Phase 2
Completed N=363
A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)
Source: ClinicalTrials.gov NCT00127192 ↗Enrolled (actual)
363
Serious AEs
—
Results posted
Sep 2009
Primary outcomePrimary: Change From Baseline in HbA1c at Week 12 — -0.41; -0.71; -0.69; -0.76 Percent — p=<0.001
Summary
The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 12 |
-0.41; -0.71; -0.69; -0.76; 0.28 | <0.001 sig |
| SECONDARY Change From Baseline in Glycosylated Albumin at Week 12 |
-1.9; -2.6; -2.6; -2.9; 0.7 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 12 |
-9.6; -11.4; -14.6; -16.9; 6.3 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients with type 2 diabetes mellitus
Exclusion Criteria
- Patients with type 1 diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT00127192). 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.