metformin has been researched along with Hypoglycemia in 488 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.
Hypoglycemia: A syndrome of abnormally low BLOOD GLUCOSE level. Clinical hypoglycemia has diverse etiologies. Severe hypoglycemia eventually lead to glucose deprivation of the CENTRAL NERVOUS SYSTEM resulting in HUNGER; SWEATING; PARESTHESIA; impaired mental function; SEIZURES; COMA; and even DEATH.
| Excerpt | Relevance | Reference |
|---|---|---|
| "This study provides evidence that, compared to glimepiride, saxagliptin more effectively achieves a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in T2D patients who are inadequately controlled with metformin monotherapy, especially in overweight patients with moderate hyperglycaemia and a relatively short duration of diabetes." | 9.30 | Comparative effect of saxagliptin and glimepiride with a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in patients uncontrolled with metformin therapy: Results from the SPECIFY study, a 48-week, multi-centr ( Bi, Y; Cheng, J; Gu, T; Li, D; Ma, J; Shao, J; Shi, B; Sun, Z; Xu, L; Zhang, H; Zhang, Q; Zhong, S; Zhu, D; Zhu, L, 2019) |
| "Metformin prevents weight gain in patients with type 2 diabetes (T2D)." | 9.27 | Metformin-associated prevention of weight gain in insulin-treated type 2 diabetic patients cannot be explained by decreased energy intake: A post hoc analysis of a randomized placebo-controlled 4.3-year trial. ( Jager-Wittenaar, H; Kooy, A; Krijnen, W; Lehert, P; Miedema, I; Out, M; Stehouwer, C; van der Schans, C, 2018) |
| "Metformin inhibits cyclic AMP generation and activates AMP-activated protein kinase (AMPK), which inhibits the cystic fibrosis transmembrane conductance regulator and Mammalian Target of Rapamycin pathways." | 9.27 | A Randomized Clinical Trial of Metformin to Treat Autosomal Dominant Polycystic Kidney Disease. ( Abebe, KZ; Bae, KT; Hallows, KR; Miskulin, DC; Perrone, RD; Seliger, SL; Watnick, T, 2018) |
| "Metformin has been used in pregnancy since the 1970s." | 9.22 | Metformin for pregnancy and beyond: the pros and cons. ( Dunne, FP; Newman, C, 2022) |
| "The percentage of patients experiencing any hypoglycemia event (ie, symptomatic event or event of plasma glucose concentration <54 mg/dL regardless of symptoms) was lower with saxagliptin compared with glimepiride (5." | 9.22 | Effects of Glimepiride versus Saxagliptin on β-Cell Function and Hypoglycemia: A Post Hoc Analysis in Older Patients with Type 2 Diabetes Inadequately Controlled with Metformin. ( Cook, W; Hirshberg, B; Ohman, P; Perl, S; Wei, C, 2016) |
| " This study examined the efficacy and safety of liraglutide monotherapy compared with metformin monotherapy in overweight/obese Japanese patients with type 2 diabetes (T2DM)." | 9.20 | Efficacy and safety of liraglutide monotherapy compared with metformin in Japanese overweight/obese patients with type 2 diabetes. ( Atsumi, Y; Imai, T; Irie, J; Itoh, H; Kawai, T; Meguro, S; Morimoto, J; Saisho, Y; Shigihara, T; Takei, I; Tanaka, K; Tanaka, M; Yajima, K, 2015) |
| "Saxagliptin + metformin was associated with fewer patients reporting hypoglycemia and fewer and less severe hypoglycemic events in those experiencing hypoglycemia compared with glipizide + metformin." | 9.19 | Saxagliptin versus glipizide as add-on therapy to metformin: assessment of hypoglycemia. ( Minervini, G; Mintz, ML, 2014) |
| "Linagliptin as add-on therapy to metformin and pioglitazone produced significant and clinically meaningful improvements in glycaemic control, without an additional risk of hypoglycaemia or weight gain (Clinical Trials Registry No: NCT 00996658)." | 9.19 | Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone: a 24-week randomized, double-blind study. ( Bajaj, M; Gilman, R; Kempthorne-Rawson, J; Lewis-D'Agostino, D; Patel, S; Woerle, HJ, 2014) |
| "To evaluate the effects of vildagliptin compared to glimepiride on glycemic control, insulin resistance and post-prandial lipemia." | 9.19 | Vildagliptin compared to glimepiride on post-prandial lipemia and on insulin resistance in type 2 diabetic patients. ( Bianchi, L; Bonaventura, A; D'Angelo, A; Derosa, G; Fogari, E; Maffioli, P; Romano, D, 2014) |
| "In obese, difficult-to-treat patients with T2DM inadequately controlled on high MDI insulin doses, empagliflozin improved glycemic control and reduced weight without increasing the risk of hypoglycemia and with lower insulin requirements." | 9.19 | Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. ( Broedl, UC; Frappin, G; Jelaska, A; Kim, G; Rosenstock, J; Salsali, A; Woerle, HJ, 2014) |
| "0 mmol/mol) without hypoglycaemia and weight gain was higher with vildagliptin than glimepiride after 2 years in type 2 diabetes patients inadequately controlled on metformin monotherapy, regardless of age and duration of diabetes." | 9.17 | Vildagliptin more effectively achieves a composite endpoint of HbA₁c < 7.0% without hypoglycaemia and weight gain compared with glimepiride after 2 years of treatment. ( Bader, G; Geransar, P; Schweizer, A, 2013) |
| "In metformin-treated patients, exenatide BID was noninferior to PIA for glycemic control but superior for hypoglycemia and weight control." | 9.15 | Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia. ( Bachmann, O; Becker, B; Böhmer, M; Gallwitz, B; Helsberg, K; Milek, K; Mölle, A; Peters, N; Petto, H; Segiet, T, 2011) |
| "Vildagliptin add-on has similar efficacy to glimepiride after 2 years' treatment, with markedly reduced hypoglycaemia risk and no weight gain." | 9.14 | Vildagliptin add-on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: results from a 2-year study. ( Ahren, B; Couturier, A; Dejager, S; Ferrannini, E; Foley, JE; Fonseca, V; Matthews, DR; Zinman, B, 2010) |
| "To explore the non-severe hypoglycemia risk difference (RD) for SU use compared with SGLT2-I in randomized controlled trials (RCTs) as an add on to metformin." | 8.95 | Non-severe Hypoglycemia Risk Difference between Sulfonylurea and Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2-I) as an Add-On to Metformin in Randomized Controlled Trials. ( Farahani, P, 2017) |
| "To synthesize data addressing outcomes of metformin use in populations with type 2 diabetes and moderate to severe chronic kidney disease (CKD), congestive heart failure (CHF), or chronic liver disease (CLD) with hepatic impairment." | 8.95 | Clinical Outcomes of Metformin Use in Populations With Chronic Kidney Disease, Congestive Heart Failure, or Chronic Liver Disease: A Systematic Review. ( Cameron, CB; Crowley, MJ; Diamantidis, CJ; Kosinski, AS; McDuffie, JR; Mock, CK; Nagi, A; Stanifer, JW; Tang, S; Wang, X; Williams, JW, 2017) |
| "To determine the comparative efficacy, risk of weight gain, and hypoglycemia associated with noninsulin antidiabetic drugs in patients with type 2 DM not controlled by metformin alone." | 8.86 | Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. ( Coleman, CI; Phung, OJ; Scholle, JM; Talwar, M, 2010) |
| "Metformin-associated lactic acidosis (MALA) is an extremely rare but life-threatening adverse effect of metformin treatment." | 8.12 | Metformin-associated Lactic Acidosis with Hypoglycemia during the COVID-19 Pandemic. ( Hazama, Y; Irie, Y; Kosugi, M; Maruo, Y; Obata, Y; Takayama, K; Yamaguchi, H; Yasuda, T, 2022) |
| " This study will provide robust evidence regarding the efficacy and safety of metformin use in pregnancy, and may identify subgroups of patients who may benefit most from this treatment modality." | 7.96 | Metformin in Pregnancy Study (MiPS): protocol for a systematic review with individual patient data meta-analysis. ( Burden, C; Carlsen, SM; Dodd, JM; Hague, W; Hilkka, I; Løvvik, T; Morin-Papunen, L; Mousa, A; Nicolaides, K; Norman, JE; Rönnemaa, T; Rowan, J; Shehata, H; Syngelaki, A; Teede, HJ; Tertti, K; Vanky, E, 2020) |
| "Liraglutide seems to reduce GV in the acute phase of acute coronary syndrome, and patients achieved optimal control with a low incidence of hypoglycemia." | 7.96 | Glycemic variability in type 2 diabetes mellitus and acute coronary syndrome: liraglutide compared with insulin glargine: a pilot study. ( Arnau Vives, MA; Ballesteros Martin-Portugués, A; Catalá Gregori, A; Caudet Esteban, J; Cerveró Rubio, A; Del Olmo-García, MI; Hervás Marín, D; Merino-Torres, JF; Penalba Martínez, M, 2020) |
| "Prior research suggests that warfarin, when given concomitantly with some sulfonylureas, may increase the risk of serious hypoglycemia." | 7.91 | Serious Hypoglycemia and Use of Warfarin in Combination With Sulfonylureas or Metformin. ( Bilker, WB; Brensinger, CM; Han, X; Hennessy, S; Leonard, CE; Nam, YH, 2019) |
| "To report a case of severe lactic acidosis and hypoglycemia due to acute metformin intoxication in a dog." | 7.88 | Severe lactic acidosis and hypoglycemia due to acute metformin intoxication in a dog. ( Borchers, A; Ueda, Y; Wong, C, 2018) |
| "Metformin toxicity is well known to cause lactic acidosis." | 7.88 | Recurrent hypoglycemia secondary to metformin toxicity in the absence of co-ingestions: a case report. ( Aldobeaban, S; Alshehri, AA; Mzahim, B, 2018) |
| "The objective of this nationwide study was to compare the risk of all-cause mortality, fatal and nonfatal cardiovascular disease (CVD), and severe hypoglycemia in patients with type 2 diabetes (T2D) on metformin monotherapy treatment starting second-line treatment with either insulin or dipeptidyl peptidase-4 inhibitor (DPP-4i)." | 7.85 | Second line initiation of insulin compared with DPP-4 inhibitors after metformin monotherapy is associated with increased risk of all-cause mortality, cardiovascular events, and severe hypoglycemia. ( Bodegard, J; Eriksson, JW; Nathanson, D; Norhammar, A; Nyström, T; Thuresson, M, 2017) |
| " significantly improved glycemic control without an increased risk of hypoglycemia in Asian, predominantly Chinese, patients with T2DM inadequately controlled on insulin, with or without metformin." | 7.83 | Vildagliptin as add-on therapy to insulin improves glycemic control without increasing risk of hypoglycemia in Asian, predominantly Chinese, patients with type 2 diabetes mellitus. ( Kothny, W; Li, L; Lukashevich, V; Lv, X; Ma, J; Ning, G; Wang, W; Woloschak, M; Yang, M, 2016) |
| " Metformin initiators who intensified treatment with insulin or sulfonylurea were followed to either their first or recurrent hypoglycemia event using Cox proportional hazard models." | 7.83 | Risk of hypoglycemia following intensification of metformin treatment with insulin versus sulfonylurea. ( Elasy, T; Greevy, RA; Griffin, MR; Grijalva, CG; Hung, AM; Liu, X; Min, JY; Roumie, CL, 2016) |
| "To assess hypoglycemia incidence rates and associated costs in patients who initiated second-line treatment with the antidiabetic agents linagliptin or a sulfonylurea (SU) after metformin." | 7.83 | Hypoglycemia Incidence Rates and Associated Health Care Costs in Patients with Type 2 Diabetes Mellitus Treated with Second-Line Linagliptin or Sulfonylurea After Metformin Monotherapy. ( Cai, B; D'Souza, AO; Raju, A; Shetty, S, 2016) |
| " The objective of this nationwide study was to compare the risk of cardiovascular disease (CVD), all-cause mortality and severe hypoglycemia in patients with type 2 diabetes (T2D) starting second-line treatment with either metformin+sulphonylurea or metformin+dipeptidyl peptidase-4 inhibitor (DPP-4i)." | 7.83 | Sulphonylurea compared to DPP-4 inhibitors in combination with metformin carries increased risk of severe hypoglycemia, cardiovascular events, and all-cause mortality. ( Bodegard, J; Eriksson, JW; Nathanson, D; Norhammar, A; Nyström, T; Thuresson, M, 2016) |
| "Despite the limitations of this observational study, diabetes patients with MS who were treated with metformin plus DPP-4 inhibitors had better compliance, greater metabolic control, and lower rates of hypoglycemia, causing lower costs for the Spanish national health system than patients receiving metformin plus other antidiabetes drugs." | 7.80 | Healthcare costs of the combination of metformin/dipeptidyl peptidase-4 inhibitors compared with metformin/other oral antidiabetes agents in patients with type 2 diabetes and metabolic syndrome. ( Navarro-Artieda, R; Sicras-Mainar, A, 2014) |
| "Lactic acidosis is a well-recognized consequence of metformin." | 7.79 | Metformin overdose-induced hypoglycemia in the absence of other antidiabetic drugs. ( Al-Abri, SA; Hayashi, S; Olson, KR; Thoren, KL, 2013) |
| "In pre-specified analyses adjusting for the most recently measured HbA(1c) value, there was a substantial reduction in risk for confirmed hypoglycemia with sitagliptin compared to glipizide when added to ongoing metformin therapy in patients with T2DM." | 7.78 | Lower risk of hypoglycemia with sitagliptin compared to glipizide when either is added to metformin therapy: a pre-specified analysis adjusting for the most recently measured HbA(1c) value. ( Davies, MJ; Ferrante, SA; Goldstein, BJ; Kaufman, KD; Krobot, KJ; Meininger, GE; Seck, T; Williams-Herman, D, 2012) |
| "Lactic acidosis has been associated with use of metformin." | 7.74 | Metformin, sulfonylureas, or other antidiabetes drugs and the risk of lactic acidosis or hypoglycemia: a nested case-control analysis. ( Bodmer, M; Jick, SS; Krähenbühl, S; Meier, C; Meier, CR, 2008) |
| "Bicyclol is a synthetic compound known to protect the liver against oxidation and lipid injuries." | 6.79 | Randomized, vitamin E-controlled trial of bicyclol plus metformin in non-alcoholic fatty liver disease patients with impaired fasting glucose. ( Ding, XD; Fan, JG; Han, Y; Ma, AL; Shi, JP; Xu, Y, 2014) |
| "Metformin has been shown to prevent insulin therapy-induced body weight gain when used in combination with insulin." | 6.70 | Metformin does not adversely affect hormonal and symptomatic responses to recurrent hypoglycemia. ( Born, J; Fehm, HL; Fruehwald-Schultes, B; Kern, W; Oltmanns, KM; Peters, A; Sopke, S; Toschek, B, 2001) |
| "Repaglinide is an insulin secretion enhancer with a different mechanism of action to the sulphonylureas, which means it does not continuously stimulate insulin secretion." | 6.41 | [Repaglinide, potentially a therapeutic improvement for diabetes mellitus type 2]. ( Rutten, GE, 2001) |
| "Although patients with type 2 diabetes mellitus (T2DM) may fail to achieve adequate hemoglobin A1c (HbA1c) control despite metformin-sulfonylurea (Met-SU) dual therapy, a third-line glucose-lowering medication-including dipeptidyl peptidase-4 inhibitor (DPP4i), insulin, or thiazolidinedione (TZD)-can be added to achieve this." | 5.51 | Intensification with dipeptidyl peptidase-4 inhibitor, insulin, or thiazolidinediones and risks of all-cause mortality, cardiovascular diseases, and severe hypoglycemia in patients on metformin-sulfonylurea dual therapy: A retrospective cohort study. ( Chan, EW; Ho, CW; Lam, CLK; Man, KKC; Shi, M; Tse, ETY; Wong, CKH; Wong, ICK, 2019) |
| "Metformin is a first-line oral antidiabetic therapy for patients with type 2 diabetes mellitus." | 5.46 | Hemodialysis-refractory metformin-associated lactate acidosis with hypoglycemia, hypothermia, and bradycardia in a diabetic patient with belated diagnosis and chronic kidney disease . ( Zibar, K; Zibar, L, 2017) |
| "Metformin (Met), which is an insulin-sensitizer, decreases insulin resistance and fasting insulin levels." | 5.42 | Intracerebroventricular metformin decreases body weight but has pro-oxidant effects and decreases survival. ( Brochier, AW; de Assis, AM; de Carvalho, AK; Gnoatto, J; Haas, CB; Hansel, G; Muller, AP; Oses, JP; Portela, LV; Zimmer, ER, 2015) |
| "Unlike insulin, metformin lowered neonatal birth weights (mean difference - 122." | 5.41 | Short-term neonatal outcomes in women with gestational diabetes treated using metformin versus insulin: a systematic review and meta-analysis of randomized controlled trials. ( Jiang, G; Li, H; Lin, X; Lv, B; Ni, J; Sheng, B, 2023) |
| "sulphonylurea (SU) compounds." | 5.38 | Worry vs. knowledge about treatment-associated hypoglycaemia and weight gain in type 2 diabetic patients on metformin and/or sulphonylurea. ( Knop, FK; Lund, A, 2012) |
| "Drug-induced hypoglycemia is possible even in diabetics not receiving insulin or oral antidiabetic agents increasing insulin secretion." | 5.31 | Severe hypoglycemia in an elderly patient treated with metformin. ( Reimann, IR; Schmechel, H; Zitzmann, S, 2002) |
| "This study provides evidence that, compared to glimepiride, saxagliptin more effectively achieves a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in T2D patients who are inadequately controlled with metformin monotherapy, especially in overweight patients with moderate hyperglycaemia and a relatively short duration of diabetes." | 5.30 | Comparative effect of saxagliptin and glimepiride with a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in patients uncontrolled with metformin therapy: Results from the SPECIFY study, a 48-week, multi-centr ( Bi, Y; Cheng, J; Gu, T; Li, D; Ma, J; Shao, J; Shi, B; Sun, Z; Xu, L; Zhang, H; Zhang, Q; Zhong, S; Zhu, D; Zhu, L, 2019) |
| "Metformin prevents weight gain in patients with type 2 diabetes (T2D)." | 5.27 | Metformin-associated prevention of weight gain in insulin-treated type 2 diabetic patients cannot be explained by decreased energy intake: A post hoc analysis of a randomized placebo-controlled 4.3-year trial. ( Jager-Wittenaar, H; Kooy, A; Krijnen, W; Lehert, P; Miedema, I; Out, M; Stehouwer, C; van der Schans, C, 2018) |
| "Metformin inhibits cyclic AMP generation and activates AMP-activated protein kinase (AMPK), which inhibits the cystic fibrosis transmembrane conductance regulator and Mammalian Target of Rapamycin pathways." | 5.27 | A Randomized Clinical Trial of Metformin to Treat Autosomal Dominant Polycystic Kidney Disease. ( Abebe, KZ; Bae, KT; Hallows, KR; Miskulin, DC; Perrone, RD; Seliger, SL; Watnick, T, 2018) |
| "Empagliflozin/linagliptin as monotherapy or add-on to metformin for 52 weeks was well tolerated in patients with T2DM, with safety profiles similar to individual components, including a low risk of hypoglycemia." | 5.27 | Safety and Tolerability of Combinations of Empagliflozin and Linagliptin in Patients with Type 2 Diabetes: Pooled Data from Two Randomized Controlled Trials. ( DeFronzo, RA; Kohler, S; Lee, C, 2018) |
| "This is a randomized double-blind multi-center clinical trial of insulin plus metformin versus insulin plus placebo for the treatment of type 2 diabetes complicating pregnancy." | 5.27 | Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study. ( Berry, DC; Boggess, K; de Los Angeles Abreu, M; Dorman, KF; Ivins, AR; Thomas, SD; Young, L, 2018) |
| " to metformin monotherapy improved glycemic control over 104 weeks and was generally welltolerated with a low risk of hypoglycemia." | 5.24 | A randomized clinical trial evaluating the efficacy and safety of the once-weekly dipeptidyl peptidase-4 inhibitor omarigliptin in patients with type 2 diabetes inadequately controlled on metformin monotherapy. ( Ceesay, P; Engel, SS; Gantz, I; Inzucchi, SE; Kaufman, KD; Lai, E; Scarabello, V; Shankar, RR; Suryawanshi, S, 2017) |
| "Vildagliptin effectively improved glucose level with a significantly greater reduction in glycemic variability and hypoglycemia than glimepiride in patients with T2DM ongoing metformin therapy." | 5.24 | The efficacy and safety of adding either vildagliptin or glimepiride to ongoing metformin therapy in patients with type 2 diabetes mellitus. ( Hur, KY; Jin, SM; Kim, G; Kim, JH; Lee, MK; Oh, S, 2017) |
| "In Japanese patients with type 2 diabetes treated with vildagliptin and low-dose metformin, metformin up-titration significantly but modestly improved glycemic control without hypoglycemia and weight gain." | 5.24 | Safety and efficacy of metformin up-titration in Japanese patients with type 2 diabetes mellitus treated with vildagliptin and low-dose metformin. ( Azuma, K; Goto, H; Ikeda, F; Kanazawa, A; Komiya, K; Masuyama, A; Mita, T; Ogihara, T; Ohmura, C; Osonoi, T; Osonoi, Y; Saito, M; Sato, J; Shimizu, T; Someya, Y; Suzuki, L; Takayanagi, N; Takeno, K; Uzawa, H; Watada, H, 2017) |
| "Metformin has been used in pregnancy since the 1970s." | 5.22 | Metformin for pregnancy and beyond: the pros and cons. ( Dunne, FP; Newman, C, 2022) |
| "The aim of the meta-analysis of randomized controlled trials (RCTs) was to compare the effectiveness of glycemic control and hypoglycemia risk of combination therapy (metformin plus a low hypoglycemic risk antidiabetic drug) vs." | 5.22 | Metformin plus a low hypoglycemic risk antidiabetic drug vs. metformin monotherapy for untreated type 2 diabetes mellitus: A meta-analysis of randomized controlled trials. ( Chen, YJ; Cheng, CY; Hsu, CY; Hung, WT; Lee, M; Ovbiagele, B, 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) |
| "Titrated canagliflozin significantly improved HbA1c, FPG, body weight and SBP, and was generally well tolerated over 26 weeks in patients with T2DM as add-on to metformin and sitagliptin." | 5.22 | Efficacy and safety of titrated canagliflozin in patients with type 2 diabetes mellitus inadequately controlled on metformin and sitagliptin. ( Aggarwal, N; Alba, M; Cao, A; Fung, A; Pfeifer, M; Rodbard, HW; Seufert, J, 2016) |
| "Teneligliptin co-administered with metformin produced significant reductions in HbA1c in patients with T2DM without increasing the risk of hypoglycemia." | 5.22 | The efficacy and safety of teneligliptin added to ongoing metformin monotherapy in patients with type 2 diabetes: a randomized study with open label extension. ( Bryson, A; Deak, L; Jennings, PE; Lawson, M; Paveliu, FS, 2016) |
| "To provide evidence-based options on how to intensify basal insulin, we explored head-to-head prandial interventions in overweight patients with type 2 diabetes inadequately controlled on basal insulin glargine with or without 1-3 oral antidiabetic agents (OADs)." | 5.22 | Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial. ( Aronson, R; Gentile, S; Guerci, B; Hanefeld, M; Heller, S; Perfetti, R; Rosenstock, J; Roy-Duval, C; Souhami, E; Tinahones, FJ; Wardecki, M; Ye, J, 2016) |
| "Severely burned adult patients with burns over 20% total body surface area (TBSA) burn were prospectively randomized in this Phase II clinical trial to either metformin or insulin (standard of care) treatment." | 5.22 | Glucose Control in Severely Burned Patients Using Metformin: An Interim Safety and Efficacy Analysis of a Phase II Randomized Controlled Trial. ( Abdullahi, A; Burnett, M; Jeschke, MG; Rehou, S; Stanojcic, M, 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) |
| "Triple therapy with saxagliptin add-on to dapagliflozin plus metformin for 52 weeks resulted in sustained improvements in glycaemic control without an increase in body weight or increased risk of hypoglycaemia." | 5.22 | One-year efficacy and safety of saxagliptin add-on in patients receiving dapagliflozin and metformin. ( Aggarwal, N; Chen, H; Chin, A; Garcia-Hernandez, P; Hansen, L; Iqbal, N; Johnsson, E; Matthaei, S, 2016) |
| "The percentage of patients experiencing any hypoglycemia event (ie, symptomatic event or event of plasma glucose concentration <54 mg/dL regardless of symptoms) was lower with saxagliptin compared with glimepiride (5." | 5.22 | Effects of Glimepiride versus Saxagliptin on β-Cell Function and Hypoglycemia: A Post Hoc Analysis in Older Patients with Type 2 Diabetes Inadequately Controlled with Metformin. ( Cook, W; Hirshberg, B; Ohman, P; Perl, S; Wei, C, 2016) |
| "Development of aleglitazar was halted because of a lack of cardiovascular efficacy and peroxisome proliferator-activated receptor-related side effects in patients with type 2 diabetes post-acute coronary syndrome; however, in the present studies, aleglitazar was well tolerated and effective in improving HbA1c, insulin resistance and lipid variables." | 5.20 | Efficacy, safety and tolerability of aleglitazar in patients with type 2 diabetes: pooled findings from three randomized phase III trials. ( Andjelkovic, M; Buse, JB; Durrwell, L; El Azzouzi, B; Henry, RR; Herz, M; Jaekel, K; Mingrino, R; Wu, H, 2015) |
| "In patients completing 4 years of treatment, dapagliflozin was well tolerated and associated with sustained glycaemic efficacy and greater reductions in body weight and SBP versus glipizide." | 5.20 | Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data. ( Del Prato, S; Durán-Garcia, S; Maffei, L; Nauck, M; Parikh, S; Rohwedder, K; Theuerkauf, A, 2015) |
| " This study examined the efficacy and safety of liraglutide monotherapy compared with metformin monotherapy in overweight/obese Japanese patients with type 2 diabetes (T2DM)." | 5.20 | Efficacy and safety of liraglutide monotherapy compared with metformin in Japanese overweight/obese patients with type 2 diabetes. ( Atsumi, Y; Imai, T; Irie, J; Itoh, H; Kawai, T; Meguro, S; Morimoto, J; Saisho, Y; Shigihara, T; Takei, I; Tanaka, K; Tanaka, M; Yajima, K, 2015) |
| "Ertugliflozin (1-25 mg/day) improved glycaemic control, body weight and blood pressure in patients with T2DM suboptimally controlled on metformin, and was well tolerated." | 5.20 | Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin. ( Amin, NB; Jain, SM; Lee, DS; Nucci, G; Rusnak, JM; Wang, X, 2015) |
| "5 mg, compared with daily insulin glargine without forced titration, demonstrated greater HbA1c reduction and weight loss, with a higher incidence of gastrointestinal adverse events and a lower risk of hypoglycemia." | 5.20 | Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2). ( Benroubi, M; Giorgino, F; Pechtner, V; Sun, JH; Zimmermann, AG, 2015) |
| "Adding liraglutide to a basal insulin analogue ± metformin significantly improved glycaemic control, body weight and systolic blood pressure compared with placebo." | 5.20 | Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial. ( Ahmann, A; Boopalan, A; de Loredo, L; Lahtela, JT; Nauck, MA; Rodbard, HW; Rosenstock, J; Tornøe, K, 2015) |
| "Saxagliptin + metformin was associated with fewer patients reporting hypoglycemia and fewer and less severe hypoglycemic events in those experiencing hypoglycemia compared with glipizide + metformin." | 5.19 | Saxagliptin versus glipizide as add-on therapy to metformin: assessment of hypoglycemia. ( Minervini, G; Mintz, ML, 2014) |
| "Linagliptin as add-on therapy to metformin and pioglitazone produced significant and clinically meaningful improvements in glycaemic control, without an additional risk of hypoglycaemia or weight gain (Clinical Trials Registry No: NCT 00996658)." | 5.19 | Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone: a 24-week randomized, double-blind study. ( Bajaj, M; Gilman, R; Kempthorne-Rawson, J; Lewis-D'Agostino, D; Patel, S; Woerle, HJ, 2014) |
| "To evaluate the effects of vildagliptin compared to glimepiride on glycemic control, insulin resistance and post-prandial lipemia." | 5.19 | Vildagliptin compared to glimepiride on post-prandial lipemia and on insulin resistance in type 2 diabetic patients. ( Bianchi, L; Bonaventura, A; D'Angelo, A; Derosa, G; Fogari, E; Maffioli, P; Romano, D, 2014) |
| "In obese, difficult-to-treat patients with T2DM inadequately controlled on high MDI insulin doses, empagliflozin improved glycemic control and reduced weight without increasing the risk of hypoglycemia and with lower insulin requirements." | 5.19 | Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. ( Broedl, UC; Frappin, G; Jelaska, A; Kim, G; Rosenstock, J; Salsali, A; Woerle, HJ, 2014) |
| "Alogliptin monotherapy maintained glycaemic control comparable to that of glipizide in elderly patients with T2DM over 1 year of treatment, with substantially lower risk of hypoglycaemia and without weight gain." | 5.17 | Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double-blind, randomized, 1-year study. ( Fleck, P; Rosenstock, J; Wilson, C, 2013) |
| "0 mmol/mol) without hypoglycaemia and weight gain was higher with vildagliptin than glimepiride after 2 years in type 2 diabetes patients inadequately controlled on metformin monotherapy, regardless of age and duration of diabetes." | 5.17 | Vildagliptin more effectively achieves a composite endpoint of HbA₁c < 7.0% without hypoglycaemia and weight gain compared with glimepiride after 2 years of treatment. ( Bader, G; Geransar, P; Schweizer, A, 2013) |
| "The glucose-lowering efficiency of combination therapy with metformin + vildagliptin, a DPP-4 inhibitor, was comparable with that of a metformin + SU combination, but safer with respect to the risk of developing hypoglycemia." | 5.17 | [A combination of dipeptidyl peptidase-4 inhibitor and metformin in the treatment of patients with type 2 diabetes mellitus: effective control of glycemia, weight, and quantitative body composition]. ( Aleksandrov, AA; Chernova, TO; Dedov, II; Il'in, AV; Shestakova, MV; Shmushkovich, IA; Suhareva, OIu, 2013) |
| "Canagliflozin added onto metformin significantly improved glycemic control in type 2 diabetes and was associated with low incidence of hypoglycemia and significant weight loss." | 5.16 | Dose-ranging effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, as add-on to metformin in subjects with type 2 diabetes. ( Aggarwal, N; Arbit, D; Canovatchel, W; Capuano, G; Polidori, D; Rosenstock, J; Usiskin, K; Zhao, Y, 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) |
| " The neonates of metformin group had less rate of birth weight centile >90 than insulin group (RR: 0." | 5.16 | Metformin compared with insulin in the management of gestational diabetes mellitus: a randomized clinical trial. ( Akbari, S; Alavi, A; Amjadi, N; Moosavi, S; Niromanesh, S; Sharbaf, FR, 2012) |
| "In metformin-treated patients, exenatide BID was noninferior to PIA for glycemic control but superior for hypoglycemia and weight control." | 5.15 | Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia. ( Bachmann, O; Becker, B; Böhmer, M; Gallwitz, B; Helsberg, K; Milek, K; Mölle, A; Peters, N; Petto, H; Segiet, T, 2011) |
| "Metformin treatment prevented weight gain (mean weight gain, -3." | 5.14 | Long-term effects of metformin on metabolism and microvascular and macrovascular disease in patients with type 2 diabetes mellitus. ( Bets, D; de Jager, J; Donker, AJ; Kooy, A; Lehert, P; Stehouwer, CD; Wulffelé, MG, 2009) |
| " Vildagliptin provided additional HbA(1c) lowering to that achieved with metformin alone and comparable to that achieved with pioglitazone, with only pioglitazone causing weight gain." | 5.14 | Comparison of vildagliptin and pioglitazone in patients with type 2 diabetes inadequately controlled with metformin. ( Bolli, G; Colin, L; Dotta, F; Goodman, M; Minic, B, 2009) |
| "The only significant difference in outcome between the 2 treatment drugs was that maternal weight gain during pregnancy was less in the metformin (n=40) than in the glyburide group (n=32) (10." | 5.14 | Metformin compared with glyburide for the management of gestational diabetes. ( Bertini, AM; Bizato, J; de Souza, BV; Pacheco, C; Ribeiro, TE; Silva, JC, 2010) |
| "Vildagliptin add-on has similar efficacy to glimepiride after 2 years' treatment, with markedly reduced hypoglycaemia risk and no weight gain." | 5.14 | Vildagliptin add-on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: results from a 2-year study. ( Ahren, B; Couturier, A; Dejager, S; Ferrannini, E; Foley, JE; Fonseca, V; Matthews, DR; Zinman, B, 2010) |
| " If insufficient in monotherapy, it can preferably be used in combination with metformin, which targets insulin resistance, and also in combination with sodium-glucose cotransporter 2 inhibition, thiazolidinediones and insulin, which target other mechanisms." | 5.12 | Glucose-lowering action through targeting islet dysfunction in type 2 diabetes: Focus on dipeptidyl peptidase-4 inhibition. ( Ahrén, B, 2021) |
| "in patients with type 2 diabetes failing on metformin or a sulfonylurea, Mix25+M provided similar overall glycemic control, lower ppPG, reduced nocturnal hypoglycemia, and fewer hyperglycemic symptoms compared to G+M." | 5.10 | Therapy after single oral agent failure: adding a second oral agent or an insulin mixture? ( Beattie, SD; Campaigne, BN; Howard, AS; Johnson, PA; Malone, JK; Milicevic, Z, 2003) |
| "08]), but less hypoglycemia as add-on to metformin (odds ratio [OR] 0." | 5.01 | Sodium-Glucose Co-Transporter 2 Inhibitors Compared with Sulfonylureas in Patients with Type 2 Diabetes Inadequately Controlled on Metformin: A Meta-Analysis of Randomized Controlled Trials. ( Chen, Z; Li, G, 2019) |
| "To explore the non-severe hypoglycemia risk difference (RD) for SU use compared with SGLT2-I in randomized controlled trials (RCTs) as an add on to metformin." | 4.95 | Non-severe Hypoglycemia Risk Difference between Sulfonylurea and Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2-I) as an Add-On to Metformin in Randomized Controlled Trials. ( Farahani, P, 2017) |
| "To synthesize data addressing outcomes of metformin use in populations with type 2 diabetes and moderate to severe chronic kidney disease (CKD), congestive heart failure (CHF), or chronic liver disease (CLD) with hepatic impairment." | 4.95 | Clinical Outcomes of Metformin Use in Populations With Chronic Kidney Disease, Congestive Heart Failure, or Chronic Liver Disease: A Systematic Review. ( Cameron, CB; Crowley, MJ; Diamantidis, CJ; Kosinski, AS; McDuffie, JR; Mock, CK; Nagi, A; Stanifer, JW; Tang, S; Wang, X; Williams, JW, 2017) |
| "Adding different AHAs to metformin was associated with varying effects on HbA1c, BW, SBP, hypoglycemia, UTI and GTI which should impact clinician choice when selecting adjunctive therapy." | 4.91 | Comparative efficacy and safety of antidiabetic drug regimens added to metformin monotherapy in patients with type 2 diabetes: a network meta-analysis. ( Coleman, CI; Doleh, Y; Kohn, CG; Mearns, ES; Saulsberry, WJ; Sobieraj, DM; White, CM; Zaccaro, E, 2015) |
| "In women with gestational diabetes, metformin use and insulin therapy have comparable glycemic control profile, but metformin use was associated with lower risk of neonatal hypoglycemia." | 4.91 | Metformin for the treatment of gestational diabetes: An updated meta-analysis. ( Kitwitee, P; Limwattananon, C; Limwattananon, S; Nguyen, TV; Phimphilai, M; Pongchaiyakul, C; Ratanachotpanich, T; Waleekachonlert, O, 2015) |
| "Compared with other oral insulinotropic agents, gliclazide significantly reduced HbA1c with no difference regarding hypoglycemia risk." | 4.91 | Systematic review and meta-analysis of the efficacy and hypoglycemic safety of gliclazide versus other insulinotropic agents. ( Chan, SP; Colagiuri, S, 2015) |
| " This is the case for metformin (risk of lactic acidosis) and for many sulfonylureas (risk of hypoglycemia)." | 4.89 | Pharmacokinetic considerations for the treatment of diabetes in patients with chronic kidney disease. ( Scheen, AJ, 2013) |
| " These options are mostly new and have the advantage a neutral or favourable (for GLP-1) effect on body weight in obese type 2 DM patient and the absence of any hypoglycaemic risk in both classes of incretins." | 4.89 | [Management of type 2 diabetes: new or previous agents, how to choose?]. ( Halimi, S, 2013) |
| " The traditional approach involves: i) metformin, acting mainly on fasting blood glucose; ii) sulphonylureas, that have shown a number of drawbacks, including the high risk of hypoglycemia; iii) pioglitazone, with a substantial effect on fasting and postprandial glucose and a low risk of hypoglycaemia; iv) insulin, that can be utilized with the basal or prandial approach." | 4.89 | What are the preferred strategies for control of glycaemic variability in patients with type 2 diabetes mellitus? ( Marangoni, A; Zenari, L, 2013) |
| " The use of pioglitazone has been associated with an increased risk of bladder cancer, edema, heart failure, weight gain, and distal bone fractures in postmenopausal women." | 4.89 | [Limitations of insulin-dependent drugs in the treatment of type 2 diabetes mellitus]. ( de Pablos-Velasco, PL; Valerón, PF, 2013) |
| "In patients with type 2 diabetes who do not achieve the glycaemic targets with metformin alone, DPP-4 inhibitors can lower HbA(1c), in a similar way to sulfonylureas or pioglitazone, with neutral effects on body weight." | 4.88 | Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis. ( Karagiannis, T; Matthews, DR; Paletas, K; Paschos, P; Tsapas, A, 2012) |
| "To determine the comparative efficacy, risk of weight gain, and hypoglycemia associated with noninsulin antidiabetic drugs in patients with type 2 DM not controlled by metformin alone." | 4.86 | Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. ( Coleman, CI; Phung, OJ; Scholle, JM; Talwar, M, 2010) |
| " The only drug that proved to be effective in reducing cardiovascular events is metformin, which increases AMP-activated protein kinase activity and has a potent cardioprotective effect against ischemia-reperfusion injury." | 4.86 | [Hypoglycemic therapy in heart disease patients with type 2 diabetes mellitus]. ( Cosmi, D; Cosmi, F, 2010) |
| " The sulfonyluereas, repaglinide, metformin, acarbose and the thiazolidinediones are effective in decreasing fasting plasma glucose levels, but their limitations may include adverse effects, such as weight gain and hypoglycemia, and an inability to modify some of the important comorbidities of diabetes." | 4.80 | Advances in oral therapy for type 2 diabetes. ( Davis, SN, 2000) |
| "To assess if switching to or adding sulfonylureas increases major adverse cardiovascular events (MACE) or severe hypoglycemia versus remaining on metformin alone." | 4.31 | Sulfonylureas as second line therapy for type 2 diabetes among veterans: Results from a National Longitudinal Cohort Study. ( Axon, RN; Chandler, O; Gebregziabher, M; Strychalski, ML; Taber, DJ; Ward, R; Weeda, ER, 2023) |
| " This study aimed to compare glycemic control and the incidence of hypoglycemia and chronic complications among adult patients with type 2 diabetes prescribed metformin, dipeptidyl peptidase-4 inhibitors (DPP4I), and sulfonylurea (SU) as monotherapy or dual combination therapy." | 4.12 | Real-world comparison of mono and dual combination therapies of metformin, sulfonylurea, and dipeptidyl peptidase-4 inhibitors using a common data model: A retrospective observational study. ( Cho, EH; Jin, HY; Kim, SS; Kim, YJ; Lee, KA; Park, TS, 2022) |
| " We used blinded continuous glucose monitoring (CGM) and self-report to compare hypoglycemia rates and duration in 179 type 2 diabetes patients treated with sulphonylureas (n=100) and insulin (n=51) in comparison with those treated with metformin only (n=28)." | 4.12 | Continuous glucose monitoring demonstrates low risk of clinically significant hypoglycemia associated with sulphonylurea treatment in an African type 2 diabetes population: results from the OPTIMAL observational multicenter study. ( Balungi, PA; Carr, ALJ; Hattersley, AT; Jones, AG; Mwebaze, R; Niwaha, AJ; Nyirenda, MJ; Rodgers, LR; Shields, BM, 2022) |
| "Metformin-associated lactic acidosis (MALA) is an extremely rare but life-threatening adverse effect of metformin treatment." | 4.12 | Metformin-associated Lactic Acidosis with Hypoglycemia during the COVID-19 Pandemic. ( Hazama, Y; Irie, Y; Kosugi, M; Maruo, Y; Obata, Y; Takayama, K; Yamaguchi, H; Yasuda, T, 2022) |
| "To compare the risk of myocardial infarction (MI), ischemic stroke, or cardiovascular death in patients with T2D treated with mitoKATP channel high-affinity sulfonylureas and low-affinity sulfonylureas as add-on to metformin." | 4.12 | Comparison of Mitochondrial Adenosine Triphosphate-Sensitive Potassium Channel High- vs Low-Affinity Sulfonylureas and Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With Metformin. ( Hsu, YJ; Huang, YL; Lai, JH; Lee, CH; Lin, C; Lin, TC; Pan, HY; Wang, MT; Wang, PC; Wu, LW, 2022) |
| "Metformin is beneficial for GDM women to control total GWG compared with insulin, regulate fetal birth weight more than insulin and glyburide, and increase the risk of unmet treatment targets compared with insulin." | 4.12 | Efficacy and safety of hypoglycemic agents on gestational diabetes mellitus in women: A Bayesian network analysis of randomized controlled trials. ( Chen, H; Cui, W; Guo, H; Huang, L; Jing, Y; Liu, X; Song, L; Sun, B; Wang, M; Wang, N; Wang, T; Xu, J, 2022) |
| "Initial triple combination therapy with the DPP4 inhibitor, metformin, and thiazolidinedione showed a higher achievement of the target HbA1c goal with a lower risk of hypoglycemia, better restoration of β-cell function, and multiple metabolic benefits, implying durable glycemic control." | 3.96 | Therapeutic efficacy and safety of initial triple combination of metformin, sitagliptin, and lobeglitazone in drug-naïve patients with type 2 diabetes: initial triple study. ( Davies, MJ; Kim, KM; Ku, EJ; Lee, JE; Lee, JH; Lee, SY; Lim, S, 2020) |
| " This study will provide robust evidence regarding the efficacy and safety of metformin use in pregnancy, and may identify subgroups of patients who may benefit most from this treatment modality." | 3.96 | Metformin in Pregnancy Study (MiPS): protocol for a systematic review with individual patient data meta-analysis. ( Burden, C; Carlsen, SM; Dodd, JM; Hague, W; Hilkka, I; Løvvik, T; Morin-Papunen, L; Mousa, A; Nicolaides, K; Norman, JE; Rönnemaa, T; Rowan, J; Shehata, H; Syngelaki, A; Teede, HJ; Tertti, K; Vanky, E, 2020) |
| "Liraglutide seems to reduce GV in the acute phase of acute coronary syndrome, and patients achieved optimal control with a low incidence of hypoglycemia." | 3.96 | Glycemic variability in type 2 diabetes mellitus and acute coronary syndrome: liraglutide compared with insulin glargine: a pilot study. ( Arnau Vives, MA; Ballesteros Martin-Portugués, A; Catalá Gregori, A; Caudet Esteban, J; Cerveró Rubio, A; Del Olmo-García, MI; Hervás Marín, D; Merino-Torres, JF; Penalba Martínez, M, 2020) |
| "Prior research suggests that warfarin, when given concomitantly with some sulfonylureas, may increase the risk of serious hypoglycemia." | 3.91 | Serious Hypoglycemia and Use of Warfarin in Combination With Sulfonylureas or Metformin. ( Bilker, WB; Brensinger, CM; Han, X; Hennessy, S; Leonard, CE; Nam, YH, 2019) |
| "To report a case of severe lactic acidosis and hypoglycemia due to acute metformin intoxication in a dog." | 3.88 | Severe lactic acidosis and hypoglycemia due to acute metformin intoxication in a dog. ( Borchers, A; Ueda, Y; Wong, C, 2018) |
| "Metformin toxicity is well known to cause lactic acidosis." | 3.88 | Recurrent hypoglycemia secondary to metformin toxicity in the absence of co-ingestions: a case report. ( Aldobeaban, S; Alshehri, AA; Mzahim, B, 2018) |
| "Sitagliptin can reduce BMI and the occurrence of hypoglycemia in obese patients with insulin treatment-induced diabetes mellitus, and the effect may be related to decreased HOMA-IR, decreased leptin and visfatin levels, and increased adiponectin levels." | 3.85 | The effect of sitagliptin on obese patients with insulin treatment-induced diabetes mellitus. ( Li, H; Li, S; Wang, R; Zhang, JP, 2017) |
| "The objective of this nationwide study was to compare the risk of all-cause mortality, fatal and nonfatal cardiovascular disease (CVD), and severe hypoglycemia in patients with type 2 diabetes (T2D) on metformin monotherapy treatment starting second-line treatment with either insulin or dipeptidyl peptidase-4 inhibitor (DPP-4i)." | 3.85 | Second line initiation of insulin compared with DPP-4 inhibitors after metformin monotherapy is associated with increased risk of all-cause mortality, cardiovascular events, and severe hypoglycemia. ( Bodegard, J; Eriksson, JW; Nathanson, D; Norhammar, A; Nyström, T; Thuresson, M, 2017) |
| "DPP4is as a second-line add-on to metformin had a significantly lower stroke risk [hazard ratio (HR) 0." | 3.85 | Comparative cardiovascular risks of dipeptidyl peptidase 4 inhibitors with other second- and third-line antidiabetic drugs in patients with type 2 diabetes. ( Chang, KC; Li, CY; Ou, HT; Wu, JS, 2017) |
| " significantly improved glycemic control without an increased risk of hypoglycemia in Asian, predominantly Chinese, patients with T2DM inadequately controlled on insulin, with or without metformin." | 3.83 | Vildagliptin as add-on therapy to insulin improves glycemic control without increasing risk of hypoglycemia in Asian, predominantly Chinese, patients with type 2 diabetes mellitus. ( Kothny, W; Li, L; Lukashevich, V; Lv, X; Ma, J; Ning, G; Wang, W; Woloschak, M; Yang, M, 2016) |
| "Linagliptin added to basal insulin and metformin improved glycaemic control, without increasing the risk of hypoglycaemia or body weight gain." | 3.83 | Efficacy and safety of linagliptin as add-on therapy to basal insulin and metformin in people with Type 2 diabetes. ( Durán-Garcia, S; Hehnke, U; Lee, J; Patel, S; Rosenstock, J; Thiemann, S; Woerle, HJ; Yki-Järvinen, H, 2016) |
| " Metformin initiators who intensified treatment with insulin or sulfonylurea were followed to either their first or recurrent hypoglycemia event using Cox proportional hazard models." | 3.83 | Risk of hypoglycemia following intensification of metformin treatment with insulin versus sulfonylurea. ( Elasy, T; Greevy, RA; Griffin, MR; Grijalva, CG; Hung, AM; Liu, X; Min, JY; Roumie, CL, 2016) |
| "To assess hypoglycemia incidence rates and associated costs in patients who initiated second-line treatment with the antidiabetic agents linagliptin or a sulfonylurea (SU) after metformin." | 3.83 | Hypoglycemia Incidence Rates and Associated Health Care Costs in Patients with Type 2 Diabetes Mellitus Treated with Second-Line Linagliptin or Sulfonylurea After Metformin Monotherapy. ( Cai, B; D'Souza, AO; Raju, A; Shetty, S, 2016) |
| " The objective of this nationwide study was to compare the risk of cardiovascular disease (CVD), all-cause mortality and severe hypoglycemia in patients with type 2 diabetes (T2D) starting second-line treatment with either metformin+sulphonylurea or metformin+dipeptidyl peptidase-4 inhibitor (DPP-4i)." | 3.83 | Sulphonylurea compared to DPP-4 inhibitors in combination with metformin carries increased risk of severe hypoglycemia, cardiovascular events, and all-cause mortality. ( Bodegard, J; Eriksson, JW; Nathanson, D; Norhammar, A; Nyström, T; Thuresson, M, 2016) |
| "56]) compared with sulfonylureas as add-on therapy to metformin but had no effect on risks for myocardial infarction and hospitalization for heart failure." | 3.81 | Effects on Clinical Outcomes of Adding Dipeptidyl Peptidase-4 Inhibitors Versus Sulfonylureas to Metformin Therapy in Patients With Type 2 Diabetes Mellitus. ( Chao, PW; Chen, TJ; Chen, YT; Chu, H; Kuo, SC; Lee, YJ; Li, SY; Lin, CC; Ou, SM; Shih, CJ; Tarng, DC; Wang, SJ; Yang, CY, 2015) |
| "Despite the limitations of this observational study, diabetes patients with MS who were treated with metformin plus DPP-4 inhibitors had better compliance, greater metabolic control, and lower rates of hypoglycemia, causing lower costs for the Spanish national health system than patients receiving metformin plus other antidiabetes drugs." | 3.80 | Healthcare costs of the combination of metformin/dipeptidyl peptidase-4 inhibitors compared with metformin/other oral antidiabetes agents in patients with type 2 diabetes and metabolic syndrome. ( Navarro-Artieda, R; Sicras-Mainar, A, 2014) |
| "Lactic acidosis is a well-recognized consequence of metformin." | 3.79 | Metformin overdose-induced hypoglycemia in the absence of other antidiabetic drugs. ( Al-Abri, SA; Hayashi, S; Olson, KR; Thoren, KL, 2013) |
| "The aim of this study was to evaluate the frequency of metformin-associated lactic acidosis in our metformin-intoxicated patients, the general approach for their management, and determine the frequency of hypoglycemia and outcome in these patients." | 3.79 | Metformin toxicity: a report of 204 cases from Iran. ( Askari, A; Barzi, F; Ebrahimian, K; Hassanian-Moghaddam, H; Shadnia, S; Zamani, N, 2013) |
| "In pre-specified analyses adjusting for the most recently measured HbA(1c) value, there was a substantial reduction in risk for confirmed hypoglycemia with sitagliptin compared to glipizide when added to ongoing metformin therapy in patients with T2DM." | 3.78 | Lower risk of hypoglycemia with sitagliptin compared to glipizide when either is added to metformin therapy: a pre-specified analysis adjusting for the most recently measured HbA(1c) value. ( Davies, MJ; Ferrante, SA; Goldstein, BJ; Kaufman, KD; Krobot, KJ; Meininger, GE; Seck, T; Williams-Herman, D, 2012) |
| "To evaluate the experience of hypoglycemia in patients treated with metformin in combination with sulphonylureas (SUs) and the impact on patients' quality of life (QoL) and worry about hypoglycemia." | 3.77 | Self-reported experience of hypoglycemia among adults with type 2 diabetes mellitus (Exhype). ( Deleskog, A; Journath, G; Pettersson, B; Rosenqvist, U; Wändell, P, 2011) |
| " Because patient compliance may be affected when media sensationalism about controversial findings is misunderstood, we sought to clarify the recent controversy surrounding the cardiovascular and bone-health risks of thiazolidinediones, the risk of lactic acidosis with metformin, and the risk of hypoglycemia with oral therapies." | 3.75 | Balancing risk and benefit with oral hypoglycemic drugs. ( Hamnvik, OP; McMahon, GT, 2009) |
| "Lactic acidosis has been associated with use of metformin." | 3.74 | Metformin, sulfonylureas, or other antidiabetes drugs and the risk of lactic acidosis or hypoglycemia: a nested case-control analysis. ( Bodmer, M; Jick, SS; Krähenbühl, S; Meier, C; Meier, CR, 2008) |
| " There were 42 cases of metformin-associated lactic acidosis (MALA) with 18 deaths (43%); 40 of the MALA cases had documented contra-indications, especially renal impairment, and the remaining two cases were due to drug overdosage, one being a suicide." | 3.67 | Metformin and the sulphonylureas: the comparative risk. ( Campbell, IW, 1985) |
| "Seventy drug-naïve patients with type 2 diabetes (mean age, 52." | 3.30 | Effects of Initial Combinations of Gemigliptin Plus Metformin Compared with Glimepiride Plus Metformin on Gut Microbiota and Glucose Regulation in Obese Patients with Type 2 Diabetes: The INTESTINE Study. ( Ahn, J; Florez, JC; Lim, S; Nauck, MA; Sohn, M, 2023) |
| "In VERTIS CV, mean duration of type 2 diabetes was 13." | 3.30 | Ertugliflozin Delays Insulin Initiation and Reduces Insulin Dose Requirements in Patients With Type 2 Diabetes: Analyses From VERTIS CV. ( Cannon, CP; Cherney, DZI; Cosentino, F; Dagogo-Jack, S; Frederich, R; Gantz, I; Liu, J; Masiukiewicz, U; Pratley, RE; Shi, H, 2023) |
| "iGlarLixi achieved significant HbA1c reductions, to near-normoglycaemic levels, compared with iGlar or Lixi, with no meaningful additional risk of hypoglycaemia and mitigated body weight gain versus iGlar, with fewer gastrointestinal adverse events versus Lixi." | 3.11 | Efficacy and safety benefits of iGlarLixi versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with suboptimally controlled type 2 diabetes on oral agents: The LixiLan-O-AP randomized controlled trial. ( Chen, L; Cheng, Z; Dong, X; Gu, S; Li, Q; Liu, M; Niemoeller, E; Ping, L; Souhami, E; Xiao, J; Yang, W; Yuan, G, 2022) |
| "This phase 3 confirmatory diabetes mellitus treatment study compared the safety and efficacy of Rapilin and NovoRapid insulin asparts in combination with metformin." | 3.11 | Comparative efficacy and safety of two insulin aspart formulations (Rapilin and NovoRapid) when combined with metformin, for patients with diabetes mellitus: a multicenter, randomized, open-label, controlled clinical trial. ( Guo, X; Han, P; Li, Q; Lu, J; Lv, X; Mo, Z; Peng, Y; Shi, Y; Sun, L; Wang, D; Wang, W; Wang, Z; Xue, Y; Yan, D; Yang, T; Yang, W; Yao, J; Yu, X; Zhang, F; Zhang, L; Zhang, X; Zhu, L, 2022) |
| "Pregnancies affected by gestational diabetes mellitus (GDM) are associated with an increased risk of adverse maternal and foetal outcomes." | 3.11 | A randomised placebo-controlled trial of the effectiveness of early metformin in addition to usual care in the reduction of gestational diabetes mellitus effects (EMERGE): study protocol. ( Alvarez-Iglesias, A; Browne, M; Devane, D; Dunne, F; Gillespie, P; Newman, C; O'Donnell, M; Smyth, A, 2022) |
| "Metformin treatment was associated with a better postprandial glycemic control than insulin for some meals, a lower risk of hypoglycemic episodes, less maternal weight gain, and a low rate of failure as an isolated treatment." | 3.01 | Metformin for gestational diabetes study: metformin vs insulin in gestational diabetes: glycemic control and obstetrical and perinatal outcomes: randomized prospective trial. ( González-Mesa, E; González-Romero, S; Molina-Vega, M; Olveira, G; Picón-César, MJ; Roldan-López, R; Romero-Narbona, F; Sola-Moyano, AP; Suárez-Arana, M; Tinahones, FJ, 2021) |
| " The incidence of overall adverse events and the number of hypoglycaemic adverse events were similar between the study groups." | 2.94 | Efficacy and safety of gemigliptin as add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus (ZEUS II study). ( Benjachareonwong, S; Chamnan, P; Cho, YM; Choi, S; Deerochanawong, C; Kang, ES; Kim, S; Kosachunhanun, N; Kwon, S; Lee, MK; Lee, WJ; Oh, T; Pratipanawatr, T; Sattanon, S; Seekaew, S; Sirirak, T; Suraamornkul, S; Suwanwalaikorn, S, 2020) |
| "Given the current lack of clinical data, this study will provide evidence supporting safe and effective glycemic control using basal insulin glargine-based therapy plus OADs compared with twice-daily premixed insulin in Chinese patients with T2DM after short-term IIT." | 2.94 | Efficacy and Safety of Basal Insulin-Based Treatment Versus Twice-Daily Premixed Insulin After Short-Term Intensive Insulin Therapy in Patients with Type 2 Diabetes Mellitus in China: Study Protocol for a Randomized Controlled Trial (BEYOND V). ( Cui, N; Guo, L; Jiang, X; Liu, J; Mu, Y; Wang, G; Xu, B; Zhang, X, 2020) |
| " The incidence of adverse events, including the incidence of hypoglycemia (18." | 2.94 | Efficacy and safety of generic exenatide injection in Chinese patients with type 2 diabetes: a multicenter, randomized, controlled, non-inferiority trial. ( Gao, Y; Guo, L; Hong, T; Li, Q; Tian, Q; Xiao, W; Yang, J; Zhong, L, 2020) |
| " Adverse events overall and changes from baseline in body weight were similar between the two treatment groups." | 2.90 | Double-blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase-4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT-I Study. ( Darmiento, C; Duran-García, S; Engel, SS; Gantz, I; Golm, GT; Kaufman, KD; Lam, RLH; O'Neill, EA; Roussel, R; Shah, S; Shankar, RR; Zhang, Y, 2019) |
| " DAPA plus SAXA was generally well tolerated and the incidence of adverse events was similar in both treatment arms." | 2.90 | Sustained 52-week efficacy and safety of triple therapy with dapagliflozin plus saxagliptin versus dual therapy with sitagliptin added to metformin in patients with uncontrolled type 2 diabetes. ( Del Prato, S; Garcia-Sanchez, R; Handelsman, Y; Iqbal, N; Johnsson, E; Kurlyandskaya, R; Mathieu, C; Rosenstock, J, 2019) |
| "Metformin use was associated with decreased fracture risk (HR = 0." | 2.90 | Glycemic Control and Insulin Treatment Alter Fracture Risk in Older Men With Type 2 Diabetes Mellitus. ( Adler, RA; Colón-Emeric, C; LaFleur, J; Lee, RH; Lyles, KW; Pieper, C; Sloane, R; Van Houtven, C, 2019) |
| "In patients with uncontrolled type 2 diabetes while using metformin, co-administration of ertugliflozin and sitagliptin provided more effective glycaemic control through 52 weeks compared with the individual agents." | 2.87 | Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial. ( Eldor, R; Engel, SS; Golm, G; Huyck, SB; Johnson, J; Lauring, B; Mancuso, JP; Pratley, RE; Qiu, Y; Raji, A; Sunga, S; Terra, SG, 2018) |
| " After 24 weeks, incidences of adverse events and serious adverse events were similar between triple and dual therapy and between concomitant and sequential add-on regimens." | 2.87 | Safety and tolerability of dapagliflozin, saxagliptin and metformin in combination: Post-hoc analysis of concomitant add-on versus sequential add-on to metformin and of triple versus dual therapy with metformin. ( Chen, H; Del Prato, S; Garcia-Sanchez, R; Hansen, L; Iqbal, N; Johnsson, E; Mathieu, C; Rosenstock, J, 2018) |
| "Elderly subjects with metformin-treated type 2 diabetes have lower glucagon levels at 3." | 2.87 | Effects on the glucagon response to hypoglycaemia during DPP-4 inhibition in elderly subjects with type 2 diabetes: A randomized, placebo-controlled study. ( Ahrén, B; Farngren, J; Persson, M, 2018) |
| "Patients with type 2 diabetes and HbA1c 53-86 mmol/mol (7% to 10%) were randomized to empagliflozin 25 mg or glimepiride 1 to 4 mg for 104 weeks as add-on to metformin." | 2.87 | Empagliflozin compared with glimepiride in metformin-treated patients with type 2 diabetes: 208-week data from a masked randomized controlled trial. ( Andersen, KR; Ridderstråle, M; Rosenstock, J; Salsali, A; Woerle, HJ, 2018) |
| "More dapagliflozintreated than saxagliptin-treated patients achieved the composite endpoint of HbA1c reduction ≥ 0." | 2.87 | Dapagliflozin versus saxagliptin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin. ( Chen, H; Garcia-Sanchez, R; Mathieu, C; Rosenstock, J; Saraiva, GL, 2018) |
| " The overall frequency of adverse events was similar among the groups." | 2.84 | Randomized, double-blind, phase III study to evaluate the efficacy and safety of once-daily treatment with alogliptin and metformin hydrochloride in Japanese patients with type 2 diabetes. ( Kaku, K; Katou, M; Kinugawa, Y; Nishiyama, Y; Sumino, S, 2017) |
| " A higher incidence of serious adverse events was observed in the sitagliptin group (5." | 2.84 | A randomized clinical trial of the safety and efficacy of sitagliptin in patients with type 2 diabetes mellitus inadequately controlled by acarbose alone. ( Engel, SS; Fujita, KP; Kaufman, KD; Liu, X; Ma, J; Ning, G; O'Neill, EA; Shankar, RR; Wang, W; Wu, F; Xu, L; Zheng, S, 2017) |
| " In general, both treatments were well tolerated, with incidences and types of adverse events comparable between the two groups." | 2.84 | Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes: A 24-week randomized, controlled trial with open label extension. ( Chung, CH; Han, KA; Hong, SM; Hwang, DM; Lee, CB; Mok, JO; Park, CY; Park, KS; Park, SW; Yoon, KH, 2017) |
| "Glyburide was started in 53 patients and metformin in 51." | 2.84 | Glyburide Versus Metformin and Their Combination for the Treatment of Gestational Diabetes Mellitus: A Randomized Controlled Study. ( Gam Ze Letova, Y; Hasanein, J; Hissin, N; Nachum, Z; Salim, R; Suleiman, A; Yefet, E; Zafran, N, 2017) |
| "0%, the proportion of patients with gastrointestinal adverse events (GI AEs), and the proportion of patients achieving HbA1c < 7." | 2.84 | Efficacy and safety of saxagliptin compared with acarbose in Chinese patients with type 2 diabetes mellitus uncontrolled on metformin monotherapy: Results of a Phase IV open-label randomized controlled study (the SMART study). ( Bian, F; Du, J; Fang, H; Li, W; Liang, L; Mu, Y; Shen, L; Wang, X; Xu, C; Xu, F, 2017) |
| " The primary outcome was the HbA1c level, and secondary outcomes included the body mass index (BMI), total insulin daily dose (TIDD) (unit/kg/d), hypoglycemia events, diabetes ketoacidosis (DKA) events, and gastrointestinal adverse events (GIAEs)." | 2.82 | Effect and Safety of Adding Metformin to Insulin Therapy in Treating Adolescents With Type 1 Diabetes Mellitus: An Updated Meta-Analysis of 10 Randomized Controlled Trials. ( Chen, H; Li, H; Li, L; Liu, Y; Wu, J, 2022) |
| "Hypoglycemia was defined as sensor glucose level of less than 60 mg/dl in two or more consecutive readings from CGM." | 2.82 | Glycemic excursions are positively associated with changes in duration of asymptomatic hypoglycemia after treatment intensification in patients with type 2 diabetes. ( Lee, IT; Lee, WJ; Lin, SD; Lin, SY; Sheu, WH; Su, SL; Tseng, YH; Tu, ST; Wang, JS, 2016) |
| "To assess the effect of metformin versus placebo both in combination with insulin analogue treatment on changes in carotid intima-media thickness (IMT) in patients with type 2 diabetes." | 2.82 | Metformin versus placebo in combination with insulin analogues in patients with type 2 diabetes mellitus-the randomised, blinded Copenhagen Insulin and Metformin Therapy (CIMT) trial. ( Almdal, TP; Boesgaard, TW; Breum, L; Carstensen, B; Duun, E; Gade-Rasmussen, B; Gluud, C; Hedetoft, C; Hemmingsen, B; Jensen, T; Krarup, T; Lund, SS; Lundby-Christensen, L; Madsbad, S; Mathiesen, ER; Pedersen, O; Perrild, H; Røder, M; Sneppen, SB; Snorgaard, O; Tarnow, L; Thorsteinsson, B; Vaag, A; Vestergaard, H; Wetterslev, J; Wiinberg, N, 2016) |
| "Participants with type 2 diabetes (glycated haemoglobin (HbA1c) ≥ 7." | 2.82 | Effects of biphasic, basal-bolus or basal insulin analogue treatments on carotid intima-media thickness in patients with type 2 diabetes mellitus: the randomised Copenhagen Insulin and Metformin Therapy (CIMT) trial. ( Almdal, TP; Boesgaard, TW; Breum, L; Carstensen, B; Duun, E; Gade-Rasmussen, B; Gluud, C; Hedetoft, C; Hemmingsen, B; Jensen, T; Krarup, T; Lund, SS; Lundby-Christensen, L; Madsbad, S; Mathiesen, ER; Pedersen, O; Perrild, H; Røder, M; Sneppen, SB; Snorgaard, O; Tarnow, L; Thorsteinsson, B; Vaag, A; Vestergaard, H; Wetterslev, J; Wiinberg, N, 2016) |
| "Among patients with uncontrolled type 2 diabetes taking glargine and metformin, treatment with degludec/liraglutide compared with up-titration of glargine resulted in noninferior HbA1c levels, with secondary analyses indicating greater HbA1c level reduction after 26 weeks of treatment." | 2.82 | Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes: The DUAL V Randomized Clinical Trial. ( Buse, JB; García-Hernández, P; Lehmann, L; Lingvay, I; Norwood, P; Pérez Manghi, F; Tarp-Johansen, MJ, 2016) |
| "8 mg in combination with metformin (≥1500 mg) were randomized to addition of once-daily IDeg ('IDeg add-on to liraglutide' arm; n = 174) or placebo ('placebo add-on to liraglutide' arm; n = 172), with dosing of both IDeg and placebo based on titration guidelines." | 2.82 | Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study). ( Andersen, TH; Aroda, VR; Bailey, TS; Cariou, B; Kumar, S; Leiter, LA; Philis-Tsimikas, A; Raskin, P; Zacho, J, 2016) |
| " The mean terminal half-life (t1/2 ) was 2-3 h." | 2.82 | Safety, tolerability, pharmacokinetics and pharmacodynamics of AZP-531, a first-in-class analogue of unacylated ghrelin, in healthy and overweight/obese subjects and subjects with type 2 diabetes. ( Abribat, T; Allas, S; Delale, T; Julien, M; Ngo, N; Ritter, J; Sahakian, P; van der Lely, AJ, 2016) |
| "After run-in on metformin and basal-bolus insulin (BBI), 102 participants continued metformin and basal insulin and were randomized to exenatide dosing before the two largest meals (glucacon-like peptide-1 receptor agonist and insulin [GLIPULIN group]) or continuation of rapid-acting insulin analogs (BBI group)." | 2.82 | Glucose Variability in a 26-Week Randomized Comparison of Mealtime Treatment With Rapid-Acting Insulin Versus GLP-1 Agonist in Participants With Type 2 Diabetes at High Cardiovascular Risk. ( , 2016) |
| "LixiLan achieved statistically significant reductions to near-normal HbA1c levels with weight loss and no increased hypoglycemic risk, compared with insulin glargine alone, and a low incidence of gastrointestinal adverse events in type 2 diabetes inadequately controlled on metformin." | 2.82 | Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Lixisenatide and Insulin Glargine, Versus Insulin Glargine in Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy: The LixiLan Proof-of-Concept Randomized Trial. ( Aroda, VR; Diamant, M; Fonseca, V; Perfetti, R; Rosenstock, J; Silvestre, L; Souhami, E; Zhou, T, 2016) |
| " The key secondary endpoints included percentage of patients achieving target HbA1c without adverse gastrointestinal (GI) events and mean change in fasting plasma glucose (FPG) from baseline to week 24." | 2.82 | Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin uptitration in Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy: a randomized, open-label, prospective study (VISION). ( Ji, LN; Li, H; Li, Q; Li, QF; Lu, JM; Pan, CY; Peng, YD; Tian, HM; Wang, BH; Wang, L; Yao, C; Zhao, ZG; Zhu, DL, 2016) |
| " The insulin dosing algorithm was not sufficient to equalize nocturnal hypoglycaemia between the two insulins." | 2.80 | Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes. ( Bolli, GB; Candelas, C; Dain, MP; Deerochanawong, C; Home, PD; Landgraf, W; Mathieu, C; Pilorget, V; Riddle, MC, 2015) |
| "Hypoglycemia was infrequent, with no episodes of major hypoglycemia." | 2.80 | Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin. ( Cook, W; Hansen, L; Hirshberg, B; Iqbal, N; Li, Y; Rosenstock, J; Zee, P, 2015) |
| "In a south Indian population with gestational diabetes, metformin was associated with better neonatal outcomes than glibenclamide." | 2.80 | Comparison of neonatal outcomes in women with gestational diabetes with moderate hyperglycaemia on metformin or glibenclamide--a randomised controlled trial. ( Abraham, A; Antonisamy, B; Beck, M; Benjamin, SJ; George, A; Jana, AK; Mathews, JE; Sam, D; Thomas, N, 2015) |
| "Patients with type 2 diabetes who were inadequately controlled on twice-daily premixed insulin were randomly assigned (1:1) to receive either insulin lispro mix (mix 50 before breakfast and lunch plus mix 25 before dinner) or basal-bolus therapy (insulin glargine at bedtime plus prandial insulin lispro thrice-daily) for 24 weeks." | 2.80 | Comparison of thrice-daily premixed insulin (insulin lispro premix) with basal-bolus (insulin glargine once-daily plus thrice-daily prandial insulin lispro) therapy in east Asian patients with type 2 diabetes insufficiently controlled with twice-daily pre ( Ahn, KJ; Bao, Y; Chen, L; Chuang, LM; Gao, F; Ji, Q; Jia, W; Li, P; Pang, C; Tu, Y; Xiao, X; Yang, J, 2015) |
| "The dapagliflozin treatment arm was associated with a mean incremental benefit of 0." | 2.80 | The cost-effectiveness of dapagliflozin versus sulfonylurea as an add-on to metformin in the treatment of Type 2 diabetes mellitus. ( Bergenheim, K; Callan, L; Charokopou, M; Lister, S; McEwan, P; Postema, R; Roudaut, M; Tolley, K; Townsend, R, 2015) |
| " Changes from baseline in gastric emptying, 24-h plasma glucose profile, HbA1c, fasting plasma glucose (FPG), 24-h ambulatory heart rate and blood pressure, amylase and lipase levels, and adverse events (AEs) were also assessed." | 2.80 | Contrasting Effects of Lixisenatide and Liraglutide on Postprandial Glycemic Control, Gastric Emptying, and Safety Parameters in Patients With Type 2 Diabetes on Optimized Insulin Glargine With or Without Metformin: A Randomized, Open-Label Trial. ( Coester, HV; Delfolie, A; Forst, T; Hincelin-Méry, A; Kapitza, C; Meier, JJ; Menge, BA; Rosenstock, J; Roy-Duval, C, 2015) |
| "Glucose-lowering treatment options for type 2 diabetes mellitus patients with chronic kidney disease are limited." | 2.80 | Combination of the dipeptidyl peptidase-4 inhibitor linagliptin with insulin-based regimens in type 2 diabetes and chronic kidney disease. ( Crowe, S; McGill, JB; von Eynatten, M; Woerle, HJ; Yki-Järvinen, H, 2015) |
| " Overall, all treatments were well tolerated and no new adverse events or tolerability issues were observed for IDegLira." | 2.80 | One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial. ( Bode, BW; Buse, JB; Gough, SC; Linjawi, S; Reiter, PD; Rodbard, HW; Woo, VC; Zacho, M, 2015) |
| "In people with Type 2 diabetes, empagliflozin 10 mg and 25 mg given as add-on to metformin for 76 weeks were well tolerated and led to sustained reductions in HbA1c , weight and systolic blood pressure." | 2.80 | Empagliflozin as add-on to metformin in people with Type 2 diabetes. ( Broedl, UC; Christiansen, AV; Häring, HU; Kim, G; Meinicke, T; Merker, L; Roux, F; Salsali, A; Woerle, HJ, 2015) |
| " No acute adverse events (AEs) were associated with infusion." | 2.80 | Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose-Escalation Safety and Tolerability Pilot Study. ( Fonseca, VA; Rosenstock, J; Segal, KR; Skyler, JS, 2015) |
| "Patients with type 2 diabetes mellitus (T2DM) using sulphonylurea and metformin received dapagliflozin 10 mg/day or placebo added to therapy for 52 weeks (24-week randomized, double-blind period plus 28-week double-blind extension)." | 2.80 | Durability and tolerability of dapagliflozin over 52 weeks as add-on to metformin and sulphonylurea in type 2 diabetes. ( Bowering, K; Johnsson, E; Matthaei, S; Parikh, S; Rohwedder, K; Sugg, J, 2015) |
| "Treatment with dapagliflozin add-on to saxagliptin plus metformin resulted in a greater mean HbA1c reduction than placebo (-0." | 2.80 | Randomized, Double-Blind, Phase 3 Trial of Triple Therapy With Dapagliflozin Add-on to Saxagliptin Plus Metformin in Type 2 Diabetes. ( Chen, H; Cook, W; Ekholm, E; Hansen, L; Hirshberg, B; Iqbal, N; Li, D; Mathieu, C; Ranetti, AE, 2015) |
| " The percentage of subjects who experienced all adverse events including hypoglycemia with alogliptin were comparable to those with placebo." | 2.80 | [Efficacy and safety of alogliptin in treatment of type 2 diabetes mellitus: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial in mainland China]. ( Bu, R; Gu, W; Han, P; Ji, Q; Jiang, Z; Lei, M; Li, C; Li, L; Li, W; Li, X; Li, Z; Liu, J; Liu, X; Liu, Y; Liu, Z; Lu, J; Lyu, X; Pan, C; Peng, Y; Qu, S; Shi, B; Song, Q; Xu, X; Xue, Y; Yan, L; Yang, J; Zeng, J; Zheng, B, 2015) |
| " Adverse events (AEs) were evaluated throughout 104 weeks." | 2.79 | Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. ( Parikh, S; Rohwedder, K; Sugg, J; Wilding, JP; Woo, V, 2014) |
| "Bicyclol is a synthetic compound known to protect the liver against oxidation and lipid injuries." | 2.79 | Randomized, vitamin E-controlled trial of bicyclol plus metformin in non-alcoholic fatty liver disease patients with impaired fasting glucose. ( Ding, XD; Fan, JG; Han, Y; Ma, AL; Shi, JP; Xu, Y, 2014) |
| " Safety and tolerability assessments included adverse events (AEs), hypoglycaemia and body weight." | 2.79 | A randomized controlled trial of the efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes and inadequate glycaemic control on metformin plus a sulphonylurea. ( Brook, D; Fisher, SA; Kalra, S; Montanaro, M; Monyak, J; Moses, RG; Sockler, J; Visvanathan, J, 2014) |
| "Insulin degludec (IDeg) is a new basal insulin with an ultra-long and stable glucose-lowering effect." | 2.79 | Health status and hypoglycaemia with insulin degludec versus insulin glargine: a 2-year trial in insulin-naïve patients with type 2 diabetes. ( Cariou, B; Handelsman, Y; Mathieu, C; Rana, A; Rodbard, HW; Wolden, ML; Zinman, B, 2014) |
| "People with inadequately controlled type 2 diabetes (n = 99) were randomly assigned on a 1∶1∶1 basis to receive insulin glargin, with fixed doses of glimepiride, metformin, and glimepiride plus metformin." | 2.79 | Comparison between the therapeutic effect of metformin, glimepiride and their combination as an add-on treatment to insulin glargine in uncontrolled patients with type 2 diabetes. ( Chon, S; Kang, JG; Lee, CB; Noh, J; Oh, SJ; Park, CY; Park, SW, 2014) |
| "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) |
| "In patients with type 2 diabetes inadequately controlled on once-daily basal insulin glargine and metformin and/or pioglitazone, intensification with LM25 was superior to a basal-prandial approach in terms of reduction in HbA1c after 24 weeks and did not increase hypoglycaemia episodes." | 2.79 | Insulin lispro low mixture twice daily versus basal insulin glargine once daily and prandial insulin lispro once daily in patients with type 2 diabetes requiring insulin intensification: a randomized phase IV trial. ( Cleall, S; Gross, JL; Onaca, A; Rodríguez, A; Tinahones, FJ, 2014) |
