From: Glucagon-like peptide analogues for type 2 diabetes mellitus: systematic review and meta-analysis
Study and Country | Interventions | Characteristics of participants | Study duration | Outcomes measured |
---|---|---|---|---|
ALBIGLUTIDE | ||||
Rosenstock 2009[23]; USA, Mexico, Chile, Dominican Republic | 1) Albiglutide 30 mg weekly 2) Albiglutide 30 mg every two weeks 3) Placebo All groups also received Met (The arms with other doses of albiglutide and exenatide excluded from this review) | number: 361 (31/32/51) mean age: 54.0 to 55.5 years gender: 45.1 to 74.2% female HbA1c (%): Albi Weekly 30 mg: 8.0, Placebo: 7.9, Albi every 2 weeks 30 mg: 8.0 BMI (kg/m 2 ): Albi weekly 30 mg: 33.0, Albi every 2 weeks 30 mg: 31.2, Placebo: 31.8 ethnicity: Caucasian (43.8 to 71%) diabetes duration: 4.9 years (3.9 to 5.2 years) previous medication: diet and exercise only: 29.0 to 34.4%, Met: 65.6 to 71.0% | 16 weeks | primary: HbA1c other: FPG, fasting fructosamine, C-peptide, glucagon, insulin, lipid profiles, beta-cell function (homeostasis model), adverse events and safety analyses |
EXENATIDE | Â | Â | Â | Â |
Apovian 2010[43]; US; 11 sites | 1) Exenatide 10 μg twice daily 2) Placebo All groups also received intensive life style modifications and Met/Met + Su/Su | number: 196 (97/99) mean age: 54.5 to 55.1 gender: 62 to 63% female HbA1c (%): Exe 10 μg BID: 7.7; Placebo: 7.5 BMI (kg/m 2 ): Exe 10 μg BID: 33.6; Placebo: 33.9 ethnicity: NR diabetes duration: 5.3 to 5.7 years previous medication: Met; Met + Su; Su | 24 weeks | primary: body weight other: HbA1c, 6-point SMBG profiles, waist circumference, HOMA-B, HOMA-S, fasting lipids, proportion of participants with weight loss >5% and 10%, SBP and DBP and subgroup analysis by oral agents |
Bergenstal 2009[28]; USA | 1) Exenatide 10 μg twice daily 2) BIAsp 30 twice daily 3) BIAsp 30 once daily All groups also received Met + Su (glim) | number: 372 (124 in each comparison group) mean age: 51.8 to 53.4 years gender: 51.6 to 52.4% female HbA1c (%): Exe 10 μg BID: 10.2; BIAsp 30 OD: 10.1; BIAsp 30 BID: 10.3 BMI (kg/m 2 ): Exe 10 μg BID: 34.2; BIAsp 30 OD: 33.7; BIAsp 30 BID: 33.5 ethnicity: 59.7 to 67.7% White; 18.5% to 26.6% Black; 1.6 to 2.4% Asian diabetes duration: 8.4 to 9.9 years previous medication: Met + Su | 24 weeks | primary: HbA1c other: FPG; 8 point plasma glucose profiles changes in body weight; superiority and inferiority tested, adverse events |
Bergenstal 2010[37]; USA, India, Mexico; 72 sites | 1) Exenatide 2 mg once weekly 2) Sitagliptin 100 mg once daily 3) Pioglitazone 45 mg once daily All groups also received Met + placebo | number: 491 (160/166/165) mean age: 52 to 53 years gender: 44 to 52% female HbA1c (%): Exe 2 mg QW: 8.6; Sita 100 mg OD: 8.5; Pio 45 mg OD: 8.5 BMI (kg/m 2 ): Exe 2 mg QW: 32; Sita 100 mg OD: 32; Pio 45 mg OD: 32 ethnicity: 30 to 39% White; 8 to 12% Black; 27 to 31% Hispanic; 23 to 25% Asian; 0 to 2% Native American; 1 to 2% other diabetes duration: 5 to 6 years previous medication: Met | 26 weeks | primary: HbA1c other: proportion of participants achieving HbA1c level ≤7% or ≤6.5%; FPG ≤7 mmol/l; 6-point SMBG; bodyweight; lipid profile; BP; cardiovascular risk markers; health-related outcomes; adverse events; hypoglycaemia; exenatide antibodies |
