Phase 3
Completed N=1,250
MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
Source: ClinicalTrials.gov NCT00482729 ↗Enrolled (actual)
1,250
Serious AEs
5.3%
Results posted
Mar 2010
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (A1C) at Week 18 — -2.37; -1.76 Percent — p=<0.001
Summary
The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (A1C) at Week 18 |
-2.37; -1.76 | <0.001 sig |
| SECONDARY Number of Patients With A1C < 7.0% at Week 18 |
275; 193; 284; 371 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 |
-69.4; -53.7 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient has type 2 diabetes mellitus
- Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent
- Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy
- Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months
- Patient is a male, or a female who is unlikely to conceive
Exclusion Criteria
- Patient has type 1 diabetes mellitus or history of ketoacidosis
Data sourced from ClinicalTrials.gov (NCT00482729). 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.