| " The most common gastrointestinal adverse events for dulaglutide were nausea, vomiting, and diarrhea." | 2.79 | Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). ( Arakaki, R; Atisso, C; Blevins, T; Colon, G; Garcia, P; Kuhstoss, D; Lakshmanan, M; Wysham, C, 2014) |
| "To show that albiglutide, a glucagon-like peptide-1 receptor agonist, is an effective and generally safe treatment to improve glycaemic control in patients with type 2 diabetes mellitus whose hyperglycaemia is inadequately controlled with pioglitazone (with or without metformin)." | 2.79 | Efficacy and safety of once-weekly glucagon-like peptide 1 receptor agonist albiglutide (HARMONY 1 trial): 52-week primary endpoint results from a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes mellitus not controlled ( Bode, BW; Cirkel, DT; Perkins, CM; Perry, CR; Reinhardt, RR; Reusch, J; Stewart, MW; Ye, J, 2014) |
| " Adverse events (AE) and hypoglycemia were monitored." | 2.79 | Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. ( Bryzinski, B; Cook, W; Hirshberg, B; Minervini, G, 2014) |
| " Overall, lixisenatide once daily was well tolerated, with a similar proportion of treatment-emergent adverse events (TEAEs) and serious TEAEs between groups (lixisenatide: 72." | 2.78 | Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). ( Aronson, R; Goldenberg, R; Guo, H; Muehlen-Bartmer, I; Niemoeller, E; Pinget, M, 2013) |
| "Vildagliptin treatment was associated with less fluctuation of glucose levels than glimepiride treatment as assessed by 24-h CGM device, suggesting vildagliptin may have the potential to offer long-term beneficial effects for patients with T2DM in preventing the development of complications of diabetes." | 2.78 | Differential effects of vildagliptin and glimepiride on glucose fluctuations in patients with type 2 diabetes mellitus assessed using continuous glucose monitoring. ( Forst, T; Foteinos, G; He, YL; Kulmatycki, K; Mattapalli, D; Neelakantham, S; Taylor, A, 2013) |
| " Most adverse events were mild or moderate, with slightly greater frequency of upper respiratory infections with saxagliptin." | 2.78 | Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes. ( Aguilar-Salinas, C; Berglind, N; Fleming, D; Gross, JL; Hissa, M; Ravichandran, S; Rosenstock, J, 2013) |
| " The rate of adverse events was comparable in both groups." | 2.78 | [Efficacy and safety of vildagliptin as a second-line therapy vs other oral antidiabetic agents in patients with type 2 diabetes: Czech results within the worldwide prospective cohort EDGE study]. ( Brada, M; Dohnalová, L; Edelsberger, T; Gerle, J; Haluzík, M; Houdová, J; Veselá, V, 2013) |
| "Optimal dosing of basal insulin is needed to achieve target fasting blood glucose and to avoid hypoglycaemia on the other hand in patients of type 2 diabetes on bedtime basal insulin and daytime sulfonylureas." | 2.78 | Study of optimal basal insulin glargine dose requirement in Indian population as an add on therapy to oral hypoglycaemic agents to achieve target fasting blood glucose levels. ( Agarwal, SK; Singh, BK; Wadhwa, R, 2013) |
| "Patients with Type 2 diabetes inadequately controlled with sitagliptin plus metformin were randomly assigned to 20 weeks of treatment with twice-daily exenatide plus placebo and metformin (SWITCH, n = 127) or twice-daily exenatide plus sitagliptin and metformin (ADD, n = 128)." | 2.77 | A randomized non-inferiority study comparing the addition of exenatide twice daily to sitagliptin or switching from sitagliptin to exenatide twice daily in patients with type 2 diabetes experiencing inadequate glycaemic control on metformin and sitaglipti ( Bachmann, OP; Chan, JY; Lüdemann, J; Oliveira, JH; Reed, VA; Violante, R; Yoon, KH; Yu, MB, 2012) |
| "Despite half of all type 2 diabetes mellitus (T2DM) patients being over 65 and treatment being complicated by an elevated risk of iatrogenic hypoglycaemia, information about antidiabetic treatment is scarce in this age group." | 2.77 | Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: the HYPOCRAS study. ( Bourdel-Marchasson, I; Dejager, S; Penfornis, A; Quere, S, 2012) |
| "patients with type 2 diabetes and an HbA(1c) of 6." | 2.76 | Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial. ( Arechavaleta, R; Chen, Y; Duran, L; Goldstein, BJ; Kaufman, KD; Krobot, KJ; O'Neill, EA; Seck, T; Williams-Herman, D, 2011) |
| " Safety endpoints included adverse events (AEs) and hypoglycaemia." | 2.76 | Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. ( Hollander, P; Liutkus, JF; Raslova, K; Råstam, J; Skjøth, TV, 2011) |
| "glipizide was associated with a significantly smaller proportion of patients with hypoglycaemic events (3." | 2.75 | Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: a 52-week randomised controlled trial. ( Eriksson, J; Gallwitz, B; Gause-Nilsson, I; Göke, B; Hellqvist, A, 2010) |
| "Patients with Type 2 diabetes (n = 88, age 56." | 2.74 | Nateglinide combination therapy with basal insulin and metformin in patients with Type 2 diabetes. ( Juurinen, L; Kauppinen-Mäkelin, R; Kock, T; Kotronen, A; Lanki, H; Leppävuori, E; Nikkilä, K; Saltevo, J; Teikari-Myyrä, T; Tiikkainen, M; Yki-Järvinen, H, 2009) |
| "Vildagliptin is an effective and well-tolerated treatment option in elderly patients with type 2 diabetes, demonstrating similar improvement in glycaemic control as metformin, with superior GI tolerability." | 2.74 | Comparison of vildagliptin and metformin monotherapy in elderly patients with type 2 diabetes: a 24-week, double-blind, randomized trial. ( Bosi, E; Dejager, S; Schweizer, A, 2009) |
| "Efficacy measurements included haemoglobin A(1c) (HbA(1c)) and eight-point plasma glucose (PG); safety included adverse events (AEs) and hypoglycaemic episodes." | 2.74 | Three different premixed combinations of biphasic insulin aspart - comparison of the efficacy and safety in a randomized controlled clinical trial in subjects with type 2 diabetes. ( Christiansen, JS; Cucinotta, D; Kanc, K; le Devehat, C; Liebl, A; López de la Torre, M; Smirnova, O; Wojciechowska, M, 2009) |
| "The efficacy of twice-daily dosing of a repaglinide/metformin FDC tablet was non-inferior to that of three-times-daily dosing." | 2.74 | Twice-daily and three-times-daily dosing of a repaglinide/metformin fixed-dose combination tablet provide similar glycaemic control. ( Lewin, A; Lyness, W; Raskin, P; Reinhardt, R, 2009) |
| "The mean weight gain was higher in the prandial group than in either the biphasic group or the basal group." | 2.74 | Three-year efficacy of complex insulin regimens in type 2 diabetes. ( Darbyshire, JL; Davies, MJ; Farmer, AJ; Holman, RR; Keenan, JF; Levy, JC; Paul, SK, 2009) |
| "Weight gain was less with metformin plus biphasic insulin aspart 70/30 than with repaglinide plus biphasic insulin aspart 70/30 (difference in mean body weight between treatments -2." | 2.74 | Combining insulin with metformin or an insulin secretagogue in non-obese patients with type 2 diabetes: 12 month, randomised, double blind trial. ( Frandsen, M; Hansen, BV; Lund, SS; Nielsen, BB; Parving, HH; Pedersen, O; Tarnow, L; Vaag, AA, 2009) |
| "Hypoglycemia was similar in the 2 groups, but sample size limited the ability to make a definite safety assessment." | 2.73 | Addition of neutral protamine lispro insulin or insulin glargine to oral type 2 diabetes regimens for patients with suboptimal glycemic control: a randomized trial. ( Beneduce, F; Ceriello, A; Ciotola, M; Esposito, K; Feola, G; Giugliano, D; Gualdiero, R; Maiorino, MI; Schisano, B, 2008) |
" Insulin dosage in each group was titrated to target fasting blood glucose (FBG) of 100 mg/dL or less (| 2.73 | Combination of oral antidiabetic agents with basal insulin versus premixed insulin alone in randomized elderly patients with type 2 diabetes mellitus. ( Busch, K; Janka, HU; Plewe, G, 2007) | |
| "Treatment with nateglinide plus metformin for up to 12 months was not associated with weight gain." | 2.73 | Nateglinide or gliclazide in combination with metformin for treatment of patients with type 2 diabetes mellitus inadequately controlled on maximum doses of metformin alone: 1-year trial results. ( Collober-Maugeais, C; Cressier, F; Pecher, E; Ristic, S; Tang, P, 2007) |
| " 47%) and drug-related adverse experiences (AEs) (15 vs." | 2.73 | Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. ( Fanurik, D; Hermansen, K; Khatami, H; Kipnes, M; Luo, E; Stein, P, 2007) |
| "One nateglinide/metformin-treated patient experienced a mild hypoglycaemic episode compared with eight episodes in eight patients on glyburide/metformin; one severe episode led to discontinuation." | 2.73 | Nateglinide, alone or in combination with metformin, is effective and well tolerated in treatment-naïve elderly patients with type 2 diabetes. ( Baron, MA; Gerich, JE; Jean-Louis, L; Marcellari, A; Purkayastha, D; Schwarz, SL, 2008) |
| "In these patients with type 2 diabetes that was poorly controlled by OADs, BIAsp 30 TID and BIAsp 30 BID plus MET were associated with significantly greater reductions in HbA(1c) and postprandial BG compared with OADs alone." | 2.73 | Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: a 16-week, randomized, open-label, parallel-group trial ( Al-Tayar, B; Kazakova, E; Morozova, A; Saifullina, M; Sazonova, O; Shapiro, I; Sokolovskaya, V; Starceva, M; Starkova, N; Tarasov, A; Ushakova, O; Valeeva, F; Zanozina, O; Zhadanova, E, 2007) |
| "Metformin is a logical treatment for women with gestational diabetes mellitus, but randomized trials to assess the efficacy and safety of its use for this condition are lacking." | 2.73 | Metformin versus insulin for the treatment of gestational diabetes. ( Battin, MR; Gao, W; Hague, WM; Moore, MP; Rowan, JA, 2008) |
| "Semaglutide is an advantageous choice for the treatment of T2D since it has greater efficacy in reducing glycated hemoglobin and body weight compared with other GLP-1RAs, has demonstrated benefits in reducing major adverse cardiovascular events, and has a favorable profile in special populations (e." | 2.72 | Clinical Perspectives on the Use of Subcutaneous and Oral Formulations of Semaglutide. ( Gallwitz, B; Giorgino, F, 2021) |
| "In type 2 diabetic patients we compared 9 months of combination therapy with insulin glargine and metformin with 9 months of NPH insulin combined with metformin." | 2.72 | Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. ( Hänninen, J; Hardy, K; Hulme, S; Kauppinen-Mäkelin, R; Lahdenperä, S; Lehtonen, R; Levänen, H; McNulty, S; Nikkilä, K; Ryysy, L; Tiikkainen, M; Tulokas, T; Vähätalo, M; Virtamo, H; Yki-Järvinen, H, 2006) |
| " Other adverse events, except increased cough in the INH group, were similar." | 2.72 | An open, randomized, parallel-group study to compare the efficacy and safety profile of inhaled human insulin (Exubera) with metformin as adjunctive therapy in patients with type 2 diabetes poorly controlled on a sulfonylurea. ( Barnett, AH; Dreyer, M; Lange, P; Serdarevic-Pehar, M, 2006) |
| "Consenting adults aged 18-80 years with Type 2 diabetes for at least 6 months, HbA1c of 7." | 2.72 | A randomized trial of adding insulin glargine vs. avoidance of insulin in people with Type 2 diabetes on either no oral glucose-lowering agents or submaximal doses of metformin and/or sulphonylureas. The Canadian INSIGHT (Implementing New Strategies with ( Dempsey, E; Gerstein, HC; Harris, SB; Issa, M; Stewart, JA; Yale, JF, 2006) |
| "Starting insulin in Type 2 diabetes patients with twice-daily BIAsp 30 plus met can reduce HbA (1c) and mean prandial plasma glucose increment to a greater extent than once-daily glarg plus glim." | 2.72 | Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. ( Kann, PH; Medding, J; Moeller, J; Mokan, M; Mrevlje, F; Regulski, M; Szocs, A; Wascher, T; Zackova, V, 2006) |
| " Insulin dosage was titrated to target FBG | 2.71 | Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. ( Janka, HU; Kliebe-Frisch, C; Plewe, G; Riddle, MC; Schweitzer, MA; Yki-Järvinen, H, 2005) |
| "In patients with Type 2 diabetes and inadequate glucose control while on insulin or insulin and oral agent(s) combination therapy, treatment with a twice-daily insulin lispro mixture plus metformin, which targets both post-prandial and pre-meal BG, provided clinically significant improvements in A1c, significantly reduced post-prandial BG after each meal, and reduced nocturnal hypoglycaemia as compared with once-daily glargine plus metformin, a treatment that targets fasting BG." | 2.71 | Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with Type 2 diabetes. ( Augendre-Ferrante, B; Bai, S; Campaigne, BN; Malone, JK; Reviriego, J, 2005) |
| "0 mg/metformin (M) 400 mg combination with a G 2." | 2.71 | Effects of two different glibenclamide dose-strengths in the fixed combination with metformin in patients with poorly controlled T2DM: a double blind, prospective, randomised, cross-over clinical trial. ( Brunetti, P; Gori, M; Pagano, G; Perriello, G; Turco, C, 2004) |
| "To evaluate the efficacy and safety of two dosage strengths of a single-tablet metformin-glibenclamide (glyburide) combination, compared with the respective monotherapies, in patients with Type 2 diabetes mellitus (DM) inadequately controlled by metformin monotherapy." | 2.70 | Improved glycaemic control with metformin-glibenclamide combined tablet therapy (Glucovance) in Type 2 diabetic patients inadequately controlled on metformin. ( Allavoine, T; Howlett, H; Lehert, P; Marre, M, 2002) |
| "Metformin has been shown to prevent insulin therapy-induced body weight gain when used in combination with insulin." | 2.70 | Metformin does not adversely affect hormonal and symptomatic responses to recurrent hypoglycemia. ( Born, J; Fehm, HL; Fruehwald-Schultes, B; Kern, W; Oltmanns, KM; Peters, A; Sopke, S; Toschek, B, 2001) |
| "458 patients with newly diagnosed type 2 diabetes that could not be controlled with diet and had hyperglycemic symptoms or fasting plasma glucose levels greater than 15 mmol/L during the initial 3 months of diet therapy (primary diet failure group) and 1620 patients in whom disease was controlled by diet therapy and who had fasting plasma glucose levels of 6 to 15 mmol/L and no hyperglycemic symptoms while receiving diet therapy alone." | 2.69 | United Kingdom Prospective Diabetes Study 24: a 6-year, randomized, controlled trial comparing sulfonylurea, insulin, and metformin therapy in patients with newly diagnosed type 2 diabetes that could not be controlled with diet therapy. United Kingdom Pro ( , 1998) |
| " Adverse events were generally similar between the treatment groups." | 2.61 | Efficacy and safety of sitagliptin added to treatment of patients with type 2 diabetes inadequately controlled with premixed insulin. ( Chen, G; Engel, SS; Lin, J; Liu, S; O'Neill, EA; Shankar, RR; Tu, Y; Yu, M; Zhang, R; Zhang, Y, 2019) |
| "The number of people with type 2 diabetes mellitus (T2DM) is increasing worldwide." | 2.61 | Metformin and second- or third-generation sulphonylurea combination therapy for adults with type 2 diabetes mellitus. ( Gnesin, F; Hemmingsen, B; Kähler, LKA; Kähler, P; Madsbad, S; Madsen, KS; Metzendorf, MI; Richter, B, 2019) |
| "The choice of therapy for type 2 diabetes after metformin is guided by overall estimates of glycemic response and side effects seen in large cohorts." | 2.58 | Sex and BMI Alter the Benefits and Risks of Sulfonylureas and Thiazolidinediones in Type 2 Diabetes: A Framework for Evaluating Stratification Using Routine Clinical and Individual Trial Data. ( Dennis, JM; Hamilton, WT; Hattersley, AT; Henley, WE; Holman, RR; Janmohamed, S; Jones, AG; Lonergan, M; Pearson, ER; Rodgers, LR; Sattar, N; Shields, BM; Weedon, MN, 2018) |
| "Metformin has also proven to be safe and may be considered as an initial single agent for milder gestational diabetes." | 2.55 | The care of pregestational and gestational diabetes and drug metabolism considerations. ( Davis, SN; Hedrington, MS, 2017) |
| "Glyburide has good efficacy and short-term data but it also crosses the placenta and may be associated with increased rates of large-for-gestational-age (LGA) infants and neonatal hypoglycaemia when compared with insulin." | 2.55 | Pharmacological Management of Gestational Diabetes Mellitus. ( Feig, DS; Mukerji, G, 2017) |
| "Vildagliptin is an effective and safe therapeutic option for patients with T2DM, both as monotherapy and as add-on treatment." | 2.53 | Systematic review and meta-analysis of vildagliptin for treatment of type 2 diabetes. ( Athanasiadou, E; Bekiari, E; Boura, P; Karagiannis, T; Liakos, A; Mainou, M; Papatheodorou, K; Rika, M; Rizava, C; Tsapas, A, 2016) |
| " This meta-analysis revealed the use of dulaglutide as a monotherapy or an add-on to OAM and lispro appeared to be effective and safe for adults with T2DM." | 2.53 | Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review. ( Tong, N; Zhang, L; Zhang, M; Zhang, Y, 2016) |
| "Iatrogenic and compensatory hyperinsulinemia are metabolic disruptors of β-cells, liver, muscle, kidney, brain, heart and vasculature, inflammation, and lipid homeostasis, among other systems." | 2.53 | Obviating much of the need for insulin therapy in type 2 diabetes mellitus: A re-assessment of insulin therapy's safety profile. ( Herman, ME; Jellinger, PS; Schwartz, SS, 2016) |
| " Other oral medications have not been shown to be safe in pregnancy." | 2.52 | Safety considerations with pharmacological treatment of gestational diabetes mellitus. ( Simmons, D, 2015) |
| "At short term, in women with gestational diabetes requiring drug treatment, glibenclamide is clearly inferior to both insulin and metformin, while metformin (plus insulin when required) performs slightly better than insulin." | 2.52 | Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis. ( Balsells, M; Corcoy, R; García-Patterson, A; Gich, I; Roqué, M; Solà, I, 2015) |
| " Incretins are associated with a low risk of hypoglycemia when used as monotherapy; the dosage of sulfonylurea or insulin should be reduced when used in combination." | 2.52 | Combination therapy when metformin is not an option for type 2 diabetes. ( Goldman-Levine, JD, 2015) |
| " RCTs were selected for meta-analysis if (1) they were RCTs comparing DPP-4 inhibitors plus metformin as initial combination therapy or DPP-4 inhibitor monotherapy to metformin monotherapy, (2) duration of treatment was ≥12 weeks and (3) reported data on haemoglobin A1c (HbA1c) change, fasting plasma glucose (FPG) change, weight change, adverse cardiovascular (CV) events, hypoglycaemia or gastrointestinal adverse events (AEs)." | 2.50 | Efficacy and safety of dipeptidyl peptidase-4 inhibitors and metformin as initial combination therapy and as monotherapy in patients with type 2 diabetes mellitus: a meta-analysis. ( Li, L; Liu, C; Wu, D, 2014) |
| "RCTs enrolling subjects with type 2 diabetes inadequately controlled on metformin monotherapy were included." | 2.50 | Dapagliflozin compared with other oral anti-diabetes treatments when added to metformin monotherapy: a systematic review and network meta-analysis. ( Barnett, AH; Goring, S; Hawkins, N; Roudaut, M; Townsend, R; Wood, I; Wygant, G, 2014) |
| "Hypoglycemia is a frequent adverse effect of treatment with sulfonylurea, glinides, or insulin in older adults with diabetes." | 2.49 | [Attention to the use of oral anti-diabetic medication in older adults with type 2 diabetes]. ( Aso, Y; Jojima, T, 2013) |
| " Of the recently introduced oral hypoglycemic/antihyperglycemic agents, the DPP-4 inhibitors are moderately efficacious compared with mainstay treatment with metformin with a low side-effect profile and have good efficacy in combination with other oral agents and insulin." | 2.49 | A review of the efficacy and safety of oral antidiabetic drugs. ( Davis, SN; Lamos, EM; Stein, SA, 2013) |
| "The average glucose level at which hemiparesis developed was 1." | 2.48 | A case of hypoglycemic hemiparesis and literature review. ( Itoh, A; Itoh, H; Kawai, T; Meguro, S; Soeda, Y; Yoshino, T, 2012) |
| " In this article, we review the pharmacokinetic DDIs concerning oral antidiabetics, including metformin, sulfonylureas, meglitinide analogs, thiazolidinediones and dipeptidyl peptidase-4 inhibitors, and the underlying mechanistic basis that can help to predict and prevent DDIs." | 2.48 | Drug interactions with oral antidiabetic agents: pharmacokinetic mechanisms and clinical implications. ( Backman, JT; Neuvonen, PJ; Niemi, M; Tornio, A, 2012) |
| "Although drugs for type 2 diabetes are studied in heterogeneous samples of patients, their efficacy can be predicted by some clinical parameters." | 2.47 | Predictors of response to dipeptidyl peptidase-4 inhibitors: evidence from randomized clinical trials. ( Cremasco, F; Lamanna, C; Mannucci, E; Marchionni, N; Monami, M, 2011) |
| "Adolescents with type 1 diabetes mellitus (DM1) often have problems in achieving optimal glycaemic control." | 2.47 | [Metformin in adolescents and adults with type 1 diabetes mellitus: not evidence-based]. ( Aanstoot, HJ; Bilo, HJ; Brand, PL; Kleefstra, N; Spaans, EA; van Hateren, KJ, 2011) |
| " DPP-4 inhibitors are safe and tolerable with no increased risk of adverse events compared to placebo and have a low risk of hypoglycaemia." | 2.45 | Clinical results of treating type 2 diabetic patients with sitagliptin, vildagliptin or saxagliptin--diabetes control and potential adverse events. ( Ahrén, B, 2009) |
| "The aim of this study was to quantify the effect of a sulphonylurea on glycaemic control and the risk adverse events when incorporated into the treatment regimen of patients with type 2 diabetes inadequately controlled on metformin." | 2.44 | Glycaemic control and adverse events in patients with type 2 diabetes treated with metformin + sulphonylurea: a meta-analysis. ( Belsey, J; Krishnarajah, G, 2008) |
| "However, hyperglycemia (especially postprandial hyperglycemia) and hypoglicemia continue to be problematic in the management of type 1 diabetes." | 2.44 | [Adjunctive therapies to glycaemic control of type 1 diabetes mellitus]. ( Gabbay, Mde A, 2008) |
| "Repaglinide is an insulin secretion enhancer with a different mechanism of action to the sulphonylureas, which means it does not continuously stimulate insulin secretion." | 2.41 | [Repaglinide, potentially a therapeutic improvement for diabetes mellitus type 2]. ( Rutten, GE, 2001) |
| "MetforminHydrochloride is an antidiabetic used for many years, currently; it considered the first choice in treatment of type 2 diabetes (T2D)." | 1.91 | [Cross-Sectional Study on Adverse Effects of Metformin Hydrochloride on 130 Patients Type 2 Diabetic Admitted to Medical Center and Diabetes Home of Sidi Bel-Abbès]. ( Belakhdar, K; Kraroubi, A; Matmour, D; Sakouhi, M, 2023) |
| "Amongst the OAD's used in type 2 diabetes mellitus patients in this study, total number of hyperglycemic and hypoglycemic episodes were found to be more in patients taking sulfonylurea as compared with DPP4 inhibitors when used in combination with metformin with or without insulin." | 1.72 | Role of Ambulatory Glucose Profile in Precision Medicine in Type 2 Diabetes Mellitus. ( Aggarwal, R; Prakash, A; Sidharth, S, 2022) |
| "could be used as a new strategy to treat cancer under hypoglycemia through glucose metabolism reprogramming." | 1.72 | Arene-Ruthenium(II)/Osmium(II) Complexes Potentiate the Anticancer Efficacy of Metformin via Glucose Metabolism Reprogramming. ( Chen, ZF; Gu, YQ; Liang, H; Ma, R; Xu, XF; Yang, QY, 2022) |
| " Sodium glucose co-transporter -2 inhibitors (SGLT2i) are considered safe with a low risk of hypoglycemia." | 1.72 | Efficacy and safety of combination of empagliflozin and metformin with combination of sitagliptin and metformin during Ramadan: an observational study. ( Aamir, AH; Ahmed, I; Asghar, A; Ghaffar, T; Ishtiaq, O; Khan, S; Kumar, S; Masood, F; Raja, UY; Randhawa, FA; Raza, A; Rehman, T; Sherin, A; Wahab, MU, 2022) |
| " The proportion of the people who had hypoglycaemia, or any adverse event related to the study drug was assessed after-Ramadan." | 1.72 | Efficacy and safety of empagliflozin in people with type 2 diabetes during Ramadan fasting. ( Ahmedani, MY; Yousuf, S, 2022) |
| "Serious hypoglycemia is a major adverse event associated with insulin secretagogues." | 1.72 | Angiotensin-Converting Enzyme Inhibitors Used Concomitantly with Insulin Secretagogues and the Risk of Serious Hypoglycemia. ( Bilker, WB; Brensinger, CM; Flory, JH; Hee Nam, Y; Hennessy, S; Leonard, CE, 2022) |
| "Metformin use was associated with lower risk for all-cause mortality (hazard ratio [HR], 0." | 1.56 | A Safety Comparison of Metformin vs Sulfonylurea Initiation in Patients With Type 2 Diabetes and Chronic Kidney Disease: A Retrospective Cohort Study. ( Clemens, KK; Hougen, I; Komenda, P; Rigatto, C; Tangri, N; Whitlock, RH, 2020) |
| "Patients with type 2 diabetes mellitus (T2DM) often experience hypoglycaemia and weight gain due to treatment side effects." | 1.56 | Real-world Evaluation of glycemic control and hypoglycemic Events among type 2 Diabetes mellitus study (REEDS): a multicentre, cross-sectional study in Thailand. ( Benjasuratwong, Y; Nitiyanant, W; Ongphiphadhanakul, B; Pratipanawatr, T; Satirapoj, B; Suwanwalaikorn, S, 2020) |
| "All adults diagnosed with documented type 2 diabetes (extrapolated to the German population: 6." | 1.56 | Changes in incidence of severe hypoglycaemia in people with type 2 diabetes from 2006 to 2016: analysis based on health insurance data in Germany considering the anti-hyperglycaemic medication. ( Günster, C; Kloos, C; Klöss, A; Lehmann, T; Müller, N; Müller, UA, 2020) |
| "A total of 66,807 people with type 2 diabetes were treated with metformin (MET) plus a combination of second- and third-line therapies." | 1.56 | Risk of Major Adverse Cardiovascular Events, Severe Hypoglycemia, and All-Cause Mortality for Widely Used Antihyperglycemic Dual and Triple Therapies for Type 2 Diabetes Management: A Cohort Study of All Danish Users. ( Hejlesen, O; Jakobsen, PE; Jensen, MH; Kjolby, M; Vestergaard, P, 2020) |
| "Metformin appears to be an effective treatment for women with GDM and may reduce risk of some adverse neonatal outcomes when compared with insulin." | 1.51 | Comparative effectiveness of metformin versus insulin for gestational diabetes in New Zealand. ( Boggess, K; Engel, SM; Howe, AS; Jonsson Funk, M; Landi, SN; Radke, S; Stürmer, T, 2019) |
| "The prevalence of type 2 diabetes mellitus is expected to rise in the frail elderly population, which will have significant consequences for the health economy." | 1.51 | Pharmacotherapy of type 2 diabetes mellitus in frail elderly patients. ( Muraleedharan, V; Rabindranathnambi, A; Sathyanarayanan, A, 2019) |
| "Although patients with type 2 diabetes mellitus (T2DM) may fail to achieve adequate hemoglobin A1c (HbA1c) control despite metformin-sulfonylurea (Met-SU) dual therapy, a third-line glucose-lowering medication-including dipeptidyl peptidase-4 inhibitor (DPP4i), insulin, or thiazolidinedione (TZD)-can be added to achieve this." | 1.51 | Intensification with dipeptidyl peptidase-4 inhibitor, insulin, or thiazolidinediones and risks of all-cause mortality, cardiovascular diseases, and severe hypoglycemia in patients on metformin-sulfonylurea dual therapy: A retrospective cohort study. ( Chan, EW; Ho, CW; Lam, CLK; Man, KKC; Shi, M; Tse, ETY; Wong, CKH; Wong, ICK, 2019) |
| "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) |
| "0%, change in body weight at 12 and 24 weeks, change in HbA1c by sub-groups (baseline HbA1c, age, body mass index [BMI], dosage strength, co-morbidities) from baseline to week 24, and safety." | 1.48 | Initial combination therapy with vildagliptin plus metformin in drug-naïve patients with T2DM: a 24-week real-life study from Asia. ( Chawla, M; Cooke, K; Faruque, P; Hours-Zesiger, P; Kim, TH; Mirasol, RC; Shete, A, 2018) |
| "Metformin is a first-line drug for the treatment of individuals with type 2 diabetes, yet its precise mechanism of action remains unclear." | 1.48 | Metformin reduces liver glucose production by inhibition of fructose-1-6-bisphosphatase. ( Hughey, CC; Hunter, RW; Jessen, N; Lantier, L; Peggie, M; Sakamoto, K; Sicheri, F; Sundelin, EI; Wasserman, DH; Zeqiraj, E, 2018) |
| "Hypoglycemia is associated with local invasion and angiogenesis, whereas hyperglycemia promotes metastatic colonization." | 1.48 | Glycemic Variability Promotes Both Local Invasion and Metastatic Colonization by Pancreatic Ductal Adenocarcinoma. ( Akkan, J; Benitz, S; Bruns, P; Ceyhan, GO; Cheng, T; Friess, H; Hofmann, T; Huang, P; Jäger, C; Jastroch, M; Jian, Z; Kleeff, J; Kleigrewe, K; Kong, B; Lamp, D; Maeritz, N; Michalski, CW; Nie, S; Raulefs, S; Shen, S; Shi, K; Steiger, K; Zhang, Z; Zou, X, 2018) |
| "We compared, in 733 women with gestational diabetes mellitus treated with metformin and/or insulin, rates of neonatal hypoglycaemia in those who had received a dextrose/insulin infusion during labour and prior to delivery (n = 132) with those who did not (n = 601)." | 1.46 | The use of dextrose/insulin infusions during labour and delivery in women with gestational diabetes mellitus: Is there any point? ( Battin, M; Farrant, MT; Hague, WM; Rowan, JA; Williamson, K, 2017) |
| "Metformin is a first-line oral antidiabetic therapy for patients with type 2 diabetes mellitus." | 1.46 | Hemodialysis-refractory metformin-associated lactate acidosis with hypoglycemia, hypothermia, and bradycardia in a diabetic patient with belated diagnosis and chronic kidney disease . ( Zibar, K; Zibar, L, 2017) |
| " Safety was assessed by reporting of adverse events and serious adverse events (SAEs)." | 1.46 | Effectiveness and safety of vildagliptin and vildagliptin add-on to metformin in real-world settings in Egypt - results from the GUARD study. ( Rakha, S; Shelbaya, S, 2017) |
| "Many patients with type 2 diabetes mellitus (T2DM) do not achieve glycaemic control targets on basal insulin regimens." | 1.43 | How much is too much? Outcomes in patients using high-dose insulin glargine. ( Gao, L; Gill, J; Reid, T; Rhinehart, A; Stuhr, A; Traylor, L; Vlajnic, A, 2016) |
| "The included 3810 patients with type 2 diabetes had their treatment intensified at baseline." | 1.43 | Incidence, characteristics and impact of hypoglycaemia in patients receiving intensified treatment for inadequately controlled type 2 diabetes mellitus. ( Bramlage, P; Gitt, AK; Schneider, S; Tschöpe, D, 2016) |
| " Adverse effect rates were 64% with placebo, 63." | 1.43 | Efficacy and safety of empagliflozin in combination with other oral hypoglycemic agents in patients with type 2 diabetes mellitus. ( Ampudia-Blasco, FJ; Ariño, B; Giljanovic Kis, S; Naderali, E; Pérez, A; Pfarr, E; Romera, I, 2016) |
| "Optimal glucose-lowering therapy in type 2 diabetes mellitus requires a patient-specific approach." | 1.42 | A decision support tool for appropriate glucose-lowering therapy in patients with type 2 diabetes. ( Ampudia-Blasco, FJ; Benhamou, PY; Charpentier, G; Consoli, A; Diamant, M; Gallwitz, B; Khunti, K; Mathieu, C; Phan, TM; Ridderstråle, M; Seufert, J; Stoevelaar, H; Tack, C; Vilsbøll, T, 2015) |
| "Metformin (Met), which is an insulin-sensitizer, decreases insulin resistance and fasting insulin levels." | 1.42 | Intracerebroventricular metformin decreases body weight but has pro-oxidant effects and decreases survival. ( Brochier, AW; de Assis, AM; de Carvalho, AK; Gnoatto, J; Haas, CB; Hansel, G; Muller, AP; Oses, JP; Portela, LV; Zimmer, ER, 2015) |
| "Bariatric surgery rapidly improves Type 2 diabetes mellitus (T2DM)." | 1.42 | Effect of bariatric surgery combined with medical therapy versus intensive medical therapy or calorie restriction and weight loss on glycemic control in Zucker diabetic fatty rats. ( Abegg, K; Boza, C; Corteville, C; Docherty, NG; le Roux, CW; Lutz, TA; Muñoz, R, 2015) |
| "Vildagliptin treatment with or without metformin was generally well tolerated." | 1.42 | Clinical effectiveness and safety of vildagliptin in >19 000 patients with type 2 diabetes: the GUARD study. ( Abou Jaoude, E; Al-Arouj, M; DiTommaso, S; Fawwad, A; Latif, ZA; Orabi, A; Rosales, R; Shah, P; Vaz, J, 2015) |
| " In total, 136 adverse events (AEs) were observed in 71 (10." | 1.42 | Real-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey--GALATA study. ( Akin, F; Ar, IB; Ayvaz, G; Dokmetas, HS; Keskin, L; Tasan, E; Uren, E, 2015) |
| "Type 2 diabetes is a chronic disease that cannot be treated adequately using the known monotherapies, especially when the disease progresses to an advanced stage." | 1.42 | Combination therapy with oleanolic acid and metformin as a synergistic treatment for diabetes. ( Abdelkader, D; Chen, Y; Hassan, W; Liu, J; Sun, H; Wang, X, 2015) |
| "The Cardiff Model was used to simulate disease progression and estimate the long-term effect of treatments on patients." | 1.42 | Cost-effectiveness of saxagliptin vs glimepiride as a second-line therapy added to metformin in Type 2 diabetes in China. ( Deng, J; Dong, H; Gu, S; Mu, Y; Shi, L, 2015) |
| "The treatment of newly diagnosed type 2 diabetes mellitus is diverse, with no clear consensus regarding the initial drug regimen or dosing to achieve optimal glycemic control." | 1.42 | Getting to goal in newly diagnosed type 2 diabetes using combination drug "subtraction therapy". ( George, TM; Jennings, AS; Jennings, JS; Lovett, AJ, 2015) |
| "In elderly Americans with type 2 diabetes, use of insulin and oral antidiabetic drugs (OADs) accounts for almost one-fourth of drug adverse event-related hospitalizations." | 1.42 | Sulfonylurea monotherapy and emergency room utilization among elderly patients with type 2 diabetes. ( Brodovicz, K; Engel, SS; Fu, C; Heaton, PC; Rajpathak, SN, 2015) |
| "Her treatment was metformin 850 mg every 12 hours and glimepiride 4 mg every 24 hours." | 1.40 | How to prevent and treat pharmacological hypoglycemias. ( Mezquita Raya, P; Reyes García, R, 2014) |
| "The treatment for patients with type 2 diabetes mellitus (T2DM) follows a stepwise progression." | 1.40 | The evaluation of clinical and cost outcomes associated with earlier initiation of insulin in patients with type 2 diabetes mellitus. ( Curtis, BH; Gahn, JC; Murphy, DR; Smolen, HJ; Yu, X, 2014) |
| "Gliclazide or metformin-treated patients demonstrated lesser mortality risk than glibenclamide-treated ones in all four evaluation models, but age and duration stratification can influence this phenomenon in case of "first prescription model"." | 1.40 | Evaluation approach can significantly influence oral glucose-lowering drugs total mortality risks in retrospective cohorts of type 2 diabetes mellitus patients. ( Khalangot, M; Kovtun, V, 2014) |
| "DiaRegis included 3810 patients with type 2 diabetes in which antidiabetic therapy was intensified." | 1.39 | Prognostic implications of DPP-4 inhibitor vs. sulfonylurea use on top of metformin in a real world setting - results of the 1 year follow-up of the prospective DiaRegis registry. ( Binz, C; Bramlage, P; Deeg, E; Gitt, AK; Krekler, M; Tschöpe, D, 2013) |
| " We conclude that this treatment intensification approach may be useful, efficient, and safe in daily clinical practice for patients with type 2 diabetes." | 1.39 | Efficacy and safety of insulin glargine added to a fixed-dose combination of metformin and a dipeptidyl peptidase-4 inhibitor: results of the GOLD observational study. ( Bramlage, P; Pegelow, K; Seufert, J, 2013) |
| "A total of 660 insulin-naive type 2 diabetes patients with poor glycemic control (glycosylated hemoglobin [HbA1c] ≥7." | 1.38 | The impact of initiating biphasic human insulin 30 therapy in type 2 diabetes patients after failure of oral antidiabetes drugs. ( Bao, Y; Cai, Q; Gu, Y; Hou, X; Jia, W; Pan, J; Zhang, L, 2012) |
| "sulphonylurea (SU) compounds." | 1.38 | Worry vs. knowledge about treatment-associated hypoglycaemia and weight gain in type 2 diabetic patients on metformin and/or sulphonylurea. ( Knop, FK; Lund, A, 2012) |
| "Metformin was combined with MPI in 81 patients." | 1.37 | Improved glycaemic control with reduced hypoglycaemic episodes and without weight gain using long-term modern premixed insulins in type 2 diabetes. ( Levit, S; Toledano, Y; Wainstein, J, 2011) |
| "The study cohort consisted of type 2 diabetes mellitus patients (n = 80) on regular therapy with glibenclamide either alone or with concomitant metformin." | 1.37 | Influence of CYP2C9 gene polymorphisms on response to glibenclamide in type 2 diabetes mellitus patients. ( Adithan, C; Agrawal, A; Anichavezhi, D; Pradhan, SC; Rajan, S; Subrahmanyam, DK; Surendiran, A, 2011) |
| "This article describes a patient with type 2 diabetes mellitus achieving glycemic control after transitioning from premixed to basal-prandial insulin." | 1.36 | Effective switch from premixed to basal-prandial insulin to achieve glycemic goals in type 2 diabetes. ( Lavernia, F, 2010) |
| "Patients with type 2 diabetes are at an increased risk for disease and treatment related complications after the initial approach of oral mono/dual antidiabetic therapy has failed." | 1.36 | Diabetes treatment patterns and goal achievement in primary diabetes care (DiaRegis) - study protocol and patient characteristics at baseline. ( Binz, C; Bramlage, P; Deeg, E; Gitt, AK; Krekler, M; Plate, T; Tschöpe, D, 2010) |
| "A total of 400 patients with type 2 diabetes, who were > or = 35 years old and who had been treated with metformin and a sulphonylurea for at least 6 months, completed questionnaires during their usual primary care office visit." | 1.35 | Hypoglycaemia in patients with type 2 diabetes treated with a combination of metformin and sulphonylurea therapy in France. ( Krishnarajah, G; Lyu, R; Mavros, P; Vexiau, P; Yin, D, 2008) |
| "Patients with type 2 diabetes who added a sulphonylurea or a thiazolidinedione to ongoing metformin therapy on a date (index date) from January 2001 through January 2006 and who had at least one haemoglobin A1C (HbA1C) measurement in the 12-month period before the visit date were eligible." | 1.35 | Hypoglycaemic symptoms, treatment satisfaction, adherence and their associations with glycaemic goal in patients with type 2 diabetes mellitus: findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) Study. ( Alvarez Guisasola, F; Krishnarajah, G; Lyu, R; Mavros, P; Tofé Povedano, S; Yin, D, 2008) |
| "(1) When type 2 diabetes is inadequately controlled with oral antidiabetic therapy, one option is to add subcutaneous insulin injections (or to accept less stringent glycaemic control)." | 1.34 | Exenatide: new drug. Type 2 diabetes for some overweight patients. ( , 2007) |
| " Adverse reactions attributed to drugs included hypoglycemia and gastrointestinal distress." | 1.33 | Efficacy and safety of hypoglycemic drugs in children with type 2 diabetes mellitus. ( Benavides, S; Germak, J; Nahata, MC; Striet, J, 2005) |
| "Drug-induced hypoglycemia is possible even in diabetics not receiving insulin or oral antidiabetic agents increasing insulin secretion." | 1.31 | Severe hypoglycemia in an elderly patient treated with metformin. ( Reimann, IR; Schmechel, H; Zitzmann, S, 2002) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 13 (2.66) | 18.7374 |
| 1990's | 6 (1.23) | 18.2507 |
| 2000's | 71 (14.55) | 29.6817 |
| 2010's | 335 (68.65) | 24.3611 |
| 2020's | 63 (12.91) | 2.80 |
| Authors | Studies |
|---|---|
| Newman, C | 2 |
| Dunne, FP | 1 |
| Tomlinson, B | 1 |
| Patil, NG | 1 |
| Fok, M | 1 |
| Chan, P | 1 |
| Lam, CWK | 1 |
| Molina-Vega, M | 3 |
| Picón-César, MJ | 3 |
| Gutiérrez-Repiso, C | 1 |
| Fernández-Valero, A | 1 |
| Lima-Rubio, F | 1 |
| González-Romero, S | 3 |
| Moreno-Indias, I | 1 |
| Tinahones, FJ | 6 |
| Lee, KA | 1 |
| Jin, HY | 1 |
| Kim, YJ | 1 |
| Kim, SS | 1 |
| Cho, EH | 1 |
| Park, TS | 2 |
| Reiff, S | 1 |
| Fava, S | 1 |
| Mehrpour, O | 1 |
| Saeedi, F | 1 |
| Hoyte, C | 1 |
| Hadianfar, A | 1 |
| Nakhaee, S | 1 |
| Brent, J | 1 |
| Yang, W | 4 |
| Dong, X | 2 |
| Li, Q | 5 |
| Cheng, Z | 1 |
| Yuan, G | 1 |
| Liu, M | 1 |
| Xiao, J | 1 |
| Gu, S | 3 |
| Niemoeller, E | 4 |
| Chen, L | 4 |
| Ping, L | 1 |
| Souhami, E | 3 |
| Sidharth, S | 1 |
| Aggarwal, R | 1 |
| Prakash, A | 1 |
| Niwaha, AJ | 1 |
| Rodgers, LR | 2 |
| Carr, ALJ | 1 |
| Balungi, PA | 1 |
| Mwebaze, R | 1 |
| Hattersley, AT | 3 |
| Shields, BM | 3 |
| Nyirenda, MJ | 1 |
| Jones, AG | 2 |
| Kellerer, M | 2 |
| Kaltoft, MS | 2 |
| Lawson, J | 1 |
| Nielsen, LL | 1 |
| Strojek, K | 1 |
| Tabak, Ö | 1 |
| Jacob, S | 2 |
| Takayama, K | 1 |
| Obata, Y | 1 |
| Maruo, Y | 1 |
| Yamaguchi, H | 1 |
| Kosugi, M | 1 |
| Irie, Y | 1 |
| Hazama, Y | 1 |
| Yasuda, T | 1 |
| Pan, Q | 1 |
| Li, Y | 4 |
| Wan, H | 1 |
| Wang, J | 1 |
| Xu, B | 2 |
| Wang, G | 2 |
| Jiang, C | 1 |
| Liang, L | 2 |
| Feng, W | 1 |
| Liu, J | 9 |
| Wang, T | 2 |
| Zhang, X | 4 |
| Cui, N | 2 |
| Mu, Y | 5 |
| Guo, L | 4 |
| Hung, WT | 1 |
| Chen, YJ | 1 |
| Cheng, CY | 1 |
| Ovbiagele, B | 1 |
| Lee, M | 1 |
| Hsu, CY | 1 |
| Liu, Y | 6 |
| Chen, H | 7 |
| Li, H | 5 |
| Li, L | 5 |
| Wu, J | 1 |
| Yao, J | 1 |
| Guo, X | 1 |
| Sun, L | 2 |
| Han, P | 3 |
| Lv, X | 5 |
| Mo, Z | 1 |
| Zhang, L | 3 |
| Wang, Z | 4 |
| Zhu, L | 2 |
| Yang, T | 2 |
| Wang, W | 5 |
| Xue, Y | 2 |
| Shi, Y | 1 |
| Lu, J | 2 |
| Peng, Y | 3 |
| Zhang, F | 1 |
| Yan, D | 1 |
| Wang, D | 1 |
| Yu, X | 2 |
| Yang, QY | 1 |
| Ma, R | 1 |
| Gu, YQ | 1 |
| Xu, XF | 1 |
| Chen, ZF | 1 |
| Liang, H | 2 |
| Wang, CY | 1 |
| Huang, KC | 1 |
| Lu, CW | 1 |
| Chu, CH | 1 |
| Huang, CN | 2 |
| Chen, HS | 1 |
| Lee, IT | 2 |
| Chen, JF | 1 |
| Chen, CC | 1 |
| Chen, CS | 1 |
| Hsieh, CH | 1 |
| Tien, KJ | 1 |
| Chien, HY | 1 |
| Huang, YY | 2 |
| Hsu, JP | 1 |
| Shane, GT | 1 |
| Chang, AC | 1 |
| Wu, YC | 1 |
| Sheu, WH | 3 |
| Dunne, F | 1 |
| Devane, D | 1 |
| Smyth, A | 1 |
| Alvarez-Iglesias, A | 1 |
| Gillespie, P | 1 |
| Browne, M | 1 |
| O'Donnell, M | 1 |
| Ahmed, I | 1 |
| Raja, UY | 1 |
| Wahab, MU | 1 |
| Rehman, T | 1 |
| Ishtiaq, O | 1 |
| Aamir, AH | 1 |
| Ghaffar, T | 1 |
| Raza, A | 1 |
| Kumar, S | 2 |
| Sherin, A | 1 |
| Masood, F | 1 |
| Randhawa, FA | 1 |
| Asghar, A | 1 |
| Khan, S | 1 |
| Volke, V | 1 |
| Katus, U | 1 |
| Johannson, A | 1 |
| Toompere, K | 1 |
| Heinla, K | 1 |
| Rünkorg, K | 1 |
| Uusküla, A | 1 |
| Yousuf, S | 1 |
| Ahmedani, MY | 1 |
| Sakouhi, M | 3 |
| Matmour, D | 3 |
| Belakhdar, K | 3 |
| Kraroubi, A | 3 |
| Wang, MT | 2 |
| Pan, HY | 2 |
| Huang, YL | 2 |
| Wu, LW | 2 |
| Wang, PC | 2 |
| Hsu, YJ | 2 |
| Lin, TC | 2 |
| Lin, C | 2 |
| Lai, JH | 2 |
| Lee, CH | 2 |
| Jing, Y | 1 |
| Guo, H | 2 |
| Xu, J | 1 |
| Wang, M | 1 |
| Huang, L | 1 |
| Cui, W | 1 |
| Song, L | 1 |
| Liu, X | 5 |
| Sun, B | 1 |
| Wang, N | 1 |
| Sheng, B | 1 |
| Ni, J | 1 |
| Lv, B | 1 |
| Jiang, G | 1 |
| Lin, X | 1 |
| Lim, S | 4 |
| Sohn, M | 1 |
| Florez, JC | 1 |
| Nauck, MA | 4 |
| Ahn, J | 1 |
| Shrivastava, A | 1 |
| Kesavadev, J | 2 |
| Mohan, V | 1 |
| Saboo, B | 1 |
| Shrestha, D | 1 |
| Maheshwari, A | 1 |
| Makkar, BM | 1 |
| Modi, KD | 1 |
| Kumar Das, A | 1 |
| Dagogo-Jack, S | 1 |
| Frederich, R | 2 |
| Cannon, CP | 1 |
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| Cherney, DZI | 1 |
| Cosentino, F | 1 |
| Masiukiewicz, U | 1 |
| Gantz, I | 3 |
| Pratley, RE | 3 |
| Weeda, ER | 1 |
| Ward, R | 1 |
| Gebregziabher, M | 1 |
| Chandler, O | 1 |
| Strychalski, ML | 1 |
| Axon, RN | 1 |
| Taber, DJ | 1 |
| Hamano, K | 1 |
| Akita, K | 1 |
| Takeuchi, Y | 1 |
| Suwa, T | 1 |
| Takeda, J | 1 |
| Dodo, S | 1 |
| Wojszel, ZB | 1 |
| Kasiukiewicz, A | 1 |
| Cho, YM | 1 |
| Deerochanawong, C | 2 |
| Seekaew, S | 1 |
| Suraamornkul, S | 1 |
| Benjachareonwong, S | 1 |
| Sattanon, S | 1 |
| Chamnan, P | 2 |
| Sirirak, T | 1 |
| Kosachunhanun, N | 1 |
| Pratipanawatr, T | 3 |
| Suwanwalaikorn, S | 3 |
| Lee, WJ | 2 |
| Kim, S | 1 |
| Choi, S | 1 |
| Kang, ES | 1 |
| Oh, T | 1 |
| Kwon, S | 2 |
| Lee, MK | 3 |
| Araki, E | 2 |
| Unno, Y | 1 |
| Tanaka, Y | 3 |
| Sakamoto, W | 1 |
| Miyamoto, Y | 1 |
| Bao, LX | 1 |
| Shi, WT | 1 |
| Han, YX | 1 |
| Aberer, F | 1 |
| Pferschy, PN | 1 |
| Tripolt, NJ | 1 |
| Sourij, C | 1 |
| Obermayer, AM | 1 |
| Prüller, F | 1 |
| Novak, E | 1 |
| Reitbauer, P | 1 |
| Kojzar, H | 1 |
| Prietl, B | 1 |
| Kofler, S | 1 |
| Brunner, M | 1 |
| Svehlikova, E | 1 |
| Stojakovic, T | 1 |
| Scharnagl, H | 1 |
| Oulhaj, A | 1 |
| Aziz, F | 1 |
| Riedl, R | 1 |
| Sourij, H | 1 |
| Kelty, E | 1 |
| Tran, DD | 1 |
| Atkinson, A | 1 |
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| Havard, A | 1 |
| Landi, SN | 1 |
| Radke, S | 1 |
| Boggess, K | 2 |
| Engel, SM | 1 |
| Stürmer, T | 1 |
| Howe, AS | 1 |
| Jonsson Funk, M | 1 |
| Sathyanarayanan, A | 1 |
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| Muraleedharan, V | 1 |
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| Cannon, AJ | 1 |
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| Malkin, S | 1 |
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| Johnsson, E | 7 |
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| Scarabello, V | 1 |
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| Lai, E | 1 |
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| Suryawanshi, S | 1 |
| Engel, SS | 8 |
| Farahani, P | 1 |
| Zhang, Y | 4 |
| Zhao, Z | 1 |
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| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Randomized, 24 Week, Active-controlled, Open-label, 3-arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to Insulin Glargine and Lixisenatide in Type 2 Diabetes Mellitus Patients Insufficiently Controlled With Oral Anti[NCT03798054] | Phase 3 | 878 participants (Actual) | Interventional | 2019-02-15 | Completed | ||
| Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed,[NCT03689374] | Phase 3 | 2,274 participants (Actual) | Interventional | 2018-10-01 | Completed | ||
| A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of CS02 Tablet in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone[NCT03317028] | Phase 2 | 201 participants (Actual) | Interventional | 2017-10-10 | Completed | ||
| A Randomised Placebo Controlled Trial of the Effectiveness of Early MEtformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects (EMERGE)[NCT02980276] | Phase 3 | 535 participants (Actual) | Interventional | 2017-06-06 | Completed | ||
| A 24 Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Trial of Once Daily Linagliptin, 5 Milligrams Orally, as Add on to Basal Insulin in Elderly Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control[NCT02240680] | Phase 4 | 302 participants (Actual) | Interventional | 2014-09-23 | Completed | ||
| A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in C[NCT02419612] | Phase 3 | 444 participants (Actual) | Interventional | 2015-08-14 | Completed | ||
| A 26-Week, Multi-Center, Open-label, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-Term Intensive Insulin Therapy: Basal Insulin Based Treatment (With Prandial O[NCT03359837] | Phase 4 | 384 participants (Actual) | Interventional | 2018-01-20 | Completed | ||
| A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Da[NCT02229396] | Phase 3 | 695 participants (Actual) | Interventional | 2014-09-04 | Completed | ||
| An Investigational Trial Comparing the Efficacy and Safety of Once Weekly NNC0148-0287 C (Insulin 287) Versus Once Daily Insulin Glargine, Both in Combination With Metformin, With or Without DPP-4 Inhibitors, in Insulin naïve Subjects With Type 2 Diabetes[NCT03751657] | Phase 2 | 247 participants (Actual) | Interventional | 2018-11-29 | Completed | ||
| Effect of Metformin on Healthy Live Birth After In-vitro Fertilization in Women With Prediabetes Mellitus: a Multicenter Double-blind Placebo Controlled Randomized Trial[NCT06064669] | 988 participants (Anticipated) | Interventional | 2023-10-01 | Not yet recruiting | |||
| Effect of a Quadruple Therapy on Pancreatic Islet Function, Insulin Resistance and Cardiovascular Function in Patients With Mixed Prediabetes and Obesity: Randomized Clinical Trial[NCT04131582] | Phase 3 | 34 participants (Anticipated) | Interventional | 2019-09-01 | Recruiting | ||
| A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy[NCT01755156] | Phase 3 | 402 participants (Actual) | Interventional | 2013-01-11 | Completed | ||
| A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V - Basal Insulin Switch)[NCT01952145] | Phase 3 | 557 participants (Actual) | Interventional | 2013-09-20 | Completed | ||
| Study of Metformin HCL in Patients With Type 2 Diabetes Intensively Treated With Insulin: a Treatment Strategy for Insulin Resistance in Type 2 Diabetes Mellitus: a Randomized Controlled Trial[NCT00375388] | Phase 3 | 400 participants | Interventional | 1998-01-31 | Completed | ||
| The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes[NCT01404676] | Phase 4 | 34 participants (Actual) | Interventional | 2010-06-30 | Completed | ||
| Efficacy, Safety & Tolerability of Combination of Ertugliflozin and Sitagliptin in Patients With Type II Diabetes Mellitus[NCT05556291] | 190 participants (Anticipated) | Observational | 2022-12-01 | Recruiting | |||
| A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin Compared With Ertugliflozin Alone and Sitagliptin Alone, in the Treatment of Subjects W[NCT02099110] | Phase 3 | 1,233 participants (Actual) | Interventional | 2014-04-22 | Completed | ||
| Use of Combination Empagliflozin/Linagliptin or Dapagliflozin/Saxagliptin vs Empagliflozin or Dapagliflozin Alone, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.[NCT04735042] | 60 participants (Anticipated) | Observational | 2020-10-07 | Recruiting | |||
| A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Indivi[NCT01422876] | Phase 3 | 1,405 participants (Actual) | Interventional | 2011-08-31 | Completed | ||
| Efficacy and Safety of the Oral Combined Therapy Glimepiride / Vildagliptin / Metformin in Patients With Type 2 Diabetes With Dual Treatment Failure[NCT04841096] | Phase 3 | 172 participants (Anticipated) | Interventional | 2023-03-21 | Recruiting | ||
| A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combinatio[NCT01606007] | Phase 3 | 1,282 participants (Actual) | Interventional | 2012-07-31 | Completed | ||
| A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of the Continuation of Sitagliptin Compared With the Withdrawal of Sitagliptin During Initiation and Titration of Insulin Glargine (LANT[NCT02738879] | Phase 3 | 746 participants (Actual) | Interventional | 2016-05-09 | Completed | ||
| A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk Peopl[NCT00069784] | Phase 3 | 12,537 participants (Actual) | Interventional | 2003-08-31 | Completed | ||
| Efficacy and Safety of Saxagliptin and Glimepiride in Chinese Patients With Type 2 Diabetes Controlled Inadequately With Metformin Monotherapy (SPECIFY Study) : a 48-week, Multi-center, Randomized, Open-label Trial[NCT02280486] | Phase 4 | 388 participants (Actual) | Interventional | 2015-01-31 | Completed | ||
| Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy[NCT02932475] | Phase 3 | 831 participants (Actual) | Interventional | 2017-05-25 | Terminated (stopped due to Recommendation by the DSMB that the study be stopped for futility) | ||
| A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study With a 78-Week Extension To Evaluate The Efficacy And Safety Of Ertugliflozin In Subjects With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monothe[NCT02033889] | Phase 3 | 621 participants (Actual) | Interventional | 2013-12-13 | Completed | ||
| A 26 Week Randomised, Multinational, Open Labelled, 2 Armed, Parallel Group, Treat-to-target Once Daily Treatment Trial With Insulin Detemir Versus Insulin Glargine, Both in Combination With Metformin in Subjects With Type 2 Diabetes[NCT00909480] | Phase 4 | 457 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Pioglitazone in Patients With Type 2 Diabetes Not Adequate[NCT00763815] | Phase 3 | 484 participants (Actual) | Interventional | 2008-09-30 | Completed | ||
| Effects of Lixisenatide on Gastric Emptying, Glycaemia and 'Postprandial' Blood Pressure in Type 2 Diabetes and Healthy Subjects.[NCT02308254] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2013-11-30 | Recruiting | ||
| A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylure[NCT00575588] | Phase 3 | 891 participants (Actual) | Interventional | 2007-12-31 | Completed | ||
| A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin in Type 2 Diabetes Mellitus Patients ≥ 70 Years (Drug-naive or Inadequately Controlled on Oral Agents)[NCT01257451] | Phase 3 | 431 participants (Actual) | Interventional | 2010-12-31 | Completed | ||
| Pilot Study to Assess the Difference in Glycemic Profiles Between Vildagliptin and Glimepiride Using Continuous Glucose Monitoring Device[NCT01262586] | Phase 3 | 24 participants (Actual) | Interventional | 2010-11-30 | Completed | ||
| A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen: The 'Can Do Ramadan' Study[NCT02694263] | Phase 4 | 25 participants (Actual) | Interventional | 2016-07-31 | Completed | ||
| "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"[NCT00121667] | Phase 3 | 1,462 participants (Actual) | Interventional | 2005-08-31 | Completed | ||
| A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control[NCT00295633] | Phase 3 | 565 participants (Actual) | Interventional | 2006-03-31 | Completed | ||
| A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects[NCT00327015] | Phase 3 | 1,306 participants (Actual) | Interventional | 2006-05-31 | Completed | ||
| A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone[NCT00313313] | Phase 3 | 768 participants (Actual) | Interventional | 2006-04-30 | Completed | ||
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise[NCT00121641] | Phase 3 | 1,035 participants (Actual) | Interventional | 2005-07-31 | Completed | ||
| A 24-week International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Patients With Type 2 Diabetes W[NCT00673231] | Phase 3 | 1,240 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| Effect of Anti-diabetic Drugs on Glycemic Variability. A Comparison Between Gliclazide MR (Modified Release) and Dapagliflozin on Glycemic Variability Measured by Continuous Glucose Monitoring (CGM) in Patients With Uncontrolled Type 2 Diabetes[NCT02925559] | Phase 4 | 135 participants (Actual) | Interventional | 2016-10-31 | Completed | ||
| A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes[NCT01233622] | Phase 3 | 317 participants (Actual) | Interventional | 2010-10-31 | Completed | ||
| A Multicentre, Open Label, Observational 24-week Study to Evaluate Safety of Initiating Insulin Therapy With Levemir® (Insulin Detemir) Once-daily in Oral Antidiabetic Drug-treated Patients With Type 2 Diabetes[NCT00825643] | 18,481 participants (Actual) | Observational | 2008-04-30 | Completed | |||
| Evaluation on Safety of Self-titration in Insulin naïve People With Type 2 Diabetes Treated With Levemir® (Insulin Detemir) and Oral Antidiabetic Agents[NCT00740519] | 882 participants (Actual) | Observational | 2008-09-30 | Completed | |||
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin Plus Metformin, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes[NCT01023581] | Phase 3 | 784 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
| Insulin Glargine Combined With Sulfonylurea Versus Metformin in Patients With Type 2 Diabetes: A Randomized, Controlled Trial.[NCT00708578] | Phase 4 | 99 participants (Actual) | Interventional | 2008-05-31 | 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 | ||
| Comparison of Twice-Daily Insulin Lispro Low Mixture Versus Once-Daily Basal Insulin Glargine and Once-Daily Prandial Insulin Lispro as Insulin Intensification Strategies in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insul[NCT01175824] | Phase 4 | 478 participants (Actual) | Interventional | 2011-04-30 | Completed | ||
| A Phase III, Randomised, Double Blind, Placebo Controlled Parallel Group Efficacy and Safety Study of Linagliptin 5 mg Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metfor[NCT00996658] | Phase 3 | 278 participants (Actual) | Interventional | 2009-10-31 | Completed | ||
| A Study of the Effects of Dapagliflozin on Ambulatory Aortic Pressure, Arterial Stiffness and Urine Albumin Excretion in Patients With Type 2 Diabetes[NCT02887677] | Phase 4 | 85 participants (Actual) | Interventional | 2016-10-31 | Terminated (stopped due to On February 2019 Astra-Zeneca Greece decided to stop the financial support of the study.) | ||
| Effectiveness of the Treatment With Dapagliflozin and Metformin Compared to Metformin Monotherapy for Weight Loss on Diabetic and Prediabetic Patients With Obesity Class III[NCT03968224] | Phase 2/Phase 3 | 90 participants (Anticipated) | Interventional | 2018-07-07 | Recruiting | ||
| SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation: A Randomised Double-blind Placebo-controlled Trial (The SEESAW Study)[NCT02798744] | Phase 4 | 68 participants (Actual) | Interventional | 2016-12-31 | Completed | ||
| Comparative Effects of Empagliflozin Versus Glimepiride After 26-weeks of Treatment Add on Metformin on Myocardial Metabolic Rate of Glucose Estimated Through 18FDG-PET in Patients With Type 2 Diabetes[NCT04183868] | Phase 4 | 26 participants (Actual) | Interventional | 2016-04-30 | Completed | ||
| A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on[NCT01306214] | Phase 3 | 566 participants (Actual) | Interventional | 2011-02-28 | Completed | ||
| Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation (DAPA-AF) Prospective, Randomized, Multicenter, Placebo-Controlled Trial[NCT04792190] | Phase 4 | 25 participants (Actual) | Interventional | 2021-07-27 | Completed | ||
| Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled[NCT00949442] | Phase 4 | 708 participants (Actual) | Interventional | 2009-07-31 | Completed | ||
| A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Ins[NCT00960661] | Phase 3 | 1,036 participants (Actual) | Interventional | 2009-09-30 | Completed | ||
| Is the Stepping-down Approach a Better Option Than Multiple Daily Injections in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?[NCT02846233] | 22 participants (Actual) | Interventional | 2016-08-31 | Completed | |||
| Variability of Glucose Assessed in a Randomized Trial Comparing the Initiation of A Treatment Approach With Biosimilar Basal Insulin Analog Or a Titratable iGlarLixi combinatioN in Type 2 Diabetes Among South Asian Subjects (VARIATION 2 SA Trial)[NCT03819790] | Phase 4 | 119 participants (Actual) | Interventional | 2018-10-02 | Completed | ||
| A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes[NCT01392573] | Phase 3 | 413 participants (Actual) | Interventional | 2011-11-28 | Completed | ||
| A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Co[NCT00968812] | Phase 3 | 1,452 participants (Actual) | Interventional | 2009-09-30 | Completed | ||
| A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of LX4211 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metfor[NCT01376557] | Phase 2 | 299 participants (Actual) | Interventional | 2011-06-30 | Completed | ||
| Evaluation of the Benefit at 6 Months of a 3 Weeks Spa Treatment in the Type 2 Diabetic Patient. Multicenter Randomized Therapeutic Trial[NCT03912623] | 200 participants (Anticipated) | Interventional | 2019-09-13 | Recruiting | |||
| Effectiveness and Tolerability of Novel, Initial Triple Combination Therapy With Xigduo (Dapagliflozin Plus Metformin) and Saxagliptin vs. Conventional Stepwise add-on Therapy in Drug-naïve Patients With Type 2 Diabetes[NCT02946632] | Phase 3 | 104 participants (Anticipated) | Interventional | 2016-12-31 | Not yet recruiting | ||
| A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Ins[NCT00757588] | Phase 3 | 455 participants (Actual) | Interventional | 2008-11-30 | Completed | ||
| A 16-wk, Uni-center, Randomized, Double-blind, Parallel, Phase 3b Trial to Evaluate Efficacy of Saxagliptin + Dapagliflozin vs.Dapagliflozin With Regard to EGP in T2DM With Insufficient Glycemic Control on Metformin+/-Sulfonylurea Therapy[NCT02613897] | 56 participants (Actual) | Interventional | 2016-01-31 | Completed | |||
| Effect of Dapagliflozin on the Progression From Prediabetes to T2DM in Subjects With Myocardial Infarction[NCT03658031] | Phase 3 | 576 participants (Anticipated) | Interventional | 2019-03-01 | Not yet recruiting | ||
| A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™: INTENSIFY ALL)[NCT01059812] | Phase 3 | 424 participants (Actual) | Interventional | 2010-02-01 | Completed | ||
| A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate G[NCT01392677] | Phase 3 | 311 participants (Actual) | Interventional | 2011-10-31 | Completed | ||
| Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin[NCT03076112] | Phase 3 | 170 participants (Actual) | Interventional | 2017-04-25 | Completed | ||
| Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus. A Systematic Review and Meta-analysis of Randomized Controlled Trials Comparing These Drugs Either vs Insulin or vs Each Other.[NCT01998113] | 2,509 participants (Actual) | Observational | 2013-03-31 | Completed | |||
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Monotherapy Compared With Placebo in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Drug-Naïve to Anti-Hyperg[NCT01691755] | Phase 3 | 196 participants (Actual) | Interventional | 2012-11-30 | Completed | ||
| A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PHASE III STUDY TO ASSESS THE EFFICACY,SAFETY AND TOLERABILITY OF ALEGLITAZAR ADDED TO A SU OR ADDED TO A SU IN COMBINATION WITH MET IN PATIENTS WITH T2D INADEQUATELY CONTROLLED WITH SU MONOTHERA[NCT01691989] | Phase 3 | 197 participants (Actual) | Interventional | 2012-12-31 | Completed | ||
| Prospective, Parallel Goups Study, Aimed to Evaluating Possible Benefits of the Treatment of New Generation Hypoglycaemic Drugs Compared to Sulphonylureas for the Tratment of Type 2 Diabetes Mellitus[NCT04272359] | 138 participants (Anticipated) | Observational [Patient Registry] | 2019-05-06 | Recruiting | |||
| A 12-Week, Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety, Tolerability and Efficacy Of Once Daily PF-04971729 And Sitagliptin On Glycemic Control And Body Weight In Adult Patients With T[NCT01059825] | Phase 2 | 375 participants (Actual) | Interventional | 2010-02-24 | Completed | ||
| A Comparison of Premixed and Basal-Bolus Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Twice-daily Premixed Insulin[NCT01175811] | Phase 4 | 402 participants (Actual) | Interventional | 2011-02-28 | Completed | ||
| A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Contr[NCT01006603] | Phase 4 | 957 participants (Actual) | Interventional | 2009-10-31 | Completed | ||
| A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha [NCT01368081] | Phase 3 | 1,162 participants (Actual) | Interventional | 2011-05-31 | Completed | ||
| Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)[NCT00359762] | Phase 3 | 1,029 participants (Actual) | Interventional | 2006-09-30 | Completed | ||
| A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Glimepiride In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin[NCT01517373] | Phase 2 | 304 participants (Actual) | Interventional | 2012-02-29 | Completed | ||
| A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Sitagliptin On Glycemic Control In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Met[NCT01475461] | Phase 2 | 345 participants (Actual) | Interventional | 2011-11-30 | Completed | ||
| An Open-label, Randomized, Three-parallel-group Study on Pharmacodynamic Effects of 8-week QD Treatment With Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin[NCT01596504] | Phase 2 | 142 participants (Actual) | Interventional | 2012-05-31 | Completed | ||
| A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus[NCT01582230] | Phase 3 | 293 participants (Actual) | Interventional | 2012-04-30 | Completed | ||
| A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Tr[NCT01336023] | Phase 3 | 1,663 participants (Actual) | Interventional | 2011-05-23 | Completed | ||
| The Study About Glucose Lowering Effect of Vildagliptin in Type 2 Diabetes Patients Who Are Uncontrolled With Metformin and a Sulphonylurea[NCT01099137] | Phase 4 | 344 participants (Actual) | Interventional | 2010-01-31 | Completed | ||
| Effect of Dulaglutide on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial[NCT03590626] | 60 participants (Actual) | Interventional | 2019-01-01 | Completed | |||
| A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride[NCT01075282] | Phase 3 | 810 participants (Actual) | Interventional | 2010-02-28 | Completed | ||
| A Randomized, Placebo-Controlled Dose-Escalation Study to Assess the Safety and Tolerability of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Type 2 Diabetes Sub-optimally Controlled on Metformin[NCT01576328] | Phase 1/Phase 2 | 61 participants (Actual) | Interventional | 2012-04-30 | Completed | ||
| The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes[NCT01617434] | Phase 3 | 451 participants (Actual) | Interventional | 2012-09-30 | Completed | ||
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy With Dapagliflozin Added to Saxagliptin in Combination With Metformin Compared to Therapy With Placebo Added to Saxag[NCT01646320] | Phase 3 | 320 participants (Actual) | Interventional | 2012-09-30 | Completed | ||
| A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Triple Therapy With Saxagliptin Added to Dapagliflozin in Combination With Metformin Compared to Therapy With Placebo Added t[NCT01619059] | Phase 3 | 315 participants (Actual) | Interventional | 2012-06-30 | Completed | ||
| Effect of Lixisenatide on Glucagon Secretion During Hypoglycemia in Patients With Insulin-treated Type 2 Diabetes[NCT02020629] | Phase 4 | 18 participants (Actual) | Interventional | 2013-12-31 | Completed | ||
| The Effect of Metformin Versus Placebo, Including Three Insulin-Analogue Regimens With Variating Postprandial Glucose Regulation, on CIMT in T2DM Patients - A Randomized, Multicenter Trial[NCT00657943] | Phase 4 | 415 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification[NCT01664247] | Phase 3 | 346 participants (Actual) | Interventional | 2012-10-01 | Completed | ||
| 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 Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™: ONCE)[NCT01849289] | Phase 3 | 833 participants (Actual) | Interventional | 2013-06-02 | Completed | ||
| FLAT-SUGAR: FLuctuATion Reduction With inSULin and Glp-1 Added togetheR[NCT01524705] | Phase 4 | 102 participants (Actual) | Interventional | 2012-08-31 | Completed | ||
| Using Closed-Loop Artificial Pancreas Technology to Reduce Glycemic Variability and Subsequently Improve Cardiovascular Health in Type 1 Diabetes[NCT05653518] | 40 participants (Anticipated) | Interventional | 2023-09-09 | Recruiting | |||
| A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficien[NCT01768559] | Phase 3 | 894 participants (Actual) | Interventional | 2013-01-31 | Completed | ||
| A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients[NCT01476475] | Phase 2 | 323 participants (Actual) | Interventional | 2011-11-30 | Completed | ||
| Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes[NCT01973231] | Phase 4 | 404 participants (Actual) | Interventional | 2013-10-31 | Completed | ||
| 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 | ||
| An Open-labeled, Randomized, Multicenter, Prospective, Parallel Group, Interventional Study to Demonstrate the Effectiveness of 24 Weeks Treatment With Vildagliptin 50mg Bid as Add on to Metformin 500 mg Bid Compared to Metformin up to 1000 mg Bid in Chin[NCT01541956] | Phase 4 | 3,091 participants (Actual) | Interventional | 2012-02-29 | Completed | ||
| SPIDER: A Structured Process Informed by Data, Evidence and Research - A Research and Quality Improvement Collaboration Supporting Practices in Improving Care for Complex Elderly Patients[NCT03689049] | 104 participants (Anticipated) | Interventional | 2018-03-26 | Enrolling by invitation | |||
| A Phase III, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Linagliptin 5 mg Compared to Placebo, Administered as Oral Fixed Dose Combination With Empagliflozin 10 mg or 25 mg for 24 Weeks, in Patients With Type 2 Di[NCT01778049] | Phase 3 | 708 participants (Actual) | Interventional | 2013-01-31 | Completed | ||
| A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therap[NCT01177384] | Phase 3 | 380 participants (Actual) | Interventional | 2011-01-25 | Completed | ||
| [NCT01563120] | Phase 4 | 108 participants (Actual) | Interventional | 2012-01-31 | Completed | ||
| SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With Type 2[NCT02243176] | Phase 4 | 689 participants (Actual) | Interventional | 2014-09-30 | Completed | ||
| Modulating Endoplasmic Reticulum Stress as a Prophylactic Approach Against Symptomatic Viral Infection[NCT04267809] | Phase 2 | 44 participants (Anticipated) | Interventional | 2021-10-22 | Recruiting | ||
| Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients New to Insulin Therapy Who Were Inadequately Controlled on Oral Agents[NCT00036504] | Phase 4 | 100 participants | Interventional | 2001-08-31 | Completed | ||
| Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes: A Comparison of Premeal Insulin Lispro Mixtures to Once-Daily Insulin Glargine[NCT00191464] | Phase 4 | 320 participants | Interventional | 2003-12-31 | Completed | ||
| Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes[NCT04943692] | Phase 3 | 500 participants (Anticipated) | Interventional | 2021-08-31 | Suspended (stopped due to Administrative decision of the investigation direction) | ||
| Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30, Biphasic Insulin Aspart 50/50, and Biphasic Insulin Aspart 30/70 All in Combination With Metformin in Subjects With Type 2 Diabetes (the INTENSIMIX Trial).[NCT00184574] | Phase 3 | 603 participants (Actual) | Interventional | 2005-04-30 | Completed | ||
| Repaglinide and Metformin Combination Tablet (NN4440) in a TID Regimen Compared to a BID Regimen and BID Avandamet in Subjects With Type 2 Diabetes: A Twenty-Six Week, Open-Label, Multicenter, Randomized, Parallel Group Trial to Investigate Efficacy and S[NCT00399711] | Phase 3 | 560 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
| A 36-month, Multi-centre, Open-label, Randomised, Parallel-group Trial Comparing the Safety, Efficacy and Durability of Adding a Basal Insulin Versus a Twice Daily Insulin Mixture Versus a Meal-time Rapid-Acting Insulin in Subjects With Type 2 Diabetes In[NCT00184600] | Phase 3 | 708 participants (Actual) | Interventional | 2004-11-30 | Completed | ||
| Effect of Repaglinide Versus Metformin Treatment in Combination With Insulin Biasp30 (Novologmix 70/30) Predinner on Glycemic and Non-Glycemic Cardiovascular Risk-Factors in Non-Obese Patients With Type-2-Diabetes With Unsatisfactory Glycaemic Control Wit[NCT00118963] | Phase 4 | 102 participants (Actual) | Interventional | 2003-01-31 | Completed | ||
| The Effects of Saxagliptin 5mg, Once Daily for 52 Weeks on 24 Hour Urine Albumin Creatinine Rate(ACR) , in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin or/and Acarbose[NCT02462369] | Phase 4 | 88 participants (Anticipated) | Interventional | 2015-06-30 | Enrolling by invitation | ||
| Safety and Efficacy of Metformin Glycinate vs Metformin Hydrochloride on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes Patients[NCT01386671] | Phase 3 | 203 participants (Actual) | Interventional | 2014-06-30 | Completed | ||
| DPP-4 Inhibitors in Patients With Type 2 Diabetes and Acute Myocardial Infarction:Effects on Platelet Function[NCT02377388] | Phase 3 | 74 participants (Actual) | Interventional | 2017-02-07 | Completed | ||
| A Comparison of a Pulse-Based Diet and the Therapeutic Lifestyle Changes Diet on Reproductive and Metabolic Parameters in Women With Polycystic Ovary Syndrome[NCT05428566] | 110 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting | |||
