Placebo	0.95	0.96

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Change in Fasting Insulin (Ratio to Baseline)

Change from baseline (week 0) in fasting insulin (measured as picomoles per liter [pmol/L]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

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Intervention	Ratio of insulin (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	1.14	1.06
Oral Semaglutide 14 mg	1.10	1.04
Oral Semaglutide 3 mg	1.19	1.07
Oral Semaglutide 7 mg	1.27	1.16
Placebo	0.92	0.93

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Change in Fasting Plasma Glucose

Change from baseline (week 0) in fasting plasma glucose. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26, week 52

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Intervention	Millimoles per liter (mmol/L) (Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	-2.48	-2.28
Oral Semaglutide 14 mg	-2.37	-2.29
Oral Semaglutide 3 mg	-1.62	-1.13
Oral Semaglutide 7 mg	-1.60	-1.60
Placebo	-0.37	0.33

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Change in Fasting Pro-insulin (Ratio to Baseline)

Change from baseline (week 0) in fasting pro-insulin (measured as pmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

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Intervention	Ratio of pro-insulin (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.61	0.72
Oral Semaglutide 14 mg	0.51	0.56
Oral Semaglutide 3 mg	0.69	0.83
Oral Semaglutide 7 mg	0.68	0.78
Placebo	0.85	1.04

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Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline)

Change from baseline (week 0) in fasting pro-insulin/insulin ratio is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

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Intervention	Ratio of pro-insulin/insulin ratio (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.55	0.69
Oral Semaglutide 14 mg	0.49	0.56
Oral Semaglutide 3 mg	0.59	0.78
Oral Semaglutide 7 mg	0.54	0.67
Placebo	0.92	1.11

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Semaglutide Plasma Concentration

"Semaglutide plasma concentration is presented. Samples for pharmacokinetic (PK) analysis were drawn at any time during the visit except for the visit at week 26 where samples were taken both pre-dose and 60-90 minutes post dosing. This endpoint is applicable only to the reporting groups, Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation." (NCT03018028)
Timeframe: Week 26 and week 52

Intervention	Nanomoles per liter (nmol/L) (Geometric Mean)
	Week 26 pre-dose	Week 26 post-dose	Week 52
Oral Semaglutide 14 mg	20.6	30.7	20.0
Oral Semaglutide 3 mg	3.7	5.3	3.2
Oral Semaglutide 7 mg	9.5	13.9	9.2

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Change in HDL Cholesterol (Ratio to Baseline)

Change from baseline (week 0) in high density lipoprotein (HDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

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Intervention	Ratio of HDL cholesterol (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.99	0.98
Oral Semaglutide 14 mg	0.96	0.99
Oral Semaglutide 3 mg	0.97	1.05
Oral Semaglutide 7 mg	0.98	1.01
Placebo	1.03	1.04

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Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline)

Change from baseline (week 0) in insulin resistance (measured as percentage of insulin resistance) by homeostatic model assessment index of insulin resistance (HOMA-IR) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

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Intervention	Ratio of insulin resistance (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.86	0.82
Oral Semaglutide 14 mg	0.83	0.78
Oral Semaglutide 3 mg	0.98	0.93
Oral Semaglutide 7 mg	1.02	0.95
Placebo	0.88	0.97

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Change in LDL Cholesterol (Ratio to Baseline)

Change from baseline (week 0) in low density lipoprotein (LDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

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Intervention	Ratio of LDL cholesterol (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.91	0.95
Oral Semaglutide 14 mg	0.85	0.91
Oral Semaglutide 3 mg	0.87	0.99
Oral Semaglutide 7 mg	0.89	0.96
Placebo	1.03	1.06

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Change in Lipase (Ratio to Baseine)

Change in lipase (measured as U/L) is presented as ratio to baseline. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. (NCT03018028)
Timeframe: Week 0, week 26, week 52

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Intervention	Ratio of lipase (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	1.47	1.60
Oral Semaglutide 14 mg	1.61	1.47
Oral Semaglutide 3 mg	1.25	1.29
Oral Semaglutide 7 mg	1.35	1.41
Placebo	1.04	1.03

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Change in Mean Postprandial Increment Over All Meals in SMPG

Change from baseline (week 0) in the average of the post-prandial increments over all meals. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

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Intervention	mmol/L (Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	-1.1	-0.6
Oral Semaglutide 14 mg	-2.0	-2.0
Oral Semaglutide 3 mg	-0.7	-0.5
Oral Semaglutide 7 mg	-1.2	-0.9
Placebo	-0.5	-0.1

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Change in Physical Examination

Physical examination included examination of cardiovascular system, nervous system (central and peripheral), gastrointestinal system including mouth, general appearence, head and neck (head, ears, eyes, nose, throat, neck), lymph node palpation, musculoskeletal system, respiratory system, skin and thyroid gland. Physical examination was performed by the investigator and categorised as normal, abnormal NCS or abnormal CS. Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. (NCT03018028)
Timeframe: Baseline (Week -8), week 26, week 52

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Intervention	Participants (Count of Participants)
	Week -8: Cardiovascular- Normal	Week -8: Cardiovascular- Abnormal NCS	Week -8: Cardiovascular- Abnormal CS	Week 26: Cardiovascular- Normal	Week 26: Cardiovascular- Abnormal NCS	Week 26: Cardiovascular- Abnormal CS	Week 52: Cardiovascular- Normal	Week 52: Cardiovascular- Abnormal NCS	Week 52: Cardiovascular- Abnormal CS	Week -8: Nervous system- Normal	Week -8: Nervous system- Abnormal NCS	Week -8: Nervous system- Abnormal CS	Week 26: Nervous system- Normal	Week 26: Nervous system- Abnormal NCS	Week 26: Nervous system- Abnormal CS	Week 52: Nervous system- Normal	Week 52: Nervous system- Abnormal NCS	Week 52: Nervous system- Abnormal CS	Week -8: Gastrointestinal sys- Normal	Week -8: Gastrointestinal sys- Abnormal NCS	Week -8: Gastrointestinal sys- Abnormal CS	Week 26: Gastrointestinal sys - Normal	Week 26: Gastrointestinal sys- Abnormal NCS	Week 26: Gastrointestinal sys- Abnormal CS	Week 52: Gastrointestinal sys- Normal	Week 52: Gastrointestinal sys- Abnormal NCS	Week 52: Gastrointestinal sys- Abnormal CS	Week -8: General appearance- Normal	Week -8: General appearance- Abnormal NCS	Week -8: General appearance- Abnormal CS	Week 26: General appearance- Normal	Week 26: General appearance- Abnormal NCS	Week 26: General appearance- Abnormal CS	Week 52: General appearance- Normal	Week 52: General appearance- Abnormal NCS	Week 52: General appearance- Abnormal CS	Week -8: Head and neck- Normal	Week -8: Head and neck- Abnormal NCS	Week -8: Head and neck- Abnormal CS	Week 26: Head and neck- Normal	Week 26: Head and neck- Abnormal NCS	Week 26: Head and neck- Abnormal CS	Week 52: Head and neck- Normal	Week 52: Head and neck- Abnormal NCS	Week 52: Head and neck- Abnormal CS	Week -8: Lymph node- Normal	Week -8: Lymph node- Abnormal NCS	Week -8: Lymph node- Abnormal CS	Week 26: Lymph node- Normal	Week 26: Lymph node- Abnormal NCS	Week 26: Lymph node- Abnormal CS	Week 52: Lymph node- Normal	Week 52: Lymph node- Abnormal NCS	Week 52: Lymph node- Abnormal CS	Week -8: Musculoskeletal- Normal	Week -8: Musculoskeletal- Abnormal NCS	Week -8: Musculoskeletal- Abnormal CS	Week 26: Musculoskeletal- Normal	Week 26: Musculoskeletal- Abnormal NCS	Week 26: Musculoskeletal- Abnormal CS	Week 52: Musculoskeletal- Normal	Week 52: Musculoskeletal- Abnormal NCS	Week 52: Musculoskeletal- Abnormal CS	Week -8: Respiratory sys- Normal	Week -8: Respiratory sys- Abnormal NCS	Week -8: Respiratory sys- Abnormal CS	Week 26: Respiratory sys- Normal	Week 26: Respiratory sys- Abnormal NCS	Week 26: Respiratory sys- Abnormal CS	Week 52: Respiratory sys- Normal	Week 52: Respiratory sys- Abnormal NCS	Week 52: Respiratory sys- Abnormal CS	Week -8: Skin- Normal	Week -8: Skin- Abnormal NCS	Week -8: Skin- Abnormal CS	Week 26: Skin- Normal	Week 26: Skin- Abnormal NCS	Week 26: Skin- Abnormal CS	Week 52: Skin- Normal	Week 52: Skin- Abnormal NCS	Week 52: Skin- Abnormal CS	Week -8: Thyroid - Normal	Week -8: Thyroid- Abnormal NCS	Week -8: Thyroid- Abnormal CS	Week 26: Thyroid- Normal	Week 26: Thyroid- Abnormal NCS	Week 26: Thyroid- Abnormal CS	Week 52: Thyroid- Normal	Week 52: Thyroid- Abnormal NCS	Week 52: Thyroid- Abnormal CS
Liraglutide 0.9 mg	48	0	0	45	0	0	45	0	0	48	0	0	45	0	0	45	0	0	47	0	1	44	0	1	44	0	1	47	1	0	44	1	0	44	1	0	45	3	0	44	1	0	44	1	0	48	0	0	45	0	0	45	0	0	48	0	0	43	1	1	45	0	0	47	1	0	44	1	0	44	1	0	47	1	0	43	1	1	45	0	0	48	0	0	45	0	0	45	0	0
Oral Semaglutide 14 mg	48	0	0	47	0	0	47	0	0	48	0	0	47	0	0	47	0	0	47	0	1	45	1	1	45	1	1	47	1	0	45	2	0	46	1	0	44	1	3	43	1	3	43	2	2	48	0	0	47	0	0	47	0	0	47	0	1	46	0	1	46	0	1	46	0	2	45	0	2	45	0	2	45	0	3	44	0	3	44	0	3	48	0	0	47	0	0	47	0	0
Oral Semaglutide 3 mg	49	0	0	46	0	0	46	0	0	48	1	0	45	1	0	45	1	0	46	2	1	44	1	1	43	2	1	47	2	0	44	2	0	43	2	1	44	5	0	43	3	0	42	4	0	49	0	0	46	0	0	46	0	0	47	2	0	42	4	0	41	5	0	49	0	0	46	0	0	46	0	0	46	2	1	44	1	1	44	1	1	48	1	0	45	1	0	45	1	0
Oral Semaglutide 7 mg	49	0	0	49	0	0	49	0	0	48	0	1	48	0	1	48	0	1	47	1	1	47	1	1	45	3	1	47	2	0	47	2	0	48	1	0	45	1	3	47	0	2	47	0	2	49	0	0	49	0	0	49	0	0	44	3	2	45	2	2	45	2	2	49	0	0	48	1	0	49	0	0	48	1	0	47	1	1	47	1	1	48	0	1	48	0	1	48	0	1
Placebo	49	0	0	49	0	0	49	0	0	48	1	0	48	1	0	48	1	0	48	1	0	48	1	0	47	2	0	46	3	0	46	3	0	46	3	0	46	3	0	44	3	2	44	3	2	49	0	0	49	0	0	49	0	0	44	4	1	42	6	1	43	6	0	49	0	0	49	0	0	49	0	0	45	2	2	45	2	2	46	2	1	49	0	0	49	0	0	49	0	0

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Change in Body Mass Index

Change from baseline (week 0) in body mass index (BMI). BMI was calculated based on body weight and height based on the formulae: BMI kg/m^2 = body weight (kg)/(Height (m) x Height (m)). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

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Intervention	Kilogram per square meter (kg/m^2) (Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.0	0.2
Oral Semaglutide 14 mg	-0.9	-1.1
Oral Semaglutide 3 mg	-0.1	0.0
Oral Semaglutide 7 mg	-0.4	-0.3
Placebo	-0.4	-0.4

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Change in SF-36: Mental Component Summary (MCS)

Change in short form 36 v2.0 acute domain MCS from baseline (week 0) to week 56. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented. (NCT03018028)
Timeframe: Week 0, week 26, week 52

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Intervention	Score on a scale (Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.49	0.10
Oral Semaglutide 14 mg	-1.61	-1.16
Oral Semaglutide 3 mg	-1.81	-1.56
Oral Semaglutide 7 mg	0.56	-0.58
Placebo	-2.18	-1.94

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Change in SF-36: Physical Component Summary (PCS)

Change in short form 36 v2.0 acute domain PCS from baseline (week 0) to week 56. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented. (NCT03018028)
Timeframe: Week 0, week 26, week 52

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Intervention	Score on a scale (Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	-0.14	0.10
Oral Semaglutide 14 mg	0.93	0.02
Oral Semaglutide 3 mg	-1.33	-1.28
Oral Semaglutide 7 mg	-0.38	-0.12
Placebo	0.20	-0.10

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Change in SF-36: Sub-domains

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores is presented. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented. (NCT03018028)
Timeframe: Week 0, week 26, week 52

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Intervention	Score on a scale (Mean)
	Week 26: Physical Functioning	Week 52: Physical Functioning	Week 26: Role-Physical	Week 52: Role-Physical	Week 26: Bodily Pain	Week 52: Bodily Pain	Week 26: General Health	Week 52: General Health	Week 26: Vitality	Week 52: Vitality	Week 26: Social Functioning	Week 52: Social Functioning	Week 26: Role-Emotional	Week 52: Role-Emotional	Week 26: Mental Health	Week 52: Mental Health
Liraglutide 0.9 mg	0.09	-0.09	0.10	-0.59	0.48	0.98	-0.00	0.62	-0.18	-0.13	-0.66	-0.48	-0.09	-0.19	1.71	0.72
Oral Semaglutide 14 mg	0.04	-0.00	0.05	-0.86	1.18	0.03	0.41	-0.47	-1.49	-1.06	-0.45	0.00	0.35	-0.47	-2.36	-1.69
Oral Semaglutide 3 mg	-0.22	-0.31	-1.79	-2.14	-2.02	-2.43	-2.43	-0.99	-2.85	-1.93	-0.11	-0.78	-1.60	-0.70	-1.90	-2.41
Oral Semaglutide 7 mg	-0.09	0.30	0.00	0.15	-0.89	-0.16	0.52	-1.24	-0.48	-0.82	0.77	-0.58	-0.00	0.18	0.77	-0.52
Placebo	-0.14	-0.00	-0.86	-0.58	-0.19	-0.79	-0.08	-0.99	-1.99	-1.60	-1.20	-1.16	-1.12	-1.80	-2.17	-1.31

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Change in Total Cholesterol (Ratio to Baseline)

Change from baseline (week 0) in total cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

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Intervention	Ratio of total cholesterol (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.94	0.95
Oral Semaglutide 14 mg	0.89	0.93
Oral Semaglutide 3 mg	0.92	0.99
Oral Semaglutide 7 mg	0.93	0.95
Placebo	1.00	1.01

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Change in Triglycerides (Ratio to Baseline)

Change from baseline (week 0) in triglycerides (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

,,,,

Intervention	Ratio of triglycerides (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.99	0.87
Oral Semaglutide 14 mg	0.93	0.86
Oral Semaglutide 3 mg	1.03	0.86
Oral Semaglutide 7 mg	0.94	0.84
Placebo	0.87	0.82

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Change in VLDL Cholesterol (Ratio to Baseline)

Change from baseline (week 0) in very low density lipoprotein (VLDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

,,,,

Intervention	Ratio of VLDL cholesterol (Geometric Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.99	0.87
Oral Semaglutide 14 mg	0.93	0.86
Oral Semaglutide 3 mg	1.02	0.86
Oral Semaglutide 7 mg	0.94	0.84
Placebo	0.87	0.81

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Change in Waist Circumference

Change from baseline (week 0) in waist circumference. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 0, week 26 and week 52

,,,,

Intervention	Centimeters (cm) (Mean)
	Week 26	Week 52
Liraglutide 0.9 mg	0.0	1.0
Oral Semaglutide 14 mg	-1.3	-2.7
Oral Semaglutide 3 mg	0.5	0.2
Oral Semaglutide 7 mg	-0.6	-1.0
Placebo	-0.5	-0.9

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Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)

Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 milligrams per deciliter [mg/dL]) with symptoms consistent with hypoglycaemia. Number of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 26 and week 52

Intervention	Participants (Count of Participants)
	Week 2672495962		Week 2672495965	Week 2672495966	Week 2672495963	Week 2672495964	Week 5272495963	Week 5272495964	Week 5272495965	Week 5272495962	Week 5272495966
	Yes	No
Oral Semaglutide 3 mg	15
Oral Semaglutide 7 mg	26
Oral Semaglutide 14 mg	30
Liraglutide 0.9 mg	15
Placebo	4
Oral Semaglutide 3 mg	28
Oral Semaglutide 7 mg	19
Oral Semaglutide 14 mg	14
Liraglutide 0.9 mg	30
Placebo	37
Oral Semaglutide 3 mg	12
Oral Semaglutide 7 mg	24
Oral Semaglutide 14 mg	28
Liraglutide 0.9 mg	9
Oral Semaglutide 3 mg	26
Oral Semaglutide 14 mg	13
Liraglutide 0.9 mg	32
Placebo	30

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Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No)

Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists target (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 26 and week 52

Intervention	Participants (Count of Participants)
	Week 2672495962		Week 2672495964	Week 2672495963	Week 2672495965	Week 2672495966	Week 5272495962	Week 5272495963	Week 5272495965	Week 5272495964	Week 5272495966
	No	Yes
Oral Semaglutide 3 mg	13
Oral Semaglutide 7 mg	24
Oral Semaglutide 14 mg	28
Liraglutide 0.9 mg	16
Placebo	2
Oral Semaglutide 3 mg	30
Oral Semaglutide 7 mg	21
Oral Semaglutide 14 mg	16
Liraglutide 0.9 mg	29
Placebo	39
Oral Semaglutide 3 mg	11
Oral Semaglutide 7 mg	20
Oral Semaglutide 14 mg	24
Liraglutide 0.9 mg	11
Placebo	1
Oral Semaglutide 3 mg	27
Oral Semaglutide 7 mg	23
Oral Semaglutide 14 mg	17
Liraglutide 0.9 mg	30
Placebo	33

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Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3%

Participants who achieved above or equal to 1% (10.9 mmol/mol) reduction in HbA1c and losing 3% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. (NCT03018028)
Timeframe: Week 26 and week 52

Intervention	Participants (Count of Participants)
	Week 2672495962		Week 2672495964	Week 2672495966	Week 2672495963	Week 2672495965	Week 5272495966	Week 5272495962	Week 5272495963	Week 5272495964	Week 5272495965
	Yes	No
Oral Semaglutide 3 mg	7
Oral Semaglutide 7 mg	11
Oral Semaglutide 14 mg	21
Liraglutide 0.9 mg	5
Placebo	3
Oral Semaglutide 3 mg	36
Oral Semaglutide 7 mg	34
Oral Semaglutide 14 mg	23
Liraglutide 0.9 mg	40
Placebo	38
Oral Semaglutide 3 mg	8
Oral Semaglutide 7 mg	7
Oral Semaglutide 14 mg	20
Liraglutide 0.9 mg	2
Placebo	1
Oral Semaglutide 3 mg	30
Oral Semaglutide 7 mg	36
Liraglutide 0.9 mg	39
Placebo	33

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Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI

"The effect on relative percent reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment.~Positive numbers reflect the reduction in the value from baseline to study endpoint as a percent of the baseline.~Reduction in this variable is believed to be associated with lower cardiovascular risk." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percentage of reduction in VAT (Mean)
Liraglutide 3.0 mg	12.49
Placebo	1.63

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Relative Percent Reduction in Waist Circumference

"The effect on relative percent reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint.~Reduction in this variable is believed to be associated with lower cardiovascular risk." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	6.90
Placebo	4.16