Bunck 2009[29]; | 1) Exenatide 10 μg twice daily 2) Glargine 10 IU day, titrated accordingly | number: 69 (36/33) mean age: 58.3 to 58.4 years | 52 weeks | primary: Beta-cell function other: HbA1c; FPG; body weight; insulin sensitivity; |
Netherlands, Finland, Sweden, USA | Both groups also received Met | gender: 33.3 to 36.1% female HbA1c (%): Exe 10 μg BID: 7.6; Glar: 7.4 BMI(kg/m 2 ): Exe 10 μg BID: 30.9; Glar: 30.1 ethnicity: NR diabetes duration: 4.0 to 5.7 years previous medication: Met |  | safety; hypoglycaemia (BG <3.3 mmol/L) |
Davies 2009 (HEELA)[30]; UK | 1) Exenatide 10 μg twice daily 2) Glargine 10 IU/day, titrated accordingly Both groups also remained on previous therapy: Met +/- Su +/- Tzd | number: 235 (118/117) mean age: 56.2 to 56.8 years gender: 29.7 to 33.6% female HbA1c (%): Exe 10 μg BID: 8.65; Glar: 8.48 BMI (kg/m 2 ): Exe 10 μg BID: 34.6; Glar: 33.7 ethnicity: NR diabetes duration: 8.4 to 9.0 years previous medication: Met + Su: 42.3%; Met + Tzd: 13.7%; Su + Tzd: 2.6%; Met + Su + Tzd: 40.6% | 26 weeks | primary: proportion of patients with an HbA1c level ≤7.4% and weight gain ≤1 kg i.e. composite outcome. other: body weight, waist circumference, FPG, serum lipids, BP, adverse events, hypoglycaemia |
Davis 2007[31]; USA | 1) Exenatide 10 μg twice daily 2) Insulin (remained on pre-study insulin regimen) Both groups also received Met+ Su | number: 51 (35/16) mean age: 52 to 54 years gender: 50 to 54% female HbA1c (%): Exe 10 μg BID: 8.0; Ins: 8.3 BMI (kg/m 2 ): Exe 10 μg BID: 33; Ins: 35 ethnicity: NR diabetes duration: 10.4 to 11.9 years previous medication: Met only: 43%; Su only: 8%; Met + Su: 49%; GLAR: 20%; NPH insulin: 2%; Ultralente: 2%; mixtures: 20%; multiple insulin therapies: 14% | 16 weeks | primary: maintenance of glycaemic control, predefined as an HbA1c increase of <0.5% other: body weight; SMBG profiles; adverse events; hypoglycaemic events |
DeFronzo 2005[42]; USA | 1) Exenatide 10 μg twice daily 2) Placebo All groups also received Met (other dose of exenatide, 5 μg BID, excluded from this review) | number: 336 (113/113) mean age: 52 to 54 years gender: 39.8 to 40.7% female HbA1c (%): Exe 10 μg BID: 8.18; Placebo: 8.2 BMI(kg/m 2 ): 34 ethnicity: 72.6 to 79.6% Caucasians; 8.8 to 13.3% Black; 8 to 10.6% Hispanic; 3.5% other diabetes duration: 4.9 to 6.6 years previous medication: Met | 30 weeks | primary: HbA1c other: safety, hypoglycaemia; anti-exenatide antibodies); FPG and PPG fasting proinsulin; lipids |
DeFronzo 2010[22]; USA | 1) Exenatide 10 μg twice daily 2) Rosiglitazone 4 mg twice daily (one arm receiving both exenatide and rosiglitazone was excluded from the review) All groups also received Met | number: 137 (45/45) mean age: 56 years gender: 49% female HbA1c (%): 7.8 BMI: 32.5 diabetes duration: 3.7 to 4.7 years ethnicity: Caucasian, 61%, Hispanic 23%; African American 12%; Others 4% previous medication: Met ≥ 1500 mg/day | 20 weeks | primary: measurement of glucose potentiated arginine stimulated incremental area under the curve during hyperglycaemic clamp test other: glucose AUC, HbA1c, glucose, insulin, C-peptide, lipids and body weight, adverse events, vital signs, haematology and chemistries. |
Derosa 2010[27]; Italy | 1) Exenatide 10 μg twice daily 2) Glibenclamide 5 mg, 3 times daily Both groups also received Met | number: 128 (63/65) mean age: 57 to 56 years gender: 52 to 49% female HbA1c (%): Exe 10 μg BID: 8.8; Glib: 8.9 BMI (kg/m 2 ): Exe 10 μg BID: 28.7; Glib: 28.5 ethnicity: all white diabetes duration: NR previous medication: Met at mean dose of 1,500 ± 500 mg/day | 12 months | primary: body weight, glycaemic control, β-cell function other: insulin resistance and inflammatory state parameters |
