metformin has been researched along with Nausea in 41 studies
Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1.
Nausea: An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.
Excerpt | Relevance | Reference |
---|---|---|
"Treatment with Metformin XR in participants admitted with stroke and with pre-diabetes is feasible and safe." | 9.41 | Feasibility trial of metformin XR in people with pre-diabetes and stroke (MIPPS)-randomised open blinded endpoint controlled trial. ( Borschmann, K; Churilov, L; Donnan, G; Ekinci, EI; Hachem, M; Lau, LH; Price, SAL; Sumithran, P; Tabesh, M; Thijs, V; Zajac, J, 2021) |
"Exenatide is an analogue of GLP1 designed to improve the glycemic control in patients with obesity and type 2 diabetes." | 9.16 | [Metabolic control and weight loss in patients with obesity and type 2 diabetes mellitus, treated with exenatide]. ( Ferrer Gómez, M; García Zafra, MV; Hellín Gil, MD; Pujante Alarcón, P; Román, LM; Tébar Massó, J, 2012) |
" Pioglitazone treatment (n = 10) reduced hepatic fat as assessed by magnetic resonance spectroscopy, despite a significant increase in body weight (Δ = 3." | 9.15 | Exenatide decreases hepatic fibroblast growth factor 21 resistance in non-alcoholic fatty liver disease in a mouse model of obesity and in a randomised controlled trial. ( Bajaj, M; Chan, L; Gonzalez, EV; Gutierrez, A; Jogi, M; Krishnamurthy, R; Muthupillai, R; Samson, SL; Sathyanarayana, P, 2011) |
"BACKGROUND Metformin-associated lactic acidosis (MALA) is a relatively rare adverse effect of metformin therapy." | 8.12 | Transient Complete Blindness Due to Metformin-Associated Lactic Acidosis (MALA) Reversed with Hemodialysis. ( Barusya, C; Charokopos, A; Dumic, I; Knopps, L; Rueda Prada, L; Subramanian, A; Zurob, AS, 2022) |
"Lactic acidosis is a rare, serious adverse effect of metformin, which can be prevented by carefully observing the contra-indications." | 6.41 | [Metformin efficacious in poorly controlled diabetes mellitus type 2]. ( Hoekstra, JB; Holleman, F; Stades, AM, 2000) |
"Treatment with Metformin XR in participants admitted with stroke and with pre-diabetes is feasible and safe." | 5.41 | Feasibility trial of metformin XR in people with pre-diabetes and stroke (MIPPS)-randomised open blinded endpoint controlled trial. ( Borschmann, K; Churilov, L; Donnan, G; Ekinci, EI; Hachem, M; Lau, LH; Price, SAL; Sumithran, P; Tabesh, M; Thijs, V; Zajac, J, 2021) |
"Compared with glimepiride, Sita/Met as an initial treatment led to significantly greater improvements in glycemic control and body weight changes, with a lower incidence of hypoglycemia, over 30 weeks." | 5.24 | Efficacy and safety of sitagliptin/metformin fixed-dose combination compared with glimepiride in patients with type 2 diabetes: A multicenter randomized double-blind study. ( Chung, SC; Kim, IJ; Kim, SS; Kim, YI; Lee, KJ; Lee, SJ; Lee, YS; Park, JH, 2017) |
" In these studies, metformin use was associated with higher risk of abdominal pain, diarrhea and nausea comparing to control." | 5.22 | Gastrointestinal adverse events of metformin treatment in patients with type 2 diabetes mellitus: A systematic review, meta-analysis and meta-regression of randomized controlled trials. ( Gumprecht, J; Hendel, M; Irlik, K; Januszkiewicz, K; Kwiendacz, H; Lip, GYH; Nabrdalik, K; Skonieczna-Żydecka, K; Łoniewski, I, 2022) |
"There is low-certainty evidence to suggest that metformin may be effective in preventing weight gain." | 5.22 | Pharmacological interventions for prevention of weight gain in people with schizophrenia. ( Agarwal, SM; Ahsan, ZA; Cohn, T; Duncan, MJ; Faulkner, GEJ; Hahn, M; Lockwood, JT; Remington, G; Stogios, N; Takeuchi, H; Taylor, VH, 2022) |
"Liraglutide provided better glycaemic control and greater body weight reduction than sitagliptin when administered as add-on to metformin." | 5.22 | Efficacy and safety of liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: a 26-week, open-label, randomized, active comparator clinical trial. ( Bian, F; Bosch-Traberg, H; Geng, J; Li, Y; Liu, J; Liu, Y; Luo, Y; Lv, X; Mu, Y; Peng, Y; Sun, Y; Yang, J; Zang, L, 2016) |
"Subjects insufficiently controlled with sitagliptin who switch to liraglutide can obtain clinically relevant reductions in glycaemia and body weight, without compromising safety." | 5.22 | Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH): a randomized, double-blind, double-dummy, active-controlled 26-week trial. ( Bailey, TS; Kaltoft, MS; Maislos, M; Rao, PV; Takács, R; Thomsen, AB; Tinahones, FJ; Tsoukas, GM, 2016) |
"Metformin administration reduced occurrence of chemotherapy induced-nausea." | 5.20 | Metformin Addition to Chemotherapy in Stage IV Non-Small Cell Lung Cancer: an Open Label Randomized Controlled Study. ( Badary, O; El Wakeel, L; Elkholy, E; Saad, AS; Sayed, R, 2015) |
"Exenatide is an analogue of GLP1 designed to improve the glycemic control in patients with obesity and type 2 diabetes." | 5.16 | [Metabolic control and weight loss in patients with obesity and type 2 diabetes mellitus, treated with exenatide]. ( Ferrer Gómez, M; García Zafra, MV; Hellín Gil, MD; Pujante Alarcón, P; Román, LM; Tébar Massó, J, 2012) |
"Exenatide demonstrated more beneficial effects on HbA(1C), weight reduction and insulin resistance during 26 weeks of treatment, but there were more hypoglycemic events and mild-to-moderate nausea compared with metformin." | 5.16 | Efficacy and tolerability of exenatide monotherapy in obese patients with newly diagnosed type 2 diabetes: a randomized, 26 weeks metformin-controlled, parallel-group study. ( Gao, Y; Guo, XH; Huang, YY; Song, WL; Yuan, GH, 2012) |
" Pioglitazone treatment (n = 10) reduced hepatic fat as assessed by magnetic resonance spectroscopy, despite a significant increase in body weight (Δ = 3." | 5.15 | Exenatide decreases hepatic fibroblast growth factor 21 resistance in non-alcoholic fatty liver disease in a mouse model of obesity and in a randomised controlled trial. ( Bajaj, M; Chan, L; Gonzalez, EV; Gutierrez, A; Jogi, M; Krishnamurthy, R; Muthupillai, R; Samson, SL; Sathyanarayana, P, 2011) |
" We performed a systematic analysis and compared the proportion of patients reporting nausea, vomiting or diarrhoea, for different doses and glucose-lowering background medications, and relative to a reference compound within the subclasses of short- (exenatide b." | 4.95 | 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) |
"7% as monotherapy or in combination with metformin (MET), sulfonylureas (SFU), and/or thiazolidinediones (TZD); with mean weight losses of -1." | 4.89 | Evolution of exenatide as a diabetes therapeutic. ( Bhavsar, S; Cherrington, A; Mudaliar, S, 2013) |
"BACKGROUND Metformin-associated lactic acidosis (MALA) is a relatively rare adverse effect of metformin therapy." | 4.12 | Transient Complete Blindness Due to Metformin-Associated Lactic Acidosis (MALA) Reversed with Hemodialysis. ( Barusya, C; Charokopos, A; Dumic, I; Knopps, L; Rueda Prada, L; Subramanian, A; Zurob, AS, 2022) |
" People who received PEX168 alone or with metformin showed more common gastrointestinal adverse effects, especially nausea and vomiting (p < 0." | 3.01 | Efficacy and safety of polyethylene glycol loxenatide in type 2 diabetic patients: a systematic review and meta-analysis of randomized controlled trials. ( Abd-Elgawad, M; Abdelhaleem, IA; Abo-Elnour, DE; Abualkhair, KA; Elsayed, E; Hasan, MT; Mahmoud, A; Marey, A; Salamah, HM, 2023) |
"In patients with type 2 diabetes, tirzepatide was noninferior and superior to semaglutide with respect to the mean change in the glycated hemoglobin level from baseline to 40 weeks." | 3.01 | Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. ( Bergman, BK; Brown, K; Cui, X; Davies, MJ; Fernández Landó, L; Frías, JP; Liu, B; Pérez Manghi, FC; Rosenstock, J, 2021) |
"Nondiabetic patients with LAHNSCC were enrolled in the current study to receive escalating doses of metformin and CRT based on the modified toxicity probability interval design." | 2.94 | Phase 1 dose-finding study of metformin in combination with concurrent cisplatin and radiotherapy in patients with locally advanced head and neck squamous cell cancer. ( Desai, J; Desai, PB; Gulati, S; Gutkind, JS; Jandarov, R; Mierzwa, M; Molinolo, A; Morris, JC; Palackdharry, SM; Riaz, MK; Sadraei, NH; Takiar, V; Wise-Draper, TM; Zhu, Z, 2020) |
" The most frequent adverse reactions in the PEX168 groups were mild to moderate dose-dependent gastrointestinal reactions." | 2.84 | Polyethylene glycol loxenatide injections added to metformin effectively improve glycemic control and exhibit favorable safety in type 2 diabetic patients. ( Chen, X; Cheng, Q; Jiang, H; Li, X; Li, Y; Lu, D; Lv, X; Peng, Y; Piao, C; Sun, L; Xiao, X; Xie, Y; Yang, G; Yang, J; Yang, W; Zhang, X; Zheng, S, 2017) |