| A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin[NCT00701090] | Phase 3 | 1,035 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
| Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus[NCT00789191] | Phase 3 | 222 participants (Actual) | Interventional | 2008-11-30 | Completed | ||
| A Multi-centre, Open-labeled, Randomized, Parallel Study on Liver Fat Content and Visceral Fat Mass in Overweight and Obese Type 2 Diabetes Patients After 26 Weeks Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily[NCT01310452] | 50 participants (Anticipated) | Interventional | 2011-01-31 | Active, not recruiting | |||
| Effect of Exenatide Plus Metformin vs. Premixed Human Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Inadequate Control of Type 2 Diabetes on Oral Antidiabetic Treatment[NCT00434954] | Phase 3 | 494 participants (Actual) | Interventional | 2007-02-28 | Completed | ||
| A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy[NCT00094770] | Phase 3 | 1,172 participants (Actual) | Interventional | 2004-09-30 | Completed | ||
| A 12 Week, Parallel, Open-label, Randomized, Multi-center Study Evaluating Use, Safety and Effectiveness of a Web Based Tool vs. Enhanced Usual Therapy of Glargine Titration in T2DM Patients With a 4 Week Safety Extension[NCT02540486] | 139 participants (Actual) | Interventional | 2013-12-31 | Completed | |||
| Protocol Driven Management of Type 2 Diabetes After Gastric Bypass Surgery[NCT01213563] | 50 participants (Actual) | Interventional | 2009-01-31 | Terminated (stopped due to Data were published that superseded this study.) | |||
| A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin[NCT00870194] | Phase 4 | 255 participants (Actual) | Interventional | 2009-03-31 | Completed | ||
| Effect of the Combination of Dipeptidyl Peptidase-4 Inhibitor (DPP4i) and Insulin in Comparison to Insulin on Metabolic Control and Prognosis in Hospitalized Patients With COVID-19[NCT04542213] | Phase 3 | 70 participants (Actual) | Interventional | 2020-08-01 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Parallel Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered SGLT2 Inhibitor JNJ-28431754 [NCT00642278] | Phase 2 | 451 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| A Randomised, db, Placebo-controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5mg), Administered Orally Once Daily for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic [NCT00740051] | Phase 3 | 227 participants (Actual) | Interventional | 2008-08-31 | Completed | ||
| A Multicenter, Prospective, Randomized, Open-label, Parallel Group Study to Investigate the Clinical Benefit on Hypoglycemia Frequency of 24 Weeks Treatment With Galvus Versus Usual Care (Any OAD of Another Class Added to Metformin Within SmPc) in Older P[NCT01238978] | Phase 4 | 46 participants (Actual) | Interventional | 2010-10-31 | Completed | ||
| Phase 4 Study of Comparison of Combination Therapy of Gliclazide MR and Basal Insulin With Pre-mix Insulin Monotherapy for the Patients With Type 2 Diabetes Mellitus[NCT00736515] | Phase 4 | 160 participants (Actual) | Interventional | 2008-10-31 | Completed | ||
| Basal Insulin Therapy in Patients With Insulin Resistance: A 6 Month Comparison of Insulin Glargine and NPH Insulin[NCT01854723] | Phase 4 | 0 participants (Actual) | Interventional | 2013-04-30 | Withdrawn | ||
| Comparison of Carbohydrate Metabolism During the Night and at Hypoglycemia in Type-2 Diabetic Patients Either on Glargine or NPH Insulin[NCT00468364] | 12 participants (Actual) | Observational | 2003-07-31 | Completed | |||
| Bedtime Insulin Glargine or Bedtime Neutral Protamine Lispro Combined With Sulfonylurea and Metformin in Type 2 Diabetes. A Randomized, Controlled Trial[NCT00641407] | Phase 4 | 100 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
| Difference of Basal Insulin Titration Method in Reducing HbA1c Among Type 2 Diabetes Mellitus (T2DM) Patients.[NCT05331469] | Phase 4 | 70 participants (Anticipated) | Interventional | 2021-07-19 | Recruiting | ||
| Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes[NCT00619697] | Phase 4 | 260 participants (Actual) | Interventional | 2003-12-31 | 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 | ||
| A Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Glimepiride Alone or in Combination With Metf[NCT00106704] | Phase 3 | 441 participants (Actual) | Interventional | 2005-03-31 | Completed | ||
| Effects of Sitagliptin on Postprandial Glycaemia, Incretin Hormones and Blood Pressure in Type 2 Diabetes - Relationship to Gastric Emptying[NCT02324010] | Phase 2 | 14 participants (Actual) | Interventional | 2015-07-31 | Completed | ||
| Effect of Biphasic Insulin Aspart 30 on Glycaemic Control in Subjects With Type 2 Diabetes[NCT00280046] | Phase 3 | 307 participants (Actual) | Interventional | 2003-11-30 | Completed | ||
| Does Metformin Improve Pregnancy Outcomes (Incidence of LGA (≥90% Birth Weight Centile) Babies, Onset of Maternal GDM, Hypertension, PET, Macrosomia, Shoulder Dystocia, Admission to SCBU) in Obese Non-diabetic Women?[NCT01273584] | Phase 2/Phase 3 | 450 participants (Actual) | Interventional | 2010-10-31 | Completed | ||
| Prevention of Pre-eclampsia Using Metformin: a Randomized Control Trial[NCT04855513] | 414 participants (Anticipated) | Interventional | 2022-03-24 | Not yet recruiting | |||
| Preventing Recurrent Gestational Diabetes Mellitus With Early Metformin Intervention[NCT02394158] | Phase 4 | 112 participants (Anticipated) | Interventional | 2015-01-27 | Recruiting | ||
| Non-inferiority Between Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. ACARB-GDM Study.[NCT03380546] | Phase 3 | 341 participants (Actual) | Interventional | 2018-07-04 | Active, not recruiting | ||
| A Randomized Phase 3 Trial of Metformin in Patients Initiating Androgen Deprivation Therapy as Prevention and Intervention of Metabolic Syndrome: The Prime Study[NCT03031821] | Phase 3 | 168 participants (Actual) | Interventional | 2018-07-12 | Terminated (stopped due to Manufacturer discontinued the production of study drugs.) | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Change from baseline in HbA1c at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Percentage of HbA1c (Mean) |
|---|---|
| Semaglutide | -1.5 |
| Insulin Aspart | -1.2 |
Change from baseline in 7-point self-measured plasma glucose profile: mean 7-PP at week 52 is presented. All participants were instructed to perform 7-point SMPG profiles before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal (dinner), 90 minutes after the start of main evening meal (dinner) and at bedtime. The measurements were to be performed before any injection of bolus insulin and just before the start of the meal (breakfast, lunch or main evening meal), and values measured before breakfast were performed in a fasting condition. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | mmol/L (Mean) |
|---|---|
| Semaglutide | -2.1 |
| Insulin Aspart | -2.1 |
Change from baseline in 7-point SMPG profile: mean post-prandial increment (over all meals) at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | mmol/L (Mean) |
|---|---|
| Semaglutide | -0.7 |
| Insulin Aspart | -0.9 |
Change from baseline in BMI at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | kilograms per meter square (kg/m^2) (Mean) |
|---|---|
| Semaglutide | -1.5 |
| Insulin Aspart | 1.0 |
Change from baseline in body weight at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | kilograms (Mean) |
|---|---|
| Semaglutide | -4.2 |
| Insulin Aspart | 2.9 |
Change from baseline in body weight (measured in percentage) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Ratio of body weight (Mean) |
|---|---|
| Semaglutide | 1.0 |
| Insulin Aspart | 1.0 |
Change from baseline in HDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Ratio of HDL cholesterol (Geometric Mean) |
|---|---|
| Semaglutide | 1.0 |
| Insulin Aspart | 1.0 |
Change from baseline in LDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Ratio of LDL cholesterol (Geometric Mean) |
|---|---|
| Semaglutide | 1.0 |
| Insulin Aspart | 1.0 |
Change from baseline in total cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Ratio of total cholesterol (Geometric Mean) |
|---|---|
| Semaglutide | 1.0 |
| Insulin Aspart | 1.0 |
Change from baseline in triglycerides (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Ratio of triglycerides (Geometric Mean) |
|---|---|
| Semaglutide | 0.9 |
| Insulin Aspart | 1.0 |
Change from baseline in FPG at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | millimoles per liter (mmol/L) (Mean) |
|---|---|
| Semaglutide | -1.3 |
| Insulin Aspart | -0.8 |
Change from baseline in pulse rate at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Beats per minute (beats/min) (Mean) |
|---|---|
| Semaglutide | 2.2 |
| Insulin Aspart | 1.1 |
Change from baseline in waist circumference at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | centimeters (cm) (Mean) |
|---|---|
| Semaglutide | -3.3 |
| Insulin Aspart | 2.1 |
Daily basal insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: At week 52
| Intervention | Units of insulin (Mean) |
|---|---|
| Semaglutide | 35.8 |
| Insulin Aspart | 40.7 |
Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG <3.1 mmol/L (56 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode, that was BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52
| Intervention | Episodes (Number) |
|---|---|
| Semaglutide | 254 |
| Insulin Aspart | 1744 |
Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG <=3.9 mmol/L (70 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode during which symptoms of hypoglycaemia were not accompanied by a PG determination but that was presumably caused by a PG concentration <= 3.9 mmol/L (70 mg/dL). Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52
| Intervention | Episodes (Number) |
|---|---|
| Semaglutide | 1420 |
| Insulin Aspart | 5616 |
Number of EAC-confirmed severe or clinically significant hypoglycaemic episodes (plasma glucose < 3.0 mmol/L (54 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Hypoglycaemic episode with plasma glucose < 3.0 mmol/L (54 mg/dL)) was considered as clinically significant. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52
| Intervention | Episodes (Number) |
|---|---|
| Semaglutide | 339 |
| Insulin Aspart | 2270 |
Number of EAC-confirmed severe hypoglycaemic episodes from randomization (week 0) up to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52
| Intervention | Episodes (Number) |
|---|---|
| Semaglutide | 4 |
| Insulin Aspart | 7 |
Number of EAC-confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life-threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52
| Intervention | Episodes (Number) |
|---|---|
| Semaglutide | 2 |
| Insulin Aspart | 4 |
First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with plasma glucose (PG) less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligrams per deciliter (mg/dL)). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) up to week 52
| Intervention | First event per 100 years of exposure (Number) |
|---|---|
| Semaglutide | 0.4 |
| Insulin Aspart | 0.7 |
First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) up to week 52
| Intervention | First event per 100 years of exposure (Number) |
|---|---|
| Semaglutide | 0.2 |
| Insulin Aspart | 0.4 |
Total daily insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: At week 52
| Intervention | Units of insulin (Mean) |
|---|---|
| Semaglutide | 35.8 |
| Insulin Aspart | 77.7 |
SF-36v2 is 36-item patient-reported survey of patient health to measure participant's overall health-related quality of life (HRQoL). It has 36 items: 8 domains of physical, mental health status (physical functioning, role physical health (range:21.23-57.16), bodily pain (range: 21.68-62.00), general health (range: 18.95-66.50), vitality (range: 22.89-70.42), social functioning (range: 17.23-57.34), role emotional problem (range: 14.39-56.17) and mental health (range: 11.63-63.95)) and 2 total summary scores: physical components summary (range: 7.32-70.14) and mental components summary (range: 5.79-69.91) calculated from domain scores. All 10 scores range from 5.79-70.42 . Higher scores indicated a better health state. Change from baseline in SF-36v2, 2 summary and 8 domains scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from date of first dose of trial product (week 0) to last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Scores on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Physical Component Summary | Mental Component Summary | Physical Functioning | Role Physical Health | Bodily Pain | General Health | Vitality | Social Functioning | Role Emotional Problem | Mental Health | |
| Insulin Aspart | 0.4 | -0.3 | 0.2 | -0.2 | 0.8 | 0.3 | 0.1 | -0.6 | -0.2 | 0.1 |
| Semaglutide | 1.4 | 0.1 | 1.4 | 0.1 | 1.5 | 1.6 | 1.1 | 0.2 | 0.0 | 0.6 |
The DQLCTQ-R questionnaire was used to assess participants' HRQoL. The DQLCTQ-R questionnaire contains 57 items and measures and provide scores for the 8 domains (physical function, energy or fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility and frequency of symptoms). The 8 domain scores related to DQLCTQ-R are measured on a scale from 0-100. For all scores, higher values indicated better health status. Change from baseline in DQLCTQ-R 8 domain scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Scores on a scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Physical function | Energy or fatigue | Health distress | Mental health | Satisfaction | Treatment satisfaction | Treatment flexibility | Frequency of symptoms | |
| Insulin Aspart | -0.4 | 0.4 | 0.3 | 0.5 | -0.2 | 0.8 | -1.2 | 1.8 |
| Semaglutide | 2.4 | 2.3 | -0.2 | 7.2 | 4.1 | 9.9 | 4.2 | 4.1 |
Change from baseline in systolic and diastolic blood pressure at week 52 are presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | millimeter of mercury (mmHg) (Mean) | |
|---|---|---|
| Diastolic Blood Pressure | Systolic Blood Pressure | |
| Insulin Aspart | -0.4 | 1.0 |
| Semaglutide | -1.4 | -2.8 |
This outcome has measured difference between FPG values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication (NCT02240680)
Timeframe: Baseline and Week 24
| Intervention | milligram/decilitre (Least Squares Mean) |
|---|---|
| Placebo (Up to 24 Weeks) | 0.2 |
| Linagliptin 5 Milligram (Up to 24 Weeks) | -11.3 |
This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range. (NCT02240680)
Timeframe: Baseline and Week 24
| Intervention | Percentage (%) of HbA1c (Least Squares Mean) |
|---|---|
| Placebo (Up to 24 Weeks) | -0.38 |
| Linagliptin 5 Milligram (Up to 24 Weeks) | -1.01 |
The percentage of patients who attained lowering of HbA1c by ≥0.5% from baseline after 24 weeks of treatment were analysed. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson. (NCT02240680)
Timeframe: 24 weeks
| Intervention | Percentage of patients (%) (Number) |
|---|---|
| Placebo (Up to 24 Weeks) | 37.4 |
| Linagliptin 5 Milligram (Up to 24 Weeks) | 69.1 |
This is the percentage of patients with HbA1c on treatment <7.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson. (NCT02240680)
Timeframe: 24 weeks
| Intervention | Percentage of Patients (%) (Number) |
|---|---|
| Placebo (Up to 24 Weeks) | 14.6 |
| Linagliptin 5 Milligram (Up to 24 Weeks) | 37.8 |
This is the percentage of patients with HbA1c on treatment <8.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson. (NCT02240680)
Timeframe: 24 weeks
| Intervention | Percentage of patients (%) (Number) |
|---|---|
| Placebo (Up to 24 Weeks) | 40.2 |
| Linagliptin 5 Milligram (Up to 24 Weeks) | 70.1 |
Hypoglycaemia accompanied by a prespecified glucose value is defined as any investigator reported hypoglycaemia (event or AE) with a reported blood glucose level of less than 54 milligram/deciLitre (3.0 millimole/Litre) or any investigator reported symptomatic hypoglycaemic AE with a reported blood glucose level of less or equal 70 milligram/deciLitre (3.9millimole/Litre) or any severe hypoglycaemic AE. Severe hypoglycaemia is an event that requires the assistance of another person to actively administer carbohydrates or glucagon because the patient is unable to take the substance on his or her own. The confidence intervals mentioned in measure of dispersion are exact 95% confidence interval by Clopper and Pearson. The percentage of patients with at least one hypoglycaemia accompanied by a glucose value less than 54mg/dL alone has also represented separately according American Diabetes Association definition of clinically significant hypoglycaemia. (NCT02240680)
Timeframe: 24 weeks
| Intervention | Percentage of patients (%) (Number) | |
|---|---|---|
| Prespecified glucose value | Glucose value <54 mg/dL | |
| Linagliptin 5 Milligram (Up to 24 Weeks) | 30.9 | 16.8 |
| Placebo (Up to 24 Weeks) | 23.8 | 15.0 |
To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. (NCT02419612)
Timeframe: Baseline and Week 52
| Intervention | % HbA1c (Least Squares Mean) |
|---|---|
| Dapagliflozin 10mg and Saxagliptin 5mg | -1.35 |
| Titrated Glimepiride | -0.98 |
To examine whether the change from baseline in SBP with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. (NCT02419612)
Timeframe: Baseline and Week 52
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Dapagliflozin 10mg and Saxagliptin 5mg | -2.6 |
| Titrated Glimepiride | 1.0 |
To examine whether the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. (NCT02419612)
Timeframe: Baseline and Week 52
| Intervention | kilogram (kg) (Least Squares Mean) |
|---|---|
| Dapagliflozin 10mg and Saxagliptin 5mg | -3.11 |
| Titrated Glimepiride | 0.95 |
Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 156 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c. (NCT02419612)
Timeframe: At Week 156
| Intervention | Percentage of Subjects (Number) |
|---|---|
| Dapagliflozin 10mg and Saxagliptin 5mg | 21.4 |
| Titrated Glimepiride | 11.7 |
Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 52 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c. (NCT02419612)
Timeframe: At Week 52
| Intervention | Percentage of subjects (Number) |
|---|---|
| Dapagliflozin 10mg and Saxagliptin 5mg | 44.3 |
| Titrated Glimepiride | 34.3 |
Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 156-week treatment period. (NCT02419612)
Timeframe: Up to Week 156
| Intervention | Percentage of Subjects (Number) |
|---|---|
| Dapagliflozin 10mg and Saxagliptin 5mg | 37.0 |
| Titrated Glimepiride | 55.6 |
Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after the 52-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 52 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 52-week short -term treatment period. (NCT02419612)
Timeframe: Up to Week 52
| Intervention | Percentage of Subjects (Number) |
|---|---|
| Dapagliflozin 10mg and Saxagliptin 5mg | 1.3 |
| Titrated Glimepiride | 8.8 |
Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. Time to treatment intensification curves were generated using Kaplan-Meier estimates and compared using a Cox proportional hazards model. (NCT02419612)
Timeframe: Up to Week 156
| Intervention | Weeks (Median) |
|---|---|
| Dapagliflozin 10mg and Saxagliptin 5mg | NA |
| Titrated Glimepiride | 92.3 |
To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Dapagliflozin + Placebo | -61.05 |
| Exenatide + Dapagliflozin | -87.83 |
| Exenatide + Placebo | -60.09 |
To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28
| Intervention | kilogram (Least Squares Mean) |
|---|---|
| Dapagliflozin + Placebo | -2.22 |
| Exenatide + Dapagliflozin | -3.55 |
| Exenatide + Placebo | -1.56 |
To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 2
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Dapagliflozin + Placebo | -26.31 |
| Exenatide + Dapagliflozin | -41.34 |
| Exenatide + Placebo | -21.08 |
To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28
| Intervention | milligrams/deciliter (mg/dL) (Least Squares Mean) |
|---|---|
| Dapagliflozin + Placebo | -49.19 |
| Exenatide + Dapagliflozin | -65.83 |
| Exenatide + Placebo | -45.75 |
To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28
| Intervention | % HbA1c (Least Squares Mean) |
|---|---|
| Dapagliflozin + Placebo | -1.39 |
| Exenatide + Dapagliflozin | -1.98 |
| Exenatide + Placebo | -1.60 |
To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28
| Intervention | millimeters of mercury (mmHg) (Least Squares Mean) |
|---|---|
| Dapagliflozin + Placebo | -1.8 |
| Exenatide + Dapagliflozin | -4.3 |
| Exenatide + Placebo | -1.2 |
To compare the percentage of patients achieving HbA1c <7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28
| Intervention | % of patients (Number) |
|---|---|
| Dapagliflozin + Placebo | 19.1 |
| Exenatide + Dapagliflozin | 44.7 |
| Exenatide + Placebo | 26.9 |
To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28
| Intervention | % of patients (Number) |
|---|---|
| Dapagliflozin + Placebo | 20.0 |
| Exenatide + Dapagliflozin | 33.3 |
| Exenatide + Placebo | 13.7 |
Samples from the insulin 287 arm of the study were analysed for anti-insulin 287 antibodies. Confirmed anti-insulin 287 antibody positive samples had an antibody titre value determined. The endpoint was evaluated based on the data from in-trial period, starting at randomisation, and ending at the last direct participant-site contact, or when participant withdrew their informed consent, or the last participant-investigator contact for participants lost to follow-up, or death. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 31 (Visit 30)
| Intervention | Antibody titers (Mean) |
|---|---|
| Insulin 287 | 979.9 |
Change in body weight from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)
| Intervention | Kilogram (Least Squares Mean) |
|---|---|
| Insulin 287 | 1.49 |
| Insulin Glargine | 1.56 |
Change in fasting plasma glucose from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)
| Intervention | mmol/l (Least Squares Mean) |
|---|---|
| Insulin 287 | -3.20 |
| Insulin Glargine | -2.99 |
Change in HbA1c from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)
| Intervention | Percentage point of HbA1c (Least Squares Mean) |
|---|---|
| Insulin 287 | -1.33 |
| Insulin Glargine | -1.15 |
Change in HbA1c from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)
| Intervention | mmol/mol (Least Squares Mean) |
|---|---|
| Insulin 287 | -14.51 |
| Insulin Glargine | -12.54 |
Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)
| Intervention | mmol/l (Least Squares Mean) |
|---|---|
| Insulin 287 | -2.70 |
| Insulin Glargine | -2.26 |
Fasting C-peptide at week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: At week 26 (Visit 28)
| Intervention | Nanomoles per liter (nmol/l) (Least Squares Mean) |
|---|---|
| Insulin 287 | 0.44 |
| Insulin Glargine | 0.47 |
Participants measured their plasma glucose (PG) levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Presented fluctuation in 9-point SMPG profile is the integrated absolute distance from the mean profile value divided by measurement time and is calculated using the trapezoidal method. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: Week 26 (Visit 28)
| Intervention | mmol/l (Least Squares Mean) |
|---|---|
| Insulin 287 | 0.92 |
| Insulin Glargine | 0.94 |
Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG) meter or severe hypoglycaemic episodes (level 3) that occurred from week 0 to week 26 are presented. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)
| Intervention | Episodes (Number) |
|---|---|
| Insulin 287 | 38 |
| Insulin Glargine | 31 |
Hypoglycaemia alert value (level 1) was defined as episodes that were sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy with plasma glucose value of equal to or above (>=) 3.0 and less than (<) 3.9 mmol/L (>= 54 and < 70 mg/dL) confirmed by BG meter. Number of hypoglycaemic alert episodes (level 1) that occurred from week 0 to week 26 are presented. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)
| Intervention | Episodes (Number) |
|---|---|
| Insulin 287 | 358 |
| Insulin Glargine | 145 |
Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of severe hypoglycaemic episodes that occurred from week 0 to week 26 are presented. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 26 (Visit 28)
| Intervention | Episodes (Number) |
|---|---|
| Insulin 287 | 1 |
| Insulin Glargine | 0 |
An adverse event (AE) is any untoward medical occurrence in a clinical trial subject administered or using a medicinal product, whether or not considered related to the medicinal product or usage. A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. The endpoint was evaluated based on the data from on-treatment period, starting at the date of first dose of trial product, and ending at follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 31 (Visit 30)
| Intervention | Events (Number) |
|---|---|
| Insulin 287 | 229 |
| Insulin Glargine | 158 |
Weekly dose of insulin 287 and weekly dose of glargine at week 25 and week 26 are presented.The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: week 25 (Visit 27) and 26 (Visit 28)
| Intervention | Units of Insulin (Least Squares Mean) |
|---|---|
| Insulin 287 | 229.06 |
| Insulin Glargine | 284.05 |
Participants measured their plasma glucose (PG) levels using blood glucose meters (as plasma equivalent values of capillary whole blood glucose) at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 9-point SMPG values after 26 weeks are presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i. (NCT03751657)
Timeframe: Week 26 (Visit 28)
| Intervention | mmol/l (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Before breakfast | 90 minutes after start of breakfast | Before lunch | 90 minutes after start of lunch | Before main evening meal | 90 minutes after the start of main evening meal | Before bedtime | At 4:00 a.m. | Before breakfast the following day | |
| Insulin 287 | 5.70 | 7.90 | 6.09 | 7.83 | 6.55 | 8.01 | 7.35 | 5.72 | 5.74 |
| Insulin Glargine | 6.19 | 8.51 | 6.19 | 8.50 | 6.96 | 8.47 | 7.87 | 5.98 | 6.05 |
Anti-insulin 287 or glargine antibodies were classified as negative if % B/T was below a certain cut point. Samples positive for anti-insulin 287 or glargine antibodies were further tested for cross-reactivity to endogenous insulin. Samples not further tested are categorised as not applicable (NA). Unknown refers to samples with insufficient volume to perform analysis. The endpoint was evaluated based on the data from in-trial period, starting at randomisation, and ending at the last direct participant-site contact, or when participant withdrew their informed consent, or the last participant-investigator contact for participants lost to follow-up, or death. (NCT03751657)
Timeframe: From baseline (Visit 2) to week 31 (Visit 30)
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 072515459 | Week 072515460 | Week 3172515460 | Week 3172515459 | |||||||||||||
| Positive | Unknown | Not Applicable | Negative | |||||||||||||
| Insulin Glargine | 1 | |||||||||||||||
| Insulin 287 | 1 | |||||||||||||||
| Insulin Glargine | 9 | |||||||||||||||
| Insulin 287 | 124 | |||||||||||||||
| Insulin Glargine | 112 | |||||||||||||||
| Insulin 287 | 9 | |||||||||||||||
| Insulin Glargine | 0 | |||||||||||||||
| Insulin 287 | 86 | |||||||||||||||
| Insulin Glargine | 26 | |||||||||||||||
| Insulin 287 | 0 | |||||||||||||||
| Insulin 287 | 25 | |||||||||||||||
| Insulin Glargine | 89 | |||||||||||||||
Change from baseline in 2-hour PMG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment. (NCT01755156)
Timeframe: Baseline and Week 24
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Omarigliptin (Phase A) | -26.8 |
| Placebo to Omarigliptin (Phase A) | -12.2 |
A1C is measured as a percent. Change from baseline in A1C at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment. (NCT01755156)
Timeframe: Baseline and Week 104
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Omarigliptin (Phase A) → Omarigliptin (Phase B) | -0.42 |
| Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) | -0.51 |
Change from baseline in fasting insulin at Week 104 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment. (NCT01755156)
Timeframe: Baseline and Week 104
| Intervention | μIU/mL (Least Squares Mean) |
|---|---|
| Omarigliptin (Phase A) → Omarigliptin (Phase B) | 1.2 |
| Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) | 1.8 |
Change from baseline in fasting insulin at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment. (NCT01755156)
Timeframe: Baseline and Week 24
| Intervention | micro International Unit (μIU)/mL (Least Squares Mean) |
|---|---|
| Omarigliptin (Phase A) | 1.8 |
| Placebo to Omarigliptin (Phase A) | -1.9 |
Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment. (NCT01755156)
Timeframe: Baseline and Week 24
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Omarigliptin (Phase A) | -10.7 |
| Placebo to Omarigliptin (Phase A) | -1.2 |
Change from baseline in FPG at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment. (NCT01755156)
Timeframe: Baseline and Week 104
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Omarigliptin (Phase A) → Omarigliptin (Phase B) | -7.8 |
| Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) | -18.2 |
A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment. (NCT01755156)
Timeframe: Baseline and Week 24
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Omarigliptin (Phase A) | -0.54 |
| Placebo to Omarigliptin (Phase A) | 0.00 |
Change from baseline in PMG total AUC at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment. Plasma glucose levels were measured before the meal (0 minutes), and at 60 and 120 minutes after the meal. (NCT01755156)
Timeframe: Baseline and Week 24
| Intervention | mg*h/dL (Least Squares Mean) |
|---|---|
| Omarigliptin (Phase A) | -46.4 |
| Placebo to Omarigliptin (Phase A) | -18.6 |
Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride. If during Phase B participants on open-label glimepiride or blinded glimepiride/glimepiride matching placebo needed rescue after maximum up-titration, then insulin glargine was initiated and the dose of open-label glimepiride or blinded glimepiride/glimepiride-matching placebo was discontinued. (NCT01755156)
Timeframe: Up to 104 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Omarigliptin (Phase A) → Omarigliptin (Phase B) | 20.2 |
| Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) | 16.2 |
Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride. (NCT01755156)
Timeframe: Up to 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Omarigliptin (Phase A) | 8.5 |
| Placebo to Omarigliptin (Phase A) | 9.7 |
Percentage of participants attaining A1C glycemic goals of <6.5% (48 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques. (NCT01755156)
Timeframe: 104 weeks
| Intervention | Percentage of participants (Least Squares Mean) |
|---|---|
| Omarigliptin (Phase A) → Omarigliptin (Phase B) | 13.7 |
| Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) | 17.9 |
Percentage of participants attaining A1C glycemic goals of <6.5% (48 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques. (NCT01755156)
Timeframe: 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Omarigliptin (Phase A) | 10.6 |
| Placebo to Omarigliptin (Phase A) | 6.4 |
Percentage of participants attaining A1C glycemic goals of <7.0% (53 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques. (NCT01755156)
Timeframe: 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Omarigliptin (Phase A) | 38.0 |
| Placebo to Omarigliptin (Phase A) | 18.8 |
Percentage of participants attaining A1C glycemic goals of <7.0% (53 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques. (NCT01755156)
Timeframe: 104 weeks
| Intervention | Percentage of participants (Least Squares Mean) |
|---|---|
| Omarigliptin (Phase A) → Omarigliptin (Phase B) | 32.2 |
| Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) | 39.0 |
Data presented are a cumulative incidence of participants with glycemic rescue by Week 104. (NCT01755156)
Timeframe: Up to 104 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Omarigliptin (Phase A) → Omarigliptin (Phase B) | 17.4 |
| Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) | 13.9 |
Data presented are a cumulative incidence of participants with glycemic rescue by Week 24. (NCT01755156)
Timeframe: Up to 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Omarigliptin (Phase A) | 8.0 |
| Placebo to Omarigliptin (Phase A) | 9.0 |
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue. (NCT01755156)
Timeframe: Up to 104 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Omarigliptin (Phase A) → Omarigliptin (Phase B) | 2.0 |
| Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) | 4.5 |
The following laboratory parameters were included: blood chemistry, hematology, electrocardiograms, lipids, body weight, and vital signs. (NCT01755156)
Timeframe: Up to 104 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Omarigliptin (Phase A) → Omarigliptin (Phase B) | 21.9 |
| Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) | 17.4 |
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue. (NCT01755156)
Timeframe: Up to 107 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Omarigliptin (Phase A) → Omarigliptin (Phase B) | 65.7 |
| Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) | 65.2 |
Change from baseline in body weight after 26 weeks of treatment (NCT01952145)
Timeframe: Week 0, week 26
| Intervention | Kg (Mean) |
|---|---|
| Insulin Degludec/Liraglutide (IDegLira) | -1.4 |
| Insulin Glargine (IGlar) | 1.8 |
Change from baseline in HbA1c after 26 weeks of treatment (NCT01952145)
Timeframe: Week 0, week 26
| Intervention | Percentage (%) (Mean) |
|---|---|
| Insulin Degludec/Liraglutide (IDegLira) | -1.81 |
| Insulin Glargine (IGlar) | -1.13 |
Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia. (NCT01952145)
Timeframe: During 26 weeks of treatment
| Intervention | Number of episodes (Number) |
|---|---|
| Insulin Degludec/Liraglutide (IDegLira) | 289 |
| Insulin Glargine (IGlar) | 683 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy. (NCT02099110)
Timeframe: Baseline and Week 26
| Intervention | Percentage (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -1.02 |
| Ertugliflozin 15 mg | -1.08 |
| Sitagliptin 100 mg | -1.05 |
| Ertugliflozin 5 mg + Sitagliptin 100 mg | -1.49 |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | -1.52 |
This change from baseline reflects the Week 26 body weight minus the Week 0 body weight. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy. (NCT02099110)
Timeframe: Baseline and Week 26
| Intervention | Kilograms (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -2.69 |
| Ertugliflozin 15 mg | -3.74 |
| Sitagliptin 100 mg | -0.67 |
| Ertugliflozin 5 mg + Sitagliptin 100 mg | -2.52 |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | -2.94 |
Blood glucose was measured on a fasting basis after at least a 10-hour fast. This change from baseline reflects the Week 26 FPG minus the Week 0 FPG. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy. (NCT02099110)
Timeframe: Baseline and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -35.73 |
| Ertugliflozin 15 mg | -36.91 |
| Sitagliptin 100 mg | -25.56 |
| Ertugliflozin 5 mg + Sitagliptin 100 mg | -43.96 |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | -48.70 |
This change from baseline reflects the Week 26 systolic blood pressure minus the Week 0 systolic blood pressure. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy. (NCT02099110)
Timeframe: Baseline and Week 26
| Intervention | mm Hg (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -3.89 |
| Ertugliflozin 15 mg | -3.69 |
| Sitagliptin 100 mg | -0.66 |
| Ertugliflozin 5 mg + Sitagliptin 100 mg | -3.42 |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | -3.67 |
Static beta-cell sensitivity to glucose index (SBCSGI) estimates the ratio of insulin secretion (expressed in pmol/min) related to above-basal glucose concentration (expressed in mmol/L * L) following a meal. Blood samples were collected before and after a standard meal and glucose, insulin, and C-peptide levels were analyzed. The C-peptides minimal model was used to estimate the insulin secretion rate (ISR). Analysis included both non-model-based [including insulinogenic index with C-peptide, glucose area under the curve (AUC)/insulin AUC] and model-based [beta cell function and insulin secretion rate at 9 mM glucose] testing. Analysis was performed with non-linear least squares using the Software Architecture Analysis Method (SAAM) II software. SBCSGI was expressed in units of 10^-9 min^-1. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy. (NCT02099110)
Timeframe: 30 min. before and 0, 15, 30, 60, 90, 120, and 180 minutes following the start of the standard meal at Baseline and Week 26
| Intervention | SBCSGI (10^-9min^-1) (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | 8.62 |
| Ertugliflozin 15 mg | 9.71 |
| Sitagliptin 100 mg | 21.11 |
| Ertugliflozin 5 mg + Sitagliptin 100 mg | 16.24 |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | 11.51 |
A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy. (NCT02099110)
Timeframe: Week 26
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 26.4 |
| Ertugliflozin 15 mg | 31.9 |
| Sitagliptin 100 mg | 32.8 |
| Ertugliflozin 5 mg + Sitagliptin 100 mg | 52.3 |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | 49.2 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy. (NCT02099110)
Timeframe: Up to 52 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 3.2 |
| Ertugliflozin 15 mg | 3.2 |
| Sitagliptin 100 mg | 2.8 |
| Ertugliflozin 5 mg + Sitagliptin 100 mg | 3.3 |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | 3.7 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy. (NCT02099110)
Timeframe: Up to 54 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 62.0 |
| Ertugliflozin 15 mg | 57.7 |
| Sitagliptin 100 mg | 57.5 |
| Ertugliflozin 5 mg + Sitagliptin 100 mg | 58.8 |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | 55.7 |
Change from baseline in body weight for Metformin Background patients. (NCT01422876)
Timeframe: Baseline and 24 Weeks
| Intervention | kg change from baseline (Least Squares Mean) |
|---|---|
| Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg | -2.99 |
| Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg | -2.60 |
| Metformin Background: Empagliflozin 25 mg | -3.18 |
| Metformin Background: Empagliflozin 10 mg | -2.53 |
| Metformin Background: Linagliptin 5 mg | -0.69 |
Change from baseline in body weight for Treatment Naive patients. (NCT01422876)
Timeframe: Baseline and 24 Weeks
| Intervention | kg change from baseline (Least Squares Mean) |
|---|---|
| Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg | -2.00 |
| Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg | -2.74 |
| Treatment Naive: Empagliflozin 25 mg | -2.13 |
| Treatment Naive: Empagliflozin 10 mg | -2.27 |
| Treatment Naive: Linagliptin 5 mg | -0.78 |
Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients. (NCT01422876)
Timeframe: Baseline and 24 Weeks
| Intervention | mg/dL change from baseline (Least Squares Mean) |
|---|---|
| Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg | -35.25 |
| Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg | -32.18 |
| Metformin Background: Empagliflozin 25 mg | -18.83 |
| Metformin Background: Empagliflozin 10 mg | -20.84 |
| Metformin Background: Linagliptin 5 mg | -13.05 |
Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients. (NCT01422876)
Timeframe: Baseline and 24 Weeks
| Intervention | mg/dL change from baseline (Least Squares Mean) |
|---|---|
| Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg | -29.55 |
| Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg | -28.21 |
| Treatment Naive: Empagliflozin 25 mg | -24.24 |
| Treatment Naive: Empagliflozin 10 mg | -22.39 |
| Treatment Naive: Linagliptin 5 mg | -5.92 |
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage. (NCT01422876)
Timeframe: Baseline and 24 weeks
| Intervention | % change from baseline (Least Squares Mean) |
|---|---|
| Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg | -1.19 |
| Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg | -1.08 |
| Metformin Background: Empagliflozin 25 mg | -0.62 |
| Metformin Background: Empagliflozin 10 mg | -0.66 |
| Metformin Background: Linagliptin 5 mg | -0.70 |
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage. (NCT01422876)
Timeframe: Baseline and 24 weeks
| Intervention | % change from baseline (Least Squares Mean) |
|---|---|
| Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg | -1.08 |
| Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg | -1.24 |
| Treatment Naive: Empagliflozin 25 mg | -0.95 |
| Treatment Naive: Empagliflozin 10 mg | -0.83 |
| Treatment Naive: Linagliptin 5 mg | -0.67 |
Occurrence of the treat-to-target efficacy response for Metformin Background patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline. (NCT01422876)
Timeframe: 24 Weeks
| Intervention | % of patients satisfying HbA1c <7.0% (Number) |
|---|---|
| Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg | 61.8 |
| Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg | 57.8 |
| Metformin Background: Empagliflozin 25 mg | 32.6 |
| Metformin Background: Empagliflozin 10 mg | 28.0 |
| Metformin Background: Linagliptin 5 mg | 36.1 |
Occurrence of the treat-to-target efficacy response for Treatment Naive patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline. (NCT01422876)
Timeframe: 24 Weeks
| Intervention | % of patients satisfying HbA1c <7.0% (Number) |
|---|---|
| Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg | 55.4 |
| Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg | 62.3 |
| Treatment Naive: Empagliflozin 25 mg | 41.5 |
| Treatment Naive: Empagliflozin 10 mg | 38.8 |
| Treatment Naive: Linagliptin 5 mg | 32.3 |
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at week 24 in the doubleblind period, including observations prior to rescue. (NCT01606007)
Timeframe: Baseline (Week 0) and at Week 24
| Intervention | MG/DL PPG (Mean) |
|---|---|
| Arm 1: Saxagliptin+Metformin XR+Placebo | -35.6 |
| Arm 2: Dapagliflozin+Metformin XR+Placebo | -70.4 |
| Arm 3: Saxagliptin+Dapagliflozin+Metformin XR | -79.6 |
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue. (NCT01606007)
Timeframe: Baseline (Week 0) and at Week 24
| Intervention | Body weight Kg (Mean) |
|---|---|
| Arm 1: Saxagliptin+Metformin XR+Placebo | 0.00 |
| Arm 2: Dapagliflozin+Metformin XR+Placebo | -2.39 |
| Arm 3: Saxagliptin+Dapagliflozin+Metformin XR | -2.05 |
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue. (NCT01606007)
Timeframe: Baseline (Week 0) and at Week 24
| Intervention | mg/dL (Mean) |
|---|---|
| Arm 1: Saxagliptin+Metformin XR+Placebo | -14.0 |
| Arm 2: Dapagliflozin+Metformin XR+Placebo | -31.7 |
| Arm 3: Saxagliptin+Dapagliflozin+Metformin XR | -37.8 |
HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue. (NCT01606007)
Timeframe: Baseline (Week 0) and at Week 24
| Intervention | % HbA1c (Mean) |
|---|---|
| Arm 1: Saxagliptin+Metformin XR+Placebo | -0.88 |
| Arm 2: Dapagliflozin+Metformin XR+Placebo | -1.20 |
| Arm 3: Saxagliptin+Dapagliflozin+Metformin XR | -1.47 |
Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. (NCT01606007)
Timeframe: At Week 24
| Intervention | % of Participants (Number) |
|---|---|
| Arm 1: Saxagliptin+Metformin XR+Placebo | 18.3 |
| Arm 2: Dapagliflozin+Metformin XR+Placebo | 22.2 |
| Arm 3: Saxagliptin+Dapagliflozin+Metformin XR | 41.4 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 30 A1C minus the Week 0 A1C. (NCT02738879)
Timeframe: Baseline and Week 30
| Intervention | Percent A1C (Least Squares Mean) |
|---|---|
| Sitagliptin | -1.88 |
| Placebo | -1.42 |
Blood glucose was measured on a fasting basis. 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 Week 0). (NCT02738879)
Timeframe: Baseline and Week 30
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Sitagliptin | -84.8 |
| Placebo | -78.3 |
Change from baseline reflects the Week 30 total daily insulin dose minus the Week 0 total daily insulin dose. The Week 0 total daily insulin dose was 0, by definition, because insulin was not administered at baseline. (NCT02738879)
Timeframe: Baseline and Week 30
| Intervention | Insulin Units (Least Squares Mean) |
|---|---|
| Sitagliptin | 53.2 |
| Placebo | 61.3 |
Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. (NCT02738879)
Timeframe: Up to 30 weeks
| Intervention | Events/Participant-Years (Number) |
|---|---|
| Sitagliptin | 0.30 |
| Placebo | 0.36 |
Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. (NCT02738879)
Timeframe: Up to 30 weeks
| Intervention | Events/Participant-Years (Number) |
|---|---|
| Sitagliptin | 5.05 |
| Placebo | 6.21 |
Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. (NCT02738879)
Timeframe: Up to 30 weeks
| Intervention | Events/Participant-Years (Number) |
|---|---|
| Sitagliptin | 0.17 |
| Placebo | 0.22 |
Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. (NCT02738879)
Timeframe: Up to 30 weeks
| Intervention | Events/Participant-Years (Number) |
|---|---|
| Sitagliptin | 1.55 |
| Placebo | 2.12 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT02738879)
Timeframe: Up to 30 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Sitagliptin | 1.3 |
| Placebo | 1.6 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT02738879)
Timeframe: Up to 32 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Sitagliptin | 57.9 |
| Placebo | 60.0 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. (NCT02738879)
Timeframe: Week 30
| Intervention | Percentage of participants (Number) |
|---|---|
| Sitagliptin | 15.3 |
| Placebo | 10.0 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. (NCT02738879)
Timeframe: Week 30
| Intervention | Percentage of participants (Number) |
|---|---|
| Sitagliptin | 54.2 |
| Placebo | 35.4 |
Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). (NCT02738879)
Timeframe: Up to 30 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Sitagliptin | 12.4 |
| Placebo | 13.6 |
Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). (NCT02738879)
Timeframe: Up to 30 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Sitagliptin | 66.8 |
| Placebo | 68.0 |
Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). (NCT02738879)
Timeframe: Up to 30 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Sitagliptin | 7.6 |
| Placebo | 8.3 |
Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The incidence (number of participants with ≥1 event divided by number of participants) of documented symptomatic hypoglycemia was determined. (NCT02738879)
Timeframe: Up to 30 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Sitagliptin | 33.5 |
| Placebo | 37.7 |
The incidence was determined by calculating the proportion of randomized participants without diabetes at randomization who either developed diabetes during the study or who were classified as having possible diabetes based on results of two oral glucose tolerance tests (OGTT) performed after the last follow-up visit (within 21-28 days for OGTT#1 and within 10-14 weeks for OGTT#2). (NCT00069784)
Timeframe: from randomization until the last follow-up visit or last OGTT (median duration of follow-up: 6.2 years)
| Intervention | percentage of patients (Number) |
|---|---|
| Insulin Glargine | 24.7 |
| Standard Care | 31.2 |
Data on cancers that occurred in association with hospitalizations were collected systematically in both groups from the start of the study. All reported cancers occurring during the trial (new or recurrent) were adjudicated by the Event Adjudication Committee. (NCT00069784)
Timeframe: from randomization until study cut-off date (median duration of follow-up: 6.2 years)
| Intervention | participants (Number) |
|---|---|
| Insulin Glargine | 559 |
| Standard Care | 561 |
Number of deaths due to any cause (NCT00069784)
Timeframe: from randomization until study cut-off date (median duration of follow-up: 6.2 years)
| Intervention | participants (Number) |
|---|---|
| Insulin Glargine | 951 |
| Standard Care | 965 |
"The composite outcome used to analyze microvascular disease progression contained components of clinical events:~the occurrence of laser surgery or vitrectomy for diabetic retinopathy (DR);~the development of blindness due to DR;~the occurrence of renal death or renal replacement therapy; as well as the following laboratory-based events:~doubling of serum creatinine; or~progression of albuminuria (from none to microalbuminuria [at least 30 mg/g creatinine], to macroalbuminuria [at least 300 mg/g creatinine])." (NCT00069784)
Timeframe: from randomization until study cut-off date (median duration of follow-up: 6.2 years)
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Participants with a composite endpoint | Endpoint's composition: vitrectomy | Endpoint's composition: laser therapy for DR | Endpoint's composition: dialysis | Endpoint's composition: renal transplant | Endpoint's composition: serum creatinine doubled | Endpoint's composition: death due to renal failure | Endpoint's composition: albuminuria progression | |
| Insulin Glargine | 1323 | 24 | 57 | 18 | 0 | 82 | 4 | 1153 |
| Standard Care | 1363 | 25 | 67 | 28 | 0 | 88 | 3 | 1171 |
"Number of participants with a first occurrence of one of the above events.~The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.~Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of CV death, nonfatal MI or nonfatal stroke) is provided in the first row of the statistical table." (NCT00069784)
Timeframe: from randomization until study cut-off date (median duration of follow-up: 6.2 years)
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Participants with a composite endpoint | Endpoint's composition: CV death | Endpoint's composition: nonfatal MI | Endpoint's composition: nonfatal stroke | |
| Insulin Glargine | 1041 | 484 | 297 | 261 |
| Standard Care | 1013 | 476 | 282 | 256 |
"Number of participants with a first occurrence of one of the above events (revascularization procedures included coronary artery bypass graft, percutaneous transluminal coronary angioplasty (PTCA) i.e. balloon, PTCA with stent, other percutaneous intervention, carotid angioplasty with/without stent, carotid endarterectomy, peripheral angioplasty with or without stent, peripheral vascular surgery, and limb amputation due to vascular disease).~The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.~Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of the events) is provided in the first row of the statistical table." (NCT00069784)
Timeframe: from randomization until study cut-off date (median duration of follow-up: 6.2 years)
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Participants with a composite endpoint | Endpoint's composition: CV death | Endpoint's composition: nonfatal MI | Endpoint's composition: nonfatal stroke | Endpoint's composition: revascularization | Endpoint's composition: hospitalization for HF | |
| Insulin Glargine | 1792 | 350 | 257 | 231 | 763 | 249 |
| Standard Care | 1727 | 339 | 238 | 227 | 717 | 259 |
"Symptomatic hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia, based on data recorded in the participant's diary. These were further categorized as confirmed (ie, with a concomitant home glucose reading ≤54 mg/dL [≤3.0 mmol/L]) or unconfirmed.~Severe hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia in which the participant required the assistance of another person, and one of the following:~the event was associated with a documented self-measured or laboratory plasma glucose level ≤36 mg/dL (≤2.0 mmol/L), or~the event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration." (NCT00069784)
Timeframe: on-treatment period (median duration of follow-up: 6.2 years)
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Patients with hypoglycemia events | Patients with non-severe hypoglycemia | Patients with confirmed non-severe hypoglycemia | Patients with severe hypoglycemia | |
| Insulin Glargine | 3597 | 3533 | 2581 | 352 |
| Standard Care | 1624 | 1582 | 904 | 113 |
Neonatal fat mass measured by skin-fold thickness (anthropometrics).The circumference of the upper limb is the circumference of the upper arm, and the circumference of the lower limb equals the mean of the circumferences measured at the midthigh and calf. The volume of the subcutaneous layer of fat covering each cylinder is estimated by multiplying the length times the circumference times the layer of fat estimated by the skinfold measures. The triceps skinfold measure is used as an estimate of the fat thickness of the limbs, and the subscapular skinfold measure approximates the fat thickness of the trunk. Total body fat is estimated by summing the volumes of fat covering each of the cylinders and multiplying by 0.9 (the density of fat). (NCT02932475)
Timeframe: Within 72 hrs of birth
| Intervention | kg (Mean) |
|---|---|
| Maternal Metformin | 0.46 |
| Maternal Placebo | 0.5 |
"Participants with one or more of the following:~capillary blood glucose level of < 30 mg/dL or capillary blood glucose requiring medical treatment, or~Birth trauma (umbilical cord artery pH < 7.0 or shoulder dystocia with brachial plexus injury), or~Hyperbilirubinemia requiring phototherapy, or~Deliver < 37 weeks' gestation, or~Miscarry, are stillborn, experience a neonatal demise, or~Large for gestational age infant (birth weight > 90th percentile for gestational age), or~Small for gestational age infant (birth weight < 10th percentile for gestational age) or low birth weight (< 2500 gm)" (NCT02932475)
Timeframe: An average of 48 hours for term infants and 30 days for preterm infants
| Intervention | Participants (Count of Participants) |
|---|---|
| Metformin | 269 |
| Placebo | 277 |
Adverse maternal outcomes. (NCT02932475)
Timeframe: An average of 48 hours following delivery
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Any adverse event leading to early study agent discontinuation | Any adverse event associated with maternal death | Any adverse event associated with fetal death | Any maternal serious adverse event | Any maternal non-serious adverse event | |
| Metformin | 13 | 2 | 10 | 113 | 149 |
| Placebo | 20 | 1 | 10 | 111 | 157 |
Adverse neonatal outcomes (NCT02932475)
Timeframe: up to 28 days of life
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Any neonatal serious adverse event | Any neonatal non-serious adverse event | |
| Maternal Metformin | 81 | 157 |
| Maternal Placebo | 105 | 162 |
"Secondary outcome of maternal side effects were defined as:~clinically relevant hypoglycemia defined as capillary blood glucose < 60 or < 80 with symptoms~GI side effects defined as nausea, vomiting, diarrhea" (NCT02932475)
Timeframe: Throughout study until delivery at 40 weeks gestation
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Clinically relevant hypoglycemia | Gastrointestinal side effects | |
| Metformin | 87 | 182 |
| Placebo | 85 | 171 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 104 A1C minus the Week 0 A1C. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104
| Intervention | Percent A1C (Mean) |
|---|---|
| Placebo/Glimepiride | -0.58 |
| Ertugliflozin 5 mg | -0.60 |
| Ertugliflozin 15 mg | -0.89 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26
| Intervention | Percent A1C (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | -0.03 |
| Ertugliflozin 5 mg | -0.73 |
| Ertugliflozin 15 mg | -0.91 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 52 A1C minus the Week 0 A1C. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52
| Intervention | Percent A1C (Mean) |
|---|---|
| Placebo/Glimepiride | -0.68 |
| Ertugliflozin 5 mg | -0.72 |
| Ertugliflozin 15 mg | -0.96 |
The change in body weight from baseline reflects the Week 104 body weight minus the Week 0 body weight. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104
| Intervention | Kilograms (Mean) |
|---|---|
| Placebo/Glimepiride | -0.18 |
| Ertugliflozin 5 mg | -3.77 |
| Ertugliflozin 15 mg | -3.63 |
The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26
| Intervention | Kilograms (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | -1.33 |
| Ertugliflozin 5 mg | -3.01 |
| Ertugliflozin 15 mg | -2.93 |
The change in body weight from baseline reflects the Week 52 body weight minus the Week 0 body weight. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52
| Intervention | Kilograms (Mean) |
|---|---|
| Placebo/Glimepiride | 0.07 |
| Ertugliflozin 5 mg | -3.23 |
| Ertugliflozin 15 mg | -3.35 |
Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 104 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 104 minus FPG at Week 0). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104
| Intervention | mg/dL (Mean) |
|---|---|
| Placebo/Glimepiride | -10.9 |
| Ertugliflozin 5 mg | -18.2 |
| Ertugliflozin 15 mg | -28.2 |
Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | -0.85 |
| Ertugliflozin 5 mg | -27.54 |
| Ertugliflozin 15 mg | -39.10 |
Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 52 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 52 minus FPG at Week 0). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52
| Intervention | mg/dL (Mean) |
|---|---|
| Placebo/Glimepiride | -12.0 |
| Ertugliflozin 5 mg | -22.4 |
| Ertugliflozin 15 mg | -35.2 |
This change from baseline reflects the Week 104 sitting DBP minus the Week 0 sitting DBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104
| Intervention | mmHg (Mean) |
|---|---|
| Placebo/Glimepiride | -0.46 |
| Ertugliflozin 5 mg | -2.36 |
| Ertugliflozin 15 mg | -1.52 |
This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | 0.23 |
| Ertugliflozin 5 mg | -1.59 |
| Ertugliflozin 15 mg | -2.19 |
This change from baseline reflects the Week 52 sitting DBP minus the Week 0 sitting DBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52
| Intervention | mmHg (Mean) |
|---|---|
| Placebo/Glimepiride | 0.38 |
| Ertugliflozin 5 mg | -1.40 |
| Ertugliflozin 15 mg | -1.19 |
This change from baseline reflects the Week 104 sitting SBP minus the Week 0 sitting SBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104
| Intervention | mmHg (Mean) |
|---|---|
| Placebo/Glimepiride | 0.05 |
| Ertugliflozin 5 mg | -3.61 |
| Ertugliflozin 15 mg | -3.13 |
This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | -0.70 |
| Ertugliflozin 5 mg | -4.38 |
| Ertugliflozin 15 mg | -5.20 |
This change from baseline reflects the Week 52 sitting SBP minus the Week 0 sitting SBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52
| Intervention | mmHg (Mean) |
|---|---|
| Placebo/Glimepiride | 0.65 |
| Ertugliflozin 5 mg | -2.63 |
| Ertugliflozin 15 mg | -4.28 |
BMD at the femoral neck was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | -1.23 |
| Ertugliflozin 5 mg | -1.11 |
| Ertugliflozin 15 mg | -0.96 |
BMD at the femoral neck was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | 0.09 |
| Ertugliflozin 5 mg | -0.19 |
| Ertugliflozin 15 mg | -0.13 |
BMD at the total hip was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | -1.18 |
| Ertugliflozin 5 mg | -1.72 |
| Ertugliflozin 15 mg | -2.02 |
BMD at the distal forearm was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | 0.06 |
| Ertugliflozin 5 mg | -0.15 |
| Ertugliflozin 15 mg | -0.13 |
BMD at the femoral neck was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | -0.40 |
| Ertugliflozin 5 mg | -0.10 |
| Ertugliflozin 15 mg | 0.30 |
BMD at the femoral neck was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26
| Intervention | Percentage change (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | 0.22 |
| Ertugliflozin 5 mg | -0.01 |
| Ertugliflozin 15 mg | 0.12 |
BMD at the total hip was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | -0.63 |
| Ertugliflozin 5 mg | -0.55 |
| Ertugliflozin 15 mg | -0.36 |
BMD at the distal forearm was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | -0.44 |
| Ertugliflozin 5 mg | -0.59 |
| Ertugliflozin 15 mg | -0.39 |
BMD at the femoral neck was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | -0.69 |
| Ertugliflozin 5 mg | -0.49 |
| Ertugliflozin 15 mg | -0.44 |
BMD at the femoral neck was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | -0.10 |
| Ertugliflozin 5 mg | -0.28 |
| Ertugliflozin 15 mg | 0.07 |
BMD at the total hip was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | -0.82 |
| Ertugliflozin 5 mg | -1.04 |
| Ertugliflozin 15 mg | -1.32 |
CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26
| Intervention | Percent change (Mean) |
|---|---|
| Placebo/Glimepiride | 10.8 |
| Ertugliflozin 5 mg | 51.9 |
| Ertugliflozin 15 mg | 80.2 |
CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104
| Intervention | Percent change (Mean) |
|---|---|
| Placebo/Glimepiride | 19.29 |
| Ertugliflozin 5 mg | 26.94 |
| Ertugliflozin 15 mg | 32.53 |
CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52
| Intervention | Percent change (Mean) |
|---|---|
| Placebo/Glimepiride | 15.54 |
| Ertugliflozin 5 mg | 34.36 |
| Ertugliflozin 15 mg | 41.57 |
P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104
| Intervention | Percent change (Mean) |
|---|---|
| Placebo/Glimepiride | 19.38 |
| Ertugliflozin 5 mg | 10.11 |
| Ertugliflozin 15 mg | 24.21 |
P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52
| Intervention | Percent Change (Mean) |
|---|---|
| Placebo/Glimepiride | 24.50 |
| Ertugliflozin 5 mg | 8.41 |
| Ertugliflozin 15 mg | 19.79 |
PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26
| Intervention | Percent change (Mean) |
|---|---|
| Placebo/Glimepiride | -0.98 |
| Ertugliflozin 5 mg | 0.28 |
| Ertugliflozin 15 mg | 0.14 |
P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26
| Intervention | Percent change (Mean) |
|---|---|
| Placebo/Glimepiride | 0.5 |
| Ertugliflozin 5 mg | 0.8 |
| Ertugliflozin 15 mg | 0.5 |
PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104
| Intervention | Percent change (Mean) |
|---|---|
| Placebo/Glimepiride | 10.12 |
| Ertugliflozin 5 mg | 8.16 |
| Ertugliflozin 15 mg | 5.46 |
PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52
| Intervention | Percent Change (Mean) |
|---|---|
| Placebo/Glimepiride | 8.11 |
| Ertugliflozin 5 mg | 11.09 |
| Ertugliflozin 15 mg | 2.48 |
BMD at the distal forearm was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Glimepiride | -0.58 |
| Ertugliflozin 5 mg | -0.40 |
| Ertugliflozin 15 mg | -0.64 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or basal insulin according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 104
| Intervention | Percentage of Participants (Number) |
|---|---|
| Placebo/Glimepiride | 2.4 |
| Ertugliflozin 5 mg | 3.4 |
| Ertugliflozin 15 mg | 3.9 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or basal insulin according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 106
| Intervention | Percentage of Participants (Number) |
|---|---|
| Placebo/Glimepiride | 77.5 |
| Ertugliflozin 5 mg | 70.5 |
| Ertugliflozin 15 mg | 75.6 |
Per protocol participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 104
| Intervention | Percentage of participants (Number) |
|---|---|
| Placebo/Glimepiride | 24.4 |
| Ertugliflozin 5 mg | 11.1 |
| Ertugliflozin 15 mg | 10.7 |
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 26
| Intervention | Percentage of Participants (Number) |
|---|---|
| Placebo/Glimepiride | 17.7 |
| Ertugliflozin 5 mg | 2.9 |
| Ertugliflozin 15 mg | 1.5 |
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 52
| Intervention | Percentage of Participants (Number) |
|---|---|
| Placebo/Glimepiride | 17.2 |
| Ertugliflozin 5 mg | 4.3 |
| Ertugliflozin 15 mg | 1.5 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 104
| Intervention | Percentage of Participants (Number) |
|---|---|
| Placebo/Glimepiride | 7.2 |
| Ertugliflozin 5 mg | 10.6 |
| Ertugliflozin 15 mg | 12.2 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 26
| Intervention | Percentage of Participants (Number) |
|---|---|
| Placebo/Glimepiride | 2.9 |
| Ertugliflozin 5 mg | 8.7 |
| Ertugliflozin 15 mg | 12.2 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 52
| Intervention | Percentage of Participants (Number) |
|---|---|
| Placebo/Glimepiride | 11.0 |
| Ertugliflozin 5 mg | 10.6 |
| Ertugliflozin 15 mg | 14.6 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 104
| Intervention | Percentage of Participants (Number) |
|---|---|
| Placebo/Glimepiride | 19.1 |
| Ertugliflozin 5 mg | 24.6 |
| Ertugliflozin 15 mg | 33.7 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 26
| Intervention | Percentage of Participants (Number) |
|---|---|
| Placebo/Glimepiride | 15.8 |
| Ertugliflozin 5 mg | 35.3 |
| Ertugliflozin 15 mg | 40.0 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 52
| Intervention | Percentage of Participants (Number) |
|---|---|
| Placebo/Glimepiride | 30.6 |
| Ertugliflozin 5 mg | 34.8 |
| Ertugliflozin 15 mg | 36.6 |
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Week 26
| Intervention | Days (Median) |
|---|---|
| Placebo/Glimepiride | 105 |
| Ertugliflozin 5 mg | 112 |
| Ertugliflozin 15 mg | 139 |
Pharmacokinetic samples were collected at approximately 24 hours following the prior day's dose and before administration of the current day's dose. The lower limit of quantitation (LLOQ) was 0.500 mg/mL. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Pre-dose and/or 60 minutes post-dose on Weeks 6, 12, 18, and 30
| Intervention | ng/mL (Mean) | |||||
|---|---|---|---|---|---|---|
| Week 6:Pre-dose | Week 12:Pre-dose | Week 12:60 mins post-dose | Week 18:Pre-dose | Week 18:60 mins post-dose | Week 30:Pre-dose | |
| Ertugliflozin 15 mg | 38.38 | 29.23 | 228.13 | 24.46 | 214.96 | 30.55 |
| Ertugliflozin 5 mg | 14.89 | 12.34 | 74.84 | 9.91 | 74.39 | 12.66 |
| Placebo/Glimepiride | NA | NA | NA | 0.01 | 0.01 | 0.15 |
"Number of subjects having the adverse event incorrect dose administered within the system organ class Injury, poisoning and procedural complications" (NCT00909480)
Timeframe: Weeks 0-26
| Intervention | Subjects (Number) |
|---|---|
| IDet | 12 |
| IGlar | 24 |
(NCT00909480)
Timeframe: Week 0, Week 26
| Intervention | kg (Mean) |
|---|---|
| IDet | -0.49 |
| IGlar | 1 |
(NCT00909480)
Timeframe: Week 0, Week 26
| Intervention | percentage point change (Mean) |
|---|---|
| IDet | -0.48 |
| IGlar | -0.74 |
(NCT00909480)
Timeframe: Week 26
| Intervention | mmol/L (Mean) |
|---|---|
| IDet | 6.22 |
| IGlar | 6.09 |
Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am. (NCT00909480)
Timeframe: Week 26
| Intervention | mmol/L (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Before breakfast (N=200, N=197) | 2 hours after breakfast (N=192, N=188) | Before Lunch (N=193, N=189) | 2 hours After Lunch (N=194, N=186) | Before Dinner (N=194, N=186) | 2 hours after dinner (N=192, N=190) | Bedtime (N=190, N=183) | At 3AM (N=193, N=186) | Before Breakfast Next Day (N=197, N=195) | |
| IDet | 5.8 | 9.1 | 7.2 | 9.7 | 8.2 | 10.3 | 9.5 | 6.6 | 5.7 |
| IGlar | 5.9 | 8.7 | 6.6 | 8.8 | 7.5 | 9.8 | 9 | 6.3 | 5.6 |
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. (NCT00909480)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) | ||
|---|---|---|---|
| Major | Minor | Symptoms only | |
| IDet | 0 | 75 | 128 |
| IGlar | 2 | 118 | 222 |
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. (NCT00909480)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) | ||
|---|---|---|---|
| Major | Minor | Symptoms only | |
| IDet | 0 | 39 | 76 |
| IGlar | 0 | 30 | 61 |
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. (NCT00909480)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) | ||
|---|---|---|---|
| Major | Minor | Symptoms only | |
| IDet | 0 | 5 | 6 |
| IGlar | 0 | 8 | 16 |
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. (NCT00909480)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) | |||
|---|---|---|---|---|
| All Events | Major | Minor | Symptoms only | |
| IDet | 329 | 0 | 119 | 210 |
| IGlar | 457 | 2 | 156 | 299 |
The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less (NCT00909480)
Timeframe: Week 26
| Intervention | percentage (%) of subjects (Number) | |||
|---|---|---|---|---|
| Metformin monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | All | |
| IDet | 22 | 13 | 5 | 11 |
| IGlar | 30 | 13 | 17 | 21 |
The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7% (NCT00909480)
Timeframe: Week 26
| Intervention | percentage of subjects (Number) | |||
|---|---|---|---|---|
| Metformin monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | All | |
| IDet | 55 | 40 | 31 | 38 |
| IGlar | 70 | 40 | 47 | 53 |
The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. (NCT00909480)
Timeframe: Week 26
| Intervention | percentage (%) of subjects (Number) | |||
|---|---|---|---|---|
| Metformin monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | All | |
| IDet | 22 | 7 | 3 | 9 |
| IGlar | 21 | 13 | 13 | 15 |
The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. (NCT00909480)
Timeframe: Week 26
| Intervention | percentage (%) of subjects (Number) | |||
|---|---|---|---|---|
| Metformin monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | All | |
| IDet | 48 | 33 | 25 | 32 |
| IGlar | 52 | 33 | 33 | 38 |
The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time. (NCT00909480)
Timeframe: Week 26
| Intervention | mmol/L (Median) | |||
|---|---|---|---|---|
| Metformin Monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | Overall | |
| IDet | 0.48 | 0.72 | 0.6 | 0.57 |
| IGlar | 0.67 | 0.84 | 0.71 | 0.71 |
Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. (NCT00763815)
Timeframe: Baseline, Week 24
| Intervention | percentage of hemoglobin (Least Squares Mean) |
|---|---|
| Placebo | -0.34 |
| Lixisenatide | -0.90 |
Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (fasting plasma glucose [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. (NCT00763815)
Timeframe: Baseline, Week 24
| Intervention | % of normal beta cells function (Least Squares Mean) |
|---|---|
| Placebo | 6.98 |
| Lixisenatide | 6.72 |
Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. (NCT00763815)
Timeframe: Baseline, Week 24
| Intervention | kilogram (Least Squares Mean) |
|---|---|
| Placebo | 0.21 |
| Lixisenatide | -0.21 |
Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. (NCT00763815)
Timeframe: Baseline, Week 24
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Placebo | -0.32 |
| Lixisenatide | -1.16 |
Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. (NCT00763815)
Timeframe: Baseline, Week 24
| Intervention | pmol/L (Least Squares Mean) |
|---|---|
| Placebo | -1.01 |
| Lixisenatide | -10.36 |
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 >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 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 assessment for at least 1 efficacy variable, were required. (NCT00763815)
Timeframe: Baseline up to Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 11.3 |
| Lixisenatide | 3.8 |
The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. (NCT00763815)
Timeframe: Baseline, Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 5.1 |
| Lixisenatide | 9.2 |
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 assessment for at least 1 efficacy variable, were required. (NCT00763815)
Timeframe: Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 26.4 |
| Lixisenatide | 52.3 |
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 assessment for at least 1 efficacy variable, were required. (NCT00763815)
Timeframe: Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 10.1 |
| Lixisenatide | 28.9 |
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. (NCT00763815)
Timeframe: First dose of study drug up to 3 days after the last dose administration, for up to 132 weeks
| Intervention | participants (Number) | |
|---|---|---|
| Symptomatic Hypoglycemia | Severe Symptomatic Hypoglycemia | |
| Lixisenatide | 23 | 0 |
