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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00508287 | Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes | PHASE1 | COMPLETED | 36 | — | — | Aug 1, 2007 | Nov 1, 2007 | Mar 16, 2009 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| C | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BMS-686117 | DRUG | Injection solution, Subcutaneous, 1 mg, Once daily, Single dose. |
| Byetta | DRUG | Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose. |
| Placebo | DRUG | Injection solution, Subcutaneous, 1 mg, Once daily, Single dose. |
Inclusion Criteria: * Diagnosis of Type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve) * Fasting plasma glucose: 126 - 240 mg/dL * Hemoglobin A1c: 6 - 10% * Estimated CrCl ≥ 60 mL/min * ALT ≤ 1.5 x ...