Beta-cell Function in Glucose Abnormalities and Acute Myocardial Infarction

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion Criteria:

1. Patients diagnosed with an acute myocardial infarction or unstable angina pectoris according to the joint ESC and ACC recommendations [58].

2. Classification of impaired glucose tolerance (IGT) or type 2 diabetes (T2DM) by means of an oral glucose tolerance test (OGTT) according to WHO [59].

3. Patients who have signed a written informed consent consistent with ICH-GCP guidelines and local legislations prior to participation in the trial.

Exclusion criteria:

1. No informed consent.

2. <18 years old.

3. Previous known type 2 diabetes.

4. Admission plasma glucose >12 mmol/L.

5. Impaired renal function (S-creatinine ≥ 130 μmol/L or need of renal dialysis).

6. BMI>30.

7. Known Type 1 diabetes, GAD positive or C-peptide<0.30.

8. Patients with severe concomitant disease (i.e. malignancy, liver failure).

9. Patients who at discharge are planned for Coronary Artery Bypass Grafting or percutaneous coronary intervention.

10. Congestive heart failure (NYHA III-IV).

11. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception.

12. Patients who, in the opinion of the investigator, will have difficulties to comply with the protocol (examples: alcohol or drug abuse, psychiatric disorder, resident outside of the catchment area).