| Placebo | 7 | 0 |
Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect. (NCT00575588)
Timeframe: Week 24 to Week 104
| Intervention | Percent (Mean) |
|---|---|
| Saxagliptin + Metformin | 0.0041 |
| Glipizide + Metformin | 0.0076 |
Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect. (NCT00575588)
Timeframe: Week 24 to Week 52
| Intervention | Percent (Mean) |
|---|---|
| Saxagliptin + Metformin | 0.001 |
| Glipizide + Metformin | 0.004 |
Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set) (NCT00575588)
Timeframe: Baseline, Week 104
| Intervention | Percentage of Participants (Number) |
|---|---|
| Saxagliptin + Metformin | 3.5 |
| Glipizide + Metformin | 38.4 |
Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set) (NCT00575588)
Timeframe: From Baseline to Week 52
| Intervention | Percentage of Participants (Number) |
|---|---|
| Saxagliptin + Metformin | 3 |
| Glipizide + Metformin | 36.3 |
Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value. (NCT00575588)
Timeframe: Baseline, Week 104
| Intervention | kilograms (Mean) | ||
|---|---|---|---|
| Baseline | Week 104 | Adjusted Change from Baseline to Week 104 | |
| Glipizide + Metformin | 88.57 | 89.80 | 1.29 |
| Saxagliptin + Metformin | 88.69 | 87.47 | -1.47 |
Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value. (NCT00575588)
Timeframe: Baseline, Week 52 (Last Observation Carried Forward)
| Intervention | kilogram (Mean) | ||
|---|---|---|---|
| Baseline | Week 52 | Adjusted Change from Baseline to Week 52 | |
| Glipizide + Metformin | 88.6 | 89.7 | 1.1 |
| Saxagliptin + Metformin | 88.7 | 87.6 | -1.1 |
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value. (NCT00575588)
Timeframe: Baseline, Week 104
| Intervention | Percent (Mean) | ||
|---|---|---|---|
| Baseline | Week 104 | Adjusted Change from Baseline to Week 104 | |
| Glipizide + Metformin | 7.65 | 7.27 | -0.35 |
| Saxagliptin + Metformin | 7.65 | 7.27 | -0.41 |
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value. (NCT00575588)
Timeframe: Baseline to 52 Weeks
| Intervention | Percent (Mean) | ||
|---|---|---|---|
| Baseline | Week 52 | Adjusted Change from Baseline to Week 52 | |
| Glipizide + Metformin | 7.53 | 6.71 | -0.80 |
| Saxagliptin + Metformin | 7.46 | 6.74 | -0.74 |
Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which are hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. (NCT00121667)
Timeframe: AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla
| Intervention | participants (Number) |
|---|---|
| Saxagliptin 2.5 mg + Metformin | 23 |
| Saxagliptin 5 mg + Metformin | 20 |
| Saxagliptin 10 mg + Metformin | 21 |
| Placebo+ Metformin | 20 |
'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick glucose <= 50 mg/dL and associated symptoms. (NCT00121667)
Timeframe: AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla
| Intervention | participants (Number) |
|---|---|
| Saxagliptin 2.5 mg + Metformin | 3 |
| Saxagliptin 5 mg + Metformin | 2 |
| Saxagliptin 10 mg + Metformin | 3 |
| Placebo+ Metformin | 1 |
(NCT00121667)
Timeframe: Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Saxagliptin 2.5 mg + Metformin | 37.1 |
| Saxagliptin 5 mg + Metformin | 43.5 |
| Saxagliptin 10 mg + Metformin | 44.4 |
| Placebo+ Metformin | 16.6 |
Mean change from baseline is adjusted for baseline value. (NCT00121667)
Timeframe: Baseline, Week 24
| Intervention | mg*min/dL (Mean) | |
|---|---|---|
| Baseline Mean | Adjusted Mean Change from Baseline | |
| Placebo+ Metformin | 47407 | -3291 |
| Saxagliptin 10 mg + Metformin | 44931 | -8137 |
| Saxagliptin 2.5 mg + Metformin | 48224 | -8891 |
| Saxagliptin 5 mg + Metformin | 49021 | -9586 |
Mean change from baseline is adjusted for baseline value. (NCT00121667)
Timeframe: Baseline, Week 24
| Intervention | mg/dL (Mean) | |
|---|---|---|
| Baseline Mean | Adjusted Mean Change from Baseline | |
| Placebo+ Metformin | 174.94 | 1.24 |
| Saxagliptin 10 mg + Metformin | 175.86 | -20.50 |
| Saxagliptin 2.5 mg + Metformin | 173.57 | -14.31 |
| Saxagliptin 5 mg + Metformin | 179.03 | -22.03 |
Mean change from baseline is adjusted for baseline value. (NCT00121667)
Timeframe: Baseline, Week 24
| Intervention | percentage of glycosylated hemoglobins (Mean) | |
|---|---|---|
| Baseline Mean | Adjusted Mean Change from Baseline | |
| Placebo+ Metformin | 8.06 | 0.13 |
| Saxagliptin 10 mg + Metformin | 7.98 | -0.58 |
| Saxagliptin 2.5 mg + Metformin | 8.08 | -0.59 |
| Saxagliptin 5 mg + Metformin | 8.07 | -0.69 |
(NCT00121667)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | 10^3 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Week 0) (n=192, 191, 181, 179) | Change from BL at Week 2 (n=178, 175, 170, 169) | Change from BL at Week 4 (n=176, 175, 170, 166) | Change from BL at Week 6 (n=175, 172, 165, 158) | Change from BL at Week 8 (n=172, 172, 163, 153) | Change from BL at Week 10 (n=148, 130, 137, 128) | Change from BL at Week 12 (n=168, 166, 159, 141) | Change from BL at Week 14 (n=156, 152, 145, 136) | Change from BL at Week 16 (n=166, 166, 157, 137) | Change from BL at Week 18 (n=155, 157, 149, 139) | Change from BL at Week 20 (n=162, 153, 154, 146) | Change from BL at Week 22 (n=157, 151, 143, 138) | Change from BL at Week 24 (n=162, 160, 157, 135) | Change from BL at Week 30 (n=159, 155, 154, 136) | Change from BL at Week 37 (n=150, 149, 146, 121) | Change from BL at Week 50 (n=150, 142, 145, 124) | Change from BL at Week 63 (n=147, 136, 140, 115) | Change from BL at Week 76 (n=134, 126, 130, 94) | Change from BL at Week 89 (n=122, 113, 123, 85) | Change from BL at Week 102 (n=104, 104, 111, 68) | Change from BL at Week 115 (n=98, 92, 95, 57) | Change from BL at Week 128 (n=90, 87, 88, 50) | Change from BL at Week 141 (n=85, 78, 84, 47) | Change from BL at Week 154 (n=77, 71, 78, 45) | Change from BL at Week 167 (n=76, 67, 75, 42) | Change from BL at Week 180 (n=69, 60, 72, 41) | Change from BL at Week 193 (n=69, 60, 71, 40) | Change from BL at Week 206 (n=61, 48, 63, 31) | |
| Placebo+ Metformin | 0.02 | -0.00 | -0.00 | 0.00 | -0.00 | -0.00 | -0.01 | -0.01 | -0.00 | -0.00 | -0.00 | -0.00 | -0.00 | 0.00 | -0.00 | 0.00 | 0.00 | 0.00 | 0.00 | -0.00 | 0.00 | -0.00 | -0.01 | -0.01 | -0.00 | -0.01 | -0.01 | -0.01 |
| Saxagliptin 10 mg + Metformin | 0.02 | 0.00 | 0.00 | -0.00 | 0.00 | -0.00 | -0.00 | -0.00 | 0.00 | 0.00 | 0.00 | -0.00 | 0.00 | 0.00 | 0.01 | 0.01 | 0.01 | 0.02 | 0.01 | 0.02 | 0.01 | 0.02 | 0.01 | 0.00 | 0.01 | 0.01 | 0.00 | 0.01 |
| Saxagliptin 2.5 mg + Metformin | 0.02 | -0.00 | 0.00 | -0.00 | -0.00 | -0.00 | 0.00 | -0.00 | -0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.01 | 0.01 | 0.02 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.00 | 0.01 | -0.00 | 0.01 | 0.01 |
| Saxagliptin 5 mg + Metformin | 0.02 | -0.00 | -0.00 | -0.00 | -0.00 | -0.00 | 0.00 | 0.00 | 0.00 | 0.00 | -0.01 | 0.00 | 0.00 | 0.00 | 0.00 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | -0.00 | 0.00 | 0.01 |
(NCT00121667)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | 10^3 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Week 0) (n=192, 191, 181, 179) | Change from BL at Week 2 (n=178, 175, 170, 169) | Change from BL at Week 4 (n=176, 175, 170, 166) | Change from BL at Week 6 (n=175, 172, 165, 158) | Change from BL at Week 8 (n=172, 172, 163, 153) | Change from BL at Week 10 (n=148, 130, 137, 128) | Change from BL at Week 12 (n=168, 166, 159, 141) | Change from BL at Week 14 (n=156, 152, 145, 136) | Change from BL at Week 16 (n=166, 166, 157, 137) | Change from BL at Week 18 (n=155, 157, 149, 139) | Change from BL at Week 20 (n=162, 153, 154, 146) | Change from BL at Week 22 (n=157, 151, 143, 138) | Change from BL at Week 24 (n=162, 160, 157, 135) | Change from BL at Week 30 (n=159, 155, 154, 136) | Change from BL at Week 37 (n=150, 149, 146, 121) | Change from BL at Week 50 (n=150, 142, 145, 124) | Change from BL at Week 63 (n=147, 136, 140, 115) | Change from BL at Week 76 (n=134, 126, 130, 94) | Change from BL at Week 89 (n=122, 113, 123, 85) | Change from BL at Week 102 (n=104, 104, 111, 68) | Change from BL at Week 115 (n=98, 92, 95, 57) | Change from BL at Week 128 (n=90, 87, 88, 50) | Change from BL at Week 141 (n=85, 78, 84, 47) | Change from BL at Week 154 (n=77, 71, 78, 45) | Change from BL at Week 167 (n=76, 67, 75, 42) | Change from BL at Week 180 (n=69, 60, 72, 41) | Change from BL at Week 193 (n=69, 60, 71, 40) | Change from BL at Week 206 (n=61, 48, 63, 31) | |
| Placebo+ Metformin | 0.21 | 0.00 | 0.00 | 0.01 | 0.00 | 0.01 | 0.00 | 0.02 | 0.04 | 0.04 | 0.02 | 0.03 | 0.01 | 0.00 | -0.01 | -0.02 | -0.01 | -0.03 | -0.03 | -0.03 | -0.03 | -0.03 | -0.01 | -0.03 | -0.05 | -0.04 | -0.04 | -0.09 |
| Saxagliptin 10 mg + Metformin | 0.24 | -0.00 | -0.02 | -0.03 | -0.02 | -0.02 | -0.03 | -0.02 | -0.02 | -0.00 | -0.02 | 0.00 | -0.01 | 0.00 | -0.03 | 0.02 | -0.01 | -0.01 | -0.01 | 0.01 | 0.00 | 0.01 | -0.01 | -0.00 | 0.00 | -0.01 | -0.00 | 0.03 |
| Saxagliptin 2.5 mg + Metformin | 0.24 | -0.02 | -0.01 | -0.02 | -0.00 | -0.02 | -0.02 | 0.01 | -0.02 | -0.01 | -0.04 | -0.01 | -0.03 | -0.02 | -0.00 | -0.03 | -0.00 | -0.01 | -0.02 | -0.01 | 0.00 | -0.01 | -0.01 | -0.01 | 0.01 | 0.03 | -0.02 | -0.03 |
| Saxagliptin 5 mg + Metformin | 0.23 | 0.01 | -0.01 | -0.01 | -0.01 | -0.01 | -0.01 | -0.01 | 0.00 | -0.00 | -0.01 | -0.00 | -0.01 | -0.01 | -0.02 | -0.02 | -0.02 | -0.01 | -0.05 | 0.00 | -0.02 | -0.02 | -0.03 | -0.02 | -0.01 | -0.03 | -0.00 | -0.03 |
(NCT00121667)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | 10^3 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Week 0) (n=192, 191, 181, 179) | Change from BL at Week 2 (n=178, 175, 170, 169) | Change from BL at Week 4 (n=176, 175, 170, 166) | Change from BL at Week 6 (n=175, 172, 165, 158) | Change from BL at Week 8 (n=172, 172, 163, 153) | Change from BL at Week 10 (n=148, 130, 137, 128) | Change from BL at Week 12 (n=168, 166, 159, 141) | Change from BL at Week 14 (n=156, 152, 145, 136) | Change from BL at Week 16 (n=166, 166, 157, 137) | Change from BL at Week 18 (n=155, 157, 149, 139) | Change from BL at Week 20 (n=162, 153, 154, 146) | Change from BL at Week 22 (n=157, 151, 143, 138) | Change from BL at Week 24 (n=162, 160, 157, 135) | Change from BL at Week 30 (n=159, 155, 154, 136) | Change from BL at Week 37 (n=150, 149, 146, 121) | Change from BL at Week 50 (n=150, 142, 145, 124) | Change from BL at Week 63 (n=147, 136, 140, 115) | Change from BL at Week 76 (n=134, 126, 130, 94) | Change from BL at Week 89 (n=122, 114, 123, 85) | Change from BL at Week 102 (n=104, 104, 111, 68) | Change from BL at Week 115 (n=98, 92, 95, 58) | Change from BL at Week 128 (n=91, 88, 88, 50) | Change from BL at Week 141 (n=85, 78, 84, 48) | Change from BL at Week 154 (n=78, 71, 78, 45) | Change from BL at Week 167 (n=77, 67, 75, 42) | Change from BL at Week 180 (n=69, 60, 72, 41) | Change from BL at Week 193 (n=69, 60, 71, 40) | Change from BL at Week 206 (n=61, 48, 63, 31) | |
| Placebo+ Metformin | 2.31 | -0.02 | 0.00 | -0.03 | 0.00 | 0.15 | 0.07 | 0.11 | 0.04 | 0.14 | 0.10 | 0.18 | 0.02 | 0.04 | 0.00 | -0.10 | -0.16 | -0.17 | -0.21 | -0.20 | -0.12 | -0.21 | -0.17 | -0.19 | -0.13 | -0.14 | -0.14 | -0.32 |
| Saxagliptin 10 mg + Metformin | 2.23 | -0.03 | -0.13 | -0.12 | -0.13 | -0.03 | -0.11 | -0.08 | -0.12 | -0.06 | -0.12 | -0.09 | -0.09 | -0.07 | -0.17 | -0.25 | -0.30 | -0.30 | -0.33 | -0.30 | -0.23 | -0.28 | -0.22 | -0.35 | -0.24 | -0.26 | -0.30 | -0.36 |
| Saxagliptin 2.5 mg + Metformin | 2.29 | -0.02 | -0.02 | -0.03 | -0.01 | 0.12 | -0.02 | 0.13 | 0.04 | 0.22 | 0.08 | 0.16 | 0.07 | 0.06 | 0.04 | -0.12 | -0.12 | -0.11 | -0.14 | -0.20 | -0.13 | -0.15 | -0.04 | -0.23 | -0.11 | -0.21 | -0.18 | -0.40 |
| Saxagliptin 5 mg + Metformin | 2.29 | -0.07 | -0.04 | -0.06 | -0.04 | 0.07 | -0.02 | 0.04 | -0.08 | 0.04 | -0.07 | 0.05 | -0.02 | 0.03 | 0.00 | -0.17 | -0.17 | -0.23 | -0.23 | -0.14 | -0.15 | -0.24 | -0.20 | -0.28 | -0.25 | -0.35 | -0.31 | -0.39 |
(NCT00121667)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | 10^3 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Week 0) (n=192, 191, 181, 179) | Change from BL at Week 2 (n=178, 175, 170, 169) | Change from BL at Week 4 (n=176, 175, 170, 166) | Change from BL at Week 6 (n=175, 172, 165, 158) | Change from BL at Week 8 (n=172, 172, 163, 153) | Change from BL at Week 10 (n=148, 130, 137, 128) | Change from BL at Week 12 (n=168, 166, 159, 141) | Change from BL at Week 14 (n=156, 152, 145, 136) | Change from BL at Week 16 (n=166, 166, 157, 137) | Change from BL at Week 18 (n=155, 157, 149, 139) | Change from BL at Week 20 (n=162, 153, 154, 146) | Change from BL at Week 22 (n=157, 151, 143, 138) | Change from BL at Week 24 (n=162, 160, 157, 135) | Change from BL at Week 30 (n=159, 155, 154, 136) | Change from BL at Week 37 (n=150, 149, 146, 121) | Change from BL at Week 50 (n=150, 142, 145, 124) | Change from BL at Week 63 (n=147, 136, 140, 115) | Change from BL at Week 76 (n=134, 126, 130, 94) | Change from BL at Week 89 (n=122, 113, 123, 85) | Change from BL at Week 102 (n=104, 104, 111, 68) | Change from BL at Week 115 (n=98, 92, 95, 57) | Change from BL at Week 128 (n=90, 87, 88, 50) | Change from BL at Week 141 (n=85, 78, 84, 47) | Change from BL at Week 154 (n=77, 71, 78, 45) | Change from BL at Week 167 (n=76, 67, 75, 42) | Change from BL at Week 180 (n=69, 60, 72, 41) | Change from BL at Week 193 (n=69, 60, 71, 40) | Change from BL at Week 206 (n=61, 48, 63, 31) | |
| Placebo+ Metformin | 0.40 | 0.01 | 0.03 | 0.02 | 0.01 | 0.05 | 0.03 | 0.05 | 0.03 | 0.06 | 0.04 | 0.07 | 0.04 | 0.05 | 0.03 | 0.03 | 0.04 | 0.05 | 0.06 | 0.06 | 0.04 | 0.04 | 0.07 | 0.05 | 0.05 | 0.04 | 0.04 | 0.01 |
| Saxagliptin 10 mg + Metformin | 0.42 | -0.00 | -0.01 | 0.01 | -0.02 | 0.03 | 0.01 | 0.03 | 0.02 | 0.05 | 0.02 | 0.03 | 0.02 | 0.02 | 0.02 | 0.04 | 0.06 | 0.04 | 0.06 | 0.03 | 0.08 | 0.04 | 0.07 | 0.03 | 0.03 | 0.06 | 0.06 | 0.02 |
| Saxagliptin 2.5 mg + Metformin | 0.40 | -0.01 | 0.01 | 0.01 | 0.00 | 0.05 | 0.02 | 0.04 | 0.02 | 0.06 | 0.02 | 0.06 | 0.03 | 0.02 | 0.03 | 0.04 | 0.06 | 0.03 | 0.04 | 0.02 | 0.04 | 0.04 | 0.05 | 0.01 | 0.01 | 0.02 | 0.01 | 0.00 |
| Saxagliptin 5 mg + Metformin | 0.41 | -0.01 | -0.01 | -0.01 | -0.00 | 0.02 | 0.01 | 0.03 | 0.02 | 0.04 | 0.02 | 0.04 | 0.02 | 0.02 | 0.03 | 0.04 | 0.06 | 0.05 | 0.04 | 0.07 | 0.05 | 0.05 | 0.06 | 0.07 | 0.07 | 0.04 | 0.08 | 0.04 |
(NCT00121667)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | 10^3 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Week 0) (n=192, 191, 181, 179) | Change from BL at Week 2 (n=178, 175, 170, 169) | Change from BL at Week 4 (n=176, 175, 170, 166) | Change from BL at Week 6 (n=175, 172, 165, 158) | Change from BL at Week 8 (n=172, 172, 163, 153) | Change from BL at Week 10 (n=148, 130, 137, 128) | Change from BL at Week 12 (n=168, 166, 159, 141) | Change from BL at Week 14 (n=156, 152, 145, 136) | Change from BL at Week 16 (n=166, 166, 157, 137) | Change from BL at Week 18 (n=155, 157, 149, 139) | Change from BL at Week 20 (n=162, 153, 154, 146) | Change from BL at Week 22 (n=157, 151, 143, 138) | Change from BL at Week 24 (n=162, 160, 157, 135) | Change from BL at Week 30 (n=159, 155, 154, 136) | Change from BL at Week 37 (n=150, 149, 146, 121) | Change from BL at Week 50 (n=150, 142, 145, 124) | Change from BL at Week 63 (n=147, 136, 140, 115) | Change from BL at Week 76 (n=134, 126, 130, 94) | Change from BL at Week 89 (n=122, 113, 123, 85) | Change from BL at Week 102 (n=104, 104, 111, 68) | Change from BL at Week 115 (n=98, 92, 95, 57) | Change from BL at Week 128 (n=90, 87, 88, 50) | Change from BL at Week 141 (n=85, 78, 84, 47) | Change from BL at Week 154 (n=77, 71, 78, 45) | Change from BL at Week 167 (n=76, 67, 75, 42) | Change from BL at Week 180 (n=69, 60, 72, 41) | Change from BL at Week 193 (n=69, 60, 71, 40) | Change from BL at Week 206 (n=61, 48, 63, 31) | |
| Placebo+ Metformin | 4.23 | 0.12 | 0.19 | 0.07 | 0.02 | 0.19 | 0.27 | 0.17 | 0.33 | 0.34 | 0.24 | 0.24 | 0.03 | 0.04 | 0.08 | -0.25 | -0.25 | -0.13 | -0.18 | -0.35 | -0.01 | -0.11 | 0.07 | -0.34 | -0.22 | -0.20 | -0.19 | -0.29 |
| Saxagliptin 10 mg + Metformin | 4.19 | 0.21 | 0.15 | 0.22 | 0.35 | 0.26 | 0.40 | 0.32 | 0.30 | 0.41 | 0.32 | 0.30 | 0.20 | 0.26 | 0.20 | -0.01 | 0.23 | 0.03 | 0.08 | -0.05 | 0.11 | 0.11 | 0.32 | -0.23 | 0.06 | -0.17 | 0.11 | -0.03 |
| Saxagliptin 2.5 mg + Metformin | 4.27 | 0.15 | 0.21 | 0.15 | 0.16 | 0.27 | 0.22 | 0.38 | 0.24 | 0.41 | 0.17 | 0.24 | 0.06 | 0.21 | 0.27 | -0.03 | -0.05 | -0.11 | -0.17 | -0.16 | 0.00 | -0.04 | 0.00 | 0.06 | -0.04 | -0.23 | -0.25 | -0.14 |
| Saxagliptin 5 mg + Metformin | 4.27 | 0.05 | 0.11 | 0.10 | 0.03 | 0.28 | 0.11 | 0.24 | 0.14 | 0.16 | 0.06 | 0.24 | 0.15 | 0.03 | 0.11 | 0.02 | 0.03 | 0.02 | -0.08 | -0.04 | -0.13 | -0.04 | -0.23 | -0.10 | 0.02 | -0.35 | -0.11 | -0.40 |
(NCT00121667)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | percentage red blood cells (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Week 0) (n=192, 191, 181, 179) | Change from BL at Week 2 (n=181, 177, 172, 169) | Change from BL at Week 4 (n=178, 178, 174, 166) | Change from BL at Week 6 (n=176, 174, 166, 160) | Change from BL at Week 8 (n=173, 176, 165, 157) | Change from BL at Week 10 (n=149, 134, 137, 131) | Change from BL at Week 12 (n=170, 167, 160, 144) | Change from BL at Week 14 (n=156, 154, 146, 139) | Change from BL at Week 16 (n=167, 166, 159, 140) | Change from BL at Week 18 (n=155, 158, 149, 141) | Change from BL at Week 20 (n=162, 153, 154, 147) | Change from BL at Week 22 (n=157, 152, 143, 138) | Change from BL at Week 24 (n=164, 160, 159, 137) | Change from BL at Week 30 (n=161, 155, 154, 137) | Change from BL at Week 37 (n=152, 149, 146, 122) | Change from BL at Week 50 (n=151, 142, 146, 127) | Change from BL at Week 63 (n=148, 137, 142, 116) | Change from BL at Week 76 (n=134, 126, 130, 94) | Change from BL at Week 89 (n=123, 114, 123, 85) | Change from BL at Week 102 (n=108, 104, 112, 70) | Change from BL at Week 115 (n=99, 94, 98, 58) | Change from BL at Week 128 (n=92, 88, 90, 52) | Change from BL at Week 141 (n=85, 79, 85, 48) | Change from BL at Week 154 (n=81, 74, 78, 45) | Change from BL at Week 167 (n=77, 67, 75, 42) | Change from BL at Week 180 (n=70, 61, 73, 41) | Change from BL at Week 193 (n=70, 60, 72, 40) | Change from BL at Week 206 (n=61, 50, 64, 31) | |
| Placebo+ Metformin | 41.8 | -0.4 | -0.0 | -0.0 | -0.0 | -0.1 | 0.0 | 0.0 | 0.2 | -0.1 | -0.3 | -0.5 | -0.4 | -0.2 | -0.1 | -0.0 | -0.0 | -0.4 | -0.3 | -0.7 | -0.2 | -0.5 | -0.9 | -1.6 | -1.1 | -1.2 | -0.7 | -1.3 |
| Saxagliptin 10 mg + Metformin | 42.2 | -0.5 | -0.2 | -0.1 | -0.0 | -0.2 | 0.4 | -0.1 | -0.1 | -0.3 | -0.2 | -0.5 | -0.3 | -0.0 | 0.0 | -0.1 | -0.1 | 0.1 | -0.3 | -0.2 | -0.4 | -0.5 | -0.3 | -1.2 | -1.2 | -0.7 | -0.5 | -0.7 |
| Saxagliptin 2.5 mg + Metformin | 41.9 | -0.3 | -0.3 | -0.2 | -0.4 | -0.4 | -0.1 | -0.2 | -0.1 | -0.3 | -0.1 | -0.2 | -0.3 | -0.2 | -0.1 | -0.4 | 0.1 | -0.2 | -0.2 | -0.7 | -0.1 | -0.6 | -0.6 | -1.5 | -1.0 | -1.1 | -0.7 | -1.5 |
| Saxagliptin 5 mg + Metformin | 42.3 | -0.5 | -0.4 | -0.3 | -0.1 | -0.4 | -0.1 | -0.2 | 0.0 | -0.5 | -0.3 | -0.5 | -0.4 | -0.4 | -0.4 | -0.5 | -0.5 | -0.4 | -0.5 | -0.9 | 0.0 | -0.5 | -0.6 | -1.7 | -1.6 | -1.8 | -1.7 | -2.3 |
(NCT00121667)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | g/dL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (BL) (Week 0) (n=192, 191, 181, 179) | Change from BL at Week 2 (n=181, 177, 172, 169) | Change from BL at Week 4 (n=178, 178, 174, 166) | Change from BL at Week 6 (n=176, 174, 166, 160) | Change from BL at Week 8 (n=173, 176, 165, 157) | Change from BL at Week 10 (n=149, 134, 137, 131) | Change from BL at Week 12 (n=170, 167, 160, 144) | Change from BL at Week 14 (n=156, 154, 146, 139) | Change from BL at Week 16 (n=167, 166, 159, 140) | Change from BL at Week 18 (n=155, 158, 149, 141) | Change from BL at Week 20 (n=162, 153, 154, 147) | Change from BL at Week 22 (n=157, 152, 143, 138) | Change from BL at Week 24 (n=164, 160, 159, 137) | Change from BL at Week 30 (n=161, 155, 154, 137) | Change from BL at Week 37 (n=152, 149, 146, 122) | Change from BL at Week 50 (n=151, 142, 146, 127) | Change from BL at Week 63 (n=148, 137, 142, 116) | Change from BL at Week 76 (n=134, 126, 130, 94) | Change from BL at Week 89 (n=123, 114, 123, 85) | Change from BL at Week 102 (n=108, 104, 112, 70) | Change from BL at Week 115 (n=99, 94, 98, 58) | Change from BL at Week 128 (n=92, 88, 90, 52) | Change from BL at Week 141 (n=85, 79, 85, 48) | Change from BL at Week 154 (n=81, 74, 78, 45) | Change from BL at Week 167 (n=77, 67, 75, 42) | Change from BL at Week 180 (n=70, 61, 73, 41) | Change from BL at Week 193 (n=70, 60, 72, 40) | Change from BL at Week 206 (n=61, 50, 64, 31) | |
| Placebo+ Metformin | 13.99 | -0.09 | 0.03 | 0.00 | 0.01 | -0.16 | -0.05 | -0.02 | -0.01 | -0.09 | -0.12 | -0.23 | -0.24 | -0.18 | -0.17 | -0.12 | -0.07 | -0.26 | -0.25 | -0.34 | -0.26 | -0.28 | -0.45 | -0.57 | -0.51 | -0.53 | -0.53 | -0.75 |
| Saxagliptin 10 mg + Metformin | 14.18 | -0.18 | -0.09 | -0.07 | -0.02 | -0.16 | 0.03 | -0.10 | -0.10 | -0.19 | -0.10 | -0.25 | -0.25 | -0.22 | -0.19 | -0.13 | -0.17 | -0.26 | -0.32 | -0.27 | -0.36 | -0.39 | -0.42 | -0.47 | -0.53 | -0.46 | -0.47 | -0.49 |
| Saxagliptin 2.5 mg + Metformin | 14.06 | -0.08 | -0.07 | -0.06 | -0.07 | -0.16 | -0.05 | -0.15 | -0.12 | -0.24 | -0.16 | -0.21 | -0.23 | -0.19 | -0.17 | -0.22 | -0.10 | -0.27 | -0.22 | -0.36 | -0.26 | -0.40 | -0.49 | -0.59 | -0.49 | -0.62 | -0.60 | -0.62 |
| Saxagliptin 5 mg + Metformin | 14.18 | -0.18 | -0.15 | -0.15 | -0.07 | -0.17 | -0.11 | -0.20 | -0.13 | -0.28 | -0.23 | -0.33 | -0.30 | -0.29 | -0.29 | -0.22 | -0.28 | -0.31 | -0.38 | -0.40 | -0.26 | -0.41 | -0.45 | -0.56 | -0.58 | -0.81 | -0.82 | -0.87 |
(NCT00121667)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | 10^9 c/L (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Week 0) (n=192, 189, 181, 178) | Change from BL at Week 2 (n=179, 168, 167, 166) | Change from BL at Week 4 (n=176, 172, 168, 164) | Change from BL at Week 6 (n=171, 171, 164, 157) | Change from BL at Week 8 (n=172, 170, 162, 151) | Change from BL at Week 10 (n=147, 132, 137, 129) | Change from BL at Week 12 (n=170, 165, 157, 141) | Change from BL at Week 14 (n=153, 149, 145, 133) | Change from BL at Week 16 (n=166, 161, 156, 133) | Change from BL at Week 18 (n=152, 155, 147, 139) | Change from BL at Week 20 (n=160, 151, 153, 144) | Change from BL at Week 22 (n=151, 148, 142, 134) | Change from BL at Week 24 (n=158, 153, 156, 135) | Change from BL at Week 30 (n=157, 153, 148, 130) | Change from BL at Week 37 (n=149, 142, 139, 120) | Change from BL at Week 50 (n=151, 141, 143, 120) | Change from BL at Week 63 (n=147, 132, 137, 115) | Change from BL at Week 76 (n=132, 124, 130, 92) | Change from BL at Week 89 (n=122, 111, 122, 84) | Change from BL at Week 102 (n=107, 103, 110, 69) | Change from BL at Week 115 (n=99, 93, 98, 57) | Change from BL at Week 128 (n=91, 84, 88, 51) | Change from BL at Week 141 (n=83, 77, 84, 47) | Change from BL at Week 154 (n=79, 70, 77, 45) | Change from BL at Week 167 (n=75, 64, 74, 41) | Change from BL at Week 180 (n=68, 60, 71, 41) | Change from BL at Week 193 (n=67, 57, 68, 40) | Change from BL at Week 206 (n=61, 49, 64, 31) | |
| Placebo+ Metformin | 261.0 | 13.7 | 11.1 | 12.0 | 8.5 | 11.5 | 8.2 | 7.5 | 7.4 | 8.5 | 6.8 | 4.1 | -2.3 | 2.0 | -2.3 | -6.4 | -4.7 | 4.7 | 13.6 | 6.1 | 7.0 | 4.5 | 12.0 | 12.5 | 13.8 | 8.9 | 12.2 | 9.8 |
| Saxagliptin 10 mg + Metformin | 258.7 | 6.5 | 5.1 | 5.1 | 4.9 | 0.5 | 4.8 | 2.5 | -0.0 | 5.2 | -1.7 | -1.7 | -2.0 | -0.8 | -11.9 | -9.0 | 0.1 | -2.6 | 1.4 | 3.3 | 1.2 | 2.2 | 1.1 | -1.8 | -1.9 | -8.3 | -8.5 | -4.7 |
| Saxagliptin 2.5 mg + Metformin | 265.5 | 8.4 | 11.3 | 8.7 | 6.7 | 4.7 | 6.8 | 6.1 | 5.3 | 5.6 | 4.9 | 3.5 | 0.6 | -0.1 | -2.6 | -3.2 | 2.6 | 0.1 | 9.1 | 0.3 | 1.1 | 5.7 | 9.2 | 8.0 | 10.1 | -2.7 | 1.3 | -0.7 |
| Saxagliptin 5 mg + Metformin | 256.2 | 9.8 | 11.8 | 8.5 | 7.5 | 8.5 | 9.3 | 7.4 | 7.1 | 3.0 | 7.0 | 9.7 | 3.5 | 3.6 | -4.1 | -2.4 | 3.5 | 4.0 | 8.6 | 6.1 | 4.2 | 3.2 | 6.5 | 9.4 | 3.2 | -1.2 | -2.9 | 1.5 |
(NCT00121667)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | 10^6 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Week 0) (n=192, 191, 181, 179) | Change from BL at Week 2 (n=181, 177, 172, 169) | Change from BL at Week 4 (n=178, 178, 174, 166) | Change from BL at Week 6 (n=176, 174, 166, 160) | Change from BL at Week 8 (n=173, 176, 165, 157) | Change from BL at Week 10 (n=149, 134, 137, 131) | Change from BL at Week 12 (n=170, 167, 160, 144) | Change from BL at Week 14 (n=156, 154, 146, 139) | Change from BL at Week 16 (n=167, 166, 159, 140) | Change from BL at Week 18 (n=155, 158, 149, 141) | Change from BL at Week 20 (n=162, 153, 154, 147) | Change from BL at Week 22 (n=157, 152, 143, 138) | Change from BL at Week 24 (n=164, 160, 159, 137) | Change from BL at Week 30 (n=161, 155, 154, 137) | Change from BL at Week 37 (n=152, 149, 146, 122) | Change from BL at Week 50 (n=151, 142, 146, 127) | Change from BL at Week 63 (n=148, 137, 142, 116) | Change from BL at Week 76 (n=134, 126, 130, 94) | Change from BL at Week 89 (n=123, 114, 123, 85) | Change from BL at Week 102 (n=108, 104, 112, 70) | Change from BL at Week 115 (n=99, 94, 98, 58) | Change from BL at Week 128 (n=92, 88, 90, 52) | Change from BL at Week 141 (n=85, 79, 85, 48) | Change from BL at Week 154 (n=81, 74, 78, 45) | Change from BL at Week 167 (n=77, 67, 75, 42) | Change from BL at Week 180 (n=70, 61, 73, 41) | Change from BL at Week 193 (n=70, 60, 72, 40) | Change from BL at Week 206 (n=61, 50, 64, 31) | |
| Placebo+ Metformin | 4.66 | -0.03 | 0.01 | 0.03 | 0.03 | 0.00 | 0.04 | 0.04 | 0.08 | 0.03 | 0.03 | -0.02 | -0.03 | -0.01 | 0.00 | -0.03 | -0.02 | -0.09 | -0.07 | -0.14 | -0.11 | -0.08 | -0.13 | -0.20 | -0.16 | -0.16 | -0.13 | -0.15 |
| Saxagliptin 10 mg + Metformin | 4.70 | -0.05 | -0.01 | 0.00 | 0.03 | 0.00 | 0.09 | 0.04 | 0.07 | 0.04 | 0.06 | 0.01 | 0.01 | 0.02 | 0.02 | 0.00 | -0.01 | -0.02 | -0.07 | -0.07 | -0.06 | -0.06 | -0.06 | -0.11 | -0.12 | -0.09 | -0.12 | -0.09 |
| Saxagliptin 2.5 mg + Metformin | 4.68 | -0.04 | -0.02 | -0.01 | 0.00 | -0.03 | 0.03 | 0.01 | 0.04 | 0.00 | 0.02 | 0.00 | -0.02 | -0.01 | -0.00 | -0.06 | -0.01 | -0.08 | -0.09 | -0.13 | -0.08 | -0.10 | -0.13 | -0.19 | -0.14 | -0.16 | -0.14 | -0.16 |
| Saxagliptin 5 mg + Metformin | 4.73 | -0.05 | -0.04 | -0.02 | 0.02 | -0.02 | 0.03 | 0.01 | 0.05 | -0.01 | 0.02 | -0.03 | -0.02 | -0.02 | -0.01 | -0.04 | -0.04 | -0.06 | -0.09 | -0.12 | -0.04 | -0.07 | -0.10 | -0.17 | -0.15 | -0.21 | -0.22 | -0.25 |
(NCT00121667)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | 10^3 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Week 0) (n=192, 191, 181, 179) | Change from BL at Week 2 (n=178, 175, 171, 169) | Change from BL at Week 4 (n=176, 176, 171, 166) | Change from BL at Week 6 (n=175, 172, 165, 158) | Change from BL at Week 8 (n=172, 174, 163, 153) | Change from BL at Week 10 (n=148, 130, 137, 128) | Change from BL at Week 12 (n=169, 166, 159, 142) | Change from BL at Week 14 (n=156, 152, 145, 136) | Change from BL at Week 16 (n=166, 166, 159, 137) | Change from BL at Week 18 (n=155, 158, 149, 139) | Change from BL at Week 20 (n=162, 153, 154, 146) | Change from BL at Week 22 (n=157, 152, 143, 138) | Change from BL at Week 24 (n=162, 160, 157, 135) | Change from BL at Week 30 (n=160, 155, 154, 136) | Change from BL at Week 37 (n=150, 149, 146, 121) | Change from BL at Week 50 (n=150, 142, 145, 125) | Change from BL at Week 63 (n=147, 136, 140, 115) | Change from BL at Week 76 (n=134, 126, 130, 94) | Change from BL at Week 89 (n=122, 114, 123, 85) | Change from BL at Week 102 (n=105, 104, 111, 68) | Change from BL at Week 115 (n=98, 92, 95, 57) | Change from BL at Week 128 (n=90, 87, 88, 50) | Change from BL at Week 141 (n=85, 78, 85, 47) | Change from BL at Week 154 (n=77, 72, 78, 45) | Change from BL at Week 167 (n=76, 67, 75, 42) | Change from BL at Week 180 (n=70, 60, 72, 41) | Change from BL at Week 193 (n=69, 60, 72, 40) | Change from BL at Week 206 (n=61, 49, 63, 31) | |
| Placebo+ Metformin | 7.19 | 0.11 | 0.22 | 0.07 | 0.03 | 0.39 | 0.37 | 0.33 | 0.42 | 0.58 | 0.39 | 0.50 | 0.10 | 0.14 | 0.10 | -0.36 | -0.39 | -0.30 | -0.38 | -0.54 | -0.15 | -0.32 | -0.07 | -0.54 | -0.38 | -0.37 | -0.35 | -0.71 |
| Saxagliptin 10 mg + Metformin | 7.12 | 0.17 | -0.02 | 0.07 | 0.19 | 0.23 | 0.26 | 0.24 | 0.16 | 0.39 | 0.19 | 0.24 | 0.11 | 0.21 | 0.02 | -0.20 | -0.02 | -0.25 | -0.21 | -0.31 | -0.05 | -0.12 | 0.13 | -0.55 | -0.18 | -0.38 | -0.13 | -0.36 |
| Saxagliptin 2.5 mg + Metformin | 7.23 | 0.10 | 0.19 | 0.11 | 0.15 | 0.42 | 0.18 | 0.57 | 0.28 | 0.67 | 0.23 | 0.45 | 0.13 | 0.27 | 0.34 | -0.14 | -0.10 | -0.19 | -0.29 | -0.36 | -0.10 | -0.16 | -0.01 | -0.19 | -0.15 | -0.40 | -0.45 | -0.58 |
| Saxagliptin 5 mg + Metformin | 7.25 | -0.03 | 0.04 | 0.02 | -0.03 | 0.37 | 0.08 | 0.30 | 0.07 | 0.23 | -0.02 | 0.36 | 0.12 | 0.05 | 0.10 | -0.14 | -0.10 | -0.18 | -0.34 | -0.11 | -0.26 | -0.27 | -0.42 | -0.38 | -0.18 | -0.72 | -0.34 | -0.80 |
(NCT00121667)
Timeframe: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | mmHg (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change from BL at Week 2 (n=182, 181, 176, 170) | Change from BL at Week 4 (n=178, 179, 175, 164) | Change from BL at Week 6 (n=178, 176, 171, 162) | Change from BL at Week 8 (n=175, 176, 170, 152) | Change from BL at Week 10 (n=116, 108, 101, 101) | Change from BL at Week 12 (n=170, 166, 161, 138) | Change from BL at Week 14 (n=132, 129, 124, 116) | Change from BL at Week 16 (n=166, 164, 156, 140) | Change from BL at Week 18 (n=144, 141, 132, 123) | Change from BL at Week 20 (n=163, 155, 153, 147) | Change from BL at Week 22 (n=146, 140, 136, 126) | Change from BL at Week 24 (n=165, 160, 161, 140) | Change from BL at Week 30 (n=162, 156, 155, 138) | Change from BL at Week 37 (n=154, 151, 149, 123) | Change from BL at Week 50 (n=155, 147, 151, 130) | Change from BL at Week 63 (n=151, 138, 145, 117) | Change from BL at Week 76 (n=134, 126, 133, 98) | Change from BL at Week 89 (n=124, 117, 125, 86) | Change from BL at Week 102 (n=111, 107, 113, 73) | Change from BL at Week 115 (n=100, 94, 98, 58) | Change from BL at Week 128 (n=94, 88, 90, 52) | Change from BL at Week 141 (n=87, 82, 85, 49) | Change from BL at Week 154 (n=84, 75, 79, 45) | Change from BL at Week 167 (n=78, 67, 75, 42) | Change from BL at Week 180 (n=71, 63, 74, 41) | Change from BL at Week 193 (n=70, 60, 72, 40) | Change from BL at Week 206 (n=61, 53, 64, 33) | |
| Placebo+ Metformin | -1.5 | -1.4 | -1.4 | -2.2 | -3.4 | -1.7 | -2.1 | -1.0 | -1.8 | -1.9 | -1.6 | -2.4 | -1.6 | -1.6 | -1.4 | -0.7 | -1.8 | -2.1 | -3.6 | -3.6 | -3.1 | -2.7 | -4.6 | -2.0 | -1.6 | -2.6 | -2.8 |
| Saxagliptin 10 mg + Metformin | -0.9 | -1.3 | -0.5 | -1.5 | -1.6 | -2.1 | -2.2 | -1.7 | -2.3 | -2.1 | -1.6 | -2.5 | -1.6 | -1.9 | -1.5 | -0.9 | -1.6 | -1.9 | -2.3 | -1.1 | -1.2 | -3.0 | -2.7 | -1.6 | -0.9 | -1.7 | -2.3 |
| Saxagliptin 2.5 mg + Metformin | -1.0 | -0.3 | -0.1 | -1.1 | 0.3 | -0.6 | -0.2 | -0.7 | -1.4 | -1.2 | -0.7 | -1.3 | -0.9 | -0.9 | -1.1 | -0.8 | -0.2 | -1.2 | -2.2 | -0.1 | -0.6 | 0.7 | -0.7 | 2.1 | -0.3 | 0.4 | -2.8 |
| Saxagliptin 5 mg + Metformin | -1.1 | -0.9 | -1.6 | -1.9 | -0.5 | -1.0 | -0.4 | -1.0 | -0.7 | -1.0 | -1.2 | -1.3 | -0.5 | -1.1 | -1.7 | -0.3 | -1.2 | -0.8 | -0.4 | 0.7 | 0.0 | 0.3 | -1.8 | -1.4 | -1.4 | -2.6 | -0.6 |
(NCT00121667)
Timeframe: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | beats/min (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change from BL at Week 2 (n=182, 181, 176, 170) | Change from BL at Week 4 (n=178, 179, 175, 164) | Change from BL at Week 6 (n=178, 176, 171, 162) | Change from BL at Week 8 (n=175, 176, 170, 152) | Change from BL at Week 10 (n=116, 106, 100, 101) | Change from BL at Week 12 (n=170, 166, 161, 138) | Change from BL at Week 14 (n=132, 129, 124, 116) | Change from BL at Week 16 (n=166, 164, 156, 140) | Change from BL at Week 18 (n=144, 141, 132, 123) | Change from BL at Week 20 (n=163, 155, 153, 147) | Change from BL at Week 22 (n=146, 140, 136, 126) | Change from BL at Week 24 (n=165, 160, 161, 140) | Change from BL at Week 30 (n=162, 156, 154, 138) | Change from BL at Week 37 (n=154, 151, 149, 123) | Change from BL at Week 50 (n=154, 147, 151, 130) | Change from BL at Week 63 (n=151, 138, 145, 117) | Change from BL at Week 76 (n=134, 126, 133, 98) | Change from BL at Week 89 (n=124, 116, 125, 86) | Change from BL at Week 102 (n=111, 107, 113, 73) | Change from BL at Week 115 (n=100, 94, 98, 58) | Change from BL at Week 128 (n=94, 88, 90, 52) | Change from BL at Week 141 (n=87, 82, 85, 49) | Change from BL at Week 154 (n=84, 75, 79, 45) | Change from BL at Week 167 (n=78, 67, 75, 42) | Change from BL at Week 180 (n=71, 63, 74, 41) | Change from BL at Week 193 (n=70, 60, 72, 40) | Change from BL at Week 206 (n=61, 53, 64, 33) | |
| Placebo+ Metformin | 0.7 | 0.1 | -0.5 | -0.6 | -1.5 | -1.5 | -1.5 | -0.5 | -0.5 | -0.8 | -1.6 | -0.7 | -0.1 | -0.6 | -1.0 | -0.5 | -1.4 | -1.6 | -1.8 | -2.4 | -0.9 | -1.2 | -2.8 | -0.9 | -2.7 | -1.8 | -1.1 |
| Saxagliptin 10 mg + Metformin | -0.4 | -0.0 | -0.2 | 0.6 | 0.2 | 0.1 | 1.0 | -0.5 | 0.3 | -0.3 | 0.3 | 0.4 | -0.3 | -0.3 | 0.1 | -0.8 | -0.5 | -0.2 | 0.6 | -0.8 | -0.9 | -0.6 | -0.0 | -1.2 | 0.2 | -1.1 | -1.2 |
| Saxagliptin 2.5 mg + Metformin | -0.3 | -0.1 | -0.2 | 0.5 | -0.5 | -0.2 | -0.1 | -0.6 | -0.0 | -0.0 | 0.4 | -0.6 | -0.7 | -1.2 | -1.0 | -0.8 | -1.3 | -1.5 | -0.6 | -0.5 | -0.2 | -1.7 | -0.6 | 0.3 | -0.8 | -0.3 | 0.1 |
| Saxagliptin 5 mg + Metformin | 1.0 | 1.3 | 1.0 | 0.8 | 0.9 | 0.7 | 1.4 | 0.4 | 1.6 | 0.9 | 2.4 | 0.2 | 0.5 | 0.6 | 0.8 | 0.4 | -0.0 | -0.3 | 0.5 | -0.3 | -0.7 | -1.7 | -0.9 | -0.0 | -2.8 | -2.2 | -0.9 |
(NCT00121667)
Timeframe: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | mmHg (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change from BL at Week 2 (n=182, 181, 176, 170) | Change from BL at Week 4 (n=178, 179, 175, 164) | Change from BL at Week 6 (n=178, 176, 171, 162) | Change from BL at Week 8 (n=175, 176, 170, 152) | Change from BL at Week 10 (n=116, 108, 101, 101) | Change from BL at Week 12 (n=170, 166, 161, 138) | Change from BL at Week 14 (n=132, 129, 124, 116) | Change from BL at Week 16 (n=166, 164, 156, 140) | Change from BL at Week 18 (n=144, 141, 132, 123) | Change from BL at Week 20 (n=163, 155, 153, 147) | Change from BL at Week 22 (n=146, 140, 136, 126) | Change from BL at Week 24 (n=165, 160, 161, 140) | Change from BL at Week 30 (n=162, 156, 155, 138) | Change from BL at Week 37 (n=154, 151, 149, 123) | Change from BL at Week 50 (n=155, 147, 151, 130) | Change from BL at Week 63 (n=151, 138, 145, 117) | Change from BL at Week 76 (n=134, 126, 133, 98) | Change from BL at Week 89 (n=124, 117, 125, 86) | Change from BL at Week 102 (n=111, 107, 113, 73) | Change from BL at Week 115 (n=100, 94, 98, 58) | Change from BL at Week 128 (n=94, 88, 90, 52) | Change from BL at Week 141 (n=87, 82, 85, 49) | Change from BL at Week 154 (n=84, 75, 79, 45) | Change from BL at Week 167 (n=78, 67, 75, 42) | Change from BL at Week 180 (n=71, 63, 74, 41) | Change from BL at Week 193 (n=70, 60, 72, 40) | Change from BL at Week 206 (n=61, 53, 64, 33) | |
| Placebo+ Metformin | -3.3 | -2.9 | -2.8 | -3.7 | -6.8 | -4.3 | -2.6 | -2.6 | -4.1 | -4.3 | -4.7 | -4.5 | -3.4 | -2.3 | -2.9 | -0.0 | -1.7 | 0.3 | -2.0 | -2.8 | -2.5 | 0.3 | -2.8 | -1.8 | 2.7 | -1.4 | -0.4 |
| Saxagliptin 10 mg + Metformin | -1.6 | -3.3 | -2.8 | -4.2 | -2.8 | -4.3 | -3.4 | -4.4 | -4.2 | -4.9 | -3.1 | -3.8 | -2.5 | -3.3 | -1.9 | -0.6 | -0.7 | -1.7 | -2.8 | -1.3 | 1.5 | -1.5 | 1.5 | 0.7 | 3.5 | 0.2 | 1.7 |
| Saxagliptin 2.5 mg + Metformin | -1.6 | -2.0 | -2.8 | -2.9 | -2.1 | -2.2 | -0.7 | -2.7 | -1.9 | -2.9 | -2.0 | -4.3 | -3.6 | -2.6 | -2.6 | -0.6 | -0.1 | -3.7 | -3.2 | -0.4 | -0.4 | -0.7 | 0.3 | 0.8 | -0.0 | -0.1 | -2.6 |
| Saxagliptin 5 mg + Metformin | -2.5 | -2.3 | -4.1 | -4.2 | -3.3 | -2.8 | -2.3 | -3.5 | -2.2 | -2.2 | -3.1 | -3.6 | -1.1 | -1.8 | -1.7 | 0.9 | -0.6 | 0.3 | 0.6 | 2.0 | 2.9 | 2.0 | -0.0 | -0.4 | 3.1 | 0.9 | 2.2 |
The normality/abnormality of the ECG tracing was determined by the investigator. (NCT00121667)
Timeframe: Baseline, Weeks 12, 24, 76, 102, 154, 206,
| Intervention | participants (Number) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Normal BL, Normal Week 12(BL n=108, 109, 104, 104) | Normal BL, Abnormal Week 12 (BL n=108,109,104,104) | Abnormal BL, Normal Week 12 (BL n=69, 66, 70, 58) | Abnormal BL, Abnormal Week 12(BL n=69, 66, 70, 58) | Normal BL, Normal Week 24 (BL n=96, 87, 83, 77) | Normal BL, Abnormal Week 24 (BL n=96, 87, 83, 77) | Abnormal BL, Normal Week 24 (BL n=58, 58, 56, 41) | Abnormal BL, Abnormal Week 24(BL n=58, 58, 56, 41) | Normal BL, Normal Week 76 (BL n=94, 89, 92, 81) | Normal BL, Abnormal Week 76 (BL n=94, 89, 92, 81) | Abnormal BL, Normal Week 76 (BL n=51, 52, 59, 44) | Abnormal BL, Abnormal Week 76 (BL n=51,52,59,44) | Normal BL, Normal Week 102 (BL n=80, 66, 65, 50) | Normal BL, Abnormal Week 102 (BL n=80, 66, 65, 50) | Abnormal BL, Normal Week 102 (BL n=43,45,49, 21) | Abnormal BL, Abnormal Week 102 (BL n=43,45,49, 21) | Normal BL, Normal Week 154 (BL n=60, 46, 53, 34) | Normal BL, Abnormal Week 154 (BL n=60, 46, 53, 34) | Abnormal BL, Normal Week 154 (BL n=26, 34, 34, 16) | Abnormal BL, Abnormal Week 154 (BL n=26,34,34,16) | Normal BL, Normal Week 206 (BL n=48, 31, 42, 24) | Normal BL, Abnormal Week 206 (BL n=48, 31, 42, 24) | Abnormal BL, Normal Week 206 (BL n=20, 25, 28, 13) | Abnormal BL, Abnormal Week 206 (BL n=20,25,28,13) | |
| Placebo+ Metformin | 82 | 22 | 12 | 46 | 61 | 16 | 14 | 27 | 60 | 21 | 13 | 31 | 41 | 9 | 6 | 15 | 26 | 8 | 7 | 9 | 16 | 8 | 7 | 6 |
| Saxagliptin 10 mg + Metformin | 94 | 10 | 22 | 48 | 70 | 13 | 15 | 41 | 73 | 19 | 18 | 41 | 48 | 17 | 14 | 35 | 37 | 16 | 12 | 22 | 32 | 10 | 11 | 17 |
| Saxagliptin 2.5 mg + Metformin | 97 | 11 | 14 | 55 | 82 | 14 | 16 | 42 | 75 | 19 | 13 | 38 | 63 | 17 | 11 | 32 | 48 | 12 | 10 | 16 | 39 | 9 | 9 | 11 |
| Saxagliptin 5 mg + Metformin | 98 | 11 | 22 | 44 | 79 | 8 | 22 | 36 | 74 | 15 | 18 | 34 | 55 | 11 | 14 | 31 | 36 | 10 | 13 | 21 | 27 | 4 | 9 | 16 |
A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal. (NCT00121667)
Timeframe: Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure: 124, 118, 130, 95 weeks, respectively, for 2.5mg, 5mg, 10 mg, placebo.
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hemoglobin < 8 g/dL (n=189, 190, 181, 179) | Hematocrit < 0.75 x pre-Rx (n=189, 190, 181, 179) | Platelets < 50 x 10^9 c/L (n=189, 188, 181, 178) | Platelets > 1.5 x ULN (n=189, 188, 181, 178) | Leukocytes < 2 x 1000 c/µL (n=189, 190, 181, 179) | Neutrophils+Bands <1x1000 c/µL (n=189,190,181,179) | Eosinophils >0.9x1000 c/µL (n=189, 190, 181, 179) | Lymphocytes <=0.75x1000 c/µL (n=189,190,181,179) | ALP >3 x pre-Rx and >ULN (n=190, 190, 181, 179) | ALP >1.5 x ULN (n=190, 190, 181, 179) | AST >3 x ULN (n=190, 190, 181, 179) | AST >5 x ULN (n=190, 190, 181, 179) | AST >10 x ULN (n=190, 190, 181, 179) | AST >20 x ULN (n=190, 190, 181, 179) | ALT >3 x ULN (n=190, 190, 181, 179) | ALT >5 x ULN (n=190, 190, 181, 179) | ALT >10 x ULN (n=190, 190, 181, 179) | ALT >20 x ULN (n=190, 190, 181, 179) | Bilirubin Total >2mg/dL (n=190,190,181,179) | Bilirubin Total >1.5xULN (n=190,190,181,179) | Bilirubin Total >2xULN (n=190,190,181,179) | BUN >2 x pre-Rx and >ULN (n=190,190,181,179) | Creatinine >2.5 mg/dL (n=190,190,181,179) | Glucose, Serum Fasting < 50 mg/dL (n=0, 0, 0, 0) | Glucose, Serum Fasting > 500 mg/dL (n=0, 0, 0, 0) | Glucose, Serum Unspec. < 50 mg/dL (n=0,0,0,0) | Glucose, Serum Unspec. > 500 mg/dL (n=0,0,0,0) | Glucose, Plasma Fasting<50mg/dL(n=189,189,181,179) | Glucose,Plasma Fasting>500mg/dL(n=189,189,181,179) | Glucose, Plasma Unspec.<50mg/dL(n=192,191,181,179) | Glucose,Plasma Unspec.>500mg/dL(n=192,191,181,179) | Sodium,Serum Low (*) (n=190,190,181,179) | Sodium,Serum High (*) (n=190,190,181,179) | Potassium, Serum Low (*) (n=190,190,181,179) | Potassium, Serum High (n=190,190,181,179) | Chloride < 90 mEq/L (n=190, 190, 181, 179) | Chloride > 120 mEq/L (n=190, 190, 181, 179) | Albumin < 0.9 LLN (n=190, 190, 181, 179) | Creatine Kinase > 5 x ULN (n=190, 190, 181, 179) | Uric Acid > 1.5 x ULN (n=0, 0, 0, 0) | Protein Urine, >=2-4 (n=187, 189, 180, 178) | Blood Urine, >=2-4 (n=187, 189, 180, 178) | Red Blood Cells Urine >=2-4 (n=175,176,162,166) | White Blood Cells Urine >=2-4 (n=175,176,162,166) | |
| Placebo+ Metformin | 0 | 2 | 0 | 1 | 0 | 1 | 9 | 2 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 9 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 9 | 1 | 1 | 0 | 1 | 7 | 0 | 0 | 0 | 1 | 0 | 12 | 13 | 20 | 28 |
| Saxagliptin 10 mg + Metformin | 1 | 5 | 0 | 4 | 0 | 0 | 18 | 4 | 0 | 1 | 3 | 1 | 0 | 0 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 6 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 9 | 1 | 4 | 1 | 1 | 5 | 3 | 0 | 0 | 3 | 0 | 13 | 18 | 22 | 26 |
| Saxagliptin 2.5 mg + Metformin | 1 | 2 | 0 | 0 | 0 | 1 | 12 | 3 | 0 | 3 | 6 | 1 | 0 | 0 | 4 | 1 | 1 | 0 | 2 | 2 | 0 | 12 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 19 | 1 | 1 | 0 | 0 | 4 | 2 | 1 | 1 | 1 | 0 | 7 | 17 | 28 | 43 |
| Saxagliptin 5 mg + Metformin | 1 | 5 | 0 | 0 | 0 | 1 | 12 | 4 | 0 | 1 | 1 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 1 | 1 | 1 | 9 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 7 | 1 | 2 | 0 | 1 | 5 | 3 | 0 | 0 | 2 | 0 | 9 | 21 | 27 | 38 |
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing. (NCT00121667)
Timeframe: AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| At Least 1 AE | At Least 1 Related AE | Deaths | At Least 1 SAE | At Least 1 Related SAE | Discontinuations Due to SAEs | Discontinuations Due to AEs | |
| Placebo+ Metformin | 142 | 56 | 2 | 15 | 1 | 0 | 9 |
| Saxagliptin 10 mg + Metformin | 161 | 65 | 1 | 22 | 1 | 6 | 13 |
| Saxagliptin 2.5 mg + Metformin | 177 | 53 | 1 | 23 | 0 | 4 | 11 |
| Saxagliptin 5 mg + Metformin | 155 | 57 | 0 | 27 | 3 | 6 | 18 |
Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24. (NCT00295633)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin 2.5 mg Plus Open-label TZD | 42.2 |
| Saxagliptin 5 mg Plus Open-label TZD | 41.8 |
| Placebo Plus Open-label TZD | 25.6 |
Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00295633)
Timeframe: Baseline, Week 24
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Placebo Plus Open-label TZD | 162.4 | 159.3 | -2.8 |
| Saxagliptin 2.5 mg Plus Open-label TZD | 163.0 | 148.2 | -14.3 |
| Saxagliptin 5 mg Plus Open-label TZD | 159.5 | 143.0 | -17.3 |
Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00295633)
Timeframe: Baseline, Week 24
| Intervention | percent (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Placebo Plus Open-label TZD | 8.19 | 7.91 | -0.30 |
| Saxagliptin 2.5 mg Plus Open-label TZD | 8.25 | 7.59 | -0.66 |
| Saxagliptin 5 mg Plus Open-label TZD | 8.35 | 7.39 | -0.94 |
Mean change from baseline for 0 to 180 minutes PPG AUC achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value. (NCT00295633)
Timeframe: Baseline, Week 24
| Intervention | mg*min/dL (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Placebo Plus Open-label TZD | 47256 | 44819 | -2690 |
| Saxagliptin 2.5 mg Plus Open-label TZD | 48301 | 40255 | -7849 |
| Saxagliptin 5 mg Plus Open-label TZD | 47866 | 38587 | -9269 |
Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. (NCT00327015)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin 5 mg + Metformin | 60.3 |
| Saxagliptin 10 mg + Metformin | 59.7 |
| Metformin | 41.1 |
Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. (NCT00327015)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin 5 mg + Metformin | 60.3 |
| Saxagliptin 10 mg + Metformin | 59.7 |
| Saxagliptin 10 mg | 32.2 |
Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. (NCT00327015)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin 5 mg + Metformin | 45.3 |
| Saxagliptin 10 mg + Metformin | 40.6 |
| Metformin | 29.0 |
Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. (NCT00327015)
Timeframe: Week 24
| Intervention | Percentage of Participants (Number) |
|---|---|
| Saxagliptin 5 mg + Metformin | 45.3 |
| Saxagliptin 10 mg + Metformin | 40.6 |
| Saxagliptin 10 mg | 20.3 |
Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone. (NCT00327015)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin 5 mg + Metformin | 7.5 |
| Saxagliptin 10 mg + Metformin | 5.9 |
| Metformin | 10.1 |
Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone. (NCT00327015)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin 5 mg + Metformin | 7.5 |
| Saxagliptin 10 mg + Metformin | 5.9 |
| Saxagliptin 10 mg | 21.2 |
Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24
| Intervention | percent (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Metformin | 9.43 | 7.48 | -1.99 |
| Saxagliptin 10 mg + Metformin | 9.53 | 7.02 | -2.49 |
| Saxagliptin 5 mg + Metformin | 9.41 | 6.93 | -2.53 |
Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Metformin | 199.1 | 152.7 | -47.3 |
| Saxagliptin 10 mg + Metformin | 204.3 | 140.1 | -62.2 |
| Saxagliptin 5 mg + Metformin | 198.9 | 140.2 | -59.8 |
Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Saxagliptin 10 mg | 200.9 | 169.9 | -30.9 |
| Saxagliptin 10 mg + Metformin | 204.3 | 140.1 | -62.2 |
| Saxagliptin 5 mg + Metformin | 198.9 | 140.2 | -59.8 |
Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24
| Intervention | percent (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Saxagliptin 10 mg | 9.61 | 7.86 | -1.69 |
| Saxagliptin 10 mg + Metformin | 9.53 | 7.02 | -2.49 |
| Saxagliptin 5 mg + Metformin | 9.41 | 6.93 | -2.53 |
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24
| Intervention | mg*min/dL (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Metformin | 57937 | 42428 | -15005 |
| Saxagliptin 10 mg + Metformin | 57219 | 35790 | -21336 |
| Saxagliptin 5 mg + Metformin | 55531 | 35324 | -21080 |
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24
| Intervention | mg*min/dL (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Saxagliptin 10 mg | 57584 | 41229 | -16054 |
| Saxagliptin 10 mg + Metformin | 57219 | 35790 | -21336 |
| Saxagliptin 5 mg + Metformin | 55531 | 35324 | -21080 |
Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus glyburide versus placebo plus upward titrated glyburide at Week 24. (NCT00313313)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin 2.5 mg + Glyburide 7.5 mg | 22.4 |
| Saxagliptin 5 mg + Glyburide 7.5 mg | 22.8 |
| Placebo + Glyburide 7.5 mg | 9.1 |
Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00313313)
Timeframe: Baseline, Week 24
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Placebo + Glyburide 7.5 mg | 174.4 | 174.6 | 0.7 |
| Saxagliptin 2.5 mg + Glyburide 7.5 mg | 170.1 | 164.4 | -7.1 |
| Saxagliptin 5 mg + Glyburide 7.5 mg | 175.0 | 164.6 | -9.7 |
Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00313313)
Timeframe: Baseline, Week 24
| Intervention | percent (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Placebo + Glyburide 7.5 mg | 8.44 | 8.52 | 0.08 |
| Saxagliptin 2.5 mg + Glyburide 7.5 mg | 8.36 | 7.83 | -0.54 |
| Saxagliptin 5 mg + Glyburide 7.5 mg | 8.48 | 7.83 | -0.64 |
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values. (NCT00313313)
Timeframe: Baseline, Week 24
| Intervention | mg*min/dL (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Placebo + Glyburide 7.5 mg | 51801 | 52416 | 1196 |
| Saxagliptin 2.5 mg + Glyburide 7.5 mg | 49124 | 45402 | -4296 |
| Saxagliptin 5 mg + Glyburide 7.5 mg | 50342 | 45391 | -5000 |
Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. (NCT00121641)
Timeframe: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.
| Intervention | participants (Number) |
|---|---|
| Saxagliptin 2.5 mg | 9 |
| Saxagliptin 5 mg | 11 |
| Saxagliptin 10 mg | 10 |
| Placebo | 9 |
Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. (NCT00121641)
Timeframe: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.
| Intervention | participants (Number) |
|---|---|
| Open-Label Treatment Cohort (Direct Enrollees) | 2 |
This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report. (NCT00121641)
Timeframe: Baseline
| Intervention | years (Mean) |
|---|---|
| Open-Label Treatment Cohort (Direct Enrollees) | 49.09 |
This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report. (NCT00121641)
Timeframe: Baseline
| Intervention | kg/m^2 (Mean) |
|---|---|
| Open-Label Treatment Cohort (Direct Enrollees) | 31.73 |
This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report. (NCT00121641)
Timeframe: Baseline
| Intervention | kg (Mean) |
|---|---|
| Open-Label Treatment Cohort (Direct Enrollees) | 91.41 |
'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms (NCT00121641)
Timeframe: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.
| Intervention | participants (Number) |
|---|---|
| Saxagliptin 2.5 mg | 1 |
| Saxagliptin 5 mg | 1 |
| Saxagliptin 10 mg | 0 |
| Placebo | 0 |
'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms (NCT00121641)
Timeframe: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.
| Intervention | participants (Number) |
|---|---|
| Open-Label Treatment Cohort (Direct Enrollees) | 0 |
(NCT00121641)
Timeframe: Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Saxagliptin 2.5 mg | 35.0 |
| Saxagliptin 5 mg | 37.9 |
| Saxagliptin 10 mg | 41.1 |
| Placebo | 23.9 |
(NCT00121641)
Timeframe: Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Open Label Cohort (Direct Enrollees) | 14.1 |
To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%. (NCT00121641)
Timeframe: Baseline, Week 24
| Intervention | Percentage of glycosylated hemoglobins (Mean) | |
|---|---|---|
| Baseline Mean | Mean Change from Baseline | |
| Open Label Cohort (Direct Enrollees) | 10.70 | -1.87 |
(NCT00121641)
Timeframe: Baseline, Week 24
| Intervention | mg/dL (Mean) | |
|---|---|---|
| Baseline | Adjusted Change from Baseline | |
| Placebo | 171.85 | 6.06 |
| Saxagliptin 10 mg | 176.51 | -16.75 |
| Saxagliptin 2.5 mg | 177.72 | -14.53 |
| Saxagliptin 5 mg | 171.31 | -8.67 |
(NCT00121641)
Timeframe: Baseline, Week 24
| Intervention | mg/dL (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Open-Label Cohort (Direct Enrollees) | 241.08 | -33.42 |
(NCT00121641)
Timeframe: Baseline, Week 24
| Intervention | mg*min/dL (Mean) | |
|---|---|---|
| Baseline | Adjusted Change from Baseline | |
| Placebo | 46030 | -646.6 |
| Saxagliptin 10 mg | 44614 | -8084 |
| Saxagliptin 2.5 mg | 45030 | -6868 |
| Saxagliptin 5 mg | 45691 | -6896 |
(NCT00121641)
Timeframe: Baseline, Week 24
| Intervention | mg*min/dL (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Open Label Cohort (Direct Enrollees) | 60687 | -11078 |
(NCT00121641)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | x 10^3 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (BL) (Week 0) (n=102, 106, 98, 94) | Change from BL at Week 2 (n=95, 99, 92, 86) | Change from BL at Week 4 (n=91, 99, 90, 90) | Change from BL at Week 6 (n=89, 95, 87, 82) | Change from BL at Week 8 (n=91, 88, 90, 79) | Change from BL at Week 10 (n=68, 76, 69, 63) | Change from BL at Week 12 (n=83, 88, 87, 82) | Change from BL at Week 14 (n=76, 77, 80, 75) | Change from BL at Week 16 (n=90, 91, 83, 71) | Change from BL at Week 18 (n=78, 75, 82, 71) | Change from BL at Week 20 (n=83, 79, 78, 72) | Change from BL at Week 22 (n=77, 74, 75, 65) | Change from BL at Week 24 (n=83, 81, 78, 74) | Change from BL at Week 30 (n=76, 78, 79, 67) | Change from BL at Week 37 (n=74, 72, 70, 60) | Change from BL at Week 50 (n=67, 69, 71, 61) | Change from BL at Week 63 (n=60, 66, 67, 55) | Change from BL at Week 76 (n=51, 58, 63, 49) | Change from BL at Week 89 (n=48, 58, 56, 42) | Change from BL at Week 102 (n=39, 47, 50, 40) | Change from BL at Week 115 (n=34, 43, 42, 34) | Change from BL at Week 128 (n=30, 40, 40, 29) | Change from BL at Week 141 (n=28, 38, 34, 28) | Change from BL at Week 154 (n=26, 33, 31, 24) | Change from BL at Week 167 (n=24, 33, 30, 25) | Change from BL at Week 180 (n=21, 28, 28, 26) | Change from BL at Week 193 (n=19, 25, 26, 23) | Change from BL at Week 206 (n=17, 22, 23, 21) | |
| Placebo | 0.02 | 0.00 | -0.00 | -0.01 | -0.01 | -0.01 | -0.00 | -0.00 | -0.01 | -0.01 | -0.00 | -0.00 | -0.01 | 0.01 | 0.00 | 0.02 | 0.02 | 0.01 | 0.02 | 0.02 | 0.03 | 0.03 | 0.02 | 0.01 | 0.02 | 0.02 | 0.02 | 0.01 |
| Saxagliptin 10 mg | 0.02 | -0.01 | -0.01 | -0.01 | -0.01 | -0.01 | -0.00 | -0.01 | -0.01 | -0.00 | -0.01 | 0.00 | -0.01 | -0.01 | 0.00 | 0.01 | 0.02 | 0.02 | 0.02 | 0.02 | 0.01 | 0.01 | 0.01 | 0.02 | 0.01 | 0.00 | 0.01 | 0.01 |
| Saxagliptin 2.5 mg | 0.01 | 0.00 | 0.00 | 0.01 | 0.00 | 0.00 | -0.00 | 0.00 | 0.00 | 0.00 | 0.01 | 0.01 | 0.00 | 0.00 | 0.00 | 0.02 | 0.02 | 0.02 | 0.02 | 0.02 | 0.02 | 0.03 | 0.02 | 0.03 | 0.02 | 0.01 | 0.01 | 0.00 |
| Saxagliptin 5 mg | 0.02 | -0.01 | -0.01 | -0.01 | -0.00 | -0.01 | -0.01 | 0.00 | -0.00 | 0.00 | -0.01 | -0.00 | -0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.02 | 0.02 | 0.03 | 0.03 | 0.02 | 0.02 | 0.01 | 0.02 | 0.01 | 0.02 |
(NCT00121641)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | x 10^3 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (BL) (Week 0) (n=102, 106, 98, 94) | Change from BL at Week 2 (n=95, 99, 92, 86) | Change from BL at Week 4 (n=91, 99, 90, 90) | Change from BL at Week 6 (n=89, 95, 87, 82) | Change from BL at Week 8 (n=91, 88, 90, 79) | Change from BL at Week 10 (n=68, 76, 69, 63) | Change from BL at Week 12 (n=83, 88, 87, 82) | Change from BL at Week 14 (n=76, 77, 80, 75) | Change from BL at Week 16 (n=90, 91, 83, 71) | Change from BL at Week 18 (n=78, 75, 82, 71) | Change from BL at Week 20 (n=83, 79, 78, 72) | Change from BL at Week 22 (n=77, 74, 75, 65) | Change from BL at Week 24 (n=83, 81, 78, 74) | Change from BL at Week 30 (n=76, 78, 79, 67) | Change from BL at Week 37 (n=74, 72, 70, 60) | Change from BL at Week 50 (n=67, 69, 71, 61) | Change from BL at Week 63 (n=60, 66, 67, 55) | Change from BL at Week 76 (n=51, 58, 63, 49) | Change from BL at Week 89 (n=48, 58, 56, 42) | Change from BL at Week 102 (n=39, 47, 50, 40) | Change from BL at Week 115 (n=34, 43, 42, 34) | Change from BL at Week 128 (n=30, 40, 40, 29) | Change from BL at Week 141 (n=28, 38, 34, 28) | Change from BL at Week 154 (n=26, 33, 31, 24) | Change from BL at Week 167 (n=24, 33, 30, 25) | Change from BL at Week 180 (n=21, 28, 28, 26) | Change from BL at Week 193 (n=19, 25, 26, 23) | Change from BL at Week 206 (n=17, 22, 23, 21) | |
| Placebo | 0.20 | -0.02 | -0.02 | -0.02 | -0.01 | 0.01 | -0.02 | -0.01 | -0.00 | 0.00 | -0.03 | -0.02 | -0.04 | -0.03 | -0.02 | -0.01 | -0.02 | -0.03 | -0.02 | -0.01 | -0.00 | -0.01 | 0.01 | 0.03 | 0.06 | 0.07 | 0.05 | 0.06 |
| Saxagliptin 10 mg | 0.20 | -0.02 | -0.01 | -0.02 | -0.02 | -0.02 | -0.01 | -0.01 | -0.03 | -0.03 | -0.04 | -0.04 | -0.03 | -0.02 | -0.04 | -0.02 | -0.00 | -0.02 | -0.02 | 0.02 | -0.01 | -0.03 | -0.00 | -0.01 | 0.01 | -0.00 | 0.00 | 0.03 |
| Saxagliptin 2.5 mg | 0.18 | -0.01 | -0.02 | 0.01 | 0.00 | -0.01 | 0.00 | -0.01 | -0.02 | -0.02 | -0.02 | -0.00 | -0.02 | -0.03 | -0.03 | -0.03 | -0.00 | -0.03 | -0.03 | 0.02 | -0.00 | -0.02 | -0.01 | 0.00 | -0.02 | -0.02 | -0.01 | 0.00 |
| Saxagliptin 5 mg | 0.20 | 0.01 | -0.01 | -0.01 | -0.01 | -0.02 | -0.02 | -0.01 | -0.02 | -0.02 | -0.03 | -0.03 | -0.03 | -0.03 | -0.01 | -0.01 | 0.00 | -0.04 | -0.02 | 0.01 | 0.07 | 0.02 | -0.00 | -0.00 | -0.02 | -0.01 | -0.01 | -0.00 |
(NCT00121641)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | x 10^3 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (BL) (Week 0) (n=102, 106, 98, 94) | Change from BL at Week 2 (n=95, 99, 92, 86) | Change from BL at Week 4 (n=91, 99, 90, 90) | Change from BL at Week 6 (n=89, 95, 87, 82) | Change from BL at Week 8 (n=91, 88, 90, 79) | Change from BL at Week 10 (n=68, 76, 69, 63) | Change from BL at Week 12 (n=83, 88, 87, 82) | Change from BL at Week 14 (n=76, 77, 80, 75) | Change from BL at Week 16 (n=90, 91, 83, 71) | Change from BL at Week 18 (n=78, 75, 82, 71) | Change from BL at Week 20 (n=83, 79, 78, 72) | Change from BL at Week 22 (n=77, 74, 75, 65) | Change from BL at Week 24 (n=83, 81, 78, 74) | Change from BL at Week 30 (n=76, 78, 79, 67) | Change from BL at Week 37 (n=74, 72, 70, 60) | Change from BL at Week 50 (n=67, 69, 71, 61) | Change from BL at Week 63 (n=60, 66, 67, 55) | Change from BL at Week 76 (n=51, 58, 63, 49) | Change from BL at Week 89 (n=49, 58, 56, 42) | Change from BL at Week 102 (n=39, 48, 51, 40) | Change from BL at Week 115 (n=34, 43, 43, 35) | Change from BL at Week 128 (n=30, 40, 40, 30) | Change from BL at Week 141 (n=28, 38, 34, 28) | Change from BL at Week 154 (n=26, 33, 31, 24) | Change from BL at Week 167 (n=24, 33, 30, 25) | Change from BL at Week 180 (n=21, 28, 28, 26) | Change from BL at Week 193 (n=19, 25, 26, 23) | Change from BL at Week 206 (n=17, 22, 23, 21) | |
| Placebo | 2.22 | -0.13 | -0.04 | -0.09 | -0.00 | 0.05 | -0.02 | 0.06 | 0.01 | 0.08 | -0.11 | 0.09 | -0.01 | -0.03 | -0.08 | -0.03 | -0.16 | -0.20 | -0.23 | -0.16 | -0.10 | -0.06 | 0.00 | -0.14 | -0.16 | -0.05 | 0.01 | -0.08 |
| Saxagliptin 10 mg | 2.14 | -0.11 | -0.18 | -0.23 | -0.20 | -0.10 | -0.16 | -0.01 | -0.11 | 0.01 | -0.10 | -0.07 | -0.13 | -0.09 | -0.17 | -0.25 | -0.19 | -0.18 | -0.19 | -0.23 | -0.21 | -0.16 | -0.10 | -0.23 | -0.11 | -0.06 | -0.04 | -0.05 |
| Saxagliptin 2.5 mg | 2.16 | -0.04 | -0.03 | -0.04 | -0.07 | 0.07 | -0.06 | 0.20 | 0.03 | 0.11 | 0.08 | 0.16 | -0.00 | 0.08 | 0.05 | -0.06 | -0.06 | -0.10 | -0.12 | -0.17 | -0.15 | -0.12 | -0.13 | -0.23 | -0.23 | -0.15 | -0.06 | -0.17 |
| Saxagliptin 5 mg | 2.21 | -0.10 | -0.12 | -0.09 | -0.11 | 0.02 | -0.12 | 0.08 | 0.01 | 0.13 | -0.02 | 0.13 | -0.07 | -0.00 | 0.02 | -0.09 | -0.10 | -0.09 | -0.02 | -0.07 | -0.00 | -0.00 | -0.03 | 0.04 | -0.13 | -0.22 | -0.09 | -0.14 |
(NCT00121641)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | x 10^3 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (BL) (Week 0) (n=102, 106, 98, 94) | Change from BL at Week 2 (n=95, 99, 92, 86) | Change from BL at Week 4 (n=91, 99, 90, 90) | Change from BL at Week 6 (n=89, 95, 87, 82) | Change from BL at Week 8 (n=91, 88, 90, 79) | Change from BL at Week 10 (n=68, 76, 69, 63) | Change from BL at Week 12 (n=83, 88, 87, 82) | Change from BL at Week 14 (n=76, 77, 80, 75) | Change from BL at Week 16 (n=90, 91, 83, 71) | Change from BL at Week 18 (n=78, 75, 82, 71) | Change from BL at Week 20 (n=83, 79, 78, 72) | Change from BL at Week 22 (n=77, 74, 75, 65) | Change from BL at Week 24 (n=83, 81, 78, 74) | Change from BL at Week 30 (n=76, 78, 79, 67) | Change from BL at Week 37 (n=74, 72, 70, 60) | Change from BL at Week 50 (n=67, 69, 71, 61) | Change from BL at Week 63 (n=60, 66, 67, 55) | Change from BL at Week 76 (n=51, 58, 63, 49) | Change from BL at Week 89 (n=48, 58, 56, 42) | Change from BL at Week 102 (n=39, 47, 50, 40) | Change from BL at Week 115 (n=34, 43, 42, 34) | Change from BL at Week 128 (n=30, 40, 40, 29) | Change from BL at Week 141 (n=28, 38, 34, 28) | Change from BL at Week 154 (n=26, 33, 31, 24) | Change from BL at Week 167 (n=24, 33, 30, 25) | Change from BL at Week 180 (n=21, 28, 28, 26) | Change from BL at Week 193 (n=19, 25, 26, 23) | Change from BL at Week 206 (n=17, 22, 23, 21) | |
| Placebo | 0.32 | -0.01 | 0.01 | 0.02 | -0.02 | 0.03 | 0.01 | 0.04 | 0.01 | 0.04 | 0.01 | 0.05 | 0.03 | 0.03 | 0.00 | 0.06 | 0.07 | 0.05 | 0.05 | 0.07 | 0.13 | 0.07 | 0.10 | 0.08 | 0.11 | 0.11 | 0.13 | 0.09 |
| Saxagliptin 10 mg | 0.32 | -0.05 | -0.01 | -0.01 | -0.01 | 0.04 | 0.00 | 0.03 | 0.04 | 0.06 | 0.04 | 0.06 | 0.03 | 0.04 | 0.04 | 0.05 | 0.07 | 0.06 | 0.08 | 0.09 | 0.06 | 0.07 | 0.10 | 0.06 | 0.10 | 0.11 | 0.11 | 0.13 |
| Saxagliptin 2.5 mg | 0.31 | 0.01 | 0.05 | 0.05 | 0.03 | 0.08 | 0.05 | 0.09 | 0.06 | 0.06 | 0.04 | 0.08 | 0.04 | 0.05 | 0.06 | 0.07 | 0.08 | 0.12 | 0.11 | 0.14 | 0.12 | 0.12 | 0.08 | 0.10 | 0.07 | 0.08 | 0.09 | 0.05 |
| Saxagliptin 5 mg | 0.34 | 0.01 | 0.00 | -0.01 | 0.03 | 0.04 | 0.00 | 0.06 | 0.04 | 0.05 | 0.02 | 0.05 | 0.01 | 0.03 | 0.02 | 0.03 | 0.05 | 0.04 | 0.03 | 0.04 | 0.05 | 0.04 | 0.02 | 0.05 | 0.04 | 0.04 | 0.04 | 0.05 |
(NCT00121641)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | x 10^3 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (BL) (Week 0) (n=102, 106, 98, 94) | Change from BL at Week 2 (n=95, 99, 92, 86) | Change from BL at Week 4 (n=91, 99, 90, 90) | Change from BL at Week 6 (n=89, 95, 87, 82) | Change from BL at Week 8 (n=91, 88, 90, 79) | Change from BL at Week 10 (n=68, 76, 69, 63) | Change from BL at Week 12 (n=83, 88, 87, 82) | Change from BL at Week 14 (n=76, 77, 80, 75) | Change from BL at Week 16 (n=90, 91, 83, 71) | Change from BL at Week 18 (n=78, 75, 82, 71) | Change from BL at Week 20 (n=83, 79, 78, 72) | Change from BL at Week 22 (n=77, 74, 75, 65) | Change from BL at Week 24 (n=83, 81, 78, 74) | Change from BL at Week 30 (n=76, 78, 79, 67) | Change from BL at Week 37 (n=74, 72, 70, 60) | Change from BL at Week 50 (n=67, 69, 71, 61) | Change from BL at Week 63 (n=60, 66, 67, 55) | Change from BL at Week 76 (n=51, 58, 63, 49) | Change from BL at Week 89 (n=48, 58, 56, 42) | Change from BL at Week 102 (n=39, 47, 50, 40) | Change from BL at Week 115 (n=34, 43, 42, 34) | Change from BL at Week 128 (n=30, 40, 40, 29) | Change from BL at Week 141 (n=28, 38, 34, 28) | Change from BL at Week 154 (n=26, 33, 31, 24) | Change from BL at Week 167 (n=24, 33, 30, 25) | Change from BL at Week 180 (n=21, 28, 28, 26) | Change from BL at Week 193 (n=19, 25, 26, 23) | Change from BL at Week 206 (n=17, 22, 23, 21) | |
| Placebo | 4.01 | -0.07 | 0.23 | 0.17 | 0.19 | 0.45 | 0.30 | 0.46 | 0.18 | 0.21 | 0.15 | 0.32 | -0.03 | 0.00 | 0.20 | 0.27 | 0.16 | -0.01 | 0.01 | 0.01 | 0.42 | 0.22 | 0.40 | 0.41 | 0.33 | 0.51 | -0.01 | 0.31 |
| Saxagliptin 10 mg | 4.16 | 0.00 | 0.05 | 0.04 | 0.03 | 0.17 | 0.18 | 0.17 | 0.16 | 0.32 | 0.07 | 0.44 | 0.16 | 0.32 | 0.24 | 0.19 | 0.08 | 0.08 | 0.05 | 0.24 | 0.29 | 0.56 | 0.45 | 0.47 | 0.27 | 0.55 | 0.51 | 0.90 |
| Saxagliptin 2.5 mg | 4.00 | -0.06 | 0.09 | 0.01 | 0.02 | 0.18 | 0.01 | 0.07 | 0.17 | 0.23 | 0.19 | 0.44 | 0.09 | 0.04 | 0.13 | 0.03 | 0.11 | 0.05 | 0.58 | 0.19 | 0.28 | 0.61 | 0.41 | 0.25 | -0.04 | 0.23 | 0.34 | 0.15 |
| Saxagliptin 5 mg | 3.98 | 0.11 | 0.16 | 0.19 | 0.27 | 0.48 | 0.21 | 0.64 | 0.49 | 0.67 | 0.32 | 0.58 | 0.57 | 0.29 | 0.42 | 0.40 | 0.25 | 0.33 | 0.18 | 0.43 | 0.81 | 0.59 | 0.80 | 0.39 | 0.56 | 0.50 | 0.08 | 0.63 |
(NCT00121641)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | percentage red blood cells (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (BL) (Week 0) (n=102, 106, 98, 94) | Change from BL at Week 2 (n=95,100, 93, 87) | Change from BL at Week 4 (n=92, 99, 91, 91) | Change from BL at Week 6 (n=91, 96, 87, 82) | Change from BL at Week 8 (n=92, 90, 91, 79) | Change from BL at Week 10 (n=70, 76, 69, 63) | Change from BL at Week 12 (n=85, 88, 87, 82) | Change from BL at Week 14 (n=76, 80, 81, 75) | Change from BL at Week 16 (n=90. 91, 83, 71) | Change from BL at Week 18 (n=78, 75, 82, 71) | Change from BL at Week 20 (n=83, 80, 78, 72) | Change from BL at Week 22 (n=78, 74, 76, 65) | Change from BL at Week 24 (n=83, 82, 78, 74) | Change from BL at Week 30 (n=77, 78, 79, 67) | Change from BL at Week 37 (n=75, 73, 70, 62) | Change from BL at Week 50 (n=67, 71, 71, 61) | Change from BL at Week 63 (n=61, 66, 67, 55) | Change from BL at Week 76 (n=51, 59, 63, 49) | Change from BL at Week 89 (n=49, 58, 56, 42) | Change from BL at Week 102 (n=40, 49, 51, 40) | Change from BL at Week 115 (n=34, 43, 43, 35) | Change from BL at Week 128 (n=30, 40, 40, 30) | Change from BL at Week 141 (n=28, 39, 34, 28) | Change from BL at Week 154 (n=26, 34, 31, 24) | Change from BL at Week 167 (n=24, 33, 30, 26) | Change from BL at Week 180 (n=21, 28, 28, 26) | Change from BL at Week 193 (n=19, 26, 26, 23) | Change from BL at Week 206 (n=17, 22, 24, 21) | |
| Placebo | 42.8 | -0.4 | 0.3 | 0.3 | 0.5 | 0.5 | 0.7 | 0.2 | 0.3 | 0.4 | 0.2 | 0.5 | 0.5 | 0.4 | -0.4 | 0.2 | 0.7 | 0.8 | 0.4 | -0.7 | 0.2 | -0.1 | -0.2 | -0.3 | -0.4 | -0.5 | -0.0 | -0.5 |
| Saxagliptin 10 mg | 42.7 | -0.7 | -0.1 | 0.0 | 0.2 | -0.2 | 0.6 | 0.2 | 0.6 | 0.3 | 0.1 | -0.3 | -0.1 | 0.2 | 0.4 | 0.1 | 0.6 | 0.7 | 1.2 | -0.0 | 0.2 | 0.0 | 0.2 | -1.0 | 0.2 | 1.0 | 0.5 | 0.2 |
| Saxagliptin 2.5 mg | 42.5 | -0.4 | -0.2 | 0.1 | 0.5 | 0.6 | 0.6 | 0.6 | 0.5 | 0.2 | 0.7 | 0.3 | 0.0 | 0.5 | 0.0 | 0.1 | 0.3 | 0.7 | 0.9 | -0.2 | -0.0 | 0.2 | -0.1 | -0.8 | -0.1 | 1.1 | 0.6 | -0.4 |
| Saxagliptin 5 mg | 42.8 | -0.2 | -0.2 | 0.3 | 0.4 | -0.0 | 0.4 | 0.6 | 0.7 | 0.4 | 0.4 | 0.2 | 0.2 | -0.1 | -0.1 | 0.3 | 0.1 | 0.5 | 0.9 | 0.5 | 0.6 | 0.3 | -0.1 | -0.8 | 0.2 | 0.6 | 1.1 | 0.2 |
(NCT00121641)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | g/dL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (BL) (Week 0) (n=102, 106, 98, 94) | Change from BL at Week 2 (n=95,100, 93, 87) | Change from BL at Week 4 (n=92, 99, 91, 91) | Change from BL at Week 6 (n=91, 96, 87, 82) | Change from BL at Week 8 (n=92, 90, 91, 79) | Change from BL at Week 10 (n=70, 76, 69, 63) | Change from BL at Week 12 (n=85, 88, 87, 82) | Change from BL at Week 14 (n=76, 80, 81, 75) | Change from BL at Week 16 (n=90, 91, 83, 71) | Change from BL at Week 18 (n=78, 75, 82, 71) | Change from BL at Week 20 (n=83, 80, 78, 72) | Change from BL at Week 22 (n=78, 74, 76, 65) | Change from BL at Week 24 (n=83, 82, 78, 74) | Change from BL at Week 30 (n=77, 78, 79, 67) | Change from BL at Week 37 (n=75, 73, 70, 62) | Change from BL at Week 50 (n=67, 71, 71, 61) | Change from BL at Week 63 (n=61, 66, 67, 55) | Change from BL at Week 76 (n=51, 59, 63, 49) | Change from BL at Week 89 (n=49, 58, 56, 42) | Change from BL at Week 102 (n=40, 49, 51, 40) | Change from BL at Week 115 (n=34, 43, 43, 35) | Change from BL at Week 128 (n=30, 40, 40, 30) | Change from BL at Week 141 (n=28, 39, 34, 28) | Change from BL at Week 154 (n=26, 34, 31, 24) | Change from BL at Week 167 (n=24, 33, 30, 26) | Change from BL at Week 180 (n=21, 28, 28, 26) | Change from BL at Week 193 (n=19, 26, 26, 23) | Change from BL at Week 206 (n=17, 22, 24, 21) | |
| Placebo | 14.50 | -0.09 | 0.10 | 0.04 | 0.09 | 0.04 | 0.16 | -0.03 | 0.04 | -0.03 | -0.19 | -0.18 | -0.14 | -0.18 | -0.33 | -0.01 | 0.08 | -0.10 | -0.10 | -0.29 | -0.19 | -0.33 | -0.36 | -0.25 | -0.24 | -0.61 | -0.39 | -0.32 |
| Saxagliptin 10 mg | 14.47 | -0.22 | -0.09 | -0.07 | -0.02 | -0.13 | -0.07 | -0.12 | 0.00 | -0.07 | -0.25 | -0.36 | -0.32 | -0.19 | -0.06 | -0.02 | 0.07 | -0.07 | -0.04 | -0.07 | -0.18 | -0.25 | -0.15 | -0.24 | -0.03 | -0.08 | -0.16 | 0.10 |
| Saxagliptin 2.5 mg | 14.49 | -0.21 | -0.16 | -0.12 | -0.00 | 0.01 | -0.04 | -0.09 | -0.10 | -0.26 | -0.16 | -0.35 | -0.37 | -0.25 | -0.31 | -0.17 | -0.18 | -0.27 | -0.18 | -0.32 | -0.41 | -0.38 | -0.40 | -0.45 | -0.51 | -0.38 | -0.45 | -0.51 |
| Saxagliptin 5 mg | 14.45 | -0.13 | -0.15 | -0.00 | 0.04 | -0.20 | -0.07 | -0.05 | 0.01 | -0.10 | -0.14 | -0.23 | -0.25 | -0.29 | -0.22 | 0.06 | -0.11 | -0.19 | -0.09 | -0.00 | -0.07 | -0.17 | -0.35 | -0.37 | -0.05 | -0.08 | -0.03 | -0.07 |
(NCT00121641)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | x 10^9 c/L (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (BL) (Week 0) (n=101, 106, 96, 94) | Change from BL at Week 2 (n=92, 96, 85, 82) | Change from BL at Week 4 (n=88, 97, 90, 90) | Change from BL at Week 6 (n=88, 93, 84, 81) | Change from BL at Week 8 (n=86, 85, 86, 77) | Change from BL at Week 10 (n=68, 75, 67, 62) | Change from BL at Week 12 (n=83, 84, 85, 82) | Change from BL at Week 14 (n=72, 79, 77, 74) | Change from BL at Week 16 (n=86, 88, 81, 69) | Change from BL at Week 18 (n=77, 71, 79, 70) | Change from BL at Week 20 (n=78, 78, 72, 70) | Change from BL at Week 22 (n=74, 72, 73, 62) | Change from BL at Week 24 (n=80, 76, 73, 72) | Change from BL at Week 30 (n=73, 74, 74, 67) | Change from BL at Week 37 (n=70, 68, 66, 59) | Change from BL at Week 50 (n=66, 67, 66, 59) | Change from BL at Week 63 (n=59, 64, 65, 54) | Change from BL at Week 76 (n=50, 58, 61, 49) | Change from BL at Week 89 (n=47, 56, 54, 42) | Change from BL at Week 102 (n=39, 47, 49, 39) | Change from BL at Week 115 (n=33, 41, 41, 34) | Change from BL at Week 128 (n=30, 38, 39, 30) | Change from BL at Week 141 (n=27, 39, 33, 27) | Change from BL at Week 154 (n=25, 35, 31, 23) | Change from BL at Week 167 (n=22, 32, 28, 26) | Change from BL at Week 180 (n=20, 27, 27, 25) | Change from BL at Week 193 (n=17, 25, 25, 22) | Change from BL at Week 206 (n=15, 21, 23, 21) | |
| Placebo | 259.8 | 9.5 | 11.3 | 9.5 | 4.0 | 7.1 | 4.0 | 5.2 | 3.2 | 5.8 | -1.3 | 5.0 | -3.0 | 4.5 | 0.1 | 6.6 | 10.2 | 1.2 | 2.7 | 9.7 | 9.2 | 2.6 | -1.3 | 8.8 | 4.3 | 4.0 | -12.0 | -6.1 |
| Saxagliptin 10 mg | 261.6 | 2.2 | 5.6 | -0.2 | -4.3 | -4.4 | -4.8 | -3.7 | -6.0 | -2.7 | -8.3 | -5.4 | -15.5 | -9.9 | -15.6 | -11.5 | -6.3 | -6.0 | -6.7 | -4.8 | -12.0 | -2.6 | -0.3 | -2.9 | -14.6 | -17.3 | -13.4 | 6.2 |
| Saxagliptin 2.5 mg | 251.1 | 1.8 | 11.2 | 4.3 | 0.4 | -0.8 | -6.3 | 1.2 | -2.3 | -1.1 | -1.9 | 0.3 | -7.1 | -2.0 | -14.3 | -2.5 | -3.1 | -2.0 | 3.5 | 3.2 | 5.0 | 3.8 | -1.1 | 5.0 | -18.0 | -11.1 | -13.6 | -2.6 |
| Saxagliptin 5 mg | 253.1 | 4.4 | 8.6 | 4.3 | 1.0 | 3.0 | -1.3 | 3.2 | 1.1 | 2.0 | -4.8 | -2.5 | -6.0 | -3.3 | -8.1 | -5.6 | -3.4 | -1.5 | 1.9 | -2.3 | -8.8 | -2.1 | -4.6 | 5.8 | -0.1 | -24.0 | -13.4 | -18.7 |
(NCT00121641)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | x 10^6 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (BL) (Week 0) (n=102, 106, 98, 94) | Change from BL at Week 2 (n=95,100, 93, 87 | Change from BL at Week 4 (n=92, 99, 91, 91) | Change from BL at Week 6 (n=91, 96, 87, 82) | Change from BL at Week 8 (n=92, 90, 91, 79) | Change from BL at Week 10 (n=70, 76, 69, 63) | Change from BL at Week 12 (n=85, 88, 87, 82) | Change from BL at Week 14 (n=76, 80, 81, 75) | Change from BL at Week 16 (n=90, 91, 83, 71) | Change from BL at Week 18 (n=78, 75, 82, 71) | Change from BL at Week 20 (n=83, 80, 78, 72) | Change from BL at Week 22 (n=78, 74, 76, 65) | Change from BL at Week 24 (n=83, 82, 78, 74) | Change from BL at Week 30 (n=77, 78, 79, 67) | Change from BL at Week 37 (n=75, 73, 70, 62) | Change from BL at Week 50 (n=67, 71, 71, 61) | Change from BL at Week 63 (n=61, 66, 67, 55) | Change from BL at Week 76 (n=51, 59, 63, 49) | Change from BL at Week 89 (n=49, 58, 56, 42) | Change from BL at Week 102 (n=40, 49, 51, 40) | Change from BL at Week 115 (n=34, 43, 43, 35) | Change from BL at Week 128 (n=30, 40, 40, 30) | Change from BL at Week 141 (n=28, 39, 34, 28) | Change from BL at Week 154 (n=26, 35, 31, 24) | Change from BL at Week 167 (n=24, 33, 30, 26) | Change from BL at Week 180 (n=21, 28, 28, 26) | Change from BL at Week 193 (n=19, 26, 26, 23) | Change from BL at Week 206 (n=17, 22, 24, 21) | |
| Placebo | 4.82 | -0.05 | 0.04 | 0.02 | 0.05 | 0.07 | 0.08 | 0.04 | 0.06 | 0.04 | -0.01 | -0.01 | -0.01 | -0.03 | -0.09 | 0.01 | 0.05 | -0.03 | -0.07 | -0.13 | -0.06 | -0.10 | -0.11 | -0.09 | -0.10 | -0.17 | -0.10 | -0.08 |
| Saxagliptin 10 mg | 4.82 | -0.08 | -0.02 | 0.00 | 0.03 | -0.02 | 0.07 | 0.04 | 0.08 | 0.05 | 0.01 | -0.05 | -0.03 | -0.01 | 0.04 | 0.02 | 0.08 | 0.00 | -0.01 | -0.03 | -0.02 | -0.04 | -0.02 | -0.08 | -0.01 | -0.01 | -0.02 | 0.06 |
| Saxagliptin 2.5 mg | 4.80 | -0.06 | -0.01 | 0.00 | 0.05 | 0.05 | 0.05 | 0.05 | 0.06 | 0.01 | 0.03 | -0.01 | -0.04 | 0.00 | -0.04 | -0.02 | 0.00 | -0.07 | -0.04 | -0.10 | -0.04 | -0.05 | -0.10 | -0.13 | -0.11 | -0.05 | -0.05 | -0.03 |
| Saxagliptin 5 mg | 4.80 | -0.04 | -0.04 | 0.02 | 0.03 | -0.03 | 0.03 | 0.03 | 0.08 | 0.04 | 0.02 | -0.01 | -0.04 | -0.07 | -0.04 | 0.04 | -0.01 | -0.07 | -0.06 | -0.03 | -0.01 | -0.07 | -0.13 | -0.13 | -0.04 | -0.08 | -0.06 | -0.06 |