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Relative Percent Reduction in Body Weight

"The effect on relative percent reduction from baseline in body weight after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint.~Reduction in this variable is believed to be associated with lower cardiovascular risk." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	6.59
Placebo	1.19

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Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue

"The effect on relative percent reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	9.87
Placebo	0.77

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Relative Percent Change in Triglyceride/HDL-C Ratio

"The relative percent change in triglyceride/HDL-C ratio from baseline to study end point as a percent of baseline by treatment group.~Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.~Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	-2.10
Placebo	-2.18

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Relative Percent Change in Nt-proBNP

"The relative percent change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point as a percent of baseline by treatment group.~Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.~NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	12.10
Placebo	20.47

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Relative Percent Change in Insulin

"The relative percent change in insulin from baseline to study end point as a percent of baseline by treatment group.~Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.~This is a blood based biomarker in which lower fasting levels are desirable." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	20.58
Placebo	7.73

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Relative Percent Change in HOMA-IR

"The relative percent change in HOMA-IR from baseline to study end point as a percent of baseline by treatment group.~Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.~The relative percent change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	15.35
Placebo	11.85

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Relative Percent Change in Fasting Blood Glucose

"The relative percent change in fasting blood glucose from baseline to study end point as a percent of baseline by treatment group.~Negative values reflect a reduction. This is a blood based biomarker for diabetes in which normal levels are desirable (70-100 mg/dL)." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	-5.62
Placebo	0.83

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Relative Percent Change in C-reactive Protein

"The relative percent change in biomarker of inflammation: C-reactive protein (CRP) from baseline to study end point as a percent of baseline by treatment group.~Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.~This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	-19.91
Placebo	19.02

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Relative Percent Reduction in Total Thigh Muscle Volume

"The effect on relative percent reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	3.48
Placebo	0.68

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Change From Baseline in VAT/SAT Ratio

"The effect on absolute reduction from baseline in Visceral adipose tissue/subcutaneous adipose tissue (VAT/SAT) ratio measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint.~This is the ratio of visceral adipose tissue to subcutaneous adipose tissue and it is thought that lower values (relatively less visceral adipose tissue) are better." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	ratio (Mean)
Liraglutide 3.0 mg	0.01
Placebo	0

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Change From Baseline in Total Fat/Fat-free Mass Ratio

"The effect on absolute change from baseline in total fat/fat-free mass ratio measured by MRI after 40 weeks on treatment versus placebo.~This is a ratio of fat to lean mass and it is believed that lower values (less fat relative to lean mass) is better." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	ratio (Mean)
Liraglutide 3.0 mg	-7.23
Placebo	0.01

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Change From Baseline in Heart Rate

The change in heart rate/pulse from baseline to study endpoint visit by treatment group. (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	beats per minute (Mean)
Liraglutide 3.0 mg	4.84
Placebo	2.67

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Change From Baseline in Blood Pressure

The change in systolic blood pressure from baseline to study endpoint visit by treatment group. (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	mmHg (Mean)
Liraglutide 3.0 mg	-5.84
Placebo	-0.02

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Absolute Reduction in Waist Circumference

"The effect on absolute reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint.~Reduction in this variable is believed to be associated with lower cardiovascular risk." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	cm (Mean)
Liraglutide 3.0 mg	7.4
Placebo	4.6

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Absolute Reduction in Visceral Adipose Tissue Volume

"The effect on absolute reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint.~Reduction in this variable is believed to be associated with lower cardiovascular risk." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	Liters (Mean)
Liraglutide 3.0 mg	0.53
Placebo	0.10

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Absolute Reduction in Total Thigh Muscle Volume

"The effect on absolute reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	Liters (Mean)
Liraglutide 3.0 mg	0.35
Placebo	0.06

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Absolute Reduction in Total Body Lean Volume

"The effect on absolute reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	Liters (Mean)
Liraglutide 3.0 mg	0.54
Placebo	0.17

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Absolute Reduction in Total Body Adipose Tissue

"The effect on absolute reduction from baseline in total body adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint.~Reduction in this variable is believed to be associated with lower cardiovascular risk." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	Liters (Mean)
Liraglutide 3.0 mg	3.76
Placebo	0.42

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Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent

"The effect on absolute reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.~Reduction in this variable is believed to be associated with lower risk for metabolic disease" (NCT03038620)
Timeframe: Baseline,40 weeks

Intervention	percentage of fat infiltration (Mean)
Liraglutide 3.0 mg	0.23
Placebo	0.01

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Absolute Reduction in Lower Body Subcutaneous Adipose Tissue

"The effect on absolute reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	Liters (Mean)
Liraglutide 3.0 mg	1.51
Placebo	0.19

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Absolute Reduction in Body Weight

"The effect on absolute reduction from baseline in body weight after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint.~Reduction in this variable is believed to be associated with lower cardiovascular risk." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	Kilograms (Mean)
Liraglutide 3.0 mg	6.75
Placebo	1.3

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Absolute Reduction in Abdominal Subcutaneous Adipose Tissue

"The effect on absolute reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	Liters (Mean)
Liraglutide 3.0 mg	1.52
Placebo	0.15

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Absolute Change in Triglyceride/HDL-C Ratio

"The change in triglyceride/HDL-C ratio from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.~Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	ratio (Mean)
Liraglutide 3.0 mg	-0.02
Placebo	-0.16

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On-treatment Time, Weeks

The mean duration of treatment during study follow-up. (NCT03038620)
Timeframe: weeks

Intervention	weeks (Mean)
Liraglutide 3.0 mg	36.2
Placebo	36.1

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Absolute Change in Nt-proBNP

"The change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.~NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	pg/mL (Mean)
Liraglutide 3.0 mg	-8.10
Placebo	1.44

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Absolute Change in Insulin

The absolute change in insulin from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits. (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	mIU/L (Mean)
Liraglutide 3.0 mg	0.75
Placebo	-1.48

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Absolute Change in HOMA-IR

The absolute change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1. Collection was impacted by COVID-19 and changes to study visits. (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	Molar units (Mean)
Liraglutide 3.0 mg	-0.15
Placebo	-0.69

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Absolute Change in Fasting Blood Glucose

The change in fasting blood glucose from baseline to study end point by treatment group. (NCT03038620)
Timeframe: Baseline,40 weeks

Intervention	mg/dL (Mean)
Liraglutide 3.0 mg	-6.49
Placebo	-0.22

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Absolute Reduction in Liver Fat Percent

"The effect on absolute reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.~Reduction in this variable is believed to be associated with lower cardiovascular risk." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percentage of liver fat (Mean)
Liraglutide 3.0 mg	2.35
Placebo	-0.01

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Absolute Change in CRP

"The change in Markers of inflammation: C-reactive protein (CRP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.~This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	mg/L (Mean)
Liraglutide 3.0 mg	-2.18
Placebo	-0.64

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Relative Percent Reduction in Total Body Lean Volume

"The effect on relative percent reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	2.47
Placebo	0.90

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Relative Percent Reduction in Total Body Adipose Tissue

"The effect on relative percent reduction from baseline in total body adipose tissue (fat) mass measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint.~Reduction in this variable is believed to be associated with lower cardiovascular risk." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	9.59
Placebo	0.95

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Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent

"The effect on relative percent reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.~Reduction in this variable is believed to be associated with lower risk for metabolic disease." (NCT03038620)
Timeframe: Baseline,40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	2.81
Placebo	-0.29

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Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue

"The effect on relative percent reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	9.95
Placebo	1.29

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Relative Percent Reduction in Liver Fat Percent

"The effect on relative percent reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.~Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.~Reduction in this variable is believed to be associated with lower cardiovascular risk." (NCT03038620)
Timeframe: Baseline, 40 weeks

Intervention	percent change (Mean)
Liraglutide 3.0 mg	12.37
Placebo	-20.63

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Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5

"Satiety, fullness, hunger, and prospective consumption were measured at the study site using a validated VAS questionnaire. The VAS measurement of the subcomponent scores were the same as that of the appetite score. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0).The VAS was an assessment in which subjects place a vertical line across a validated 100 millimeter (mm) line to rank their response to various questions. The line was anchored by responses such as Not At All Full and Totally Full at either end. Scoring consisted of measuring the distance in mm of the vertical line from the response at the left end. The scores (total and subscale) ranged from 0 to 100. The lower values represent the better outcomes.The overall appetite score was calculated as the average of the 4 individual scores [satiety+fullness+(100-prospective food consumption)+(100-hunger)] divided by 4." (NCT03041792)
Timeframe: Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)

Intervention	units on a scale (Mean)
	Satiety (Visit 4)	Satiety (Visit 5)	Fullness (Visit 4)	Fullness (Visit 5)	Prospective food consumption (Visit 4)	Prospective food consumption (Visit 5)	Hunger (Visit 4)	Hunger (Visit 5)
Liraglutide	3.94	4.51	4.04	2.40	-7.74	-6.18	-3.71	-3.41
Placebo	-0.55	1.02	1.88	1.89	1.59	4.23	2.13	2.63

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Number of Participants With Vital Signs Data Meeting Categorical Criteria

Absolute values and changes from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate (PR) were recorded in supine position. Vital signs categorical summarization criteria were 1), blood pressure: SBP greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, SBP less than (<) 90 mm Hg; DBP >=20 mm Hg change from baseline, DBP <50 mm Hg; 2), PR <40 or greater than (>) 120 beats per minute (bpm). Baseline was defined as pre-treatment measurement on Day 1. (NCT03041792)
Timeframe: Baseline (Visit 3) up to Visit 6 (Study Day 53)

Intervention	Participants (Count of Participants)
	Supine DBP <50 mmHg	Supine PR <40 bpm	Supine PR >120 bpm	Supine SBP <90 mmHg	Increase in supine DBP >=20 mmHg	Increase in supine SBP >=30 mmHg	Decrease in supine DBP >=20 mmHg	Decrease in supine SBP >=30 mmHg
Liraglutide	3	0	0	1	3	1	3	1
Placebo	5	0	0	2	1	1	9	0

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Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)

ECG categorical summarization criteria: 1) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): absolute value greater than or equal to (>=) 300 msec, percent change >=25% if baseline was greater than (>) 200 msec, and >=50% if baseline was less than or equal to (<=) 200 msec; 2) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): absolute value >=200 msec, percent change >=25% if baseline was 100 msec, and >=50% if baseline was <=100 msec; 3) QTcF interval (QT corrected for heart rate using Fridericia's formula): absolute value >450 to <=480 msec, >480 to <=500 msec, >500 msec, an increase from baseline >30 to <=60 msec or >60 msec. Baseline was defined as pre-treatment measurement on Day -2. (NCT03041792)
Timeframe: Baseline (Visit 3) up to Visit 6 (Study Day 53)

Intervention	Participants (Count of Participants)
	PR interval >=300 milliseconds (msec)	QRS interval >=200 msec	QTcF >450 - <=480 msec	QTcF >480 - <=500 msec	QTcF >500 msec	PR interval percent increase >=25/50%	QRS interval percent increase >=25/50%	QTcF increase >30 - <=60 msec	QTcF increase >60 msec
Liraglutide	0	0	2	0	0	0	0	2	0
Placebo	0	0	2	0	0	0	0	1	0

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Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5

Energy intake was measured over a period of 48 hours to assess day to day variability in food intake. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Baseline was defined as the 48 hour period at Visit 3 (Study Day -1 and 0). (NCT03041792)
Timeframe: Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)

Intervention	kcal (Mean)
	Visit 4	Visit 5
Liraglutide	-1058.8	-1152.5
Placebo	-205.64	-242.84

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Change From Baseline in Area Under the Plasma Concentration-Time Profile of Acetaminophen for 0-60 Minutes and 0-300 Minutes (AUC0-60min and AUC0-300min) After Acetaminophen Dose at Visits 4 and 5

A non investigational medicinal product (acetaminophen 1.5 gram [g]) was administered as a challenge agent for the assessment of gastric emptying. The blood sampling for determining acetaminophen concentrations was performed at 7 time points: prior to breakfast and at 30, 60, 90, 120, 180 and 300 minutes after intake of the acetaminophen with breakfast. Baseline was calculated at Visit 3 (Study Day -1). (NCT03041792)
Timeframe: Prior to breakfast and at 30,60,90,120,180 and 300 minutes after intake of the acetaminophen with breakfast on Visit 3,Visit 4 (Study Day 20) and Visit 5 (Study Day 41)

Intervention	microgramminute/milliliter (ugmin/mL) (Mean)
	AUC0-60min (Visit 4)	AUC0-60min (Visit 5)	AUC0-300min (Visit 4)	AUC0-300min (Visit 5)
Liraglutide	18.30	81.19	197.79	394.22
Placebo	-4.55	-8.28	-12.92	47.31

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Change From Baseline in Appetite Score (Mean Rating Area Under Curve From Time 30 to 120 Minutes [AUC30-120min]) for Mean Lunch at Visits 4 and 5

"Appetite, satiety, fullness, hunger, and prospective consumption were measured using a validated Visual Analog scale (VAS) questionnaire. VAS was an assessment in which participants place a vertical line across a validated 100 millimeter (mm) line with the example of Not At All Full and Totally Full at either end, scoring from 0 to 100. The overall appetite score was calculated as the average of the four individual scores [satiety + fullness + (100 - prospective food consumption)+(100 - hunger)] divided by 4. The VAS questionnaire was completed by the participant immediately prior to meal administration, and at 30, 60 and 120 minutes after start of the specified meals. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0)." (NCT03041792)
Timeframe: Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)

Intervention	units on a scale (Mean)
	Visit 4	Visit 5
Liraglutide	4.52	4.13
Placebo	-0.60	-0.99

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Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5

The mean energy intake was collected to assess the effect of liraglutide on food intake in non-diabetic, obese participants. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Mean energy intakes at Visit 4 was defined as the mean values of the measurements at Study Day 20 and 21. Same definition applies to Visit 5 (Study Day 41 and 42). Baseline was defined as the mean of Visit 3 (Study Day -1 and 0). (NCT03041792)
Timeframe: Visit 3, Visit 4 and Visit 5

Intervention	kilocalories (kcal) (Mean)
	Visit 4	Visit 5
Liraglutide	-254.48	-278.78
Placebo	-19.93	-37.43

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Number of Participants With Treatment-Emergent Adverse Events (All-Causality)

Adverse event (AE) was defined as any untoward medical occurrence in a study participant administered a product or medical device, regardless of its causal relationship with study treatment. An AE is considered treatment-emergent relative to a given treatment if: the event occurs for the first time during the effective duration of treatment and was not seen prior to the start of treatment (for example, during the baseline or run-in period); or the event was seen prior to the start of treatment but increased in severity during treatment. (NCT03041792)
Timeframe: Baseline (Visit 3) up to 31 days post last dose (75 days)

Intervention	Participants (Count of Participants)
Liraglutide	31
Placebo	20

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Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

Below parameters were evaluated:1), Hematology: hemoglobin (HGB), hematocrit, erythrocytes (absolute value/mean corpuscular volume/mean corpuscular HGB/mean corpuscular HGB concentration), platelets, leukocytes, lymphocytes, neutrophils, basophils, monocytes; 2), clinical chemistry: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, amylase, triacylglycerol lipase; 3), urinalysis: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria. (NCT03041792)
Timeframe: Baseline (Visit 3) up to Visit 6 (Study Day 53)

Intervention	Participants (Count of Participants)
Liraglutide	32
Placebo	26

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Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test

CMH is a test used in the analysis of stratified or matched categorical data. It allows testing of the association between a binary predictor or treatment and a binary outcome such as case or control status while taking into account the stratification (NCT03048578)
Timeframe: 12 Months

Intervention	percentage of participants (Number)
Saxenda	76
Placebo	17

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Urine Albumin-to-creatinine Ratio

Ratio of urine albumin to creatinine in a spot urine collected after overnight rest (NCT03101930)
Timeframe: Baseline to 13 weeks

Intervention	mg/g (Mean)
	Baseline	13 Weeks
Hypocaloric Diet	6.3	10.1
Liraglutide	12.0	10.5
Sitagliptin	7.9	9.2

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Heart Rate

The mean of three measurements with the patient in the supine position (NCT03101930)
Timeframe: Baseline, and after 2 weeks and 14 weeks of treatment

Intervention	Beats per minute (Mean)
	Baseline	2 weeks	14 weeks
Hypocaloric Diet	63.8	63.2	61.7
Liraglutide	64.9	68.9	68.9
Sitagliptin	67.2	66.2	65.9

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Fasting Insulin

Plasma insulin collected after overnight fast (NCT03101930)
Timeframe: Baseline, and after 2 weeks and 14 weeks of treatment

Intervention	uU/mL (Mean)
	Baseline	2 weeks	14 weeks
Hypocaloric Diet	26.7	19.7	20.3
Liraglutide	22.7	18.3	20.3
Sitagliptin	23.3	29.4	26.0

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Fasting Glucose

Blood glucose collected after overnight fast (NCT03101930)
Timeframe: Baseline, and after 2 weeks and 14 weeks of treatment

Intervention	mg/dl (Mean)
	Baseline	2 weeks	14 weeks
Hypocaloric Diet	94.5	92.4	91.2
Liraglutide	95.3	84.26	85.2
Sitagliptin	97.6	93.9	96.6

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Change in Plasminogen Activator Inhibitor-1

Plasma plasminogen activator inhibitor-1 antigen (NCT03101930)
Timeframe: Baseline to 2 and 14 weeks

Intervention	units/mL (Mean)
	Baseline to 2 weeks	Baseline to 14 weeks
Hypocaloric Diet	1.1	-3.6
Liraglutide	-2.4	-3.7
Sitagliptin	-1.3	1.3

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Change in Flow-mediated Dilation

Brachial artery diameter is measured under basal conditions and during reactive hyperemia (Flow Mediated Dilation as %) (NCT03101930)
Timeframe: Baseline to 2 and 14 weeks

Intervention	Percentage (Mean)
	Baseline to 2 weeks (Placebo infusion)	Baseline to 2 weeks (Exendin infusion)	Baseline to 14 weeks (Placebo infusion)	Baseline to 14 weeks (Exendin infusion)
Hypocaloric Diet	1.24	1.43	1.01	0.42
Liraglutide	0.71	0.48	1.43	1.73
Sitagliptin	2.06	0.13	1.59	1.42

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Blood Pressure

The mean of three systolic blood pressure measurements one minute apart using a oscillometric recording device with patient in supine position (NCT03101930)
Timeframe: Baseline, and after 2 weeks and 14 weeks of treatment

Intervention	mmHg (Mean)
	Baseline	2 weeks	14 weeks
Hypocaloric Diet	127.7	121.7	119.7
Liraglutide	124.1	122.9	122.2
Sitagliptin	120.2	117.5	118.2

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Change in Weight

Weight measured in light clothing without shoes (NCT03101930)
Timeframe: Change from baseline to 14 weeks

Intervention	kg (Mean)
Liraglutide	-2.72
Sitagliptin	-0.71
Hypocaloric Diet	-4.95

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Assessment of Reproductive Functions

Concentration of LH was measured in mIU/ml. (NCT03151005)
Timeframe: 12 weeks

Intervention	mIU/ml (Mean)
Metformin-GLP-1 Receptor Agonist	5.52
Metformin-Oral Contraceptive(OC)	5.33

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Assessment of Blood Pressure

Systolic blood pressure was measured in mmHg. (NCT03151005)
Timeframe: 12 weeks

Intervention	mmHg (Mean)
Metformin-GLP-1 Receptor Agonist	122.83
Metformin-Oral Contraceptive(OC)	122.40

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Assessment of Reproductive Function

Changes in testosterone levels were measured (NCT03151005)
Timeframe: 12 weeks

Intervention	nmol/L (Mean)
Metformin-GLP-1 Receptor Agonist	1.82
Metformin-Oral Contraceptive(OC)	2.14

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Basic Vital Signs

Weight and height will be combined to report BMI in kg/m^2. (NCT03151005)
Timeframe: 12 weeks

