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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01933672 | Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes | PHASE1 | COMPLETED | 33 | — | — | Oct 1, 2013 | Mar 1, 2014 | Sep 27, 2016 | 8 | United States |
Plasma glucose concentration was determined predose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours postdose on Days 0 (baseline) and 14. WMDG was calculated as the area under the curve (AUC) of the 12-point plasma glucose concentration-time profile divided by 24 hours.
| Arm | Type | Description |
|---|---|---|
| PF-04937319 once-daily | EXPERIMENTAL | - |
| PF-04937319 split-dose | EXPERIMENTAL | - |
| Sitagliptin once-daily | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-04937319 once-daily | DRUG | Tablets, 300 mg once-daily with breakfast, 14-days |
| PF-04937319 split-dose | DRUG | tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days |
| Sitagliptin once-daily | DRUG | tablets, 100 mg once-daily with breakfast, 14-days |
Inclusion Criteria: * Patients with type 2 diabetes, on background metformin therapy either alone or with 1 other oral anti-diabetic agent (excluding Actos) Exclusion Criteria: * Patients with cardiovascular event within 6-months of screening * Patients with diabetic complications * Female subjec...