Diamant 2010[34]; USA | 1) Exenatide 2 mg once a week 2) Insulin glargine once daily | number: 456 (233/223) mean age: 58 years gender: 45 to 48% female HbA1c (%): Exe 2 mg QW: 8.3; Glar: 8.3 BMI (kg/m 2 ): Exe 2 mg QW: 32; Glar: 32 Ethnicity: African American up to 1%, White 82 to 85%, Asian 6%, Hispanic 9 to 12% diabetes duration: 7.8 to 8.0 years previous medication: Met: 70%; Met plus Su: 30% | 26 weeks | primary: HbA1c other: proportion of participants reaching HbA1c <7.0% and 6.5%, FPG, self-monitored blood glucose, body weight, lipids, HOMA levels, health outcomes, adverse events, hypoglycaemia |
Drucker 2008[41]; Canada/USA | 1) Exenatide 10 μg twice daily 2) Exenatide 2 mg once weekly Both groups also remained on previous therapy: diet/exercise or Met, Su, or Tzd as monotherapy or combination of any two. | number: 303 (147/148) mean age: 55 years gender: 45 to 49% female HbA1c (%): Exe 2 mg QW: 8.3; Exe 10 μg BID: 8.3 BMI (kg/m 2 ): Exe 2 mg QW: 35; Exe 10 μg BID: 35 ethnicity: 73 to 83% White, 6 to 13% Black, 11 to 14% Hispanic, 0 to 1% Asian diabetes duration: 6 to 7 years previous medication: Monotherapy: 43% to 46%, combination therapy: 36 to 39%; all Met: 69 to 77%, all Su: 37%, all Tzd: 15 to 17%; diet/exercise only: 14 to 16% | 30 weeks | primary: HbA1c other: safety and tolerability, body weight, FPG, PPG, fasting lipids, fasting glucagon, BP, adverse events, patients who lost glucose control, hypoglycaemic episodes (symptoms and PG <3 mmol/l) |
Gao 2009[45]; China, India, Korea, Taiwan | 1) Exenatide 10 μg twice daily 2) Placebo Both groups also remained on previous therapy: Met and/or Su | number: 472 (238/234) mean age: 54 to 55 years gender: 52 to 59% female HbA1c (%): 8.3 (in both groups) BMI (kg/m 2 ): 26.1 to 26.4 ethnicity: all Asian (Chinese 49.6 to 53%; Indian 20.3 to 21.4%; Korean 16.4 to 17.9%; Taiwanese 10.3 to 11.1%) diabetes duration: 8 years previous medication: Met alone: 19.2 to 19.8%; Met and Su: 80.2 to 80.8% | 16 weeks | primary: HbA1c other: body weight; hypoglycaemic events (symptoms and BG <3.3 mmol/l); FPG; PPG, adverse events, exenatide antibody levels |
Gill 2010[26]; Canada and Netherland | 1) Exenatide 10 μg twice daily 2) Placebo Both groups also remained on previous therapy: Met and/or Tzd antihypertensives remained constant | number: 54 (28/26) mean age: 54 to 57 years gender: 32 to 58% female HbA1c (%): 7.1 to 7.5 BMI (kg/m 2 ): 29.5 to 30.1 ethnicity: Caucasian 86 to 96%; African 0 to 7%; East Asian 1%; Hispanic 0 to 1% diabetes duration: 6 to 7 years previous medications: Met±Tzd; antihypertensives | 12 weeks | primary: 24 hour heart rate (HR) other: HbA1c; body weight hourly; SBP; DBP; rate pressure product; hourly HR; daytime/night time HR; mean arterial pressure |
Heine 2005[32]; 13 countries (Australia, 9 European countries, Brazil, Puerto Rico, USA) | 1) Exenatide 10 μg twice daily 2) Glargine 10 IU/day, titrated accordingly Both groups also received Met and Su | number: 551 (282/267) mean age: 58 to 59.8 years gender: 43.4 to 45.0% female HbA1c (%): Exe 10 μg BID: 8.2; Glar: 8.3 BMI: Exe 10 μg BID: 31.4; Glar: 31.3 ethnicity: 79.8 to 80.5% White; 0.7 to 1.1% Black; 0.7 to 1.8% Asian; 15 to 15.6% Hispanic; 2.1 to 2.6% other diabetes duration: 9.2 to 9.9 years previous medication: Met+ Su | 26 weeks | primary: HbA1c other: body weight, FPG, blood glucose, patient reported health outcome measures, adverse events, hypoglycaemia |
