Beta-cell Function in Glucose Abnormalities and Acute Myocardial Infarction

NCT00627744 | Completed Phase 4 DMC

• 1 other identifier: BEGAMI
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief 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. 1.Improvement of glucose tolerance by means of an OGTT
2. 2.Improvement in endothelial function
3. 3.Improvement in incretin-independent beta-cell function measured as the Acute Insulin Response (ΔAIRG) during an intravenous glucose tolerance test

Conditions

Myocardial Infarction; Unstable Angina Pectoris; Diabetes Mellitus; Impaired Glucose Tolerance

Keywords

Type 2 diabetes, IGT, Myocardial infarction, Incretins

Outcome Measures

Primary Outcomes (1)

• Improvement in beta-cell function measured by means of the insulinogenic index (ΔI30/ΔG30) obtained from an oral glucose tolerance test (OGTT)

  By the end of the study as stated

Secondary Outcomes (3)

• Improvement of glucose tolerance by means of an OGTT

  As stated for the study

• Improvement in endothelial function

  As stated for the study

• Improvement in incretin-independent beta-cell function measured as the Acute Insulin Response (ΔAIRG) during an intravenous glucose tolerance test.

  As stated for the study

Study Arms (2)

BE 1

PLACEBO COMPARATOR

Patients in this arm are randomly assigned to treatment with placebo

Drug: Sitagliptin

BE 2

ACTIVE COMPARATOR

Patients in this arm are randomly assigned to treatment with Sitagliptin

Drug: Sitagliptin

Interventions

Sitagliptin DRUG

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

Also known as: Active drug is Januvia produced by Merck

BE 1; BE 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with an acute myocardial infarction or unstable angina pectoris according to the joint ESC and ACC recommendations \[58\].
• Classification of impaired glucose tolerance (IGT) or type 2 diabetes (T2DM) by means of an oral glucose tolerance test (OGTT) according to WHO \[59\].
• Patients who have signed a written informed consent consistent with ICH-GCP guidelines and local legislations prior to participation in the trial.

You may not qualify if:

• No informed consent.
• \<18 years old.
• Previous known type 2 diabetes.
• Admission plasma glucose \>12 mmol/L.
• Impaired renal function (S-creatinine ≥ 130 μmol/L or need of renal dialysis).
• BMI\>30.
• Known Type 1 diabetes, GAD positive or C-peptide\<0.30.
• Patients with severe concomitant disease (i.e. malignancy, liver failure).
• Patients who at discharge are planned for Coronary Artery Bypass Grafting or percutaneous coronary intervention.
• Congestive heart failure (NYHA III-IV).
• Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception.
• 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).

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (2)

Karolinska Institutet

Stockholm, 171 76, Sweden

Location

Karolinska University Hospital Solna

Stockholm, Sweden

Location

Related Publications (1)

• Hage C, Lundman P, Ryden L, Mellbin L. Fasting glucose, HbA1c, or oral glucose tolerance testing for the detection of glucose abnormalities in patients with acute coronary syndromes. Eur J Prev Cardiol. 2013 Aug;20(4):549-54. doi: 10.1177/2047487312444371. Epub 2012 Mar 28.

  PMID: 22456695 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Angina, Unstable; Diabetes Mellitus; Glucose Intolerance; Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Lars Rydén, Professor

  Karolinska Institutet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: March 3, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

SE (2)