Phase 3
N=520
Initial Combination With Pioglitazone Study (0431-064)
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00397631 ↗Enrolled (actual)
520
Serious AEs
—
Results posted
Jul 2009
Primary outcome: Primary: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 — -2.38; -1.49 Percent — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- sitagliptin 100 mg q.d./pioglitazone 30 mg q.d (Drug); Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d. (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2008
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 |
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.
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.