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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01028391 | 30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064) | PHASE3 | COMPLETED | 317 | — | — | Sep 1, 2007 | Jan 1, 2009 | May 12, 2017 | - | — |
| NCT00397631 | Initial Combination With Pioglitazone Study (0431-064) | PHASE3 | COMPLETED | 520 | — | — | Dec 19, 2006 | Jun 28, 2008 | May 12, 2017 | - | — |
HbA1c is measured as percent. Thus this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
| Arm | Type | Description |
|---|---|---|
| Sitagliptin + Pioglitazone | EXPERIMENTAL | - |
| Pioglitazone + Placebo | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | sitagliptin 100 mg q.d./pioglitazone 30 mg q.d. |
| 2 | ACTIVE_COMPARATOR | sitagliptin 100 mg placebo q.d./pioglitazone 30 mg q.d. |
| Name | Type | Description |
|---|---|---|
| Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d. | DRUG | Patients will receive combination therapy with blinded sitagliptin 100 mg q.d. (q.d. = once daily) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. Sitagliptin 100 mg q.d. and pioglitazone 45 mg q.d. will be administered as oral tablets. |
| Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d. | DRUG | Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. The placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. will be administered as oral tablets. |
| Metformin | DRUG | Patients not meeting specific glycemic goals during the 30-week extension study will receive open-label metformin at a dose determined by the investigator. |
| sitagliptin 100 mg q.d./pioglitazone 30 mg q.d | DRUG | Patients will receive initial combination therapy with blinded sitagliptin 100 mg q.d. and open- label pioglitazone 30 mg q.d. for up to 24 Weeks. Sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. will be administered as oral tablets. |
| Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d. | DRUG | Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open label pioglitazone 30 mg q.d. for up to 24 Weeks. Placebo to match sitagliptin 100 mg q.d.(blinded) and open-label pioglitazone 30 mg q.d. will be administered as oral tablets. |
Inclusion Criteria: * Patients must complete the double-blind base study (MK-0431-064-00)(NCT00397631) and have at least 75% compliance with study medication during the base study treatment period. * Women of childbearing potential must continue to comply with the protocol-specified contraceptive m...