Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sitagliptin q.d./metformin ≥/day · 1 trial · 1 indication
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
| Arm | Type | Description |
|---|---|---|
| sitagliptin 100 mg once a day (q.d.)/metformin ≥1500 mg a day | EXPERIMENTAL | - |
| sitagliptin 100 mg placebo q.d./ metformin ≥ 1500 mg/day | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day | DRUG | Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets. |
| comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day | DRUG | Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets. |
Inclusion Criteria: * Patient has type 2 diabetes mellitus * Males * Females who are highly unlikely to become pregnant * Patients poorly controlled while taking one or two oral antidiabetic medications Exclusion Criteria: * Patient has a history of type 1 diabetes mellitus or history of ketoacid...
Sitagliptin q.d.+ Pioglitazone q.d is an investigational combination of two small molecules being developed for Type 2 Diabetes Mellitus (T2DM). It is intended to improve glycemic control in adults with this condition. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Sitagliptin q.d.+ Pioglitazone q.d is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting Phase 3 clinical trials to evaluate the safety and efficacy of this combination therapy for Type 2 Diabetes Mellitus.
Sitagliptin q.d.+ Pioglitazone q.d is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. The Phase 3 trials have been completed, and the data are being analyzed to determine the next steps in the regulatory process.
Sitagliptin q.d.+ Pioglitazone q.d has been studied in three completed Phase 3 trials: NCT00337610, NCT00397631, and NCT01028391. These trials enrolled a total of 837 participants with Type 2 Diabetes Mellitus. All trials were randomized, double-blind, and active-controlled, with no biomarker selection.
Sitagliptin q.d.+ Pioglitazone q.d is a fixed-dose combination of sitagliptin and pioglitazone, both administered once daily. It combines a DPP-4 inhibitor and a thiazolidinedione to target multiple pathways in Type 2 Diabetes Mellitus. The drug is being developed as a single product for improved convenience.