Kadowaki 2009[20]; Japan | 1) Exenatide 10 μg twice daily 2) Placebo Both groups also remained on previous medication: Su or Su +Met or Su +Tzd (Two other doses of exenatide, 2.5 μg BID and 5 μg BID were excluded from this review) | number: 153 (37/40) mean age: 57.8 to 60.5 years gender: 25 to 38% female HbA1c (%): Exe 10 μg BID: 7.9; Placebo: 8.1 BMI(kg/m 2 ): Exe 10 μg BID: 26.1; Placebo: 25.8 ethnicity: presumably all Japanese diabetes duration: 9.6 to 11.9 years previous medication: Su alone: 8.1 to 10%; Su + alpha-GI: 0 to 2.7%; Su + Met: 45 to 48.6%; Su + Met + alpha-GI: 18.9 to 22.5%; Su + Met + meglitinide derivative: 0 to 2.7%; Su + Tzd: 5.4 to 10%; Su + Tzd + alpha-GI: 12.5 to 13.5% | 12 weeks | primary: HbA1c other: FPG; body weight; serum lipids, adverse events, hypoglycaemia (SMBG <3.9 mmol/l), amylase, antibodies to exenatide |
Kendall 2005[21]; USA | 1) Exenatide 10 μg twice daily 2) Placebo (2 placebo arms combined) Both groups also remained on Met + Su (other dose of exenatide, 5 μg BID, excluded from this review) | number: 733 (241/247) mean age: 55 to 56 years gender: 40.7 to 44.1% female HbA1c (%): Exe 10 μg BID: 8.5; Placebo: 8.5 BMI: Exe 10 μg BID: 34; Placebo: 34 ethnicity: 66.4 to 69% White; 11.6 to 12.1% Black; 15.8 to 16.6% Hispanic; 1.6 to 2.9% Asian; 0.4 to 0.8% Native American; 1.6 to 2% other diabetes duration: 8.7 to 9.4 years previous medication: Met and Su | 30 weeks | primary: HbA1c other: FPG, PPG, body weight, lipids, adverse events, clinical laboratory tests, hypoglycaemia (BG <3.3 mmol/l) |
Nauck 2007[33]; 13 countries | 1) Exenatide 10 μg twice daily 2)BIAsp 30 twice daily Both groups also remained on Met + Su | number: 501 (253/248) mean age: 58 to 59 years gender: 47 to 51% female HbA1c (%): Exe 10 μg BID: 8.6; BIAsp 30: 8.6 BMI (kg/m 2 ): Exe 10 μg BID: 30.6; BIAsp 30: 30.2 ethnicity: NR diabetes duration: 9.8 to 10.0 years previous medication: Met and Su | 52 weeks | primary: HbA1c other: FPG, PPG, SMBG profiles, beta-cell function, body weight, adverse events, anti-exenatide antibodies, hypoglycaemia (symptoms or BG <3.4 mmol/L) |
Zinman 2007[67]; Canada, Spain, USA | 1) Exenatide 10 μg twice daily 2) Placebo Both groups also remained on previous medication: Tzd +/- Met | number: 233 (121/112) mean age: 55.6 to 56.6 years gender: 42.9 to 46.3% female HbA1c (%): Exe: 7.9; Placebo: 7.9 BMI (kg/m 2 ): Exe: 34; Placebo: 34 ethnicity: 82.1 to 85.1% White; 14.9 to 17.9% other diabetes duration: 7.3 to 8.2 years previous medication: Tzd alone: 19.6 to 23%; Tzd + Met: 76.9 to 80.4% | 16 weeks | primary: HbA1c other: FPG, body weight, SMBG levels, HOMA levels, blood chemistry for safety monitoring; hypoglycaemia |
LIRAGLUTIDE | ||||
Kaku 2010[18]; Japan; 49 centres | 1) Liraglutide 0.6 mg once daily 2) Liraglutide 0.9 mg once daily 3) Placebo All groups also received Su | number: 264 (88/88/88) mean age: 58.6 to 61.3 gender: 33 to 40% female HbA1c (%): Lir 0.6 mg: 8.6; Lir 0.9 mg: 8.21; Placebo: 8.45 BMI (kg/m 2 ): Lir 0.6 mg: 25.3; Lir 0.9 mg: 24.4; Placebo: 24.9 ethnicity: All Japanese diabetes duration: 9.3 to 11.6 years previous medication: Su | 24 weeks | primary: HbA1c other: 7-point SMBG profiles, body weight, FPG, PPG, lipid profile and biomarkers for cardiovascular effects, proportions of subjects reaching HbA1c <7% or <6.5% |
