Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02343926 | Phase 3 Study to Compare the Efficacy and Safety of Gemigliptin and Vildagliptin as Add-on Therapy to Metformin in People With Type 2 Diabetes Inadequately Controlled With Metformin | PHASE3 | COMPLETED | 443 | — | — | Dec 1, 2014 | Apr 1, 2016 | May 18, 2016 | 1 | Russia |
| Arm | Type | Description |
|---|---|---|
| Gemigliptin | EXPERIMENTAL | GEMIGLIPTIN LS15-0444 administered once a day for 24 weeks as add-on therapy to metformin |
| Vildagliptin | ACTIVE_COMPARATOR | Vildagliptin administered twice a day for 24 weeks as add-on therapy to metformin |
| Name | Type | Description |
|---|---|---|
| GEMIGLIPTIN LS15-0444 | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| vildagliptin | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| metformin | DRUG | Pharmaceutical form:tablet Route of administration: oral |
Inclusion criteria: * Patients with Type 2 diabetes mellitus. * Patients inadequately controlled with metformin at the maximal effective and tolerated dose of metformin for at least 12 weeks or who are on a stable dose of ≥1500 mg daily for a minimum of ≥4 weeks prior to study entry. * Signed infor...