Intervention	kg/m^2 (Mean)
Metformin-GLP-1 Receptor Agonist	26.26
Metformin-Oral Contraceptive(OC)	27.12

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Assessment of Liver Function

Alanine transaminase was measured in IU/L. (NCT03151005)
Timeframe: 12 weeks

Intervention	IU/L (Mean)
Metformin-GLP-1 Receptor Agonist	39.09
Metformin-Oral Contraceptive(OC)	36.73

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Change in Haematology: Haemoglobin Blood

Change in haemoglobin from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	-0.10
Insulin Degludec	-0.06
Liraglutide	-0.05

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Change in Haemotological Parameter- Eosinophils

Change in eosinophils from baseline after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	% of eosinophils (Mean)
Insulin Degludec/Liraglutide	-0.06
Insulin Degludec	0.19
Liraglutide	0.11

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Change in Haemotological Parameter- Monocytes

Change in monocytes from baseline (week 0) after 26 weeks of treatment is presented (NCT03172494)
Timeframe: Week 0, week 26

Intervention	% of monocytes (Mean)
Insulin Degludec/Liraglutide	-0.03
Insulin Degludec	0.01
Liraglutide	0.05

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Change in HbA1c

Change in HbA1c from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Percentage points of HbA1c (Mean)
Insulin Degludec/Liraglutide	-1.71
Insulin Degludec	-1.20
Liraglutide	-1.16

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Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1

This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Cross reacting antibodies were assessed when anti-liraglutide antibody was positive. Number of participants who measured with neutralising liraglutide antibodies cross-reacting to native GLP-1 at week 27 are presented. (NCT03172494)
Timeframe: Week 27

Intervention	Participants (Count of Participants)
Insulin Degludec/Liraglutide	0
Liraglutide	0

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Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose (BG) confirmed by a plasma glucose (PG) value < 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of treatment-emergent severe or BG confirmed hypoglycaemic episodes per patient years of exposure (PYE) (number of episodes divided by PYE multiplied by 100) during 26 weeks of treatment are presented. (NCT03172494)
Timeframe: Weeks 0-26

Intervention	(Number of episodes/PYE)*100 (Number)
Insulin Degludec/Liraglutide	23.94
Insulin Degludec	17.01
Liraglutide	3.60

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Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1)

This outcome measure is applicable to the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of cross-reacting antibodies to native GLP-1. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented. (NCT03172494)
Timeframe: Week 27

Intervention	Participants (Count of Participants)
Insulin Degludec/Liraglutide	6
Liraglutide	3

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Occurence of Antibodies Cross-reacting to Human Insulin

This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of cross-reacting antibodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T). (NCT03172494)
Timeframe: Week 27

Intervention	%B/T (Mean)
Insulin Degludec/Liraglutide	6.61
Insulin Degludec	2.99

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Occurence of Anti-insulin Degludec Specific Antibodies

This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T). (NCT03172494)
Timeframe: Week 27

Intervention	%B/T (Mean)
Insulin Degludec/Liraglutide	0.22
Insulin Degludec	0.12

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Number of Treatment-emergent Adverse Events (TEAE)

A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The observed rates of adverse events (AEs) per patient years of exposure (PYE) (number of AEs divided by PYE multiplied by 100) after 26 weeks are presented. (NCT03172494)
Timeframe: Weeks 0-26

Intervention	(Number of AEs/PYE)*100 (Number)
Insulin Degludec/Liraglutide	410.82
Insulin Degludec	306.19
Liraglutide	541.00

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Change in Fasting Triglycerides - Ratio to Baseline.

Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Ratio of fasting triglycerides (Geometric Mean)
Insulin Degludec/Liraglutide	0.88
Insulin Degludec	0.82
Liraglutide	0.90

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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented. (NCT03172494)
Timeframe: Weeks 0-26

Intervention	(Number of episodes/PYE)*100 (Number)
Insulin Degludec/Liraglutide	15.03
Insulin Degludec	9.07
Liraglutide	1.20

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Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented. (NCT03172494)
Timeframe: Weeks 0-26

Intervention	(Number of episodes/PYE)*100 (Number)
Insulin Degludec/Liraglutide	2.78
Insulin Degludec	3.40

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Occurence of Neutralising Liraglutide Antibodies

This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Neutralising antibodies were assessed when the corresponding anti-Liraglutide antibody were positive at week 27. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented. (NCT03172494)
Timeframe: Week 27

Intervention	Participants (Count of Participants)
Insulin Degludec/Liraglutide	9
Liraglutide	8

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Occurence of Total Insulin Antibodies

This outcome measure is only applicable for the Insulin degludec/liraglutide arm and Insulin degludec arm. Serum samples were analysed for the presence of antobodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T). (NCT03172494)
Timeframe: Week 27

Intervention	%B/T (Mean)
Insulin Degludec/Liraglutide	6.83
Insulin Degludec	3.11

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Change in Fasting Total Cholesterol - Ratio to Baseline

Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Ratio of fasting total cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide	0.94
Insulin Degludec	0.99
Liraglutide	0.97

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Serum Concentrations of Insulin Degludec

This outcome measure is applicable for Insulin degludec and Insulin degludec/liraglutide arms. Serum samples from the Insulin degludec/liraglutide and Insulin degludec arms were assayed using population PK analysis. The maximum serum concentrations (Cmax) are summarised for the two arms. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	pmol/L (Geometric Mean)
Insulin Degludec/Liraglutide	3583
Insulin Degludec	4133

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9-point SMPG Profile

Intervention	mmol/L (Mean)
	Before breakfast	90 minutes after the start of breakfast	Before lunch	90 minutes after the start of the lunch	Before dinner	90 minutes after start of the dinner	At bedtime	At 4:00 am	Before breakfast the following day
Insulin Degludec	5.66	9.85	7.10	10.18	7.39	10.27	8.86	6.12	5.47
Insulin Degludec/Liraglutide	5.41	8.97	6.31	8.87	6.52	9.33	7.99	5.60	5.35
Liraglutide	6.89	10.04	7.48	9.54	7.50	9.45	8.49	6.86	6.81

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Change in Biochemistry Parameters (Albumin Serum, Total Protein)

Change in total protein, albumin serum from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	grams per decileter (g/dL) (Mean)
	Albumin serum	Total protein
Insulin Degludec	-0.09	-0.08
Insulin Degludec/Liraglutide	-0.05	-0.08
Liraglutide	0.04	-0.01

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Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum

Change in calcium serum (total), calcium corrected serum, potassium serum, sodium serum, urea serum from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
	Calcium serum (total)	Calcium corrected serum	Sodium serum	Urea serum	Potassium serum
Insulin Degludec	-0.02	-0.00	0.98	0.03	-0.09
Insulin Degludec/Liraglutide	-0.01	-0.00	1.21	0.05	-0.04
Liraglutide	-0.00	-0.01	0.32	0.16	-0.04

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Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum

Change in total bilirubin serum, creatinine serum from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	micromoles per liter (umol/L) (Mean)
	Total bilirubin	creatinine serum
Insulin Degludec	-0.55	1.36
Insulin Degludec/Liraglutide	-0.78	1.02
Liraglutide	-1.16	-0.60

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Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) after 26 weeks of treatment is presented (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Millimeters of mercury (mmHg) (Mean)
	Systolic blood pressure	Distolic blood pressure
Insulin Degludec	-1.2	-0.7
Insulin Degludec/Liraglutide	-3.5	-0.4
Liraglutide	-3.3	0.0

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Change in Calcitonin

Calcitonin levels were measured and were categorised as low, normal or high in relation to reference range (8.31- 14.3 picogram/milliliter [pg/mL]). Number of participants in each category at baseline (week 0) and week 26 are presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Participants (Count of Participants)
	Week 072192332			Week 072192333	Week 072192331	Week 2672192331	Week 2672192332	Week 2672192333
	Normal	High	Low
Insulin Degludec	0
Liraglutide	0
Insulin Degludec/Liraglutide	351
Insulin Degludec	172
Liraglutide	178
Insulin Degludec/Liraglutide	7
Insulin Degludec	3
Liraglutide	2
Insulin Degludec/Liraglutide	0
Insulin Degludec/Liraglutide	334
Insulin Degludec	165
Liraglutide	147
Insulin Degludec/Liraglutide	6
Insulin Degludec	2
Liraglutide	3

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Change in Electrocardiogram (ECG)

Electrocardiogram was assessed by the investigator as normal, abnormal NCS and abnormal CS. Number of participants at screening (week -2) and at week 26 is presented. (NCT03172494)
Timeframe: Week -2, week 26

Intervention	Participants (Count of Participants)
	Week -272192333			Week -272192331	Week -272192332	Week 2672192332	Week 2672192333	Week 2672192331
	Abnormal, NCS	Abnormal CS	Normal
Insulin Degludec/Liraglutide	223
Insulin Degludec	109
Liraglutide	108
Insulin Degludec/Liraglutide	94
Insulin Degludec	46
Liraglutide	52
Insulin Degludec/Liraglutide	41
Insulin Degludec	20
Liraglutide	20
Insulin Degludec/Liraglutide	227
Insulin Degludec	108
Liraglutide	87
Insulin Degludec/Liraglutide	76
Insulin Degludec	47
Liraglutide	40
Insulin Degludec/Liraglutide	38
Insulin Degludec	12
Liraglutide	24

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Change in Physical Examination

Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at screening (week -2) and week 26 per each category is presented. (NCT03172494)
Timeframe: Week -2, week 26

Intervention	Participants (Count of Participants)
	Week -2: Cardiovascular system72192331			Week -2: Cardiovascular system72192333	Week -2: Cardiovascular system72192332	Week 26: Cardiovascular system72192332	Week 26: Cardiovascular system72192333	Week 26: Cardiovascular system72192331	Week -2: Central and peripheral nervous system72192331	Week -2: Central and peripheral nervous system72192332	Week -2: Central and peripheral nervous system72192333	Week 26: Central and peripheral nervous system72192331	Week 26: Central and peripheral nervous system72192332	Week 26: Central and peripheral nervous system72192333	Week -2: Gastrointestinal system including mouth72192333	Week -2: Gastrointestinal system including mouth72192331	Week -2: Gastrointestinal system including mouth72192332	Week 26: Gastrointestinal system including mouth72192331	Week 26: Gastrointestinal system including mouth72192332	Week 26: Gastrointestinal system including mouth72192333	Week -2: General appearance72192331	Week -2: General appearance72192332	Week -2: General appearance72192333	Week 26: General appearance72192331	Week 26: General appearance72192332	Week 26: General appearance72192333	Week -2: Head, ears, eyes, nose, throat, neck72192333	Week -2: Head, ears, eyes, nose, throat, neck72192331	Week -2: Head, ears, eyes, nose, throat, neck72192332	Week 26: Head, ears, eyes, nose, throat, neck72192332	Week 26: Head, ears, eyes, nose, throat, neck72192333	Week 26: Head, ears, eyes, nose, throat, neck72192331	Week -2: Lymph node palpation72192333	Week -2: Lymph node palpation72192331	Week -2: Lymph node palpation72192332	Week 26: Lymph node palpation72192331	Week 26: Lymph node palpation72192332	Week 26: Lymph node palpation72192333	Week -2: Musculoskeletal system72192332	Week -2: Musculoskeletal system72192333	Week -2: Musculoskeletal system72192331	Week 26: Musculoskeletal system72192332	Week 26: Musculoskeletal system72192333	Week 26: Musculoskeletal system72192331	Week-2: Respiratory system72192332	Week-2: Respiratory system72192331	Week-2: Respiratory system72192333	Week 26: Respiratory system72192332	Week 26: Respiratory system72192333	Week 26: Respiratory system72192331	week -2: Skin72192331	week -2: Skin72192332	week -2: Skin72192333	Week 26: Skin72192332	Week 26: Skin72192333	Week 26: Skin72192331	Week -2: Thyroid gland72192331	Week -2: Thyroid gland72192332	Week -2: Thyroid gland72192333	Week 26: Thyroid gland72192332	Week 26: Thyroid gland72192331	Week 26: Thyroid gland72192333
	Abnormal, NCS	Abnormal CS	Normal
Insulin Degludec	173
Insulin Degludec/Liraglutide	336
Insulin Degludec	166
Insulin Degludec/Liraglutide	355
Insulin Degludec/Liraglutide	338
Insulin Degludec	164
Liraglutide	150
Liraglutide	179
Liraglutide	1
Insulin Degludec	0
Insulin Degludec/Liraglutide	339
Insulin Degludec/Liraglutide	351
Insulin Degludec	169
Insulin Degludec	2
Insulin Degludec/Liraglutide	4
Insulin Degludec	4
Insulin Degludec	161
Insulin Degludec	170
Liraglutide	175
Insulin Degludec	1
Insulin Degludec/Liraglutide	332
Insulin Degludec/Liraglutide	6
Insulin Degludec/Liraglutide	357
Insulin Degludec	174
Insulin Degludec/Liraglutide	0
Insulin Degludec/Liraglutide	1
Insulin Degludec/Liraglutide	340
Insulin Degludec/Liraglutide	353
Insulin Degludec	172
Liraglutide	177
Insulin Degludec/Liraglutide	2
Insulin Degludec/Liraglutide	3
Liraglutide	3
Insulin Degludec	165
Liraglutide	149
Insulin Degludec/Liraglutide	7
Liraglutide	2
Insulin Degludec/Liraglutide	358
Insulin Degludec	175
Liraglutide	180
Liraglutide	0
Insulin Degludec/Liraglutide	341
Insulin Degludec	167
Insulin Degludec/Liraglutide	312
Insulin Degludec	152
Liraglutide	156
Insulin Degludec/Liraglutide	37
Insulin Degludec	20
Liraglutide	20
Insulin Degludec/Liraglutide	9
Insulin Degludec	3
Liraglutide	4
Insulin Degludec/Liraglutide	297
Insulin Degludec	146
Liraglutide	134
Insulin Degludec/Liraglutide	36
Insulin Degludec	19
Liraglutide	15
Insulin Degludec/Liraglutide	8
Insulin Degludec/Liraglutide	348
Insulin Degludec	171
Insulin Degludec/Liraglutide	5
Insulin Degludec/Liraglutide	334
Insulin Degludec	163
Liraglutide	151

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Eye Examination

Dilated fundoscopy or fundus photography was performed by the investigator at screening (week -2) and week 26. The results of the examination were interpreted for each eye (left and right) and are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at screening (week -2) and week 26 is presented. (NCT03172494)
Timeframe: Week -2, Week 26

Intervention	Participants (Count of Participants)
	Week -2: Left eye72192333			Week -2: Left eye72192332	Week -2: Left eye72192331	Week 26: Left eye72192332	Week 26: Left eye72192333	Week 26: Left eye72192331	Week -2: Right eye72192332	Week -2: Right eye72192333	Week -2: Right eye72192331	Week 26: Right eye72192331	Week 26: Right eye72192333	Week 26: Right eye72192332
	Abnormal, NCS	Abnormal, CS	Normal
Insulin Degludec/Liraglutide	222
Insulin Degludec	109
Liraglutide	110
Insulin Degludec/Liraglutide	45
Insulin Degludec	14
Liraglutide	20
Insulin Degludec/Liraglutide	91
Insulin Degludec	52
Liraglutide	50
Insulin Degludec	99
Liraglutide	100
Insulin Degludec/Liraglutide	39
Insulin Degludec	20
Liraglutide	13
Insulin Degludec/Liraglutide	85
Insulin Degludec	48
Liraglutide	38
Insulin Degludec/Liraglutide	230
Insulin Degludec	112
Liraglutide	111
Insulin Degludec/Liraglutide	42
Insulin Degludec	16
Liraglutide	22
Insulin Degludec/Liraglutide	86
Insulin Degludec	47
Liraglutide	47
Insulin Degludec/Liraglutide	217
Insulin Degludec	103
Liraglutide	96
Insulin Degludec/Liraglutide	40
Insulin Degludec	23
Liraglutide	15
Insulin Degludec/Liraglutide	84
Insulin Degludec	41
Liraglutide	40

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Urinalysis (Protein, Glucose, Erythrocytes and Ketones)

The urinalysis assessment was the measurements of protein, glucose, erythrocytes and ketones in urine at baseline (week 0) and week 26 and categorised as negative, trace and positive. Number of participants in each category at week 0 and week 26 is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Participants (Count of Participants)
	Week 0: Erythrocytes72192331			Week 0: Erythrocytes72192332	Week 0: Erythrocytes72192333	Week 26: Erythrocytes72192331	Week 26: Erythrocytes72192332	Week 26: Erythrocytes72192333	Week 0: Glucose72192331	Week 0: Glucose72192332	Week 0: Glucose72192333	Week 26: Glucose72192331	Week 26: Glucose72192332	Week 26: Glucose72192333	Week 0: Ketones72192331	Week 0: Ketones72192332	Week 0: Ketones72192333	Week 26: Ketones72192331	Week 26: Ketones72192332	Week 26: Ketones72192333	Week 0: Protein72192331	Week 0: Protein72192332	Week 0: Protein72192333	Week 26: Protein72192331	Week 26: Protein72192332	Week 26: Protein72192333
	Negative	Trace	Positive
Insulin Degludec/Liraglutide	299
Insulin Degludec	153
Liraglutide	156
Insulin Degludec/Liraglutide	36
Insulin Degludec	16
Liraglutide	16
Insulin Degludec/Liraglutide	22
Insulin Degludec	6
Liraglutide	8
Insulin Degludec/Liraglutide	297
Insulin Degludec	146
Liraglutide	136
Insulin Degludec/Liraglutide	28
Insulin Degludec/Liraglutide	14
Insulin Degludec	5
Liraglutide	4
Insulin Degludec/Liraglutide	253
Insulin Degludec	119
Liraglutide	123
Insulin Degludec/Liraglutide	35
Insulin Degludec	19
Insulin Degludec/Liraglutide	69
Insulin Degludec	37
Liraglutide	39
Insulin Degludec/Liraglutide	322
Insulin Degludec	157
Liraglutide	131
Insulin Degludec/Liraglutide	11
Liraglutide	5
Insulin Degludec/Liraglutide	6
Insulin Degludec	7
Liraglutide	15
Insulin Degludec/Liraglutide	325
Insulin Degludec	152
Liraglutide	167
Insulin Degludec/Liraglutide	25
Insulin Degludec	20
Liraglutide	11
Insulin Degludec/Liraglutide	7
Insulin Degludec	3
Liraglutide	2
Insulin Degludec/Liraglutide	334
Insulin Degludec	163
Liraglutide	141
Insulin Degludec/Liraglutide	4
Liraglutide	10
Insulin Degludec/Liraglutide	1
Insulin Degludec	1
Liraglutide	0
Insulin Degludec/Liraglutide	216
Insulin Degludec	104
Liraglutide	116
Insulin Degludec/Liraglutide	86
Insulin Degludec	40
Liraglutide	37
Insulin Degludec/Liraglutide	55
Insulin Degludec	31
Liraglutide	27
Insulin Degludec/Liraglutide	254
Insulin Degludec	120
Liraglutide	105
Insulin Degludec/Liraglutide	58
Insulin Degludec	26
Liraglutide	28
Insulin Degludec/Liraglutide	27
Insulin Degludec	21
Liraglutide	18

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Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes.

