Table 1

Characteristics of the included studies.

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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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/m2): 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


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

Shyangdan et al. BMC Endocrine Disorders 2010 10:20   doi:10.1186/1472-6823-10-20

Open Data