Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sitagliptin q.d.+ Pioglitazone q.d · 2 trials · 1 indication
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...
Sitagliptin q.d.+ Pioglitazone q.d is an investigational combination of two small-molecule drugs being studied for the treatment of Type 2 Diabetes Mellitus (T2DM). It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 3 clinical development.
Sitagliptin q.d.+ Pioglitazone q.d is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting Phase 3 clinical trials to evaluate this combination therapy for Type 2 Diabetes Mellitus.
Sitagliptin q.d.+ Pioglitazone q.d is in Phase 3 clinical development. It is an investigational combination therapy for Type 2 Diabetes Mellitus and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total enrollment of 837 patients.
Sitagliptin q.d.+ Pioglitazone q.d has been studied in three completed Phase 3 trials: NCT00337610, NCT00397631, and NCT01028391. These trials evaluated the combination in patients with Type 2 Diabetes Mellitus, with enrollments of 190, 520, and 317 patients respectively.
Sitagliptin q.d.+ Pioglitazone q.d is a combination therapy that includes sitagliptin and pioglitazone, administered once daily. It is being studied as a fixed-dose combination for Type 2 Diabetes Mellitus, distinct from the individual drugs used separately.