"In Asian patients with type 2 diabetes mellitus insufficiently controlled on metformin ± sulfonylurea, lixisenatide significantly improved glycaemic control and was well tolerated during the 24-week study." | 2.79 | Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia). ( Feng, P; Han, P; Jin Kui, Y; Liu, X; Lv, X; Niemoeller, E; Shang, S; Su, B; Tian, H; Yan, S; Yu Pan, C; Zhou, Z, 2014) |
" Subjects were monitored for adverse events (AEs) throughout the study and 4-week follow-up." | 2.75 | Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. ( Asnaghi, V; Balena, R; Boldrin, M; Kapitza, C; Nauck, M; Ratner, R, 2010) |
"Exenatide added to TZDs alone or in combination with metformin significantly improved glycaemic control as determined by significant improvement in HbA(1c) without associated hypoglycaemia." | 2.75 | A placebo-controlled trial of exenatide twice-daily added to thiazolidinediones alone or in combination with metformin. ( Cao, D; Liutkus, J; Northrup, J; Norwood, P; Pop, L; Rosas Guzman, J; Trautmann, M, 2010) |
"Metformin XR was well tolerated; gastrointestinal side effects were more common with metformin XR vs." | 2.71 | Efficacy, dose-response relationship and safety of once-daily extended-release metformin (Glucophage XR) in type 2 diabetic patients with inadequate glycaemic control despite prior treatment with diet and exercise: results from two double-blind, placebo-c ( Brazg, RL; Bruce, S; Fujioka, K; Joyal, S; Pans, M; Raz, I; Swanink, R, 2005) |
" The daily dosage of phenformin and metformin was increased at weekly intervals up to 300 mg." | 2.63 | Weight-reducing effect of diguanides in obese non-diabetic women. ( Duncan, LJ; MacCuish, AC; Marshall, A; Munro, JF; Wilson, EM, 1969) |
"Lactic acidosis is a rare, serious adverse effect of metformin, which can be prevented by carefully observing the contra-indications." | 2.41 | [Metformin efficacious in poorly controlled diabetes mellitus type 2]. ( Hoekstra, JB; Holleman, F; Stades, AM, 2000) |
"No significant difference in the other treatment groups." | 1.48 | Are we missing hypoglycaemia? Elderly patients with insulin-treated diabetes present to primary care frequently with non-specific symptoms associated with hypoglycaemia. ( Hamilton, W; Hattersley, AT; Hope, SV; Shields, BM; Taylor, PJ, 2018) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 2 (4.88) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 5 (12.20) | 29.6817 |
2010's | 24 (58.54) | 24.3611 |
2020's | 10 (24.39) | 2.80 |
Authors | Studies |
---|---|
Mehrpour, O | 1 |
Saeedi, F | 1 |
Hoyte, C | 1 |
Hadianfar, A | 1 |
Nakhaee, S | 1 |
Brent, J | 1 |
Rueda Prada, L | 1 |
Knopps, L | 1 |
Dumic, I | 1 |
Barusya, C | 1 |
Subramanian, A | 1 |
Charokopos, A | 1 |
Zurob, AS | 1 |
Nabrdalik, K | 1 |
Skonieczna-Żydecka, K | 1 |
Irlik, K | 1 |
Hendel, M | 1 |
Kwiendacz, H | 1 |
Łoniewski, I | 1 |
Januszkiewicz, K | 1 |
Gumprecht, J | 1 |
Lip, GYH | 1 |
Agarwal, SM | 1 |
Stogios, N | 1 |
Ahsan, ZA | 1 |
Lockwood, JT | 1 |
Duncan, MJ | 1 |
Takeuchi, H | 1 |
Cohn, T | 1 |
Taylor, VH | 1 |
Remington, G | 1 |
Faulkner, GEJ | 1 |
Hahn, M | 1 |
Salamah, HM | 1 |
Marey, A | 1 |
Elsayed, E | 1 |
Hasan, MT | 1 |
Mahmoud, A | 1 |
Abualkhair, KA | 1 |
Abo-Elnour, DE | 1 |
Abdelhaleem, IA | 1 |
Abd-Elgawad, M | 1 |
Zinman, B | 2 |
Aroda, VR | 1 |
Buse, JB | 1 |
Cariou, B | 1 |
Harris, SB | 1 |
Hoff, ST | 1 |
Pedersen, KB | 1 |
Tarp-Johansen, MJ | 1 |
Araki, E | 1 |
Gulati, S | 1 |
Desai, J | 1 |
Palackdharry, SM | 1 |
Morris, JC | 1 |
Zhu, Z | 1 |
Jandarov, R | 1 |
Riaz, MK | 1 |
Takiar, V | 1 |
Mierzwa, M | 1 |
Gutkind, JS | 1 |
Molinolo, A | 1 |
Desai, PB | 1 |
Sadraei, NH | 1 |
Wise-Draper, TM | 1 |
Patoulias, D | 1 |
Katsimardou, A | 1 |
Kalogirou, MS | 1 |
Zografou, I | 1 |
Toumpourleka, M | 1 |
Imprialos, K | 1 |
Stavropoulos, K | 1 |
Stergiou, I | 1 |
Papadopoulos, C | 1 |
Doumas, M | 1 |
Tabesh, M | 1 |
Hachem, M | 1 |
Lau, LH | 1 |
Borschmann, K | 1 |
Churilov, L | 1 |
Price, SAL | 1 |
Sumithran, P | 1 |
Donnan, G | 1 |
Zajac, J | 1 |
Thijs, V | 1 |
Ekinci, EI | 1 |
Yeku, OO | 1 |
Medford, AJ | 1 |
Fenves, AZ | 1 |
Uljon, SN | 1 |
Frías, JP | 1 |
Davies, MJ | 1 |
Rosenstock, J | 1 |
Pérez Manghi, FC | 1 |
Fernández Landó, L | 1 |
Bergman, BK | 1 |
Liu, B | 1 |
Cui, X | 1 |
Brown, K | 1 |
Hope, SV | 1 |
Taylor, PJ | 1 |
Shields, BM | 1 |
Hattersley, AT | 1 |
Hamilton, W | 1 |
Wysham, C | 1 |
Grimm, M | 1 |
Chen, S | 1 |
Matyjaszek-Matuszek, B | 1 |
Lenart-Lipińska, M | 1 |
Rogalska, D | 1 |
Nowakowski, A | 1 |
Yu Pan, C | 1 |
Han, P | 1 |
Liu, X | 1 |
Yan, S | 1 |
Feng, P | 1 |
Zhou, Z | 1 |
Lv, X | 3 |
Tian, H | 1 |
Jin Kui, Y | 1 |
Su, B | 1 |
Shang, S | 1 |
Niemoeller, E | 1 |
Sayed, R | 1 |
Saad, AS | 1 |
El Wakeel, L | 1 |
Elkholy, E | 1 |
Badary, O | 1 |
Chen, X | 1 |
Yang, G | 1 |
Lu, D | 1 |
Piao, C | 1 |
Zhang, X | 1 |
Jiang, H | 1 |
Xie, Y | 1 |
Yang, J | 2 |
Li, X | 1 |
Li, Y | 3 |
Xiao, X | 1 |
Sun, L | 1 |
Zheng, S | 1 |
Cheng, Q | 1 |
Peng, Y | 2 |
Yang, W | 1 |
Zang, L | 1 |
Liu, Y | 1 |
Geng, J | 1 |
Luo, Y | 1 |
Bian, F | 1 |
Liu, J | 1 |
Sun, Y | 1 |
Bosch-Traberg, H | 1 |
Mu, Y | 1 |
Kim, SS | 1 |
Kim, IJ | 1 |
Lee, KJ | 1 |
Park, JH | 1 |
Kim, YI | 1 |
Lee, YS | 1 |
Chung, SC | 1 |
Lee, SJ | 1 |
Bailey, TS | 1 |
Takács, R | 1 |
Tinahones, FJ | 1 |
Rao, PV | 1 |
Tsoukas, GM | 1 |
Thomsen, AB | 2 |
Kaltoft, MS | 1 |
Maislos, M | 1 |
Broglio, F | 1 |
Mannucci, E | 1 |
Napoli, R | 1 |
Nicolucci, A | 1 |
Purrello, F | 1 |
Nikonova, E | 1 |
Stager, W | 1 |
Trevisan, R | 1 |
Bettge, K | 1 |
Kahle, M | 1 |
Abd El Aziz, MS | 1 |
Meier, JJ | 1 |
Nauck, MA | 2 |
Pelletier, AL | 1 |
Butler, AM | 1 |
Gillies, RA | 1 |
May, JR | 1 |
Ratner, R | 1 |
Nauck, M | 1 |
Kapitza, C | 1 |
Asnaghi, V | 1 |
Boldrin, M | 2 |
Balena, R | 2 |
Liutkus, J | 1 |
Rosas Guzman, J | 1 |
Norwood, P | 1 |
Pop, L | 1 |
Northrup, J | 1 |
Cao, D | 1 |
Trautmann, M | 1 |
Li, XJ | 1 |
Yu, YX | 1 |
Liu, CQ | 1 |
Zhang, W | 1 |
Zhang, HJ | 1 |
Yan, B | 1 |
Wang, LY | 1 |
Yang, SY | 1 |
Zhang, SH | 1 |
Samson, SL | 1 |
Sathyanarayana, P | 1 |
Jogi, M | 1 |
Gonzalez, EV | 1 |
Gutierrez, A | 1 |
Krishnamurthy, R | 1 |
Muthupillai, R | 1 |
Chan, L | 1 |
Bajaj, M | 1 |
Pujante Alarcón, P | 1 |
Hellín Gil, MD | 1 |
Román, LM | 1 |
Ferrer Gómez, M | 1 |
García Zafra, MV | 1 |
Tébar Massó, J | 1 |
Gough, SC | 1 |
Pratley, RE | 2 |
Bailey, T | 1 |
Montanya, E | 1 |
Filetti, S | 1 |
Garber, AJ | 1 |
Furber, S | 1 |
Davies, M | 1 |
Yuan, GH | 1 |
Song, WL | 1 |
Huang, YY | 1 |
Guo, XH | 1 |
Gao, Y | 1 |
Flaherty, AM | 1 |
Urosevic, D | 1 |
Bhavsar, S | 1 |
Mudaliar, S | 1 |
Cherrington, A | 1 |
Hollander, P | 1 |
Maggs, DG | 1 |
Ruggles, JA | 1 |
Fineman, M | 1 |
Shen, L | 1 |
Kolterman, OG | 1 |
Weyer, C | 1 |
Fujioka, K | 1 |
Brazg, RL | 1 |
Raz, I | 1 |
Bruce, S | 1 |
Joyal, S | 1 |
Swanink, R | 1 |
Pans, M | 1 |
Hoogwerf, BJ | 1 |
Durán García, S | 1 |
Milton, DR | 1 |
Giaconia, JM | 1 |
Kim, DD | 1 |
Trautmann, ME | 1 |
Brodows, RG | 1 |
Stades, AM | 1 |
Holleman, F | 1 |
Hoekstra, JB | 1 |
Munro, JF | 1 |
MacCuish, AC | 1 |
Marshall, A | 1 |
Wilson, EM | 1 |
Duncan, LJ | 1 |
Heikinheimo, R | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Comparison of Bupropion SR and Placebo for Smoking Cessation[NCT00176449] | Phase 4 | 52 participants (Actual) | Interventional | 2001-04-30 | Completed | ||
Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)[NCT03021187] | Phase 3 | 731 participants (Actual) | Interventional | 2017-02-02 | Completed | ||
A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes[NCT03987919] | Phase 3 | 1,879 participants (Actual) | Interventional | 2019-07-30 | Completed | ||
Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (With or Without Sulfonylurea): a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With 24-week Treatment P[NCT01169779] | Phase 3 | 391 participants (Actual) | Interventional | 2010-07-31 | 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 | ||
A Multicenter, Randomized, Double Blind Study to Compare the Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (Janumet®) Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus[NCT00993187] | Phase 4 | 292 participants (Actual) | Interventional | 2010-05-04 | 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 Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.[NCT00460941] | Phase 2 | 133 participants (Actual) | Interventional | 2007-04-30 | Completed | ||
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin[NCT00603239] | Phase 3 | 165 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
Effect of Exenatide Treatment on Hepatic Fat Content and Plasma Adipocytokine Levels in Patients With Type 2 Diabetes Mellitus[NCT01432405] | Phase 4 | 24 participants (Actual) | Interventional | 2007-06-30 | 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 | ||