(NCT00121641)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | x 10^3 c/µL (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (BL) (Week 0) (n=102, 106, 98, 94) | Change from BL at Week 2 (n=95, 99, 92, 86) | Change from BL at Week 4 (n=92, 99, 90, 90) | Change from BL at Week 6 (n=89, 95, 87, 82) | Change from BL at Week 8 (n=91, 89, 90, 79) | Change from BL at Week 10 (n=68, 76, 69, 63) | Change from BL at Week 12 (n=83, 88, 87, 82) | Change from BL at Week 14 (n=76, 78, 80, 75) | Change from BL at Week 16 (n=90, 91, 83, 71) | Change from BL at Week 18 (n=78, 75, 82, 71) | Change from BL at Week 20 (n=83, 79, 78, 72) | Change from BL at Week 22 (n=77, 74, 76, 65) | Change from BL at Week 24 (n=83, 82, 78, 74) | Change from BL at Week 30 (n=77, 78, 79, 67) | Change from BL at Week 37 (n=74, 73, 70, 62) | Change from BL at Week 50 (n=67, 69, 71, 61) | Change from BL at Week 63 (n=60, 66, 67, 55) | Change from BL at Week 76 (n=51, 58, 63, 49) | Change from BL at Week 89 (n=48, 58, 56, 42) | Change from BL at Week 102 (n=39, 47, 51, 40) | Change from BL at Week 115 (n=34, 43, 42, 34) | Change from BL at Week 128 (n=30, 40, 40, 29) | Change from BL at Week 141 (n=28, 39, 34, 28) | Change from BL at Week 154 (n=26, 34, 31, 24) | Change from BL at Week 167 (n=24, 33, 30, 25) | Change from BL at Week 180 (n=21, 28, 28, 26) | Change from BL at Week 193 (n=19, 26, 26, 23) | Change from BL at Week 206 (n=17, 22, 23, 21) | |
| Placebo | 6.79 | -0.23 | 0.17 | 0.09 | 0.16 | 0.53 | 0.26 | 0.56 | 0.19 | 0.32 | 0.02 | 0.45 | -0.06 | -0.03 | 0.14 | 0.29 | 0.06 | -0.20 | -0.18 | -0.09 | 0.44 | 0.22 | 0.51 | 0.38 | 0.35 | 0.65 | 0.19 | 0.38 |
| Saxagliptin 10 mg | 6.82 | -0.14 | -0.16 | -0.18 | -0.17 | 0.12 | 0.05 | 0.22 | 0.04 | 0.42 | 0.01 | 0.44 | 0.08 | 0.28 | 0.12 | -0.03 | -0.04 | -0.07 | -0.10 | 0.10 | 0.11 | 0.44 | 0.44 | 0.30 | 0.27 | 0.59 | 0.60 | 1.01 |
| Saxagliptin 2.5 mg | 6.71 | -0.11 | 0.06 | 0.01 | -0.02 | 0.32 | -0.00 | 0.33 | 0.24 | 0.37 | 0.29 | 0.66 | 0.10 | 0.15 | 0.21 | 0.01 | 0.12 | 0.03 | 0.51 | 0.16 | 0.24 | 0.58 | 0.35 | 0.12 | -0.22 | 0.13 | 0.34 | 0.01 |
| Saxagliptin 5 mg | 6.75 | 0.05 | 0.05 | 0.10 | 0.18 | 0.55 | 0.09 | 0.71 | 0.54 | 0.82 | 0.29 | 0.72 | 0.47 | 0.33 | 0.42 | 0.33 | 0.20 | 0.23 | 0.17 | 0.44 | 0.93 | 0.66 | 0.78 | 0.44 | 0.44 | 0.30 | 0.02 | 0.55 |
This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report. (NCT00121641)
Timeframe: Baseline
| Intervention | participants (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age <65 years | Age >=65 years | Age >=75 years | Gender, Male | Gender, Female | Age =<50 years, females only | Age >50 years, females only | Race, White | Race, Black/African American | Race, Asian | Race, Other | Ethnicity, Hispanic/Latino | Ethnicity, Not Hispanic/Latino | Ethnicity, Not Reported | Body Mass Index <30% | Body Mass Index >=30% | |
| Open-Label Treatment Cohort (Direct Enrollees) | 64 | 2 | 0 | 32 | 34 | 19 | 15 | 61 | 3 | 1 | 1 | 13 | 37 | 16 | 22 | 44 |
(NCT00121641)
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | mmHg (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change from BL at Week 2 (n=96, 100, 94, 89) | Change from BL at Week 4 (n=96, 100, 92, 91) | Change from BL at Week 6 (n=91, 98, 88, 84) | Change from BL at Week 8 (n=94, 91, 91, 80) | Change from BL at Week 10 (n=51, 66, 51, 50) | Change from BL at Week 12 (n=82, 83, 87, 79) | Change from BL at Week 14 (n=65, 72, 66, 62) | Change from BL at Week 16 (n=87, 87, 81, 72) | Change from BL at Week 18 (n=73, 69, 76, 66) | Change from BL at Week 20 (n=84, 80, 76, 73) | Change from BL at Week 22 (n=78, 73, 76, 64) | Change from BL at Week 24 (n=84, 83, 77, 75) | Change from BL at Week 30 (n=79, 78, 79, 66) | Change from BL at Week 37 (n=77, 74, 71, 66) | Change from BL at Week 50 (n=70, 73, 73, 62) | Change from BL at Week 63 (n=61, 66, 69, 56) | Change from BL at Week 76 (n=53, 59, 64, 50) | Change from BL at Week 89 (n=49, 58, 56, 44) | Change from BL at Week 102 (n=42, 51, 51, 42) | Change from BL at Week 115 (n=34, 43, 43, 37) | Change from BL at Week 128 (n=31, 40, 41, 31) | Change from BL at Week 141 (n=29, 40, 35, 29) | Change from BL at Week 154 (n=27, 36, 33, 27) | Change from BL at Week 167 (n=24, 33, 30, 27) | Change from BL at Week 180 (n=21, 28, 28, 27) | Change from BL at Week 193 (n=19, 26, 27, 24) | Change from BL at Week 206 (n=17, 24, 24, 23) | |
| Placebo | -1.5 | -1.8 | -1.9 | -2.4 | -3.4 | -1.8 | -2.7 | -2.1 | -2.1 | -2.2 | -1.7 | -3.4 | -2.8 | -2.0 | -0.6 | -0.5 | -0.3 | -0.1 | -1.2 | -1.0 | 1.0 | 1.3 | 1.3 | -1.1 | -0.8 | -0.2 | -0.2 |
| Saxagliptin 10 mg | -0.5 | 0.3 | -0.8 | -0.7 | -1.3 | -0.7 | -2.4 | -0.1 | -1.9 | -1.9 | -2.5 | -2.3 | -0.3 | -0.6 | -0.3 | -0.0 | 0.1 | -1.6 | -0.4 | -1.1 | 1.1 | 1.1 | 2.5 | 2.4 | 0.5 | 0.5 | 1.9 |
| Saxagliptin 2.5 mg | -0.0 | -1.4 | -1.5 | -1.4 | -0.8 | -1.3 | -2.5 | -1.5 | -2.3 | -2.2 | -3.0 | -1.5 | -1.4 | -0.4 | -1.7 | -0.1 | -1.6 | 0.4 | -1.1 | -0.9 | -1.8 | 0.9 | 1.2 | 0.8 | 1.4 | 0.8 | 0.3 |
| Saxagliptin 5 mg | -1.2 | -1.1 | -0.9 | -0.9 | -1.1 | -2.0 | -2.4 | -0.5 | -1.6 | -1.8 | -2.0 | -1.7 | -2.2 | -1.7 | 0.3 | -0.4 | -2.0 | -2.1 | -2.0 | -2.7 | -3.7 | -2.0 | -0.8 | 0.3 | -2.0 | -1.6 | -0.6 |
(NCT00121641)
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167
| Intervention | mmHg (Mean) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change from BL at Week 2 (n=62) | Change from BL at Week 4 (n=59) | Change from BL at Week 6 (n=60) | Change from BL at Week 8 (n=49) | Change from BL at Week 10 (n=24) | Change from BL at Week 12 (n=47) | Change from BL at Week 14 (n=35) | Change from BL at Week 16 (n=46) | Change from BL at Week 18 (n=42) | Change from BL at Week 20 (n=45) | Change from BL at Week 22 (n=44) | Change from BL at Week 24 (n=44) | Change from BL at Week 30 (n=40) | Change from BL at Week 37 (n=35) | Change from BL at Week 50 (n=36) | Change from BL at Week 63 (n=26) | Change from BL at Week 76 (n=24) | Change from BL at Week 89 (n=23) | Change from BL at Week 102 (n=15) | Change from BL at Week 115 (n=13) | Change from BL at Week 128 (n=11) | Change from BL at Week 141 (n=10) | Change from BL at Week 154 (n=10) | Change from BL at Week 167 (n=10) | |
| Open-Label Treatment Cohort (Direct Enrollees) | -3.7 | -1.7 | -2.8 | -2.0 | -1.0 | -3.7 | -4.5 | -2.8 | -3.3 | -2.1 | -2.8 | -3.4 | -3.8 | -2.0 | -1.3 | -0.9 | -1.0 | -2.6 | 1.0 | -4.1 | -3.7 | -6.0 | -0.5 | -2.5 |
(NCT00121641)
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | beats per minute (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change from BL at Week 2 (n=96, 100, 94, 89) | Change from BL at Week 4 (n=96, 100, 92, 91) | Change from BL at Week 6 (n=91, 98, 88, 84) | Change from BL at Week 8 (n=94, 91, 91, 80) | Change from BL at Week 10 (n=51, 66, 51, 49) | Change from BL at Week 12 (n=82, 83, 87, 79) | Change from BL at Week 14 (n=65, 72, 65, 62) | Change from BL at Week 16 (n=87, 87, 81, 72) | Change from BL at Week 18 (n=73, 69, 76, 66) | Change from BL at Week 20 (n=84, 80, 76, 73) | Change from BL at Week 22 (n=78, 73, 76, 64) | Change from BL at Week 24 (n=84, 83, 77, 75) | Change from BL at Week 30 (n=79, 78, 79, 66) | Change from BL at Week 37 (n=77, 74, 71, 66) | Change from BL at Week 50 (n=70, 73, 73, 62) | Change from BL at Week 63 (n=62, 66, 69, 56) | Change from BL at Week 76 (n=53, 59, 64, 50) | Change from BL at Week 89 (n=49, 58, 56, 44) | Change from BL at Week 102 (n=42, 51, 51, 42) | Change from BL at Week 115 (n=34, 43, 43, 37) | Change from BL at Week 128 (n=31, 40, 41, 31) | Change from BL at Week 141 (n=29, 40, 35, 29) | Change from BL at Week 154 (n=27, 36, 33, 27) | Change from BL at Week 167 (n=24, 33, 30, 27) | Change from BL at Week 180 (n=21, 28, 28, 27) | Change from BL at Week 193 (n=19, 26, 27, 24) | Change from BL at Week 206 (n=17, 24, 24, 23) | |
| Placebo | 0.3 | -0.1 | 1.4 | -0.2 | 0.1 | 0.8 | 1.9 | -0.1 | 2.6 | 0.8 | 1.5 | -0.4 | -1.2 | -0.9 | -0.2 | 0.6 | 0.2 | -0.3 | -0.0 | 0.8 | 1.7 | 0.9 | -0.6 | 0.5 | -1.2 | 1.1 | -0.8 |
| Saxagliptin 10 mg | 0.2 | 0.7 | -0.6 | 0.2 | -1.0 | 0.5 | 0.6 | -0.1 | 1.5 | 1.3 | 0.9 | -0.7 | -0.7 | 0.5 | -0.2 | 0.9 | 0.4 | -0.9 | -0.1 | 1.0 | -0.7 | -0.6 | -1.3 | -2.1 | -2.0 | -2.4 | 0.0 |
| Saxagliptin 2.5 mg | -0.1 | 0.2 | -1.5 | -0.5 | -0.2 | 0.3 | 0.1 | -0.8 | -0.0 | 1.3 | 0.1 | -0.3 | -0.1 | -0.4 | -0.1 | -0.4 | -0.3 | -0.5 | -2.8 | -3.2 | -2.1 | -2.8 | -2.0 | -5.1 | -3.1 | -4.6 | -5.3 |
| Saxagliptin 5 mg | -0.5 | -1.1 | -0.6 | -0.9 | -1.5 | -1.2 | -0.5 | -1.5 | -0.8 | -1.5 | -0.3 | 0.1 | -1.2 | -1.4 | -0.7 | -2.5 | -3.3 | -1.5 | -1.5 | -2.3 | -4.5 | -3.5 | -2.6 | -0.8 | -5.3 | -4.2 | -2.6 |
(NCT00121641)
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167
| Intervention | beats per minute (Mean) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change from BL at Week 2 (n=62) | Change from BL at Week 4 (n=59) | Change from BL at Week 6 (n=60) | Change from BL at Week 8 (n=49) | Change from BL at Week 10 (n=23) | Change from BL at Week 12 (n=47) | Change from BL at Week 14 (n=34) | Change from BL at Week 16 (n=46) | Change from BL at Week 18 (n=42) | Change from BL at Week 20 (n=45) | Change from BL at Week 22 (n=43) | Change from BL at Week 24 (n=44) | Change from BL at Week 30 (n=40) | Change from BL at Week 37 (n=35) | Change from BL at Week 50 (n=36) | Change from BL at Week 63 (n=26) | Change from BL at Week 76 (n=24) | Change from BL at Week 89 (n=23) | Change from BL at Week 102 (n=15) | Change from BL at Week 115 (n=13) | Change from BL at Week 128 (n=11) | Change from BL at Week 141 (n=10) | Change from BL at Week 154 (n=10) | Change from BL at Week 167 (n=10) | |
| Open-Label Treatment Cohort (Direct Enrollees) | -0.8 | -0.4 | -0.3 | -0.7 | -1.8 | -3.0 | -2.0 | -0.7 | -2.0 | 1.6 | -0.4 | -0.4 | 0.6 | -1.6 | -2.9 | -3.0 | -0.4 | -1.3 | -0.3 | 1.7 | -1.6 | -3.4 | -1.5 | -1.9 |
(NCT00121641)
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
| Intervention | mmHg (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change from BL at Week 2 (n=96, 100, 94, 89) | Change from BL at Week 4 (n=96, 100, 92, 91) | Change from BL at Week 6 (n=91, 98, 88, 84) | Change from BL at Week 8 (n=94, 91, 91, 80) | Change from BL at Week 10 (n=51, 66, 51, 50) | Change from BL at Week 12 (n=82, 83, 87, 79) | Change from BL at Week 14 (n=65, 72, 66, 62) | Change from BL at Week 16 (n=87, 87, 81, 72) | Change from BL at Week 18 (n=73, 69, 76, 66) | Change from BL at Week 20 (n=84, 80, 76, 73) | Change from BL at Week 22 (n=78, 73, 76, 64) | Change from BL at Week 24 (n=84, 83, 77, 75) | Change from BL at Week 30 (n=79, 78, 79, 66) | Change from BL at Week 37 (n=77, 74, 71, 66) | Change from BL at Week 50 (n=70, 73, 73, 62) | Change from BL at Week 63 (n=62, 66, 69, 56) | Change from BL at Week 76 (n=53, 59, 64, 50) | Change from BL at Week 89 (n=49, 58, 56, 44) | Change from BL at Week 102 (n=42, 47, 50, 40) | Change from BL at Week 115 (n=34, 43, 43, 37) | Change from BL at Week 128 (n=31, 40, 41, 31) | Change from BL at Week 141 (n=29, 40, 35, 29) | Change from BL at Week 154 (n=27, 36, 33, 27) | Change from BL at Week 167 (n=24, 33, 30, 27) | Change from BL at Week 180 (n=21, 28, 28, 27) | Change from BL at Week 193 (n=19, 26, 27, 24) | Change from BL at Week 206 (n=17, 24, 24, 23) | |
| Placebo | -3.1 | -4.3 | -4.5 | -5.5 | -6.1 | -3.2 | -1.9 | -2.1 | -4.7 | -4.9 | -3.9 | -6.3 | -5.4 | -3.6 | -0.4 | -2.4 | -0.9 | -2.2 | -1.0 | 0.9 | 1.1 | -1.4 | 2.3 | -0.6 | -0.8 | -2.6 | 0.7 |
| Saxagliptin 10 mg | -2.3 | -2.3 | -3.5 | -4.0 | -5.0 | -2.8 | -6.0 | -3.8 | -4.3 | -3.3 | -5.9 | -6.2 | -3.9 | -5.2 | -3.3 | -1.1 | -3.1 | -5.4 | -2.9 | -1.6 | 0.0 | 0.3 | 3.5 | 4.0 | 0.9 | 0.0 | 2.3 |
| Saxagliptin 2.5 mg | -1.0 | -1.9 | -1.5 | -3.0 | -3.6 | -3.3 | -4.9 | -3.2 | -5.1 | -5.0 | -6.1 | -2.8 | -3.6 | -3.0 | -2.5 | -1.2 | -2.9 | -2.8 | -0.6 | -2.6 | -5.1 | -1.8 | -0.8 | 0.7 | 0.9 | 3.4 | 4.8 |
| Saxagliptin 5 mg | -2.0 | -1.2 | -2.1 | -1.8 | -2.9 | -2.9 | -2.0 | -2.1 | -0.9 | -3.2 | -4.5 | -4.1 | -3.8 | -3.5 | 0.1 | -0.3 | -2.6 | -3.4 | -1.1 | -2.6 | -5.5 | -5.2 | -0.5 | -1.8 | -5.4 | -7.5 | -2.8 |
(NCT00121641)
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167
| Intervention | mmHg (Mean) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change from BL at Week 2 (n=62) | Change from BL at Week 4 (n=59) | Change from BL at Week 6 (n=60) | Change from BL at Week 8 (n=49) | Change from BL at Week 10 (n=24) | Change from BL at Week 12 (n=47) | Change from BL at Week 14 (n=35) | Change from BL at Week 16 (n=46) | Change from BL at Week 18 (n=42) | Change from BL at Week 20 (n=45) | Change from BL at Week 22 (n=44) | Change from BL at Week 24 (n=44) | Change from BL at Week 30 (n=40) | Change from BL at Week 37 (n=35) | Change from BL at Week 50 (n=36) | Change from BL at Week 63 (n=26) | Change from BL at Week 76 (n=24) | Change from BL at Week 89 (n=23) | Change from BL at Week 102 (n=15) | Change from BL at Week 115 (n=13) | Change from BL at Week 128 (n=11) | Change from BL at Week 141 (n=10) | Change from BL at Week 154 (n=10) | Change from BL at Week 167 (n=10) | |
| Open-Label Treatment Cohort (Direct Enrollees) | -4.4 | -3.8 | -2.7 | -5.1 | -4.2 | -4.9 | -5.1 | -1.9 | -5.8 | -3.6 | -4.0 | -4.3 | -4.8 | -4.7 | -1.6 | -0.7 | -1.9 | -4.0 | 0.9 | -6.6 | -5.6 | -7.2 | 5.7 | -2.2 |
The normality/abnormality of the ECG tracing was determined by the investigator. (NCT00121641)
Timeframe: Baseline, Weeks 12, 24, 76, 102, 154, 206
| Intervention | participants (Number) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Normal BL, Normal Week 12 (BL n=65, 66, 67, 47) | Normal BL, Abnormal Week 12 (BL n=65, 66, 67, 47) | Abnormal BL, Normal Week 12 (BL n=27, 32, 26, 43) | Abnormal BL, Abnormal Week 12(BL n=27, 32, 26, 43) | Normal BL, Normal Week 24 (BL n=53, 52, 47, 33) | Normal BL, Abnormal Week 24 (BL n=53, 52, 47, 33) | Abnormal BL, Normal Week 24 (BL n=19, 24, 21, 25) | Abnormal BL, Abnormal Week 24(BL n=19, 24, 21, 25) | Normal BL, Normal Week 76 (BL n=48, 49, 48, 36) | Normal BL, Abnormal Week 76 (BL n=48, 49, 48, 36) | Abnormal BL, Normal Week 76 (BL n=19, 23, 21, 27) | Abnormal BL, Abnormal Week 76(BL n=19, 23, 21, 27) | Normal BL, Normal Week 102 (BL n=32, 32, 36, 22) | Normal BL, Abnormal Week 102 (BL n=32, 32, 36, 22) | Abnormal BL, Normal Week 102 (BL n=12, 18, 17, 20) | Abnormal BL,Abnormal Week 102(BL n=12, 18, 17, 20) | Normal BL, Normal Week 154 (BL n=20, 21, 26, 15) | Normal BL, Abnormal Week 154 (BL n=20, 21, 26, 15) | Abnormal BL, Normal Week 154 (BL n=7, 16, 11, 13) | Abnormal BL, Abnormal Week 154(BL n=7, 16, 11, 13) | Normal BL, Normal Week 206 (BL n=15, 13, 20, 14) | Normal BL, Abnormal Week 206 (BL n=15, 13, 20, 14) | Abnormal BL, Normal Week 206 (BL n=4, 13, 8, 11) | Abnormal BL, Abnormal Week 206 (BL n=4, 13, 8, 11) | |
| Placebo | 43 | 4 | 15 | 28 | 31 | 2 | 8 | 17 | 30 | 6 | 13 | 14 | 18 | 4 | 11 | 9 | 14 | 1 | 7 | 6 | 11 | 3 | 4 | 7 |
| Saxagliptin 10 mg | 59 | 8 | 9 | 17 | 43 | 4 | 9 | 12 | 40 | 8 | 6 | 15 | 31 | 5 | 12 | 5 | 23 | 3 | 5 | 6 | 18 | 2 | 4 | 4 |
| Saxagliptin 2.5 mg | 57 | 8 | 6 | 21 | 43 | 10 | 5 | 14 | 37 | 11 | 8 | 11 | 25 | 7 | 4 | 8 | 16 | 4 | 4 | 3 | 15 | 0 | 2 | 2 |
| Saxagliptin 5 mg | 56 | 10 | 6 | 26 | 44 | 8 | 8 | 16 | 44 | 5 | 8 | 15 | 26 | 6 | 5 | 13 | 17 | 4 | 4 | 12 | 12 | 1 | 3 | 10 |
The normality/abnormality of the ECG tracing was determined by the investigator. (NCT00121641)
Timeframe: Baseline, Weeks 12, 24, 76, 102, 154, 206
| Intervention | participants (Number) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Normal BL, Normal Week 12 (BL n=23) | Normal BL, Abnormal Week 12 (BL n=23) | Abnormal BL, Normal Week 12 (BL n=18) | Abnormal BL, Abnormal Week 12 (BL n=18) | Normal BL, Normal Week 24 (BL n=10) | Normal BL, Abnormal Week 24 (BL n=10) | Abnormal BL, Normal Week 24 (BL n=6) | Abnormal BL, Abnormal Week 24(BL n=6) | Normal BL, Normal Week 76 (BL n=17) | Normal BL, Abnormal Week 76 (BL n=17) | Abnormal BL, Normal Week 76 (BL n=13) | Abnormal BL, Abnormal Week 76 (BL n=13) | Normal BL, Normal Week 102 (BL n=8) | Normal BL, Abnormal Week 102 (BL n=8) | Abnormal BL, Normal Week 102 (BL n=4) | Abnormal BL, Abnormal Week 102 (BL n=4) | Normal BL, Normal Week 154 (BL n=4) | Normal BL, Abnormal Week 154 (BL n=4) | Abnormal BL, Normal Week 154 (BL n=2) | Abnormal BL, Abnormal Week 154 (BL n=2) | Normal BL, Normal Week 206 (BL n=3) | Normal BL, Abnormal Week 206 (BL n=3) | Abnormal BL, Normal Week 206 (BL n=1) | Abnormal BL, Abnormal Week 206 (BL n=1) | |
| Open-Label Treatment Cohort (Direct Enrollees) | 19 | 4 | 5 | 13 | 8 | 2 | 2 | 4 | 13 | 4 | 4 | 9 | 6 | 2 | 1 | 3 | 3 | 1 | 0 | 2 | 2 | 1 | 0 | 1 |
To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%. (NCT00121641)
Timeframe: Baseline, Week 24
| Intervention | Percentage of glycosylated hemoglobins (Mean) | |
|---|---|---|
| Baseline Mean | Adjusted Mean Change from Baseline | |
| Placebo | 7.88 | 0.19 |
| Saxagliptin 10 mg | 7.85 | -0.54 |
| Saxagliptin 2.5 mg | 7.91 | -0.43 |
| Saxagliptin 5 mg | 7.98 | -0.46 |
A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal. (NCT00121641)
Timeframe: Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hemoglobin < 8 g/dL (n=101, 105, 97, 93) | Hematocrit < 0.75 x pre-Rx (n=101, 105, 97, 93) | Platelets < 50 x 10^9 c/L (n=100, 104, 94, 93) | Platelets > 1.5 x ULN (n=100,104, 94, 93) | Leukocytes < 2 x 1000 c/µL (n=101, 105, 97, 93) | Neutrophils+Bands <1x1000 c/µL(n=101, 105, 97, 93) | Eosinophils >0.9x1000 c/µL (n=101, 105, 97, 93) | Lymphocytes <=0.75x1000 c/µL (n=101, 105, 97, 93) | ALP >3 x pre-Rx and >ULN (n=101,105, 97, 94) | ALP >1.5 x ULN (n=101, 105, 97, 94) | AST >3 x ULN (n=101, 105, 97, 94) | AST >5 x ULN (n=101, 105, 97, 94) | AST >10 x ULN (n=101, 105, 97, 94) | AST >20 x ULN (n=101, 105, 97, 94) | ALT >3 x ULN (n=101, 105, 97, 94) | ALT >5 x ULN (n=101, 105, 97, 94) | ALT >10 x ULN (n=101, 105, 97, 94) | ALT >20 x ULN (n=101, 105, 97, 94) | Bilirubin Total >2mg/dL (n=101, 105, 97, 94) | Bilirubin Total >1.5xULN (n=101, 105, 97, 94) | Bilirubin Total >2xULN (n=101, 105, 97, 94) | BUN >2 x pre-Rx and >ULN (n=101, 105, 97, 94) | Creatinine >2.5 mg/dL (n=101, 105, 97, 94) | Glucose, Serum Fasting < 50 mg/dL (n=0, 0, 0, 0) | Glucose, Serum Fasting > 500 mg/dL (n=0, 0, 0, 0) | Glucose, Serum Unspec. < 50 mg/dL (n=0,0,0,0) | Glucose, Serum Unspec. > 500 mg/dL (n=0,0,0,0) | Glucose, Plasma Fasting<50mg/dL(n=101, 104, 96,94) | Glucose,Plasma Fasting>500mg/dL(n=101, 104, 96,94) | Glucose, Plasma Unspec.<50mg/dL(n=102, 105, 98,95) | Glucose,Plasma Unspec.>500mg/dL(n=102, 105, 98,95) | Sodium,Serum Low (see above) (n=101, 105, 97, 94) | Sodium,Serum High(see above) (n=101, 105, 97, 94) | Potassium,Serum Low(see above)(n=101, 105, 97, 94) | Potassium, Serum High(see above)(n=101,105,97,94) | Chloride < 90 mEq/L (n=101, 105, 97, 94) | Chloride > 120 mEq/L (n=101, 105, 97, 94) | Albumin < 0.9 LLN (n=101, 105, 97, 94) | Creatine Kinase > 5 x ULN (n=101, 105, 97, 94) | Uric Acid > 1.5 x ULN (n=0, 0, 0, 0) | Protein Urine, >=2-4 (n=99, 103, 94, 92) | Blood Urine, >=2-4 (n=99, 103, 94, 92) | Red Blood Cells Urine >=2-4 (n=95, 97, 89, 88) | White Blood Cells Urine >=2-4 (n=95, 97, 89, 88) | |
| Placebo | 0 | 0 | 0 | 1 | 0 | 0 | 4 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 3 | 2 | 1 | 0 | 0 | 3 | 1 | 0 | 0 | 4 | 0 | 3 | 16 | 14 | 12 |
| Saxagliptin 10 mg | 0 | 1 | 0 | 0 | 0 | 1 | 3 | 2 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 4 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 4 | 8 | 8 | 15 |
| Saxagliptin 2.5 mg | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 4 | 0 | 2 | 3 | 2 | 1 | 0 | 3 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 7 | 0 | 0 | 1 | 0 | 3 | 0 | 0 | 0 | 2 | 0 | 8 | 5 | 6 | 13 |
| Saxagliptin 5 mg | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 2 | 0 | 1 | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 4 | 0 | 9 | 11 | 8 | 19 |
A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal. (NCT00121641)
Timeframe: Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 34 weeks.
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hemoglobin < 8 g/dL (n=64) | Hematocrit < 0.75 x pre-Rx (n=64) | Platelets < 50 x 10^9 c/L (n=64) | Platelets > 1.5 x ULN (n=64) | Leukocytes < 2 x 1000 c/µL (n=64) | Neutrophils+Bands <1x1000 c/uL (n=64) | Eosinophils >0.9x1000 c/µL (n=64) | Lymphocytes <=0.75x1000 c/uL (n=64) | ALP >3 x pre-Rx and >ULN (n=64) | ALP >1.5 x ULN (n=64) | AST >3 x ULN (n=64) | AST >5 x ULN (n=64) | AST >10 x ULN (n=64) | AST >20 x ULN (n=64) | ALT >3 x ULN (n=64) | ALT >5 x ULN (n=64) | ALT >10 x ULN (n=64) | ALT >20 x ULN (n=64) | Bilirubin Total >2mg/dL (n=64) | Bilirubin Total >1.5xULN (n=64) | Bilirubin Total >2xULN (n=64) | BUN >2 x pre-Rx and >ULN (n=64) | Creatinine >2.5 mg/dL (n=64) | Glucose, Serum Fasting < 50 mg/dL (n=1) | Glucose, Serum Fasting > 500 mg/dL (n=1) | Glucose, Serum Unspec. < 50 mg/dL (n=1) | Glucose, Serum Unspec. > 500 mg/dL (n=1) | Glucose, Plasma Fasting <50 mg/dL (n=64) | Glucose,Plasma Fasting >500 mg/dL (n=64) | Glucose, Plasma Unspec. <50 mg/dL (n=65) | Glucose,Plasma Unspec. >500 mg/dL (n=65) | Sodium,Serum Low (see above) (n=65) | Sodium,Serum High (see above) (n=65) | Potassium,Serum Low (see above) (n=65) | Potassium, Serum High (see above) (n=65) | Chloride < 90 mEq/L (n=65) | Chloride > 120 mEq/L (n=65) | Albumin < 0.9 LLN (n=64) | Creatine Kinase > 5 x ULN (n=64) | Uric Acid > 1.5 x ULN (n=0) | Protein Urine, >=2-4 (n=64) | Blood Urine, >=2-4 (n=64) | Red Blood Cells Urine >=2-4 (n=58) | White Blood Cells Urine >=2-4 (n=58) | |
| Open-Label Treatment Cohort (Direct Enrollees) | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 2 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 2 | 4 | 7 | 6 |
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing. (NCT00121641)
Timeframe: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| At Least 1 AE | At Least 1 Related AE | Deaths | At Least 1 SAE | At Least 1 Related SAE | Discontinuations Due to SAEs | Discontinuations Due to AEs | |
| Placebo | 77 | 25 | 1 | 11 | 0 | 1 | 5 |
| Saxagliptin 10 mg | 87 | 25 | 0 | 9 | 0 | 3 | 10 |
| Saxagliptin 2.5 mg | 89 | 25 | 0 | 11 | 0 | 6 | 9 |
| Saxagliptin 5 mg | 94 | 23 | 0 | 18 | 1 | 2 | 10 |
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing. (NCT00121641)
Timeframe: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| At Least 1 AE | At Least 1 Related AE | Deaths | At Least 1 SAE | At Least 1 Related SAE | Discontinuations Due to SAEs | Discontinuations Due to AEs | |
| Open-Label Treatment Cohort (Direct Enrollees) | 49 | 9 | 0 | 6 | 0 | 2 | 5 |
To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24
| Intervention | kg (Least Squares Mean) |
|---|---|
| Placebo | 0.02 |
| Dapagliflozin 2.5mg | -0.98 |
| Dapagliflozin 5mg | -0.98 |
| Dapagliflozin 10mg | -1.67 |
To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24
| Intervention | IU/day (Least Squares Mean) |
|---|---|
| Placebo | 5.08 |
| Dapagliflozin 2.5mg | -1.80 |
| Dapagliflozin 5mg | -0.61 |
| Dapagliflozin 10mg | -1.16 |
To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 3.3 |
| Dapagliflozin 2.5mg | -12.5 |
| Dapagliflozin 5mg | -18.8 |
| Dapagliflozin 10mg | -21.7 |
To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | -0.30 |
| Dapagliflozin 2.5mg | -0.75 |
| Dapagliflozin 5mg | -0.82 |
| Dapagliflozin 10mg | -0.90 |
To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction >= 10%) as compared to placebo added to insulin treatment. (NCT00673231)
Timeframe: Baseline to Week 24
| Intervention | Percentage of participants (Least Squares Mean) |
|---|---|
| Placebo | 11.0 |
| Dapagliflozin 2.5mg | 18.1 |
| Dapagliflozin 5mg | 16.8 |
| Dapagliflozin 10mg | 19.7 |
Participants with lack of glycemic control or insulin up-titration for failing to achieve pre-specified glycemic targets (NCT00673231)
Timeframe: Baseline to Week 24
| Intervention | Participants (Number) |
|---|---|
| Placebo | 54 |
| Dapagliflozin 2.5mg | 22 |
| Dapagliflozin 5mg | 24 |
| Dapagliflozin 10mg | 19 |
The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). (NCT01023581)
Timeframe: Baseline and Week 26.
| Intervention | percentage glycosylated hemoglobin (Least Squares Mean) |
|---|---|
| Placebo | 0.15 |
| Alogliptin 25 QD | -0.52 |
| Alogliptin 12.5 BID | -0.56 |
| Metformin 500 BID | -0.65 |
| Metformin 1000 BID | -1.11 |
| Alogliptin 12.5 BID + Metformin 500 BID | -1.22 |
| Alogliptin 12.5 BID + Metformin 1000 BID | -1.55 |
The change from Baseline in fasting plasma glucose was assessed at Weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as fixed effects, and baseline fasting plasma glucose as a covariate. (NCT01023581)
Timeframe: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
| Intervention | mg/dL (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 1 (n=102, 103, 94, 95, 104, 101, 109) | Week 2 (n=105, 112, 105, 102, 108, 106, 111) | Week 4 (n=105, 112, 106, 106, 110, 106, 111) | Week 8 (n=105, 112, 106, 106, 110, 106, 112) | Week 12 (n=105, 112, 106, 106, 110, 106, 112) | Week 16 (n=105, 112, 106, 106, 110, 106, 112) | Week 20 (n=105, 112, 106, 106, 110, 106, 112) | Week 26 (n=105, 112, 106, 106, 110, 106, 112) | |
| Alogliptin 12.5 BID | -11.9 | -11.6 | -16.6 | -12.1 | -14.7 | -14.7 | -12.3 | -9.7 |
| Alogliptin 12.5 BID + Metformin 1000 BID | -36.3 | -43.6 | -44.1 | -43.8 | -44.7 | -47.7 | -44.6 | -45.9 |
| Alogliptin 12.5 BID + Metformin 500 BID | -32.7 | -34.5 | -37.6 | -32.9 | -31.6 | -35.9 | -33.8 | -31.7 |
| Alogliptin 25 QD | -3.9 | -7.4 | -11.5 | -10.9 | -9.7 | -7.1 | -9.2 | -6.1 |
| Metformin 1000 BID | -23.1 | -22.2 | -29.0 | -30.7 | -30.7 | -33.5 | -35.1 | -31.9 |
| Metformin 500 BID | -12.6 | -14.5 | -16.9 | -11.8 | -14.0 | -13.3 | -10.9 | -11.5 |
| Placebo | 5.7 | 4.6 | 7.2 | 7.1 | 11.6 | 10.1 | 8.7 | 12.4 |
"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was assessed at Weeks 4, 8, 12, 16 and 20.~Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as fixed effects, and baseline HbA1c as a covariate." (NCT01023581)
Timeframe: Baseline and Weeks 4, 8, 12, 16, and 20.
| Intervention | percentage glycosylated hemoglobin (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Week 4 (n=95, 97, 89, 94, 102, 94, 101) | Week 8 (n=102, 104, 104, 103, 108, 102, 111) | Week 12 (n=102, 104, 104, 103, 108, 102, 111) | Week 16 (n=102, 104, 104, 103, 108, 102, 111) | Week 20 (n=102, 104, 104, 103, 108, 102, 111) | |
| Alogliptin 12.5 BID | -0.42 | -0.58 | -0.62 | -0.63 | -0.59 |
| Alogliptin 12.5 BID + Metformin 1000 BID | -0.75 | -1.17 | -1.40 | -1.50 | -1.54 |
| Alogliptin 12.5 BID + Metformin 500 BID | -0.70 | -1.08 | -1.22 | -1.26 | -1.25 |
| Alogliptin 25 QD | -0.34 | -0.51 | -0.53 | -0.58 | -0.57 |
| Metformin 1000 BID | -0.58 | -0.86 | -1.02 | -1.09 | -1.14 |
| Metformin 500 BID | -0.37 | -0.59 | -0.68 | -0.72 | -0.68 |
| Placebo | 0.09 | 0.08 | 0.12 | 0.13 | 0.12 |
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 |
The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 24 weeks
| Intervention | percentage of HbA1c (Least Squares Mean) |
|---|---|
| Insulin Lispro Low Mixture | -1.30 |
| Insulin Glargine+Insulin Lispro | -1.08 |
The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 24 weeks
| Intervention | percentage of HbA1c (Least Squares Mean) |
|---|---|
| Insulin Lispro Low Mixture | -1.30 |
| Insulin Glargine+Insulin Lispro | -1.09 |
The change from baseline to 12 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 12 weeks
| Intervention | percentage of HbA1c (Least Squares Mean) |
|---|---|
| Insulin Lispro Low Mixture | -1.12 |
| Insulin Glargine+Insulin Lispro | -1.01 |
ITSQ: validated instrument containing 22 items which are measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother) used to assess insulin treatment satisfaction. Items are divided into 5 domains: Inconvenience of Regimen (5 items: domain score range 5 to 35), Lifestyle Flexibility (3 items: domain score range 3 to 21), Glycemic Control (3 items: domain score range 3 to 21), Hypoglycemic Control (5 items: domain score range 5 to 35), Insulin Delivery Device (6 items: domain score range 6 to 42) lower scores reflect better outcome. ITSQ Total Overall Score ranged from 22 to 154. Raw domain scores transformed on 0-100 scale, where transformed domain score = 100×[(7-raw domain score)/6]. Higher scores indicate better treatment satisfaction. Least squares (LS) mean estimated from analysis of covariance (ANCOVA) model that included baseline score as covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects. (NCT01175824)
Timeframe: 24 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Insulin Lispro Low Mixture | 80.91 |
| Insulin Glargine+Insulin Lispro | 81.84 |
A hypoglycemic episode was defined as an event associated with 1) reported signs and symptoms of hypoglycemia, and/or 2) a documented blood glucose (BG) concentration of <= 70 milligrams per deciliter [mg/dL, 3.9 millimoles per liter (mmol/L)]. (NCT01175824)
Timeframe: Baseline through 24 weeks
| Intervention | participants (Number) |
|---|---|
| Insulin Lispro Low Mixture | 144 |
| Insulin Glargine+Insulin Lispro | 150 |
The number of participants who had a severe hypoglycemic episode anytime during the study. Severe hypoglycemia was defined as any event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. (NCT01175824)
Timeframe: Baseline through 24 weeks
| Intervention | participants (Number) |
|---|---|
| Insulin Lispro Low Mixture | 2 |
| Insulin Glargine+Insulin Lispro | 0 |
The hypoglycemia rate per 30 days was calculated as the number of episodes reported for the interval between visits and during the study divided by the number of days in the given interval and multiplied by 30. (NCT01175824)
Timeframe: Baseline through 24 weeks
| Intervention | hypoglycemic episodes per 30 day period (Mean) |
|---|---|
| Insulin Lispro Low Mixture | 1.07 |
| Insulin Glargine+Insulin Lispro | 1.36 |
7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: 12 weeks, 24 weeks
| Intervention | millimoles per liter (mmol/L) (Least Squares Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| pre-morning meal (Week 12) (n=223, 222) | 2 hour post-morning meal (Week 12) (n=220, 221) | pre-midday meal (Week 12) (n=220, 221) | 2 hours post-midday meal (Week 12) (n=220, 221) | pre-evening meal (Week 12) (n=221, 221) | 2 hours post-evening meal (Week 12) (n=217, 220) | 3 am - during the night (Week 12)(n=197, 201) | pre-morning meal (Week 24) (n=217, 216) | 2 hours post-morning meal (Week 24) (n=216, 215) | pre-midday meal (Week 24) (n=215, 216) | 2 hours post-midday meal (Week 24) (n=216, 216) | pre-evening meal (Week 24) (n=216, 216) | 2 hours post-evening meal (Week 24) (n=212, 216) | 3 am - during the night (Week 24)(n=198, 195) | |
| Insulin Glargine+Insulin Lispro | 6.20 | 9.01 | 7.44 | 9.14 | 8.25 | 9.10 | 8.52 | 6.26 | 8.86 | 7.44 | 8.99 | 7.95 | 8.95 | 8.26 |
| Insulin Lispro Low Mixture | 6.87 | 8.82 | 6.96 | 9.46 | 7.98 | 9.15 | 8.21 | 6.60 | 8.52 | 6.82 | 9.08 | 7.70 | 9.11 | 8.05 |
The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline fasting plasma glucose value as a covariate, treatment, country, baseline HbA1c stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 12 weeks, and 24 weeks
| Intervention | millimoles per liter (mmol/L) (Least Squares Mean) | |
|---|---|---|
| Change at 12 Weeks (n= 222, 222) | Change at 24 Weeks (n=219, 217) | |
| Insulin Glargine+Insulin Lispro | 0.64 | 0.75 |
| Insulin Lispro Low Mixture | 1.04 | 0.89 |
The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline weight as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c) stratification level, week of visit, and the treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: Baseline, 12 weeks, 24 weeks
| Intervention | kilograms (kg) (Least Squares Mean) | |
|---|---|---|
| Change at 12 weeks (n=224, 225) | Change at 24 weeks (n=219, 217) | |
| Insulin Glargine+Insulin Lispro | 0.34 | 0.50 |
| Insulin Lispro Low Mixture | 0.54 | 1.13 |
(NCT01175824)
Timeframe: 12 weeks, 24 weeks
| Intervention | international units (IU) (Mean) | |||||
|---|---|---|---|---|---|---|
| Total Insulin Dose at 12 Weeks (n=224, 224) | Total Insulin Dose at 24 Weeks LOCF (n=236, 240) | Basal Insulin Dose at 12 Weeks (n=224, 224) | Basal Insulin Dose at 24 Weeks LOCF (n=236, 240) | Prandial Insulin Dose at 12 Weeks (n=224, 224) | Prandial Insulin Dose at 24 Weeks LOCF(n=236, 240) | |
| Insulin Glargine+Insulin Lispro | 49.2 | 50.8 | 37.1 | 37.4 | 12.1 | 13.5 |
| Insulin Lispro Low Mixture | 51.2 | 53.1 | 38.4 | 39.8 | 12.8 | 13.3 |
The 7-point SMBG profile was calculated as the average blood glucose concentration across the 7 pre-specified time points in a day that was then averaged over 3 non-consecutive days in the 2 weeks prior to the 12 week visit and 24 week visit. Glycemic variability was calculated as the standard deviation of the 7-point SMBG profiles. Standard deviation was first calculated for each day and then averaged over 3 non-consecutive days for each visit. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects. (NCT01175824)
Timeframe: 12 weeks, 24 weeks
| Intervention | millimoles/liter (mmol/L) (Least Squares Mean) | |
|---|---|---|
| SMBG glycemic variability, 12 weeks (n=220, 221) | SMBG glycemic variability, 24 weeks (n=216, 216) | |
| Insulin Glargine+Insulin Lispro | 2.13 | 1.99 |
| Insulin Lispro Low Mixture | 2.12 | 2.03 |
(NCT01175824)
Timeframe: 24 weeks
| Intervention | participants (Number) | |
|---|---|---|
| HbA1c <7% | HbA1c <=6.5% | |
| Insulin Glargine+Insulin Lispro | 66 | 31 |
| Insulin Lispro Low Mixture | 76 | 36 |
PAM-D21 is a validated questionnaire consisting of 21 items to assess a participant's perceptions about their diabetes treatment regimens and perceived emotional and physical side-effects. The PAM-D21 consists of 4 subscales: Convenience/Flexibility (items 1 to 3); Perceived Effectiveness (items 4 to 6); Emotional Effects (items 7 to 11); and Physical Effects (items 12 to 21). Item scores range from 1 (none of the time) to 4 (all of the time). Subscale scores were linearly transformed to a 0-100, with higher score corresponds to better perceptions about diabetes medications. The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included baseline score as a covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects. (NCT01175824)
Timeframe: 24 weeks
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Convenience/Flexibility (n= 231, 230) | Perceived Effectiveness (n=231, 230) | Emotional Effects (n=231, 230) | Physical Effects (n=231, 228) | |
| Insulin Glargine+Insulin Lispro | 84.13 | 78.76 | 81.86 | 89.04 |
| Insulin Lispro Low Mixture | 83.90 | 76.78 | 81.84 | 87.89 |
Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12 (NCT00996658)
Timeframe: baseline, 12 weeks
| Intervention | mg/dL (milligrams per deciliter) (Least Squares Mean) |
|---|---|
| Placebo Tablet | 3.8 |
| Linagliptin 5 mg Tablet | -7.1 |
Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18 (NCT00996658)
Timeframe: baseline, 18 weeks
| Intervention | mg/dL (milligrams per deciliter) (Least Squares Mean) |
|---|---|
| Placebo Tablet | -2.4 |
| Linagliptin 5 mg Tablet | -8.6 |
Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24 (NCT00996658)
Timeframe: baseline, 24 weeks
| Intervention | mg/dL (milligrams per deciliter) (Least Squares Mean) |
|---|---|
| Placebo Tablet | 0.1 |
| Linagliptin 5 mg Tablet | -10.3 |
Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6 (NCT00996658)
Timeframe: baseline, 6 weeks
| Intervention | mg/dL (milligrams per deciliter) (Least Squares Mean) |
|---|---|
| Placebo Tablet | 12.4 |
| Linagliptin 5 mg Tablet | -3.3 |
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: baseline, 12 weeks
| Intervention | Percentage (Least Squares Mean) |
|---|---|
| Placebo Tablet | -0.28 |
| Linagliptin 5 mg Tablet | -0.82 |
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: baseline, 18 weeks
| Intervention | Percentage (Least Squares Mean) |
|---|---|
| Placebo Tablet | -0.37 |
| Linagliptin 5 mg Tablet | -0.91 |
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: baseline, 24 weeks
| Intervention | Percentage (Least Squares Mean) |
|---|---|
| Placebo Tablet | -0.27 |
| Linagliptin 5 mg Tablet | -0.84 |
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: baseline, 6 weeks
| Intervention | Percentage (Least Squares Mean) |
|---|---|
| Placebo Tablet | -0.19 |
| Linagliptin 5 mg Tablet | -0.60 |
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: 24 weeks
| Intervention | Participants (Number) | ||
|---|---|---|---|
| Responder (HbA1c < 6.5%) | Non-responder (HbA1c >= 6.5%) | Missing | |
| Linagliptin 5 mg Tablet | 34 | 143 | 1 |
| Placebo Tablet | 5 | 84 | 0 |
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: 24 weeks
| Intervention | Participants (Number) | ||
|---|---|---|---|
| Responder (HbA1c < 7.0%) | Non-responder (HbA1c >= 7.0%) | Missing | |
| Linagliptin 5 mg Tablet | 57 | 118 | 1 |
| Placebo Tablet | 12 | 75 | 0 |
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin (NCT00996658)
Timeframe: 24 weeks
| Intervention | Participants (Number) | ||
|---|---|---|---|
| Responder (reduction in HbA1c >= 0.5%) | Non-responder (reduction in HbA1c < 0.5%) | Missing | |
| Linagliptin 5 mg Tablet | 117 | 61 | 1 |
| Placebo Tablet | 44 | 45 | 0 |
The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment (NCT01306214)
Timeframe: Baseline and 52 weeks
| Intervention | kg (Least Squares Mean) |
|---|---|
| Placebo | 0.44 |
| Empagliflozin 10 mg | -1.95 |
| Empagliflozin 25 mg | -2.04 |
The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment. (NCT01306214)
Timeframe: Baseline and 18 weeks
| Intervention | percentage of HbA1c (Least Squares Mean) |
|---|---|
| Placebo | -0.50 |
| Empagliflozin 10 mg | -0.94 |
| Empagliflozin 25 mg | -1.02 |
The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment (NCT01306214)
Timeframe: Baseline and 52 weeks
| Intervention | percentage of HbA1c (Least Squares Mean) |
|---|---|
| Placebo | -0.81 |
| Empagliflozin 10 mg | -1.18 |
| Empagliflozin 25 mg | -1.27 |
The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment (NCT01306214)
Timeframe: Baseline and 52 weeks
| Intervention | IU/day (Least Squares Mean) |
|---|---|
| Placebo | 10.16 |
| Empagliflozin 10 mg | 1.33 |
| Empagliflozin 25 mg | -1.06 |
Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. (NCT00960661)
Timeframe: baseline, week 30
| Intervention | kg (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -2.45 |
| Insulin Lispro (BBT) | 2.11 |
Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. (NCT00960661)
Timeframe: baseline, Week 30
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -0.64 |
| Insulin Lispro (BBT) | -0.14 |
Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. (NCT00960661)
Timeframe: Baseline, Week 30
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -0.46 |
| Insulin Lispro (BBT) | 0.18 |
Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline). (NCT00960661)
Timeframe: Baseline, 30 weeks
| Intervention | percent of hemoglobin (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -1.13 |
| Insulin Lispro (BBT) | -1.10 |
Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. (NCT00960661)
Timeframe: Baseline, week 30
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -0.04 |
| Insulin Lispro (BBT) | 0.03 |
Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. (NCT00960661)
Timeframe: Baseline, Week 30
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -0.12 |
| Insulin Lispro (BBT) | -0.03 |
Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. (NCT00960661)
Timeframe: Baseline, Week 30
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -4.13 |
| Insulin Lispro (BBT) | 0.37 |
Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. (NCT00960661)
Timeframe: Baseline, week 30
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -0.14 |
| Insulin Lispro (BBT) | -0.03 |
Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and requiring the assistance of another person because of severe impairment in consciousness or behavior. (NCT00960661)
Timeframe: 30 weeks
| Intervention | rate per year (Mean) |
|---|---|
| Exenatide (BET) | 0.0 |
| Insulin Lispro (BBT) | 0.1 |
Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) (NCT00960661)
Timeframe: 30 weeks
| Intervention | rate per year (Mean) |
|---|---|
| Exenatide (BET) | 2.1 |
| Insulin Lispro (BBT) | 5.0 |
Percent of participants achieving HbA1c ≤ 6.5%. (NCT00960661)
Timeframe: Week 30
| Intervention | percentage of participants (Number) |
|---|---|
| Exenatide (BET) | 26.2 |
| Insulin Lispro (BBT) | 25.5 |
Percentage of participants achieving HbA1C < 7.0% (NCT00960661)
Timeframe: Week 30
| Intervention | Percentage of participants (Number) |
|---|---|
| Exenatide (BET) | 46.7 |
| Insulin Lispro (BBT) | 42.6 |
Daily Insulin Glargine Dose at baseline and at Week 30 (NCT00960661)
Timeframe: Baseline, week 30
| Intervention | IU/day (Mean) | |
|---|---|---|
| Baseline | Week 30 | |
| Exenatide (BET) | 61.5 | 56.9 |
| Insulin Lispro (BBT) | 61.1 | 51.5 |
change in A1c (%) from baseline to end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | % change of A1c (Mean) |
|---|---|
| Treatment Group | -2.38 |
| Control Group | -0.83 |
change (mmHg) of systolic BP from baseline to the end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | mmHg (Mean) |
|---|---|
| Treatment Group | -16 |
| Control Group | 15 |
change (beats/min) from baseline to the end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks
| Intervention | beats per min (Mean) |
|---|---|
| Treatment Group | 4.3 |
| Control Group | 5.13 |
change (mg/dL) from baseline to the end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | mg/dL (Mean) |
|---|---|
| Treatment Group | -15.7 |
| Control Group | 21 |
change (mg/dL) from baseline to the end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | mg/dL (Mean) |
|---|---|
| Treatment Group | 0.04 |
| Control Group | 0.04 |
change (mg/dL) from baseline to the end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | mg/dL (Mean) |
|---|---|
| Treatment Group | -18.5 |
| Control Group | 18.38 |
"Patient satisfaction with treatment in both groups will be measured by the validated the Diabetes Medications Satisfaction Tool (DM-SAT). Response options range from 0=not at all satisfied to 10=extremely satisfied and a total score is calculated ranging from 0 to 100, with higher scores indicating more diabetes medication satisfaction." (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | score on a scale (Mean) |
|---|---|
| Treatment Group | 45.3 |
| Control Group | 4.63 |
change (in pounds) from baseline to the end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | pounds (Mean) |
|---|---|
| Treatment Group | -16.38 |
| Control Group | -0.1 |
Observed mean change from baseline in HbA1c after 26 Weeks of treatment. (NCT01392573)
Timeframe: Week 0, week 26
| Intervention | percentage of glycosylated haemoglobin (Mean) |
|---|---|
| IDegLira | -1.90 |
| IDeg | -0.89 |
Observed mean change from baseline in body weight after 26 Weeks of treatment. (NCT01392573)
Timeframe: Week 0, week 26
| Intervention | kg (Mean) |
|---|---|
| IDegLira | -2.7 |
| IDeg | 0.0 |
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change. (NCT00968812)
Timeframe: Baseline, Week 104
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -0.65 |
| Canagliflozin 300 mg | -0.74 |
| Glimepiride | -0.55 |
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change. (NCT00968812)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -0.82 |
| Canagliflozin 300 mg | -0.93 |
| Glimepiride | -0.81 |
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change. (NCT00968812)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -4.2 |
| Canagliflozin 300 mg | -4.7 |
| Glimepiride | 1.0 |
The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages. (NCT00968812)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percentage of patients (Number) |
|---|---|
| Canagliflozin 100 mg | 5.6 |
| Canagliflozin 300 mg | 4.9 |
| Glimepiride | 34.2 |
(NCT01376557)
Timeframe: 12 weeks
| Intervention | kg (Mean) |
|---|---|
| 75 mg LX4211 qd | -0.995 |
| 200 mg LX4211 qd | -1.956 |
| 400 mg LX4211 qd | -1.848 |
| 200 mg LX4211 Bid | -2.477 |
| Placebo qd | -0.395 |
(NCT01376557)
Timeframe: 12 weeks
| Intervention | mg/dL (Mean) |
|---|---|
| 75 mg LX4211 qd | -9.5 |
| 200 mg LX4211 qd | -17.4 |
| 400 mg LX4211 qd | -27.1 |
| 200 mg LX4211 Bid | -26.9 |
| Placebo qd | 2.2 |
(NCT01376557)
Timeframe: 12 weeks
| Intervention | % change (Mean) |
|---|---|
| 75 mg LX4211 qd | -0.42 |
| 200 mg LX4211 qd | -0.52 |
| 400 mg LX4211 qd | -0.92 |
| 200 mg LX4211 Bid | -0.80 |
| Placebo qd | -0.09 |
(NCT01376557)
Timeframe: 12 weeks
| Intervention | mm Hg (Mean) |
|---|---|
| 75 mg LX4211 qd | -0.123 |
| 200 mg LX4211 qd | -3.878 |
| 400 mg LX4211 qd | -5.746 |
| 200 mg LX4211 Bid | -4.452 |
| Placebo qd | -0.283 |
(NCT01376557)
Timeframe: 12 weeks
| Intervention | mg/dL (Mean) |
|---|---|
| 75 mg LX4211 qd | -16.2 |
| 200 mg LX4211 qd | 6.6 |
| 400 mg LX4211 qd | -16.8 |
| 200 mg LX4211 Bid | -16.9 |
| Placebo qd | -30.5 |
(NCT01376557)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|---|
| 75 mg LX4211 qd | 16 |
| 200 mg LX4211 qd | 15 |
| 400 mg LX4211 qd | 22 |
| 200 mg LX4211 Bid | 17 |
| Placebo qd | 14 |
Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use (NCT00757588)
Timeframe: Baseline to Week 24
| Intervention | Percentage of change (Mean) |
|---|---|
| Saxagliptin, 5 mg + Insulin | -0.73 |
| Placebo + Insulin | -0.32 |
An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal. (NCT00757588)
Timeframe: Baseline to Week 24
| Intervention | mg/dL (Mean) |
|---|---|
| Saxagliptin, 5 mg + Insulin | -27.2 |
| Placebo + Insulin | -4.2 |
(NCT00757588)
Timeframe: Baseline to Week 24
| Intervention | mg/dL (Mean) |
|---|---|
| Saxagliptin, 5 mg + Insulin | -10.1 |
| Placebo + Insulin | -6.1 |
Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline. (NCT00757588)
Timeframe: Baseline to Week 24
| Intervention | Units (Mean) |
|---|---|
| Saxagliptin, 5 mg + Insulin | 1.71 |
| Placebo + Insulin | 5.01 |
An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal (NCT00757588)
Timeframe: Baseline to Week 24
| Intervention | mg*min/dL (Mean) |
|---|---|
| Saxagliptin, 5 mg + Insulin | -4548.5 |
| Placebo + Insulin | -718.8 |
"ECG abnormalities included those in nonspecific other categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions." (NCT00757588)
Timeframe: Baseline to Week 52
| Intervention | Participants (Number) |
|---|---|
| Saxagliptin, 5 mg + Insulin | 15 |
| Placebo + Insulin | 11 |
Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value. (NCT00757588)
Timeframe: Baseline to Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin, 5 mg + Insulin | 17.3 |
| Placebo + Insulin | 6.7 |
(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52
| Intervention | Beats per minute (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2 (n=294, 147) | Week 4 (n=293, 144) | Week 6 (n=280, 141) | Week 8 (n=290, 142) | Week 12 (n=286, 144) | Week 16 (n=278, 139) | Week 20 (n=276, 137) | Week 24 (n=273, 134) | Week 28 (n=264, 132) | Week 36 (n=261, 129) | Week 44 (n=250, 125) | Week 52 (n=246, 125) | |
| Placebo + Insulin | -0.7 | -1.0 | -0.9 | -0.7 | 0.2 | -0.6 | 0.4 | -1.0 | -0.6 | -0.0 | -0.7 | 0.2 |
| Saxagliptin, 5 mg + Insulin | -0.5 | -0.5 | -0.5 | -0.0 | 0.3 | -1.0 | -0.5 | 0.0 | -1.0 | 0.0 | 0.2 | -0.3 |
(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52
| Intervention | mm Hg (Number) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Systolic blood pressure (Week 2) (n=294, 147) | Systolic blood pressure (Week 4) (n=293, 144) | Systolic blood pressure (Week 6) (n=280, 141) | Systolic blood pressure (Week 8) (n=290, 142) | Systolic blood pressure (Week 12) (n=286, 144) | Systolic blood pressure (Week 16) (n=278, 139) | Systolic blood pressure (Week 20) (n=276, 137) | Systolic blood pressure (Week 24) (n=273, 134) | Systolic blood pressure (Week 28) (n=264, 132) | Systolic blood pressure (Week 36) (n=261, 129) | Systolic blood pressure (Week 44) (n=250, 125) | Systolic blood pressure (Week 52) (n=246, 125) | Diastolic blood pressure (Week 2) (n=294, 147) | Diastolic blood pressure (Week 4) (n=293, 144) | Diastolic blood pressure (Week 6) (n=280, 141) | Diastolic blood pressure (Week 8) (n=290, 142) | Diastolic blood pressure (Week 12) (n=286, 144) | Diastolic blood pressure (Week 16) (n=278, 139) | Diastolic blood pressure (Week 20) (n=276, 137) | Diastolic blood pressure (Week 24) (n=273, 134) | Diastolic blood pressure (Week 28) (n=264, 132) | Diastolic blood pressure (Week 36) (n=261, 129) | Diastolic blood pressure (Week 44) (n=250, 125) | Diastolic blood pressure (Week 52) (n=246, 125) | |
| Placebo + Insulin | 2.3 | 0.0 | 1.0 | 2.4 | 2.2 | 1.1 | 1.3 | -0.1 | 1.8 | 3.6 | 2.6 | 1.0 | 1.4 | 1.8 | 0.3 | 2.1 | 1.0 | 1.3 | 1.1 | 0.5 | 0.2 | 0.2 | 0.4 | 0.1 |
| Saxagliptin, 5 mg + Insulin | -1.0 | -1.2 | -0.8 | -0.8 | -1.7 | -1.2 | -0.6 | -1.5 | -1.4 | -0.7 | -0.6 | 0.0 | 0.1 | 0.0 | 0.0 | -0.5 | -0.8 | -1.1 | -0.7 | -1.7 | -1.6 | -1.2 | -0.3 | -0.5 |
An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment. (NCT00757588)
Timeframe: Baseline to Week 52, continuously
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| At least 1 AE | At least 1 treatment-related AE | Deaths | At least 1 SAE | At least 1 treatment-related SAE | Discontinuations due to SAEs | Discontinuations due to AEs | |
| Placebo + Insulin | 108 | 34 | 0 | 13 | 0 | 0 | 3 |
| Saxagliptin, 5 mg + Insulin | 202 | 56 | 2 | 25 | 3 | 4 | 9 |
"Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment.~Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4." (NCT00757588)
Timeframe: Baseline and during and up to 14 days after last dose of study drug (in Week 52)
| Intervention | Participants (Number) | |||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hemoglobin <8 g/dL (n=300; 150) | Hematocrit <0.75*prx (n=300; 150) | Platelets <50*10^9 c/L (n=297; 145) | Platelets >1.5*ULN (n=297; 145) | Leukocytes <2*1000 c/uL (n=300; 150) | Neutrophils <1*1000 c/uL (n=296; 150) | Eosinophils >0.9*1000 c/uL (n=296; 150) | Lymphocytes <=0.75*1000 c/uL (n=296; 150) | Alkaline phosphatase >3*prx & >ULN (n=302; 150) | Alkaline phosphatase >1.5 ULN (n=302; 150) | Aspartate aminotransferase >3* ULN (n=298; 148) | Aspartate aminotransferase>5* ULN (n=298; 148) | Aspartate aminotransferase >10*ULN (n=298; 148) | Aspartate aminotransferase >20*ULN (n=298; 148) | Alanine transaminase >3*ULN (n=300; 148) | Alanine transaminase >5*ULN (n=300; 148) | Alanine transaminase >10*ULN (n=300; 148) | Alanine transaminase >20*ULN (n=300; 148) | Bilirubin, total >2 mg/dL (n=301; 150) | Bilirubin, total >1.5*ULN (n=301; 150) | Bilirubin, total >2*ULN (n=301; 150) | Blood urea nitrogen >2*prx & >ULN (n=302; 150) | Creatinine >2.5 mg/dL (n=303; 150) | Glucose, serum fasting <50 mg/dL (n=0; 0) | Glucose, serum fasting >500 mg/dL (n=0; 0) | Glucose, serum unspecified <50 mg/dL (n=0; 0) | Glucose, serum unspecified >500 mg/dL (n=0; 0) | Glucose, plasma fasting <50 mg/dL (n=301;150) | Glucose, plasma fasting >500 mg/dL (n=301;150) | Glucose, plasma unspecified <50 mg/dL (n=272; 133) | Glucose, plasma unspecified >500 mg/d (n=272; 133) | Sodium, serum <0.9*prx & <=130 mEq/L (n=302; 150) | Sodium, serum >1.1*prx & >=150 mEq/L (n=302; 150) | Potassium, serum <0.8 prx &<=3.2 mEq/L(n=300; 148) | Potassium, serum >1.2*prx&>= 6.0 mEq/L(n=300; 148) | Chloride, serum <90 mEq/L (n=302; 150) | Chloride, serum >120 mEq/L (n=302; 150) | Albumin <0.9*LLN; if prx| Creatine kinase >5*ULN (n=301, 148) | Uric acid >1.5*ULN; if prx >ULN, >2 (n=0,0) | Protein urine (see criteria 1) (n=297,146) | Blood urine (see criteria 1) (n=297; 146) | Red blood cells urine (see criteria 1) (n=53; 31) | White blood cells urine (see criteria 1)(n=115;53) | | |
| Placebo + Insulin | 0 | 2 | 0 | 0 | 1 | 0 | 7 | 2 | 1 | 5 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 1 | 0 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 8 | 0 | 0 | 0 | 2 | 0 | 3 | 2 | 3 | 10 |
| Saxagliptin, 5 mg + Insulin | 2 | 2 | 0 | 0 | 0 | 1 | 9 | 3 | 2 | 10 | 2 | 1 | 0 | 0 | 5 | 1 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 5 | 1 | 1 | 0 | 3 | 8 | 1 | 0 | 1 | 6 | 0 | 8 | 14 | 8 | 35 |
Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/ (NCT00757588)
Timeframe: Baseline to Week 52
| Intervention | Percentage of Participants (Number) | |
|---|---|---|
| Reported | Confirmed | |
| Placebo + Insulin | 24.5 | 6.6 |
| Saxagliptin, 5 mg + Insulin | 19.4 | 7.6 |
Absolute lymphocyte count=value*10^3 c/uL (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52
| Intervention | Participants (Number) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline <= 0.75; Week 24 <= 0.75 | Baseline <= 0.75; Week 24 >0.75- <= 5.00 | Baseline <= 0.75; Week 24 >5.00 | Baseline >0.75- <= 5.00; Week 24 <= 0.75 | Baseline >0.75- <= 5.00; Week 24 >0.75- <= 5.00 | Baseline >0.75- <= 5.00; Week 24 >5.00 | Baseline >5.00; Week 24 <= 0.75 | Baseline >5.00; Week 24 >0.75- <= 5.00 | Baseline >5.00; Week 24 >5.00 | Baseline <= 0.75; Week 52 <= 0.75 | Baseline <= 0.75; Week 52 >0.75- <= 5.00 | Baseline <= 0.75; Week 52 >5.00 | Baseline >0.75- <= 5.00; Week 52 <= 0.75 | Baseline >0.75- <= 5.00; Week 52 >0.75- <= 5.00 | Baseline >0.75- <= 5.00; Week 52 >5.00 | Baseline >5.00; Week 52 <= 0.75 | Baseline >5.00; Week 52 >0.75- <= 5.00 | Baseline >5.00; Week 52 >5.00 | |
| Placebo + Insulin | 0 | 2 | 0 | 0 | 148 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 147 | 1 | 0 | 0 | 0 |
| Saxagliptin, 5 mg + Insulin | 0 | 0 | 0 | 1 | 293 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 295 | 0 | 0 | 0 | 1 |
Platelet count=value*10^9 c/L (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52
| Intervention | Participants (Number) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline <= 100; Week 24 <= 100 | Baseline <= 100; Week 24 >100 - <= 600 | Baseline <= 100; Week 24 >600 | Baseline >100 - <= 600; Week 24 <= 100 | Baseline >100 - <= 600; Week 24 >100 - <= 600 | Baseline >100 - <= 600; Week 24 >600 | Baseline >600; Week 24 <= 100 | Baseline >600; Week 24 >100 - <= 600 | Baseline >600; Week 24 >600 | Baseline <= 100; Week 52 <= 100 | Baseline <= 100; Week 52 >100 - <= 600 | Baseline <= 100; Week 52 >600 | Baseline >100 - <= 600; Week 52 <= 100 | Baseline >100 - <= 600; Week 52 >100 - <= 600 | Baseline >100 - <= 600; Week 52 >600 | Baseline >600; Week 52 <= 100 | Baseline >600; Week 52 >100 - <= 600 | Baseline >600; Week 52 >600 | |
| Placebo + Insulin | 0 | 0 | 0 | 1 | 143 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 144 | 0 | 0 | 0 | 0 |
| Saxagliptin, 5 mg + Insulin | 0 | 0 | 0 | 1 | 296 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 295 | 0 | 0 | 0 | 0 |
Change in BMI (body mass index) from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | Kg/m^2 (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -0.8 |
| DAPA (Dapagliflozin Plus Placebo) | -0.66 |
| PCB (Placebo Plus Placebo) | 0.16 |
Change in body weight from baseline to 16 weeks (NCT02613897)
Timeframe: Baseline to 16 weeks
| Intervention | Kg (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -2.28 |
| DAPA (Dapagliflozin Plus Placebo) | -1.76 |
| PCB (Placebo Plus Placebo) | 0.26 |
A measure of the change in fasting plasma glucagon from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | mg/dl (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -28.52 |
| DAPA (Dapagliflozin Plus Placebo) | 26.89 |
| PCB (Placebo Plus Placebo) | 6.88 |
Measure of change in Free Fatty Acids from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | mEq/L (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -0.06 |
| DAPA (Dapagliflozin Plus Placebo) | -0.01 |
| PCB (Placebo Plus Placebo) | 0.00 |
Change in percentage of glucose oxidation from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | percentage of oxidation (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -22.07 |
| DAPA (Dapagliflozin Plus Placebo) | -46.54 |
| PCB (Placebo Plus Placebo) | 4.65 |
Change in lipid oxidation percentage from baseline to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | percentage of oxidation (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -11.87 |
| DAPA (Dapagliflozin Plus Placebo) | 22.02 |
| PCB (Placebo Plus Placebo) | -6.69 |
Change in blood glucose level measured over a 3 month period from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | percentage change in blood glucose level (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -1.67 |
| DAPA (Dapagliflozin Plus Placebo) | -1.46 |
| PCB (Placebo Plus Placebo) | 0.44 |
Measure of change in OGTT from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | mg/dl (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -49.62 |
| DAPA (Dapagliflozin Plus Placebo) | -44.24 |
| PCB (Placebo Plus Placebo) | 20.26 |
All subjects received a Double-Tracer Oral Glucose Tolerance Test (OGTT) with 75g of glucose containing 14C-glucose together with intravenous primed-continuous infusion of 3(3H)-glucose for 240 minutes, at baseline (prior to) and after 16 weeks of therapy. Blood and urine samples were obtained during the OGTT to determine EGP. (NCT02613897)
Timeframe: Baseline and 16 weeks
| Intervention | mg/kg*min (Mean) | |
|---|---|---|
| Baseline Measurement | 16 weeks | |
| DAPA (Dapagliflozin Plus Placebo) | 2.56 | 2.8 |
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | 2.45 | 2.4 |
| PCB (Placebo Plus Placebo) | 1.95 | 2.15 |
Change from baseline in body weight after 26 weeks of treatment. (NCT01059812)
Timeframe: Week 0, Week 26
| Intervention | kg (Mean) |
|---|---|
| IDegAsp BID | 1.1 |
| BIAsp 30 BID | 1.4 |
Change from baseline in HbA1c after 26 weeks of treatment. (NCT01059812)
Timeframe: Week 0, Week 26
| Intervention | percentage of glycosylated haemoglobin (Mean) |
|---|---|
| IDegAsp BID | -1.38 |
| BIAsp 30 BID | -1.42 |
Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. (NCT01059812)
Timeframe: Week 26
| Intervention | mmol/L (Mean) |
|---|---|
| IDegAsp BID | 7.6 |
| BIAsp 30 BID | 7.9 |
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol. (NCT01059812)
Timeframe: Week 0 to Week 26 + 7 days follow up
| Intervention | Episodes/100 years of patient exposure (Number) |
|---|---|
| IDegAsp BID | 956 |
| BIAsp 30 BID | 952 |
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. (NCT01059812)
Timeframe: Week 0 to Week 26 + 7 days follow up
| Intervention | Episodes/100 years of patient exposure (Number) |
|---|---|
| IDegAsp BID | 111 |
| BIAsp 30 BID | 155 |
To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo (NCT01392677)
Timeframe: Baseline to week 24
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo Plus Metformin Plus Sulfonylurea | -0.78 |
| Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | -34.23 |
To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea. (NCT01392677)
Timeframe: Baseline to week 24
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo Plus Metformin Plus Sulfonylurea | -0.17 |
| Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | -0.86 |
To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo (NCT01392677)
Timeframe: Baseline to week 8
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo Plus Metformin Plus Sulfonylurea | -0.27 |
| Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | -4.04 |
To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo (NCT01392677)
Timeframe: Baseline to week 24
| Intervention | kg (Least Squares Mean) |
|---|---|
| Placebo Plus Metformin Plus Sulfonylurea | -0.58 |
| Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | -2.65 |
To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo (NCT01392677)
Timeframe: Baseline to week 24
| Intervention | Percentage of participants (Least Squares Mean) |
|---|---|
| Placebo Plus Metformin Plus Sulfonylurea | 11.1 |
| Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | 31.8 |
(NCT01059825)
Timeframe: Baseline
| Intervention | kg (Mean) |
|---|---|
| Placebo | 83.78 |
| Ertugliflozin 1 mg | 83.44 |
| Ertugliflozin 5 mg | 85.74 |
| Ertugliflozin 10 mg | 82.28 |
| Ertugliflozin 25 mg | 81.81 |
| Sitagliptin 100 mg | 85.52 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. (NCT01059825)
Timeframe: Baseline
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | 79.14 |
| Ertugliflozin 1 mg | 78.95 |
| Ertugliflozin 5 mg | 78.19 |
| Ertugliflozin 10 mg | 78.45 |
| Ertugliflozin 25 mg | 78.61 |
| Sitagliptin 100 mg | 79.15 |
Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline
| Intervention | mg/dL (Mean) |
|---|---|
| Placebo | 165.3 |
| Ertugliflozin 1 mg | 162.5 |
| Ertugliflozin 5 mg | 156.5 |
| Ertugliflozin 10 mg | 163.3 |
| Ertugliflozin 25 mg | 171.3 |
| Sitagliptin 100 mg | 166.2 |
HbA1c is measured as percent. (NCT01059825)
Timeframe: Baseline
| Intervention | Percent (Mean) |
|---|---|
| Placebo | 8.08 |
| Ertugliflozin 1 mg | 8.01 |
| Ertugliflozin 5 mg | 7.88 |
| Ertugliflozin 10 mg | 8.13 |
| Ertugliflozin 25 mg | 8.30 |
| Sitagliptin 100 mg | 8.24 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. (NCT01059825)
Timeframe: Baseline
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | 126.7 |
| Ertugliflozin 1 mg | 126.5 |
| Ertugliflozin 5 mg | 127.9 |
| Ertugliflozin 10 mg | 125.8 |
| Ertugliflozin 25 mg | 124.9 |
| Sitagliptin 100 mg | 126.6 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 12
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | 0.81 |
| Ertugliflozin 1 mg | -1.12 |
| Ertugliflozin 5 mg | -1.01 |
| Ertugliflozin 10 mg | -3.18 |
| Ertugliflozin 25 mg | -1.83 |
| Sitagliptin 100 mg | 1.68 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -0.57 |
| Ertugliflozin 1 mg | -1.25 |
| Ertugliflozin 5 mg | -1.26 |
| Ertugliflozin 10 mg | -1.97 |
| Ertugliflozin 25 mg | -3.01 |
| Sitagliptin 100 mg | 0.92 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -0.80 |
| Ertugliflozin 1 mg | -2.47 |
| Ertugliflozin 5 mg | -3.08 |
| Ertugliflozin 10 mg | -2.81 |
| Ertugliflozin 25 mg | -2.10 |
| Sitagliptin 100 mg | -0.51 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | 0.80 |
| Ertugliflozin 1 mg | -1.40 |
| Ertugliflozin 5 mg | -0.69 |
| Ertugliflozin 10 mg | -2.23 |
| Ertugliflozin 25 mg | -1.20 |
| Sitagliptin 100 mg | 0.32 |
The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 12
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 2.76 |
| Ertugliflozin 1 mg | -18.23 |
| Ertugliflozin 5 mg | -23.06 |
| Ertugliflozin 10 mg | -31.47 |
| Ertugliflozin 25 mg | -29.26 |
| Sitagliptin 100 mg | -17.29 |
The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 2
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 5.89 |
| Ertugliflozin 1 mg | -15.07 |
| Ertugliflozin 5 mg | -15.68 |
| Ertugliflozin 10 mg | -26.65 |
| Ertugliflozin 25 mg | -16.44 |
| Sitagliptin 100 mg | -14.69 |
The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 4
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 5.17 |
| Ertugliflozin 1 mg | -16.91 |
| Ertugliflozin 5 mg | -22.77 |
| Ertugliflozin 10 mg | -27.95 |
| Ertugliflozin 25 mg | -26.62 |
| Sitagliptin 100 mg | -18.00 |
The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 8
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 3.82 |
| Ertugliflozin 1 mg | -18.25 |
| Ertugliflozin 5 mg | -24.69 |
| Ertugliflozin 10 mg | -31.59 |
| Ertugliflozin 25 mg | -30.99 |
| Sitagliptin 100 mg | -18.93 |
HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]). (NCT01059825)
Timeframe: Baseline and Week 12
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | -0.11 |
| Ertugliflozin 1 mg | -0.56 |
| Ertugliflozin 5 mg | -0.80 |
| Ertugliflozin 10 mg | -0.73 |
| Ertugliflozin 25 mg | -0.83 |
| Sitagliptin 100 mg | -0.87 |
HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | 0.00 |
| Ertugliflozin 1 mg | -0.14 |
| Ertugliflozin 5 mg | -0.29 |
| Ertugliflozin 10 mg | -0.22 |
| Ertugliflozin 25 mg | -0.17 |
| Sitagliptin 100 mg | -0.26 |
HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | -0.04 |
| Ertugliflozin 1 mg | -0.40 |
| Ertugliflozin 5 mg | -0.49 |
| Ertugliflozin 10 mg | -0.48 |
| Ertugliflozin 25 mg | -0.40 |
| Sitagliptin 100 mg | -0.48 |
HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | -0.10 |
| Ertugliflozin 1 mg | -0.57 |
| Ertugliflozin 5 mg | -0.76 |
| Ertugliflozin 10 mg | -0.73 |
| Ertugliflozin 25 mg | -0.75 |
| Sitagliptin 100 mg | -0.77 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 12
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -0.55 |
| Ertugliflozin 1 mg | -2.69 |
| Ertugliflozin 5 mg | -4.03 |
| Ertugliflozin 10 mg | -3.43 |
| Ertugliflozin 25 mg | -3.93 |
| Sitagliptin 100 mg | -1.09 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -1.93 |
| Ertugliflozin 1 mg | -2.30 |
| Ertugliflozin 5 mg | -4.73 |
| Ertugliflozin 10 mg | -2.28 |
| Ertugliflozin 25 mg | -5.39 |
| Sitagliptin 100 mg | -0.91 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -2.57 |
| Ertugliflozin 1 mg | -3.94 |
| Ertugliflozin 5 mg | -5.15 |
| Ertugliflozin 10 mg | -5.43 |
| Ertugliflozin 25 mg | -3.33 |
| Sitagliptin 100 mg | -3.32 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -0.44 |
| Ertugliflozin 1 mg | -1.53 |
| Ertugliflozin 5 mg | -2.85 |
| Ertugliflozin 10 mg | -3.04 |
| Ertugliflozin 25 mg | -3.30 |
| Sitagliptin 100 mg | -2.43 |
An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication. (NCT01059825)
Timeframe: Up to 84 days
| Intervention | Participants (Number) |
|---|---|
| Placebo | 1 |
| Ertugliflozin 1 mg | 1 |
| Ertugliflozin 5 mg | 3 |
| Ertugliflozin 10 mg | 2 |
| Ertugliflozin 25 mg | 1 |
| Sitagliptin 100 mg | 1 |
| Metformin Run-in | 3 |
An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin. (NCT01059825)
Timeframe: Up to 98 days
| Intervention | Participants (Number) |
|---|---|
| Placebo | 29 |
| Ertugliflozin 1 mg | 31 |
| Ertugliflozin 5 mg | 30 |
| Ertugliflozin 10 mg | 29 |
| Ertugliflozin 25 mg | 28 |
| Sitagliptin 100 mg | 30 |
| Metformin Run-in | 82 |
The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 12
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -0.75 |
| Ertugliflozin 1 mg | -1.90 |
| Ertugliflozin 5 mg | -2.50 |
| Ertugliflozin 10 mg | -2.90 |
| Ertugliflozin 25 mg | -2.66 |
| Sitagliptin 100 mg | -0.30 |
The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -0.24 |
| Ertugliflozin 1 mg | -0.65 |
| Ertugliflozin 5 mg | -1.36 |
| Ertugliflozin 10 mg | -1.14 |
| Ertugliflozin 25 mg | -1.11 |
| Sitagliptin 100 mg | 0.21 |
The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -0.44 |
| Ertugliflozin 1 mg | -1.20 |
| Ertugliflozin 5 mg | -1.76 |
| Ertugliflozin 10 mg | -1.68 |
| Ertugliflozin 25 mg | -1.52 |
| Sitagliptin 100 mg | 0.01 |
The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -0.62 |
| Ertugliflozin 1 mg | -1.65 |
| Ertugliflozin 5 mg | -2.18 |
| Ertugliflozin 10 mg | -2.30 |
| Ertugliflozin 25 mg | -2.40 |
| Sitagliptin 100 mg | -0.38 |
Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Placebo | 6.7 |
| Ertugliflozin 1 mg | 12.0 |
| Ertugliflozin 5 mg | 20.4 |
| Ertugliflozin 10 mg | 13.6 |
| Ertugliflozin 25 mg | 14.9 |
| Sitagliptin 100 mg | 25.5 |
Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Placebo | 15.6 |
| Ertugliflozin 1 mg | 44.0 |
| Ertugliflozin 5 mg | 42.9 |
| Ertugliflozin 10 mg | 38.6 |
| Ertugliflozin 25 mg | 36.2 |
| Sitagliptin 100 mg | 43.1 |
Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect. (NCT01175811)
Timeframe: Baseline, 24 weeks
| Intervention | percent HbA1c (Least Squares Mean) |
|---|---|
| Premixed Insulin | -1.05 |
| Basal-Bolus | -1.06 |
Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect. (NCT01175811)
Timeframe: Baseline, 12 weeks
| Intervention | percent HbA1c (Least Squares Mean) |
|---|---|
| Premixed Insulin | -0.96 |
| Basal-Bolus | -0.96 |
Severe hypoglycemic episode is defined as any event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The percentage of participants experiencing a severe hypoglycemic episode is defined as the 100 multiplied by the number of participants experiencing a severe hypoglycemic episode divided by the number of participants exposed to study drug. (NCT01175811)
Timeframe: baseline through 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Premixed Insulin | 0.0 |
| Basal-Bolus | 0.0 |
Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to study drug. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L). (NCT01175811)
Timeframe: baseline through 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Premixed Insulin | 54.8 |
| Basal-Bolus | 55.0 |
The rate of hypoglycemic episodes is defined as the mean number of hypoglycemic episodes per 30 days per participant. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L). (NCT01175811)
Timeframe: baseline through 24 weeks
| Intervention | hypoglycemic episode/30 days/participant (Mean) |
|---|---|
| Premixed Insulin | 0.468 |
| Basal-Bolus | 0.409 |
Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) using change from baseline in BMI at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline BMI value as a covariate and participants as a random effect. (NCT01175811)
Timeframe: Baseline, 12 weeks, and 24 weeks
| Intervention | kilogram per square meter (kg/m^2) (Least Squares Mean) | |
|---|---|---|
| Change at 12 weeks | Change at 24 weeks | |
| Basal-Bolus | 0.20 | 0.29 |
| Premixed Insulin | 0.26 | 0.31 |
(NCT01175811)
Timeframe: 24 weeks
| Intervention | International Units per kilogram (IU/kg) (Mean) | ||
|---|---|---|---|
| Total Daily Dose | Daily Insulin Dose Basal | Daily Insulin Dose Bolus (prandial) | |
| Basal-Bolus | 0.760 | 0.348 | 0.412 |
| Premixed Insulin | 0.738 | 0.440 | 0.298 |
(NCT01175811)
Timeframe: 24 weeks
| Intervention | International Units (IU) (Mean) | ||
|---|---|---|---|
| Total Daily Dose | Daily Insulin Dose Basal | Daily Insulin Dose Bolus (prandial) | |
| Basal-Bolus | 54.0 | 24.717 | 29.269 |
| Premixed Insulin | 52.9 | 31.539 | 21.385 |
7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24. (NCT01175811)
Timeframe: Baseline, 12 weeks, and 24 weeks
| Intervention | milligrams per deciliter (mg/dL) (Mean) | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Morning Pre-meal (Week 0) (n=195, 201) | Morning Pre-meal (Week 12) (n=187, 191) | Morning Pre-meal (Week 24) (n=177, 186) | Morning 2 hours Post-meal (Week 0) (n=194, 201) | Morning 2 hours Post-meal (Week 12) (n=187, 190) | Morning 2 hours Post-meal (Week 24) (n=176, 184) | Midday Pre-meal (Week 0) (n=195, 200) | Midday Pre-meal (Week 12) (n=187, 190) | Midday Pre-meal (Week 24) (n=177, 186) | Midday 2 hours Post-meal (Week 0) (n=194, 201) | Midday 2 hours Post-meal (Week 12) (n=186, 189) | Midday 2 hours Post-meal (Week 24) (n=175, 184) | Evening Pre-meal (Week 0) (n=195, 200) | Evening Pre-meal (Week 12) (n=187, 190) | Evening Pre-meal (Week 24) (n=177, 186) | Evening 2 hours Post-meal (Week 0) (n=194, 201) | Evening 2 hours Post-meal (Week 12) (n=186, 190) | Evening 2 hours Post-meal (Week 24)(n=176, 185) | 0300 Hours (3 am) (Week 0) (n=185, 193) | 0300 Hours (3 am) (Week 12) (n=177, 185) | 0300 Hours (3 am) (Week 24) (n=171, 179) | |
| Basal-Bolus | 157.7 | 136.5 | 132.4 | 213.6 | 176.5 | 165.8 | 164.9 | 149.4 | 142.1 | 227.5 | 177.2 | 171.1 | 190.0 | 157.6 | 151.1 | 209.9 | 176.2 | 165.6 | 180.0 | 163.6 | 155.8 |
| Premixed Insulin | 155.0 | 141.8 | 137.4 | 207.1 | 179.6 | 169.7 | 160.7 | 142.5 | 139.5 | 219.7 | 162.5 | 161.9 | 186.6 | 148.1 | 145.0 | 204.8 | 177.1 | 172.0 | 175.9 | 150.3 | 145.1 |
The Percentage of participants achieving a haemoglobin A1c (HbA1c) less than or equal (<=) to 6.5% or 7% is defined as 100 multiplied by the number of participants with a HbA1c of the cut-off value (6% or 7%) divided by the number of participants exposed to study drug. Participants with missing HbA1c values at endpoint were treated as not achieving the HbA1c goal. (NCT01175811)
Timeframe: 12 weeks, 24 weeks
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| <=6.5 Percent HbA1c at 12 weeks | <=7.0 Percent HbA1c at 12 weeks | <=6.5 Percent HbA1c at 24 weeks | <=7.0 Percent HbA1c at 24 weeks | |
| Basal-Bolus | 8.9 | 27.7 | 11.9 | 34.2 |
| Premixed Insulin | 6.1 | 26.4 | 9.1 | 29.9 |
Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date)and the last pre-randomisation fasting plasma glucose value, as determined by central laboratory. Full analysis set. (NCT01006603)
Timeframe: From week 0 to week 52
| Intervention | mmol/L (Mean) |
|---|---|
| Saxagliptin 5 mg | -0.73 |
| Glimepiride 1 - 6 mg | -1.29 |
Measured as the difference between the last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), and the last pre-randomisation HbA1c value, as determined by central laboratory. Full analysis set. (NCT01006603)
Timeframe: From week 0 to week 52.
