Phase 3
Completed N=273
Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)
Source: ClinicalTrials.gov NCT00541775 ↗Enrolled (actual)
273
Serious AEs
5.5%
Results posted
Jun 2010
Primary outcomePrimary: Hemoglobin A1C (A1C) at Week 18 — -0.73; -0.79; -0.22 Percent of glycosylated hemoglobin (A1C) — p=<=0.001
Summary
The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1C (A1C) at Week 18 |
-0.73; -0.79; -0.22 | <=0.001 sig |
| SECONDARY Fasting Plasma Glucose (FPG) at Week 18 |
-11.7; -24.5; 6.1 | <=0.001 sig |
| SECONDARY 2-hour Post-meal Glucose (PMG) at Week 18 |
-35.4; -51.3; -4.9 | <=0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient has Type 2 diabetes
- Currently taking metformin >1500 mg/day for at least 10 weeks
- Male or female
Exclusion Criteria
- Patient has peripheral edema
- History of type 1 diabetes
- Patient required insulin within prior 8 weeks
- Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study
- Participating in a weight loss program
Data sourced from ClinicalTrials.gov (NCT00541775). 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.