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented. (NCT03172494)
Timeframe: Weeks 0-26

Intervention	(Number of episodes/PYE)*100 (Number)
Insulin Degludec/Liraglutide	4.45
Insulin Degludec	4.54

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Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition

A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes (according to the ADA definition) per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented. (NCT03172494)
Timeframe: Weeks 0-26

Intervention	(Number of episodes/PYE)*100 (Number)
Insulin Degludec/Liraglutide	668.55
Insulin Degludec	746.20
Liraglutide	37.19

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Insulin Dose

The actual daily total insulin dose after 26 weeks of treatment is presented. This outcome measure is only applicable for Insulin degludec/liraglutide and Insulin degludec treatment arms. (NCT03172494)
Timeframe: Week 26

Intervention	Units of insulin (U) (Mean)
Insulin Degludec/Liraglutide	24.8
Insulin Degludec	30.1

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Change in Waist Circumferance

Change from baseline (week 0) in waist circumferance after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Centimeters (cm) (Mean)
Insulin Degludec/Liraglutide	-0.3
Insulin Degludec	1.2
Liraglutide	-2.6

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Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	-3.64
Insulin Degludec	-3.45
Liraglutide	-1.86

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Change in Haematological Parameter: Haematocrits

Change in haematocrits from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Percentage points (%) of red blood cells (Mean)
Insulin Degludec/Liraglutide	-0.56
Insulin Degludec	-0.49
Liraglutide	-0.42

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Change in Fasting Human Insulin - Ratio to Baseline

Change in fasting human insulin (measured in picomoles per liter [pmol/L]) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Ratio of fasting human insulin (Geometric Mean)
Insulin Degludec/Liraglutide	0.53
Insulin Degludec	0.38
Liraglutide	1.04

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Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline

Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Ratio of fasting HDL cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide	1.01
Insulin Degludec	1.02
Liraglutide	1.03

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Change in Fasting Glucagon - Ratio to Baseline

Change in fasting glucagon (measured in picograms per milliliter [pg/mL]) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Ratio of fasting glucagon (Geometric Mean)
Insulin Degludec/Liraglutide	0.90
Insulin Degludec	0.95
Liraglutide	0.98

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Change in Pulse

Change in pulse from baseline (week 0) after 26 weeks of treatment is presented (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Beats per minuts (beats/min) (Mean)
Insulin Degludec/Liraglutide	4.6
Insulin Degludec	-0.1
Liraglutide	4.9

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Change in Mean Post-prandial Plasma Glucose (PG) Increments

Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Post-prandial SMPG increments from before meal to 90 minutes after for breakfast, lunch and dinner were calculated. The mean increment over all meals was derived as the mean of all available meal increments. Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	-0.20
Insulin Degludec	0.09
Liraglutide	-0.54

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Change in Mean of 9-point SMPG Profile

Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	-3.17
Insulin Degludec	-2.47
Liraglutide	-2.13

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Change in HOMA-B (Beta Cell Function)- Ratio to Baseline

Change in HOMA-B (measured in %) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Ratio of HOMA-B (beta cell function) (Geometric Mean)
Insulin Degludec/Liraglutide	1.38
Insulin Degludec	0.94
Liraglutide	1.53

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Change in Fasting Free Fatty Acid - Ratio to Baseline

Change in fasting free fatty acid (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Ratio of fasting free fatty acid (Geometric Mean)
Insulin Degludec/Liraglutide	0.55
Insulin Degludec	0.48
Liraglutide	0.80

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Change in Fasting C-peptide - Ratio to Baseline

Change in fasting C-peptide (measured in nanomoles per liter [nmol/L]) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Ratio of fasting C-peptide (Geometric Mean)
Insulin Degludec/Liraglutide	0.54
Insulin Degludec	0.38
Liraglutide	0.98

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Change in Body Weight

Change in body weight from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Kilogram (Kg) (Mean)
Insulin Degludec/Liraglutide	0.2
Insulin Degludec	1.3
Liraglutide	-2.5

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Plasma Concentration of Liraglutide

This outcome measure is for Insulin degludec/liraglutide and liraglutide arms. Serum samples from the Insulin degludec/liraglutide and liraglutide arms were assayed using population PK analysis. The Cmax are summarised for the two arms. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	pmol/L (Geometric Mean)
Insulin Degludec/Liraglutide	9963
Liraglutide	21602

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Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline

Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Ratio of fasting LDL cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide	0.92
Insulin Degludec	1.01
Liraglutide	0.96

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Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum

Change in alkaline phosphatase, ALT, AST, creatine kinase, amylase, lipase, creatine kinase serum from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Units per liter (U/L) (Mean)
	Alkaline phosphatase	ALT	AST	Creatine kinase	Amylase	Lipase
Insulin Degludec	-2.29	-6.17	-2.65	15.37	5.09	-1.87
Insulin Degludec/Liraglutide	-2.0	-4.63	-1.31	10.67	9.84	16.13
Liraglutide	-0.48	-2.81	-0.99	0.52	5.68	14.11

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Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline

Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline (NCT03172494)
Timeframe: Week 0, week 26

Intervention	Ratio of fasting VLDL cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide	0.90
Insulin Degludec	0.84
Liraglutide	0.92

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Change in Haematologcal Parameter: Leukocytes

Change in leukocytes from baseline (week 0) after 26 weeks of treatment (NCT03172494)
Timeframe: Week 0, week 26

Intervention	10^9 cells per liter (10^9/L) (Mean)
Insulin Degludec/Liraglutide	0.25
Insulin Degludec	0.23
Liraglutide	-0.01

[back to top]

Change in Haematological Parameter - Lymphocytes

Change in lymphocytes from baseline (week 0) after 26 weeks of treatment is presented (NCT03172494)
Timeframe: Week 0, week 26

Intervention	% of lymphocytes (Mean)
Insulin Degludec/Liraglutide	-0.46
Insulin Degludec	-0.38
Liraglutide	0.40

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Change in Haematological Parameter - Neutrophils

Change in neutrophils from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	% of neutrophils (Mean)
Insulin Degludec/Liraglutide	0.57
Insulin Degludec	0.18
Liraglutide	-0.53

[back to top]

Change in Haematological Parameter: Basophils

Change in basophils from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	% of basophils (Mean)
Insulin Degludec/Liraglutide	-0.02
Insulin Degludec	-0.01
Liraglutide	-0.03

[back to top]

Change in Haematological Parameter: Erythrocytes Blood

Change in erythrocyte blood from baseline (week 0) after 26 weeks of treatment is presented. (NCT03172494)
Timeframe: Week 0, week 26

Intervention	10^12 cells per liter (10^12/L) (Mean)
Insulin Degludec/Liraglutide	-0.05
Insulin Degludec	-0.00
Liraglutide	-0.05

[back to top]

Change in Haematological Parameter: Thrombocytes

Change in thrombocytes from baseline (week 0) after 26 weeks of treatment (NCT03172494)
Timeframe: Week 0, week 26

Intervention	10^9 cells per liter (10^9/L) (Mean)
Insulin Degludec/Liraglutide	8.19
Insulin Degludec	8.32
Liraglutide	4.32

[back to top]

Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline

Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Ratio of HDL cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide	1.00
Insulin Degludec	1.03

[back to top]

Change in Fasting Glucagon- Ratio to Baseline

Change in fasting glucagon (measured in picograms per milliliter (pg/mL)) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Ratio of glucagon (Geometric Mean)
Insulin Degludec/Liraglutide	1.01
Insulin Degludec	1.09

[back to top]

Change in Fasting Free Fatty Acids- Ratio to Baseline

Change in fasting free fatty acids (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Ratio of free fatty acids (Geometric Mean)
Insulin Degludec/Liraglutide	0.65
Insulin Degludec	0.64

[back to top]

Change in Fasting C-peptide- Ratio to Baseline

Change in fasting C-peptide (measured in nanomoles per liter (nmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Ratio of C-peptide (Geometric Mean)
Insulin Degludec/Liraglutide	0.64
Insulin Degludec	0.52

[back to top]

Change in Creatinine

Change in creatinine from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	umol/L (Mean)
Insulin Degludec/Liraglutide	0.44
Insulin Degludec	-0.32

[back to top]

Change in Body Weight

Change in body weight from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Kilogram (kg) (Mean)
Insulin Degludec/Liraglutide	-0.7
Insulin Degludec	0.5

[back to top]

Change in Albumin

Change in albumin from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Grams per deciliter (g/dL) (Mean)
Insulin Degludec/Liraglutide	0.05
Insulin Degludec	0.02

[back to top]

Antibodies Cross-reacting to Human Insulin

Serum samples were analysed for the presence of antibodies cross-reacting to human insulin. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T). (NCT03175120)
Timeframe: Week 27

Intervention	%B/T (Mean)
Insulin Degludec/Liraglutide	9.07
Insulin Degludec	8.64

[back to top]

Anti-insulin Degludec Specific Antibodies

Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T). (NCT03175120)
Timeframe: Week 27

Intervention	%B/T (Mean)
Insulin Degludec/Liraglutide	0.25
Insulin Degludec	0.13

[back to top]

Eye Examination

Dilated fundoscopy or fundus photography was performed by the investigator at week -2 and week 26. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week -2 and week 26 were presented. (NCT03175120)
Timeframe: Week -2, week 26

Intervention	Participants (Count of Participants)
	Week -2: Left eye72482247			Week -2: Left eye72482246	Week 26: Left eye72482246	Week 26: Left eye72482247	Week -2: Right eye72482246	Week -2: Right eye72482247	Week 26: Right eye72482246	Week 26: Right eye72482247
	Normal	Abnormal CS	Abnormal NCS
Insulin Degludec/Liraglutide	167
Insulin Degludec	87
Insulin Degludec/Liraglutide	34
Insulin Degludec	15
Insulin Degludec/Liraglutide	100
Insulin Degludec	49
Insulin Degludec/Liraglutide	147
Insulin Degludec	80
Insulin Degludec/Liraglutide	35
Insulin Degludec	14
Insulin Degludec/Liraglutide	105
Insulin Degludec	45
Insulin Degludec/Liraglutide	162
Insulin Degludec	85
Insulin Degludec/Liraglutide	41
Insulin Degludec	18
Insulin Degludec/Liraglutide	98
Insulin Degludec	47
Insulin Degludec/Liraglutide	139
Insulin Degludec	84
Insulin Degludec/Liraglutide	37
Insulin Degludec	12
Insulin Degludec/Liraglutide	111
Insulin Degludec	42

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Change in Physical Examination

Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at week -2 and week 26 is presented. (NCT03175120)
Timeframe: Week -2, week 26

Intervention	Participants (Count of Participants)
	Week-2: Cardiovascular system72482246			Week-2: Cardiovascular system72482247	Week 26: Cardiovascular system72482246	Week 26: Cardiovascular system72482247	Week-2: Central and peripheral nervous system72482246	Week-2: Central and peripheral nervous system72482247	Week 26: Central and peripheral nervous system72482246	Week 26: Central and peripheral nervous system72482247	Week -2: Gastrointestinal system72482246	Week -2: Gastrointestinal system72482247	Week 26: Gastrointestinal system72482247	Week 26: Gastrointestinal system72482246	Week -2: General appearance72482246	Week -2: General appearance72482247	Week 26: General appearance72482246	Week 26: General appearance72482247	Week -2: Head, eyes, ENTand Neck72482246	Week -2: Head, eyes, ENTand Neck72482247	Week 26: Head, eyes, ENTand Neck72482246	Week 26: Head, eyes, ENTand Neck72482247	Week -2: Lymph node palpation72482247	Week -2: Lymph node palpation72482246	Week 26: Lymph node palpation72482246	Week 26: Lymph node palpation72482247	Week -2: Musculoskeletal system72482246	Week -2: Musculoskeletal system72482247	Week 26: Musculoskeletal system72482246	Week 26: Musculoskeletal system72482247	Week -2: Respiratory system72482247	Week -2: Respiratory system72482246	Week 26: Respiratory system72482246	Week 26: Respiratory system72482247	Week -2: Skin72482246	Week -2: Skin72482247	Week 26: Skin72482246	Week 26: Skin72482247	Week -2: Thyroid gland72482247	Week -2: Thyroid gland72482246	Week 26: Thyroid gland72482246	Week 26: Thyroid gland72482247
	Normal	Abnormal NCS	Abnormal CS
Insulin Degludec	149
Insulin Degludec/Liraglutide	286
Insulin Degludec	137
Insulin Degludec/Liraglutide	287
Insulin Degludec/Liraglutide	0
Insulin Degludec/Liraglutide	299
Insulin Degludec	150
Insulin Degludec/Liraglutide	285
Insulin Degludec	139
Insulin Degludec/Liraglutide	2
Insulin Degludec	0
Insulin Degludec/Liraglutide	1
Insulin Degludec/Liraglutide	283
Insulin Degludec	141
Insulin Degludec/Liraglutide	11
Insulin Degludec/Liraglutide	7
Insulin Degludec	8
Insulin Degludec/Liraglutide	273
Insulin Degludec	130
Insulin Degludec	2
Insulin Degludec/Liraglutide	6
Insulin Degludec	7
Insulin Degludec	1
Insulin Degludec/Liraglutide	296
Insulin Degludec	145
Insulin Degludec/Liraglutide	3
Insulin Degludec	3
Insulin Degludec/Liraglutide	280
Insulin Degludec/Liraglutide	5
Insulin Degludec/Liraglutide	301
Insulin Degludec	151
Insulin Degludec/Liraglutide	288
Insulin Degludec/Liraglutide	270
Insulin Degludec	132
Insulin Degludec/Liraglutide	22
Insulin Degludec	13
Insulin Degludec/Liraglutide	9
Insulin Degludec	6
Insulin Degludec/Liraglutide	259
Insulin Degludec	126
Insulin Degludec	9
Insulin Degludec	4
Insulin Degludec/Liraglutide	295
Insulin Degludec	147
Insulin Degludec/Liraglutide	4
Insulin Degludec/Liraglutide	284
Insulin Degludec	134

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Change in Electrocardiogram (ECG)

The ECG was assessed by the investigator at baseline (week -2) and week 26 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 26 were presented. (NCT03175120)
Timeframe: Week -2, week 26

Intervention	Participants (Count of Participants)
	Week -272482246			Week -272482247	Week 2672482246	Week 2672482247
	Normal	Abnormal NCS	Abnormal CS
Insulin Degludec/Liraglutide	175
Insulin Degludec	90
Insulin Degludec/Liraglutide	76
Insulin Degludec	41
Insulin Degludec/Liraglutide	50
Insulin Degludec	20
Insulin Degludec	91
Insulin Degludec/Liraglutide	73
Insulin Degludec	32
Insulin Degludec/Liraglutide	39
Insulin Degludec	16

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Change in Calcitonin

Calcitonin levels were measured and were categorised as low, normal or high. Number of participants in each category at week 0 and week 26 were presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Participants (Count of Participants)
	Week 072482246			Week 072482247	Week 2672482246	Week 2672482247
	Normal	Low	High
Insulin Degludec/Liraglutide	293
Insulin Degludec	149
Insulin Degludec/Liraglutide	8
Insulin Degludec	2
Insulin Degludec/Liraglutide	0
Insulin Degludec	0
Insulin Degludec/Liraglutide	279
Insulin Degludec	136
Insulin Degludec/Liraglutide	10
Insulin Degludec	3

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SMPG-9-point Profile (Individual Points in the Profile)

Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. SMPG-9-point profile (individual points in the profile) at week 26 is presented. (NCT03175120)
Timeframe: Week 26

Intervention	mmol/L (Mean)
	Before breakfast	90 minutes after start of breakfast	Before lunch	90 minutes after start of lunch	Before main evening meal	90 minutes after main evening meal	At bedtime	At 4:00 a.m.	Before breakfast the following day
Insulin Degludec	5.88	10.50	8.17	11.21	7.87	10.86	9.52	6.61	5.83
Insulin Degludec/Liraglutide	5.48	9.51	6.93	9.68	7.24	9.87	8.57	5.97	5.48

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Change in Haematological Parameter- Leukocytes and Thrombocytes

Change in leukocytes and thrombocytes from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	10^9 cells per liter (10^9/L) (Mean)
	Leukocytes	Thrombocytes
Insulin Degludec	0.31	12.19
Insulin Degludec/Liraglutide	0.32	14.13

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Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Millimeters of mercury (mmHg) (Mean)
	Systolic blood pressure	Diastolic blood pressure
Insulin Degludec	-0.5	-0.4
Insulin Degludec/Liraglutide	-3.5	0.1

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Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea

Change in calcium (total), albumin corrected calcium, potassium, sodium, urea from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
	Calcium (total)	Albumin corrected calcium	Potassium	Sodium	Urea
Insulin Degludec	-0.01	-0.01	-0.11	1.40	0.17
Insulin Degludec/Liraglutide	0.01	-0.00	-0.03	1.03	-0.09

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Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)

Change in amylase, lipase, creatinine kinase, ALT, AST, ALP from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Units per liter (U/L) (Mean)
	Amylase	Lipase	Creatinine kinase	ALT	AST	ALP
Insulin Degludec	2.69	-0.35	6.99	-4.06	-2.06	-1.70
Insulin Degludec/Liraglutide	10.45	16.97	3.32	-3.02	-1.42	-1.62

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Total Insulin Antibodies

Serum samples were analysed for the presence of total insulin antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T). (NCT03175120)
Timeframe: Week 27

Intervention	%B/T (Mean)
Insulin Degludec/Liraglutide	9.31
Insulin Degludec	8.77

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Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed hypoglycaemic episodes during 26 weeks of treatment is presented. (NCT03175120)
Timeframe: Up to 26 weeks

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	38
Insulin Degludec	36

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Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes is presented. (NCT03175120)
Timeframe: Weeks 0-27

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	23
Insulin Degludec	21

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Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes is presented. (NCT03175120)
Timeframe: Weeks 0-27

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	7
Insulin Degludec	7

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Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes

Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed hypoglycaemic episodes is presented. (NCT03175120)
Timeframe: Weeks 0-27

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	9
Insulin Degludec	8

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Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition

Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent hypoglycaemic episodes according to ADA definition is presented. (NCT03175120)
Timeframe: Weeks 0-27

Intervention	Episodes (Number)
Insulin Degludec/Liraglutide	1099
Insulin Degludec	680

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Number of Treatment-emergent Adverse Events (TEAEs)

A TEAE was defined as an adverse event with onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE. (NCT03175120)
Timeframe: Weeks 0-27

Intervention	Adverse events (Number)
Insulin Degludec/Liraglutide	641
Insulin Degludec	230

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Insulin Dose

The mean of actual daily total insulin dose after 26 weeks of treatment is presented. (NCT03175120)
Timeframe: Week 26

Intervention	Units of insulin (U) (Mean)
Insulin Degludec/Liraglutide	34.6
Insulin Degludec	37.9

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Urinalysis (Erythrocytes, Protein, Glucose and Ketones)

The urinalysis was the measurements of protein, glucose, erythrocytes and ketones at week 0 and week 26 and categorised as negative, trace, 1+, 2+ and 3+. Number of participants in each category at week 0 and week 26 are presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Participants (Count of Participants)
	Week 0: Erythrocytes72482247					Week 0: Erythrocytes72482246	Week 26: Erythrocytes72482246	Week 26: Erythrocytes72482247	Week 0: Glucose72482246	Week 0: Glucose72482247	Week 26: Glucose72482246	Week 26: Glucose72482247	Week 0: Ketones72482246	Week 0: Ketones72482247	Week 26: Ketones72482246	Week 26: Ketones72482247	Week 0: Protein72482246	Week 0: Protein72482247	Week 26: Protein72482246	Week 26: Protein72482247
	Trace	1+	2+	3+	Negative
Insulin Degludec/Liraglutide	258
Insulin Degludec	121
Insulin Degludec	22
Insulin Degludec	4
Insulin Degludec	3
Insulin Degludec	1
Insulin Degludec/Liraglutide	255
Insulin Degludec	120
Insulin Degludec/Liraglutide	22
Insulin Degludec	11
Insulin Degludec/Liraglutide	6
Insulin Degludec/Liraglutide	171
Insulin Degludec	92
Insulin Degludec/Liraglutide	33
Insulin Degludec	13
Insulin Degludec/Liraglutide	30
Insulin Degludec	17
Insulin Degludec/Liraglutide	25
Insulin Degludec/Liraglutide	41
Insulin Degludec/Liraglutide	256
Insulin Degludec	110
Insulin Degludec/Liraglutide	14
Insulin Degludec	16
Insulin Degludec/Liraglutide	10
Insulin Degludec/Liraglutide	4
Insulin Degludec/Liraglutide	3
Insulin Degludec/Liraglutide	274
Insulin Degludec	137
Insulin Degludec/Liraglutide	21
Insulin Degludec/Liraglutide	5
Insulin Degludec	0
Insulin Degludec/Liraglutide	272
Insulin Degludec	132
Insulin Degludec	7
Insulin Degludec/Liraglutide	1
Insulin Degludec/Liraglutide	0
Insulin Degludec/Liraglutide	172
Insulin Degludec	89
Insulin Degludec/Liraglutide	72
Insulin Degludec	32
Insulin Degludec/Liraglutide	36
Insulin Degludec	18
Insulin Degludec/Liraglutide	16
Insulin Degludec	10
Insulin Degludec	2
Insulin Degludec/Liraglutide	198
Insulin Degludec/Liraglutide	47
Insulin Degludec/Liraglutide	29
Insulin Degludec/Liraglutide	11
Insulin Degludec	9
Insulin Degludec/Liraglutide	2

