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Beta-cell Function in Glucose Abnormalities and Acute Myocardial Infarction

NCT00627744 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2021-02-12

No results posted yet for this study

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

Conditions

Interventions

DRUG

Sitagliptin

BE 1 receives Placebo tablets od during 12 weeks BE 2 receives Sitagliptin tablets 100 mg od during 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Lars Rydén, Professor · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00627744 on ClinicalTrials.gov