Marre 2009 (LEAD 1)[39]; 21 countries (mainly in Europe and Asia) | 1) Liraglutide 1.2 mg once daily 2) Liraglutide 1.8 mg once daily 3) Placebo 4) Rosiglitazone 4 mg once daily All groups also received Su (Glim) (Lir 0.6 was excluded in this review) | number: 1041 (228/234/114/232) mean age: 54.7 to 57.7 years gender: 47 to 55% female HbA1c (%): Lir 1.2 mg: 8.5; Lir 1.8 mg: 8.5; Placebo: 8.4; Rosi: 8.4 BMI (kg/m 2 ): Lir 1.2 mg: 29.8; Lir 1.8 mg: 30; Placebo: 30.3; Rosi: 29.4 ethnicity: NR diabetes duration: (median, 25th and 75th percentile) 6.5 to 6.7 years previous medication: monotherapy: 27/32%, combination: 68/73% | 26 weeks | primary: HbA1c other: body weight, FPG, PPG, beta-cell function, BP; superiority of liraglutide to placebo and non-inferiority to rosiglitazone, hypoglycaemic episodes(PG <3.1 mmol/L), liraglutide antibodies, tolerability (gastrointestinal complaints), adverse events, biochemical and haematological parameters, calcitonin, vital signs, ECG |
Nauck 2009 (LEAD 2)[36]; Multinational (21 countries) | 1) Liraglutide 1.2 mg once daily 2) Liraglutide 1.8 mg once daily 3) Glimepiride 4 mg once daily 4) Placebo All groups also received Met (Lir 0.6 was excluded in this review) | number: 1091(240/242/242/121) mean age: 56 to 57 years gender: 40 to 46% female HbA1c (%): Lir 1.2 mg: 8.3, Lir 1.8 mg: 8.4, Su: 8.4, Placebo: 8.4 BMI (kg/m 2 ): Lir 1.2 mg: 31.1, Lir 1.8 mg: 30.9, Su: 31.2, Placebo: 31.6 ethnicity: 88 to 89% White, 2 to 4% Black, 7 to 9% Asian, 1 to 3% other diabetes duration: 7 to 8 years previous medication: 62 to 66% combination, 34 to 38% monotherapy (86 to 93% Met) | 26 weeks | primary: HbA1c other: body weight, FPG, PPG, beta cell function, adverse events, biochemical and haematology measures, hypoglycaemic episodes (symptoms and PG <3.1 mmol/L), vital signs, ECG |
Pratley 2010[38]; 11 European countries; USA and Canada; 158 office-based sites | 1) Liraglutide 1.2 mg once daily 2) Liraglutide 1.8 mg once daily 3) Sitagliptin 100 mg once daily All groups also received Met | number: 665 (225/221/219) mean age: 55 to 55.9 gender: 45 to 48% female HbA1c (%): Lir 1.2 mg: 8.4, Lir 1.8 mg: 8.4, Sita 100 mg: 8.5 BMI (kg/m 2 ): Lir 1.2 mg: 32.6, Lir 1.8 mg: 33.1, Sita 100 mg: 32.6 ethnicity: 82 to 91% White (15 to 17% Hispanic or latino), 5 to 10% Black, 1 to 3% Asian or Pacific Islander, 4 to 5% Other diabetes duration: 6.0 to 6.4 years previous medications: Met | 26 weeks | primary: HbA1c other: superiority and non-inferiority comparisons, proportion of participants reaching HbA1c targets of < 7% or ≤6.5%, FPG, PPG, body weight, β-cell function, fasting lipid profiles, cardiovascular markers, BP, HR, physical measures, treatment satisfaction, hypoglycaemia |