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin[NCT00099320] | Phase 3 | 182 participants (Actual) | Interventional | 2004-05-31 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Change from baseline (week 0) in body weight to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 52
Intervention | Kg (Mean) |
---|---|
Oral Semaglutide 3 mg | -0.9 |
Oral Semaglutide 7 mg | -2.2 |
Oral Semaglutide 14 mg | -3.8 |
Placebo | 0.5 |
Change from baseline (week 0) in HbA1c to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 52
Intervention | Percentage of HbA1c (Mean) |
---|---|
Oral Semaglutide 3 mg | -0.6 |
Oral Semaglutide 7 mg | -0.9 |
Oral Semaglutide 14 mg | -1.2 |
Placebo | -0.2 |
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 was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT03021187)
Timeframe: Weeks 0-57
Intervention | Events (Number) |
---|---|
Oral Semaglutide 3 mg | 626 |
Oral Semaglutide 7 mg | 555 |
Oral Semaglutide 14 mg | 586 |
Placebo | 464 |
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during 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. (NCT03021187)
Timeframe: Weeks 0-57
Intervention | Episodes (Number) |
---|---|
Oral Semaglutide 3 mg | 196 |
Oral Semaglutide 7 mg | 180 |
Oral Semaglutide 14 mg | 147 |
Placebo | 156 |
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during 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. (NCT03021187)
Timeframe: Weeks 0-57
Intervention | Participants (Count of Participants) |
---|---|
Oral Semaglutide 3 mg | 52 |
Oral Semaglutide 7 mg | 47 |
Oral Semaglutide 14 mg | 48 |
Placebo | 54 |
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. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | Ratio of amylase (Geometric Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | 1.14 | 1.17 |
Oral Semaglutide 3 mg | 1.08 | 1.07 |
Oral Semaglutide 7 mg | 1.12 | 1.11 |
Placebo | 1.01 | 0.99 |
Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. BMI was calculated based on body weight and height based on the formula: BMI kg/m^2 = body weight (kg)/(Height (m) x Height (m)). Data based on in-trial observation period is presented. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | kg/m^2 (Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | -1.4 | -1.4 |
Oral Semaglutide 3 mg | -0.5 | -0.3 |
Oral Semaglutide 7 mg | -1.0 | -0.8 |
Placebo | -0.2 | 0.2 |
Relative change from baseline (week 0) in body weight (%) was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | Percentage change (Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | -4.30 | -4.42 |
Oral Semaglutide 3 mg | -1.73 | -1.18 |
Oral Semaglutide 7 mg | -3.11 | -2.54 |
Placebo | -0.47 | 0.65 |
Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also evaluated based on data from the on-treatment without rescue medication observation period. It started at the date of first dose of trial product and excluded the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26
Intervention | Kg (Mean) | |
---|---|---|
In trial | On-treatment without rescue medication | |
Oral Semaglutide 14 mg | -3.7 | -3.9 |
Oral Semaglutide 3 mg | -1.4 | -1.5 |
Oral Semaglutide 7 mg | -2.6 | -3.0 |
Placebo | -0.5 | -0.5 |
"Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 and week 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." (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | Score 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 understading of diabetes: wk 26 | Satisfaction with understading 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 treatmemt satisfaction: wk 52 | |
Oral Semaglutide 14 mg | 0.63 | 0.78 | -1.29 | -1.34 | 0.13 | -0.06 | 0.50 | 0.44 | 0.40 | 0.46 | 0.27 | 0.34 | 0.53 | 0.65 | 0.58 | 0.65 | 2.90 | 3.32 |
Oral Semaglutide 3 mg | 0.47 | 0.53 | -0.62 | -0.70 | 0.07 | 0.04 | 0.51 | 0.38 | 0.31 | 0.25 | 0.24 | 0.25 | 0.20 | 0.32 | 0.40 | 0.41 | 2.12 | 2.14 |
Oral Semaglutide 7 mg | 0.59 | 0.51 | -1.23 | -1.15 | -0.06 | -0.10 | 0.50 | 0.52 | 0.37 | 0.42 | 0.31 | 0.35 | 0.66 | 0.63 | 0.57 | 0.56 | 3.00 | 2.99 |
Placebo | 0.18 | 0.20 | -0.28 | -0.41 | -0.15 | -0.02 | 0.20 | 0.19 | 0.23 | 0.23 | 0.04 | 0.03 | 0.02 | -0.01 | 0.09 | 0.03 | 0.76 | 0.67 |
Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal; abnormal and not clinically significant (NCS); abnormal and clinically significant (CS)) from week 0 to week 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. (NCT03021187)
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 to Normal (Week 52) | Abnormal NCS to Abnormal NCS (Week 52) | Abnormal NCS to Abnormal CS (Week 52) | Abnormal CS to Normal (Week 52) | Abnormal CS to Abnormal NCS (Week 52) | Abnormal CS to Abnormal CS (Week 52) | |
Oral Semaglutide 14 mg | 90 | 17 | 0 | 16 | 47 | 0 | 1 | 1 | 1 | 85 | 20 | 1 | 19 | 42 | 0 | 0 | 2 | 1 |
Oral Semaglutide 3 mg | 101 | 10 | 0 | 22 | 44 | 0 | 0 | 0 | 0 | 95 | 14 | 2 | 13 | 50 | 0 | 0 | 0 | 0 |
Oral Semaglutide 7 mg | 98 | 12 | 0 | 17 | 42 | 0 | 0 | 0 | 4 | 91 | 15 | 2 | 17 | 40 | 1 | 0 | 0 | 4 |
Placebo | 93 | 12 | 0 | 19 | 51 | 0 | 1 | 0 | 1 | 84 | 17 | 1 | 21 | 47 | 1 | 0 | 1 | 1 |
Change from baseline (week 0) in FPG to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | mmol/L (Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | -1.36 | -1.60 |
Oral Semaglutide 3 mg | -0.45 | -0.81 |
Oral Semaglutide 7 mg | -1.14 | -1.12 |
Placebo | 0.51 | -0.09 |
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period started at the date of the first dose of trial product and includes the period after initiation of rescue medication, if any, and excludes the period after premature trial discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26
Intervention | Percentage of HbA1c (Mean) | |
---|---|---|
In-trial | On-treatment without rescue medication | |
Oral Semaglutide 14 mg | -1.3 | -1.4 |
Oral Semaglutide 3 mg | -0.5 | -0.6 |
Oral Semaglutide 7 mg | -1.0 | -1.1 |
Placebo | -0.1 | -0.1 |
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. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | Ratio of HDL cholesterol (Geometric Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | 0.98 | 1.01 |
Oral Semaglutide 3 mg | 1.00 | 1.01 |
Oral Semaglutide 7 mg | 0.98 | 0.98 |
Placebo | 1.01 | 1.00 |
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | Score on a scale (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
1) Psychosocial (Week 26) | 1) Psychosocial (Week 52) | 2) Physical (Week 26) | 2) Physical (Week 52) | 3) Physical function(Week 26) | 3) Physical function(Week 52) | 4) Pain/discomfort (Week 26) | 4) Pain/discomfort (Week 52) | 5) IWQOL-Lite-CT Total (Week 26) | 5) IWQOL-Lite-CT Total (Week 52) | |
Oral Semaglutide 14 mg | 4.10 | 5.35 | 2.15 | 2.50 | 2.51 | 2.59 | 1.23 | 2.28 | 3.41 | 4.35 |
Oral Semaglutide 3 mg | 1.45 | 1.96 | 2.29 | 3.10 | 1.88 | 3.45 | 3.30 | 2.23 | 1.74 | 2.35 |
Oral Semaglutide 7 mg | -0.32 | -0.92 | -0.66 | -0.53 | -0.35 | -0.59 | -1.45 | -0.37 | -0.45 | -0.79 |
Placebo | -0.49 | -0.46 | -1.75 | -1.24 | -1.70 | -0.98 | -1.85 | -1.88 | -0.94 | -0.73 |
Change from baseline in LDL cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | Ratio of LDL cholesterol (Geometric Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | 0.93 | 0.95 |
Oral Semaglutide 3 mg | 0.98 | 0.97 |
Oral Semaglutide 7 mg | 0.93 | 0.96 |
Placebo | 1.03 | 1.00 |
Change from baseline (week 0) in lipase (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 (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | Ratio of lipase (Geometric Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | 1.35 | 1.35 |
Oral Semaglutide 3 mg | 1.14 | 1.09 |
Oral Semaglutide 7 mg | 1.34 | 1.25 |
Placebo | 0.99 | 0.99 |
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. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | Beats/minute (Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | 3 | 2 |
Oral Semaglutide 3 mg | 1 | -0 |
Oral Semaglutide 7 mg | 2 | 1 |
Placebo | -0 | 0 |
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. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | mmHg (Mean) | |||
---|---|---|---|---|
SBP: Week 26 | SBP: Week 52 | DBP: Week 26 | DBP: Week 52 | |
Oral Semaglutide 14 mg | -5 | -6 | -1 | -2 |
Oral Semaglutide 3 mg | -1 | -1 | -0 | -1 |
Oral Semaglutide 7 mg | -3 | -3 | -1 | -2 |
Placebo | 1 | 0 | 0 | -0 |
Change from baseline (week 0) in self-measured plasma glucose (SMPG) mean 7-point profile to week 26 and week 52. 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. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | mmol/L (Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | -2.0 | -2.0 |
Oral Semaglutide 3 mg | -1.2 | -1.6 |
Oral Semaglutide 7 mg | -1.8 | -1.7 |
Placebo | -0.3 | -0.9 |
