Phase 3
Completed N=701
Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)
Diabetes Mellitus, Type II
Source: ClinicalTrials.gov NCT00086515 ↗
Enrolled (actual)
701
Serious AEs
10.7%
Results posted
Dec 2010
Primary outcomePrimary: Change From Baseline in Hemoglobin A1C (A1C) at Week 24 — -0.67; -0.02 Percent — p=<0.001
Summary
The purpose of this study is 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 (A1C) at Week 24 |
-0.67; -0.02 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
-16.9; 8.5 | <0.001 sig |
| SECONDARY Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 |
-62.0; -11.4 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients with type 2 diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT00086515). 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.