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Change in Total Protein

Change in total protein from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	g/dL (Mean)
Insulin Degludec/Liraglutide	0.08
Insulin Degludec	0.03

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Change in Total Bilirubin

Change in total bilirubin from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Micromoles per liter (umol/L) (Mean)
Insulin Degludec/Liraglutide	-0.30
Insulin Degludec	-0.54

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Change in SMPG-mean Post Prandial Increments

Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	0.08
Insulin Degludec	0.28

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Change in Pulse

Change in pulse from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Beats per minute (beats/min) (Mean)
Insulin Degludec/Liraglutide	5.7
Insulin Degludec	1.3

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Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile

Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	-3.35
Insulin Degludec	-2.31

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Change in HOMA-B (Beta-cell Function)- Ratio to Baseline

Change in HOMA-B from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Ratio of beta-cell function (Geometric Mean)
Insulin Degludec/Liraglutide	1.47
Insulin Degludec	0.99

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Change in HbA1c

Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Percentage point of HbA1c (Mean)
Insulin Degludec/Liraglutide	-1.93
Insulin Degludec	-1.06

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Change in Haematological Parameter- Neutrophils

Change in neutrophils from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Percentage of neutrophils (Mean)
Insulin Degludec/Liraglutide	1.34
Insulin Degludec	0.99

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Change in Haematological Parameter- Monocytes

Change in monocytes from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Percentage of monocytes (Mean)
Insulin Degludec/Liraglutide	-0.19
Insulin Degludec	-0.06

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Change in Haematological Parameter- Lymphocytes

Change in lymphocytes from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Percentage of lymphocytes (Mean)
Insulin Degludec/Liraglutide	-1.00
Insulin Degludec	-0.82

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Change in Haematological Parameter- Haemoglobin

Change in haemoglobin from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	-0.08
Insulin Degludec	-0.09

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Change in Haematological Parameter- Haematocrit

Change in haematocrit from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Percentage of red blood cells (Mean)
Insulin Degludec/Liraglutide	-0.07
Insulin Degludec	-0.12

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Change in Haematological Parameter- Erythrocytes

Change in erythrocytes from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	10^12 cells per liter (10^12/L) (Mean)
Insulin Degludec/Liraglutide	-0.06
Insulin Degludec	-0.05

[back to top]

Change in Haematological Parameter- Eosinophils

Change in eosinophils from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Percentage of eosinophils (Mean)
Insulin Degludec/Liraglutide	-0.15
Insulin Degludec	-0.25

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Change in Haematological Parameter- Basophils

Change in basophils from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Percentage of basophils (Mean)
Insulin Degludec/Liraglutide	0.00
Insulin Degludec	0.01

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Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline

Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Ratio of VLDL cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide	0.92
Insulin Degludec	0.93

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Change in Fasting Triglycerides- Ratio to Baseline

Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Ratio of triglycerides (Geometric Mean)
Insulin Degludec/Liraglutide	0.91
Insulin Degludec	0.92

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Change in Fasting Total Cholesterol- Ratio to Baseline

Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Ratio of total cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide	0.92
Insulin Degludec	0.97

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Change in Fasting Plasma Glucose (FPG)

Change in FPG from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	mmol/L (Mean)
Insulin Degludec/Liraglutide	-3.57
Insulin Degludec	-2.82

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Change in Waist Circumference

Change in waist circumference from baseline (week 0) to week 26 is presented. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Centimeter (cm) (Mean)
Insulin Degludec/Liraglutide	-0.4
Insulin Degludec	0.7

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Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline

Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Ratio of LDL cholesterol (Geometric Mean)
Insulin Degludec/Liraglutide	0.89
Insulin Degludec	0.95

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Change in Fasting Insulin- Ratio to Baseline

Change in fasting insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline. (NCT03175120)
Timeframe: Week 0, week 26

Intervention	Ratio of insulin (Geometric Mean)
Insulin Degludec/Liraglutide	0.63
Insulin Degludec	0.50

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Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately

"The DTSQs questionnaire was used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for diabetes in terms of convenience, flexibility and general feelings regarding treatment. Q 1 = satisfaction with current treatment; Q 2 = hyperglycemia; Q 3 = hypoglycemia; Q 4 = flexibility; Q 5 = convenience; Q 6 = understanding of diabetes; Q 7 = recommend treatment to others; and Q 8 = willingness to continue. Each item is rated on a 7-point Likert scale with a score ranging from 0 (ie, very dissatisfied) to 6 (ie, very satisfied). DTSQ items 2 and 3 are rated differently: 0 reflects 'never' and 6 reflects 'most of the time'. The 'treatment satisfaction' score is the sum of 6 of the 8 DTSQs components (Q 1, 4, 5, 6, 7 and 8) (range 0-36). Higher scores on the DTSQ total score indicate higher treatment satisfaction. The results presented is the change from baseline (week 0) to week 30 in DTSQ scores." (NCT03191396)
Timeframe: Week 0, week 30

Intervention	scores on a scale (Mean)
	Q1. Satisfaction with current treatment	Q2. Hyperglycemia	Q3. Hypoglycemia	Q4. Flexibility	Q5. Convenience	Q6. Understanding of diabetes	Q7. Recommend treatment to others	Q8. Willingness to continue	Treatment satisfaction summary score
Liraglutide 1.2 mg	0.9	-1.6	0.1	0.6	0.6	0.5	0.7	0.9	4.2
Semaglutide 1.0 mg	0.9	-2.1	0.1	0.7	0.7	0.6	0.7	1.0	4.6

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Change in Fasting Blood Lipids: Total Cholesterol

The change from baseline in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	ratio (Geometric Mean)
Semaglutide 1.0 mg	0.96
Liraglutide 1.2 mg	0.98

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Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol

The change from baseline in LDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	ratio (Geometric Mean)
Semaglutide 1.0 mg	0.99
Liraglutide 1.2 mg	0.99

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Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol

The change from baseline in HDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	ratio (Geometric Mean)
Semaglutide 1.0 mg	1.01
Liraglutide 1.2 mg	0.99

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Change in Diastolic Blood Pressure

Change in diastolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	mmHg (Mean)
Semaglutide 1.0 mg	-1.5
Liraglutide 1.2 mg	-1.3

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Change in Calcitonin

Mean change from baseline (week 0) to week 30 in calcitonin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	ng/L (Geometric Mean)
Semaglutide 1.0 mg	1.3
Liraglutide 1.2 mg	1.1

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Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain

Percentage of subjects who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: After 30 weeks of treatment

Intervention	Percentage of participants (Number)
Semaglutide 1.0 mg	75.6
Liraglutide 1.2 mg	36.8

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Change in Body Weight (kg)

Mean change from baseline (week 0) to week 30 in body weight measured in kilograms. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	kg (Mean)
Semaglutide 1.0 mg	-5.8
Liraglutide 1.2 mg	-2.0

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Change in Body Mass Index (BMI)

Mean change from baseline (week 0) to week 30 in BMI. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	kg/sqm (Mean)
Semaglutide 1.0 mg	-2.0
Liraglutide 1.2 mg	-0.7

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Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR).

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter eGFR. eGFR is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) as defined in KDIGO guidelines. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	mL/min/1.73m2 (Geometric Mean)
Semaglutide 1.0 mg	4.0
Liraglutide 1.2 mg	4.1

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Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains

Short form-36 version 2 (SF-36v2) is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL). The questionnaire measures the individual overall HRQoL on 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Each domain is scored using the sum of the individual item responses and normalised relative to the 2009 US reference population. Overall, the domain scores range from around 0-100 (higher scores indicated a better HRQoL), where the range of possible scores depends on the 2009 US reference population for each domain. The two total summary scores (mental and physical summary components) are calculated through weighted sums of the 8 domain scores. The presented result is the change from baseline (week 0) to week 30 in SF-36v2 scores. A positive change in score indicates an improvement since baseline. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	scores on a scale (Mean)
	Physical functioning	Role-physical	Bodily pain	General health	Social functioning	Role-emotional	Vitality	Mental health	Mental component summary	Physical component summary
Liraglutide 1.2 mg	1.4	0.6	1.5	1.6	0.9	1.0	1.1	0.3	0.5	1.4
Semaglutide 1.0 mg	1.8	1.4	2.2	2.7	1.7	1.2	3.0	1.7	1.7	2.1

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Change in Haematology - Thrombocytes and Leukocytes

Mean change from baseline (week 0) to week 30 in haematology laboratory parameters thrombocytes and leukocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	10^9 cells/L (Geometric Mean)
	Thrombocytes	Leukocytes
Liraglutide 1.2 mg	21.5	0.14
Semaglutide 1.0 mg	18.4	0.14

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Change in Biochemistry - Albumin

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter albumin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	g/dL (Geometric Mean)
Semaglutide 1.0 mg	0.2
Liraglutide 1.2 mg	0.2

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Change in Biochemistry - Creatinine and Bilirubin

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters creatinine and bilirubin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	umol/L (Geometric Mean)
	Creatinine	Bilirubin
Liraglutide 1.2 mg	3.6	2.0
Semaglutide 1.0 mg	4.1	1.9

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Change in Biochemistry - Calcium, Pottassium and Sodium

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters calcium, pottassium and sodium. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	mmol/L (Geometric Mean)
	Calcium	Pottassium	Sodium
Liraglutide 1.2 mg	0.07	0.3	1.7
Semaglutide 1.0 mg	0.07	0.3	1.8

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Change in Biochemistry - Amylase and Lipase

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters amylase and lypase. Observed data with multiple imputation for missing data is presented. Missing data were imputed using observed data from subjects within the same group defined by actual treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	U/L (Geometric Mean)
	Amylase	Lipase
Liraglutide 1.2 mg	8.4	14.0
Semaglutide 1.0 mg	10.3	15.8

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Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase.

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	mmol/L (Geometric Mean)
	Alkaline phosphatase	Alanine Aminotransferase	Aspartate Aminotransferase
Liraglutide 1.2 mg	6.4	5.0	3.1
Semaglutide 1.0 mg	5.5	5.3	3.5

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Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes

Number of subjects with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes is presented. Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. (NCT03191396)
Timeframe: Week 0 to week 35

Intervention	Participants (Number)
Semaglutide 1.0 mg	5
Liraglutide 1.2 mg	7

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Subjects Who Achieve Weight Loss Above or Equal to 5%

Percentage of subjects who achieved weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: After 30 weeks of treatment

Intervention	Percentage of participants (Number)
Semaglutide 1.0 mg	55.9
Liraglutide 1.2 mg	17.7

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Subjects Who Achieve Weight Loss Above or Equal to 3%

Percentage of subjects who achieved weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: After 30 weeks of treatment

Intervention	percentage of participants (Number)
Semaglutide 1.0 mg	72.7
Liraglutide 1.2 mg	33.9

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Subjects Who Achieve Weight Loss Above or Equal to 10%

Percentage of subjects who achieved weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: After 30 weeks of treatment

Intervention	Percentage of participants (Number)
Semaglutide 1.0 mg	19.1
Liraglutide 1.2 mg	4.4

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Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%

Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: After 30 weeks of treatment

Intervention	Percentage of participants (Number)
Semaglutide 1.0 mg	49.6
Liraglutide 1.2 mg	11.9

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Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%

Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: After 30 weeks of treatment

Intervention	Percentage of participants (Number)
Semaglutide 1.0 mg	62.4
Liraglutide 1.2 mg	20.9

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Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%

Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: After 30 weeks of treatment

Intervention	Percentage of participants (Number)
Semaglutide 1.0 mg	17.1
Liraglutide 1.2 mg	3.6

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Subjects Who Achieve HbA1c Reduction Above or Equal to 1%

Percentage of subjects who achieved weight loss above or equal to 1% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: After 30 weeks of treatment

Intervention	Percentage of participants (Number)
Semaglutide 1.0 mg	82.8
Liraglutide 1.2 mg	48.3

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Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target

Percentage of subjects who achieved HbA1c less than 6.5% (48 mmol/mol) according to AACE target,after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: After 30 weeks of treatment

Intervention	percentage of participants (Number)
Semaglutide 1.0 mg	58.5
Liraglutide 1.2 mg	24.8

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Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target

Percentage of subjects who achieved HbA1c less than 7.0% (53 mmol/mol) according to American Diabetes Association (ADA) target, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: After 30 weeks of treatment

Intervention	percentage of participants (Number)
Semaglutide 1.0 mg	80.4
Liraglutide 1.2 mg	45.9

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Change in Body Weight (%)

Mean relative change from baseline in body weight measured in percentage. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	percentage of body weight (Mean)
Semaglutide 1.0 mg	-6.1
Liraglutide 1.2 mg	-2.0

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Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes

Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. (NCT03191396)
Timeframe: Week 0 to week 35

Intervention	Episodes of hypoglycaemia (Number)
Semaglutide 1.0 mg	8
Liraglutide 1.2 mg	8

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Number of Treatment-emergent Adverse Events (TEAE)

A TEAE was defined as an adverse event with onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period represents the time period where subjects were considered exposed to trial product. (NCT03191396)
Timeframe: Week 0 to week 35

Intervention	Events (Number)
Semaglutide 1.0 mg	758
Liraglutide 1.2 mg	691

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Change in Waist Circumference

Mean change in waist circumference (cm) from baseline (week 0) to week 30. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	cm (Mean)
Semaglutide 1.0 mg	-5.2
Liraglutide 1.2 mg	-2.4

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Change in Systolic Blood Pressure

Change in systolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	mmHg (Mean)
Semaglutide 1.0 mg	-4.3
Liraglutide 1.2 mg	-3.7

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Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)

Mean post prandial glucose incrememts over all meals. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	mmol/L (Mean)
Semaglutide 1.0 mg	-1.0
Liraglutide 1.2 mg	-0.4

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Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile

Mean change from baseline in 7-point profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The mean of the 7-point SMPG profile, defined as the area under the profile, was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	mmol/L (Mean)
Semaglutide 1.0 mg	-3.0
Liraglutide 1.2 mg	-2.1

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Change in Pulse Rate

Mean change from baseline (week 0) to week 30 in pulse rate. Pulse rate is measured as number of heart beats per minute. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	beats/min (Geometric Mean)
Semaglutide 1.0 mg	2.4
Liraglutide 1.2 mg	3.9

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Change in HbA1c

Mean change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) %. The endpoint was evaluated based on the 'on-treatment without rescue medication period' where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	Percentage of glycosylated haemoglobin (Mean)
Semaglutide 1.0 mg	-1.7
Liraglutide 1.2 mg	-1.1

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Change in Haematology - Haemoglobin

Mean change from baseline (week 0) to week 30 in haemoglobin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	mmol/L (Geometric Mean)
Semaglutide 1.0 mg	1.0
Liraglutide 1.2 mg	1.0

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Change in Haematology - Haematocrit

Mean change from baseline (week 0) to week 30 in haematology laboratory parameter haematocrit. Haematocrit is the volume of red blood cells in the total blood. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	percent change (Geometric Mean)
Semaglutide 1.0 mg	1.5
Liraglutide 1.2 mg	1.1

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Change in Haematology - Erythrocytes

Mean change from baseline (week 0) to week 30 in haematology laboratory parameter erythrocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	10^12 cells/L (Geometric Mean)
Semaglutide 1.0 mg	0.14
Liraglutide 1.2 mg	0.14

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Change in Fasting Plasma Glucose (FPG)

Mean change from baseline in fasting plasma glucose measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	mmol/L (Mean)
Semaglutide 1.0 mg	-2.65
Liraglutide 1.2 mg	-1.46

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Change in Fasting Blood Lipids: Triglycerides

The change from baseline in triglycerides is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. (NCT03191396)
Timeframe: Week 0, week 30

Intervention	Ratio (Geometric Mean)
Semaglutide 1.0 mg	0.83
Liraglutide 1.2 mg	0.91

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Percent Change in Body Weight Versus Active Comparator

To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily (NCT03235050)
Timeframe: from baseline to 14 weeks, 26 weeks and 54 weeks

,,,

Intervention	percentage (Least Squares Mean)
	Percent change at 14 weeks	Percent change at 26 weeks	Percent change at 54 weeks
Liraglutide	-3.40	-4.12	-3.20
MEDI0382 100 mcg	-2.70	-3.23	-3.27
MEDI0382 200 mcg	-3.47	-3.94	-3.08
MEDI0382 300 mcg	-4.33	-4.60	-4.16

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Percent Change in Body Weight

To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus placebo (NCT03235050)
Timeframe: from baseline to 26 weeks and 54 weeks

,,,

Intervention	percentage (Least Squares Mean)
	from baseline to 26 weeks	from baseline to 54 weeks
MEDI0382 100 mcg	-3.23	-3.27
MEDI0382 200 mcg	-3.94	-3.08
MEDI0382 300 mcg	-4.60	-4.16
Placebo	-1.14	-0.84

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Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)

To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide (NCT03235050)
Timeframe: Baseline through 54-week treatment period and 28-day follow-up

,,,

Intervention	Participants (Count of Participants)
	ADA positive at baseline	ADA incidence	ADA positive post-baseline
MEDI0382 100 mcg	1	55	54
MEDI0382 200 mcg	0	152	152
MEDI0382 300 mcg	0	155	155
Placebo	1	3	3

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Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants

To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide (NCT03235050)
Timeframe: Baseline through 54-week treatment period and 28-day follow-up

,,,

Intervention	titer (Median)
	ADA positive at baseline, median titer	ADA incidence, median of maximum titer	ADA positive post-baseline, median of max. titer
MEDI0382 100 mcg	5.0	20.0	20.0
MEDI0382 200 mcg	0	20.0	20.0
MEDI0382 300 mcg	0	20.0	20.0
Placebo	5.0	5.0	5.0

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Change in HbA1c

To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo (NCT03235050)
Timeframe: from baseline to 26 weeks and 54 weeks

,,,

Intervention	percentage (Least Squares Mean)
	from baseline to 26 weeks	from baseline to 54 weeks
MEDI0382 100 mcg	-1.06	-0.96
MEDI0382 200 mcg	-1.22	-1.06
MEDI0382 300 mcg	-1.12	-1.01
Placebo	-0.40	-0.44

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Absolute Change in Body Weight

To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo (NCT03235050)
Timeframe: from baseline to 14 weeks, 26 weeks and 54 weeks

,,,

Intervention	kg (Least Squares Mean)
	from baseline to 14 weeks	from baseline to 26 weeks	from baseline to 54 weeks
MEDI0382 100 mcg	-2.66	-3.20	-3.20
MEDI0382 200 mcg	-3.45	-3.94	-3.09
MEDI0382 300 mcg	-4.42	-4.75	-4.35
Placebo	-0.71	-1.20	-0.94

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Percent Change in Body Weight

To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo (NCT03235050)
Timeframe: From baseline to 14 weeks

Intervention	percentage (Least Squares Mean)
Placebo	-0.70
MEDI0382 100 mcg	-2.70
MEDI0382 200 mcg	-3.47
MEDI0382 300 mcg	-4.33