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 weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | Score on a scale (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1) Physical functioning (Week 26) | 1) Physical functioning (Week 52) | 2) Role Physical (Week 26) | 2) Role Physical (Week 52) | 3) Bodily Pain (Week 26) | 3) Bodily Pain (Week 52) | 4) General Health (Week 26) | 4) General Health (Week 52) | 5) Vitality (Week 26) | 5) Vitality (Week 52) | 6) Social functioning (Week 26) | 6) Social functioning (Week 52) | 7) Role emotional (Week 26) | 7) Role emotional (Week 52) | 8) Mental health (Week 26) | 8) Mental health (Week 52) | 9) Physical component summary (Week 26) | 9) Physical component summary (Week 52) | 10) Mental component summary (Week 26) | 10) Mental component summary (Week 52) | |
Oral Semaglutide 14 mg | -0.07 | -0.32 | 0.04 | -0.87 | -0.18 | -0.21 | 1.26 | 1.38 | 0.14 | 0.70 | -0.51 | 0.03 | 0.24 | 0.09 | 0.99 | 0.89 | -0.02 | -0.36 | 0.49 | 0.82 |
Oral Semaglutide 3 mg | 0.53 | 0.51 | -0.32 | 0.00 | -0.02 | -0.40 | 1.43 | 0.92 | -0.56 | -0.53 | -0.31 | 0.11 | -0.94 | 0.77 | -1.41 | -0.48 | 0.94 | 0.26 | -1.41 | -0.09 |
Oral Semaglutide 7 mg | 0.52 | -0.40 | -0.43 | -0.76 | 1.47 | 0.56 | 0.70 | 0.75 | -1.27 | -1.43 | 0.34 | -0.61 | 0.62 | -0.34 | -0.82 | -0.74 | 0.75 | 0.12 | -0.55 | -0.89 |
Placebo | -0.82 | -0.77 | -0.39 | -0.93 | -0.72 | -0.64 | -0.36 | -1.43 | -1.69 | -1.09 | -1.10 | -1.74 | -1.50 | -2.78 | -2.32 | -1.30 | -0.05 | -0.41 | -2.16 | -2.19 |
Change from baseline (week 0) in SMPG mean postprandial increment over all meals to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | mmol/L (Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | -1.2 | -0.7 |
Oral Semaglutide 3 mg | -0.3 | -0.3 |
Oral Semaglutide 7 mg | -0.8 | -0.7 |
Placebo | -0.1 | -0.3 |
Change from baseline in total cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | Ratio of total cholesterol (Geometric Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | 0.95 | 0.95 |
Oral Semaglutide 3 mg | 0.99 | 0.98 |
Oral Semaglutide 7 mg | 0.95 | 0.97 |
Placebo | 1.03 | 1.00 |
Change from baseline in total daily insulin dose to week 26 and week 52 is presented. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | Units/day (Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | -8 | -5 |
Oral Semaglutide 3 mg | -5 | 1 |
Oral Semaglutide 7 mg | -9 | -8 |
Placebo | -2 | 8 |
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. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | Ratio of triglycerides (Geometric Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | 0.91 | 0.86 |
Oral Semaglutide 3 mg | 0.97 | 0.93 |
Oral Semaglutide 7 mg | 0.92 | 0.94 |
Placebo | 0.99 | 0.97 |
Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
Intervention | cm (Mean) | |
---|---|---|
Week 26 | Week 52 | |
Oral Semaglutide 14 mg | -3.6 | -4.0 |
Oral Semaglutide 3 mg | -0.9 | -0.8 |
Oral Semaglutide 7 mg | -2.3 | -2.3 |
Placebo | -0.6 | 0.3 |
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations were measured at week 4, 14, 26, 38 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. (NCT03021187)
Timeframe: Weeks 0-52
Intervention | nmol/L (Geometric Mean) | ||||
---|---|---|---|---|---|
Week 4 | Week 14 | Week 26 | Week 38 | Week 52 | |
Oral Semaglutide 14 mg | 2.9 | 14.5 | 12.6 | 10.8 | 11.9 |
Oral Semaglutide 3 mg | 2.9 | 2.9 | 2.7 | 2.5 | 2.4 |
Oral Semaglutide 7 mg | 2.9 | 7.5 | 7.2 | 6.9 | 5.8 |
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 use of new anti-diabetic medication 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. (NCT03021187)
Timeframe: Weeks 0-52
Intervention | Participants (Count of Participants) | |
---|---|---|
Week 0-26 | Week 0-52 | |
Oral Semaglutide 14 mg | 8 | 44 |
Oral Semaglutide 3 mg | 9 | 61 |
Oral Semaglutide 7 mg | 8 | 45 |
Placebo | 11 | 75 |
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 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 (week 1) 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. (NCT03021187)
Timeframe: Weeks 0-52
Intervention | Participants (Count of Participants) | |
---|---|---|
Week 0-26 | Week 0-52 | |
Oral Semaglutide 14 mg | 4 | 31 |
Oral Semaglutide 3 mg | 5 | 54 |
Oral Semaglutide 7 mg | 2 | 33 |
Placebo | 9 | 67 |
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. (NCT03021187)
Timeframe: Week -2, week 52
Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Left eye (week -2)72577392 | Left eye (week -2)72577393 | Left eye (week -2)72577394 | Left eye (week -2)72577395 | Left eye (week 52)72577392 | Left eye (week 52)72577393 | Left eye (week 52)72577394 | Left eye (week 52)72577395 | Right eye (week -2)72577392 | Right eye (week -2)72577393 | Right eye (week -2)72577394 | Right eye (week -2)72577395 | Right eye (week 52)72577392 | Right eye (week 52)72577393 | Right eye (week 52)72577394 | Right eye (week 52)72577395 | |||||||||||||||||||||||||||||||||
Normal | Abnormal NCS | Abnormal CS | ||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 89 | |||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 108 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 64 | |||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 55 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 19 | |||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 21 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 83 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 102 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 92 | |||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 88 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 65 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 51 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 52 | |||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 53 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 22 | |||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 25 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 85 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 104 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 99 | |||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 106 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 76 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 63 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 64 | |||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 58 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 13 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 18 | |||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 20 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 79 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 99 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 97 | |||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 90 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 67 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 54 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 51 | |||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 50 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 23 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 14 | |||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 15 | |||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 26 |
Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 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. (NCT03021187)
Timeframe: Week -2, week 52
Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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1) Cardiovascular system (week -2)72577392 | 1) Cardiovascular system (week -2)72577393 | 1) Cardiovascular system (week -2)72577394 | 1) Cardiovascular system (week -2)72577395 | 1) Cardiovascular system (week 52)72577392 | 1) Cardiovascular system (week 52)72577393 | 1) Cardiovascular system (week 52)72577394 | 1) Cardiovascular system (week 52)72577395 | 2) Central and peripheral nervous system (week -2)72577392 | 2) Central and peripheral nervous system (week -2)72577395 | 2) Central and peripheral nervous system (week -2)72577393 | 2) Central and peripheral nervous system (week -2)72577394 | 2) Central and peripheral nervous system (week 52)72577392 | 2) Central and peripheral nervous system (week 52)72577393 | 2) Central and peripheral nervous system (week 52)72577394 | 2) Central and peripheral nervous system (week 52)72577395 | 3) Gastrointestinal system, incl. mouth (week -2)72577393 | 3) Gastrointestinal system, incl. mouth (week -2)72577395 | 3) Gastrointestinal system, incl. mouth (week -2)72577392 | 3) Gastrointestinal system, incl. mouth (week -2)72577394 | 3) Gastrointestinal system, incl. mouth (week 52)72577392 | 3) Gastrointestinal system, incl. mouth (week 52)72577393 | 3) Gastrointestinal system, incl. mouth (week 52)72577395 | 3) Gastrointestinal system, incl. mouth (week 