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Table 1 Characteristics of the included studies.

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     
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
  1. Albi: Albiglutide; Exe: Exenatide; Lir: Liraglutide; Tas: Taspoglutide; Ins: Insulin; Glar: Insulin glargine; Tzd: Thiazolidinedione; Rosi: Rosiglitazone; Sita: Sitagliptin; Su: Sulphonylureas; Glim: Glimepiride; Met: Metformin; OD/QD: Once daily; BID: Twice daily; TID: Thrice daily; QW: Once weekly; HbA1c: Glycated haemoglobin; BMI: Body mass index; FPG: Fasting plasma glucose; PPG: Postprandial glucose; BG; Blood glucose; PG: Plasma glucose; BP: Blood pressure; SMBG: Self monitoring of blood glucose; HOMA: Homeostasis model assessment; ECG: Electrocardiogram; NR: Not reported; HEELA: Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin; LEAD: Liraglutide Effect and Action in Diabetes