Phase 3
Completed N=319
A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)
Diabetes Mellitus, Non-Insulin-Dependent
Source: ClinicalTrials.gov NCT00411554 ↗
Enrolled (actual)
319
Serious AEs
—
Results posted
Sep 2009
Primary outcomePrimary: Change From Baseline in HbA1c at Week 12 — -0.70; -0.30 Percent — p=<0.001
Summary
The clinical study determines the safety and efficacy of Sitagliptin (MK0431) in patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 12 |
-0.70; -0.30 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 12 |
-19.6; -8.9 | <0.001 sig |
| SECONDARY Change From Baseline in 2 Hour Postprandial Glucose at Week 12 |
-51.0; -32.2 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients have type 2 diabetes mellitus on diet/exercise therapy
Exclusion Criteria
- Patients have type 1 diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT00411554). 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.