52)72577394 | 4) General appearance (week -2)72577392 | 4) General appearance (week -2)72577393 | 4) General appearance (week -2)72577394 | 4) General appearance (week -2)72577395 | 4) General appearance (week 52)72577392 | 4) General appearance (week 52)72577393 | 4) General appearance (week 52)72577394 | 4) General appearance (week 52)72577395 | 5) Head, ears, eyes, nose, throat, neck (week -2)72577392 | 5) Head, ears, eyes, nose, throat, neck (week -2)72577393 | 5) Head, ears, eyes, nose, throat, neck (week -2)72577394 | 5) Head, ears, eyes, nose, throat, neck (week -2)72577395 | 5) Head, ears, eyes, nose, throat, neck (week 52)72577392 | 5) Head, ears, eyes, nose, throat, neck (week 52)72577393 | 5) Head, ears, eyes, nose, throat, neck (week 52)72577394 | 5) Head, ears, eyes, nose, throat, neck (week 52)72577395 | 6) Lymph node palpation (week -2)72577392 | 6) Lymph node palpation (week -2)72577393 | 6) Lymph node palpation (week -2)72577394 | 6) Lymph node palpation (week -2)72577395 | 6) Lymph node palpation (week 52)72577392 | 6) Lymph node palpation (week 52)72577393 | 6) Lymph node palpation (week 52)72577394 | 6) Lymph node palpation (week 52)72577395 | 7) Musculoskeletal system (week -2)72577392 | 7) Musculoskeletal system (week -2)72577393 | 7) Musculoskeletal system (week -2)72577395 | 7) Musculoskeletal system (week -2)72577394 | 7) Musculoskeletal system (week 52)72577392 | 7) Musculoskeletal system (week 52)72577393 | 7) Musculoskeletal system (week 52)72577394 | 7) Musculoskeletal system (week 52)72577395 | 8) Respiratory system (week -2)72577392 | 8) Respiratory system (week -2)72577393 | 8) Respiratory system (week -2)72577394 | 8) Respiratory system (week -2)72577395 | 8) Respiratory system (week 52)72577392 | 8) Respiratory system (week 52)72577393 | 8) Respiratory system (week 52)72577394 | 8) Respiratory system (week 52)72577395 | 9) Skin (week -2)72577392 | 9) Skin (week -2)72577393 | 9) Skin (week -2)72577394 | 9) Skin (week -2)72577395 | 9) Skin (week 52)72577392 | 9) Skin (week 52)72577393 | 9) Skin (week 52)72577394 | 9) Skin (week 52)72577395 | 10) Thyroid gland (week -2)72577393 | 10) Thyroid gland (week -2)72577392 | 10) Thyroid gland (week -2)72577394 | 10) Thyroid gland (week -2)72577395 | 10) Thyroid gland (week 52)72577393 | 10) Thyroid gland (week 52)72577392 | 10) Thyroid gland (week 52)72577394 | 10) Thyroid gland (week 52)72577395 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Abnormal NCS | Normal | Abnormal CS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 166 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 166 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 157 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 170 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 15 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 14 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 157 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 158 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 145 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 160 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 24 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 158 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 157 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 158 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 163 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 26 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 24 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 149 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 150 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 147 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 25 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 22 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 175 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 177 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 180 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 163 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 166 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 171 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 159 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 162 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 160 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 22 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 151 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 148 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 153 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 152 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 23 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 168 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 173 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 172 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 178 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 15 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 161 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 165 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 166 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 184 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 181 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 181 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 172 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 172 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 171 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 170 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 169 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 175 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 13 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 160 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 160 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 164 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 182 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 177 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 180 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 184 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 173 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 164 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 170 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 173 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 156 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 153 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 159 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 162 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 27 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 28 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 152 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 144 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 151 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 155 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 26 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 177 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 176 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 176 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 177 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 7 mg | 165 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 14 mg | 168 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Oral Semaglutide 3 mg | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo | 6 |
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. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiatiion of of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 26, week 52
Intervention | Participants (Count of Participants) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 2672577393 | Week 2672577394 | Week 2672577395 | Week 2672577392 | Week 5272577392 | Week 5272577393 | Week 5272577395 | Week 5272577394 | |||||||||
Yes | No | |||||||||||||||
Oral Semaglutide 3 mg | 2 | |||||||||||||||
Oral Semaglutide 7 mg | 12 | |||||||||||||||
Oral Semaglutide 14 mg | 19 | |||||||||||||||
Placebo | 1 | |||||||||||||||
Oral Semaglutide 3 mg | 175 | |||||||||||||||
Oral Semaglutide 7 mg | 162 | |||||||||||||||
Oral Semaglutide 14 mg | 154 | |||||||||||||||
Placebo | 176 | |||||||||||||||
Oral Semaglutide 3 mg | 4 | |||||||||||||||
Oral Semaglutide 7 mg | 17 | |||||||||||||||
Oral Semaglutide 14 mg | 21 | |||||||||||||||
Oral Semaglutide 3 mg | 170 | |||||||||||||||
Oral Semaglutide 7 mg | 154 | |||||||||||||||
Oral Semaglutide 14 mg | 149 | |||||||||||||||
Placebo | 172 |
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. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 26, week 52
Intervention | Participants (Count of Participants) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 2672577392 | Week 2672577393 | Week 2672577394 | Week 2672577395 | Week 5272577395 | Week 5272577392 | Week 5272577393 | Week 5272577394 | |||||||||