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Change in HbA1c

To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo (NCT03235050)
Timeframe: From baseline to 14 weeks

Intervention	percentage (Least Squares Mean)
Placebo	-0.18
MEDI0382 100 mcg	-1.01
MEDI0382 200 mcg	-1.22
MEDI0382 300 mcg	-1.09

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Absolute Change in Body Weight Versus Active Comparator

To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily (NCT03235050)
Timeframe: from baseline to 14 weeks, 26 weeks and 54 weeks

,,,

Intervention	kg (Least Squares Mean)
	Absolute change at 14 weeks	Absolute change at 26 weeks	Absolute change at 54 weeks
Liraglutide	-3.25	-3.90	-2.94
MEDI0382 100 mcg	-2.66	-3.20	-3.20
MEDI0382 200 mcg	-3.45	-3.94	-3.09
MEDI0382 300 mcg	-4.42	-4.75	-4.35

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Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)

To characterise the PK profile of 100, 200, and 300 μg of cotadutide (NCT03235050)
Timeframe: Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54

Intervention	ng/mL (Mean)
	Week 1	Week 2	Week 6	Week 10	Week 14	Week 18	Week 22	Week 26	Week 54
MEDI0382 100 mcg	2.68	2.66	2.75	3.18	3.79	4.58	4.63	4.39	4.58
MEDI0382 200 mcg	2.76	5.13	5.20	5.74	6.50	7.43	8.07	8.12	8.99
MEDI0382 300 mcg	2.77	5.18	7.77	8.23	9.71	10.8	11.5	12.9	13.2

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Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control

To assess the effect of 100, 200, and 300 μg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo (NCT03235050)
Timeframe: at 14 weeks, 26 weeks and 54 weeks

,,,

Intervention	Participants (Count of Participants)
	received rescue medication at 14 wks	received rescue medication at 26 wks	received rescue medication at 54 wks	discontinued study IP at 14 wks	discontinued study IP at 26 wks	discontinued study IP at 54 wks
MEDI0382 100 mcg	1	3	10	0	1	1
MEDI0382 200 mcg	3	8	26	1	2	3
MEDI0382 300 mcg	2	6	24	0	0	0
Placebo	11	20	34	2	4	4

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Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%

To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of subjects achieving weight loss of ≥5% and ≥10% versus placebo (NCT03235050)
Timeframe: after 14 weeks, 26 weeks and 54 weeks

,,,

Intervention	Participants (Count of Participants)
	Participants with weight loss ≥5% at Wk 14 (LOCF)	Participants with weight loss ≥5% at Wk 26 (LOCF)	Participants with weight loss ≥5% at Wk 54 (LOCF)	Participants with weight loss ≥10% at Wk 14 (LOCF)	Participants with weight loss ≥10% at Wk 26 (LOCF)	Participants with weight loss ≥10% at Wk 54 (LOCF)
MEDI0382 100 mcg	18	28	34	6	7	11
MEDI0382 200 mcg	65	76	71	15	28	21
MEDI0382 300 mcg	92	110	98	20	27	32
Placebo	3	11	14	0	1	2

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Percentage of Participants Achieving an HbA1c Target < 7.0%

To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of participants achieving an HbA1c target of <7% versus placebo (NCT03235050)
Timeframe: after 14, 26, and 54 weeks

,,,

Intervention	Participants (Count of Participants)
	after 14 weeks	after 26 weeks	after 54 weeks
MEDI0382 100 mcg	50	48	52
MEDI0382 200 mcg	143	139	125
MEDI0382 300 mcg	143	143	128
Placebo	19	25	23

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Binge Episodes

Change in objective binge episodes per week from randomization (week 0) to study end (week 17) (NCT03279731)
Timeframe: baseline and 17 weeks (or last observation carried forward)

Intervention	objective binge episodes per week (Mean)
Liraglutide	-3.97
Placebo	-2.50

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Assessment of Improvement of Binge Eating Symptoms

week 17 rating on the interviewer-based Clinical Global Impression of Improvement (CGII) Scale for global assessment of BED symptoms The CGII includes the following rating scale: Compared to the patient's condition at baseline to the project [prior to medication initiation], this patient's condition is: 1 very much improved; 2 much improved; 3 improved; 4 no change; 5 worse; 6 much worse; 7 very much worse. (NCT03279731)
Timeframe: week 17 (or last observation carried forward)

Intervention	units on a scale (Mean)
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml	1.52
Placebo	1.93

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Remission From Binge-eating

the percentage of participants (completers) who have achieved remission from binge-eating (no binge episodes between weeks 13 - 17) (NCT03279731)
Timeframe: 13 to 17 weeks

Intervention	Participants (Count of Participants)
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml	3
Placebo	4

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Change in Body Weight

changes in body weight (NCT03279731)
Timeframe: baseline and 17 weeks (or last observation carried forward)

Intervention	kg (Mean)
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml	-4.7
Placebo	-0.94

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Percentage of Responders

Percentage of participants with at least 10% total body weight loss (NCT03374956)
Timeframe: baseline to 12 weeks

Intervention	percentage of participants (Number)
Intervention Group	44
Control Group	40

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Percentage of Responders

Percentage of participants who loss 5% or more of total body weight (NCT03374956)
Timeframe: baseline to 12 weeks

Intervention	percentage of participants (Number)
Intervention Group	81
Control Group	80

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Change in Total Body Weight

Percent change in body weight (NCT03374956)
Timeframe: baseline to 12 weeks

Intervention	percent change (Median)
Intervention Group	-7.7
Control Group	-6.5

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Triglyceride Levels (TRG)

Drug effect of TRG levels after treatment (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	mg/dL (Mean)
Liraglutide Pen Injector (Saxenda)	109
Placebo Liraglutide Pen Injector	114

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Corrected First Phase Insulin Secretion (IGI/HOMA-IR)

Treatment effect on insulin secretion from 0 to 30 minutes after glucose load corrected for by fasting insulin sensitivity. A higher score shows improved first phase insulin secretion in response to glucose. (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	index score (Mean)
Liraglutide Pen Injector (Saxenda)	1.01
Placebo Liraglutide Pen Injector	0.8

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Change in Percent Body Weight

Treatment effect on reducing body weight expressed as percent body weight loss from baseline (NCT03480022)
Timeframe: Change from baseline (time 0) to study end (32 weeks)

Intervention	percentage loss in body weight (Mean)
Liraglutide Pen Injector (Saxenda)	5.7
Placebo Liraglutide Pen Injector	1.4

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Body Mass Index (BMI)

Treatment effect in reducing body mass (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	kilogram/meter squared (Mean)
Liraglutide Pen Injector (Saxenda)	39.1
Placebo Liraglutide Pen Injector	43.4

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Android-Gynoid Ratio (AGR) by DXA

Treatment impact on AGR, measure of central adiposity, as determined by DXA. A lower AGR indicates a reduction in central adiposity. (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	ratio (Mean)
Liraglutide Pen Injector (Saxenda)	1.05
Placebo Liraglutide Pen Injector	1.08

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Adrenal Dehydroepiandrosterone Sulfate (DHEAS)

Treatment efficacy in reducing adrenal hyperandrogenism (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	mcg/dL (Mean)
Liraglutide Pen Injector (Saxenda)	177.1
Placebo Liraglutide Pen Injector	171.3

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Absolute Body Weight (BW)

Treatment impact on change in body weight after 32 weeks of treatment. (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	kilogram (Mean)
Liraglutide Pen Injector (Saxenda)	104.7
Placebo Liraglutide Pen Injector	117.9

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Abdominal Adiposity (Waist Circumference [WC]

Treatment effect on loss of WC (abdominal adiposity) with drug treatment (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	centimeters (Mean)
Liraglutide Pen Injector (Saxenda)	100.9
Placebo Liraglutide Pen Injector	109.9

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5% Weight Loss From Baseline

Frequency of patients achieving 5% weight loss from baseline with treatment (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	Participants (Count of Participants)
Liraglutide Pen Injector (Saxenda)	25
Placebo Liraglutide Pen Injector	5

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10% Body Weight Loss From Baseline

Frequency of patients with at least 10% reduction in body weight from baseline (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	Participants (Count of Participants)
Liraglutide Pen Injector (Saxenda)	13
Placebo Liraglutide Pen Injector	2

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Total Fat Mass Evaluated by DEXA

Treatment effect on reduction of fat mass (kg) (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	kilogram (Mean)
Liraglutide Pen Injector (Saxenda)	49.3
Placebo Liraglutide Pen Injector	56.8

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Total Cholesterol Levels

Treatment impact on improving total cholesterol levels (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	mg/dL (Mean)
Liraglutide Pen Injector (Saxenda)	176
Placebo Liraglutide Pen Injector	178

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Total Body Fat (%) by DXA

Treatment effect on reduction of percent body fat by DXA (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	percent fat mass (Mean)
Liraglutide Pen Injector (Saxenda)	46.0
Placebo Liraglutide Pen Injector	47.9

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Systolic Blood Pressure

Treatment impact on systolic blood pressure (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	mmHg (Mean)
Liraglutide Pen Injector (Saxenda)	116.8
Placebo Liraglutide Pen Injector	123.3

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Total Testosterone Concentrations (T)

Drug treatment effect on total testosterone concentrations (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	ng/dL (Mean)
Liraglutide Pen Injector (Saxenda)	45.4
Placebo Liraglutide Pen Injector	46.8

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OGTT Mean Blood Glucose (MBG)

Treatment effect on MBG measured during the oral glucose tolerance test. A decrease in MBG shows improvement in glycemia. (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	mg/dL (Mean)
Liraglutide Pen Injector (Saxenda)	109.4
Placebo Liraglutide Pen Injector	125.5

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Menstrual Cycle Frequency

Drug treatment impact on normalization of cycle frequency (cycle every 28-30 days). All cycle data is expressed as number of menses annualized to one year. (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	menses per year (Mean)
Liraglutide Pen Injector (Saxenda)	8.65
Placebo Liraglutide Pen Injector	4.8

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Insulin Secretion- Insulin Sensitivity Index (Oral Disposition Index-IS-SI)

Treatment effect on an estimation of Beta cell compensatory function, the IS-SI is derived by applying the concept of the disposition index to measurements obtained during the 2 hour OGTT and calculated as the index of insulin secretion factored by insulin sensitivity. A higher score shows improved pancreatic beta cell function relative to insulin sensitivity. (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	index score (Mean)
Liraglutide Pen Injector (Saxenda)	532
Placebo Liraglutide Pen Injector	416

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High Density Lipoprotein Cholesterol (HDL-C)

Impact of treatment on HDL levels after 32 weeks of treatment (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	mg/dL (Mean)
Liraglutide Pen Injector (Saxenda)	41
Placebo Liraglutide Pen Injector	42

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Free Androgen Index (FAI)

Drug treatment effect on free androgen levels as calculated as FAI= total testosterone (T) concentrations divided by sex hormone binding globulin (SHBG) levels. A higher score indicates a worse outcome (more androgenic). (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	index score (Mean)
Liraglutide Pen Injector (Saxenda)	5.98
Placebo Liraglutide Pen Injector	6.4

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Fasting Insulin Sensitivity (HOMA-IR)

Treatment effect on the HOMA-IR which is an insulin resistance measured derived from fasting blood glucose and insulin . The higher the number the more insulin resistant. (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	index score (Mean)
Liraglutide Pen Injector (Saxenda)	4.1
Placebo Liraglutide Pen Injector	5.2

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Fasting Blood Glucose (FG)

Treatment effect on fasting glucose prior to an oral glucose tolerance test (OGTT) (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	mg/dL (Mean)
Liraglutide Pen Injector (Saxenda)	90.2
Placebo Liraglutide Pen Injector	94.3

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Diastolic Blood Pressure (BP)

Treatment impact on reducing diastolic blood pressure (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	mmHg (Mean)
Liraglutide Pen Injector (Saxenda)	77.6
Placebo Liraglutide Pen Injector	78.1

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Matsuda Insulin Sensitivity Index Derived From the OGTT (SI OGTT)

The SI OGTT is a measure of peripheral insulin sensitivity derived from the insulin and glucoses measured during an OGTT. A increase in SI OGTTindicates greater insulin sensitivity (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	index score (Mean)
Liraglutide Pen Injector (Saxenda)	3.7
Placebo Liraglutide Pen Injector	3.0

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Trunk/Leg Fat Ratio (TLR) by DXA

Treatment impact on TLR after 32 weeks. A reduction in TLR indicates a loss of central fat. (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	ratio (Mean)
Liraglutide Pen Injector (Saxenda)	1.02
Placebo Liraglutide Pen Injector	1.07

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Triglyceride to HDL-Cholesterol Ratio (TRG/HDL-C)

Treatment impact on TRG/HDL-C ratio which is a simple measure to estimate insulin action. A decrease in ratio indicates improvement in insulin sensitivity. (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	ratio (Mean)
Liraglutide Pen Injector (Saxenda)	2.9
Placebo Liraglutide Pen Injector	3.0

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Waist-to Height Ratio [WHtR])

Treatment effect on loss of central adiposity as determined by WHt ratio. The lower the ratio indicates less abdominal adiposity. (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	ratio (Mean)
Liraglutide Pen Injector (Saxenda)	0.62
Placebo Liraglutide Pen Injector	0.67

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Triglyceride and Glucose Index (TyG)

Treatment impact on the TyG index which estimates insulin resistance. A reduction in TyG indicates an improvement in insulin action. (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	index score (Mean)
Liraglutide Pen Injector (Saxenda)	8.39
Placebo Liraglutide Pen Injector	8.5

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Waist-to-Hip Ratio

Change in central adiposity with treatment as measured by WHR. A reduction in ratio indicates a decrease in truncal fat. (NCT03480022)
Timeframe: 32 weeks of treatment

Intervention	ratio (Mean)
Liraglutide Pen Injector (Saxenda)	0.81
Placebo Liraglutide Pen Injector	0.85

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Percent Change From Baseline in Body Weight at Week 26

Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported. (NCT03486392)
Timeframe: Baseline, Week 26

Intervention	Percent Change (Least Squares Mean)
Double Blind: Placebo	-1.76
Double Blind: JNJ-64565111 5.0 mg	-8.51
Double Blind: JNJ-64565111 7.4 mg	-9.83
Double Blind: JNJ-64565111 10.0 mg	-11.80
Open Label: Liraglutide 3.0 mg	-7.54

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Number of Participants With Treatment Emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants. (NCT03486392)
Timeframe: Up to Week 30

Intervention	Participants (Count of Participants)
Double Blind: Placebo	43
Double Blind: JNJ-64565111 5.0 mg	53
Double Blind: JNJ-64565111 7.4 mg	110
Double Blind: JNJ-64565111 10.0 mg	110
Open Label: Liraglutide 3.0 mg	96

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Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26

Number of participants with >= 10 % body weight loss from baseline to Week 26 were reported. (NCT03486392)
Timeframe: Week 26

Intervention	Participants (Count of Participants)
Double Blind: Placebo	2
Double Blind: JNJ-64565111 5.0 mg	23
Double Blind: JNJ-64565111 7.4 mg	43
Double Blind: JNJ-64565111 10.0 mg	46
Open Label: Liraglutide 3.0 mg	27

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Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26

Number of participants with >= 5% body weight loss from baseline to Week 26 were reported. (NCT03486392)
Timeframe: Week 26

Intervention	Participants (Count of Participants)
Double Blind: Placebo	8
Double Blind: JNJ-64565111 5.0 mg	34
Double Blind: JNJ-64565111 7.4 mg	70
Double Blind: JNJ-64565111 10.0 mg	62
Open Label: Liraglutide 3.0 mg	56

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Change From Baseline in Body Weight at Week 26

Change from baseline in body weight at Week 26 was reported. (NCT03486392)
Timeframe: Baseline, Week 26

Intervention	kg (Least Squares Mean)
Double Blind: Placebo	-2.05
Double Blind: JNJ-64565111 5.0 mg	-9.58
Double Blind: JNJ-64565111 7.4 mg	-11.07
Double Blind: JNJ-64565111 10.0 mg	-13.23
Open Label: Liraglutide 3.0 mg	-8.32

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Satiety

Subjects self-reported fullness after eating as much of a prescribed meal measured by kilocalories of food consumed. (NCT03523273)
Timeframe: 16 weeks

Intervention	kilocalories (Median)
Liraglutide	647.5
Placebo	793.7

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Satiation Volume to Fullness

Subjects ingest Ensure 300mL drink meal at a constant rate of 30mL/min until self-reported fullness and volume consumed will be measured in milliliters (mL). (NCT03523273)
Timeframe: 16 weeks

Intervention	milliliters (mL) (Median)
Liraglutide	622.1
Placebo	746.6

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Maximum Satiation

Subjects ingest Ensure 300mL drink meal at a constant rate of 30mL/min until they reach maximum or unbearable fullness. Volume consumed will be measured in milliliters (mL). (NCT03523273)
Timeframe: 16 weeks

Intervention	milliliters (mL) (Median)
Liraglutide	974.4
Placebo	1119.8

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Gastric Volume After Meal

Gastric volume was measured after a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach. (NCT03523273)
Timeframe: 16 weeks

Intervention	milliliters (mL) (Median)
Liraglutide	629.1
Placebo	583.8

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Change in Weight at 5 Weeks

Change in subject's weight, in kilograms (NCT03523273)
Timeframe: baseline, 5 weeks

Intervention	kilograms (Median)
Liraglutide	-3.8
Placebo	0.1

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Gastric Emptying of Solids (T1/2)

The time for half of the ingested solids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi), gastric emptying of solids was assessed with scintigraphy imaging. (NCT03523273)
Timeframe: 5 weeks

Intervention	minutes (Median)
Liraglutide	191.6
Placebo	105.9

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Change in Weight at 16 Weeks

Change in subject's weight, in kilograms (NCT03523273)
Timeframe: baseline, 16 weeks

Intervention	kilograms (Median)
Liraglutide	-5.8
Placebo	0.0

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Gastric Emptying of Solids (T1/2)

Intervention	minutes (Median)
Liraglutide	154.4
Placebo	111.4

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Gastric Accommodation

Measured in milliliters (mL), using the difference between the fasting gastric volume prior to the meal and the gastric volume after the meal. (NCT03523273)
Timeframe: 16 weeks

Intervention	milliliters (mL) (Median)
Liraglutide	385.4
Placebo	391.8

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Fasting Gastric Volume Prior to Meal

Gastric fasting volume was measured prior to a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach. (NCT03523273)
Timeframe: 16 weeks

Intervention	milliliters (mL) (Median)
Liraglutide	221.2
Placebo	191.5

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Number of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date

Biochemically verified carbon monoxide (CO) reading <5 using a Vitalograph Breath CO Analyzer (NCT03712098)
Timeframe: Week 18

Intervention	Participants (Count of Participants)
Smoking Cessation Counseling & Liraglutide	2
Smoking Cessation Counseling & Placebo	2

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Body Weight at 26 Weeks Post-Target Quit Date

Body weight will be measured by digital scale (pounds, ounces) wearing light clothing without shoes (NCT03712098)
Timeframe: Week 32

Intervention	lb (Mean)
Smoking Cessation Counseling & Liraglutide	234.4
Smoking Cessation Counseling & Placebo	209.8

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Body Weight at 12 Weeks Post-Target Quit Date

Body weight will be measured by digital scale (pounds, ounces) wearing light clothing without shoes (NCT03712098)
Timeframe: Week 18

Intervention	lb (Mean)
Smoking Cessation Counseling & Liraglutide	209.8
Smoking Cessation Counseling & Placebo	212.6

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Calories Consumed Per Day

The research team staff will use a multi-pass method with an interactive computerized software program, the Automated Self-Administered 24-hour Recall (ASA24®) tool to determine total kcal/day with participants over the phone. (NCT03712098)
Timeframe: Weeks 0, 5, 18, & 32

