Phase 3
Completed N=530
MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)
Source: ClinicalTrials.gov NCT00289848 ↗Enrolled (actual)
530
Serious AEs
1.5%
Results posted
Apr 2010
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 — -0.71; 0.31 Percent — p=<0.001
Summary
This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 |
-0.71; 0.31 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 |
-25.8; 5.2 | <0.001 sig |
| SECONDARY Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18 |
-63.8; -7.2 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and =130 mg/dL and <=280 mg/dL
Exclusion Criteria
- Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months
Data sourced from ClinicalTrials.gov (NCT00289848). 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.