Phase 3
Completed N=441
Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)
Source: ClinicalTrials.gov NCT00106704 ↗Enrolled (actual)
441
Serious AEs
6.8%
Results posted
Dec 2010
Primary outcomePrimary: Change From Baseline in A1C at Week 24 — -0.45; 0.28 Percent — p=<0.001
Summary
The purpose of this clinical 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 A1C at Week 24 |
-0.45; 0.28 | <0.001 sig |
| SECONDARY Change From Baseline in FPG at Week 24 |
-4.4; 15.7 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients with Type 2 Diabetes Mellitus with inadequate glycemic control
Exclusion Criteria
- Patients with Type 1 Diabetes Mellitus
Data sourced from ClinicalTrials.gov (NCT00106704). 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.