Zinman 2009 (LEAD 4)[44]; USA and Canada | 1) Liraglutide 1.2 mg once daily 2) Liraglutide 1.8 mg once daily 3) Placebo All groups also received Met and Tzd (Rosi) | number: 533(178/178/177) mean age: 55 years gender: 38 to 49% female HbA1c (%): Lir 1.2 mg: 8.5, Lir 1.8 mg: 8.6, Placebo: 8.4 BMI (kg/m 2 ): Lir 1.2 mg: 33.2, Lir 1.8 mg: 33.5, Placebo: 33.9 ethnicity: 81 to 84% White, 10 to 15% Black, 13 to 16% Hispanic, 1 to 3% Asian, 3 to 4% Others diabetes duration: mean 9 years previous medication: 16 to 18% monotherapy, 82 to 84% combination therapy | 26 weeks | primary: HbA1c other: body weight, FPG, PPG, beta-cell function, BP, lipids, adverse events, biochemical and haematology measures, and hypoglycaemic episodes (PG <3.1 mmol/L), superiority of liraglutide tested, vital signs, ECG |
Russell Jones 2005 (LEAD 5)[35]; Multinational (17 countries) | 1) Liraglutide 1.8 mg once daily 2) Placebo 3) Glargine (avg. dose 24IU/day) All groups also received Met and Su | number: 581(230/114/232) mean age: 57.5 to 57.6 years gender: 40 to 51% female HbA1c (%): Lir: 8.3, Placebo: 8.3, Glar: 8.2 BMI (kg/m 2 ): Lir: 30.4, Placebo: 31.3, Glar: 30.3 ethnicity: NR diabetes duration: mean 9.2 to 9.7 years previous medication: 5 to 6% monotherapy, 94 to 95% combination treatment) | 26 weeks | primary: HbA1c other: weight, FPG, eight point plasma glucose profiles, beta-cell function, BP, adverse events, hypoglycaemic episodes |
Buse 2009 (LEAD 6)[40]; 15 countries | 1) Liraglutide 1.8 mg once daily 2) Exenatide 10 μg twice daily Both groups also remained on previous medications: Met +/- Su | number: 464(233/231) mean age: 56 to 57 years gender: 45 to 51% female HbA1c: Lir: 8.2, Exe: 8.1 BMI: Lir: 32.9, Exe: 32.9 ethnicity: 91 to 93% White, <1 to 2% Asian, 5 to 6% Black, 1 to 2% other diabetes duration: mean 7.9 to 8.5 years previous medication: 62 to 64% Met plus Su, 27% Met monotherapy, 9 to 10% Su monotherapy | 26 weeks | primary: HbA1c other: FPG, body weight, SMBG profile, beta cell function, BP, lipid profiles, overall treatment satisfaction, adverse events, biochemical and haematological measures, hypoglycaemic episodes, vital signs, ECG |
TASPOGLUTIDE | ||||
Nauck 2009[24]; Germany and Switzerland | 1) Taspoglutide 10 mg once weekly 2) Taspoglutide 20 mg once weekly 3) Taspoglutide 20 mg once every two weeks 4) Placebo All groups also received Met (For this review, the following groups were excluded: 5 mg weekly and 10 mg every 2 weeks) | number: 306 (49/50/49/49) mean age: 56 years gender: 39 to 64% female HbA1c (%): Placebo: 8.0, Tas 10 mg QW: 7.9, Tas 20 mg QW: 7.8, Tas 20 mg Q2W: 7.9 BMI (kg/m 2 ): Placebo: 31.8, Tas 10 mg QW: 32.6, Tas 20 mg QW: 32.4, Tas 20 mg Q2W: 33.2 ethnicity: NR diabetes duration: mean 5 to 6 years previous medication: Met monotherapy (mean 1888 mg to 2019 mg) | 8 weeks | primary: HbA1c other: FPG, body weight, fructosamine, C-peptide, fasting insulin, pro-insulin-to-insulin ratio, fasting glucagon, lipids, adverse events, clinical laboratory tests, local tolerance at the injection site, anti-taspoglutide antibodies, vital signs, ECG |
Ratner 2010[25]; Australia, France, Germany, Mexico, Peru and USA; 27 sites | 1) Taspoglutide 20 mg once weekly 2) Placebo All groups also received Met (For this review, the following groups were excluded: 20 mg once weekly titrated to 30 mg and 40 mg once weekly) | number: 133 (32/32) mean age: 56 to 57 years gender: 53 to 59% of female HbA1c (%): Tas 20 mg QW: 8.0, Placebo: 7.8 BMI (kg/m 2 ): Tas 20 mg QW: 33.3, Placebo: 33.2 ethnicity: NR diabetes duration: 6 to 7 years previous medications: Met | 8 weeks + 4 weeks follow up | primary: GI tolerability other: HbA1c, FPG, body weight and pharmacokinetics parameters |