| Intervention | % of glycosylated hemoglobin (Mean) |
|---|---|
| Saxagliptin 5 mg | -0.44 |
| Glimepiride 1 - 6 mg | -0.64 |
Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date) and the last pre-randomisation fasting plasma insulin value, as determined by central laboratory. Full analysis set. (NCT01006603)
Timeframe: From week 0 to week 52
| Intervention | µU/mL (Mean) |
|---|---|
| Saxagliptin 5 mg | -2.0 |
| Glimepiride 1 - 6 mg | -0.6 |
β-cell function as estimated by the homeostasis model assessment (HOMA) model. Value is derived from FPG and fasting insulin; fasting insulin values below 2.074 μU/mL or above 57.595 μU/mL and FPG values below 3 mmol/L or above 25 mmol/L are excluded (as restricted by the calculation method used). Full analysis set. (NCT01006603)
Timeframe: From week 0 to week 52
| Intervention | percentage of change from baseline (Mean) |
|---|---|
| Saxagliptin 5 mg | 3.83 |
| Glimepiride 1 - 6 mg | 16.22 |
Proportion of patients with their last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), as determined by central laboratory, below the specified limits. Full analysis set. (NCT01006603)
Timeframe: From week 0 to week 52
| Intervention | percentage of responders (Number) |
|---|---|
| Saxagliptin 5 mg | 44.7 |
| Glimepiride 1 - 6 mg | 54.7 |
"Hypoglyceamic event defined as, Confirmed hypoglycaemia: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).~Major (or severe) hypoglycaemia: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Safety analysis set." (NCT01006603)
Timeframe: From week 0 to week 52.
| Intervention | percentage of patients (Number) |
|---|---|
| Saxagliptin 5 mg | 1.1 |
| Glimepiride 1 - 6 mg | 15.3 |
"Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set.~Confirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).~Major (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT01006603)
Timeframe: From week 0 to week 52.
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| All patients | patients aged <75 years (n=217, n=216) | patients aged ≥75 years (n=142, n=143) | |
| Glimepiride 1 - 6 mg | 38.2 | 33.3 | 45.5 |
| Saxagliptin 5 mg | 37.9 | 39.2 | 35.9 |
Change from baseline in HbA1c after 52 weeks of treatment (NCT01368081)
Timeframe: Baseline and 52 weeks
| Intervention | percentage of HbA1c (Least Squares Mean) |
|---|---|
| Sulfonylurea: Empa 10mg | -0.93 |
| Sulfonylurea: Empa 25mg | -0.96 |
| Sulfonylurea: Metformin | -0.97 |
| Biguanide: Empa 10mg | -0.81 |
| Biguanide: Empa 25mg | -0.98 |
| Thiazolidinedione: Empa 10mg | -0.90 |
| Thiazolidinedione: Empa 25mg | -0.96 |
| Alpha Glucosidase Inhibitor: Empa 10mg | -0.87 |
| Alpha Glucosidase Inhibitor: Empa 25mg | -0.77 |
| DPP-IV Inhibitor: Empa 10mg | -1.00 |
| DPP-IV Inhibitor: Empa 25mg | -0.83 |
| Glinide: Empa 10mg | -0.98 |
| Glinide: Empa 25mg | -0.98 |
Number of patients with confirmed hypoglycaemic adverse events (NCT01368081)
Timeframe: After the first drug intake until 7 days after the last treatment administration, up to 383 days
| Intervention | participants (Number) |
|---|---|
| Sulfonylurea: Empa 10mg | 6 |
| Sulfonylurea: Empa 25mg | 9 |
| Sulfonylurea: Metformin | 5 |
| Biguanide: Empa 10mg | 0 |
| Biguanide: Empa 25mg | 1 |
| Thiazolidinedione: Empa 10mg | 2 |
| Thiazolidinedione: Empa 25mg | 1 |
| Alpha Glucosidase Inhibitor: Empa 10mg | 0 |
| Alpha Glucosidase Inhibitor: Empa 25mg | 0 |
| DPP-IV Inhibitor: Empa 10mg | 0 |
| DPP-IV Inhibitor: Empa 25mg | 1 |
| Glinide: Empa 10mg | 0 |
| Glinide: Empa 25mg | 2 |
Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days (NCT01368081)
Timeframe: After the first drug intake until 7 days after the last treatment administration, up to 383 days
| Intervention | participants (Number) |
|---|---|
| Sulfonylurea: Empa 10mg | 19 |
| Sulfonylurea: Empa 25mg | 25 |
| Sulfonylurea: Metformin | 13 |
| Biguanide: Empa 10mg | 13 |
| Biguanide: Empa 25mg | 9 |
| Thiazolidinedione: Empa 10mg | 20 |
| Thiazolidinedione: Empa 25mg | 19 |
| Alpha Glucosidase Inhibitor: Empa 10mg | 7 |
| Alpha Glucosidase Inhibitor: Empa 25mg | 5 |
| DPP-IV Inhibitor: Empa 10mg | 9 |
| DPP-IV Inhibitor: Empa 25mg | 18 |
| Glinide: Empa 10mg | 9 |
| Glinide: Empa 25mg | 9 |
Change in Body weight from baseline to Year 3. (NCT00359762)
Timeframe: Baseline, Year 3 in Period II
| Intervention | kg (Least Squares Mean) |
|---|---|
| Exen + Met | -3.92 |
| Glim + Met | 1.47 |
Change in DI30/DG30 ratio from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Exen + Met | 12.10 |
| Glim + Met | 0.91 |
Change in disposition index from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Exen + Met | 9.15 |
| Glim + Met | 1.82 |
Change in fasting plasma glucose from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exen + Met | -0.87 |
| Glim + Met | -0.41 |
Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Exen + Met | 0.03 |
| Glim + Met | 0.05 |
Change in HbA1c from baseline to endpoint. Endpoint for HbA1c was defined as the HbA1c measured at the treatment failure for patients reaching primary endpoint and was the last observation in study period II for other patients (either followed until the end of the study period II or discontinuing the study). (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)
| Intervention | percentage of total hemoglobin (Least Squares Mean) |
|---|---|
| Exen + Met | -0.36 |
| Glim + Met | -0.21 |
Change in HbA1c from baseline to Year 2. (NCT00359762)
Timeframe: Baseline in Period III, Year 2 in Period III
| Intervention | percentage of total hemoglobin (Mean) |
|---|---|
| Glim + Met + Exen - Not Randomized | -0.47 |
Change in HbA1c from baseline to Year 2. (NCT00359762)
Timeframe: Baseline in Period III, Year 2 in Period III
| Intervention | percentage of total hemoglobin (Least Squares Mean) |
|---|---|
| Exen + Met + Glim - Randomized | -0.19 |
| Exen + Met + Pio or Rosi - Randomized | -0.47 |
Change in HbA1c from baseline to Year 3. (NCT00359762)
Timeframe: Baseline, Year 3 in Period II
| Intervention | percentage of total hemoglobin (Least Squares Mean) |
|---|---|
| Exen + Met | -0.30 |
| Glim + Met | -0.12 |
Change in HOMA-B from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Exen + Met | 5.56 |
| Glim + Met | 19.92 |
Change from baseline in postprandial (2 hours) plasma glucose to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exen + Met | -2.72 |
| Glim + Met | -0.53 |
Diastolic Blood pressure at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Exen + Met | 77.45 |
| Glim + Met | 79.16 |
Disposition Index at Year 3. Disposition index was calculated as (DI30/DG30 ratio)/(HOMA index for insulin resistance (HOMA-IR)); where HOMA-IR=(fasting insulin (measured in pmol/L) x fasting glucose (measured in mmol/L))/(22.5 x 7.175). (NCT00359762)
Timeframe: Year 3 in Period II
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Exen + Met | 12.56 |
| Glim + Met | 7.89 |
Fasting plasma glucose at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exen + Met | 7.27 |
| Glim + Met | 7.96 |
Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Exen + Met | 0.22 |
| Glim + Met | 0.23 |
Heart rate at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II
| Intervention | beats per minute (Least Squares Mean) |
|---|---|
| Exen + Met | 73.51 |
| Glim + Met | 74.23 |
HDL Cholesterol at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exen + Met | 1.31 |
| Glim + Met | 1.25 |
HOMA-B at Year 3. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B = (20 x fasting insulin (measured in pmol/L))/((fasting glucose (measured in mmol/L) - 3.5) x 7.175). (NCT00359762)
Timeframe: Year 3 in Period II
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Exen + Met | 66.86 |
| Glim + Met | 68.52 |
All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination. (NCT00359762)
Timeframe: Baseline to end of Period II (up to 4.5 years)
| Intervention | events per subject-year (Least Squares Mean) |
|---|---|
| Exen + Met | 1.52 |
| Glim + Met | 5.32 |
All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination. (NCT00359762)
Timeframe: Start of Period III to end of study
| Intervention | events per subject-year (Mean) |
|---|---|
| Exen + Metformin + Glim - Randomized | 2.78 |
| Exen + Met + Pio or Rosi - Randomized | 0.60 |
| Glim + Met + Exen - Not Randomized | 4.62 |
Postprandial (2 hours) plasma glucose at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exen + Met | 12.65 |
| Glim + Met | 15.45 |
DI30/DG30 at Year 3. DI30/DG30 ratio was calculated as (30 minute post prandial insulin - fasting insulin) (measured in pmol/L)/(30 minute post prandial glucose - fasting glucose) (measured in mmol/L). (NCT00359762)
Timeframe: Year 3 in Period II
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Exen + Met | 25.81 |
| Glim + Met | 26.38 |
Systolic Blood pressure at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Exen + Met | 130.58 |
| Glim + Met | 135.78 |
Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents. (NCT00359762)
Timeframe: Baseline to end of Period II (up to 4.5 years)
| Intervention | week (Median) |
|---|---|
| Exen + Met | 180.0 |
| Glim + Met | 142.1 |
Total Cholesterol at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exen + Met | 4.77 |
| Glim + Met | 4.75 |
Triglycerides at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exen + Met | 1.69 |
| Glim + Met | 1.95 |
Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents. (NCT00359762)
Timeframe: Baseline to end of Period II (up to 4.5 years)
| Intervention | number of patients (Number) | |
|---|---|---|
| Number of patients with treatment failure | Number of patients censored | |
| Exen + Met | 203 | 287 |
| Glim + Met | 262 | 225 |
A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported. (NCT01517373)
Timeframe: Baseline (Day 1) up to Week 14
| Intervention | events per participant (Median) |
|---|---|
| Placebo | 0 |
| PF-04937319 10 mg | 0 |
| PF-04937319 50 mg | 0 |
| PF-04937319 100 mg | 0 |
| Glimepiride | 0 |
Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test). (NCT01517373)
Timeframe: Baseline (Day 1) up to Week 14
| Intervention | participants (Number) |
|---|---|
| Placebo | 56 |
| PF-04937319 10 mg | 52 |
| PF-04937319 50 mg | 56 |
| PF-04937319 100 mg | 54 |
| Glimepiride | 51 |
A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers. (NCT01517373)
Timeframe: Baseline (Day 1) up to Week 14
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 4.9 |
| PF-04937319 10 mg | 3.3 |
| PF-04937319 50 mg | 4.9 |
| PF-04937319 100 mg | 6.6 |
| Glimepiride | 34.4 |
(NCT01517373)
Timeframe: Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up)
| Intervention | kilogram (kg) (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Baseline (n=59, 57, 58, 61, 60) | Change at Week 2 (n=59, 57, 58, 61, 58) | Change at Week 4 (n=58, 56, 55, 59, 60) | Change at Week 6 (n=57, 54, 55, 59, 56) | Change at Week 8 (n=58, 54, 53, 58, 56) | Change at Week 12 (n=56, 52, 53, 55, 54) | Change at Week 14 (n=55, 51, 53, 55, 53) | |
| Glimepiride | 90.388 | -0.024 | 0.310 | 0.473 | 0.493 | 1.211 | 1.234 |
| PF-04937319 10 mg | 89.518 | -0.069 | -0.378 | -0.604 | -0.522 | -0.685 | -0.472 |
| PF-04937319 100 mg | 87.530 | -0.021 | -0.284 | -0.290 | -0.397 | -0.545 | -0.573 |
| PF-04937319 50 mg | 89.860 | -0.028 | -0.074 | -0.228 | -0.311 | -0.961 | -0.978 |
| Placebo | 89.859 | -0.402 | -0.620 | -0.564 | -1.082 | -1.529 | -1.478 |
(NCT01517373)
Timeframe: Baseline (Day 1), Week 2, 4, 6, 8, 12
| Intervention | milligram per deciliter (mg/dL) (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline (n=60, 59, 60, 61, 61) | Change at Week 2 (n=60, 59, 60, 61, 59) | Change at Week 4 (n=59, 58, 56, 59, 60) | Change at Week 6 (n=58, 56, 56, 59, 57) | Change at Week 8 (n=59, 56, 54, 58, 57) | Change at Week 12 (n=57, 54, 54, 55, 55) | |
| Glimepiride | 163.7 | -19.9 | -26.2 | -23.4 | -26.9 | -22.5 |
| PF-04937319 10 mg | 168.7 | -2.0 | -8.4 | -6.9 | -7.0 | -6.2 |
| PF-04937319 100 mg | 160.4 | -10.5 | -11.4 | -10.4 | -13.0 | -10.3 |
| PF-04937319 50 mg | 174.7 | -7.9 | -7.7 | -7.2 | -13.0 | -9.9 |
| Placebo | 161.3 | 3.1 | -0.5 | -2.6 | 0.9 | 3.4 |
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported. (NCT01517373)
Timeframe: Baseline (Day 1), Week 12
| Intervention | percentage of hemoglobin (Mean) | |
|---|---|---|
| Baseline (n=59, 57, 55, 60, 60) | Change at Week 12 (n=56, 53, 53, 54, 54) | |
| Glimepiride | 8.12 | -1.01 |
| PF-04937319 10 mg | 7.97 | -0.18 |
| PF-04937319 100 mg | 7.88 | -0.64 |
| PF-04937319 50 mg | 7.91 | -0.45 |
| Placebo | 7.90 | -0.13 |
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported. (NCT01517373)
Timeframe: Baseline (Day 1), Week 2, 4, 6, 8
| Intervention | percentage of hemoglobin (Mean) | ||
|---|---|---|---|
| Week 4 (n=58, 57, 55, 58, 60) | Week 6 (n=57, 55, 55, 58, 55) | Week 8 (n=58, 55, 53, 57, 55) | |
| Glimepiride | -0.54 | -0.78 | -0.89 |
| PF-04937319 10 mg | -0.07 | -0.14 | -0.17 |
| PF-04937319 100 mg | -0.32 | -0.51 | -0.59 |
| PF-04937319 50 mg | -0.22 | -0.22 | -0.38 |
| Placebo | -0.08 | -0.14 | -0.19 |
Participants who met the criteria for increase from baseline in ECG data were reported. Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline value was >200 then percent change of >25% counts; if baseline value was <=200 then percent change of >50% counts]); QRS complex (percent change of >=50%); QT Fridericia's correction (QTcF) interval (change of >= 30 to <60 millisecond [msec], and change of >=60 msec). (NCT01517373)
Timeframe: Baseline (Day 1) up to Week 14
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| PR interval: Percent change of >=25/50% | QRS interval: Percent change of >=50% | QTcF interval: Change of >=30 to <60 msec | QTcF interval: Change of >=60 msec | |
| Glimepiride | 0 | 1 | 4 | 1 |
| PF-04937319 10 mg | 0 | 1 | 5 | 2 |
| PF-04937319 100 mg | 0 | 2 | 6 | 2 |
| PF-04937319 50 mg | 1 | 1 | 8 | 2 |
| Placebo | 0 | 0 | 6 | 2 |
Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator's discretion. (NCT01517373)
Timeframe: Baseline (Day 1) up to Week 14
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Increase in systolic BP (>=30 mmHg) | Increase in diastolic BP (>=20 mmHg) | Decrease in systolic BP (>=30 mmHg) | Decrease in diastolic BP (>=20 mmHg) | |
| Glimepiride | 5 | 2 | 1 | 5 |
| PF-04937319 10 mg | 1 | 3 | 3 | 3 |
| PF-04937319 100 mg | 3 | 4 | 5 | 6 |
| PF-04937319 50 mg | 3 | 0 | 3 | 2 |
| Placebo | 2 | 1 | 5 | 4 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. (NCT01517373)
Timeframe: Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days)
| Intervention | participants (Number) | |
|---|---|---|
| AEs | SAEs | |
| Glimepiride | 36 | 1 |
| PF-04937319 10 mg | 28 | 1 |
| PF-04937319 100 mg | 29 | 1 |
| PF-04937319 50 mg | 31 | 2 |
| Placebo | 26 | 0 |
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used and data are presented in categories of less than 6.5 percent and less than 7 percent. (NCT01517373)
Timeframe: Week 12
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Less Than 6.5 Percent | Less Than 7 Percent | |
| Glimepiride | 18.2 | 45.5 |
| PF-04937319 10 mg | 13 | 31.5 |
| PF-04937319 100 mg | 27.3 | 52.7 |
| PF-04937319 50 mg | 18.5 | 27.8 |
| Placebo | 7.0 | 26.3 |
A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Median number of events per participant was reported (NCT01475461)
Timeframe: Baseline (Day 1) up to Week 14
| Intervention | events per participant (Median) |
|---|---|
| Metformin 500 mg | 0 |
| Placebo | 0 |
| PF-04937319 3 mg | 0 |
| PF-04937319 20 mg | 0 |
| PF-04937319 50 mg | 0 |
| PF-04937319 100 mg | 0 |
| Sitagliptin 100 mg | 0 |
Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal[LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test). (NCT01475461)
Timeframe: Baseline (Day 1) up to Week 14
| Intervention | participants (Number) |
|---|---|
| Placebo | 46 |
| PF-04937319 3 mg | 49 |
| PF-04937319 20 mg | 45 |
| PF-04937319 50 mg | 46 |
| PF-04937319 100 mg | 53 |
| Sitagliptin 100 mg | 43 |
A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE is defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers. (NCT01475461)
Timeframe: Baseline (Day 1) up to Week 14
| Intervention | percentage of participants (Number) |
|---|---|
| Metformin 500 mg | 0 |
| Placebo | 0 |
| PF-04937319 3 mg | 0 |
| PF-04937319 20 mg | 1 |
| PF-04937319 50 mg | 0 |
| PF-04937319 100 mg | 2 |
| Sitagliptin 100 mg | 1 |
(NCT01475461)
Timeframe: Baseline (Day 1), Week 2, 4, 8 , 12 , 14
| Intervention | kilogram (kg) (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline (n=55, 55, 50, 56, 54, 55) | Change at Week 2 (n=54, 55, 49, 56, 53, 55) | Change at Week 4 (n=51, 55, 49, 55, 53, 53) | Change at Week 8 (n=49, 53, 45, 52, 50, 52) | Change at Week 12 (n=47, 52, 45, 52, 50, 53) | Change at Week 14 (n=44, 52, 44, 52, 50, 53) | |
| PF-04937319 100 mg | 91.239 | -0.053 | -0.374 | -0.475 | -0.623 | -0.916 |
| PF-04937319 20 mg | 88.371 | -0.052 | -0.192 | -0.510 | -0.455 | -0.613 |
| PF-04937319 3 mg | 87.865 | 0.435 | 0.214 | -0.003 | -0.142 | 0.011 |
| PF-04937319 50 mg | 88.066 | -0.283 | -0.203 | -0.270 | -0.352 | -0.492 |
| Placebo | 86.446 | -0.239 | -0.704 | -0.823 | -0.804 | -0.588 |
| Sitagliptin 100 mg | 87.025 | -0.384 | -0.353 | -0.702 | -0.917 | -1.172 |
(NCT01475461)
Timeframe: Baseline (Day 1), Week 1, 2, 4, 8, 12, 14
| Intervention | milligram per deciliter (mg/dL) (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline (n=56, 56, 52, 56, 55, 55) | Change at Week 2 (n=54, 56, 50, 56, 54, 55) | Change at Week 4 (n=52, 56, 51, 55, 54, 53) | Change at Week 8 (n=50, 54, 47, 52, 51, 52) | Change at Week 12 (n=48, 53, 47, 52, 51, 53) | Change at Week 14 (n=45, 53, 46, 52, 51, 53) | |
| PF-04937319 100 mg | 164.8 | -10.8 | -9.6 | -6.5 | 3.5 | 10.2 |
| PF-04937319 20 mg | 155.1 | -3.2 | -0.2 | -2.5 | -3.8 | -3.1 |
| PF-04937319 3 mg | 159.8 | 0.7 | -0.3 | 0.7 | -2.5 | -3.5 |
| PF-04937319 50 mg | 166.1 | -6.8 | -8.3 | -15.2 | -10.8 | -1.0 |
| Placebo | 168.3 | -5.2 | -1.8 | -3.1 | -7.5 | -5.9 |
| Sitagliptin | 160.7 | -13.6 | -19.3 | -15.4 | -12.9 | -2.6 |
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than (<) 6.5 percent (%) by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported. (NCT01475461)
Timeframe: Baseline (Day 1), Week 12
| Intervention | percentage of hemoglobin (Mean) | |
|---|---|---|
| Baseline (n=50,55,48,55,53,53) | Change at Week 12 (n=46,52,45,52,50,53) | |
| PF-04937319 100 mg | 8.31 | -0.80 |
| PF-04937319 20 mg | 7.80 | -0.53 |
| PF-04937319 3 mg | 8.00 | -0.33 |
| PF-04937319 50 mg | 8.15 | -0.59 |
| Placebo | 8.01 | -0.42 |
| Sitagliptin | 7.89 | -0.79 |
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported. (NCT01475461)
Timeframe: Baseline(Day 1), Week 2, 4, 8
| Intervention | percentage of hemoglobin (Mean) | |
|---|---|---|
| Change at Week 4 (n= 50, 55, 48, 55, 53, 53) | Change at Week 8 (n=48, 53, 45, 52, 50, 51) | |
| PF-04937319 100 mg | -0.50 | -0.86 |
| PF-04937319 20 mg | -0.32 | -0.46 |
| PF-04937319 3 mg | -0.24 | -0.32 |
| PF-04937319 50 mg | -0.35 | -0.50 |
| Placebo | -0.20 | -0.36 |
| Sitagliptin | -0.52 | -0.77 |
Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline>200 then percent change of >25% counts; if baseline <=200 then percent change of >50% counts]; QRS complex (percent change of >=50%); QT Fridericia's correction (QTcF) interval (change of >=30 to <60 millisecond [msec], and change of >=60 msec). (NCT01475461)
Timeframe: Baseline (Day 1) up to Week 14
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| PR interval: Percent change of >=25/50% | QRS interval: Percent change of >=50% | QTcF interval: Change of >=30 to <60 msec | QTcF interval: Change of >=60 msec | |
| PF-04937319 100 mg | 1 | 1 | 3 | 2 |
| PF-04937319 20 mg | 0 | 1 | 3 | 0 |
| PF-04937319 3 mg | 1 | 1 | 5 | 0 |
| PF-04937319 50 mg | 0 | 1 | 3 | 1 |
| Placebo | 0 | 0 | 7 | 1 |
| Sitagliptin | 2 | 1 | 7 | 0 |
Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator's discretion. (NCT01475461)
Timeframe: Baseline (Day 1) up to Week 14
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Increase in systolic BP (>=30 mmHg) | Increase in diastolic BP (>=20 mmHg) | Decrease in systolic BP (>=30 mmHg) | Decrease in diastolic BP (>=20 mmHg) | |
| PF-04937319 100 mg | 3 | 4 | 2 | 3 |
| PF-04937319 20 mg | 2 | 0 | 1 | 6 |
| PF-04937319 3 mg | 2 | 4 | 2 | 1 |
| PF-04937319 50 mg | 1 | 1 | 1 | 1 |
| Placebo | 1 | 1 | 1 | 2 |
| Sitagliptin | 2 | 2 | 1 | 1 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. (NCT01475461)
Timeframe: Baseline (Day 1) up to 14 days after last dose (up to 101 days)
| Intervention | participants (Number) | |
|---|---|---|
| AEs | SAEs | |
| Metformin 500 mg | 37 | 0 |
| PF-04937319 100 mg | 24 | 1 |
| PF-04937319 20 mg | 19 | 1 |
| PF-04937319 3 mg | 19 | 0 |
| PF-04937319 50 mg | 16 | 0 |
| Placebo | 19 | 1 |
| Sitagliptin 100 mg | 18 | 0 |
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used and data are presented in categories of <6.5 percent and <7 percent. (NCT01475461)
Timeframe: Week 12
| Intervention | percentage of participants (Number) | |
|---|---|---|
| <6.5 percent | <7 percent | |
| PF-04937319 100 mg | 17.6 | 39.2 |
| PF-04937319 20 mg | 19.1 | 42.6 |
| PF-04937319 3 mg | 9.4 | 26.4 |
| PF-04937319 50 mg | 15.4 | 30.8 |
| Placebo | 12.5 | 22.9 |
| Sitagliptin | 32.1 | 56.6 |
Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry. Gastric emptying coefficient was derived from a mathematical formula that describes the gastric emptying rate and gives an overall index of gastric emptying. (NCT01596504)
Timeframe: 0 (7:30 clock time, prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55
| Intervention | coefficient (unit-less) (Mean) |
|---|---|
| Lixisenatide 20 µg | -0.33 |
| Liraglutide 1.2 mg | -0.34 |
| Liraglutide 1.8 mg | -0.28 |
Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry. (NCT01596504)
Timeframe: 0 (prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55
| Intervention | minutes (min) (Least Squares Mean) |
|---|---|
| Lixisenatide 20 µg | 453.56 |
| Liraglutide 1.2 mg | 175.31 |
| Liraglutide 1.8 mg | 130.49 |
Seven-point SMPG (before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime) was measured using Freestyle Precision glucometer and average of the 7 measurements was calculated. (NCT01596504)
Timeframe: Before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime on Day -3 (Baseline) and on Day 56
| Intervention | mmol/L (Mean) |
|---|---|
| Lixisenatide 20 µg | -0.69 |
| Liraglutide 1.2 mg | -0.76 |
| Liraglutide 1.8 mg | -1.2 |
(NCT01596504)
Timeframe: Day -7 (Baseline), Day 56
| Intervention | units (Mean) |
|---|---|
| Lixisenatide 20 µg | -4.7 |
| Liraglutide 1.2 mg | -4.6 |
| Liraglutide 1.8 mg | -4.0 |
C-peptide was assessed using the Electro Chemiluminescence Immuno Assay.The range of the method was 0.2 to 25 nanogram per millilitre (ng/mL) and the LOD was 0.07 ng/mL. Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in C-peptide from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration. (NCT01596504)
Timeframe: 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day-3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56
| Intervention | h*nmol/L (Least Squares Mean) |
|---|---|
| Lixisenatide 20 µg | -1.16 |
| Liraglutide 1.2 mg | 1.23 |
| Liraglutide 1.8 mg | 0.88 |
Glucagon was assessed using the radioimmunoassay. The range of the method was 4.7 to 150 picomole per litre (pmol/L). Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in glucagon from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration. (NCT01596504)
Timeframe: 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56
| Intervention | h*ng/L (Least Squares Mean) |
|---|---|
| Lixisenatide 20 µg | -16.56 |
| Liraglutide 1.2 mg | 11.58 |
| Liraglutide 1.8 mg | 5.6 |
Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The value of FPG on Day -3 was the baseline. (NCT01596504)
Timeframe: 0.5 hour (prior to standardized breakfast) on Day -3; 0.5 hour (prior to standardized breakfast) on Day 56
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lixisenatide 20 µg | 0.1 |
| Liraglutide 1.2 mg | 0.12 |
| Liraglutide 1.8 mg | 0.13 |
HbA1C was assessed using the high performance liquid chromatography method. (NCT01596504)
Timeframe: Pre-dose (Hour 0) on Day 1 (Baseline) and Day 56
| Intervention | percentage of HbA1c (Least Squares Mean) |
|---|---|
| Lixisenatide 20 µg | -0.58 |
| Liraglutide 1.2 mg | -0.66 |
| Liraglutide 1.8 mg | -0.74 |
Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 milligram per decilitre (mg/dL) with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). (NCT01596504)
Timeframe: 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 56
| Intervention | h*mmol/L (Least Squares Mean) |
|---|---|
| Lixisenatide 20 μg | -13.33 |
| Liraglutide 1.2 mg | -7.32 |
| Liraglutide 1.8 mg | -8.72 |
Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 5 hours after breakfast start (time: 5.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). (NCT01596504)
Timeframe: 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56
| Intervention | h*mmol/L (Least Squares Mean) |
|---|---|
| Lixisenatide 20 µg | -13.82 |
| Liraglutide 1.2 mg | -9.09 |
| Liraglutide 1.8 mg | -10.33 |
Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. PPG excursion was determined on Day -3 (Baseline) and Day 56 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration. (NCT01596504)
Timeframe: 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lixisenatide 20 µg | -3.26 |
| Liraglutide 1.2 mg | -1.79 |
| Liraglutide 1.8 mg | -2.5 |
(NCT01596504)
Timeframe: 0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to study drug administration on Day 57
| Intervention | kg (Least Squares Mean) |
|---|---|
| Lixisenatide 20 µg | -1.61 |
| Liraglutide 1.2 mg | -1.78 |
| Liraglutide 1.8 mg | -2.42 |
(NCT01596504)
Timeframe: 0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to IMP administration on Day 57
| Intervention | cm (Mean) |
|---|---|
| Lixisenatide 20 µg | -1.40 |
| Liraglutide 1.2 mg | -1.93 |
| Liraglutide 1.8 mg | -2.12 |
The baseline value was the 24-hour mean on Day -2/-1 determined as overall, night and daytime mean. Measurements were made every 15 minutes from 07:00 to 23:00 (daytime) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and Day 57/58. Measurements were obtained after 10 minutes in the supine resting position. (NCT01596504)
Timeframe: Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/-1 (Baseline) and Day 57/58
| Intervention | beats per minute (Least Squares Mean) |
|---|---|
| Lixisenatide 20 µg | 3.34 |
| Liraglutide 1.2 mg | 9.33 |
| Liraglutide 1.8 mg | 9.17 |
Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The 2-hour PPG test measured blood glucose 2 hours after start of a standardised breakfast. (NCT01596504)
Timeframe: Day 56
| Intervention | participants (Number) |
|---|---|
| Lixisenatide 20 µg | 35 |
| Liraglutide 1.2 mg | 13 |
| Liraglutide 1.8 mg | 11 |
Visual Analogue Scale, 100 mm in length with words anchored at each end, expressing the most positive (100 mm) and the most negative rating (0 mm), was used to assess hunger, satiety, fullness and prospective food consumption. Responses were measured as distance from the left end of the line to the mark. Mean change from baseline was calculated for each parameter separately. (NCT01596504)
Timeframe: 0.5 (8:00 clock time, prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours on Day -3; 0 (prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56
| Intervention | mm (Mean) | |||
|---|---|---|---|---|
| How hungry do you feel? | How satisfied do you feel? | How full do you feel? | How much do you think you can eat? | |
| Liraglutide 1.2 mg | -3.1 | 8.9 | 9.3 | -4.5 |
| Liraglutide 1.8 mg | -1.0 | 3.6 | 6.4 | -7.2 |
| Lixisenatide 20 µg | -3.7 | 4.5 | 4.9 | -6.4 |
The baseline value was the 24-hour means on Day -2/-1 determined as overall, night and day-time mean. Measurements were made every 15 minutes from 07:00 to 23:00 (day-time) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and at Day 57/58. Measurements were obtained after 10 minutes in the supine resting position. (NCT01596504)
Timeframe: Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/ -1 (Baseline) and Day 57/58
| Intervention | mmHg (Mean) | |
|---|---|---|
| 24-Hour Mean Systolic Blood Pressure | 24-Hour Mean Diastolic Blood Pressure | |
| Liraglutide 1.2 mg | -0.5 | 2.4 |
| Liraglutide 1.8 mg | -2.5 | 1.6 |
| Lixisenatide 20 µg | 0.4 | 0.8 |
Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point. (NCT01336023)
Timeframe: Week 0, Week 26
| Intervention | mmol/L (Mean) |
|---|---|
| IDeg | -0.17 |
| IDegLira | -0.87 |
| Liraglutide | -0.78 |
Mean of the actual doses recorded at visit 28 (Week 26). (NCT01336023)
Timeframe: Week 26
| Intervention | units (Mean) |
|---|---|
| IDeg | 53 |
| IDegLira | 38 |
Values of mean change in body weight. (NCT01336023)
Timeframe: Week 0, Week 26
| Intervention | kg (Mean) |
|---|---|
| IDeg | 1.6 |
| IDegLira | -0.5 |
| Liraglutide | -3.0 |
Values of mean change in HbA1c. (NCT01336023)
Timeframe: Week 0, week 26
| Intervention | Percentage of glycosylated haemoglobin (Mean) |
|---|---|
| IDeg | -1.44 |
| IDegLira | -1.91 |
| Liraglutide | -1.28 |
Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure. (NCT01336023)
Timeframe: Weeks 0-26
| Intervention | Events per 100 patient years of exposure (Number) |
|---|---|
| IDeg | 256.7 |
| IDegLira | 180.2 |
| Liraglutide | 22.0 |
Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate. (NCT01075282)
Timeframe: Baseline, 52 weeks
| Intervention | percentage of glycosylated hemoglobin (Least Squares Mean) |
|---|---|
| LY2189265 1.5 mg | -1.08 |
| LY2189265 0.75 mg | -0.76 |
| Insulin Glargine | -0.63 |
Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate. (NCT01075282)
Timeframe: Baseline, 26 weeks, and 78 weeks
| Intervention | percent (Least Squares Mean) | |
|---|---|---|
| 26 weeks (n=263, 266, 258) | 78 weeks (n=263, 267, 259) | |
| Insulin Glargine | -0.65 | -0.59 |
| LY2189265 0.75 mg | -0.89 | -0.62 |
| LY2189265 1.5 mg | -1.16 | -0.90 |
Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks
| Intervention | kilograms per square meter (kg/m^2) (Least Squares Mean) | ||
|---|---|---|---|
| 26 weeks (n=257, 261, 245) | 52 weeks (n=250, 252, 238) | 78 weeks (n=246, 244, 238) | |
| Insulin Glargine | 0.44 | 0.62 | 0.59 |
| LY2189265 0.75 mg | -0.50 | -0.39 | -0.39 |
| LY2189265 1.5 mg | -0.64 | -0.64 | -0.64 |
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks
| Intervention | kilogram (kg) (Least Squares Mean) | ||
|---|---|---|---|
| 26 weeks | 52 weeks | 78 weeks | |
| Insulin Glargine | 1.01 | 1.44 | 1.28 |
| LY2189265 0.75 mg | -1.47 | -1.33 | -1.54 |
| LY2189265 1.5 mg | -1.82 | -1.87 | -1.96 |
The self-monitored blood glucose (SMBG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3 AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (Daily Mean) were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks
| Intervention | millimoles per liter (mmol/L) (Least Squares Mean) | ||
|---|---|---|---|
| 26 weeks (n=199, 204, 190) | 52 weeks (n=180, 185, 176) | 78 weeks (n=172, 164, 168) | |
| Insulin Glargine | -1.58 | -1.44 | -1.47 |
| LY2189265 0.75 mg | -1.46 | -1.32 | -1.15 |
| LY2189265 1.5 mg | -1.79 | -1.69 | -1.55 |
The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a 100-mm visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks
| Intervention | units on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| EQ-5D UK, 26 weeks (n=257, 254, 249) | EQ-5D UK, 52 weeks (n=259, 260, 253) | EQ-5D UK, 78 weeks (n=259, 260, 253) | VAS, 26 weeks (n=253, 252, 243) | VAS, 52 weeks (n=260, 258, 252) | VAS, 78 weeks (n=260, 258, 252) | |
| Insulin Glargine | -0.01 | -0.04 | 0.00 | 0.8 | 1.1 | 2.2 |
| LY2189265 0.75 mg | 0.00 | 0.00 | 0.00 | 3.4 | 2.3 | 3.2 |
| LY2189265 1.5 mg | 0.01 | 0.01 | 0.01 | 3.3 | 3.2 | 3.8 |
"The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate." (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| 26 weeks (n=256, 256, 248) | 52 weeks (n=260, 261, 249) | 78 weeks (n=260, 261, 249) | |
| Insulin Glargine | -0.3 | -0.6 | -0.3 |
| LY2189265 0.75 mg | 0.1 | 0.4 | 0.3 |
| LY2189265 1.5 mg | 0.7 | 0.9 | 1.0 |
The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| 26 weeks (n=258, 258, 251) | 52 weeks (n=260, 261, 252) | 78 weeks (n=260, 261, 252) | |
| Insulin Glargine | -0.1 | 0.1 | 0.1 |
| LY2189265 0.75 mg | 0.2 | 0.2 | 0.3 |
| LY2189265 1.5 mg | 0.1 | 0.5 | 0.5 |
The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| 26 weeks (n=255, 255, 244) | 52 weeks (n=258, 259, 245) | 78 weeks (n=258, 259, 245) | |
| Insulin Glargine | 0.3 | -1.0 | -2.0 |
| LY2189265 0.75 mg | -2.4 | -4.1 | -4.7 |
| LY2189265 1.5 mg | -2.8 | -4.2 | -4.6 |
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks
| Intervention | milliseconds (msec) (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| QTcF interval, 26 weeks (n=240, 245, 229) | QTcF interval, 52 weeks (n=231, 240, 228) | QTcF interval, 78 weeks (n=221, 220, 222) | PR interval, 26 weeks (n=240, 245, 229) | PR interval, 52 weeks (n=230, 240, 227) | PR interval, 78 weeks (n=221, 220, 222) | |
| Insulin Glargine | 1.24 | 3.70 | 4.44 | 1.24 | 1.50 | 1.21 |
| LY2189265 0.75 mg | -0.10 | 1.34 | 3.44 | 2.33 | 1.88 | 3.27 |
| LY2189265 1.5 mg | -1.71 | 1.55 | 1.66 | 2.78 | 2.61 | 2.62 |
Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks
| Intervention | beats per minute (bpm) (Least Squares Mean) | ||
|---|---|---|---|
| 26 weeks (n=241, 247, 231) | 52 weeks (n=232, 242, 231) | 78 weeks (n=223, 222, 225) | |
| Insulin Glargine | -1.24 | -1.01 | -0.26 |
| LY2189265 0.75 mg | 0.90 | 0.38 | 0.47 |
| LY2189265 1.5 mg | 2.64 | 2.41 | 2.49 |
Amylase (total and pancreas-derived) and lipase concentrations were measured. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks
| Intervention | units/liter (Median) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Amylase (total), 26 weeks | Amylase (total), 52 weeks | Amylase (total), 78 weeks | Amylase (pancreas-derived), 26 weeks | Amylase (pancreas-derived), 52 weeks | Amylase (pancreas-derived), 78 weeks | Lipase, 26 weeks | Lipase, 52 weeks | Lipase, 78 weeks | |
| Insulin Glargine | 2.000 | 3.000 | 1.000 | 1.000 | 1.000 | 0.000 | -1.000 | -1.000 | -2.000 |
| LY2189265 0.75 mg | 4.000 | 5.000 | 4.000 | 3.000 | 3.000 | 2.000 | 5.000 | 4.000 | 4.000 |
| LY2189265 1.5 mg | 4.000 | 4.000 | 4.000 | 3.000 | 3.000 | 2.000 | 5.000 | 4.000 | 4.000 |
(NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks
| Intervention | picogram/milliliter (Mean) | ||
|---|---|---|---|
| 26 weeks (n=266, 267, 258) | 52 weeks (n=266, 269, 259) | 78 weeks (n=267, 269, 259) | |
| Insulin Glargine | 0.149 | 0.176 | 0.151 |
| LY2189265 0.75 mg | 0.097 | 0.132 | 0.035 |
| LY2189265 1.5 mg | 0.163 | 0.128 | 0.086 |
Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks
| Intervention | milliliter of mercury (mmHG) (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| SBP, 26 weeks (n=257, 261, 245) | SBP, 52 weeks (n=250, 252, 240) | SBP, 78 weeks (n=246, 244, 238) | DBP, 26 weeks (n=257, 261, 245) | DBP, 52 weeks (n=250, 252, 240) | DBP, 78 weeks (n=246, 244, 238) | |
| Insulin Glargine | -0.03 | 0.51 | 0.51 | -0.29 | -0.93 | -1.04 |
| LY2189265 0.75 mg | -1.60 | 0.09 | -0.59 | -0.17 | -0.19 | -0.36 |
| LY2189265 1.5 mg | -1.28 | 0.17 | -0.70 | -0.16 | -0.26 | -0.44 |
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 52, and 78 weeks
| Intervention | picomoles per liter (pmol/L) (Least Squares Mean) | |
|---|---|---|
| 52 weeks (n=232, 231, 228) | 78 weeks (n=235, 235, 232) | |
| Insulin Glargine | -3.85 | -3.65 |
| LY2189265 0.75 mg | -3.31 | -3.37 |
| LY2189265 1.5 mg | -3.91 | -3.57 |
The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-B and HOMA-2S were set at 100%. Least Squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 52, and 78 weeks
| Intervention | percentage of HOMA2 (Least Squares Mean) | |||
|---|---|---|---|---|
| HOMA2-%B, 52 weeks (n=175, 181) | HOMA2-%B, 78 weeks (n=167, 165) | HOMA2-%S, 52 weeks (n=175,181) | HOMA2-%S, 78 weeks (n=167, 165) | |
| LY2189265 0.75 mg | 24.60 | 15.66 | -2.66 | -3.62 |
| LY2189265 1.5 mg | 29.95 | 28.54 | -2.89 | -2.64 |
Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks
| Intervention | beats per minute (bpm) (Least Squares Mean) | ||
|---|---|---|---|
| 26 weeks (n=257, 260, 245) | 52 weeks (n=250, 252, 240) | 78 weeks (n=246, 244, 238) | |
| Insulin Glargine | -1.21 | -0.52 | -0.91 |
| LY2189265 0.75 mg | 0.74 | 0.51 | 0.61 |
| LY2189265 1.5 mg | 1.56 | 1.29 | 1.31 |
Number of participants achieving HbA1c levels less than 7.0% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model. (NCT01075282)
Timeframe: 26, 52, and 78 weeks
| Intervention | participants (Number) | ||
|---|---|---|---|
| 26 weeks (n=263, 266, 258) | 52 weeks (n=263, 267, 259) | 78 weeks (n=263, 267, 259) | |
| Insulin Glargine | 84 | 80 | 79 |
| LY2189265 0.75 mg | 122 | 99 | 91 |
| LY2189265 1.5 mg | 153 | 140 | 129 |
Number of participants achieving HbA1c levels less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model. (NCT01075282)
Timeframe: 26, 52, and 78 weeks
| Intervention | participants (Number) | ||
|---|---|---|---|
| 26 weeks (n=263, 266, 258) | 52 weeks (n=263, 267, 259) | 78 weeks (n=263, 267, 259) | |
| Insulin Glargine | 40 | 35 | 43 |
| LY2189265 0.75 mg | 74 | 60 | 59 |
| LY2189265 1.5 mg | 97 | 71 | 74 |
Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26, 52, and 78 weeks. (NCT01075282)
Timeframe: 26, 52, and 78 weeks
| Intervention | participants (Number) | ||
|---|---|---|---|
| 26 weeks | 52 weeks | 78 weeks | |
| Insulin Glargine | 0 | 8 | 16 |
| LY2189265 0.75 mg | 4 | 20 | 34 |
| LY2189265 1.5 mg | 2 | 11 | 24 |
Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: Baseline through 26, 52, and 78 weeks
| Intervention | participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Any CV event, 26 weeks | Any fatal CV event, 26 weeks | Any non-fatal CV event, 26 weeks | Any CV event, 52 weeks | Any fatal CV event, 52 weeks | Any non-fatal CV event, 52 weeks | Any CV event, 78 week | Any fatal CV event, 78 week | Any non-fatal CV event, 78 week | |
| Insulin Glargine | 3 | 0 | 3 | 6 | 1 | 5 | 9 | 1 | 8 |
| LY2189265 0.75 mg | 1 | 0 | 1 | 4 | 0 | 4 | 6 | 1 | 6 |
| LY2189265 1.5 mg | 2 | 0 | 2 | 3 | 0 | 3 | 3 | 0 | 3 |
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: Baseline through 26, 52, and 78 weeks
| Intervention | participants (Number) | ||
|---|---|---|---|
| 26 weeks | 52 weeks | 78 weeks | |
| Insulin Glargine | 0 | 0 | 0 |
| LY2189265 0.75 mg | 1 | 1 | 1 |
| LY2189265 1.5 mg | 1 | 2 | 2 |
LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26, 52, and 78 weeks, and at the safety follow-up visit 30 days after study drug discontinuation (83 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized. (NCT01075282)
Timeframe: Baseline, 26, 52, 78, and 83 weeks
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| 26 weeks | 52 weeks | 78 weeks | 83 weeks | |
| LY2189265 1.5 mg and 0.75 mg | 11 | 3 | 1 | 0 |
A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: 26, 52, and 78 weeks
| Intervention | participants (Number) | ||
|---|---|---|---|
| 26 weeks | 52 weeks | 78 weeks | |
| Insulin Glargine | 137 | 175 | 192 |
| LY2189265 0.75 mg | 146 | 175 | 188 |
| LY2189265 1.5 mg | 160 | 189 | 201 |
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: Baseline through 26, 52, and 78 weeks
| Intervention | events (Number) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Severe HE, 26 weeks | Severe HE, 52 weeks | Severe HE, 78 weeks | Documented symptomatic HE, 26 weeks | Documented symptomatic HE, 52 weeks | Documented symptomatic HE, 78 weeks | Asymptomatic HE, 26 weeks | Asymptomatic HE, 52 weeks | Asymptomatic HE, 78 weeks | Nocturnal HE, 26 weeks | Nocturnal HE, 52 weeks | Nocturnal HE, 78 weeks | Probable symptomatic HE, 26 weeks | Probable symptomatic HE, 52 weeks | Probable symptomatic HE, 78 weeks | |
| Insulin Glargine | 1 | 2 | 2 | 447 | 789 | 1033 | 609 | 1093 | 1358 | 240 | 519 | 635 | 20 | 22 | 26 |
| LY2189265 0.75 mg | 0 | 0 | 0 | 315 | 444 | 515 | 484 | 709 | 911 | 117 | 147 | 184 | 19 | 24 | 28 |
| LY2189265 1.5 mg | 1 | 1 | 2 | 311 | 515 | 607 | 500 | 757 | 884 | 145 | 185 | 215 | 11 | 17 | 20 |
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: Baseline through 26, 52, and 78 weeks
| Intervention | events per participant per year (Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Severe HE, 26 weeks | Severe HE, 52 weeks | Severe HE, 78 weeks | Documented symptomatic HE, 26 weeks | Documented symptomatic HE, 52 weeks | Documented symptomatic HE, 78 weeks | Asymptomatic HE, 26 weeks | Asymptomatic HE, 52 weeks | Asymptomatic HE, 78 weeks | Nocturnal HE, 26 weeks | Nocturnal HE, 52 weeks | Nocturnal HE, 78 weeks | Probable symptomatic HE, 26 weeks | Probable symptomatic HE, 52 weeks | Probable symptomatic HE, 78 weeks | |
| Insulin Glargine | 0.01 | 0.01 | 0.01 | 3.64 | 3.34 | 3.03 | 4.82 | 4.41 | 3.80 | 1.86 | 2.07 | 1.81 | 0.15 | 0.08 | 0.07 |
| LY2189265 0.75 mg | 0.00 | 0.00 | 0.00 | 2.52 | 1.97 | 1.66 | 3.58 | 2.68 | 2.38 | 0.96 | 0.65 | 0.59 | 0.14 | 0.09 | 0.07 |
| LY2189265 1.5 mg | 0.01 | 0.00 | 0.01 | 2.35 | 2.03 | 1.67 | 3.79 | 3.08 | 2.56 | 1.23 | 0.90 | 0.77 | 0.08 | 0.07 | 0.05 |
The estimated mean change in body weight after 26 weeks of treatment. (NCT01617434)
Timeframe: Week 0 to Week 26
| Intervention | kg (Mean) |
|---|---|
| Liraglutide | -3.54 |
| Placebo | -0.42 |
The estimated mean change from baseline in FPG after 26 weeks of treatment. (NCT01617434)
Timeframe: Week 0 to Week 26
| Intervention | mmol/L (Mean) |
|---|---|
| Liraglutide | -1.44 |
| Placebo | -0.16 |
The estimated mean change from baseline in HbA1c after 26 weeks of treatment. (NCT01617434)
Timeframe: Week 0 to Week 26
| Intervention | percentage of glycosylated haemoglobin (Mean) |
|---|---|
| Liraglutide | -1.30 |
| Placebo | -0.11 |
The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment. (NCT01617434)
Timeframe: Week 0 to Week 26
| Intervention | mmol/L (Mean) |
|---|---|
| Liraglutide | -2.61 |
| Placebo | -1.02 |
A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL). (NCT01617434)
Timeframe: Week 0 to Week 26 + 7 days follow up
| Intervention | Events/100 years of patient exposure (Number) |
|---|---|
| Liraglutide | 126 |
| Placebo | 83 |
Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions. (NCT01617434)
Timeframe: Week 0 to Week 26 + 7 days follow up
| Intervention | Events/100 years of patient exposure (Number) |
|---|---|
| Liraglutide | 0 |
| Placebo | 0 |
Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment (NCT01617434)
Timeframe: At Week 26
| Intervention | percentage of subjects (Number) |
|---|---|
| Liraglutide | 59.24 |
| Placebo | 14.02 |
Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment. (NCT01617434)
Timeframe: At Week 26
| Intervention | percentage of subjects (Number) |
|---|---|
| Liraglutide | 42.91 |
| Placebo | 3.60 |
An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events. (NCT01617434)
Timeframe: Week 0 to Week 26 + 7 days follow up
| Intervention | Events/1000 years of patient exposure (Number) | ||||
|---|---|---|---|---|---|
| Adverse Events | Serious Adverse Events | Severe Adverse Events | Moderate Adverse Events | Mild Adverse Events | |
| Liraglutide | 4918 | 149 | 169 | 1274 | 3474 |
| Placebo | 3737 | 101 | 101 | 1060 | 2575 |
2-hour postprandial glucose (PPG) from a liquid meal tolerance test (2-h MTT) Subject must be fasted for at least 8 hrs prior to the MTT. (NCT01646320)
Timeframe: From Baseline to Week 24
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Dapa+Saxa+Met | -73.5 |
| Pla+Saxa+Met | -38.0 |
Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weights were measured during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period. (NCT01646320)
Timeframe: From baseline to Week 24
| Intervention | kg (Least Squares Mean) |
|---|---|
| Dapa+Saxa+Met | -1.91 |
| Pla+Saxa+Met | -0.41 |
Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period (NCT01646320)
Timeframe: From Baseline to Week 24
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Dapa+Saxa+Met | -32.7 |
| Pla+Saxa+Met | -5.3 |
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period. (NCT01646320)
Timeframe: From Baseline to Week 24
| Intervention | Percentage of glycosylated hemoglobin (Least Squares Mean) |
|---|---|
| Dapa+Saxa+Met | -0.82 |
| Pla+Saxa+Met | -0.1 |
Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. (NCT01646320)
Timeframe: From baseline to week 24
| Intervention | Percentage of subjects (Number) |
|---|---|
| Dapa+Saxa+Met | 36.7 |
| Pla+Saxa+Met | 13.3 |
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue. (NCT01619059)
Timeframe: From Baseline to Week 24
| Intervention | mg/dL (Mean) |
|---|---|
| Saxagliptin 5mg + Dapagliflozin 10mg + Metformin | -37.1 |
| Placebo + Dapagliflozin 10mg + Metformin | -31.3 |
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue. (NCT01619059)
Timeframe: From Baseline to Week 24
| Intervention | mg/dL (Mean) |
|---|---|
| Saxagliptin 5mg + Dapagliflozin 10mg + Metformin | -9.1 |
| Placebo + Dapagliflozin 10mg + Metformin | -5.3 |
HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue. (NCT01619059)
Timeframe: From Baseline to Week 24
| Intervention | Percent of glycosylated haemoglobin (Mean) |
|---|---|
| Saxagliptin 5mg + Dapagliflozin 10mg + Metformin | -0.51 |
| Placebo + Dapagliflozin 10mg + Metformin | -0.16 |
Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. (NCT01619059)
Timeframe: From Baseline to Week 24
| Intervention | Percent of participants (Number) |
|---|---|
| Saxagliptin 5mg + Dapagliflozin 10mg + Metformin | 35.3 |
| Placebo + Dapagliflozin 10mg + Metformin | 23.1 |
Change from baseline in FPG after 26 weeks of treatment (NCT01664247)
Timeframe: Week 0, week 26
| Intervention | mmol/L (Mean) |
|---|---|
| IDeg | -2.60 |
| Placebo | -0.28 |
Change from baseline in HbA1c after 26 weeks of treatment (NCT01664247)
Timeframe: Week 0, week 26
| Intervention | percentage of glycosylated haemoglobin (Least Squares Mean) |
|---|---|
| IDeg | -0.99 |
| Placebo | -0.07 |
Change from baseline in mean of the 8-point profile after 26 weeks of randomised treatment. (NCT01664247)
Timeframe: Week 0, week 26
| Intervention | mmol/L (Mean) |
|---|---|
| IDeg | -2.3 |
| Placebo | -0.5 |
Change from baseline after 26 weeks of treatment in the average of the pre-breakfast self measured plasma glucose (SMPG) measured on the day of the contact and the two days immediately prior to the contact. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline. (NCT01664247)
Timeframe: Week 0, week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| IDeg | 5.88 |
| Placebo | 8.23 |
Number of treatment emergent AEs (TEAEs) from week 0 to week 26 of the randomised treatment. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. (NCT01664247)
Timeframe: Weeks 0 - 26
| Intervention | events (Number) |
|---|---|
| IDeg | 285 |
| Placebo | 252 |
Number of confirmed hypoglycaemic episodes from week 0 to 26 weeks of randomised treatment. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes. (NCT01664247)
Timeframe: Weeks 0 - 26
| Intervention | events (Number) |
|---|---|
| IDeg | 47 |
| Placebo | 9 |
Number of responders for HbA1c below 7.0%, after 26 weeks of randomised treatment. (NCT01664247)
Timeframe: After 26 weeks of randomised treatment.