Yes | No | |||||||||||||||
Oral Semaglutide 3 mg | 23 | |||||||||||||||
Oral Semaglutide 7 mg | 53 | |||||||||||||||
Placebo | 5 | |||||||||||||||
Oral Semaglutide 3 mg | 154 | |||||||||||||||
Oral Semaglutide 7 mg | 121 | |||||||||||||||
Oral Semaglutide 14 mg | 106 | |||||||||||||||
Placebo | 172 | |||||||||||||||
Oral Semaglutide 3 mg | 30 | |||||||||||||||
Oral Semaglutide 7 mg | 48 | |||||||||||||||
Oral Semaglutide 14 mg | 67 | |||||||||||||||
Placebo | 9 | |||||||||||||||
Oral Semaglutide 3 mg | 144 | |||||||||||||||
Oral Semaglutide 7 mg | 123 | |||||||||||||||
Oral Semaglutide 14 mg | 103 | |||||||||||||||
Placebo | 164 |
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. (NCT03021187)
Timeframe: Week 26, week 52
Intervention | Participants (Count of Participants) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 2672577392 | Week 2672577394 | Week 2672577393 | Week 2672577395 | Week 5272577392 | Week 5272577393 | Week 5272577394 | Week 5272577395 | |||||||||
Yes | No | |||||||||||||||
Oral Semaglutide 3 mg | 32 | |||||||||||||||
Oral Semaglutide 7 mg | 47 | |||||||||||||||
Oral Semaglutide 14 mg | 76 | |||||||||||||||
Placebo | 4 | |||||||||||||||
Oral Semaglutide 3 mg | 144 | |||||||||||||||
Oral Semaglutide 7 mg | 127 | |||||||||||||||
Oral Semaglutide 14 mg | 97 | |||||||||||||||
Placebo | 172 | |||||||||||||||
Oral Semaglutide 3 mg | 27 | |||||||||||||||
Oral Semaglutide 7 mg | 43 | |||||||||||||||
Oral Semaglutide 14 mg | 61 | |||||||||||||||
Placebo | 8 | |||||||||||||||
Oral Semaglutide 3 mg | 146 | |||||||||||||||
Oral Semaglutide 7 mg | 126 | |||||||||||||||
Oral Semaglutide 14 mg | 107 | |||||||||||||||
Placebo | 164 |
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. (NCT03021187)
Timeframe: Week 26, week 52
Intervention | Participants (Count of Participants) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 2672577392 | Week 2672577395 | Week 2672577393 | Week 2672577394 | Week 5272577395 | Week 5272577392 | Week 5272577393 | Week 5272577394 | |||||||||
Yes | No | |||||||||||||||
Oral Semaglutide 3 mg | 28 | |||||||||||||||
Oral Semaglutide 7 mg | 51 | |||||||||||||||
Oral Semaglutide 14 mg | 76 | |||||||||||||||
Placebo | 7 | |||||||||||||||
Oral Semaglutide 3 mg | 148 | |||||||||||||||
Oral Semaglutide 7 mg | 123 | |||||||||||||||
Oral Semaglutide 14 mg | 97 | |||||||||||||||
Placebo | 169 | |||||||||||||||
Oral Semaglutide 3 mg | 20 | |||||||||||||||
Oral Semaglutide 7 mg | 37 | |||||||||||||||
Oral Semaglutide 14 mg | 64 | |||||||||||||||
Placebo | 5 | |||||||||||||||
Oral Semaglutide 3 mg | 153 | |||||||||||||||
Oral Semaglutide 7 mg | 132 | |||||||||||||||
Oral Semaglutide 14 mg | 104 | |||||||||||||||
Placebo | 167 |
Number of particpants achieving HbA1c < 7.0 % (53 mmol/mol) according to American Diabetes Association (ADA) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 26, week 52
Intervention | Participants (Count of Participants) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 2672577394 | Week 2672577395 | Week 2672577392 | Week 2672577393 | Week 5272577392 | Week 5272577393 | Week 5272577394 | Week 5272577395 | |||||||||
No | Yes | |||||||||||||||
Oral Semaglutide 7 mg | 74 | |||||||||||||||
Oral Semaglutide 14 mg | 101 | |||||||||||||||
Placebo | 12 | |||||||||||||||
Oral Semaglutide 3 mg | 126 | |||||||||||||||
Oral Semaglutide 7 mg | 100 | |||||||||||||||
Oral Semaglutide 14 mg | 72 | |||||||||||||||
Placebo | 164 | |||||||||||||||
Oral Semaglutide 3 mg | 50 | |||||||||||||||
Oral Semaglutide 7 mg | 67 | |||||||||||||||
Oral Semaglutide 14 mg | 91 | |||||||||||||||
Placebo | 16 | |||||||||||||||
Oral Semaglutide 3 mg | 123 | |||||||||||||||
Oral Semaglutide 7 mg | 102 | |||||||||||||||
Oral Semaglutide 14 mg | 77 | |||||||||||||||
Placebo | 156 |
Number of participants achieving HbA1c ≤ 6.5% (48 mmol/mol) according to American Association of Clinical Endocrinologists (AACE) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 26, week 52
Intervention | Participants (Count of Participants) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 2672577393 | Week 2672577394 | Week 2672577395 | Week 2672577392 | Week 5272577392 | Week 5272577394 | Week 5272577395 | Week 5272577393 | |||||||||
Yes | No | |||||||||||||||
Oral Semaglutide 3 mg | 24 | |||||||||||||||
Oral Semaglutide 7 mg | 45 | |||||||||||||||
Oral Semaglutide 14 mg | 74 | |||||||||||||||
Placebo | 6 | |||||||||||||||
Oral Semaglutide 3 mg | 152 | |||||||||||||||
Oral Semaglutide 7 mg | 129 | |||||||||||||||
Oral Semaglutide 14 mg | 99 | |||||||||||||||
Placebo | 170 | |||||||||||||||
Oral Semaglutide 3 mg | 20 | |||||||||||||||
Oral Semaglutide 7 mg | 33 | |||||||||||||||
Oral Semaglutide 14 mg | 65 | |||||||||||||||
Placebo | 4 | |||||||||||||||
Oral Semaglutide 3 mg | 153 | |||||||||||||||
Oral Semaglutide 7 mg | 136 | |||||||||||||||
Oral Semaglutide 14 mg | 103 | |||||||||||||||
Placebo | 168 |
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). (NCT03987919)
Timeframe: Baseline, Week 40
Intervention | Kilograms (kg) (Least Squares Mean) |
---|---|
5 mg Tirzepatide | -7.8 |
10 mg Tirzepatide | -10.3 |
15 mg Tirzepatide | -12.4 |
1 mg Semaglutide | -6.2 |
Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). (NCT03987919)
Timeframe: Baseline, Week 40
Intervention | milligram per Deciliter (mg/dL) (Least Squares Mean) |
---|---|
5 mg Tirzepatide | -56.0 |
10 mg Tirzepatide | -61.6 |
15 mg Tirzepatide | -63.4 |
1 mg Semaglutide | -48.6 |
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). (NCT03987919)
Timeframe: Baseline, Week 40
Intervention | Percentage of HbA1c (Least Squares Mean) |
---|---|
5 mg Tirzepatide | -2.09 |
1 mg Semaglutide | -1.86 |
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). (NCT03987919)
Timeframe: Baseline, Week 40
Intervention | Percentage of HbA1c (Least Squares Mean) |
---|---|
10 mg Tirzepatide | -2.37 |
15 mg Tirzepatide | -2.46 |
1 mg Semaglutide | -1.86 |
The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). (NCT03987919)
Timeframe: Baseline, Week 40
Intervention | mg/dL (Least Squares Mean) |
---|---|
5 mg Tirzepatide | -65.4 |
10 mg Tirzepatide | -70.6 |
15 mg Tirzepatide | -74.3 |
1 mg Semaglutide | -61.4 |
Percentage of Participants Achieving an HbA1c Target Value of <5.7%. (NCT03987919)
Timeframe: Week 40
Intervention | Percentage of Participants (Number) |
---|---|
5 mg Tirzepatide | 29.28 |
10 mg Tirzepatide | 44.66 |
15 mg Tirzepatide | 50.86 |
1 mg Semaglutide | 19.74 |
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. (NCT03987919)
Timeframe: Week 40
Intervention | Percentage of Participants (Number) |
---|---|
5 mg Tirzepatide | 85.47 |
10 mg Tirzepatide | 88.89 |
15 mg Tirzepatide | 92.24 |
1 mg Semaglutide | 81.13 |
Percentage of Participants who Achieved Weight Loss ≥5%. (NCT03987919)
Timeframe: Week 40
Intervention | Percentage of Participants (Number) |
---|---|
5 mg Tirzepatide | 68.55 |
10 mg Tirzepatide | 82.35 |
15 mg Tirzepatide | 86.21 |
1 mg Semaglutide | 58.44 |
The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL) (<3.0 mmol/L] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment. (NCT03987919)
Timeframe: Baseline through Safety Follow-Up (Up to Week 44)
Intervention | Episodes/participant/365.25 days (Mean) |
---|---|
5 mg Tirzepatide | 0.0102 |
10 mg Tirzepatide | 0.0046 |
15 mg Tirzepatide | 0.0202 |
1 mg Semaglutide | 0.0046 |
DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS Mean was determined by ANCOVA with Baseline DTSQs + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares). (NCT03987919)
Timeframe: Baseline, Week 40
Intervention | Units on a Scale (Least Squares Mean) | ||
---|---|---|---|
Hyperglycemia | Hypoglycemia | Total Score | |
1 mg Semaglutide | -1.1 | -0.7 | 15.8 |
10 mg Tirzepatide | -1.4 | -0.7 | 15.6 |
15 mg Tirzepatide | -1.5 | -0.8 | 16.1 |
5 mg Tirzepatide | -1.3 | -0.7 | 15.7 |
Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Baseline, Week 24
Intervention | percentage of hemoglobin (Least Squares Mean) |
---|---|
Placebo | -0.47 |
Lixisenatide | -0.83 |
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. (NCT01169779)
Timeframe: Baseline, Week 24
Intervention | mmol/L (Least Squares Mean) |
---|---|
Placebo | -1.33 |
Lixisenatide | -5.61 |
Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Baseline, Week 24
Intervention | kilogram (Least Squares Mean) |
---|---|
Placebo | -1.24 |
Lixisenatide | -1.50 |
Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Baseline, Week 24
Intervention | mmol/L (Least Squares Mean) |
---|---|
Placebo | -0.21 |
Lixisenatide | -0.69 |
Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. (NCT01169779)
Timeframe: Baseline, Week 24
Intervention | mmol/L (Least Squares Mean) |
