drugset / Trial / NCT00627744
Beta-cell Function in Glucose Abnormalities and Acute Myocardial Infarction
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A three months, double-blind, randomised, parallel-group study evaluating the efficacy of sitagliptin (Januvia™) versus placebo on beta-cell function in patients with newly detected glucose abnormalities and acute myocardial infarction or unstable angina pectoris. Primary endpoint Improvement in beta-cell function measured by means of the insulinogenic index (ΔI30/ΔG30) obtained from an oral glucose tolerance test (OGTT). Secondary endpoints 1. Improvement of glucose tolerance by means of an OGTT 2. Improvement in endothelial function 3. Improvement in incretin-independent beta-cell function measured as the Acute Insulin Response (ΔAIRG) during an intravenous glucose tolerance test
Timeline
- Start
- 2008-05
- Primary completion
- 2010-11
- Completion
- 2010-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sitagliptin | Small molecule | 100 mg | Oral |