Taspoglutide antidiabetic drugs

Description Results

MACE 0.48 [0.22; 1.04]

Cardiovascular death 0.51 [0.05; 5.54]

Emergency PCI for in-stent thrombosis/reinfarction/unstable angina 0.56 [0.19; 1.65]

Stroke 1.01 [0.06; 16.09]

Heart failure 0.14 [0.02; 1.17]

single bolus of 60,000 IU epoetin alfa administered intravenously within three hours after a successful PCI (n=263)

vs.

control (n=266)

open

Parallel groups

Sample size: 263/266

Primary endpoint: left ventricular ejection fraction

FU duration: 6 weeks

HbA1c inf a 7% 3.83 [1.81; 8.14]

HbA1c inf a 7% 4.88 [2.55; 9.33]

HbA1c inf a 7% 4.90 [2.56; 9.38]

HbA1c inf a 7% 3.88 [1.99; 7.56]

taspoglutide s.c. 20mg once weekly for 8 weeks (n=97)

vs.

placebo s.c. once weekly on top metformin (n=32)

3 different regimens : 20 mg taspoglutide s.c. once weekly for 4 weeks, followed by 4 weeks of 20 mg once weekly (20/20), or titration up to 30 mg once-weekly (20/30) or 40 mg once-weekly (20/40) taspoglutide

double-blind

Parallel groups

Sample size: 97/32

Primary endpoint: GI adverse events

FU duration: 8 weeks (+4wk)

phase 2

taspoglutide, either 5, 10, or 20 mg once weekly or 10 or 20 mg once every 2 weeks for 8 weeks (n=257)

vs.

placebo (n=49)

double-blind

Parallel groups

Sample size: 257/49

Primary endpoint: change in A1C

FU duration: 12 weeks

phase 2b, dose ranging

(n=-9)

vs.

(n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

(n=-9)

vs.

(n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

Patient’s Global Assessment (reported improvement) 1.00 [0.87; 1.14]

CHF-related hospitalisations 0.78 [0.48; 1.26]

All-cause mortality 0.59 [0.29; 1.21]

Adverse effect: hypertension 1.26 [0.57; 2.79]

Adverse effect: stroke 0.97 [0.20; 4.73]

Adverse effect: myocardial infarction 0.78 [0.21; 2.83]

Adverse effect: other thromboembolic effects 1.29 [0.29; 5.68]

Patient’s Global Assessment (reported improvement) 1.33 [0.99; 1.80]

CHF-related hospitalisations 0.50 [0.13; 1.92]

All-cause mortality ∞ [NaN; ∞]

Adverse effect: hypertension 0.51 [0.07; 3.52]

Adverse effect: stroke NaN [NaN; NaN]

Adverse effect: myocardial infarction ∞ [NaN; ∞]

Adverse effect: other thromboembolic effects 0.00 [0.00; NaN]

Patient’s Global Assessment (reported improvement) 1.93 [1.11; 3.36]

CHF-related hospitalisations 0.77 [0.14; 4.14]

All-cause mortality 1.16 [0.08; 17.28]

Adverse effect: hypertension ∞ [NaN; ∞]

Adverse effect: stroke ∞ [NaN; ∞]

Adverse effect: myocardial infarction 0.00 [0.00; NaN]

Adverse effect: other thromboembolic effects NaN [NaN; NaN]

CHF-related hospitalisations 0.35 [0.07; 1.79]

All-cause mortality 0.00 [0.00; NaN]

Adverse effect: hypertension ∞ [NaN; ∞]

Adverse effect: myocardial infarction NaN [NaN; NaN]

Adverse effect: other thromboembolic effects 0.00 [0.00; NaN]

CHF-related hospitalisations 0.57 [0.16; 2.08]

All-cause mortality 0.32 [0.04; 2.80]

Adverse effect: hypertension ∞ [NaN; ∞]

Adverse effect: stroke NaN [NaN; NaN]

Adverse effect: myocardial infarction 0.00 [0.00; NaN]

Adverse effect: other thromboembolic effects 0.00 [0.00; NaN]

darbepoetin alfa SC every 2 weeks for 1 year (target hemoglobin, 14.0+/-1.0 g/dL). (n=162)

vs.

placebo (n=157)

double blind

Parallel groups

Sample size: 162/157

Primary endpoint: treadmill exercise time

FU duration: 27 weeks

darbepoetin alfa subcutaneously every 2 weeks for 26 weeks at a starting weight-adjusted dose of 0.75 mcg/kg or a fixed dose of 50 mcg (n=110)

vs.

placebo (n=55)

double blind

Parallel groups

Sample size: 110/55

Primary endpoint: node defined

FU duration: 27 weeks

Subcutaneous (SC) Darbepoetin Alfa (n=19)

vs.

subcutaneous placebo (n=22)

double blind

Parallel groups

Sample size: 19/22

Primary endpoint: Exercise tolerance

FU duration: 27 weeks

3-month darbepoetin alpha regimen at 1.5 microg/kg every 20 days plus oral iron (n=21)

vs.

placebo plus oral iron (n=11)

Sample size: 21/11

Primary endpoint: none defined

FU duration:

3-month darbepoetin alfa regimen at 1.5 microg/kg every 20 days plus oral iron (n=30)

vs.

placebo plus oral iron (n=0)

Sample size: 30/0

Primary endpoint:

FU duration:

3-month darbepoietin-alpha at 1.5 microg/Kg every 20 days plus iron orally (n=21)

vs.

placebo plus iron orally (n=20)

double blind

Sample size: 21/20

Primary endpoint:

FU duration: