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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01111955 | Safety Study of BMS-823778 in Subjects With Type 2 Diabetes | PHASE2 | COMPLETED | 62 | — | — | Jul 1, 2010 | Jan 1, 2011 | Oct 12, 2015 | 14 | United States, Australia +1 |
| Arm | Type | Description |
|---|---|---|
| BMS-823778 (2 mg) | ACTIVE_COMPARATOR | \+ metformin |
| BMS-823778 (10 mg) | ACTIVE_COMPARATOR | \+ metformin |
| BMS-823778 (20 mg) | ACTIVE_COMPARATOR | \+ metformin |
| Placebo | PLACEBO_COMPARATOR | \+ metformin |
| Name | Type | Description |
|---|---|---|
| BMS-823778 | DRUG | Capsules, Oral, 2 mg, once daily, 28 days |
| Placebo | DRUG | Capsules, Oral, 0 mg, once daily, 28 days |
| Metformin | DRUG | Capsules, Oral, ≥ 1500 mg, once daily, 28 days |
Inclusion Criteria: * Type 2 diabetes mellitus * Drug naive or on stable metformin therapy * HbA1c 7-10% * FPG ≤ 240mg/dL Exclusion Criteria: * History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack,...