| Intervention | percentage (%) of subjects (Number) |
|---|---|
| IDeg | 77.6 |
| Placebo | 35.5 |
The change from baseline in the 8-point SMPG profile after 26 weeks of randomised treatment. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline. (NCT01664247)
Timeframe: Week 0, week 26
| Intervention | mmol/L (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Before breakfast, N=170, 164 | 90 min after breakfast, N=153, 148 | Before lunch, N=151,149 | 90 min after lunch, N=152,150 | Before evening meal, N=154,148 | 90 mins after evening meal, N=147,145 | Before bedtime, N=148, 142 | Before breakfast the next day, N=164,161 | |
| IDeg | 5.85 | 7.65 | 6.33 | 7.73 | 6.77 | 7.93 | 7.21 | 6.05 |
| Placebo | 8.54 | 9.75 | 8.34 | 9.67 | 9.51 | 9.65 | 8.95 | 8.55 |
Change in subject's quality of life was evaluated using the Short-Form 36 Health Survey version 2 (SF-36®v2). Evaluations were performed at baseline and at the last treatment visit (week 26). SF-36 was assessed on a scale range of 0.65 to 80.73 for physical health and -8.81 to 81.65 for mental health respectively, where higher scores indicated a better quality of life. 0-100 scores from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. (NCT01664247)
Timeframe: Week 0, week 26
| Intervention | T-scores (Mean) | |
|---|---|---|
| Physical health | Mental health | |
| IDeg | 0.5 | 0.6 |
| Placebo | 0.0 | -0.7 |
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 from baseline in FPG after 26 weeks of treatment. (NCT01849289)
Timeframe: Week 0, week 26
| Intervention | mmol/L (Mean) |
|---|---|
| IDeg OD | -3.35 |
| IGlar OD | -3.14 |
Change from baseline in HbA1c (%) after 26 weeks of treatment. (NCT01849289)
Timeframe: Week 0, week 26
| Intervention | percentage of glycosylated haemoglobin (Mean) |
|---|---|
| IDeg OD | -1.3 |
| IGlar OD | -1.2 |
Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose < 2.8 mmol/L (50 mg/dL), or PG < 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value < 2.8 mmol/L (50 mg/dL) or PG value < 3.1 mmol/L (56 mg/dL). (NCT01849289)
Timeframe: On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)
| Intervention | Episodes/100 years of patient exposure (Number) |
|---|---|
| IDeg OD | 85 |
| IGlar OD | 97 |
Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration) (NCT01849289)
Timeframe: On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)
| Intervention | number of events (Number) |
|---|---|
| IDeg OD | 612 |
| IGlar OD | 387 |
A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment. (NCT01849289)
Timeframe: Week 26
| Intervention | participants (Number) |
|---|---|
| IDeg OD | 252 |
| IGlar OD | 114 |
Within subject Coefficient of variation(CV[%]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below. (NCT01849289)
Timeframe: Week 26
| Intervention | percentage (Mean) |
|---|---|
| IDeg OD | 10.65 |
| IGlar OD | 10.01 |
The change in the coefficient of variation (CV) of continuous glucose readings, as assessed by Continuous Glucose Monitoring (CGM) (NCT01524705)
Timeframe: At baseline, 6 months of intervention
| Intervention | percentage (Mean) |
|---|---|
| Insulin Glargine, Metformin, Exenatide | -2.43 |
| Insulin Glargine, Metformin, Prandial Insulin | 0.44 |
% of glycosylated hemoglobin in whole blood at 26 weeks (NCT01524705)
Timeframe: Baseline vs 26 weeks
| Intervention | % of HbA1C (Mean) |
|---|---|
| Insulin Glargine, Metformin, Exenatide | 7.1 |
| Insulin Glargine, Metformin, Prandial Insulin | 7.2 |
Severe hypoglycemia-documented glucose <50mg/dl (participant journal), and hypoglycemic attacks requiring hospitalization, or treatment by emergency personnel. (NCT01524705)
Timeframe: 26 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Insulin Glargine, Metformin, Exenatide | 0 |
| Insulin Glargine, Metformin, Prandial Insulin | 0 |
Weight in kg at 26 weeks minus weight at baseline. (NCT01524705)
Timeframe: Baseline vs 26 weeks
| Intervention | kg (Mean) |
|---|---|
| Insulin Glargine, Metformin, Exenatide | -4.8 |
| Insulin Glargine, Metformin, Prandial Insulin | 0.7 |
Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lixisenatide | -0.784 |
| Insulin Glulisine QD | -0.782 |
| Insulin Glulisine TID | -1.053 |
"Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID.~Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug." (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | kg (Least Squares Mean) |
|---|---|
| Lixisenatide | -0.63 |
| Insulin Glulisine QD | 1.03 |
| Insulin Glulisine TID | 1.37 |
Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lixisenatide | -0.23 |
| Insulin Glulisine QD | -0.21 |
| Insulin Glulisine TID | -0.06 |
Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | mmol/L (Mean) |
|---|---|
| Lixisenatide | -3.42 |
| Insulin Glulisine QD | -1.59 |
| Insulin Glulisine TID | -1.56 |
Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period. (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | percentage of hemoglobin (Least Squares Mean) |
|---|---|
| Lixisenatide | -0.63 |
| Insulin Glulisine QD | -0.58 |
| Insulin Glulisine TID | -0.84 |
Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | U (Least Squares Mean) |
|---|---|
| Lixisenatide | 0.7 |
| Insulin Glulisine QD | -0.06 |
| Insulin Glulisine TID | -3.13 |
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | mmol/L (Mean) |
|---|---|
| Lixisenatide | -3.93 |
| Insulin Glulisine QD | -1.62 |
| Insulin Glulisine TID | -1.87 |
The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF. (NCT01768559)
Timeframe: Week 26
| Intervention | U (Mean) |
|---|---|
| Insulin Glulisine QD | 9.97 |
| Insulin Glulisine TID | 20.24 |
The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. (NCT01768559)
Timeframe: Week 26
| Intervention | percentage of participants (Number) |
|---|---|
| Lixisenatide | 31.2 |
| Insulin Glulisine QD | 16.7 |
| Insulin Glulisine TID | 17.6 |
The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. (NCT01768559)
Timeframe: Week 26
| Intervention | percentage of participants (Number) |
|---|---|
| Lixisenatide | 29.4 |
| Insulin Glulisine QD | 24.2 |
| Insulin Glulisine TID | 26.1 |
The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data. (NCT01768559)
Timeframe: Week 26
| Intervention | percentage of participants (Number) |
|---|---|
| Lixisenatide | 22.2 |
| Insulin Glulisine QD | 9.2 |
| Insulin Glulisine TID | 10.8 |
The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug. (NCT01768559)
Timeframe: Week 26
| Intervention | percentage of participants (Number) |
|---|---|
| Lixisenatide | 64.7 |
| Insulin Glulisine QD | 36.6 |
| Insulin Glulisine TID | 30.5 |
"The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.~The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9." (NCT01768559)
Timeframe: Week 26
| Intervention | U (Mean) |
|---|---|
| Insulin Glulisine QD | 73.61 |
| Insulin Glulisine TID | 81.05 |
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant 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. (NCT01768559)
Timeframe: First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Documented symptomatic hypoglycemia | Severe symptomatic hypoglycemia | |
| Insulin Glulisine QD | 37.5 | 0.7 |
| Insulin Glulisine TID | 44.6 | 0 |
| Lixisenatide | 31.5 | 0 |
The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF. (NCT01768559)
Timeframe: Week 26
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HbA1c ≤6.5% | HbA1c <7.0% | |
| Insulin Glulisine QD | 17.8 | 38.4 |
| Insulin Glulisine TID | 30.8 | 49.2 |
| Lixisenatide | 20.5 | 42.1 |
Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Week 24
| Intervention | Units (U) (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | 36.08 |
| Insulin Glargine | 39.32 |
2-hour plasma glucose excursion = 2-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -3.91 |
| Insulin Glargine | -0.67 |
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -7.49 |
| Insulin Glargine | -4.33 |
Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, over a single day, once in a week before baseline, before visit Week 12 and before visit Week 24 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -3.23 |
| Insulin Glargine | -2.93 |
Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 3 days after the last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | kg (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -0.97 |
| Insulin Glargine | 0.48 |
Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 1 day after the last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -3.35 |
| Insulin Glargine | -3.51 |
Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of investigational medicinal product (IMP). (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | percentage of hemoglobin (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -1.82 |
| Insulin Glargine | -1.64 |
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one documented symptomatic hypoglycemia before the introduction of rescue medication and up to 1 day after the last injection of IMP. Otherwise, they were counted as missing data. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP. (NCT01476475)
Timeframe: Baseline up to Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | 67.5 |
| Insulin Glargine | 59.0 |
Participants without any post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (for HbA1c and body weight) was available and showed non-response. Otherwise, they were counted as missing data. (NCT01476475)
Timeframe: Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | 56.3 |
| Insulin Glargine | 37.3 |
Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceed the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%. (NCT01476475)
Timeframe: Baseline up to Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | 0 |
| Insulin Glargine | 0.6 |
30-minute and 1-hour plasma glucose excursion = 30-minute and 1-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | mmol/L (Least Squares Mean) | |
|---|---|---|
| 30-minute plasma glucose excursion (n=151, 152) | 1-hour plasma glucose excursion (n=150, 152) | |
| Insulin Glargine | -0.05 | -0.44 |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -1.47 | -2.34 |
The 30 minute and 1-hour PPG test measured blood glucose 30 minutes and 1-hour after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | mmol/L (Least Squares Mean) | |
|---|---|---|
| 30-minute PPG (n=151, 153) | 1-hour PPG (n=150, 153) | |
| Insulin Glargine | -3.76 | -4.10 |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -5.01 | -5.94 |
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes were associated with sufficient neuroglycopenia to induce seizure, unconsciousness or coma. All episodes in which neurological impairment was severe enough to prevent self-treatment and which were thought to place participants at risk for injury to themselves or others. (NCT01476475)
Timeframe: First dose of study drug up to 3 days after the last dose administration (maximum of 219 days)
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Documented symptomatic hypoglycemia | Severe Symptomatic Hypoglycemia | |
| Insulin Glargine (Lantus® SoloSTAR®) | 22.8 | 0.0 |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | 21.7 | 0.0 |
On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP. (NCT01476475)
Timeframe: Week 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HbA1c ≤6.5% | HbA1c <7.0% | |
| Insulin Glargine | 64.6 | 78.3 |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | 71.9 | 84.4 |
Change from baseline in body weight after 26 weeks of treatment. (NCT01973231)
Timeframe: Week 0, week 26
| Intervention | kg (Mean) |
|---|---|
| Liraglutide | -4.24 |
| Lixisenatide | -3.69 |
Change from baseline in FPG after 26 weeks of treatment. (NCT01973231)
Timeframe: Week 0, week 26
| Intervention | mmol/L (Mean) |
|---|---|
| Liraglutide | -2.904 |
| Lixisenatide | -1.644 |
Change from baseline in HbA1c after 26 weeks of treatment. (NCT01973231)
Timeframe: Week 0, week 26
| Intervention | Percent (%) glycosylated haemoglobin (Mean) |
|---|---|
| Liraglutide | -1.809 |
| Lixisenatide | -1.238 |
A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator. (NCT01973231)
Timeframe: Weeks 0-26
| Intervention | events (Number) | ||||
|---|---|---|---|---|---|
| Events | Serious | Severe | Moderate | Mild | |
| Liraglutide | 540 | 13 | 10 | 109 | 421 |
| Lixisenatide | 435 | 7 | 3 | 84 | 348 |
Subjects who achieved HbA1c below 7.0% (53 mmol/mol) after 26 weeks of treatment (yes/no). (NCT01973231)
Timeframe: After 26 weeks of treatment
| Intervention | percentage (%) of subjects (Number) | |
|---|---|---|
| Yes | No | |
| Liraglutide | 74.2 | 25.8 |
| Lixisenatide | 45.5 | 54.5 |
Subjects who achieved HbA1c below 7.0% (53 mmol/mol) and no weight gain after 26 weeks of treatment (yes/no). (NCT01973231)
Timeframe: After 26 weeks of treatment
| Intervention | percentage (%) of subjects (Number) | |
|---|---|---|
| Yes | No | |
| Liraglutide | 66.5 | 33.5 |
| Lixisenatide | 41.9 | 58.1 |
Subjects who achieved HbA1c below equal to or below 6.5% (48 mmol/mol) after 26 weeks of treatment (yes/no). (NCT01973231)
Timeframe: After 26 weeks of treatment
| Intervention | percentage (%) of subjects (Number) | |
|---|---|---|
| Yes | No | |
| Liraglutide | 54.6 | 45.4 |
| Lixisenatide | 26.2 | 73.8 |
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 from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term baseline was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as pre-treatment. Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference.~Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial." (NCT01778049)
Timeframe: Baseline and 24 weeks
| Intervention | Percentage of HbA1c (Least Squares Mean) |
|---|---|
| Lina5 (E10) | -0.53 |
| Plc (E10) | -0.21 |
| Lina5 (E25) | -0.58 |
| Plc (E25) | -0.10 |
Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24. (NCT01778049)
Timeframe: Baseline and 24 weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lina5 (E10) | -0.44 |
| Plc (E10) | 0.21 |
| Lina5 (E25) | -0.68 |
| Plc (E25) | -0.24 |
Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Efficacy analyses treated data as missing after the initiation of rescue therapy. (NCT01177384)
Timeframe: Baseline and Week 24
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Sitagliptin | -17.9 |
| Placebo | -3.5 |
A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. Efficacy analyses treated data as missing after the initiation of rescue therapy. (NCT01177384)
Timeframe: Baseline and Week 24
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Sitagliptin | -0.76 |
| Placebo | -0.14 |
(NCT01177384)
Timeframe: Up to 24 Weeks
| Intervention | Participants (Number) |
|---|---|
| Sitagliptin | 5 |
| Placebo | 2 |
(NCT01177384)
Timeframe: Up to Week 24 + 14 Day Post-Study Follow-up
| Intervention | Participants (Number) |
|---|---|
| Sitagliptin | 62 |
| Placebo | 58 |
Primary Objective: Efficacy of saxagliptin plus metformin on glycemic control compared with acarbose plus metformin in patients with T2D inadequately controlled with metformin. By Measure absolute change from baseline in HbA1c at Week 24 (NCT02243176)
Timeframe: From baseline to 24 week
| Intervention | % (HbA1c) (Least Squares Mean) |
|---|---|
| Saxagliptin | -0.82 |
| Acarbose | -0.78 |
The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis. (NCT02243176)
Timeframe: From baseline to 24 week
| Intervention | % (HbA1c) (Least Squares Mean) |
|---|---|
| Saxagliptin | -0.83 |
| Acarbose | -0.80 |
Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24 (NCT02243176)
Timeframe: From baseline to 24 week
| Intervention | mmol/l (Least Squares Mean) |
|---|---|
| Saxagliptin | -0.77 |
| Acarbose | -1.07 |
Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24 (NCT02243176)
Timeframe: From baseline to 24 week
| Intervention | kg (Least Squares Mean) |
|---|---|
| Saxagliptin | -1.36 |
| Acarbose | -2.05 |
Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24 (NCT02243176)
Timeframe: From baseline to 24 week
| Intervention | mmol/l (Least Squares Mean) |
|---|---|
| Saxagliptin | -0.99 |
| Acarbose | -1.01 |
Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function was estimated by the Homeostasis model assessment-β (HOMA-β), which was defined as fasting insulin (mU/mL) x 20 / (fasting glucose (mmol/mL) - 3.5, body weight at week 24 (NCT02243176)
Timeframe: From baseline to 24 week
| Intervention | mU/mmol (Least Squares Mean) |
|---|---|
| Saxagliptin | 20.56 |
| Acarbose | 13.08 |
Secondary Objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion (%) of patients achieving a therapeutic glycemic response defined as HbA1c<7.0% (NCT02243176)
Timeframe: 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Saxagliptin | 38.3 |
| Acarbose | 41.5 |
Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients achieving HbA1c<7.0% without GI adverse events. (NCT02243176)
Timeframe: Whole study duration
| Intervention | percentage of participants (Number) |
|---|---|
| Saxagliptin | 37.0 |
| Acarbose | 28.8 |
Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients with any gastrointestinal adverse events. (NCT02243176)
Timeframe: 24 weeks
| Intervention | percentage of participants (Number) | |
|---|---|---|
| NO | YES | |
| Acarbose | 75.3 | 24.7 |
| Saxagliptin | 94.5 | 5.5 |
(NCT00184600)
Timeframe: Week 0 (baseline), month 12
| Intervention | kilogram (Mean) |
|---|---|
| Insulin Detemir (Basal Insulin) | 1.9 |
| Insulin Aspart (Prandial Insulin) | 5.7 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 4.7 |
(NCT00184600)
Timeframe: Week 0 (baseline), month 36
| Intervention | kilograms (Mean) |
|---|---|
| Insulin Detemir (Basal Insulin) | 3.6 |
| Insulin Aspart (Prandial Insulin) | 6.4 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 5.7 |
(NCT00184600)
Timeframe: Up to month 37 (36 months of treatment plus 1 month follow-up)
| Intervention | participants (Number) |
|---|---|
| Insulin Detemir (Basal Insulin) | 227 |
| Insulin Aspart (Prandial Insulin) | 235 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 228 |
Percentage of participants who achieved the target (HbA1c below or equal to 6.5%) at Month 36 (NCT00184600)
Timeframe: Month 36
| Intervention | percentage of participants (Number) |
|---|---|
| Insulin Detemir (Basal Insulin) | 43.2 |
| Insulin Aspart (Prandial Insulin) | 44.8 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 31.9 |
Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens. (NCT00184600)
Timeframe: Month 12
| Intervention | percentage of participants (Number) |
|---|---|
| Insulin Detemir (Basal Insulin) | 17.9 |
| Insulin Aspart (Prandial Insulin) | 4.2 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 8.9 |
Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens. (NCT00184600)
Timeframe: Month 36
| Intervention | percentage of participants (Number) |
|---|---|
| Insulin Detemir (Basal Insulin) | 89 |
| Insulin Aspart (Prandial Insulin) | 82 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 88 |
The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death. (NCT00184600)
Timeframe: Month 12
| Intervention | units on a scale (Mean) |
|---|---|
| Insulin Detemir (Basal Insulin) | 0.78 |
| Insulin Aspart (Prandial Insulin) | 0.76 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 0.76 |
The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death. (NCT00184600)
Timeframe: Month 36
| Intervention | units on a scale (Mean) |
|---|---|
| Insulin Detemir (Basal Insulin) | 0.80 |
| Insulin Aspart (Prandial Insulin) | 0.77 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 0.76 |
For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group. (NCT00184600)
Timeframe: Baseline, month 12
| Intervention | mg/dL (Mean) | |||
|---|---|---|---|---|
| All timepoints excluding 3am | Fasting | Postprandial | 3am | |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | -59 | -45 | -68 | -52 |
| Insulin Aspart (Prandial Insulin) | -65 | -23 | -83 | -34 |
| Insulin Detemir (Basal Insulin) | -43 | -59 | -47 | -40 |
For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group. (NCT00184600)
Timeframe: Baseline, month 36
| Intervention | mg/dL (Mean) | |||
|---|---|---|---|---|
| All timepoints excluding 3am | Fasting | Postprandial | 3am | |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | -56 | -50 | -61 | -38 |
| Insulin Aspart (Prandial Insulin) | -67 | -49 | -85 | -27 |
| Insulin Detemir (Basal Insulin) | -58 | -47 | -67 | -45 |
HbA1c values offer evidence of the efficacy and durability of the insulin regimens. (NCT00184600)
Timeframe: Baseline, Month 12
| Intervention | percentage (%) of total haemoglobin (Mean) | |
|---|---|---|
| Baseline | Month 12 | |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 8.63 | 7.33 |
| Insulin Aspart (Prandial Insulin) | 8.55 | 7.20 |
| Insulin Detemir (Basal Insulin) | 8.45 | 7.64 |
HbA1c values offer evidence of the efficacy and durability of the insulin regimens. (NCT00184600)
Timeframe: Baseline, Month 36
| Intervention | percentage (%) of total haemoglobin (Mean) | |
|---|---|---|
| Baseline | Month 36 | |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 8.63 | 7.22 |
| Insulin Aspart (Prandial Insulin) | 8.55 | 7.04 |
| Insulin Detemir (Basal Insulin) | 8.45 | 7.11 |
Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%. (NCT00184600)
Timeframe: Month 12
| Intervention | hypoglycaemic events/participant/year (Median) | |||||||
|---|---|---|---|---|---|---|---|---|
| All participants, Grade 1 | All participants, Grade 2 | All participants, Grade 3 | All participants, Grade 2 or 3 | Achieved HbA1c target, Grade 1, n=18, 50, 39 | Achieved HbA1c target, Grade 2, n=18, 50, 39 | Achieved HbA1c target, Grade 3, n=18, 50, 39 | Achieved HbA1c target, Grade 2 or 3, n=18, 50, 39 | |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 5.0 | 3.9 | 0 | 3.9 | 5.4 | 4.0 | 0 | 4.0 |
| Insulin Aspart (Prandial Insulin) | 8.0 | 8.0 | 0 | 8.0 | 7.8 | 8.0 | 0 | 8.7 |
| Insulin Detemir (Basal Insulin) | 2.0 | 0 | 0 | 0 | 3.9 | 3.0 | 0 | 3.0 |
Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%. (NCT00184600)
Timeframe: Month 36
| Intervention | hypoglycaemic events/participant/year (Median) | |||||||
|---|---|---|---|---|---|---|---|---|
| All participants, Grade 1 | All participants, Grade 2 | All participants, Grade 3 | All participants, Grade 2 or 3 | Achieved HbA1c target, Grade 1, n=73, 70, 55 | Achieved HbA1c target, Grade 2, n=73, 70, 55 | Achieved HbA1c target, Grade 3, n=73, 70, 55 | Achieved HbA1c target, Grade 2 or 3, n=73, 70, 55 | |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 3.8 | 3.0 | 0 | 3.0 | 3.0 | 2.7 | 0 | 3.0 |
| Insulin Aspart (Prandial Insulin) | 5.7 | 5.5 | 0 | 5.7 | 5.7 | 5.3 | 0 | 5.5 |
| Insulin Detemir (Basal Insulin) | 2.7 | 1.7 | 0 | 1.7 | 3.0 | 2.0 | 0 | 2.0 |
Two participant counts are listed. The first is the percentage of total participants who achieved the target (HbA1c below or equal to 6.5%) at Month 12. The second is the percentage of subset of participants who achieved the target and did not have either minor or major hypoglycaemic episode within the four weeks prior to the month 12 exam. Minor hypoglycaemic episode is an episode in which the participant was able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major hypoglycaemic episode is an episode in which the participant was unable to treat her/himself. (NCT00184600)
Timeframe: Month 12
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Total participants who achieved target | Subset who achieved target, n=18, 50, 39 | |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 17.0 | 52.5 |
| Insulin Aspart (Prandial Insulin) | 23.9 | 43.9 |
| Insulin Detemir (Basal Insulin) | 8.1 | 78.9 |
Change from baseline at Week 30 was defined as Week 30 minus Week 0. (NCT00701090)
Timeframe: Week 0 to Week 30
| Intervention | Kilograms (Least Squares Mean) |
|---|---|
| Sitagliptin | -0.8 |
| Glimepiride | 1.2 |
Change from baseline at Week 30 was defined as Week 30 minus Week 0. (NCT00701090)
Timeframe: Week 0 to Week 30
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Sitagliptin | -14.6 |
| Glimepiride | -17.5 |
Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent. (NCT00701090)
Timeframe: Week 0 to Week 30
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Sitagliptin | -0.47 |
| Glimepiride | -0.54 |
(NCT00701090)
Timeframe: Week 30
| Intervention | Percentage of Participants (Number) |
|---|---|
| Sitagliptin | 21.2 |
| Glimepiride | 27.5 |
(NCT00701090)
Timeframe: Week 30
| Intervention | Percentage of Participants (Number) |
|---|---|
| Sitagliptin | 52.4 |
| Glimepiride | 59.6 |
(NCT00701090)
Timeframe: Week 0 to Week 30
| Intervention | Percentage of Participants (Number) |
|---|---|
| Sitagliptin | 7.0 |
| Glimepiride | 22.0 |
(NCT00789191)
Timeframe: Week 0, Week 26
| Intervention | kg/m^2 (Mean) |
|---|---|
| Comb | -0.30 |
| Sita | -0.58 |
(NCT00789191)
Timeframe: Week 0, Week 26
| Intervention | kg (Mean) |
|---|---|
| Comb | -0.81 |
| Sita | -1.66 |
(NCT00789191)
Timeframe: Week 26
| Intervention | mmol/L (Mean) |
|---|---|
| Comb | 6.08 |
| Sita | 8.52 |
(NCT00789191)
Timeframe: Week 26
| Intervention | Percent (%) glycosylated haemoglobin (Mean) |
|---|---|
| Comb | 7.08 |
| Sita | 7.64 |
Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L (NCT00789191)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) | |||
|---|---|---|---|---|
| Overall | Minor | Symptoms Only | Unclassified | |
| Comb | 1 | 0 | 0 | 0 |
| Sita | 1 | 0 | 0 | 0 |
Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L (NCT00789191)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) | |||
|---|---|---|---|---|
| Overall | Minor | Symptoms Only | Unclassified | |
| Comb | 1 | 0 | 0 | 0 |
| Sita | 1 | 0 | 0 | 0 |
Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L (NCT00789191)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) | |||
|---|---|---|---|---|
| Overall | Minor | Symptoms Only | Unclassified | |
| Comb | 0 | 0 | 0 | 0 |
| Sita | 0 | 0 | 0 | 0 |
(NCT00789191)
Timeframe: Week 26
| Intervention | Subjects (Number) | |
|---|---|---|
| Target achieved | Target not achieved | |
| Comb | 20 | 83 |
| Sita | 11 | 95 |
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia (NCT00789191)
Timeframe: Week 26
| Intervention | Subjects (Number) | |
|---|---|---|
| Target achieved | Target not achieved | |
| Comb | 15 | 88 |
| Sita | 8 | 98 |
(NCT00789191)
Timeframe: Week 26
| Intervention | Subjects (Number) | |
|---|---|---|
| Target achieved | Target not achieved | |
| Comb | 46 | 57 |
| Sita | 25 | 81 |
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia (NCT00789191)
Timeframe: Week 26
| Intervention | Subjects (Number) | |
|---|---|---|
| Target achieved | Target not achieved | |
| Comb | 37 | 66 |
| Sita | 21 | 85 |
(NCT00789191)
Timeframe: Week 26
| Intervention | mmol/L (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Before breakfast | 120 minutes after start of breakfast | Before Lunch | 120 minutes after start of lunch | Before dinner | 120 minutes after start of dinner | Bedtime | At 03:00 A.M. | Before breakfast the following day | |
| Comb | 6.16 | 8.82 | 6.99 | 8.69 | 7.85 | 9.30 | 8.38 | 6.85 | 6.07 |
| Sita | 8.17 | 10.50 | 8.01 | 9.99 | 8.61 | 10.20 | 9.42 | 8.02 | 7.87 |
Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0) (NCT00434954)
Timeframe: Baseline and 26 weeks
| Intervention | kg/m^2 (Least Squares Mean) |
|---|---|
| Exenatide Twice Daily | -1.39 |
| Premixed Insulin Aspart Twice Daily | 0.32 |
Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0) (NCT00434954)
Timeframe: Baseline and 26 weeks
| Intervention | kg (Least Squares Mean) |
|---|---|
| Exenatide Twice Daily | -4.10 |
| Premixed Insulin Aspart Twice Daily | 1.02 |
Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0) (NCT00434954)
Timeframe: Baseline and 26 weeks
| Intervention | Percentage of glycosylated hemoglobin (Least Squares Mean) |
|---|---|
| Exenatide Twice Daily | -1.00 |
| Premixed Insulin Aspart Twice Daily | -1.14 |
Risk for first hypoglycemic episode (blood glucose <=3.9 mmol/L or severe episode) to occur up to week 26 (NCT00434954)
Timeframe: 26 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Exenatide Twice Daily | 8.0 |
| Premixed Insulin Aspart Twice Daily | 20.5 |
Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%] (NCT00434954)
Timeframe: 26 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Exenatide Twice Daily | 1.8 |
| Premixed Insulin Aspart Twice Daily | 6.3 |
Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) [i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%]. (NCT00434954)
Timeframe: 26 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Exenatide Twice Daily | 3.9 |
| Premixed Insulin Aspart Twice Daily | 7.0 |
Percentage of subjects achieving HbA1c target of < 6.5% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 6.5% divided by total number of subjects times 100%]. (NCT00434954)
Timeframe: 26 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Exenatide Twice Daily | 27.6 |
| Premixed Insulin Aspart Twice Daily | 24.9 |
Percentage of subjects achieving HbA1c target of < 7.0% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 7.0% divided by total number of subjects times 100%]. (NCT00434954)
Timeframe: 26 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Exenatide Twice Daily | 49.2 |
| Premixed Insulin Aspart Twice Daily | 56.6 |
7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am). (NCT00434954)
Timeframe: Baseline and 26 weeks
| Intervention | mg/dL (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-breakfast at baseline (week 0) | Pre-breakfast at endpoint (week 26) | 2 hrs post-breakfast at baseline (week 0) | 2 hrs post-breakfast at endpoint (week 26) | Pre-lunch at baseline (week 0) | Pre-lunch at endpoint (week 26) | 2 hrs post-lunch at baseline (week 0) | 2 hrs post-lunch at endpoint (week 26) | Pre-dinner at baseline (week 0) | Pre-dinner at endpoint (week 26) | 2 hrs post-dinner at baseline (week 0) | 2 hrs post-dinner at endpoint (week 26) | 3:00 am at baseline (week 0) | 3:00 am at endpoint (week 26) | |
| Exenatide Twice Daily | 8.933 | 7.774 | 10.821 | 8.014 | 8.443 | 7.506 | 9.698 | 8.513 | 8.684 | 7.616 | 10.241 | 7.727 | 8.323 | 7.518 |
| Premixed Insulin Aspart Twice Daily | 9.005 | 7.293 | 10.902 | 8.304 | 8.357 | 6.656 | 9.899 | 8.216 | 8.759 | 7.194 | 10.259 | 8.143 | 8.475 | 6.999 |
Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26) (NCT00434954)
Timeframe: Baseline and 26 weeks
| Intervention | mmol/L (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Total cholesterol at baseline (week 0) | Total cholesterol at endpoint (week 26) | HDL cholesterol at baseline (week 0) | HDL cholesterol at endpoint (week 26) | LDL cholesterol (calculated) at baseline (week 0) | LDL cholesterol (calculated) at endpoint (week 26) | Triglycerides at baseline (week 0) | Triglycerides at endpoint (week 26) | |
| Exenatide Twice Daily | 5.147 | 4.971 | 1.234 | 1.244 | 2.845 | 2.738 | 2.391 | 2.234 |
| Premixed Insulin Aspart Twice Daily | 5.084 | 5.050 | 1.255 | 1.319 | 2.768 | 2.852 | 2.410 | 2.006 |
Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction. (NCT00434954)
Timeframe: Baseline and 26 weeks
| Intervention | scores on DTSQ scale (Mean) | |
|---|---|---|
| DTSQ score at baseline (week 0) | DTSQ score at endpoint (week 26) | |
| Exenatide Twice Daily | 29.5 | 30.6 |
| Premixed Insulin Aspart Twice Daily | 29.7 | 29.3 |
SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores > 50 indicate an above-average health status. (NCT00434954)
Timeframe: Baseline and 26 weeks
| Intervention | scores on SF-12 scale (Mean) | |||
|---|---|---|---|---|
| Physical Component at baseline (week 0) | Physical Component at endpoint (week 26) | Mental Component at baseline (week 0) | Mental Component at endpoint (week 26) | |
| Exenatide Twice Daily | 35.5 | 39.1 | 31.3 | 31.1 |
| Premixed Insulin Aspart Twice Daily | 36.3 | 37.7 | 28.3 | 29.6 |
Change from baseline at Week 104 is defined as Week 104 minus Week 0. (NCT00094770)
Timeframe: Baseline and Week 104
| Intervention | Kilograms (Least Squares Mean) |
|---|---|
| Sitagliptin 100 mg | -1.6 |
| Glipizide | 0.7 |
Change from baseline at Week 52 is defined as Week 52 minus Week 0. (NCT00094770)
Timeframe: Baseline and Week 52
| Intervention | Kilograms (Least Squares Mean) |
|---|---|
| Sitagliptin 100 mg | -1.5 |
| Glipizide | 1.1 |
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent. (NCT00094770)
Timeframe: Baseline and Week 104
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Sitagliptin 100 mg | -0.54 |
| Glipizide | -0.51 |
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent. (NCT00094770)
Timeframe: Baseline and Week 52
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Sitagliptin 100 mg | -0.67 |
| Glipizide | -0.67 |
Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs. (NCT00094770)
Timeframe: Baseline to Week 104
| Intervention | Participants (Number) |
|---|---|
| Sitagliptin 100 mg | 18 |
| Glipizide | 21 |
Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia. (NCT00094770)
Timeframe: Baseline to Week 104
| Intervention | Participants (Number) | ||
|---|---|---|---|
| Participants with one or more Hypoglycemic AEs | Total number of Hypoglycemic episodes | Participants with no Hypoglycemic AEs | |
| Glipizide | 199 | 805 | 385 |
| Sitagliptin 100 mg | 31 | 57 | 557 |
Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia. (NCT00094770)
Timeframe: Baseline to Week 52
| Intervention | Participants (Number) | ||
|---|---|---|---|
| Participants with one or more Hypoglycemic AEs | Total number of Hypoglycemic episodes | Participants with no Hypoglycemic AEs | |
| Glipizide | 187 | 657 | 397 |
| Sitagliptin 100 mg | 29 | 50 | 559 |
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. (NCT00094770)
Timeframe: Baseline to Week 104
| Intervention | Participants (Number) | |
|---|---|---|
| With CAES | Without CAES | |
| Glipizide | 480 | 104 |
| Sitagliptin 100 mg | 452 | 136 |
Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs. (NCT00094770)
Timeframe: Baseline to Week 104
| Intervention | Participants (Number) | |
|---|---|---|
| With drug related CAEs | Without drug related CAEs | |
| Glipizide | 193 | 391 |
| Sitagliptin 100 mg | 97 | 491 |
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. (NCT00094770)
Timeframe: Baseline to Week 104
| Intervention | Participants (Number) | |
|---|---|---|
| With LAEs | Without LAEs | |
| Glipizide | 74 | 510 |
| Sitagliptin 100 mg | 85 | 503 |
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. (NCT00094770)
Timeframe: Baseline to Week 104
| Intervention | Participants (Number) | |
|---|---|---|
| With serious CAEs | Without serious CAEs | |
| Glipizide | 73 | 511 |
| Sitagliptin 100 mg | 64 | 524 |
Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00094770)
Timeframe: Baseline to Week 104
| Intervention | Participants (Number) | |
|---|---|---|
| With serious LAEs | Without serious LAEs | |
| Glipizide | 0 | 584 |
| Sitagliptin 100 mg | 0 | 588 |
Change in body weight from baseline to endpoint (Week 20) (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | kg (Least Squares Mean) |
|---|---|
| Exenatide + Placebo | -2.58 |
| Exenatide + Sitagliptin | -2.20 |
Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20) (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide + Placebo | 0.06 |
| Exenatide + Sitagliptin | -0.55 |
Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%] (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | Percent HbA1c (Least Squares Mean) |
|---|---|
| Exenatide + Placebo | -0.38 |
| Exenatide + Sitagliptin | -0.68 |
Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20) (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide + Placebo | -0.03 |
| Exenatide + Sitagliptin | -0.01 |
Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20) (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide + Placebo | 0.06 |
| Exenatide + Sitagliptin | 0.10 |
Change in total cholesterol from baseline to endpoint (Week 20) (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide + Placebo | 0.09 |
| Exenatide + Sitagliptin | 0.08 |
Change in triglycerides from baseline to endpoint (Week 20) (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide + Placebo | 0.17 |
| Exenatide + Sitagliptin | -0.07 |
Change in waist circumference from baseline to endpoint (Week 20) (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | cm (Least Squares Mean) |
|---|---|
| Exenatide + Placebo | -3.25 |
| Exenatide + Sitagliptin | -2.36 |
Incidence of confirmed hypoglycemia experienced overall during the study (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | Participants (Number) |
|---|---|
| Exenatide + Placebo | 1 |
| Exenatide + Sitagliptin | 2 |
Incidence of hypoglycemic episodes experienced overall during the study (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | Participants (Number) |
|---|---|
| Exenatide + Placebo | 5 |
| Exenatide + Sitagliptin | 10 |
Incidence of nocturnal hypoglycemia experienced overall during the study (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | Participants (Number) |
|---|---|
| Exenatide + Placebo | 0 |
| Exenatide + Sitagliptin | 3 |
Incidence of severe hypoglycemia experienced overall during the study (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | Participants (Number) |
|---|---|
| Exenatide + Placebo | 1 |
| Exenatide + Sitagliptin | 0 |
Percentage of patients whose baseline HbA1c was > 6.5% achieving HbA1c <=6.5% at endpoint (Week 20) (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | Percentage (Number) |
|---|---|
| Exenatide + Placebo | 16.5 |
| Exenatide + Sitagliptin | 20.7 |
Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20) (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | Percentage (Number) |
|---|---|
| Exenatide + Placebo | 29.5 |
| Exenatide + Sitagliptin | 44.3 |
Percentage of patients whose baseline HbA1c was >=7.0% achieving HbA1c <7.0% at endpoint (Week 20) (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | Percentage (Number) |
|---|---|
| Exenatide + Placebo | 26.6 |
| Exenatide + Sitagliptin | 41.7 |
7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20) (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide + Placebo | 8.57 |
| Exenatide + Sitagliptin | 8.16 |
Change in waist-to-hip ratio from baseline to endpoint (Week20) (NCT00870194)
Timeframe: Baseline to 20 Weeks
| Intervention | Ratio (Least Squares Mean) |
|---|---|
| Exenatide + Placebo | -0.01 |
| Exenatide + Sitagliptin | -0.00 |
The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group. (NCT00642278)
Timeframe: Day 1 (Baseline) and Week 12
| Intervention | kg (Mean) |
|---|---|
| Placebo | -0.78 |
| Canagliflozin 50 mg Daily | -1.96 |
| Canagliflozin 100 mg Daily | -2.25 |
| Canagliflozin 200 mg Daily | -2.32 |
| Canagliflozin 300 mg Daily | -2.88 |
| Canagliflozin 300 mg Twice Daily | -2.87 |
| Sitagliptin 100 mg Daily | -0.43 |
The table below shows the mean change in FPG from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change. (NCT00642278)
Timeframe: Day 1 (Baseline) and Week 12
| Intervention | mmol/L (Mean) |
|---|---|
| Placebo | 0.2 |
| Canagliflozin 50 mg Daily | -0.9 |
| Canagliflozin 100 mg Daily | -1.4 |
| Canagliflozin 200 mg Daily | -1.5 |
| Canagliflozin 300 mg Daily | -1.4 |
| Canagliflozin 300 mg Twice Daily | -1.3 |
| Sitagliptin 100 mg Daily | -0.7 |
The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change. (NCT00642278)
Timeframe: Day 1 (Baseline) and Week 12
| Intervention | Percent (Mean) |
|---|---|
| Placebo | -0.22 |
| Canagliflozin 50 mg Daily | -0.79 |
| Canagliflozin 100 mg Daily | -0.76 |
| Canagliflozin 200 mg Daily | -0.70 |
| Canagliflozin 300 mg Daily | -0.92 |
| Canagliflozin 300 mg Twice Daily | -0.95 |
| Sitagliptin 100 mg Daily | -0.74 |
The table below shows the mean change in overnight urine glucose/creatinine ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change. (NCT00642278)
Timeframe: Day 1 (Baseline) and Week 12
| Intervention | mg/mg (Mean) |
|---|---|
| Placebo | 1.9 |
| Canagliflozin 50 mg Daily | 35.4 |
| Canagliflozin 100 mg Daily | 51.5 |
| Canagliflozin 200 mg Daily | 50.5 |
| Canagliflozin 300 mg Daily | 49.4 |
| Canagliflozin 300 mg Twice Daily | 61.6 |
| Sitagliptin 100 mg Daily | -1.9 |
The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change. (NCT00642278)
Timeframe: Day 1 (Baseline) and Week 12
| Intervention | Percent change (Mean) |
|---|---|
| Placebo | -1.1 |
| Canagliflozin 50 mg Daily | -2.3 |
| Canagliflozin 100 mg Daily | -2.6 |
| Canagliflozin 200 mg Daily | -2.7 |
| Canagliflozin 300 mg Daily | -3.4 |
| Canagliflozin 300 mg Twice Daily | -3.4 |
| Sitagliptin 100 mg Daily | -0.6 |
The table below shows the percentage of patients who experienced symptomatic hypoglycemic events between Baseline and Week 12. (NCT00642278)
Timeframe: Up to Week 12
| Intervention | Percentage of patients (Number) |
|---|---|
| Placebo | 2 |
| Canagliflozin 50 mg Daily | 0 |
| Canagliflozin 100 mg Daily | 2 |
| Canagliflozin 200 mg Daily | 6 |
| Canagliflozin 300 mg Daily | 0 |
| Canagliflozin 300 mg Twice Daily | 3 |
| Sitagliptin 100 mg Daily | 5 |
This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis). (NCT00740051)
Timeframe: Baseline and week 18
| Intervention | mg/dl (Mean) |
|---|---|
| Placebo | 7.2 |
| Linagliptin | -13.3 |
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report. (NCT00740051)
Timeframe: Baseline and week 18
| Intervention | percent (Mean) |
|---|---|
| Placebo | 0.21 |
| Linagliptin | -0.39 |
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. (NCT00740051)
Timeframe: Baseline and week 18
| Intervention | percent (Mean) |
|---|---|
| Placebo | 0.14 |
| Linagliptin | -0.44 |
Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. (NCT00740051)
Timeframe: Week 18
| Intervention | percent of patients (Number) |
|---|---|
| Placebo | 17.8 |
| Linagliptin | 36.1 |
Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. (NCT00740051)
Timeframe: Week 18
| Intervention | percent of patients (Number) |
|---|---|
| Placebo | 2.9 |
| Linagliptin | 8.9 |
Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. (NCT00740051)
Timeframe: Week 18
| Intervention | percent of patients (Number) |
|---|---|
| Placebo | 11.8 |
| Linagliptin | 23.5 |
This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG. (NCT00740051)
Timeframe: Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52
| Intervention | mg/dL (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Change from baseline at week 6 (N=63, 134) | Change from baseline at week 12 (N=55,92) | Change from baseline at week 18 (N=47, 115) | Change from baseline at week 22 (N=46, 110) | Change from baseline at week 26 (N=50, 108) | Change from baseline at week 30 (N=48, 95) | Change from baseline at week 34 (N=48, 95) | Change from baseline at week 40 (N=47, 92) | Change from baseline at week 46 (N=47, 92) | Change from baseline at week 52 (N=43, 86) | |
| Linagliptin | -8.4 | -14.3 | -12.9 | -14.0 | -17.0 | -19.1 | -15.8 | -19.0 | -18.1 | -14.0 |
| Placebo/Glimepiride | 9.7 | 5.4 | 5.0 | -19.3 | -22.6 | -31.4 | -25.6 | -19.5 | -22.8 | -19.1 |
HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent. (NCT00740051)
Timeframe: Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52
| Intervention | percent (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Change from baseline at week 6 (N=64, 136) | Change from baseline at week 12 (N=57, 129) | Change from baseline at week 18 (N=47, 118) | Change from baseline at week 22 (N=46, 113) | Change from baseline at week 26 (N=50, 110) | Change from baseline at week 30 (N=49, 98) | Change from baseline at week 34 (N=50, 96) | Change from baseline at week 40 (N=49, 94) | Change from baseline at week 46 (N=45, 92) | Change from baseline at week 52 (N=45, 92) | |
| Linagliptin | -0.21 | -0.43 | -0.38 | -0.40 | -0.48 | -0.49 | -0.49 | -0.45 | -0.42 | -0.44 |
| Placebo/Glimepiride | 0.26 | 0.26 | 0.10 | -0.32 | -0.53 | -0.79 | -0.75 | -0.73 | -0.78 | -0.72 |
Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. (NCT00106704)
Timeframe: Baseline and 24 Weeks
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Sitagliptin | -0.45 |
| Placebo/ Pioglitazone | 0.28 |
The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG. (NCT00106704)
Timeframe: Baseline and 24 Weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Sitagliptin | -4.4 |
| Placebo/ Pioglitazone | 15.7 |
94 reviews available for metformin and Hypoglycemia
| Article | Year |
|---|---|
Metformin for pregnancy and beyond: the pros and cons.
Topics: Administration, Oral; Child; Diabetes Mellitus, Type 2; Diabetes, Gestational; Female; Gestational W | 2022 |
Metformin plus a low hypoglycemic risk antidiabetic drug vs. metformin monotherapy for untreated type 2 diabetes mellitus: A meta-analysis of randomized controlled trials.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy, Combinat | 2022 |
Effect and Safety of Adding Metformin to Insulin Therapy in Treating Adolescents With Type 1 Diabetes Mellitus: An Updated Meta-Analysis of 10 Randomized Controlled Trials.
Topics: Adolescent; Diabetes Mellitus, Type 1; Glycated Hemoglobin; Humans; Hypoglycemia; Hypoglycemic Agent | 2022 |
Systematic review and meta-analysis of head-to-head trials comparing sulfonylureas and low hypoglycaemic risk antidiabetic drugs.
Topics: Adolescent; Adult; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Dipeptidyl-Peptida | 2022 |
Short-term neonatal outcomes in women with gestational diabetes treated using metformin versus insulin: a systematic review and meta-analysis of randomized controlled trials.
Topics: Birth Weight; Diabetes, Gestational; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Infant, Newb | 2023 |
Clinical Evidence and Practice-Based Guidelines on the Utility of Basal Insulin Combined Oral Therapy (Metformin and Glimepiride) in the Current Era.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Humans; Hypoglycemia; Hypoglyce | 2023 |
Metformin versus insulin for gestational diabetes: a systematic review and meta-analysis.
Topics: Diabetes, Gestational; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Infant, Newborn; Insulin; | 2021 |
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 |
Oral antidiabetes agents for the management of inpatient hyperglycaemia: so far, yet so close.
Topics: Administration, Oral; Dipeptidyl-Peptidase IV Inhibitors; Hospitalization; Humans; Hyperglycemia; Hy | 2020 |
Incretin mimetics and sodium-glucose co-transporter 2 inhibitors as monotherapy or add-on to metformin for treatment of type 2 diabetes: a systematic review and network meta-analysis.
Topics: Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therap | 2021 |
Efficacy and safety of a sodium-glucose co-transporter-2 inhibitor versus placebo as an add-on therapy for people with type 2 diabetes inadequately treated with metformin and a dipeptidyl peptidase-4 inhibitor: a systematic review and meta-analysis of ran
Topics: Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy, Combination; Humans; Hy | 2021 |
Glucose-lowering action through targeting islet dysfunction in type 2 diabetes: Focus on dipeptidyl peptidase-4 inhibition.
Topics: Asia, Eastern; Asian People; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl Peptidase 4; Dipep | 2021 |
Clinical Perspectives on the Use of Subcutaneous and Oral Formulations of Semaglutide.
Topics: Administration, Oral; Body Weight; Cardiovascular Diseases; Comorbidity; Decision Making; Diabetes M | 2021 |
SODIUM GLUCOSE COTRANSPORTER 2 AND DIPEPTIDYL PEPTIDASE-4 INHIBITION: PROMISE OF A DYNAMIC DUO.
Topics: Adamantane; Benzhydryl Compounds; Blood Glucose; Canagliflozin; Diabetes Mellitus, Type 2; Dipeptide | 2017 |
Non-severe Hypoglycemia Risk Difference between Sulfonylurea and Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2-I) as an Add-On to Metformin in Randomized Controlled Trials.
Topics: Blood Glucose; Drug Therapy, Combination; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Male; M | 2017 |
Efficacy and safety of sodium-glucose cotransporter-2 inhibitors versus dipeptidyl peptidase-4 inhibitors as monotherapy or add-on to metformin in patients with type 2 diabetes mellitus: A systematic review and meta-analysis.
Topics: Anti-Obesity Agents; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Resistance; | 2018 |
The care of pregestational and gestational diabetes and drug metabolism considerations.
Topics: Animals; Blood Glucose; Diabetes, Gestational; Female; Glyburide; Humans; Hypoglycemia; Hypoglycemic | 2017 |
Pharmacological Management of Gestational Diabetes Mellitus.
Topics: Acarbose; Blood Glucose; Diabetes, Gestational; Female; Glyburide; Humans; Hypoglycemia; Hypoglycemi | 2017 |
Oral anti-diabetic agents for women with established diabetes/impaired glucose tolerance or previous gestational diabetes planning pregnancy, or pregnant women with pre-existing diabetes.
Topics: Administration, Oral; Diabetes Mellitus; Diabetes, Gestational; Female; Glucose Intolerance; Humans; | 2017 |
The safety of empagliflozin plus metformin for the treatment of type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D | 2018 |
Sex and BMI Alter the Benefits and Risks of Sulfonylureas and Thiazolidinediones in Type 2 Diabetes: A Framework for Evaluating Stratification Using Routine Clinical and Individual Trial Data.
Topics: Adult; Aged; Aged, 80 and over; Blood Glucose; Body Mass Index; Cost-Benefit Analysis; Datasets as T | 2018 |
Comparison of antidiabetic drugs added to sulfonylurea monotherapy in patients with type 2 diabetes mellitus: A network meta-analysis.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Comb | 2018 |
Efficacy and safety of sitagliptin added to treatment of patients with type 2 diabetes inadequately controlled with premixed insulin.
Topics: Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Combinations; Drug | 2019 |
Metformin and second- or third-generation sulphonylurea combination therapy for adults with type 2 diabetes mellitus.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Humans; Hypoglycemia; Hypoglycemic Agents; Met | 2019 |
Sodium-Glucose Co-Transporter 2 Inhibitors Compared with Sulfonylureas in Patients with Type 2 Diabetes Inadequately Controlled on Metformin: A Meta-Analysis of Randomized Controlled Trials.
Topics: Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Humans; Hypoglycemia; Hypogly | 2019 |
Use of noninsulin antidiabetic medications in hospitalized patients.
Topics: Benzamides; Biguanides; Bromocriptine; Diabetes Mellitus; Dipeptidyl-Peptidase IV Inhibitors; Glycos | 2013 |
Pharmacokinetic considerations for the treatment of diabetes in patients with chronic kidney disease.
Topics: Creatinine; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Glomerular Filtration Rat | 2013 |
[Management of type 2 diabetes: new or previous agents, how to choose?].
Topics: Administration, Oral; Body Weight; Diabetes Complications; Diabetes Mellitus, Type 2; Dipeptidyl-Pep | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.
Topics: Adamantane; Area Under Curve; Controlled Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipept | 2013 |
Efficacy and safety of dipeptidyl peptidase-4 inhibitors and metformin as initial combination therapy and as monotherapy in patients with type 2 diabetes mellitus: a meta-analysis.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Ther | 2014 |
What are the preferred strategies for control of glycaemic variability in patients with type 2 diabetes mellitus?
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Diet, Reducing; Dipeptidyl-Peptidase IV Inhib | 2013 |
Use of non-insulin therapies for type 1 diabetes.
Topics: Allylamine; Animals; Blood Glucose; Bromocriptine; Cardiovascular Diseases; Colesevelam Hydrochlorid | 2013 |
Dapagliflozin compared with other oral anti-diabetes treatments when added to metformin monotherapy: a systematic review and network meta-analysis.
Topics: Administration, Oral; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; D | 2014 |
[Attention to the use of oral anti-diabetic medication in older adults with type 2 diabetes].
Topics: Cognition Disorders; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Humans; Hypoglyc | 2013 |
[Limitations of insulin-dependent drugs in the treatment of type 2 diabetes mellitus].
Topics: Contraindications; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy, Comb | 2013 |
Lixisenatide as add-on to oral anti-diabetic therapy: an effective treatment for glycaemic control with body weight benefits in type 2 diabetes.
Topics: Administration, Oral; Clinical Trials, Phase III as Topic; Combined Modality Therapy; Diabetes Melli | 2014 |
Assessment of the relative effectiveness and tolerability of treatments of type 2 diabetes mellitus: a network meta-analysis.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glucagon-Like Peptide 1; Glycat | 2014 |
Efficacy and safety of basal insulin glargine 12 and 24 weeks after initiation in persons with type 2 diabetes: a pooled analysis of data from treatment arms of 15 treat-to-target randomised controlled trials.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Female; Follow-Up Studies; Glycated Hemoglobi | 2014 |
Indirect comparison of lixisenatide versus neutral protamine Hagedorn insulin as add-on to metformin and sulphonylurea in patients with type 2 diabetes mellitus.
Topics: Adult; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Humans; Hypoglycemia; Hypoglycemic Agen | 2014 |
[Twice-daily and weekly exenatide: clinical profile of two pioneer formulations in incretin therapy].
Topics: Delayed-Action Preparations; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Adm | 2014 |
Oral antihyperglycemic treatment options for type 2 diabetes mellitus.
Topics: Administration, Oral; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Drug Costs; Drug Monitorin | 2015 |
Safety considerations with pharmacological treatment of gestational diabetes mellitus.
Topics: Animals; Blood Glucose; Diabetes, Gestational; Female; Glyburide; Humans; Hypoglycemia; Hypoglycemic | 2015 |
Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis.
Topics: Adult; Birth Weight; Diabetes, Gestational; Female; Fetal Macrosomia; Glyburide; Humans; Hypoglycemi | 2015 |
Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis.
Topics: Adult; Birth Weight; Diabetes, Gestational; Female; Fetal Macrosomia; Glyburide; Humans; Hypoglycemi | 2015 |
Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis.
Topics: Adult; Birth Weight; Diabetes, Gestational; Female; Fetal Macrosomia; Glyburide; Humans; Hypoglycemi | 2015 |
Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis.
Topics: Adult; Birth Weight; Diabetes, Gestational; Female; Fetal Macrosomia; Glyburide; Humans; Hypoglycemi | 2015 |
Combination therapy when metformin is not an option for type 2 diabetes.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hy | 2015 |
Comparative efficacy and safety of antidiabetic drug regimens added to metformin monotherapy in patients with type 2 diabetes: a network meta-analysis.
Topics: Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglob | 2015 |
Effects of oral hypoglycemic agents on platelet function.
Topics: Administration, Oral; Blood Platelets; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Humans; H | 2015 |
Metformin for the treatment of gestational diabetes: An updated meta-analysis.
Topics: Birth Weight; Blood Glucose; Diabetes, Gestational; Female; Humans; Hypoglycemia; Hypoglycemic Agent | 2015 |
Effects of three injectable antidiabetic agents on glycaemic control, weight change and drop-out in type 2 diabetes suboptimally controlled with metformin and/or a sulfonylurea: A network meta-analysis.
Topics: Adult; Blood Glucose; Community Networks; Diabetes Mellitus, Type 2; Glucagon-Like Peptide 1; Glycat | 2015 |
Benefits of combination of insulin degludec and liraglutide are independent of baseline glycated haemoglobin level and duration of type 2 diabetes.
Topics: Aged; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Glycated Hemoglobin; Humans; Hyp | 2016 |
Systematic review and meta-analysis of the efficacy and hypoglycemic safety of gliclazide versus other insulinotropic agents.
Topics: Adult; Aged; Aged, 80 and over; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Glicl | 2015 |
Achieving the composite endpoint of glycated haemoglobin <7.0%, no weight gain and no hypoglycaemia in the once-weekly dulaglutide AWARD programme.
Topics: Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide; Female; Glucagon-Like Peptides; | 2016 |
Dipeptidyl Peptidase-4 Inhibitors in Diverse Patient Populations With Type 2 Diabetes.
Topics: Age Factors; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipepti | 2015 |
Network meta-analysis of treatments for type 2 diabetes mellitus following failure with metformin plus sulfonylurea.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy, Combinat | 2016 |
Systematic review and meta-analysis of vildagliptin for treatment of type 2 diabetes.
Topics: Adamantane; Blood Glucose; Diabetes Mellitus, Type 2; Humans; Hypoglycemia; Hypoglycemic Agents; Met | 2016 |
Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Exenatide; Glucagon-Like Peptides; Glycated H | 2016 |
Pharmacogenomics in diabetes mellitus: insights into drug action and drug discovery.
Topics: Chemical and Drug Induced Liver Injury; Diabetes Mellitus, Type 2; Drug Discovery; Drug-Related Side | 2016 |
Obviating much of the need for insulin therapy in type 2 diabetes mellitus: A re-assessment of insulin therapy's safety profile.
Topics: Blood Glucose; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus, Type 1; Diabetes | 2016 |
Hypoglycaemia when adding sulphonylurea to metformin: a systematic review and network meta-analysis.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Humans; Hypoglycemia; Hypoglycemic Agents; Met | 2016 |
Current management of diabetic patients with kidney disease: a renal‑cardio‑endocrine perspective.
Topics: alpha-Glucosidases; Blood Glucose Self-Monitoring; Blood Pressure; Diabetes Mellitus, Type 2; Diabet | 2017 |
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 |
Fixed-Dose Combination of Canagliflozin and Metformin for the Treatment of Type 2 Diabetes: An Overview.
Topics: Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Clinical Trials, Phase III as Topic; Diab | 2017 |
Cost-Effectiveness of Saxagliptin versus Acarbose as Second-Line Therapy in Type 2 Diabetes in China.
Topics: Adamantane; Asian People; Cardiovascular Diseases; China; Costs and Cost Analysis; Diabetes Mellitus | 2016 |
Clinical Outcomes of Metformin Use in Populations With Chronic Kidney Disease, Congestive Heart Failure, or Chronic Liver Disease: A Systematic Review.
Topics: Cause of Death; Chronic Disease; Contraindications; Diabetes Mellitus, Type 2; Heart Failure; Humans | 2017 |
Oral anti-diabetic pharmacological therapies for the treatment of women with gestational diabetes.
Topics: Acarbose; Administration, Oral; Diabetes, Gestational; Female; Glyburide; Humans; Hypoglycemia; Hypo | 2017 |
The effect of adding metformin to insulin therapy for type 1 diabetes mellitus children: A systematic review and meta-analysis.
Topics: Adolescent; Adult; Child; Diabetes Mellitus, Type 1; Drug Monitoring; Drug Therapy, Combination; Evi | 2017 |
Advances in oral therapy for type 2 diabetes.
Topics: Acarbose; Administration, Oral; Blood Glucose; Carbamates; Cyclohexanes; Diabetes Mellitus, Type 2; | 2000 |
Selecting among ADA/EASD tier 1 and tier 2 treatment options.
Topics: Administration, Oral; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Dr | 2009 |
Clinical results of treating type 2 diabetic patients with sitagliptin, vildagliptin or saxagliptin--diabetes control and potential adverse events.
Topics: Adamantane; Blood Glucose; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipeptides; Dipeptid | 2009 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hypoglycemia; Hyp | 2010 |
Intensive glucose control and cardiovascular outcomes in type 2 diabetes.
Topics: Age Factors; Blood Glucose; Clinical Trials as Topic; Diabetes Complications; Diabetes Mellitus, Typ | 2011 |
Iatrogenic hyperhomocysteinemia in patients with metabolic syndrome: a systematic review and metaanalysis.
Topics: Administration, Oral; Aged; Antihypertensive Agents; Clinical Trials as Topic; Fibric Acids; Homocys | 2011 |
[Hypoglycemic therapy in heart disease patients with type 2 diabetes mellitus].
Topics: Administration, Oral; Aged; Blood Glucose; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Human | 2010 |
Predictors of response to dipeptidyl peptidase-4 inhibitors: evidence from randomized clinical trials.
Topics: Adult; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Enzyme Inhibitors; Glycated He | 2011 |
An analysis of early insulin glargine added to metformin with or without sulfonylurea: impact on glycaemic control and hypoglycaemia.
Topics: Algorithms; Blood Glucose; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Therapy, Co | 2011 |
Effect of antihyperglycemic agents added to metformin and a sulfonylurea on glycemic control and weight gain in type 2 diabetes: a network meta-analysis.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Glycated Hemoglobin; Humans; Hypoglycemia; Hypoglycemic Ag | 2011 |
[Metformin in adolescents and adults with type 1 diabetes mellitus: not evidence-based].
Topics: Adolescent; Adult; Diabetes Mellitus, Type 1; Drug Therapy, Combination; Evidence-Based Medicine; Fe | 2011 |
[Hypoglycemia].
Topics: Algorithms; Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Gliclazide; Humans; | 2011 |
Second-line therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a systematic review and mixed-treatment comparison meta-analysis.
Topics: Bayes Theorem; Body Weight; Confidence Intervals; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV | 2011 |
A case of hypoglycemic hemiparesis and literature review.
Topics: Aged; Aged, 80 and over; Blood Glucose; Diabetes Mellitus; Humans; Hypoglycemia; Male; Metformin; Pa | 2012 |
Liraglutide: from clinical trials to clinical practice.
Topics: Administration, Oral; Blood Glucose; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dose-Respo | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Drug interactions with oral antidiabetic agents: pharmacokinetic mechanisms and clinical implications.
Topics: Administration, Oral; Aryl Hydrocarbon Hydroxylases; Benzamides; Cytochrome P-450 CYP2C8; Cytochrome | 2012 |
Effect of antidiabetic agents added to metformin on glycaemic control, hypoglycaemia and weight change in patients with type 2 diabetes: a network meta-analysis.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobi | 2012 |
Drug-induced hypoglycaemia in type 2 diabetes.
Topics: Adamantane; Angiotensin-Converting Enzyme Inhibitors; Diabetes Mellitus, Type 2; Dipeptides; Exenati | 2012 |
A review of the efficacy and safety of oral antidiabetic drugs.
Topics: Administration, Oral; Animals; Diabetes Mellitus, Type 2; Humans; Hypoglycemia; Hypoglycemic Agents; | 2013 |
Influence of initial hyperglycaemia, weight and age on the blood glucose lowering efficacy and incidence of hypoglycaemic symptoms with a single-tablet metformin-glibenclamide therapy (Glucovance) in type 2 diabetes.
Topics: Age Factors; Aged; Blood Glucose; Body Mass Index; Diabetes Mellitus, Type 2; Dose-Response Relation | 2003 |
[Continuation 50. Type 2 diabetes: possibilities and limitations of pharmacological therapy].
Topics: 1-Deoxynojirimycin; Acarbose; Aged; Blood Glucose; Carbamates; Contraindications; Cyclohexanes; Diab | 2003 |
DPP-4 inhibitors.
Topics: Adamantane; Animals; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Dru | 2007 |
Glycaemic control and adverse events in patients with type 2 diabetes treated with metformin + sulphonylurea: a meta-analysis.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobi | 2008 |
[Adjunctive therapies to glycaemic control of type 1 diabetes mellitus].
Topics: Acarbose; Amyloid; Blood Glucose; Diabetes Mellitus, Type 1; Drug Therapy, Combination; Gastrointest | 2008 |
[Repaglinide, potentially a therapeutic improvement for diabetes mellitus type 2].
Topics: Carbamates; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glyburide; Humans; Hypoglycemia; H | 2001 |
Practical management of diabetes in the tropics.
Topics: Blood Glucose; Chlorpropamide; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Female; Glucose | 1990 |
Oral treatment of diabetes mellitus.
Topics: Chlorpropamide; Diabetes Mellitus; Humans; Hypoglycemia; Hypoglycemic Agents; Metformin; Phenformin; | 1968 |
Advances in the treatment of diabetes mellitus.
Topics: Blood Glucose; Chlorpropamide; Clofibrate; Diabetes Mellitus; Diabetic Coma; Diabetic Ketoacidosis; | 1971 |
217 trials available for metformin and Hypoglycemia
| Article | Year |
|---|---|
Metformin action over gut microbiota is related to weight and glycemic control in gestational diabetes mellitus: A randomized trial.
Topics: Adult; Body Mass Index; Diabetes, Gestational; Female; Gastrointestinal Microbiome; Glycemic Control | 2022 |
Efficacy and safety benefits of iGlarLixi versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with suboptimally controlled type 2 diabetes on oral agents: The LixiLan-O-AP randomized controlled trial.
Topics: Administration, Oral; Adult; Blood Glucose; Diabetes Mellitus, Type 2; Drug Combinations; Glycated H | 2022 |
Effect of once-weekly semaglutide versus thrice-daily insulin aspart, both as add-on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUSTAIN 11): A randomized, open-label, multinational, phase 3b trial.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glucagon-Li | 2022 |
Efficacy and safety of a basal insulin + 2-3 oral antihyperglycaemic drugs regimen versus a twice-daily premixed insulin + metformin regimen after short-term intensive insulin therapy in individuals with type 2 diabetes: The multicentre, open-label, rando
Topics: Adult; Blood Glucose; Diabetes Mellitus, Type 2; Glycated Hemoglobin; Humans; Hypoglycemia; Hypoglyc | 2022 |
Comparative efficacy and safety of two insulin aspart formulations (Rapilin and NovoRapid) when combined with metformin, for patients with diabetes mellitus: a multicenter, randomized, open-label, controlled clinical trial.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hy | 2022 |
A Randomized Controlled Trial of R-Form Verapamil Added to Ongoing Metformin Therapy in Patients with Type 2 Diabetes.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination; Glycated H | 2022 |
A randomised placebo-controlled trial of the effectiveness of early metformin in addition to usual care in the reduction of gestational diabetes mellitus effects (EMERGE): study protocol.
Topics: Blood Glucose; Clinical Trials, Phase III as Topic; Diabetes, Gestational; Female; Galactose; Gestat | 2022 |
Effects of Initial Combinations of Gemigliptin Plus Metformin Compared with Glimepiride Plus Metformin on Gut Microbiota and Glucose Regulation in Obese Patients with Type 2 Diabetes: The INTESTINE Study.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Gastrointestinal Microbiome; Gl | 2023 |
Ertugliflozin Delays Insulin Initiation and Reduces Insulin Dose Requirements in Patients With Type 2 Diabetes: Analyses From VERTIS CV.
Topics: Bridged Bicyclo Compounds, Heterocyclic; Diabetes Mellitus, Type 2; Double-Blind Method; Humans; Hyp | 2023 |
Efficacy and safety of gemigliptin as add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus (ZEUS II study).
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Double-Blind Method; D | 2020 |
Long-Term Efficacy and Safety of Linagliptin in a Japanese Population with Type 2 Diabetes Aged ≥ 60 Years Treated with Basal Insulin: A Randomised Trial.
Topics: Aged; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Glomerular Filtration Rate; Glycated H | 2019 |
Hypoglycaemia leads to a delayed increase in platelet and coagulation activation markers in people with type 2 diabetes treated with metformin only: Results from a stepwise hypoglycaemic clamp study.
Topics: Adult; Biomarkers; Blood Coagulation; Blood Coagulation Tests; Diabetes Mellitus, Type 2; Female; Gl | 2020 |
Evaluation of the Short-Term Cost-Effectiveness of IDegLira Versus Basal Insulin and Basal-Bolus Therapy in Patients with Type 2 Diabetes Based on Attainment of Clinically Relevant Treatment Targets.
Topics: Adult; Blood Glucose; Cost-Benefit Analysis; Diabetes Mellitus, Type 2; Drug Combinations; Glycated | 2020 |
Efficacy and safety of dual add-on therapy with dapagliflozin plus saxagliptin versus glimepiride in patients with poorly controlled type 2 diabetes on a stable dose of metformin: Results from a 52-week, randomized, active-controlled trial.
Topics: Adamantane; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; Double | 2020 |
Efficacy and Safety of Basal Insulin-Based Treatment Versus Twice-Daily Premixed Insulin After Short-Term Intensive Insulin Therapy in Patients with Type 2 Diabetes Mellitus in China: Study Protocol for a Randomized Controlled Trial (BEYOND V).
Topics: Adolescent; Adult; Aged; Blood Glucose; China; Diabetes Mellitus, Type 2; Drug Therapy, Combination; | 2020 |
Efficacy and safety of generic exenatide injection in Chinese patients with type 2 diabetes: a multicenter, randomized, controlled, non-inferiority trial.
Topics: Adult; Blood Glucose; China; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Drugs, Generic; E | 2020 |
Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial.
Topics: Adolescent; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blin | 2020 |
Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Double-Blind Method; D | 2020 |
Metformin for gestational diabetes study: metformin vs insulin in gestational diabetes: glycemic control and obstetrical and perinatal outcomes: randomized prospective trial.
Topics: Adult; Cesarean Section; Diabetes, Gestational; Female; Gestational Weight Gain; Humans; Hypoglycemi | 2021 |
A randomized clinical trial evaluating the efficacy and safety of the once-weekly dipeptidyl peptidase-4 inhibitor omarigliptin in patients with type 2 diabetes inadequately controlled on metformin monotherapy.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Heterocyclic Compounds | 2017 |
Long-term Cost-effectiveness of Two GLP-1 Receptor Agonists for the Treatment of Type 2 Diabetes Mellitus in the Italian Setting: Liraglutide Versus Lixisenatide.
Topics: Body Mass Index; Cost-Benefit Analysis; Diabetes Complications; Diabetes Mellitus, Type 2; Female; G | 2017 |
Insulin degludec/liraglutide (IDegLira) was effective across a range of dysglycaemia and body mass index categories in the DUAL V randomized trial.
Topics: Anti-Obesity Agents; Blood Glucose; Body Mass Index; Diabetes Mellitus, Type 2; Drug Combinations; D | 2018 |
Insulin Glargine/Lixisenatide: A Review in Type 2 Diabetes.
Topics: Adult; Blood Glucose; Diabetes Mellitus, Type 2; Drug Combinations; Drug Therapy, Combination; Gluca | 2017 |
Metformin-associated prevention of weight gain in insulin-treated type 2 diabetic patients cannot be explained by decreased energy intake: A post hoc analysis of a randomized placebo-controlled 4.3-year trial.
Topics: Adult; Aged; Aged, 80 and over; Anti-Obesity Agents; Appetite Depressants; Body Mass Index; Diabetes | 2018 |
The efficacy and safety of adding either vildagliptin or glimepiride to ongoing metformin therapy in patients with type 2 diabetes mellitus.
Topics: Adamantane; Blood Glucose; Diabetes Mellitus, Type 2; Dinoprost; Drug Therapy, Combination; Female; | 2017 |
Metformin extended-release versus immediate-release: An international, randomized, double-blind, head-to-head trial in pharmacotherapy-naïve patients with type 2 diabetes.
Topics: Blood Glucose; Blood Glucose Self-Monitoring; Combined Modality Therapy; Delayed-Action Preparations | 2018 |
Safety and efficacy of metformin up-titration in Japanese patients with type 2 diabetes mellitus treated with vildagliptin and low-dose metformin.
Topics: Adamantane; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; | 2017 |
Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial.
Topics: Aged; Body Mass Index; Bridged Bicyclo Compounds, Heterocyclic; Diabetes Mellitus, Type 2; Dipeptidy | 2018 |
Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial.
Topics: Aged; Body Mass Index; Bridged Bicyclo Compounds, Heterocyclic; Diabetes Mellitus, Type 2; Dipeptidy | 2018 |
Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial.
Topics: Aged; Body Mass Index; Bridged Bicyclo Compounds, Heterocyclic; Diabetes Mellitus, Type 2; Dipeptidy | 2018 |
Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial.
Topics: Aged; Body Mass Index; Bridged Bicyclo Compounds, Heterocyclic; Diabetes Mellitus, Type 2; Dipeptidy | 2018 |
Long-term effects on glycaemic control and β-cell preservation of early intensive treatment in patients with newly diagnosed type 2 diabetes: A multicentre randomized trial.
Topics: Adult; Diabetes Mellitus, Type 2; Drug Resistance, Multiple; Drug Therapy, Combination; Female; Foll | 2018 |
Safety and tolerability of dapagliflozin, saxagliptin and metformin in combination: Post-hoc analysis of concomitant add-on versus sequential add-on to metformin and of triple versus dual therapy with metformin.
Topics: Adamantane; Benzhydryl Compounds; Diabetes Mellitus, Type 2; Dipeptides; Dipeptidyl-Peptidase IV Inh | 2018 |
Effects on the glucagon response to hypoglycaemia during DPP-4 inhibition in elderly subjects with type 2 diabetes: A randomized, placebo-controlled study.
Topics: Aged; Aged, 80 and over; Aging; Cross-Over Studies; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase | 2018 |
A Randomized Clinical Trial of Metformin to Treat Autosomal Dominant Polycystic Kidney Disease.
Topics: Adolescent; Adult; Clinical Trials, Phase II as Topic; Cysts; Disease Progression; Dose-Response Rel | 2018 |
Safety and Tolerability of Combinations of Empagliflozin and Linagliptin in Patients with Type 2 Diabetes: Pooled Data from Two Randomized Controlled Trials.
Topics: Benzhydryl Compounds; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Drug Monitoring; | 2018 |
A randomized, open-label, multicentre, parallel-controlled study comparing the efficacy and safety of biphasic insulin aspart 30 plus metformin with biphasic insulin aspart 30 monotherapy for type 2 diabetes patients inadequately controlled with oral anti
Topics: Aged; Biphasic Insulins; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Glycated Hemo | 2018 |
Empagliflozin compared with glimepiride in metformin-treated patients with type 2 diabetes: 208-week data from a masked randomized controlled trial.
Topics: Adult; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug The | 2018 |
Dapagliflozin versus saxagliptin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin.
Topics: Adamantane; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Typ | 2018 |
Double-blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase-4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT-I Study.
Topics: Aged; Deprescriptions; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Double-Blind M | 2019 |
Hypoglycaemia as a function of HbA1c in type 2 diabetes: Insulin glargine 300 U/mL in a patient-level pooled analysis of EDITION 1, 2 and 3.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Diabetes Mellitus, Type 2; Dose-Response Relationship, D | 2019 |
Hypoglycemia and Incident Cognitive Dysfunction: A Post Hoc Analysis From the ORIGIN Trial.
Topics: Aged; Cardiovascular Diseases; Cognitive Dysfunction; Educational Status; Female; Humans; Hypoglycem | 2019 |
Sustained 52-week efficacy and safety of triple therapy with dapagliflozin plus saxagliptin versus dual therapy with sitagliptin added to metformin in patients with uncontrolled type 2 diabetes.
Topics: Adamantane; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; Double | 2019 |
Comparative effect of saxagliptin and glimepiride with a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in patients uncontrolled with metformin therapy: Results from the SPECIFY study, a 48-week, multi-centr
Topics: Adamantane; Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptides; Female; | 2019 |
Sitagliptin vs. pioglitazone as add-on treatments in patients with uncontrolled type 2 diabetes on the maximal dose of metformin plus sulfonylurea.
Topics: Biomarkers; Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Follow-Up S | 2019 |
Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study.
Topics: Adolescent; Adult; Birth Injuries; Diabetes Mellitus, Type 2; Disease Management; Double-Blind Metho | 2018 |
Impact of Insulin Tregopil and Its Permeation Enhancer on Pharmacokinetics of Metformin in Healthy Volunteers: Randomized, Open-Label, Placebo-Controlled, Crossover Study.
Topics: Administration, Oral; Adolescent; Adult; Confidence Intervals; Cross-Over Studies; Female; Healthy V | 2019 |
Long-term efficacy and safety of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: 104-week VERTIS MET trial.
Topics: Aged; Blood Glucose; Bone Density; Bridged Bicyclo Compounds, Heterocyclic; Diabetes Mellitus, Type | 2019 |
Triple therapy with low-dose dapagliflozin plus saxagliptin versus dual therapy with each monocomponent, all added to metformin, in uncontrolled type 2 diabetes.
Topics: Adamantane; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptides; | 2019 |
Glycemic Control and Insulin Treatment Alter Fracture Risk in Older Men With Type 2 Diabetes Mellitus.
Topics: Aged; Aged, 80 and over; Bone Density; Diabetes Complications; Diabetes Mellitus, Type 2; Fractures, | 2019 |
Once-daily initiation of basal insulin as add-on to metformin: a 26-week, randomized, treat-to-target trial comparing insulin detemir with insulin glargine in patients with type 2 diabetes.
Topics: Argentina; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Drug Administrati | 2013 |
Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double-blind, randomized, 1-year study.
Topics: Aged; Aged, 80 and over; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitor | 2013 |
Vildagliptin more effectively achieves a composite endpoint of HbA₁c < 7.0% without hypoglycaemia and weight gain compared with glimepiride after 2 years of treatment.
Topics: Adamantane; Aged; Female; Glycated Hemoglobin; Humans; Hypoglycemia; Hypoglycemic Agents; Male; Metf | 2013 |
Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P).
Topics: Aged; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Administration Schedule; Drug Monitoring; | 2013 |
Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P).
Topics: Aged; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Administration Schedule; Drug Monitoring; | 2013 |
Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P).
Topics: Aged; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Administration Schedule; Drug Monitoring; | 2013 |
Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P).
Topics: Aged; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Administration Schedule; Drug Monitoring; | 2013 |
Study design and rationale of a dose-ranging trial of LX4211, a dual inhibitor of SGLT1 and SGLT2, in type 2 diabetes inadequately controlled on metformin monotherapy.
Topics: Biomarkers; Blood Glucose; Clinical Protocols; Diabetes Mellitus, Type 2; Double-Blind Method; Femal | 2013 |
Saxagliptin vs. glipizide as add-on therapy in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: long-term (52-week) extension of a 52-week randomised controlled trial.
Topics: Adamantane; Adult; Aged; Aged, 80 and over; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; Di | 2013 |
Individualised treatment targets for elderly patients with type 2 diabetes using vildagliptin add-on or lone therapy (INTERVAL): a 24 week, randomised, double-blind, placebo-controlled study.
Topics: Adamantane; Aged; Aged, 80 and over; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, C | 2013 |
Differential effects of vildagliptin and glimepiride on glucose fluctuations in patients with type 2 diabetes mellitus assessed using continuous glucose monitoring.
Topics: Adamantane; Adolescent; Adult; Aged; Biomarkers; Blood Glucose; Cross-Over Studies; Diabetes Mellitu | 2013 |
Differential effects of vildagliptin and glimepiride on glucose fluctuations in patients with type 2 diabetes mellitus assessed using continuous glucose monitoring.
Topics: Adamantane; Adolescent; Adult; Aged; Biomarkers; Blood Glucose; Cross-Over Studies; Diabetes Mellitu | 2013 |
Differential effects of vildagliptin and glimepiride on glucose fluctuations in patients with type 2 diabetes mellitus assessed using continuous glucose monitoring.
Topics: Adamantane; Adolescent; Adult; Aged; Biomarkers; Blood Glucose; Cross-Over Studies; Diabetes Mellitu | 2013 |
Differential effects of vildagliptin and glimepiride on glucose fluctuations in patients with type 2 diabetes mellitus assessed using continuous glucose monitoring.
Topics: Adamantane; Adolescent; Adult; Aged; Biomarkers; Blood Glucose; Cross-Over Studies; Diabetes Mellitu | 2013 |
Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes.
Topics: Adamantane; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; Dipeptidyl-Peptidase IV Inhibitors | 2013 |
Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes.
Topics: Adamantane; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; Dipeptidyl-Peptidase IV Inhibitors | 2013 |
Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes.
Topics: Adamantane; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; Dipeptidyl-Peptidase IV Inhibitors | 2013 |
Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes.
Topics: Adamantane; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; Dipeptidyl-Peptidase IV Inhibitors | 2013 |
Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, | 2014 |
Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, | 2014 |
Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, | 2014 |
Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, | 2014 |
A comparative study of the effects of a dipeptidyl peptidase-IV inhibitor and sulfonylurea on glucose variability in patients with type 2 diabetes with inadequate glycemic control on metformin.
Topics: Adult; Asian People; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; D | 2013 |
Randomized, vitamin E-controlled trial of bicyclol plus metformin in non-alcoholic fatty liver disease patients with impaired fasting glucose.
Topics: Alanine Transaminase; Biphenyl Compounds; Drug Therapy, Combination; Female; Humans; Hypoglycemia; L | 2014 |
[A combination of dipeptidyl peptidase-4 inhibitor and metformin in the treatment of patients with type 2 diabetes mellitus: effective control of glycemia, weight, and quantitative body composition].
Topics: Absorptiometry, Photon; Adamantane; Blood Glucose; Body Composition; Body Mass Index; Body Weight; D | 2013 |
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 |
Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea.
Topics: Adamantane; Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitu | 2014 |
Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea.
Topics: Adamantane; Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitu | 2014 |
Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea.
Topics: Adamantane; Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitu | 2014 |
Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea.
Topics: Adamantane; Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitu | 2014 |
A randomized controlled trial of the efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes and inadequate glycaemic control on metformin plus a sulphonylurea.
Topics: Adamantane; Adult; Australia; Blood Glucose; Body Mass Index; Body Weight; Canada; Diabetes Mellitus | 2014 |
Effect of once-daily insulin detemir on oral antidiabetic drug (OAD) use in patients with type 2 diabetes.
