| pathology | Demonstrated benefit and harm | k | | | |
|---|
| diabetes type 2 | versus add on insulin No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| GETGOAL-L | lixisenatide vs placebo (add on basal insulin) | | | |
| Trial | Treatments | Patients | Method |
|---|
| GETGOAL-L | 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) | Type 2 diabetes mellitus insufficiently controlled with basal insulin with or without metformin | double-blind Sample size: 328/167 Primary endpoint: change from baseline in HbA1c FU duration: 24 weeks |
|
| diabetes type 2 | versus add on oral therapy No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Ratner DRI6012, 2010 | lixisenatide vs placebo (add on MET) | | | |
| Trial | Treatments | Patients | Method |
|---|
| Ratner DRI6012, 2010 | subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily (n=433) vs. placebo (n=109) | patients with Type 2 diabetes inadequately controlled with metformin (>= 1000 mg/day) | double-blind (nature not volume) Parallel groups Sample size: 433/109 Primary endpoint: change in HbA(1c) FU duration: 13 weeks dose–response study |
|
| diabetes type 2 | versus basal insulin No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| GETGOAL-L | lixisenatide vs glargine once daily | | | |
| Trial | Treatments | Patients | Method |
|---|
| GETGOAL-L | 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 | Type 2 diabetes mellitus insufficiently controlled with basal insulin with or without metformin | double-blind Parallel groups Sample size: 328/167 Primary endpoint: change from baseline in HbA1c FU duration: 24 weeks |
|
| diabetes type 2 | versus placebo No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ELIXA | lixisenatide vs placebo | | | all causes death 0.94 [0.78; 1.13] CV events 1.02 [0.89; 1.17] |
| Trial | Treatments | Patients | Method |
|---|
| ELIXA | lixisenatide (n=6068) vs. placebo (n=0) | patients with T2DM and a recent ACS event | double-blind Sample size: 6068/0 Primary endpoint: CVdeath, MI, stroke, or hospitalization for unstable angina FU duration: 25 months (median) |
|
