Phase 3
Completed N=517
MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)
Source: ClinicalTrials.gov NCT00532935 ↗Enrolled (actual)
517
Serious AEs
3.7%
Results posted
Oct 2010
Primary outcomePrimary: Change From Baseline in A1C at Week 32 — -1.86; -1.39 Percent of glycosylated hemoglobin (A1C) — p=<0.001
Summary
A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in A1C at Week 32 |
-1.86; -1.39 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1 |
-40.5; -13.0 | <0.001 sig |
| SECONDARY Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32 |
-102.2; -82.0 | <0.001 sig |
| SECONDARY Change From Baseline in FPG at Week 32 |
-56.0; -44.0 | <0.001 sig |
| SECONDARY Percent of Participants With A1C <7.0% at Week 32 |
57.3; 43.5 | <0.001 sig |
Eligibility Criteria
General Inclusion Criteria:
- Patient has type 2 diabetes mellitus
- Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy
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 12 weeks
- Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years
Data sourced from ClinicalTrials.gov (NCT00532935). 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.