Topics: Administration, Oral; Aged; Diabetes Mellitus, Type 2; Drug Administration Schedule; Female; Humans; | 2014 |
Effect of once-daily insulin detemir on oral antidiabetic drug (OAD) use in patients with type 2 diabetes.
Topics: Administration, Oral; Aged; Diabetes Mellitus, Type 2; Drug Administration Schedule; Female; Humans; | 2014 |
Effect of once-daily insulin detemir on oral antidiabetic drug (OAD) use in patients with type 2 diabetes.
Topics: Administration, Oral; Aged; Diabetes Mellitus, Type 2; Drug Administration Schedule; Female; Humans; | 2014 |
Effect of once-daily insulin detemir on oral antidiabetic drug (OAD) use in patients with type 2 diabetes.
Topics: Administration, Oral; Aged; Diabetes Mellitus, Type 2; Drug Administration Schedule; Female; Humans; | 2014 |
[Efficacy and safety of vildagliptin as a second-line therapy vs other oral antidiabetic agents in patients with type 2 diabetes: Czech results within the worldwide prospective cohort EDGE study].
Topics: Adamantane; Adult; Aged; Cohort Studies; Czech Republic; Diabetes Mellitus, Type 2; Drug Therapy, Co | 2013 |
A randomized controlled trial comparing the GLP-1 receptor agonist liraglutide to a sulphonylurea as add on to metformin in patients with established type 2 diabetes during Ramadan: the Treat 4 Ramadan Trial.
Topics: Adult; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasting; Female; Glucagon-Like Peptide | 2014 |
Saxagliptin versus glipizide as add-on therapy to metformin: assessment of hypoglycemia.
Topics: Adamantane; Adult; Aged; Aged, 80 and over; Diabetes Mellitus, Type 2; Dipeptides; Dipeptidyl-Peptid | 2014 |
Efficacy and safety of initial combination therapy with alogliptin plus metformin versus either as monotherapy in drug-naïve patients with type 2 diabetes: a randomized, double-blind, 6-month study.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combinatio | 2014 |
Health status and hypoglycaemia with insulin degludec versus insulin glargine: a 2-year trial in insulin-naïve patients with type 2 diabetes.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Administration Sc | 2014 |
Pharmacodynamics of the glucagon-like peptide-1 receptor agonist lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus poorly controlled on sulphonylureas with/without metformin.
Topics: Adult; Aged; Asian People; Cohort Studies; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Comparison between the therapeutic effect of metformin, glimepiride and their combination as an add-on treatment to insulin glargine in uncontrolled patients with type 2 diabetes.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response | 2014 |
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 |
Insulin lispro low mixture twice daily versus basal insulin glargine once daily and prandial insulin lispro once daily in patients with type 2 diabetes requiring insulin intensification: a randomized phase IV trial.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Drug Administration Schedule; Female; Glycated Hemoglobin; | 2014 |
Efficacy of metformin-based oral antidiabetic drugs is not inferior to insulin glargine in newly diagnosed type 2 diabetic patients with severe hyperglycemia after short-term intensive insulin therapy.
Topics: Administration, Oral; Adult; Aged; Blood Glucose; China; Diabetes Mellitus, Type 2; Female; Follow-U | 2015 |
Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone: a 24-week randomized, double-blind study.
Topics: Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combinatio | 2014 |
Vildagliptin compared to glimepiride on post-prandial lipemia and on insulin resistance in type 2 diabetic patients.
Topics: Adamantane; Aged; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Double-Blind Method | 2014 |
Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1).
Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Therapy, Combinat | 2014 |
Effect of exogenously administered glucagon versus spontaneous endogenous counter-regulation on glycaemic recovery from insulin-induced hypoglycaemia in patients with type 2 diabetes treated with a novel glucokinase activator, AZD1656, and metformin.
Topics: Azetidines; Blood Glucose; Body Mass Index; Catecholamines; Cross-Over Studies; Diabetes Mellitus, T | 2014 |
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re | 2014 |
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re | 2014 |
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re | 2014 |
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Dr | 2014 |
Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes.
Topics: Aged; Asia; Blood Glucose Self-Monitoring; Circadian Rhythm; Diabetes Mellitus, Type 2; Drug Dosage | 2015 |
Study of optimal basal insulin glargine dose requirement in Indian population as an add on therapy to oral hypoglycaemic agents to achieve target fasting blood glucose levels.
Topics: Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasting; Female; H | 2013 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira).
Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Combinations; Drug Therapy | 2014 |
Durability of the efficacy and safety of alogliptin compared with glipizide in type 2 diabetes mellitus: a 2-year study.
Topics: Adult; Aged; Blood Glucose; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase | 2014 |
Efficacy and safety of once-weekly glucagon-like peptide 1 receptor agonist albiglutide (HARMONY 1 trial): 52-week primary endpoint results from a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes mellitus not controlled
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Administration Schedule; Drug Th | 2014 |
Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin: a randomized, double-blind, phase 3 study.
Topics: Blood Glucose; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Ther | 2015 |
Greater dose-ranging effects on A1C levels than on glucosuria with LX4211, a dual inhibitor of SGLT1 and SGLT2, in patients with type 2 diabetes on metformin monotherapy.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Adm | 2015 |
Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin.
Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; | 2015 |
Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin.
Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; | 2015 |
Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin.
Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; | 2015 |
Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin.
Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; | 2015 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exenatide; Female; Glycated Hemoglobin; Humans | 2015 |
Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exenatide; Female; Glycated Hemoglobin; Humans | 2015 |
Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exenatide; Female; Glycated Hemoglobin; Humans | 2015 |
Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exenatide; Female; Glycated Hemoglobin; Humans | 2015 |
Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exenatide; Female; Glycated Hemoglobin; Humans | 2015 |
Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exenatide; Female; Glycated Hemoglobin; Humans | 2015 |
Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exenatide; Female; Glycated Hemoglobin; Humans | 2015 |
Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exenatide; Female; Glycated Hemoglobin; Humans | 2015 |
Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exenatide; Female; Glycated Hemoglobin; Humans | 2015 |
Insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Asian patients with type 2 diabetes inadequately controlled on basal or pre-/self-mixed insulin: a 26-week, randomised, treat-to-target trial.
Topics: Adult; Aged; Asian People; Biphasic Insulins; Blood Glucose; Diabetes Mellitus, Type 2; Drug Combina | 2015 |
Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin.
Topics: Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; | 2015 |
Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D | 2015 |
Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D | 2015 |
Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D | 2015 |
Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D | 2015 |
Comparison of neonatal outcomes in women with gestational diabetes with moderate hyperglycaemia on metformin or glibenclamide--a randomised controlled trial.
Topics: Adult; Birth Injuries; Birth Weight; Diabetes, Gestational; Female; Fetal Macrosomia; Glyburide; Hum | 2015 |
Efficacy, safety and tolerability of aleglitazar in patients with type 2 diabetes: pooled findings from three randomized phase III trials.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasting; Female; Glycated Hemog | 2015 |
Efficacy, safety and tolerability of aleglitazar in patients with type 2 diabetes: pooled findings from three randomized phase III trials.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasting; Female; Glycated Hemog | 2015 |
Efficacy, safety and tolerability of aleglitazar in patients with type 2 diabetes: pooled findings from three randomized phase III trials.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasting; Female; Glycated Hemog | 2015 |
Efficacy, safety and tolerability of aleglitazar in patients with type 2 diabetes: pooled findings from three randomized phase III trials.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasting; Female; Glycated Hemog | 2015 |
Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D | 2015 |
Efficacy and safety of liraglutide monotherapy compared with metformin in Japanese overweight/obese patients with type 2 diabetes.
Topics: Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Humans; Hypoglyc | 2015 |
Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Bridged Bicyclo Compounds, Heterocyclic; Di | 2015 |
Comparison of thrice-daily premixed insulin (insulin lispro premix) with basal-bolus (insulin glargine once-daily plus thrice-daily prandial insulin lispro) therapy in east Asian patients with type 2 diabetes insufficiently controlled with twice-daily pre
Topics: Acarbose; Aged; China; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Glycated Hemogl | 2015 |
Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION).
Topics: Adamantane; Age Factors; Aged; Aged, 80 and over; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptid | 2015 |
Long-term treatment with empagliflozin as add-on to oral antidiabetes therapy in Japanese patients with type 2 diabetes mellitus.
Topics: Adult; Aged; Benzhydryl Compounds; Biguanides; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl- | 2015 |
The cost-effectiveness of dapagliflozin versus sulfonylurea as an add-on to metformin in the treatment of Type 2 diabetes mellitus.
Topics: Benzhydryl Compounds; Cohort Studies; Cost-Benefit Analysis; Diabetes Complications; Diabetes Mellit | 2015 |
Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study.
Topics: Adult; Aged; Blood Glucose; Body Mass Index; Diabetes Mellitus, Type 2; Drug Administration Schedule | 2015 |
Two dose-ranging studies with PF-04937319, a systemic partial activator of glucokinase, as add-on therapy to metformin in adults with type 2 diabetes.
Topics: Aged; Benzofurans; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Doubl | 2015 |
Two dose-ranging studies with PF-04937319, a systemic partial activator of glucokinase, as add-on therapy to metformin in adults with type 2 diabetes.
Topics: Aged; Benzofurans; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Doubl | 2015 |
Two dose-ranging studies with PF-04937319, a systemic partial activator of glucokinase, as add-on therapy to metformin in adults with type 2 diabetes.
Topics: Aged; Benzofurans; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Doubl | 2015 |
Two dose-ranging studies with PF-04937319, a systemic partial activator of glucokinase, as add-on therapy to metformin in adults with type 2 diabetes.
Topics: Aged; Benzofurans; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Doubl | 2015 |
Contrasting Effects of Lixisenatide and Liraglutide on Postprandial Glycemic Control, Gastric Emptying, and Safety Parameters in Patients With Type 2 Diabetes on Optimized Insulin Glargine With or Without Metformin: A Randomized, Open-Label Trial.
Topics: Adult; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination; Fem | 2015 |
Combination of the dipeptidyl peptidase-4 inhibitor linagliptin with insulin-based regimens in type 2 diabetes and chronic kidney disease.
Topics: Aged; Blood Glucose; Cohort Studies; Diabetes Mellitus, Type 2; Diabetic Nephropathies; Dipeptidyl-P | 2015 |
One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial.
Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Drug Therapy, Comb | 2015 |
Comparison of vildagliptin as an add-on therapy and sulfonylurea dose-increasing therapy in patients with inadequately controlled type 2 diabetes using metformin and sulfonylurea (VISUAL study): A randomized trial.
Topics: Adamantane; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Drug T | 2015 |
Empagliflozin as add-on to metformin in people with Type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Body Mass Index; Combined Modality Therapy; Diabetes Mellitus, Type 2; D | 2015 |
Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2).
Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Gastrointestinal Diseas | 2015 |
Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2).
Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Gastrointestinal Diseas | 2015 |
Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2).
Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Gastrointestinal Diseas | 2015 |
Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2).
Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Gastrointestinal Diseas | 2015 |
Treatment satisfaction in people with type 2 diabetes mellitus treated with once-weekly dulaglutide: data from the AWARD-1 and AWARD-3 clinical trials.
Topics: Adult; Diabetes Mellitus; Double-Blind Method; Drug Administration Schedule; Exenatide; Female; Gluc | 2015 |
Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose-Escalation Safety and Tolerability Pilot Study.
Topics: Adult; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Double-Blind Meth | 2015 |
Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial.
Topics: Aged; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Dr | 2015 |
Durability and tolerability of dapagliflozin over 52 weeks as add-on to metformin and sulphonylurea in type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Cholesterol; Diabetes Mellit | 2015 |
Randomized, Double-Blind, Phase 3 Trial of Triple Therapy With Dapagliflozin Add-on to Saxagliptin Plus Metformin in Type 2 Diabetes.
Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; | 2015 |
Randomized, Double-Blind Trial of Triple Therapy With Saxagliptin Add-on to Dapagliflozin Plus Metformin in Patients With Type 2 Diabetes.
Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; | 2015 |
Effect of liraglutide vs. NPH in combination with metformin on blood glucose fluctuations assessed using continuous glucose monitoring in patients with newly diagnosed type 2 diabetes.
Topics: Adult; Aged; Biomarkers; Blood Glucose; Body Mass Index; China; Diabetes Mellitus, Type 2; Drug Ther | 2015 |
Effect of the GLP-1 Receptor Agonist Lixisenatide on Counterregulatory Responses to Hypoglycemia in Subjects With Insulin-Treated Type 2 Diabetes.
Topics: Blood Glucose; Cross-Over Studies; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Glucagon; | 2016 |
Effect of ranolazine on glycaemic control in patients with type 2 diabetes treated with either glimepiride or metformin.
Topics: Aged; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Interactions; Dr | 2016 |
[Efficacy and safety of alogliptin in treatment of type 2 diabetes mellitus: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial in mainland China].
Topics: Asian People; Blood Glucose; China; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Co | 2015 |
Glycemic excursions are positively associated with changes in duration of asymptomatic hypoglycemia after treatment intensification in patients with type 2 diabetes.
Topics: Acarbose; Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; | 2016 |
Strategies for glucose control in a study population with diabetes, renal disease and anemia (Treat study).
Topics: Aged; Anemia; Australia; Blood Glucose; Diabetes Mellitus, Type 2; Europe; Female; Humans; Hypoglyce | 2016 |
Switching from sulphonylurea to a sodium-glucose cotransporter2 inhibitor in the fasting month of Ramadan is associated with a reduction in hypoglycaemia.
Topics: Adult; Aged; Benzhydryl Compounds; Diabetes Mellitus, Type 2; Drug Substitution; Drug Therapy, Combi | 2016 |
Metformin versus placebo in combination with insulin analogues in patients with type 2 diabetes mellitus-the randomised, blinded Copenhagen Insulin and Metformin Therapy (CIMT) trial.
Topics: Blood Glucose; Body Weight; Carotid Intima-Media Thickness; Denmark; Diabetes Mellitus, Type 2; Glyc | 2016 |
Effects of biphasic, basal-bolus or basal insulin analogue treatments on carotid intima-media thickness in patients with type 2 diabetes mellitus: the randomised Copenhagen Insulin and Metformin Therapy (CIMT) trial.
Topics: Blood Glucose; Body Weight; Carotid Intima-Media Thickness; Denmark; Diabetes Mellitus, Type 2; Drug | 2016 |
Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes: The DUAL V Randomized Clinical Trial.
Topics: Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Humans; Hypoglycemia; Hypoglycemic Agents; I | 2016 |
Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study).
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination; Fasting; F | 2016 |
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 |
Safety, tolerability, pharmacokinetics and pharmacodynamics of AZP-531, a first-in-class analogue of unacylated ghrelin, in healthy and overweight/obese subjects and subjects with type 2 diabetes.
Topics: Adolescent; Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Diarrhea; Double-Bli | 2016 |
A Multinational, Randomized, Open-label, Treat-to-Target Trial Comparing Insulin Degludec and Insulin Glargine in Insulin-Naïve Patients with Type 2 Diabetes Mellitus.
Topics: Blood Glucose; China; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Humans; Hypoglycemia; | 2016 |
Efficacy and safety of titrated canagliflozin in patients with type 2 diabetes mellitus inadequately controlled on metformin and sitagliptin.
Topics: Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; Double-B | 2016 |
The efficacy and safety of teneligliptin added to ongoing metformin monotherapy in patients with type 2 diabetes: a randomized study with open label extension.
Topics: Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combinatio | 2016 |
Glucose Variability in a 26-Week Randomized Comparison of Mealtime Treatment With Rapid-Acting Insulin Versus GLP-1 Agonist in Participants With Type 2 Diabetes at High Cardiovascular Risk.
Topics: Adult; Aged; Alanine Transaminase; Arrhythmias, Cardiac; Blood Glucose; Body Weight; Cardiovascular | 2016 |
Glucose Variability in a 26-Week Randomized Comparison of Mealtime Treatment With Rapid-Acting Insulin Versus GLP-1 Agonist in Participants With Type 2 Diabetes at High Cardiovascular Risk.
Topics: Adult; Aged; Alanine Transaminase; Arrhythmias, Cardiac; Blood Glucose; Body Weight; Cardiovascular | 2016 |
Glucose Variability in a 26-Week Randomized Comparison of Mealtime Treatment With Rapid-Acting Insulin Versus GLP-1 Agonist in Participants With Type 2 Diabetes at High Cardiovascular Risk.
Topics: Adult; Aged; Alanine Transaminase; Arrhythmias, Cardiac; Blood Glucose; Body Weight; Cardiovascular | 2016 |
Glucose Variability in a 26-Week Randomized Comparison of Mealtime Treatment With Rapid-Acting Insulin Versus GLP-1 Agonist in Participants With Type 2 Diabetes at High Cardiovascular Risk.
Topics: Adult; Aged; Alanine Transaminase; Arrhythmias, Cardiac; Blood Glucose; Body Weight; Cardiovascular | 2016 |
Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial.
Topics: Aged; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combinat | 2016 |
Baseline factors associated with glycaemic response to treatment with once-weekly dulaglutide in patients with type 2 diabetes.
Topics: Adolescent; Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Administration Schedule; Fas | 2016 |
Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Lixisenatide and Insulin Glargine, Versus Insulin Glargine in Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy: The LixiLan Proof-of-Concept Randomized Trial.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Combinations; Drug Therapy, Combin | 2016 |
Once-Daily Liraglutide Versus Lixisenatide as Add-on to Metformin in Type 2 Diabetes: A 26-Week Randomized Controlled Clinical Trial.
Topics: Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administ | 2016 |
Which oral antidiabetic drug to combine with metformin to minimize the risk of hypoglycemia when initiating basal insulin?: A randomized controlled trial of a DPP4 inhibitor versus insulin secretagogues.
Topics: Adamantane; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug | 2016 |
Glucose Control in Severely Burned Patients Using Metformin: An Interim Safety and Efficacy Analysis of a Phase II Randomized Controlled Trial.
Topics: Blood Glucose; Burns; Fats; Female; Glucose Tolerance Test; Humans; Hypoglycemia; Insulin; Insulin R | 2016 |
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 |
One-year efficacy and safety of saxagliptin add-on in patients receiving dapagliflozin and metformin.
Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2 | 2016 |
Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin uptitration in Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy: a randomized, open-label, prospective study (VISION).
Topics: Adamantane; Aged; Asian People; Blood Glucose; Body Mass Index; China; Diabetes Mellitus, Type 2; Di | 2016 |
Efficacy and safety of initial combination therapy with gemigliptin and metformin compared with monotherapy with either drug in patients with type 2 diabetes: A double-blind randomized controlled trial (INICOM study).
Topics: Adult; Aged; Blood Glucose; C-Peptide; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors | 2017 |
Hypoglycemia in Frail Elderly Patients With Type 2 Diabetes Mellitus Treated With Sulfonylurea.
Topics: Aged; Aged, 80 and over; Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 2; Female; Frail Eld | 2017 |
Linagliptin as add-on to empagliflozin and metformin in patients with type 2 diabetes: Two 24-week randomized, double-blind, double-dummy, parallel-group trials.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Ther | 2017 |
The effects of exenatide twice daily compared to insulin lispro added to basal insulin in Latin American patients with type 2 diabetes: A retrospective analysis of the 4B trial.
Topics: Adult; Aged; Argentina; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration S | 2016 |
Effects of Glimepiride versus Saxagliptin on β-Cell Function and Hypoglycemia: A Post Hoc Analysis in Older Patients with Type 2 Diabetes Inadequately Controlled with Metformin.
Topics: Adamantane; Aged; Diabetes Mellitus, Type 2; Dipeptides; Dipeptidyl-Peptidase IV Inhibitors; Double- | 2016 |
Randomized, double-blind, phase III study to evaluate the efficacy and safety of once-daily treatment with alogliptin and metformin hydrochloride in Japanese patients with type 2 diabetes.
Topics: Acute Disease; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Administrat | 2017 |
Metformin in adults with type 1 diabetes: Design and methods of REducing with MetfOrmin Vascular Adverse Lesions (REMOVAL): An international multicentre trial.
Topics: Adult; Atherosclerosis; Blood Glucose; Body Weight; Carotid Intima-Media Thickness; Cholesterol, LDL | 2017 |
Efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes mellitus inadequately controlled with combination treatment of metformin and sulphonylurea: a 24-week, multicentre, randomized, double-blind, placebo-
Topics: Aged; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Double-Blind Method; Drug Monit | 2017 |
A randomized clinical trial of the safety and efficacy of sitagliptin in patients with type 2 diabetes mellitus inadequately controlled by acarbose alone.
Topics: Acarbose; Adult; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Monitoring; Dru | 2017 |
Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes: A 24-week randomized, controlled trial with open label extension.
Topics: Aged; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Monitoring; Drug Resistanc | 2017 |
Efficacy and safety of fixed-dose combination therapy, alogliptin plus metformin, in Asian patients with type 2 diabetes: A phase 3 trial.
Topics: China; Combined Modality Therapy; Diabetes Mellitus, Type 2; Diet, Diabetic; Dipeptidyl-Peptidase IV | 2017 |
Glyburide Versus Metformin and Their Combination for the Treatment of Gestational Diabetes Mellitus: A Randomized Controlled Study.
Topics: Administration, Oral; Adolescent; Adult; Blood Glucose; Diabetes, Gestational; Drug Therapy, Combina | 2017 |
Combining the G-protein-coupled receptor 40 agonist fasiglifam with sitagliptin improves glycaemic control in patients with type 2 diabetes with or without metformin: A randomized, 12-week trial.
Topics: Benzofurans; Combined Modality Therapy; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitor | 2017 |
Efficacy and safety of saxagliptin compared with acarbose in Chinese patients with type 2 diabetes mellitus uncontrolled on metformin monotherapy: Results of a Phase IV open-label randomized controlled study (the SMART study).
Topics: Acarbose; Adamantane; Adult; Aged; Asian People; Blood Glucose; China; Diabetes Mellitus, Type 2; Di | 2017 |
Addition of neutral protamine lispro insulin or insulin glargine to oral type 2 diabetes regimens for patients with suboptimal glycemic control: a randomized trial.
Topics: Administration, Oral; Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combinati | 2008 |
Comparison of glycaemic control in patients with Type 2 diabetes on basal insulin and fixed combination oral antidiabetic treatment: results of a pilot study.
Topics: Administration, Oral; Aged; Blood Glucose; Cross-Over Studies; Diabetes Mellitus, Type 2; Female; Gl | 2009 |
Relationship between HbA1c and hypoglycaemia in patients with type 2 diabetes treated with different insulin regimens in combination with metformin.
Topics: Adult; Aged; Aged, 80 and over; Diabetes Mellitus, Type 2; Fasting; Female; Glycated Hemoglobin; Hum | 2009 |
Relationship between HbA1c and hypoglycaemia in patients with type 2 diabetes treated with different insulin regimens in combination with metformin.
Topics: Adult; Aged; Aged, 80 and over; Diabetes Mellitus, Type 2; Fasting; Female; Glycated Hemoglobin; Hum | 2009 |
Relationship between HbA1c and hypoglycaemia in patients with type 2 diabetes treated with different insulin regimens in combination with metformin.
Topics: Adult; Aged; Aged, 80 and over; Diabetes Mellitus, Type 2; Fasting; Female; Glycated Hemoglobin; Hum | 2009 |
Relationship between HbA1c and hypoglycaemia in patients with type 2 diabetes treated with different insulin regimens in combination with metformin.
Topics: Adult; Aged; Aged, 80 and over; Diabetes Mellitus, Type 2; Fasting; Female; Glycated Hemoglobin; Hum | 2009 |
Effect of two starting insulin regimens in patients with type II diabetes not controlled on a combination of oral antihyperglycemic medications.
Topics: Animals; Blood Glucose; Blood Pressure; Body Mass Index; Diabetes Mellitus, Type 2; Drug Administrat | 2009 |
Long-term effects of metformin on metabolism and microvascular and macrovascular disease in patients with type 2 diabetes mellitus.
Topics: Adult; Aged; Aged, 80 and over; Blood Pressure; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Dr | 2009 |
Long-term effects of metformin on metabolism and microvascular and macrovascular disease in patients with type 2 diabetes mellitus.
Topics: Adult; Aged; Aged, 80 and over; Blood Pressure; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Dr | 2009 |
Long-term effects of metformin on metabolism and microvascular and macrovascular disease in patients with type 2 diabetes mellitus.
Topics: Adult; Aged; Aged, 80 and over; Blood Pressure; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Dr | 2009 |
Long-term effects of metformin on metabolism and microvascular and macrovascular disease in patients with type 2 diabetes mellitus.
Topics: Adult; Aged; Aged, 80 and over; Blood Pressure; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Dr | 2009 |
Nateglinide combination therapy with basal insulin and metformin in patients with Type 2 diabetes.
Topics: Adult; Aged; Cyclohexanes; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Therapy, Co | 2009 |
Comparison of vildagliptin and metformin monotherapy in elderly patients with type 2 diabetes: a 24-week, double-blind, randomized trial.
Topics: Adamantane; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptid | 2009 |
Three different premixed combinations of biphasic insulin aspart - comparison of the efficacy and safety in a randomized controlled clinical trial in subjects with type 2 diabetes.
Topics: Biphasic Insulins; Blood Glucose; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Ther | 2009 |
Comparison of vildagliptin and pioglitazone in patients with type 2 diabetes inadequately controlled with metformin.
Topics: Adamantane; Adolescent; Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptid | 2009 |
Twice-daily and three-times-daily dosing of a repaglinide/metformin fixed-dose combination tablet provide similar glycaemic control.
Topics: Adult; Blood Glucose; Carbamates; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Ther | 2009 |
A comparison between simplified and intensive dose-titration algorithms using AIR inhaled insulin for insulin-naive patients with type 2 diabetes in a randomized noninferiority trial.
Topics: Administration, Inhalation; Adult; Aged; Body Mass Index; Diabetes Mellitus, Type 2; Drug Therapy, C | 2009 |
Three-year efficacy of complex insulin regimens in type 2 diabetes.
Topics: Administration, Oral; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Therapy, Combina | 2009 |
Combining insulin with metformin or an insulin secretagogue in non-obese patients with type 2 diabetes: 12 month, randomised, double blind trial.
Topics: Blood Glucose; Carbamates; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination | 2009 |
Patient-reported outcomes in patients with type 2 diabetes treated with liraglutide or glimepiride, both as add-on to metformin.
Topics: Aged; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Glucagon-Like Peptide 1; Humans; | 2010 |
Hypoglycemic symptoms in patients with type 2 diabetes in Asia-Pacific-Real-life effectiveness and care patterns of diabetes management: the RECAP-DM study.
Topics: Aged; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemia; Hypoglycemic | 2010 |
Metformin compared with glyburide for the management of gestational diabetes.
Topics: Birth Weight; Blood Glucose; Diabetes, Gestational; Fasting; Female; Glyburide; Glycated Hemoglobin; | 2010 |
Vildagliptin add-on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: results from a 2-year study.
Topics: Adamantane; Adolescent; Adult; Aged; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Dr | 2010 |
Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: a 52-week randomised controlled trial.
Topics: Adamantane; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; Dipeptidyl-Peptidase IV Inhi | 2010 |
Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial.
Topics: Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Double-Blind Method; Drug Therapy, Co | 2011 |
Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial.
Topics: Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Therapy, Combination; Female; Glycated | 2011 |
Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial.
Topics: Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Therapy, Combination; Female; Glycated | 2011 |
Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial.
Topics: Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Therapy, Combination; Female; Glycated | 2011 |
Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial.
Topics: Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Therapy, Combination; Female; Glycated | 2011 |
Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia.
Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide; Humans; Hyp | 2011 |
Sitagliptin more effectively achieves a composite endpoint for A1C reduction, lack of hypoglycemia and no body weight gain compared with glipizide.
Topics: Aged; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Double-Blind Method; Female; Gl | 2011 |
Multifactorial intervention in individuals with type 2 diabetes and microalbuminuria: the Microalbuminuria Education and Medication Optimisation (MEMO) study.
Topics: Adult; Aged; Aged, 80 and over; Albuminuria; Antihypertensive Agents; Aspirin; Blood Pressure; Chole | 2011 |
A randomized non-inferiority study comparing the addition of exenatide twice daily to sitagliptin or switching from sitagliptin to exenatide twice daily in patients with type 2 diabetes experiencing inadequate glycaemic control on metformin and sitaglipti
Topics: Adolescent; Adult; Aged; Argentina; Australia; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl- | 2012 |
Dose-ranging effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, as add-on to metformin in subjects with type 2 diabetes.
Topics: Adolescent; Adult; Aged; Blood Glucose; Canagliflozin; Diabetes Mellitus, Type 2; Dose-Response Rela | 2012 |
Dose-ranging effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, as add-on to metformin in subjects with type 2 diabetes.
Topics: Adolescent; Adult; Aged; Blood Glucose; Canagliflozin; Diabetes Mellitus, Type 2; Dose-Response Rela | 2012 |
Dose-ranging effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, as add-on to metformin in subjects with type 2 diabetes.
Topics: Adolescent; Adult; Aged; Blood Glucose; Canagliflozin; Diabetes Mellitus, Type 2; Dose-Response Rela | 2012 |
Dose-ranging effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, as add-on to metformin in subjects with type 2 diabetes.
Topics: Adolescent; Adult; Aged; Blood Glucose; Canagliflozin; Diabetes Mellitus, Type 2; Dose-Response Rela | 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 |
Linagliptin monotherapy in type 2 diabetes patients for whom metformin is inappropriate: an 18-week randomized, double-blind, placebo-controlled phase III trial with a 34-week active-controlled extension.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Pep | 2012 |
Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: the HYPOCRAS study.
Topics: Aged; Cohort Studies; Diabetes Mellitus, Type 2; Dipeptidyl Peptidase 4; Drug Therapy, Combination; | 2012 |
Metformin compared with insulin in the management of gestational diabetes mellitus: a randomized clinical trial.
Topics: Adult; Birth Weight; Blood Glucose; Diabetes, Gestational; Drug Therapy, Combination; Female; Fetal | 2012 |
Safety and efficacy of insulin aspart and soluble human insulin in Type 2 diabetes mellitus.
Topics: Aged; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Glycated Hemoglobin; Humans; Hyp | 2012 |
Improved glycaemic control with metformin-glibenclamide combined tablet therapy (Glucovance) in Type 2 diabetic patients inadequately controlled on metformin.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Double-Blin | 2002 |
Therapy after single oral agent failure: adding a second oral agent or an insulin mixture?
Topics: Adult; Aged; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Glycated Hemoglobin; Huma | 2003 |
Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes.
Topics: Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Humans; Hy | 2005 |
Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with Type 2 diabetes.
Topics: Adult; Aged; Blood Glucose; Circadian Rhythm; Cross-Over Studies; Diabetes Mellitus, Type 2; Drug Ad | 2005 |
Effect on glycemic control of the addition of 2.5 mg glipizide GITS to metformin in patients with T2DM.
Topics: Blood Glucose; Chemistry, Pharmaceutical; Delayed-Action Preparations; Diabetes Mellitus, Type 2; Do | 2005 |
Effects of two different glibenclamide dose-strengths in the fixed combination with metformin in patients with poorly controlled T2DM: a double blind, prospective, randomised, cross-over clinical trial.
Topics: Adult; Blood Glucose; Body Mass Index; C-Peptide; Cross-Over Studies; Diabetes Mellitus, Type 2; Dou | 2004 |
Biphasic insulin aspart 30 plus metformin: an effective combination in type 2 diabetes.
Topics: Biphasic Insulins; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedu | 2006 |
Metformin-glibenclamide versus metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Combin | 2006 |
Differential effect of glimepiride and rosiglitazone on metabolic control of type 2 diabetic patients treated with metformin: a randomized, double-blind, clinical trial.
Topics: Body Mass Index; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Combinations; Female; Glycated | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
An open, randomized, parallel-group study to compare the efficacy and safety profile of inhaled human insulin (Exubera) with metformin as adjunctive therapy in patients with type 2 diabetes poorly controlled on a sulfonylurea.
Topics: Administration, Inhalation; Adult; Aged; Blood Glucose; Body Mass Index; Diabetes Mellitus, Type 2; | 2006 |
A randomized trial of adding insulin glargine vs. avoidance of insulin in people with Type 2 diabetes on either no oral glucose-lowering agents or submaximal doses of metformin and/or sulphonylureas. The Canadian INSIGHT (Implementing New Strategies with
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Canada; Diabetes Mellitus, Type 2; Drug T | 2006 |
Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride.
Topics: Aged; Biphasic Insulins; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dose-Response Relati | 2006 |
Combination of oral antidiabetic agents with basal insulin versus premixed insulin alone in randomized elderly patients with type 2 diabetes mellitus.
Topics: Administration, Oral; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fem | 2007 |
A randomized controlled trial examining combinations of repaglinide, metformin and NPH insulin.
Topics: Adult; Aged; Aged, 80 and over; Carbamates; Diabetes Mellitus, Type 2; Drug Administration Schedule; | 2007 |
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 |
Nateglinide or gliclazide in combination with metformin for treatment of patients with type 2 diabetes mellitus inadequately controlled on maximum doses of metformin alone: 1-year trial results.
Topics: Aged; Cyclohexanes; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination; Femal | 2007 |
Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin.
Topics: Adolescent; Adult; Aged; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy | 2007 |
Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin.
Topics: Adolescent; Adult; Aged; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy | 2007 |
Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin.
Topics: Adolescent; Adult; Aged; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy | 2007 |
Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin.
Topics: Adolescent; Adult; Aged; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy | 2007 |
Nateglinide, alone or in combination with metformin, is effective and well tolerated in treatment-naïve elderly patients with type 2 diabetes.
Topics: Aged; Aged, 80 and over; Blood Glucose; Body Mass Index; Cyclohexanes; Diabetes Mellitus, Type 2; Do | 2008 |
Efficacy and treatment satisfaction of once-daily insulin glargine plus one or two oral antidiabetic agents versus continuing premixed human insulin in patients with type 2 diabetes previously on long-term conventional insulin therapy: the Switch pilot st
Topics: Administration, Oral; Aged; Blood Glucose; Body Mass Index; Case-Control Studies; Diabetes Mellitus, | 2007 |
Comparison of fixed-dose rosiglitazone/metformin combination therapy with sulphonylurea plus metformin in overweight individuals with Type 2 diabetes inadequately controlled on metformin alone.
Topics: Blood Pressure; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination; Female; G | 2008 |
Tolerability and efficacy of exenatide and titrated insulin glargine in adult patients with type 2 diabetes previously uncontrolled with metformin or a sulfonylurea: a multinational, randomized, open-label, two-period, crossover noninferiority trial.
Topics: Adult; Blood Glucose; Body Weight; Cross-Over Studies; Diabetes Mellitus, Type 2; Double-Blind Metho | 2007 |
Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: a 16-week, randomized, open-label, parallel-group trial
Topics: Biomarkers; Biphasic Insulins; Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; | 2007 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin versus insulin for the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
The UK Prospective Diabetes Study. UK Prospective Diabetes Study Group.
Topics: Adult; Aged; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Humans; Hype | 1996 |
United Kingdom Prospective Diabetes Study 24: a 6-year, randomized, controlled trial comparing sulfonylurea, insulin, and metformin therapy in patients with newly diagnosed type 2 diabetes that could not be controlled with diet therapy. United Kingdom Pro
Topics: Adult; Aged; Blood Glucose; Combined Modality Therapy; Diabetes Mellitus, Type 2; Female; Follow-Up | 1998 |
Repaglinide in combination therapy with metformin in Type 2 diabetes.
Topics: Australia; Carbamates; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Glycated Hemogl | 1999 |
Metformin does not adversely affect hormonal and symptomatic responses to recurrent hypoglycemia.
Topics: Adult; Area Under Curve; Autonomic Nervous System; Blood Glucose; Double-Blind Method; Glucose Clamp | 2001 |
Effects of metformin on plasma glucose, insulin, FFA, glucagon, growth hormone and cortisol responses to oral glucose in subjects with chemical diabetes.
Topics: Adult; Blood Glucose; Clinical Trials as Topic; Diabetes Mellitus; Fatty Acids, Nonesterified; Femal | 1979 |
[Early and late dumping treated with metformin (Glucofag)].
Topics: Dumping Syndrome; Female; Gastrectomy; Glucose Tolerance Test; Humans; Hypoglycemia; Insulin; Insuli | 1972 |
177 other studies available for metformin and Hypoglycemia
| Article | Year |
|---|---|
The role of sulfonylureas in the treatment of type 2 diabetes.
Topics: Diabetes Mellitus, Type 2; Humans; Hypoglycemia; Hypoglycemic Agents; Metformin; Sulfonylurea Compou | 2022 |
Real-world comparison of mono and dual combination therapies of metformin, sulfonylurea, and dipeptidyl peptidase-4 inhibitors using a common data model: A retrospective observational study.
Topics: Adult; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy, Combination; Fem | 2022 |
Does optimal HbA1c in diabetes differ according to drug treatment? An evaluation of national electronic database in Malta.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Electronics; Glycated Hemoglobi | 2022 |
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 |
Role of Ambulatory Glucose Profile in Precision Medicine in Type 2 Diabetes Mellitus.
Topics: Adult; Blood Glucose; Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase | 2022 |
Continuous glucose monitoring demonstrates low risk of clinically significant hypoglycemia associated with sulphonylurea treatment in an African type 2 diabetes population: results from the OPTIMAL observational multicenter study.
Topics: Blood Glucose; Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 2; Glycated Hemoglobin; Humans | 2022 |
Metformin-associated Lactic Acidosis with Hypoglycemia during the COVID-19 Pandemic.
Topics: Acidosis, Lactic; COVID-19; Diabetes Mellitus, Type 2; Humans; Hypoglycemia; Hypoglycemic Agents; Ma | 2022 |
Arene-Ruthenium(II)/Osmium(II) Complexes Potentiate the Anticancer Efficacy of Metformin via Glucose Metabolism Reprogramming.
Topics: Antineoplastic Agents; Cell Line, Tumor; Coordination Complexes; Glucose; Humans; Hypoglycemia; Metf | 2022 |
Efficacy and safety of combination of empagliflozin and metformin with combination of sitagliptin and metformin during Ramadan: an observational study.
Topics: Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl Peptidase 4; Drug Therapy | 2022 |
Efficacy and safety of empagliflozin in people with type 2 diabetes during Ramadan fasting.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Fasting; Glycated Hemoglobin; Humans; Hypoglycemia; Hypogl | 2022 |
[Cross-Sectional Study on Adverse Effects of Metformin Hydrochloride on 130 Patients Type 2 Diabetic Admitted to Medical Center and Diabetes Home of Sidi Bel-Abbès].
Topics: Acidosis, Lactic; Adult; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug-Related Side Effec | 2023 |
[Cross-Sectional Study on Adverse Effects of Metformin Hydrochloride on 130 Patients Type 2 Diabetic Admitted to Medical Center and Diabetes Home of Sidi Bel-Abbès].
Topics: Acidosis, Lactic; Adult; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug-Related Side Effec | 2023 |
[Cross-Sectional Study on Adverse Effects of Metformin Hydrochloride on 130 Patients Type 2 Diabetic Admitted to Medical Center and Diabetes Home of Sidi Bel-Abbès].
Topics: Acidosis, Lactic; Adult; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug-Related Side Effec | 2023 |
[Cross-Sectional Study on Adverse Effects of Metformin Hydrochloride on 130 Patients Type 2 Diabetic Admitted to Medical Center and Diabetes Home of Sidi Bel-Abbès].
Topics: Acidosis, Lactic; Adult; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug-Related Side Effec | 2023 |
Comparison of Mitochondrial Adenosine Triphosphate-Sensitive Potassium Channel High- vs Low-Affinity Sulfonylureas and Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With Metformin.
Topics: Adenosine Triphosphate; Cohort Studies; Diabetes Mellitus, Type 2; Heart Failure; Humans; Hypoglycem | 2022 |
Comparison of Mitochondrial Adenosine Triphosphate-Sensitive Potassium Channel High- vs Low-Affinity Sulfonylureas and Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With Metformin.
Topics: Adenosine Triphosphate; Cohort Studies; Diabetes Mellitus, Type 2; Heart Failure; Humans; Hypoglycem | 2022 |
Comparison of Mitochondrial Adenosine Triphosphate-Sensitive Potassium Channel High- vs Low-Affinity Sulfonylureas and Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With Metformin.
Topics: Adenosine Triphosphate; Cohort Studies; Diabetes Mellitus, Type 2; Heart Failure; Humans; Hypoglycem | 2022 |
Comparison of Mitochondrial Adenosine Triphosphate-Sensitive Potassium Channel High- vs Low-Affinity Sulfonylureas and Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With Metformin.
Topics: Adenosine Triphosphate; Cohort Studies; Diabetes Mellitus, Type 2; Heart Failure; Humans; Hypoglycem | 2022 |
Efficacy and safety of hypoglycemic agents on gestational diabetes mellitus in women: A Bayesian network analysis of randomized controlled trials.
Topics: Birth Weight; Diabetes, Gestational; Female; Glyburide; Humans; Hypoglycemia; Hypoglycemic Agents; I | 2022 |
Sulfonylureas as second line therapy for type 2 diabetes among veterans: Results from a National Longitudinal Cohort Study.
Topics: Aged; Cohort Studies; Diabetes Mellitus, Type 2; Humans; Hypoglycemia; Hypoglycemic Agents; Longitud | 2023 |
Glucose-responsive Insulinoma with Insulin Hypersecretion Suppressed by Metformin.
Topics: Glucose Tolerance Test; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin; Insulinoma; Male; Metfor | 2019 |
A retrospective cross-sectional study of type 2 diabetes overtreatment in patients admitted to the geriatric ward.
Topics: Aged; Aged, 80 and over; Blood Glucose; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug The | 2019 |
Maternal and Neonatal Health Outcomes Associated with the Use of Gliclazide and Metformin for the Treatment of Diabetes in Pregnancy: A Record Linkage Study.
Topics: Abnormalities, Drug-Induced; Adult; Diabetes, Gestational; Female; Gliclazide; Hospitalization; Huma | 2020 |
Comparative effectiveness of metformin versus insulin for gestational diabetes in New Zealand.
Topics: Adolescent; Adult; Birth Weight; Cesarean Section; Diabetes, Gestational; Female; Humans; Hypoglycem | 2019 |
Pharmacotherapy of type 2 diabetes mellitus in frail elderly patients.
Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Frail Elderly; Glycated Hemoglobin; Humans; Hypoglyc | 2019 |
Impact of Hypoglycemia on Health-Related Quality of Life among Type 2 Diabetes: A Cross-Sectional Study in Thailand.
Topics: Aged; Blood Glucose; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug Therapy, Combination; | 2019 |
Intensification with dipeptidyl peptidase-4 inhibitor, insulin, or thiazolidinediones and risks of all-cause mortality, cardiovascular diseases, and severe hypoglycemia in patients on metformin-sulfonylurea dual therapy: A retrospective cohort study.
Topics: Adult; Aged; Cardiovascular Diseases; Cohort Studies; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidas | 2019 |
A Safety Comparison of Metformin vs Sulfonylurea Initiation in Patients With Type 2 Diabetes and Chronic Kidney Disease: A Retrospective Cohort Study.
Topics: Canada; Cardiovascular Diseases; Creatinine; Diabetes Mellitus, Type 2; Drug Monitoring; Effect Modi | 2020 |
Hypoglycemic encephalopathy caused by overdose of metformin in an adolescent.
Topics: Adolescent; Brain Diseases; Female; Humans; Hypoglycemia; Metformin | 2020 |
Therapeutic efficacy and safety of initial triple combination of metformin, sitagliptin, and lobeglitazone in drug-naïve patients with type 2 diabetes: initial triple study.
Topics: Biomarkers; Blood Glucose; Case-Control Studies; Diabetes Mellitus, Type 2; Drug Therapy, Combinatio | 2020 |
Real-world Evaluation of glycemic control and hypoglycemic Events among type 2 Diabetes mellitus study (REEDS): a multicentre, cross-sectional study in Thailand.
Topics: Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycemic Control; Hum | 2020 |
Comparative effects of glibenclamide, metformin and insulin on fetal pancreatic histology and maternal blood glucose in pregnant streptozotocin-induced diabetic rats.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Diabetes, Gestational; Female; | 2019 |
Changes in incidence of severe hypoglycaemia in people with type 2 diabetes from 2006 to 2016: analysis based on health insurance data in Germany considering the anti-hyperglycaemic medication.
Topics: Aged; Aged, 80 and over; Databases, Factual; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhi | 2020 |
Developing a definition for Oral Antidiabetic Drug (OAD) Failure.
Topics: Administration, Oral; Clinical Decision-Making; Diabetes Mellitus, Type 2; Drug Therapy, Combination | 2020 |
Use of Antihyperglycemic Medications in U.S. Adults: An Analysis of the National Health and Nutrition Examination Survey.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Cardiovascular Diseases; Cross-Sectional Studies; Diabet | 2020 |
Risk of Major Adverse Cardiovascular Events, Severe Hypoglycemia, and All-Cause Mortality for Widely Used Antihyperglycemic Dual and Triple Therapies for Type 2 Diabetes Management: A Cohort Study of All Danish Users.
Topics: Aged; Cardiovascular Diseases; Cause of Death; Cohort Studies; Denmark; Diabetes Mellitus, Type 2; D | 2020 |
Metformin in Pregnancy Study (MiPS): protocol for a systematic review with individual patient data meta-analysis.
Topics: Blood Glucose; Diabetes, Gestational; Female; Humans; Hypoglycemia; Infant, Newborn; Meta-Analysis a | 2020 |
Glycemic variability in type 2 diabetes mellitus and acute coronary syndrome: liraglutide compared with insulin glargine: a pilot study.
Topics: Acute Coronary Syndrome; Adult; Blood Glucose; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobi | 2020 |
Long-term follow up of older people on diabetes medications: observational study using linked health databases.
Topics: Aged; Aged, 80 and over; Cardiovascular Diseases; Databases, Factual; Diabetes Mellitus; Female; Fol | 2020 |
Glucose-lowering effects of 7-day treatment with SGLT2 inhibitor confirmed by intermittently scanned continuous glucose monitoring in outpatients with type 1 diabetes. A pilot study.
Topics: Adult; Ambulatory Care; Benzhydryl Compounds; Blood Glucose; Blood Glucose Self-Monitoring; Diabetes | 2021 |
Gestational diabetes, metformin, and the risk of hypoglycemia.
Topics: Diabetes, Gestational; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Metformin; Pregnancy | 2021 |
Gestational diabetes, metformin, and risk of hypoglycemia.
Topics: Diabetes, Gestational; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Metformin; Pregnancy | 2021 |
Symptomatic Hypoglycemia During Treatment with a Therapeutic Dose of Metformin.
Topics: Blood Glucose; Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 2; Drug Therapy, Combination; | 2021 |
ROS-responsive organosilica nanocarrier for the targeted delivery of metformin against cancer with the synergistic effect of hypoglycemia.
Topics: Animals; Antineoplastic Agents; Cell Survival; Drug Carriers; Drug Delivery Systems; Drug Screening | 2021 |
Angiotensin-Converting Enzyme Inhibitors Used Concomitantly with Insulin Secretagogues and the Risk of Serious Hypoglycemia.
Topics: Administrative Claims, Healthcare; Aged; Aged, 80 and over; Angiotensin-Converting Enzyme Inhibitors | 2022 |
Impact of health policy and practice on finding the best fit for patients with type 2 diabetes after metformin failure: Croatian pilot study.
Topics: Administration, Oral; Aged; Biomarkers; Blood Glucose; Body Mass Index; Body Weight; Clinical Decisi | 2017 |
Differential increments of basal glucagon-like-1 peptide concentration among SLC47A1 rs2289669 genotypes were associated with inter-individual variability in glycaemic response to metformin in Chinese people with newly diagnosed Type 2 diabetes.
Topics: Adult; China; Cohort Studies; Diabetes Mellitus, Type 2; Drug Resistance; Female; Follow-Up Studies; | 2017 |
Missed Opportunities for Deprescription: A Teachable Moment.
Topics: Aged, 80 and over; Deprescriptions; Diabetes Complications; Diabetes Mellitus; Drug Therapy, Combina | 2017 |
Intensive insulin therapy combined with metformin is associated with reduction in both glucose variability and nocturnal hypoglycaemia in patients with type 2 diabetes.
Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Glycated Hemoglob | 2017 |
Glycemic Improvement with a Fixed-dose combination of DPP-4 inhibitor + metformin in patients with Type 2 diabetes (GIFT study).
Topics: Aged; Cohort Studies; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Combinatio | 2018 |
[Gliptin-gliflozin combination for treating type 2 diabetes].
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Combinations; Dru | 2016 |
Patterns of glycaemic control in patients with type 2 diabetes mellitus initiating second-line therapy after metformin monotherapy: Retrospective data for 10 256 individuals from the United Kingdom and Germany.
Topics: Adult; Aged; Cohort Studies; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Mon | 2018 |
The effect of sitagliptin on obese patients with insulin treatment-induced diabetes mellitus.
Topics: Adiponectin; Adult; Aged; Blood Glucose; Body Mass Index; Diabetes Mellitus, Type 2; Fasting; Female | 2017 |
Healthcare resource use and associated costs of hypoglycemia in patients with type 2 diabetes prescribed sulfonylureas.
Topics: Aged; Cohort Studies; Combined Modality Therapy; Costs and Cost Analysis; Diabetes Mellitus, Type 2; | 2017 |
Treatment of Type 1 Diabetes: Synopsis of the 2017 American Diabetes Association Standards of Medical Care in Diabetes.
Topics: Blood Glucose; Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 1; Glycated Hemoglobin; Humans | 2017 |
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 |
Sulfonylureas as Initial Treatment for Type 2 Diabetes and the Risk of Severe Hypoglycemia.
Topics: Aged; Cohort Studies; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemia; Hypoglycemic Agents; | 2018 |
Oral Hypoglycemic Agents Added to Insulin Monotherapy for Type 2 Diabetes.
Topics: Administration, Oral; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Hum | 2017 |
Dulaglutide (Trulicity) for Type 2 Diabetes Mellitus.
Topics: Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glucagon-Like Peptides; Glycated Hemoglobin; H | 2017 |
Patient and prescriber characteristics among patients with type 2 diabetes mellitus continuing or discontinuing sulfonylureas following insulin initiation: data from a large commercial database.
Topics: Adult; Databases, Factual; Diabetes Mellitus, Type 2; Drug Monitoring; Female; Humans; Hypoglycemia; | 2018 |
Comparison of costs and outcomes of dapagliflozin with other glucose-lowering therapy classes added to metformin using a short-term cost-effectiveness model in the US setting.
Topics: Benzhydryl Compounds; Blood Pressure; Body Weight; Cost-Benefit Analysis; Diabetes Mellitus, Type 2; | 2018 |
Hypoglycemia in type 2 diabetes: understanding patients' and physicians' knowledge and experience.
Topics: Aged; Clinical Decision-Making; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Health | 2018 |
Severe lactic acidosis and hypoglycemia due to acute metformin intoxication in a dog.
Topics: Acidosis, Lactic; Animals; Dog Diseases; Dogs; Female; Glucose; Hypoglycemia; Hypoglycemic Agents; I | 2018 |
Treatment Discontinuation and Clinical Events in Type 2 Diabetes Patients Treated with Dipeptidyl Peptidase-4 Inhibitors or NPH Insulin as Third-Line Therapy.
Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Female; Humans; | 2018 |
Initial combination therapy with vildagliptin plus metformin in drug-naïve patients with T2DM: a 24-week real-life study from Asia.
Topics: Adult; Asia; Body Mass Index; Diabetes Mellitus, Type 2; Drug Combinations; Female; Glycated Hemoglo | 2018 |
Serious Hypoglycemia and Use of Warfarin in Combination With Sulfonylureas or Metformin.
Topics: Aged; Aged, 80 and over; Anticoagulants; Drug Therapy, Combination; Female; Humans; Hypoglycemia; Hy | 2019 |
A herbal treatment for type 2 diabetes adulterated with undisclosed drugs.
Topics: Diabetes Mellitus, Type 2; Drug Contamination; Female; Glyburide; Humans; Hypoalbuminemia; Hypoglyce | 2018 |
Recurrent hypoglycemia secondary to metformin toxicity in the absence of co-ingestions: a case report.
Topics: Acidosis, Lactic; Anti-Obesity Agents; Female; Humans; Hypoglycemia; Metformin; Polycystic Ovary Syn | 2018 |
Metformin reduces liver glucose production by inhibition of fructose-1-6-bisphosphatase.
Topics: Adenosine Monophosphate; Aminoimidazole Carboxamide; Animals; Base Sequence; Chickens; Disease Model | 2018 |
Glycemic Variability Promotes Both Local Invasion and Metastatic Colonization by Pancreatic Ductal Adenocarcinoma.
Topics: Animals; Carcinoma, Pancreatic Ductal; Cell Line, Tumor; Cell Proliferation; Collagen Type VI; Core | 2018 |
Different daily glycemic profiles after switching from once-daily alogliptin plus twice-daily metformin to their once-daily fixed-dose combination in Japanese type 2 diabetic patients.
Topics: Aged; Asian People; Blood Glucose; Diabetes Mellitus, Type 2; Drug Combinations; Drug Substitution; | 2019 |
Recent metformin adherence and the risk of hypoglycaemia in the year following intensification with a sulfonylurea.
Topics: Aged; Cohort Studies; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Drug Therapy, Com | 2019 |
Type 2 diabetes mellitus in pregnancy: The impact of maternal weight and early glycaemic control on outcomes.
Topics: Adult; Case-Control Studies; Cesarean Section; Diabetes Mellitus, Type 2; Female; Fetal Macrosomia; | 2019 |
Combination of Hypoglycemia and Metformin Impairs Tumor Metabolic Plasticity and Growth by Modulating the PP2A-GSK3β-MCL-1 Axis.
Topics: Animals; Cell Line, Tumor; Cell Proliferation; Cell Survival; Fasting; Gene Expression Regulation, N | 2019 |
Teaching an Old Drug New Tricks.
Topics: Fasting; Glycogen Synthase Kinase 3 beta; Humans; Hypoglycemia; Metformin; Myeloid Cell Leukemia Seq | 2019 |
Metformin overdose-induced hypoglycemia in the absence of other antidiabetic drugs.
Topics: Acidosis, Lactic; Adolescent; Drug Overdose; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Hypo | 2013 |
The association between adherence to oral anti-diabetic drugs and hypoglycaemia in persons with Type 2 diabetes.
Topics: Adolescent; Adult; Aged; Algorithms; Diabetes Mellitus, Type 2; Drug Substitution; Drug Therapy, Com | 2013 |
Octreotide: a novel therapy for refractory sulfonylurea-induced hypoglycemia.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Female; Glyburide; Humans; Hypoglycemia; Hypoglycemic Agen | 2013 |
Treatment adherence with vildagliptin compared to sulphonylurea as add-on to metformin in Muslim patients with type 2 diabetes mellitus fasting during Ramadan.
Topics: Adamantane; Aged; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy, Combi | 2013 |
[Diabetes treatment in patients with chronic kidney disease].
Topics: Aged; Diabetes Mellitus, Type 2; Diabetic Nephropathies; Drug Substitution; Drug Therapy, Combinatio | 2013 |
One other explanation for hypoglycemia during metformin overdose.
Topics: Drug Overdose; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Metformin | 2013 |
Prognostic implications of DPP-4 inhibitor vs. sulfonylurea use on top of metformin in a real world setting - results of the 1 year follow-up of the prospective DiaRegis registry.
Topics: Administration, Oral; Aged; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Comb | 2013 |
Metformin toxicity: a report of 204 cases from Iran.
Topics: Acidosis, Lactic; Adolescent; Adult; Aged; Aged, 80 and over; Child; Female; Humans; Hypoglycemia; H | 2013 |
Efficacy and safety of insulin glargine added to a fixed-dose combination of metformin and a dipeptidyl peptidase-4 inhibitor: results of the GOLD observational study.
Topics: Aged; Biomarkers; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inh | 2013 |
[Prospective, multicentric, non-interventional study to assess the existing treatment of type 2 diabetes mellitus patients inadequately controlled with metformin monotherapy - KOMETA CZ].
Topics: Czech Republic; Diabetes Mellitus, Type 2; Drug Substitution; Drug Therapy, Combination; Female; Gly | 2013 |
[Anti-diabetes agents and hypoglycemia].
Topics: Diabetes Mellitus, Type 2; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin; Metformin; Sulfonylur | 2013 |
How to prevent and treat pharmacological hypoglycemias.
Topics: Anticholesteremic Agents; Antihypertensive Agents; Diabetes Mellitus, Type 2; Female; Humans; Hyperc | 2014 |
Hypoglycemia, its implications in clinical practice, and possible ways to prevent it.
Topics: Adamantane; Diabetes Mellitus, Type 2; Dipeptides; Female; Glipizide; Humans; Hypoglycemia; Male; Me | 2014 |
SGLT-2 inhibitors as second-line therapy in type 2 diabetes.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Drug Th | 2014 |
Healthcare costs of the combination of metformin/dipeptidyl peptidase-4 inhibitors compared with metformin/other oral antidiabetes agents in patients with type 2 diabetes and metabolic syndrome.
Topics: Aged; Blood Glucose; Cardiovascular Diseases; Cost-Benefit Analysis; Diabetes Mellitus, Type 2; Diab | 2014 |
The evaluation of clinical and cost outcomes associated with earlier initiation of insulin in patients with type 2 diabetes mellitus.
Topics: Cohort Studies; Cost Savings; Costs and Cost Analysis; Diabetes Complications; Diabetes Mellitus, Ty | 2014 |
Evaluation approach can significantly influence oral glucose-lowering drugs total mortality risks in retrospective cohorts of type 2 diabetes mellitus patients.
Topics: Diabetes Mellitus, Type 2; Gliclazide; Glyburide; Humans; Hypoglycemia; Hypoglycemic Agents; Metform | 2014 |
A decision support tool for appropriate glucose-lowering therapy in patients with type 2 diabetes.
Topics: Body Mass Index; Clinical Protocols; Comorbidity; Decision Support Systems, Clinical; Diabetes Melli | 2015 |
Intracerebroventricular metformin decreases body weight but has pro-oxidant effects and decreases survival.
Topics: Animals; Body Weight; Cells, Cultured; Hypoglycemia; Hypoglycemic Agents; Infusions, Intraventricula | 2015 |
Effect of bariatric surgery combined with medical therapy versus intensive medical therapy or calorie restriction and weight loss on glycemic control in Zucker diabetic fatty rats.
Topics: Age Factors; Animals; Behavior, Animal; Biomarkers; Blood Glucose; Caloric Restriction; Combined Mod | 2015 |
Clinical effectiveness and safety of vildagliptin in >19 000 patients with type 2 diabetes: the GUARD study.
Topics: Adamantane; Adult; Aged; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Dru | 2015 |
Real-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey--GALATA study.
Topics: Adamantane; Body Mass Index; Cohort Studies; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhi | 2015 |
Combination therapy with oleanolic acid and metformin as a synergistic treatment for diabetes.
Topics: Animals; Biomarkers; Body Weight; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 2; Diseas | 2015 |
Surreptitious metformin abuse in anorexia nervosa presenting as periodic hypoglycaemia.
Topics: Anorexia Nervosa; Coma; Drug Overdose; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Metformin; | 2015 |
Vildagliptin as add-on therapy to insulin improves glycemic control without increasing risk of hypoglycemia in Asian, predominantly Chinese, patients with type 2 diabetes mellitus.
Topics: Adamantane; Adolescent; Adult; Aged; Aged, 80 and over; Asia; Blood Glucose; Diabetes Mellitus, Type | 2016 |
Cost-effectiveness of saxagliptin vs glimepiride as a second-line therapy added to metformin in Type 2 diabetes in China.
Topics: Adamantane; Body Mass Index; Cardiovascular Diseases; China; Computer Simulation; Cost-Benefit Analy | 2015 |
Getting to goal in newly diagnosed type 2 diabetes using combination drug "subtraction therapy".
Topics: Adult; Aged; Aged, 80 and over; Carbamates; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fe | 2015 |
Sulfonylurea monotherapy and emergency room utilization among elderly patients with type 2 diabetes.
Topics: Aged; Aged, 80 and over; Databases, Factual; Diabetes Mellitus, Type 2; Emergency Medical Services; | 2015 |
Sitagliptin in type 2 diabetes mellitus: Efficacy after five years of therapy.
Topics: Adolescent; Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Humans; Hyp | 2015 |
Treatment satisfaction in type 2 diabetes patients taking empagliflozin compared with patients taking glimepiride.
Topics: Adult; Benzhydryl Compounds; Clinical Protocols; Diabetes Mellitus, Type 2; Double-Blind Method; Dru | 2016 |
Effects on Clinical Outcomes of Adding Dipeptidyl Peptidase-4 Inhibitors Versus Sulfonylureas to Metformin Therapy in Patients With Type 2 Diabetes Mellitus.
Topics: Cardiovascular Diseases; Cause of Death; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibito | 2015 |
How much is too much? Outcomes in patients using high-dose insulin glargine.
Topics: Adult; Aged; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Glycated Hemoglobin; Huma | 2016 |
Incidence, characteristics and impact of hypoglycaemia in patients receiving intensified treatment for inadequately controlled type 2 diabetes mellitus.
Topics: Aged; Amputation, Surgical; Angina, Stable; Asymptomatic Diseases; Blood Glucose; Depressive Disorde | 2016 |
Efficacy and safety of linagliptin as add-on therapy to basal insulin and metformin in people with Type 2 diabetes.
Topics: Aged; Clinical Trials, Phase III as Topic; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fem | 2016 |
Risk of hypoglycemia following intensification of metformin treatment with insulin versus sulfonylurea.
Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Drug Therapy, Comb | 2016 |
Hypoglycemia Incidence Rates and Associated Health Care Costs in Patients with Type 2 Diabetes Mellitus Treated with Second-Line Linagliptin or Sulfonylurea After Metformin Monotherapy.
Topics: Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Health Care Costs; Humans; Hypoglycemia; Hyp | 2016 |
Sulphonylurea compared to DPP-4 inhibitors in combination with metformin carries increased risk of severe hypoglycemia, cardiovascular events, and all-cause mortality.
Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy, Co | 2016 |
Risk of hypoglycaemia in users of sulphonylureas compared with metformin in relation to renal function and sulphonylurea metabolite group: population based cohort study.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Cohort Studies; Diabetes Mellitus, Type 2; Diabetic Neph | 2016 |
Cost-effectiveness of Canagliflozin versus Sitagliptin When Added to Metformin and Sulfonylurea in Type 2 Diabetes in Canada.
Topics: Aged; Blood Glucose; Canada; Canagliflozin; Cost-Benefit Analysis; Diabetes Mellitus, Type 2; Dipept | 2016 |
A post-hoc analysis of the comparative efficacy of canagliflozin and glimepiride in the attainment of type 2 diabetes-related quality measures.
Topics: Aged; Blood Glucose; Blood Pressure Determination; Canagliflozin; Diabetes Mellitus, Type 2; Double- | 2016 |
The use of dextrose/insulin infusions during labour and delivery in women with gestational diabetes mellitus: Is there any point?
Topics: Blood Glucose; Diabetes, Gestational; Female; Glucose; Humans; Hypoglycemia; Hypoglycemic Agents; In | 2017 |
Efficacy and safety of empagliflozin in combination with other oral hypoglycemic agents in patients with type 2 diabetes mellitus.
Topics: Aged; Benzhydryl Compounds; Clinical Trials, Phase III as Topic; Diabetes Mellitus, Type 2; Disease | 2016 |
Preventing Unnecessary Costs of Drug-Induced Hypoglycemia in Older Adults with Type 2 Diabetes in the United States and Canada.
Topics: Aged; Aged, 80 and over; Canada; Cost-Benefit Analysis; Decision Trees; Diabetes Mellitus, Type 2; H | 2016 |
Trends in Drug Utilization, Glycemic Control, and Rates of Severe Hypoglycemia, 2006-2013.
Topics: Adolescent; Adult; Aged; Blood Glucose; Comorbidity; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase | 2017 |
Different effects of basal insulin peglispro and insulin glargine on liver enzymes and liver fat content in patients with type 1 and type 2 diabetes.
Topics: Adipose Tissue; Adult; Aged; Alanine Transaminase; Aspartate Aminotransferases; Bilirubin; Blood Glu | 2016 |
Managing glycaemia in older people with type 2 diabetes: A retrospective, primary care-based cohort study, with economic assessment of patient outcomes.
Topics: Aged; Aging; Cohort Studies; Cost of Illness; Cost-Benefit Analysis; Diabetes Mellitus, Type 2; Dipe | 2017 |
Second line initiation of insulin compared with DPP-4 inhibitors after metformin monotherapy is associated with increased risk of all-cause mortality, cardiovascular events, and severe hypoglycemia.
Topics: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Female; Huma | 2017 |
Comparative cardiovascular risks of dipeptidyl peptidase 4 inhibitors with other second- and third-line antidiabetic drugs in patients with type 2 diabetes.
Topics: Adult; Aged; Cardiovascular System; Cohort Studies; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase | 2017 |
Hemodialysis-refractory metformin-associated lactate acidosis with hypoglycemia, hypothermia, and bradycardia in a diabetic patient with belated diagnosis and chronic kidney disease
.
Topics: Acidosis, Lactic; Aged; Biomarkers; Bradycardia; Delayed Diagnosis; Diabetes Mellitus, Type 2; Drug | 2017 |
Metabolic acidosis in a patient with metformin overdose.
Topics: Acidosis; Blood Gas Analysis; Cardiotonic Agents; Drug Overdose; Fatal Outcome; Female; Heart Arrest | 2017 |
Effectiveness and safety of vildagliptin and vildagliptin add-on to metformin in real-world settings in Egypt - results from the GUARD study.
Topics: Adamantane; Adult; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Monitoring; D | 2017 |
Metformin Trumps insulin in the treatment of gestational diabetes.
Topics: Adult; Diabetes, Gestational; Drug Therapy, Combination; Female; Gestational Age; Humans; Hypoglycem | 2008 |
Metformin, sulfonylureas, or other antidiabetes drugs and the risk of lactic acidosis or hypoglycemia: a nested case-control analysis.
Topics: Acidosis, Lactic; Aged; Case-Control Studies; Databases, Factual; Diabetes Mellitus, Type 2; Female; | 2008 |
Outcomes of adding second hypoglycemic drug after metformin monotherapy failure among type 2 diabetes in Hungary.
Topics: Adult; Aged; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Glycated Hemoglobin; Huma | 2008 |
Balancing risk and benefit with oral hypoglycemic drugs.
Topics: Acidosis, Lactic; Administration, Oral; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Humans | 2009 |
Vildagliptin therapy and hypoglycaemia in Muslim type 2 diabetes patients during Ramadan.
Topics: Adamantane; Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fastin | 2009 |
[Insulin secretion is increased depending on glucose.. Metabolism regulation in type 2 diabetes mellitus over five paths].
Topics: Blood Glucose; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exena | 2009 |
[Type 2 diabetes: interview with Prof. Stephan Matthaei. Reaching HbA1c target value while preventing hypoglycemia].
Topics: Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy, Combination; Glycated H | 2009 |
Sulphonyurea as a cause of severe hypoglycaemia in the community.
Topics: Adult; Aged; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Huma | 2010 |
Metformin reverses hexokinase and 6-phosphofructo-1-kinase inhibition in skeletal muscle, liver and adipose tissues from streptozotocin-induced diabetic mouse.
Topics: Adipose Tissue; Animals; Biocatalysis; Cell Line; Diabetes Mellitus, Experimental; Drug Design; Glyc | 2010 |
Insulin regimens in type 2 diabetes.
Topics: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Humans; Hypoglycemia; | 2010 |
Understanding the inter-relationship between improved glycaemic control, hypoglycaemia and weight change within a long-term economic model.
Topics: Blood Glucose; Body Weight; Cost-Benefit Analysis; Diabetes Mellitus, Type 2; Humans; Hypoglycemia; | 2010 |
Effective switch from premixed to basal-prandial insulin to achieve glycemic goals in type 2 diabetes.
Topics: Administration, Oral; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Therapy, Combina | 2010 |
Effect of a low glycemic index compared with a conventional healthy diet on polycystic ovary syndrome.
Topics: Adolescent; Adult; Blood Glucose; Body Composition; Body Mass Index; Cardiovascular Diseases; Diet; | 2010 |
Frequent reoccurrence of hypoglycemia in a type 2 diabetic patient with insulin antibodies.
Topics: Acarbose; Aged, 80 and over; Blood Glucose; Diabetes Mellitus, Type 2; Glucose; Humans; Hypoglycemia | 2010 |
Distinguishing among incretin-based therapies. Safety, tolerability, and nonglycemic effects of incretin-based therapies.
Topics: Adamantane; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides; Dipeptidyl-Peptidase IV Inhi | 2010 |
Diabetes treatment patterns and goal achievement in primary diabetes care (DiaRegis) - study protocol and patient characteristics at baseline.
Topics: Adult; Comorbidity; Diabetes Complications; Diabetes Mellitus, Type 2; Female; Follow-Up Studies; Ge | 2010 |
Impaired renal function modifies the risk of severe hypoglycaemia among users of insulin but not glyburide: a population-based nested case-control study.
Topics: Aged; Aged, 80 and over; Canada; Case-Control Studies; Diabetes Mellitus, Type 2; Female; Follow-Up | 2011 |
Improved glycaemic control with reduced hypoglycaemic episodes and without weight gain using long-term modern premixed insulins in type 2 diabetes.
Topics: Aged; Biphasic Insulins; Blood Glucose; Diabetes Mellitus, Type 2; Drug Combinations; Fasting; Femal | 2011 |
Self-reported experience of hypoglycemia among adults with type 2 diabetes mellitus (Exhype).
Topics: Aged; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Male; Metformin; | 2011 |
Influence of CYP2C9 gene polymorphisms on response to glibenclamide in type 2 diabetes mellitus patients.
Topics: Alleles; Amplified Fragment Length Polymorphism Analysis; Aryl Hydrocarbon Hydroxylases; Cohort Stud | 2011 |
Insulin management of type 2 diabetes mellitus.
Topics: Blood Glucose; Cost-Benefit Analysis; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug | 2011 |
The impact of initiating biphasic human insulin 30 therapy in type 2 diabetes patients after failure of oral antidiabetes drugs.
Topics: Aged; Biphasic Insulins; Blood Glucose; China; Cost-Benefit Analysis; Diabetes Mellitus, Type 2; Fem | 2012 |
Can a protocol for glycaemic control improve type 2 diabetes outcomes after gastric bypass?
Topics: Adolescent; Adult; Aged; Algorithms; Blood Glucose; Clinical Protocols; Cohort Studies; Diabetes Mel | 2012 |
Pregnancy management of women with pregestational diabetes.
Topics: Congenital Abnormalities; Counseling; Diabetes Complications; Diabetes Mellitus, Type 1; Diabetes Me | 2011 |
Lactic acidosis, hypotension, and sensorineural hearing loss following intentional metformin overdose.
Topics: Acidosis, Lactic; Drug Overdose; Glyburide; Hearing Loss, Sensorineural; Humans; Hypoglycemia; Hypog | 2011 |
Worry vs. knowledge about treatment-associated hypoglycaemia and weight gain in type 2 diabetic patients on metformin and/or sulphonylurea.
Topics: Adult; Aged; Cross-Sectional Studies; Denmark; Diabetes Mellitus, Type 2; Female; Health Knowledge, | 2012 |
Ketosis-prone type 2 diabetes mellitus in a patient with Sheehan's syndrome: a rare convergence of two distinct endocrine entities.
Topics: Adult; Diabetes Mellitus, Type 1; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Hypogl | 2012 |
Lower risk of hypoglycemia with sitagliptin compared to glipizide when either is added to metformin therapy: a pre-specified analysis adjusting for the most recently measured HbA(1c) value.
Topics: Adult; Aged; Aged, 80 and over; Calibration; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Th | 2012 |
Association between sitagliptin adherence and self-monitoring of blood glucose.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Biomarkers; Blood Glucose; Blood Glucose Self-Monitoring | 2012 |
[Pitfalls and precautions concerning the use of conventional oral antidiabetic drugs].
Topics: Acidosis, Lactic; Administration, Oral; Aged; Diabetes Mellitus, Type 2; Humans; Hypoglycemia; Hypog | 2002 |
[Severe hypoglycemia caused by sulfonylureas and biguanides in a patient with obstructive anuria: resolution with ureteral stent].
Topics: Aged; Anuria; Female; Glyburide; Humans; Hypoglycemia; Hypoglycemic Agents; Metformin; Remission Ind | 2002 |
Inadequacy of therapeutic education: a risk factor of hypoglycaemia.
Topics: Aged; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Humans; Hypoglycemia; Hypoglycemic Agent | 2003 |
Evidence based medicine, guidelines and common sense.
Topics: Aged; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Evidence-Based Medicine; H | 2004 |
Efficacy and safety of hypoglycemic drugs in children with type 2 diabetes mellitus.
Topics: Adolescent; Body Mass Index; Child; Comorbidity; Diabetes Mellitus, Type 2; Female; Gastrointestinal | 2005 |
Metformin and type 2 diabetes mellitus.
Topics: Diabetes Mellitus, Type 2; Humans; Hypoglycemia; Hypoglycemic Agents; Metformin | 2006 |
Toxicology case of the month: oral hypoglycaemic overdose.
Topics: Adolescent; Drug Overdose; Emergency Service, Hospital; Female; Glipizide; Humans; Hypoglycemia; Hyp | 2006 |
Severe hypoglycemia in a patient with type 2 diabetes mellitus on metformin monotherapy.
Topics: Diabetes Mellitus, Type 2; Humans; Hypoglycemia; Hypoglycemic Agents; Male; Metformin; Middle Aged | 2007 |
[New data on hypoglycemia risk and beta cell function].
Topics: C-Peptide; Cross-Over Studies; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exenatide; Gluc | 2007 |
Exenatide: new drug. Type 2 diabetes for some overweight patients.
Topics: Clinical Trials as Topic; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glucagon-Like Peptid | 2007 |
Combined therapy with insulin plus oral agents: is there any advantage? An argument in favor.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobin; Humans; Hy | 2008 |
The nuts and bolts of achieving end points with real-time continuous glucose monitoring.
Topics: Blood Glucose; Capillaries; Diabetes Mellitus, Type 2; Eating; Glycemic Index; Humans; Hypoglycemia; | 2008 |
Hypoglycaemia in patients with type 2 diabetes treated with a combination of metformin and sulphonylurea therapy in France.
Topics: Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; France; Glipi | 2008 |
Hypoglycaemic symptoms, treatment satisfaction, adherence and their associations with glycaemic goal in patients with type 2 diabetes mellitus: findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) Study.
Topics: Blood Glucose; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Europe | 2008 |
Gestational diabetes--setting limits, exploring treatments.
Topics: Blood Glucose; Diabetes, Gestational; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin; Me | 2008 |
Metformin and glibenclamide: comparative risks.
Topics: Acidosis; Aged; Diabetes Mellitus, Type 2; Glyburide; Humans; Hypoglycemia; Lactates; Metformin; Ris | 1984 |
More on metformin.
Topics: Drug Interactions; Humans; Hypoglycemia; Hypoglycemic Agents; Metformin; Sulfonylurea Compounds | 1996 |
Management of type 2 diabetes: long-awaited evidence of benefits after blood sugar control.
Topics: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Glyburide; Humans; Hypoglycemia; Hypoglycemic Ag | 1999 |
Hypoglycaemia induced by disopyramide in a patient with Type 2 diabetes mellitus.
Topics: Aged; Anti-Arrhythmia Agents; Atrial Fibrillation; Diabetes Mellitus, Type 2; Disopyramide; Drug The | 2001 |
Severe hypoglycemia in an elderly patient treated with metformin.
Topics: Aged; Drug Interactions; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Metformin | 2002 |
Comparative effects of metformin and indanorex in the treatment of reactive hypoglycemia.
Topics: Blood Glucose; Fatty Acids, Nonesterified; Female; Glucagon; Glucose Tolerance Test; Humans; Hydroco | 1979 |
Metformin and the sulphonylureas: the comparative risk.
Topics: Acidosis; Diabetes Mellitus, Type 2; Drug Interactions; Glyburide; Humans; Hypoglycemia; Metformin; | 1985 |
[Exogenous steroid diabetes in a leukemic boy. Study of insulin and GH blood levels].
Topics: Blood Glucose; Child; Diabetes Mellitus, Type 1; Fatty Acids, Nonesterified; Glucose Tolerance Test; | 1973 |
Clinical observations on the mechanism of the antidiuretic action of chlorpropamide in vasopressin-sensitive diabetes insipidus and in normal subjects.
Topics: Adolescent; Adult; Blood Glucose; Child; Child, Preschool; Chlorpropamide; Diabetes Insipidus; Drug | 1972 |
[Animal experimental studies on the mode of action of biguanides. 1. Studies with hypoglycemia-inducing doses of biguanide].
Topics: Animals; Biguanides; Blood Glucose; Carbon Isotopes; Diaphragm; Dose-Response Relationship, Drug; Fa | 1972 |
[Extragonadal endocrine manifestations of Klinefelter's disease].
Topics: Adrenal Gland Diseases; Adult; Antibodies; Autoantibodies; Blood Glucose; Diabetes Mellitus; Diazoxi | 1973 |
[Experimental demonstration of the simulating action of biguanides (phenformin, metformin) on insulin secretion].
Topics: Animals; Autoanalysis; Blood Glucose; Dogs; Hypoglycemia; In Vitro Techniques; Insulin; Insulin Secr | 1971 |
Adverse reactions to oral antidiabetic agents.
Topics: Acetohexamide; Acidosis; Administration, Oral; Anemia; Chlorpropamide; Drug Antagonism; Drug Synergi | 1971 |