---|---|
Placebo | -0.79 |
Lixisenatide | -4.78 |
Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >250 milligram/deciliter (mg/dL) (13.9 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >220 mg/dL (12.2 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Baseline up to Week 24
Intervention | percentage of participants (Number) |
---|---|
Placebo | 6.7 |
Lixisenatide | 3.6 |
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Baseline, Week 24
Intervention | percentage of participants (Number) |
---|---|
Placebo | 14.7 |
Lixisenatide | 19.7 |
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|---|
Placebo | 38.8 |
Lixisenatide | 53.0 |
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. (NCT01169779)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|---|
Placebo | 18.1 |
Lixisenatide | 32.4 |
Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. (NCT01169779)
Timeframe: First dose of study drug up to 3 days after the last dose administration
Intervention | participants (Number) | |
---|---|---|
Symptomatic hypoglycemia | Severe symptomatic hypoglycemia | |
Lixisenatide | 11 | 0 |
Placebo | 5 | 0 |
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 |
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 |
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 |
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 |
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 |
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 |
Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline) (NCT00993187)
Timeframe: Baseline and Week 30
Intervention | kg (Least Squares Mean) |
---|---|
Sitagliptin/Metformin | -0.83 |
Glimepiride | 0.90 |
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at baseline). (NCT00993187)
Timeframe: Baseline and Week 30
Intervention | mg/dL (Least Squares Mean) |
---|---|
Sitagliptin/Metformin | -47.0 |
Glimepiride | -23.5 |
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline). (NCT00993187)
Timeframe: Baseline and Week 30
Intervention | Percent of total hemoglobin (Least Squares Mean) |
---|---|
Sitagliptin/Metformin | -1.5 |
Glimepiride | -0.7 |
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product. (NCT00993187)
Timeframe: Up to 30 weeks
Intervention | Participants (Number) |
---|---|
Sitagliptin/Metformin | 8 |
Glimepiride | 8 |
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product. (NCT00993187)
Timeframe: Up to 32 weeks
Intervention | Participants (Number) |
---|---|
Sitagliptin/Metformin | 88 |
Glimepiride | 101 |
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). (NCT00993187)
Timeframe: Week 30
Intervention | Percentage of Participants (Number) |
---|---|
Sitagliptin/Metformin | 81.2 |
Glimepiride | 40.1 |
Symptomatic episodes assessed as likely to be due to hypoglycemia were reported by investigators as adverse experiences of hypoglycemia. Adverse experiences of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required. (NCT00993187)
Timeframe: Up to Week 30
Intervention | Percentage of participants (Number) |
---|---|
Sitagliptin/Metformin | 5.5 |
Glimepiride | 20.1 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Change in homeostatic model assessment-beta cell (HOMA-B) from baseline to endpoint (Week 26) (outcome measure is presented as the ratio of endpoint HOMA-B divided by baseline HOMA-B). HOMA-B is a measure of pancreatic beta-cell function. (NCT00603239)
Timeframe: baseline and 26 weeks
Intervention | ratio (Geometric Mean) |
---|---|
Exenatide Twice Daily (BID) | 1.08 |
Placebo | 0.84 |
Change in body weight from baseline to endpoint (26 weeks) (NCT00603239)
Timeframe: baseline and 26 weeks
Intervention | kg (Least Squares Mean) |
---|---|
Exenatide Twice Daily (BID) | -1.43 |
Placebo | -0.75 |
Change in FSG from baseline to endpoint (26 weeks) (NCT00603239)
Timeframe: baseline and 26 weeks
Intervention | mmol/L (Least Squares Mean) |
---|---|
Exenatide Twice Daily (BID) | -0.65 |
Placebo | 0.37 |
Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline) (NCT00603239)
Timeframe: baseline and 26 weeks
Intervention | Percentage (Least Squares Mean) |
---|---|
Exenatide Twice Daily (BID) | -0.84 |
Placebo | -0.10 |
Change in homeostatic model assessment-insulin sensitivity (HOMA-S) from baseline to endpoint (26 weeks) (outcome measure is presented as the ratio of endpoint HOMA-S divided by baseline HOMA-S). (NCT00603239)
Timeframe: baseline and 26 weeks
Intervention | ratio (Least Squares Mean) |
---|---|
Exenatide Twice Daily (BID) | 1.09 |
Placebo | 1.07 |
Change in waist circumference from baseline to endpoint (26 weeks) (NCT00603239)
Timeframe: baseline and 26 weeks
Intervention | cm (Mean) |
---|---|
Exenatide Twice Daily (BID) | -2.26 |
Placebo | -1.85 |
Overall number of subjects who experienced an episode of minor hypoglycemia. (NCT00603239)
Timeframe: 26 weeks
Intervention | Participants (Number) |
---|---|
Exenatide Twice Daily (BID) | 4 |
Placebo | 1 |
Percentage of ITT patients who had achieved HbA1c <= 6.5% at endpoint (Week 26 or early discontinuation) (NCT00603239)
Timeframe: 26 weeks
Intervention | percentage of participants (Number) |
---|---|
Exenatide Twice Daily (BID) | 33.6 |
Placebo | 13.0 |
Percentage of intent-to-treat (ITT) patients who had HbA1c > 7% at baseline that decreased to <= 7% at endpoint (Week 26 or early discontinuation) (NCT00603239)
Timeframe: 26 weeks
Intervention | percentage of participants (Number) |
---|---|
Exenatide Twice Daily (BID) | 49.0 |
Placebo | 36.5 |
EQ-5D Score - change from baseline to endpoint (26 weeks). EQ-5D is a 5-item questionnaire used to characterize current health states. The tool and accompanying visual analog scale (VAS) assess 5 domains of quality of life, including mobility, self-care, usual activity, pain, and anxiety/depression. Weights are used to score the responses to the 5 domains, with 3 options possible in each domain: extreme problems, some/moderate problems, or no problems. Scores range from 0 to 1, with a score of 1 representing a perfect health state. (NCT00603239)
Timeframe: baseline and 26 weeks
Intervention | units on a scale (Least Squares Mean) | |||||
---|---|---|---|---|---|---|
Change in Health State Score | Change in Mobility component | Change in Self Care component | Change Usual Activities component | Change in Pain/Discomfort component | Change in Anxiety/Depression component | |
Exenatide Twice Daily (BID) | 0.79 | 0.14 | 0.08 | 0.17 | 0.29 | -0.10 |
Placebo | -2.94 | 0.15 | 0.03 | 0.19 | 0.23 | -0.26 |
"IWQOL-Lite analysis of change from baseline to endpoint (26 weeks). IWQOL-Lite is a 31-item questionnaire, assessing the domains of physical function, self-esteem, sexual life, public distress, and work. Response categories for each item range from 1 = never true to 5 = always true." (NCT00603239)
Timeframe: baseline and 26 weeks
Intervention | units on a scale (Least Squares Mean) | |||||
---|---|---|---|---|---|---|
Change in Total Score | Change in Physical Function component | Change in Self-Esteem component | Change in Sexual Life component | Change in Public Distress component | Change in Work component | |
Exenatide Twice Daily (BID) | -1.56 | -3.84 | 0.20 | 0.12 | -0.48 | -0.91 |
Placebo | 0.11 | -1.05 | -0.54 | 5.01 | -0.28 | 0.08 |
The effect of exenatide and pioglitazone on liver fat content after one year of treatment in patients with type 2 diabetes. (NCT01432405)
Timeframe: one year
Intervention | percent of liver fat (Mean) |
---|---|
Pioglitazone and Exenatide | 4.7 |
Pioglitazone | 6.5 |
the effect of the intervention on plasma adiponectin levels. (NCT01432405)
Timeframe: one year
Intervention | microgram per ml (Mean) |
---|---|
Pioglitazone and Exenatide | 23.2 |
Pioglitazone | 15.8 |
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 |
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 |
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 |
"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 |
"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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 0, 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 |
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 0, 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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 | 37 | 15 | 1 |
Sita -> Sita | 0 | 11 | 10 | 0 |
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 | 51 | 29 | 1 |
Sita -> Sita | 0 | 25 | 12 | 0 |
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 | 56 | 40 | 1 |
Sita -> Sita | 0 | 34 | 13 | 0 |
12 reviews available for metformin and Nausea
Article | Year |
---|---|
Gastrointestinal adverse events of metformin treatment in patients with type 2 diabetes mellitus: A systematic review, meta-analysis and meta-regression of randomized controlled trials.
