Lixisenatide antidiabetic drugs

Description Results

all causes death 0.94 [0.78; 1.13]

CV events 1.02 [0.89; 1.17]

subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily (n=433)

vs.

placebo (n=109)

double-blind (nature not volume)

Parallel groups

Sample size: 433/109

Primary endpoint: change in HbA(1c)

FU duration: 13 weeks

dose–response study

AVE0010 (10,15 and 20 µg) in association with basal insulin, with or without metformin (n=328)

vs.

placebo on top basal insulin (n=167)

double-blind

Sample size: 328/167

Primary endpoint: change from baseline in HbA1c

FU duration: 24 weeks

AVE0010 (10,15 and 20 µg) in association with basal insulin, with or without metformin (n=328)

vs.

placebo on top basal insulin (n=167)

the type of basal insulin used during the trial is not specified in the available document

double-blind

Parallel groups

Sample size: 328/167

Primary endpoint: change from baseline in HbA1c

FU duration: 24 weeks

lixisenatide (n=6068)

vs.

placebo (n=0)

double-blind

Sample size: 6068/0

Primary endpoint: CVdeath, MI, stroke, or hospitalization for unstable angina

FU duration: 25 months (median)