Phase 3
Completed N=395
A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)
Source: ClinicalTrials.gov NCT00813995 ↗Enrolled (actual)
395
Serious AEs
3.0%
Results posted
Sep 2011
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 — -1.02; -0.14 Percent — p=<.001
Summary
A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (A1C) at Week 24 |
-1.02; -0.14 | <.001 sig |
| SECONDARY Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day |
-0.84; -0.01 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day |
-1.14; -0.21 | — |
| SECONDARY Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 |
-43.4; -10.0 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
-20.3; 0.5 | — |
Eligibility Criteria
Inclusion Criteria
- 18 - 78 years of age
- Currently on metformin monotherapy
Exclusion Criteria
- History of Type 1 diabetes mellitus or ketoacidosis
- Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks
- Has undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery
- Currently participating in a study or has participated in a study with or without an investigational compound or device within the past 12 weeks
- History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease
- HIV positive
- Pregnant, breast-feeding or planning to become pregnant during the study
- User of recreational or illicit drugs or has a recent history (within the past year) of drug or alcohol abuse or dependence
Data sourced from ClinicalTrials.gov (NCT00813995). 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.