Phase 3
Completed N=134
MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)
Source: ClinicalTrials.gov NCT00372060 ↗Enrolled (actual)
134
Serious AEs
—
Results posted
Mar 2009
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12 — -0.4; 0.4 Percent — p=<0.001
Summary
The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12 |
-0.4; 0.4 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 12 |
-12.2; 4.4 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients Have Type 2 Diabetes Mellitus
- On Diet/Exercise Therapy And Pioglitazone As Monotherapy
Exclusion Criteria
- Patients Have Type 1 Diabetes Mellitus
Data sourced from ClinicalTrials.gov (NCT00372060). 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.