Topics: Abdominal Pain; Delayed-Action Preparations; Diabetes Mellitus, Type 2; Diarrhea; Humans; Hypoglycem | 2022 |
Pharmacological interventions for prevention of weight gain in people with schizophrenia.
Topics: Antipsychotic Agents; Betahistine; Famotidine; Fluoxetine; Humans; Melatonin; Metformin; Nausea; Niz | 2022 |
Efficacy and safety of polyethylene glycol loxenatide in type 2 diabetic patients: a systematic review and meta-analysis of randomized controlled trials.
Topics: Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Metformin; Nausea; Randomized Controlled Tri | 2023 |
Glucagon-like peptide-1 receptor agonists or sodium-glucose cotransporter-2 inhibitors as add-on therapy for patients with type 2 diabetes? A systematic review and meta-analysis of surrogate metabolic endpoints.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Diarrhea; Drug Therapy, Combination; Glucagon-Like Peptide | 2020 |
Once weekly exenatide: efficacy, tolerability and place in therapy.
Topics: Blood Glucose; Delayed-Action Preparations; Diabetes Mellitus, Type 2; Diarrhea; Drug Administration | 2013 |
Beneficial effect of lixisenatide after 76 weeks of treatment in patients with type 2 diabetes mellitus: A meta-analysis from the GetGoal programme.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Femal | 2017 |
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.
Topics: Clinical Trials as Topic; Diabetes Mellitus, Type 2; Diarrhea; Drug Therapy, Combination; Exenatide; | 2017 |
Metformin vs thiazolidinediones for treatment of clinical, hormonal and metabolic characteristics of polycystic ovary syndrome: a meta-analysis.
Topics: Dehydroepiandrosterone Sulfate; Diarrhea; Female; Humans; Hypoglycemic Agents; Metformin; Nausea; Pi | 2011 |
Liraglutide: from clinical trials to clinical practice.
Topics: Administration, Oral; Blood Glucose; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dose-Respo | 2012 |
Management of diabetes and pancreatic cancer.
Topics: Adenocarcinoma; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Combined Modality Thera | 2012 |
Evolution of exenatide as a diabetes therapeutic.
Topics: Animals; Blood Glucose; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Diabetic Angiopathies; D | 2013 |
[Metformin efficacious in poorly controlled diabetes mellitus type 2].
Topics: Abdominal Pain; Acidosis, Lactic; Aged; Blood Glucose; Contraindications; Diabetes Mellitus; Diabete | 2000 |
22 trials available for metformin and Nausea
Article | Year |
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Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial.
Topics: Adult; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination; Femal | 2019 |
Phase 1 dose-finding study of metformin in combination with concurrent cisplatin and radiotherapy in patients with locally advanced head and neck squamous cell cancer.
Topics: Acute Kidney Injury; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Chemoradiotherapy | 2020 |
Feasibility trial of metformin XR in people with pre-diabetes and stroke (MIPPS)-randomised open blinded endpoint controlled trial.
Topics: Adult; Aged; Australia; Delayed-Action Preparations; Feasibility Studies; Female; Headache; Humans; | 2021 |
Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Drug Administration Sche | 2021 |
Exenatide twice daily versus insulin glargine for the treatment of type 2 diabetes in Poland - subgroup data from a randomised multinational trial GWAA.
Topics: Administration, Oral; Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Administration Sch | 2013 |
Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia).
Topics: Adult; China; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Resistance; Drug Resistance, Mult | 2014 |
Metformin Addition to Chemotherapy in Stage IV Non-Small Cell Lung Cancer: an Open Label Randomized Controlled Study.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; Cisplat | 2015 |
Polyethylene glycol loxenatide injections added to metformin effectively improve glycemic control and exhibit favorable safety in type 2 diabetic patients.
Topics: Adult; Asian People; Blood Glucose; China; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2017 |
Efficacy and safety of liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: a 26-week, open-label, randomized, active comparator clinical trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anorexia; Asian People; Blood Glucose; Body Weight; Chin | 2016 |
Efficacy and safety of sitagliptin/metformin fixed-dose combination compared with glimepiride in patients with type 2 diabetes: A multicenter randomized double-blind study.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Diarrhea; Double-Blind Method; Drug Th | 2017 |
Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH): a randomized, double-blind, double-dummy, active-controlled 26-week trial.
Topics: Adult; Aged; Aged, 80 and over; Asia; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double- | 2016 |
Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study.
Topics: Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Dose-Response Relationship, Drug; Dou | 2010 |
A placebo-controlled trial of exenatide twice-daily added to thiazolidinediones alone or in combination with metformin.
Topics: Diabetes Mellitus, Type 2; Double-Blind Method; Exenatide; Female; Glycated Hemoglobin; Humans; Hypo | 2010 |
Exenatide decreases hepatic fibroblast growth factor 21 resistance in non-alcoholic fatty liver disease in a mouse model of obesity and in a randomised controlled trial.
Topics: Adult; Aged; Animals; Body Weight; Diabetes Mellitus, Type 2; Disease Models, Animal; Drug Therapy, | 2011 |
[Metabolic control and weight loss in patients with obesity and type 2 diabetes mellitus, treated with exenatide].
Topics: Adult; Aged; Anti-Obesity Agents; Antihypertensive Agents; Blood Glucose; Combined Modality Therapy; | 2012 |
Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trial.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Gl | 2012 |
Efficacy and tolerability of exenatide monotherapy in obese patients with newly diagnosed type 2 diabetes: a randomized, 26 weeks metformin-controlled, parallel-group study.
Topics: Adult; Diabetes Mellitus, Type 2; Exenatide; Female; Glycated Hemoglobin; Humans; Hypoglycemia; Hypo | 2012 |
Efficacy and tolerability of taspoglutide versus pioglitazone in subjects with type 2 diabetes uncontrolled with sulphonylurea or sulphonylurea-metformin therapy: a randomized, double-blind study (T-emerge 6).
Topics: Adolescent; Adult; Blood Glucose; Diabetes Mellitus, Type 2; Dizziness; Double-Blind Method; Drug Ad | 2013 |
Effect of pramlintide on weight in overweight and obese insulin-treated type 2 diabetes patients.
Topics: Aged; Amyloid; Body Mass Index; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Double-Bl | 2004 |
Efficacy, dose-response relationship and safety of once-daily extended-release metformin (Glucophage XR) in type 2 diabetic patients with inadequate glycaemic control despite prior treatment with diet and exercise: results from two double-blind, placebo-c
Topics: Adult; Aged; Blood Glucose; Cholesterol, LDL; Delayed-Action Preparations; Diabetes Mellitus, Type 2 | 2005 |
The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial.
Topics: Adult; Aged; Blood Glucose; Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 2; Double-Blind M | 2007 |
Weight-reducing effect of diguanides in obese non-diabetic women.
Topics: Adult; Appetite; Bicarbonates; Body Weight; Clinical Trials as Topic; Female; Glucose Tolerance Test | 1969 |
7 other studies available for metformin and Nausea
Article | Year |
---|---|
Distinguishing characteristics of exposure to biguanide and sulfonylurea anti-diabetic medications in the United States.
Topics: Abdominal Pain; Acidosis; Adolescent; Adult; Aged; Child; Creatinine; Diabetes Mellitus; Diarrhea; D | 2022 |
Transient Complete Blindness Due to Metformin-Associated Lactic Acidosis (MALA) Reversed with Hemodialysis.
Topics: Acidosis, Lactic; Acute Kidney Injury; Aged; Blindness; Diabetes Mellitus, Type 2; Diarrhea; Female; | 2022 |
Case 15-2021: A 76-Year-Old Woman with Nausea, Diarrhea, and Acute Kidney Failure.
Topics: Acidosis, Lactic; Acute Kidney Injury; Aged; Coronary Artery Disease; Creatinine; Diabetes Mellitus, | 2021 |
Are we missing hypoglycaemia? Elderly patients with insulin-treated diabetes present to primary care frequently with non-specific symptoms associated with hypoglycaemia.
Topics: Accidental Falls; Age Factors; Aged; Biomarkers; Blood Glucose; Cross-Sectional Studies; Diabetes Me | 2018 |
Metformin stinks, literally.
Topics: Adult; Diabetes Mellitus; Dosage Forms; Drugs, Generic; Humans; Hypoglycemic Agents; Male; Metformin | 2010 |
Summaries for patients. Exenatide therapy for type 2 diabetes.
Topics: Adult; Aged; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination; Exenatide; F | 2007 |
Metformin and fibrinolysis.
Topics: Adult; Aged; Blood Glucose; Cholesterol; Female; Fibrinogen; Fibrinolysis; Gastrointestinal Diseases | 1969 |