Phase 3
Completed N=520
Initial Combination With Pioglitazone Study (0431-064)
Source: ClinicalTrials.gov NCT00397631 ↗Enrolled (actual)
520
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 — -2.38; -1.49 Percent — p=<0.001
Summary
A clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 |
-2.38; -1.49 | <0.001 sig |
| SECONDARY Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 |
-63.0; -40.2 | <0.001 sig |
| SECONDARY Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24 |
-113.6; -68.9 | <0.001 sig |
Eligibility Criteria
General Inclusion Criteria:
- Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes)
General Exclusion Criteria:
- Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
- Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 4 months
- Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 2 years
Data sourced from ClinicalTrials.gov (NCT00397631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.