Intervention	kcal/day (Mean)
	Week 0	Week 5	Week 18	Week 32
Smoking Cessation Counseling & Liraglutide	1994.4	1572.2	1352.1	1360.3
Smoking Cessation Counseling & Placebo	1703.9	1781.3	1582.6	1797.6

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Number of Participants With 7-day Point Prevalence Smoking Abstinence at 26 Weeks Post-Target Quit Date

Biochemically verified carbon monoxide (CO) reading <5 using a Vitalograph Breath CO Analyzer (NCT03712098)
Timeframe: Week 32

Intervention	Participants (Count of Participants)
Smoking Cessation Counseling & Liraglutide	2
Smoking Cessation Counseling & Placebo	2

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Number of Hospital Readmissions

The number of hospital readmissions occurring during the treatment period will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

Intervention	Number of Hospital readmissions (Number)
IDegLira	0
Basal-Bolus Insulin	4

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Number of Participants With Severe Hypoglycemic Events

Severe hypoglycemia is defined as severe cognitive impairment requiring assistance from another person. Number of participants with severe hypoglycemic events will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

Intervention	participants (Number)
IDegLira	7
Basal-Bolus Insulin	14

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Participants With HbA1c <7.0% and no Hypoglycemia

Percent of study participants experiencing HbA1c <7.0% and no hypoglycemia will be compared between groups. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. (NCT03737240)
Timeframe: Week 26

Intervention	Participants (Count of Participants)
IDegLira	19
Basal-Bolus Insulin	6

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Participants With HbA1c <7.0% and no Hypoglycemia

Percent of study participants reaching A1c < 7% without hypoglycemia will be compared between groups. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. (NCT03737240)
Timeframe: Week 12

Intervention	Participants (Count of Participants)
IDegLira	21
Basal-Bolus Insulin	8

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Participants With HbA1c <7.0% and no Weight Gain

Percent of study participants reaching A1c < 7% without weight gain will be compared between groups. (NCT03737240)
Timeframe: Week 26

Intervention	Participants (Count of Participants)
IDegLira	13
Basal-Bolus Insulin	3

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Participants With HbA1c <7.0% and no Weight Gain and no Hypoglycemia

Percent of study participants reaching A1c < 7% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. (NCT03737240)
Timeframe: Week 26

Intervention	Participants (Count of Participants)
IDegLira	8
Basal-Bolus Insulin	1

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Participants With HbA1c <7.5% and no Weight Gain and no Hypoglycemia

Percent of study participants reaching A1c < 7.5% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. (NCT03737240)
Timeframe: Week 26

Intervention	percentage of participants (Number)
IDegLira	19.6
Basal-Bolus Insulin	5.2

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Participants With HbA1c >10% Achieving HbA1c <7.5%

Percent of study participants with baseline HbA1c >10% reaching A1c < 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. (NCT03737240)
Timeframe: Baseline, Week 26

Intervention	percentage of participants (Number)
IDegLira	56.8
Basal-Bolus Insulin	37.5

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Participants With HbA1c >10% Achieving HbA1c <8.0%

Percent of study participants with baseline HbA1c >10% reaching A1c < 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. (NCT03737240)
Timeframe: Baseline, Week 26

Intervention	percentage of participants (Number)
IDegLira	61.4
Basal-Bolus Insulin	45.8

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Participants With HbA1c >11% Achieving HbA1c <7.5%

Percent of study participants with baseline HbA1c >11% reaching A1c < 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. (NCT03737240)
Timeframe: Baseline, Week 26

Intervention	percentage of participants (Number)
IDegLira	52.0
Basal-Bolus Insulin	25.9

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Participants With HbA1c >11% Achieving HbA1c <8.0%

Percent of study participants with baseline HbA1c >11% reaching A1c < 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. (NCT03737240)
Timeframe: Baseline, Week 26

Intervention	percentage of participants (Number)
IDegLira	60.0
Basal-Bolus Insulin	29.6

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Percentage of Time With Interstitial Glucose <54 mg/dL

Percentage of time with a interstitial glucose level below <54 mg/dL as obtained by CGM will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

Intervention	% of time (Mean)
IDegLira	0.31
Basal-Bolus Insulin	0.72

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Percentage of Time With Interstitial Glucose <70 mg/dL

Percentage of time with a interstitial glucose level below 70 mg/dL as obtained by CGM will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

Intervention	% of time (Mean)
IDegLira	2.67
Basal-Bolus Insulin	1.23

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Percentage of Time With Interstitial Glucose Between 70 and 180 mg/dL

Percentage of time with interstitial glucose in the range of 70-180 mg/dL as measured by CGM will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

Intervention	% of time (Mean)
IDegLira	38.39
Basal-Bolus Insulin	31.17

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Average Daily Blood Glucose

Mean daily blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. Blood glucose levels vary depending on when and what food has been consumed. A blood glucose level taken regardless of timing of meals of greater than 200 mg/dL often indicates diabetes. Blood glucose decreases with improved diabetes management. (NCT03737240)
Timeframe: Week1, Week 12, Week 26

Intervention	mg/dL (Mean)
	Week 1 (Baseline)	Week 12	Week 26
Basal-Bolus Insulin	225.18	135.08	144.25
IDegLira	220.81	143.80	134.59

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Average Fasting Blood Glucose

Mean fasting blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. The measurement taken before breakfast is used to assess fasting blood glucose. For people without diabetes, fasting blood glucose is typically between 70-100 mg/dL while fasting blood glucose for those with diabetes is in the range of 70-130 mg/dL. (NCT03737240)
Timeframe: Week1, Week 12, Week 26

Intervention	mg/dL (Mean)
	Baseline (Week 1)	Week 12	Week 26
Basal-Bolus Insulin	206.53	125.18	143.14
IDegLira	202.37	131.94	143.31

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Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score

Treatment satisfaction will be assessed with the DTSQs. The DTSQs contains eight items scored on a seven-point scale where 0 = very dissatisfied and 6 = very satisfied. The satisfaction score is obtained by summing responses to yield a total score between 0 to 48. Higher scores indicate higher satisfaction with diabetes treatment. (NCT03737240)
Timeframe: Baseline, Week 12

Intervention	score on a scale (Mean)
	Baseline	Follow up at 24 weeks
Basal-Bolus Insulin	29.07	33.94
IDegLira	26.00	33.15

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Glycemic Variability

Glycemic variability will be assessed with continuous glucose monitoring (CGM). It will be calculated using CGM and Standard Deviation. (NCT03737240)
Timeframe: Week1, Week 12, Week 26

Intervention	mg/dl (Mean)
	CGM Week 1	CGM Week 12	CGM Week 26
Basal-Bolus Insulin	51.6	47.1	48.4
IDegLira	50.5	41.8	43.6

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Number of Participants With Documented Symptomatic Hypoglycemic Events

Documented symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL that occurs at any time of the day. Number of participants with documented hypoglycemic events will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

Intervention	participants (Number)
	Hypoglycemia < 70 mg/dL	Hypoglycemia < 54 mg/dL by CGM
Basal-Bolus Insulin	35	26
IDegLira	20	21

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Total Daily Insulin Dose

The total insulin dose measured in units per day will be compared between study groups. (NCT03737240)
Timeframe: Baseline, Week 26

Intervention	units per day (Mean)
	Baseline	26 weeks
Basal-Bolus Insulin	46.05	75.65
IDegLira	24.56	35.74

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Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score

Satisfaction with the study treatment will be assessed with the TRIM-D survey. TRIM-D includes 28 items that are scored on a scale from 1 to 5. Total scores are transformed to a scale of 0 to 100 where higher scores indicate increased satisfaction. (NCT03737240)
Timeframe: Baseline, Week 12, Week 26

Intervention	score on a scale (Mean)
	Baseline	3 months follow up	6 months follow up
Basal-Bolus Insulin	15.37	15.29	15.29
IDegLira	14.94	14.82	15.19

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Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) Score

Satisfaction with the study treatment will be assessed with items 1, 4, 5, 6, 7, and 8 the DTSQc. Items are rated on a scale of -3 (much less satisfied compared to prior treatment) to 3 (much more satisfied compared to prior treatment). Total scores for these three items range from -18 to +18 with higher scores indicating greater satisfaction with the study treatment compared to their prior treatment. (NCT03737240)
Timeframe: Week 26

Intervention	score on a scale (Mean)
IDegLira	15.55
Basal-Bolus Insulin	15.77

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Change in Hemoglobin A1c (HbA1c)

HbA1c will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. (NCT03737240)
Timeframe: Baseline, Week 26

Intervention	percentage of HbA1c (Mean)
IDegLira	-3.18
Basal-Bolus Insulin	-3.00

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Nocturnal Asymptomatic Hypoglycemic Events

Nocturnal asymptomatic hypoglycemia is defined as SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL between midnight and 5:59 am. Incidence of nocturnal asymptomatic hypoglycemic events will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

Intervention	Number of events (Mean)
IDegLira	4.81
Basal-Bolus Insulin	3.45

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Nocturnal Symptomatic Hypoglycemic Events

Nocturnal symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL that occurs between midnight and 5:59 am. Incidence of nocturnal symptomatic hypoglycemic events will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

Intervention	Number of events (Mean)
IDegLira	0.15
Basal-Bolus Insulin	0.16

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Number of Emergency Room (ER) Visits

The number of emergency room visits occurring during the treatment period will be compared between study groups. (NCT03737240)
Timeframe: Baseline through Week 26

Intervention	Number of ER visits (Number)
IDegLira	14
Basal-Bolus Insulin	12

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Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57

Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. (NCT03757130)
Timeframe: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207

,,,,,

Intervention	µg/mL (Mean)
	Day 1	Day 57
AMG 598 210 mg	21.5	45.4
AMG 598 210 mg + Liraglutide	18.0	34.8
AMG 598 420 mg	51.1	93.2
AMG 598 420 mg + Liraglutide	36.9	72.4
AMG 598 70 mg	5.83	9.07
AMG 598 70 mg + Liraglutide	7.49	12.0

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Accumulation Ratio (AR) for Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57

"Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.~Accumulation ratio for Cmax = Day 57 Cmax / Day 1 Cmax." (NCT03757130)
Timeframe: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207

Intervention	ratio (Mean)
AMG 598 70 mg	1.62
AMG 598 70 mg + Liraglutide	1.70
AMG 598 210 mg	2.12
AMG 598 210 mg + Liraglutide	1.92
AMG 598 420 mg	1.83
AMG 598 420 mg + Liraglutide	2.13

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Dose-normalized AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57

,,,,,

Intervention	days*µg/mL/mg (Mean)
	Day 1	Day 57
AMG 598 210 mg	2.36	4.59
AMG 598 210 mg + Liraglutide	1.74	3.57
AMG 598 420 mg	2.57	4.75
AMG 598 420 mg + Liraglutide	1.82	3.84
AMG 598 70 mg	1.98	3.07
AMG 598 70 mg + Liraglutide	2.10	3.94

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Area Under the Concentration-time Curve From Time 0 to 28 Days (AUC0-28) for AMG 598 After Subcutaneous Injection on Day 1 and Day 57

,,,,,

Intervention	days*µg/mL (Mean)
	Day 1	Day 57
AMG 598 210 mg	495	964
AMG 598 210 mg + Liraglutide	366	749
AMG 598 420 mg	1080	1990
AMG 598 420 mg + Liraglutide	763	1610
AMG 598 70 mg	139	215
AMG 598 70 mg + Liraglutide	147	276

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Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57

,,,,,

Intervention	days (Median)
	Day 1	Day 57
AMG 598 210 mg	7.1	6.1
AMG 598 210 mg + Liraglutide	7.0	6.5
AMG 598 420 mg	6.9	5.3
AMG 598 420 mg + Liraglutide	7.0	7.0
AMG 598 70 mg	7.1	7.0
AMG 598 70 mg + Liraglutide	7.0	7.0

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Dose-normalized Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57

,,,,,

Intervention	µg/mL/mg (Mean)
	Day 1	Day 57
AMG 598 210 mg	0.102	0.216
AMG 598 210 mg + Liraglutide	0.0856	0.168
AMG 598 420 mg	0.122	0.222
AMG 598 420 mg + Liraglutide	0.0879	0.172
AMG 598 70 mg	0.0833	0.130
AMG 598 70 mg + Liraglutide	0.107	0.172

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Accumulation Ratio of AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57

"Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.~The accumulation ratio for AUC0-28 = Day 57 AUC0-28 / Day 1 AUC0-28." (NCT03757130)
Timeframe: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85

Intervention	ratio (Mean)
AMG 598 70 mg	1.74
AMG 598 70 mg + Liraglutide	1.84
AMG 598 210 mg	2.09
AMG 598 210 mg + Liraglutide	1.86
AMG 598 420 mg	1.96
AMG 598 420 mg + Liraglutide	2.17

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Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of AMG 598 After Subcutaneous Injection on Day 57

Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. (NCT03757130)
Timeframe: Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207

Intervention	days*µg/mL (Mean)
AMG 598 70 mg	458
AMG 598 70 mg + Liraglutide	612
AMG 598 210 mg	2130
AMG 598 210 mg + Liraglutide	1570
AMG 598 420 mg	4060
AMG 598 420 mg + Liraglutide	3060

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Terminal Half-life (T1/2,z) of AMG 598 After Subcutaneous Injection on Day 57

Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. (NCT03757130)
Timeframe: Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207

Intervention	days (Mean)
AMG 598 70 mg	28.2
AMG 598 70 mg + Liraglutide	31.5
AMG 598 210 mg	35.2
AMG 598 210 mg + Liraglutide	29.1
AMG 598 420 mg	35.8
AMG 598 420 mg + Liraglutide	29.8

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Number of Participants With Treatment-emergent Adverse Events

"The investigator assessed the severity of each adverse event reported during the study. The assessment was based on the Amgen Standard Grading Scale:~Mild: Aware of sign or symptom, but easily tolerated. Moderate: Discomfort enough to cause interference with usual activity. Severe: Incapacitating with inability to work or do usual activity.~A Serious adverse event is defined as any untoward medical occurrence that, met at least 1 of the following serious criteria~Death;~Was life-threatening;~Required in-patient hospitalization or prolongation of existing hospitalization;~Resulted in persistent or significant disability/incapacity;~Was a congenital anomaly/birth defect;~Other medically important serious event.~The investigator also assessed whether each adverse event was related to study drug administration based on clinical judgement." (NCT03757130)
Timeframe: 207 days

,,,,,,,

Intervention	Participants (Count of Participants)
	All treatment-emergent adverse events (TEAEs)	Mild TEAEs	Moderate TEAEs	Severe TEAEs	Serious TEAEs	TEAE leading to discontinuation of AMG 598	TEAE leading to discontinuation of liraglutide	Life-threatening TEAEs	Fatal TEAEs
AMG 598 210 mg	5	5	0	0	0	0	0	0	0
AMG 598 210 mg + Liraglutide	6	6	0	0	0	0	0	0	0
AMG 598 420 mg	0	0	0	0	0	0	0	0	0
AMG 598 420 mg + Liraglutide	4	4	1	0	0	1	2	0	0
AMG 598 70 mg	4	4	0	0	0	0	0	0	0
AMG 598 70 mg + Liraglutide	7	7	2	0	0	0	1	0	0
Placebo	1	1	0	0	0	0	0	0	0
Placebo + Liraglutide	6	6	1	0	0	0	1	0	0

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Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings

TEAEs due to laboratory, electrocardiogram (ECG) and vital sign findings include any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or electrocardiogram, or vital signs measurements, including those that worsened from baseline, that were considered clinically significant in the medical and scientific judgment of the investigator (ie, not related to progression of underlying disease). (NCT03757130)
Timeframe: 207 days

,,,,,,,

Intervention	Participants (Count of Participants)
	Blood creatine phosphokinase increased	Electrocardiogram T wave abnormal	Hepatic enzyme increased	Lipase increased	Hypertension
AMG 598 210 mg	1	0	0	0	0
AMG 598 210 mg + Liraglutide	0	0	0	1	0
AMG 598 420 mg	0	0	0	0	0
AMG 598 420 mg + Liraglutide	0	1	1	1	0
AMG 598 70 mg	0	0	0	0	1
AMG 598 70 mg + Liraglutide	0	0	0	3	0
Placebo	0	0	0	0	0
Placebo + Liraglutide	0	0	0	1	0

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Change in Waist Circumference

Change in waist circumference from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	centimeters (cm) (Mean)
Cagrilintide 0.3 mg	-6.2
Cagrilintide 0.6 mg	-6.2
Cagrilintide 1.2 mg	-7.7
Cagrilintide 2.4 mg	-8.1
Cagrilintide 4.5 mg	-9.5
Liraglutide 3.0 mg	-7.4
Pooled Placebo	-3.4

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Change in Body Weight (Kg)

Change in body weight (Kg) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	Kilograms (kg) (Mean)
Cagrilintide 0.3 mg	-6.6
Cagrilintide 0.6 mg	-7.1
Cagrilintide 1.2 mg	-9.0
Cagrilintide 2.4 mg	-10.1
Cagrilintide 4.5 mg	-11.8
Liraglutide 3.0 mg	-9.1
Pooled Placebo	-3.2

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Change in Diastolic Blood Pressure (DBP)

Blood pressure was measured in a sitting position after 5 minutes of rest. The end point is evaluated while the subject is treatment-adherent. A participant is treatment adherent until the first time of non-adherence defined as: a) the participant has not been dosed with trial product within the prior 14 days; b) the participant has received other weight management drug or bariatric surgery c) the participant has not reached target dose at a pre-specified week d) After the pre-specified evaluation week for the target dose, the participant has not received the target dose +/- 10 % within the prior 14 days. This endpoint is applicable only for the cagrilintide treatment arms. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	millimeter of mercury (mmHg) (Mean)
Cagrilintide 0.3 mg	-2.2
Cagrilintide 0.6 mg	0.8
Cagrilintide 1.2 mg	-1.3
Cagrilintide 2.4 mg	-1.2
Cagrilintide 4.5 mg	-1.8
Pooled Placebo	-2.6

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Change in FPG (mg/dL)

Change in FPG (measured as milligrams per decilitre (mg/dL)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	mg/dL (Mean)
Cagrilintide 0.3 mg	-0.7
Cagrilintide 0.6 mg	-0.6
Cagrilintide 1.2 mg	-3.2
Cagrilintide 2.4 mg	0.0
Cagrilintide 4.5 mg	-3.7
Liraglutide 3.0 mg	-9.5
Pooled Placebo	-0.5

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Change in Glycosylated Haemoglobin (HbA1c) (%-Point)

Change in HbA1c (measured as percentage point of HbA1c) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	Percentage point of HbA1c (Mean)
Cagrilintide 0.3 mg	0.0
Cagrilintide 0.6 mg	-0.1
Cagrilintide 1.2 mg	-0.1
Cagrilintide 2.4 mg	-0.1
Cagrilintide 4.5 mg	-0.1
Liraglutide 3.0 mg	-0.3
Pooled Placebo	-0.1

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Change in HbA1c (mmol/Mol)

Change in HbA1c (measured as millimoles per mole (mmol/mol)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	mmol/mol (Mean)
Cagrilintide 0.3 mg	-0.5
Cagrilintide 0.6 mg	-0.6
Cagrilintide 1.2 mg	-0.8
Cagrilintide 2.4 mg	-1.0
Cagrilintide 4.5 mg	-1.2
Liraglutide 3.0 mg	-2.9
Pooled Placebo	-0.6

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Change in High Density Lipoprotein (HDL) Cholesterol

Change in HDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	mg/dL (Mean)
Cagrilintide 0.3 mg	1.5
Cagrilintide 0.6 mg	1.9
Cagrilintide 1.2 mg	1.1
Cagrilintide 2.4 mg	1.8
Cagrilintide 4.5 mg	2.6
Liraglutide 3.0 mg	0.8
Pooled Placebo	0.1

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Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks

Percentage of participants who achieved a weight loss ≥ 10% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model. (NCT03856047)
Timeframe: Week 26

Intervention	Percentage of participants (Number)
Cagrilintide 0.3 mg	15.28
Cagrilintide 0.6 mg	24.06
Cagrilintide 1.2 mg	35.79
Cagrilintide 2.4 mg	43.97
Cagrilintide 4.5 mg	53.49
Liraglutide 3.0 mg	39.43
Pooled Placebo	10.44

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Number of Treatment-emergent Serious Adverse Events (TESAEs)

An AE was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. Serious AE is an AE that resulted in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. All SAEs reported in the below table are TESAEs. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide. (NCT03856047)
Timeframe: From week 0 to week 32

Intervention	Events (Number)
Cagrilintide 0.3 mg	8
Cagrilintide 0.6 mg	3
Cagrilintide 1.2 mg	8
Cagrilintide 2.4 mg	6
Cagrilintide 4.5 mg	4
Liraglutide 3.0 mg	4
Pooled Placebo	4

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Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

Percentage change in HOMA-IR from week 0 to week 26 is presented. Insulin resistance is a condition in which cells fail to respond to normal actions of hormone in body. HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. HOMA-IR = fasting serum insulin (micro international units per milliliter (μU/ml)) × fasting plasma glucose (millimoles per liter (mmol/l)) / 22.5. HOMA-IR scores are classified as follows: less than 1.0: considered Insulin sensitive, 0.5-1.4: considered Healthy, Above 1.8: considered Early insulin resistance; Above 2.7 is considered significant insulin resistance. HOMA-IR score ranges from 0-infinity (no upper limit). Higher the score, higher the level of insulin resistance. Endpoint was evaluated based on data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	Percentage change of HOMA-IR (Mean)
Cagrilintide 0.3 mg	-0.05
Cagrilintide 0.6 mg	-0.60
Cagrilintide 1.2 mg	-1.09
Cagrilintide 2.4 mg	-0.72
Cagrilintide 4.5 mg	-2.12
Liraglutide 3.0 mg	-0.91
Pooled Placebo	-0.71

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Number of Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide. (NCT03856047)
Timeframe: From week 0 to week 32

Intervention	Events (Number)
Cagrilintide 0.3 mg	335
Cagrilintide 0.6 mg	291
Cagrilintide 1.2 mg	361
Cagrilintide 2.4 mg	449
Cagrilintide 4.5 mg	460
Liraglutide 3.0 mg	470
Pooled Placebo	276

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Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide

Number of participants with occurrence of anti-drug antibodies towards cagrilintide from randomisation from week 0 to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. This endpoint is applicable only for the cagrilintide treatment arms. (NCT03856047)
Timeframe: From week 0 to week 32

Intervention	Participants (Count of Participants)
Cagrilintide 0.3 mg	51
Cagrilintide 0.6 mg	54
Cagrilintide 1.2 mg	52
Cagrilintide 2.4 mg	75
Cagrilintide 4.5 mg	75

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Change in Very Low Density Lipoprotein (VLDL) Cholesterol

Change in VLDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	mg/dL (Mean)
Cagrilintide 0.3 mg	-2.8
Cagrilintide 0.6 mg	-3.4
Cagrilintide 1.2 mg	-3.6
Cagrilintide 2.4 mg	-3.8
Cagrilintide 4.5 mg	-5.4
Liraglutide 3.0 mg	-4.9
Pooled Placebo	0.9

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Change in Triglycerides

Change in triglycerides from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	mg/dL (Mean)
Cagrilintide 0.3 mg	-13.29
Cagrilintide 0.6 mg	-16.25
Cagrilintide 1.2 mg	-17.98
Cagrilintide 2.4 mg	-19.24
Cagrilintide 4.5 mg	-30.35
Liraglutide 3.0 mg	-25.42
Pooled Placebo	8.17

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Change in Total Cholesterol

Change in total cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	Milligrams per deciliter (mg/dL) (Mean)
Cagrilintide 0.3 mg	3.9
Cagrilintide 0.6 mg	-1.8
Cagrilintide 1.2 mg	-3.1
Cagrilintide 2.4 mg	-2.9
Cagrilintide 4.5 mg	-5.4
Liraglutide 3.0 mg	-9.4
Pooled Placebo	0.1

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Change in Systolic Blood Pressure (SBP)

Intervention	mmHg (Mean)
Cagrilintide 0.3 mg	-4.9
Cagrilintide 0.6 mg	-0.9
Cagrilintide 1.2 mg	-4.9
Cagrilintide 2.4 mg	-5.0
Cagrilintide 4.5 mg	-6.2
Pooled Placebo	-3.8

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Change in Renin Activity

Change in renin activity from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	nanograms per milliliter per hour (Mean)
Cagrilintide 0.3 mg	2
Cagrilintide 0.6 mg	0
Cagrilintide 1.2 mg	1
Cagrilintide 2.4 mg	1
Cagrilintide 4.5 mg	1
Liraglutide 3.0 mg	0
Pooled Placebo	0

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Change in Pulse

Change in pulse from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	beats per minute (Mean)
Cagrilintide 0.3 mg	-2.1
Cagrilintide 0.6 mg	-0.6
Cagrilintide 1.2 mg	-1.2
Cagrilintide 2.4 mg	-2.0
Cagrilintide 4.5 mg	-4.5
Liraglutide 3.0 mg	1.6
Pooled Placebo	-0.1

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Change in Low Density Lipoprotein (LDL) Cholesterol

Change in LDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	mg/dL (Mean)
Cagrilintide 0.3 mg	5.2
Cagrilintide 0.6 mg	-0.3
Cagrilintide 1.2 mg	-0.5
Cagrilintide 2.4 mg	-0.9
Cagrilintide 4.5 mg	-2.7
Liraglutide 3.0 mg	-5.4
Pooled Placebo	-1.0

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Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks

Percentage of participants who achieved a weight loss of greater than or equal to (≥) 5% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model. (NCT03856047)
Timeframe: Week 26

Intervention	Percentage of participants (Number)
Cagrilintide 0.3 mg	57.47
Cagrilintide 0.6 mg	61.98
Cagrilintide 1.2 mg	75.84
Cagrilintide 2.4 mg	74.12
Cagrilintide 4.5 mg	88.74
Liraglutide 3.0 mg	76.16
Pooled Placebo	30.90

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Change in Fasting Insulin

In the below table, fasting insulin data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

,,,,,,

Intervention	Picomoles per liter (pmol/L) (Mean)
	Week 0	Week 26
Cagrilintide 0.3 mg	103.88	93.07
Cagrilintide 0.6 mg	97.43	82.98
Cagrilintide 1.2 mg	96.44	79.39
Cagrilintide 2.4 mg	90.05	71.22
Cagrilintide 4.5 mg	109.99	78.67
Liraglutide 3.0 mg	95.80	79.00
Pooled Placebo	105.77	86.55

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Change in High Sensitivity C-reactive Protein (hsCRP)

In the below table, hsCRP data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

,,,,,,

Intervention	milligrams per liter (mg/L) (Mean)
	Week 0	Week 26
Cagrilintide 0.3 mg	4.5	3.5
Cagrilintide 0.6 mg	4.6	3.4
Cagrilintide 1.2 mg	4.5	4.6
Cagrilintide 2.4 mg	5.8	4.0
Cagrilintide 4.5 mg	5.4	3.4
Liraglutide 3.0 mg	4.7	3.5
Pooled Placebo	4.6	3.9

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Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta)

Change between the value of HOMA-beta cell function collected at Week 26 and HOMA-beta cell function collected at Week 0 is presented. The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 * insulin (micro international units per milliliter (µIU/mL)) / fasting plasma glucose (millimoles per liter (mmol/L)) - 3.5. HOMA-beta score ranges from minus infinity to infinity (no limits). The higher the score the better beta-cell function for HOMA-beta. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	Percentage of Beta Cell Function (Mean)
Cagrilintide 0.3 mg	-10.7
Cagrilintide 0.6 mg	-20.0
Cagrilintide 1.2 mg	-18.3
Cagrilintide 2.4 mg	-29.9
Cagrilintide 4.5 mg	-39.7
Liraglutide 3.0 mg	16.3
Pooled Placebo	-26.0

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Change in Fasting Plasma Glucose (FPG) (mmol/L)

Change in FPG (measured as mmol/L)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	mmol/L (Mean)
Cagrilintide 0.3 mg	0.0
Cagrilintide 0.6 mg	0.0
Cagrilintide 1.2 mg	-0.2
Cagrilintide 2.4 mg	0.0
Cagrilintide 4.5 mg	-0.2
Liraglutide 3.0 mg	-0.5
Pooled Placebo	0.0

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Change in Aldosterone

Change in aldosterone from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	nanograms per deciliter (ng/dL) (Mean)
Cagrilintide 0.3 mg	0.8
Cagrilintide 0.6 mg	0.8
Cagrilintide 1.2 mg	0.7
Cagrilintide 2.4 mg	2.2
Cagrilintide 4.5 mg	1.1
Liraglutide 3.0 mg	1.0
Pooled Placebo	0.5

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Change in Body Weight (%)

Change in body weight (%) from week 0 to week 26 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period and treatment adherent period, respectively. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. Treatment-adherent: a participant is treatment adherent until the first time of non-adherence defined as: participant has not been dosed with trial product within the prior 14 days; participant has received other weight management drug or bariatric surgery; participant has not reached target dose at a pre-specified week; After the pre-specified evaluation week for the target dose, the participant has not received the target dose ±10% within the prior 14 days. (NCT03856047)
Timeframe: From baseline (week 0) to week 26

Intervention	Percentage point of body weight (Mean)
Cagrilintide 0.3 mg	-6.1
Cagrilintide 0.6 mg	-6.9
Cagrilintide 1.2 mg	-8.5
Cagrilintide 2.4 mg	-9.5
Cagrilintide 4.5 mg	-10.8
Liraglutide 3.0 mg	-8.5
Pooled Placebo	-3.0

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Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline

Change from baseline (week 0) to week 68 in hs-CRP (measured in mg/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of hs-CRP (Geometric Mean)
Semaglutide 2.4 mg	0.46
Liraglutide 3.0 mg	0.73
Pooled Placebo	0.78

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Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol))

Change from baseline (week 0) to week 68 in HbA1c is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	mmol/mol (Mean)
Semaglutide 2.4 mg	-2.8
Liraglutide 3.0 mg	-1.0
Pooled Placebo	1.2

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Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%)

Change from baseline (week 0) to week 68 in HbA1c (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Percenatge of HbA1c (Mean)
Semaglutide 2.4 mg	-0.3
Liraglutide 3.0 mg	-0.1
Pooled Placebo	0.1

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Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline

Change from baseline (week 0) to week 68 in fasting serum insulin (measured in pmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of fasting serum insulin (Geometric Mean)
Semaglutide 2.4 mg	0.73
Liraglutide 3.0 mg	0.85
Pooled Placebo	0.98

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Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline

Change from baseline (week 0) to week 68 in fasting serum insulin (measured in mIU/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of fasting serum insulin (Geometric Mean)
Semaglutide 2.4 mg	0.73
Liraglutide 3.0 mg	0.85
Pooled Placebo	0.98

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Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L)

Change from baseline (week 0) to week 68 in fasting plasma glucose is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	mmol/L (Mean)
Semaglutide 2.4 mg	-0.5
Liraglutide 3.0 mg	-0.3
Pooled Placebo	0.1

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Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)

Number of participants who achieved >= 15% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved >= 15% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 15% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: From baseline (week 0) to week 68

Intervention	Participants (Count of Participants)
	Yes	No
Liraglutide 3.0 mg	14	103
Pooled Placebo	5	73
Semaglutide 2.4 mg	65	52

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Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D))

"Number of participants in glycaemic categories, normo-glycaemia, pre-diabetes and type 2 diabetes at baseline (week 0) and 68 are presented. These categories were set as per the following criteria: 1) Normo-glycaemia: fasting plasma glucose (FPG) less than (<) 5.6 mmol/L (<100 mg/dL) and/or glycated haemoglobin (HbA1c) <5.7%; 2) Pre-diabetes: FPG 5.6 - 6.9 mmol/L (both inclusive), FPG 100 - 125 mg/dL (both inclusive) or HbA1c 5.7 - 6.4% (both inclusive); 3) Type 2 diabetes: FPG greater than or equal to (>=) 7.0 mmol/L (>=126 mg/dL) and/or HbA1c >=6.5%. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site." (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Participants (Count of Participants)
	Baseline (week 0): normo-glycaemia	Baseline (week 0): pre-diabetes	Baseline (week 0): type 2 diabetes	Week 68: normo-glycaemia	Week 68: pre-diabetes	Week 68: type 2 diabetes
Liraglutide 3.0 mg	74	37	0	89	21	1
Pooled Placebo	47	30	0	38	36	3
Semaglutide 2.4 mg	72	38	0	104	5	1

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Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75

An adverse event (AE) was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All AEs mentioned here are TEAEs defined as AEs, with the onset of the event occurred in the on-treatment period. A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days. (NCT04074161)
Timeframe: From baseline (week 0) to week 75

Intervention	Events (Number)
Semaglutide 2.4 mg	904
Liraglutide 3.0 mg	823
Pooled Placebo	522

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Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)

Number of participants who achieved >= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved >= 10% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: From baseline (week 0) to week 68

Intervention	Participants (Count of Participants)
	Yes	No
Liraglutide 3.0 mg	30	87
Pooled Placebo	12	66
Semaglutide 2.4 mg	83	34

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Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in FFA (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of FFA (Geometric Mean)
Semaglutide 2.4 mg	0.90
Liraglutide 3.0 mg	0.87
Pooled Placebo	1.10

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Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in total cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of total cholesterol (Geometric Mean)
Semaglutide 2.4 mg	0.92
Liraglutide 3.0 mg	1.00
Pooled Placebo	0.99

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Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure

Change from baseline (week 0) to week 68 in diastolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	mmHg (Mean)
Semaglutide 2.4 mg	-5
Liraglutide 3.0 mg	-1
Pooled Placebo	1

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Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL)

Intervention	mg/dL (Mean)
Semaglutide 2.4 mg	-9.0
Liraglutide 3.0 mg	-4.9
Pooled Placebo	2.4

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Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)

Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Percentage of body weight (Mean)
Semaglutide 2.4 mg	-16.4
Liraglutide 3.0 mg	-6.4

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Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Pooled Placebo and Liraglutide 3.0 mg Versus Pooled Placebo)

Intervention	Percentage of body weight (Mean)
Semaglutide 2.4 mg	-16.4
Liraglutide 3.0 mg	-6.4
Pooled Placebo	-1.6

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Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))

Change from baseline (week 0) to week 68 in body weight is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	kilograms (Mean)
Semaglutide 2.4 mg	-15.8
Liraglutide 3.0 mg	-6.8
Pooled Placebo	-1.4

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Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)

Number of participants who achieved >= 20% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved >= 20% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 20% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: From baseline (week 0) to week 68

Intervention	Participants (Count of Participants)
	Yes	No
Liraglutide 3.0 mg	7	110
Pooled Placebo	2	76
Semaglutide 2.4 mg	45	72

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Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75

An AE was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as an AE that results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. SAEs occurred based on the on-treatment period is presented. A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days. (NCT04074161)
Timeframe: From baseline (week 0) to week 75

Intervention	Events (Number)
Semaglutide 2.4 mg	14
Liraglutide 3.0 mg	18
Pooled Placebo	9

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Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product

Number of participants who from baseline (week 0) to week 68 permanently discontinued randomized trial product are presented. (NCT04074161)
Timeframe: From baseline (week 0) to week 68

Intervention	Participants (Count of Participants)
Semaglutide 2.4 mg	17
Liraglutide 3.0 mg	35
Pooled Placebo	15

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Change From Baseline (Week 0) to Week 68 in Waist Circumference

Change from baseline (week 0) to week 68 in waist circumference is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	centimeters (cm) (Mean)
Semaglutide 2.4 mg	-13.6
Liraglutide 3.0 mg	-6.8
Pooled Placebo	-2.0

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Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure

Change from baseline (week 0) to week 68 in systolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	millimeters of mercury (mmHg) (Mean)
Semaglutide 2.4 mg	-7
Liraglutide 3.0 mg	-4
Pooled Placebo	5

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Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of VLDL cholesterol (Geometric Mean)
Semaglutide 2.4 mg	0.79
Liraglutide 3.0 mg	0.89
Pooled Placebo	0.97

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Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in FFA (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of FFA (Geometric Mean)
Semaglutide 2.4 mg	0.90
Liraglutide 3.0 mg	0.87
Pooled Placebo	1.10

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Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in triglycerides (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of triglycerides (Geometric Mean)
Semaglutide 2.4 mg	0.80
Liraglutide 3.0 mg	0.89
Pooled Placebo	0.98

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Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in triglycerides (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of triglycerides (Geometric Mean)
Semaglutide 2.4 mg	0.80
Liraglutide 3.0 mg	0.89
Pooled Placebo	0.98

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Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of total cholesterol (Geometric Mean)
Semaglutide 2.4 mg	0.92
Liraglutide 3.0 mg	1.00
Pooled Placebo	0.99

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Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of LDL cholesterol (Geometric Mean)
Semaglutide 2.4 mg	0.93
Liraglutide 3.0 mg	1.01
Pooled Placebo	0.99

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Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of LDL cholesterol (Geometric Mean)
Semaglutide 2.4 mg	0.93
Liraglutide 3.0 mg	1.01
Pooled Placebo	0.99

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Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of HDL cholesterol (Geometric Mean)
Semaglutide 2.4 mg	0.99
Liraglutide 3.0 mg	1.02
Pooled Placebo	0.99

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Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of HDL cholesterol (Geometric Mean)
Semaglutide 2.4 mg	0.99
Liraglutide 3.0 mg	1.02
Pooled Placebo	0.99

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Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline)

Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. (NCT04074161)
Timeframe: Baseline (week 0), week 68

Intervention	Ratio of VLDL cholesterol (Geometric Mean)
Semaglutide 2.4 mg	0.79
Liraglutide 3.0 mg	0.89
Pooled Placebo	0.97

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liraglutide

Cross-References

Synonyms (41)

Research Excerpts

Overview

Effects

Actions

Treatment

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Roles (2)

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Protein Targets (1)

Inhibition Measurements

Activation Measurements

Biological Processes (13)

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Bioassays (90)

Research

Studies (2,335)

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Research Demand Index: 85.82

Study Types

Clinical Trials (425)

Trial Overview

Trial Outcomes

Change in Fasting Plasma Glucose at Week 156

Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52

Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104

Hypoglycaemic Episodes

Hypoglycaemic Episodes

Change in Body Weight at Week 104

Change in Body Weight at Week 156

Change in Body Weight at Week 52

Change in Fasting Plasma Glucose at Week 104

Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52

Change in Fasting Plasma Glucose at Week 52

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156

Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104

Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156

Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52

Change in Glycosylated A1c (HbA1c) at Week 104

Change in Glycosylated A1c (HbA1c) at Week 26

Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26

Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104

Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104

Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26

Hypoglycaemic Episodes at Week 104

Hypoglycaemic Episodes at Week 26

Change in Fasting Plasma Glucose (FPG) at Week 26

Change in Beta-cell Function at Week 104

Change in Beta-cell Function at Week 26

Change in Body Weight at Week 104

Change in Body Weight at Week 26

Change in Fasting Plasma Glucose (FPG) at Week 104

Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment

Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

Postprandial Glucose AUC After 24 Weeks of Treatment

Postprandial Glucose AUC After 52 Weeks of Treatment

Fasting Plasma Glucose After 52 Weeks of Treatment

Body Weight After 52 Weeks of Treatment

Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment

Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

Fasting Plasma Glucose After 24 Weeks of Treatment

Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

Hypoglycaemic Episodes

Body Weight After 24 Weeks of Treatment

Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

Hypoglycaemic Episodes

Postprandial Glucose AUC After 52 Weeks of Treatment

Postprandial Glucose AUC After 24 Weeks of Treatment

Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment