Beta-cell Function in Glucose Abnormalities and Acute Myocardial Infarction (BEGAMI)

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00627744
First received: February 22, 2008
Last updated: June 24, 2011
Last verified: October 2008
  Purpose

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

Condition Intervention Phase
Myocardial Infarction
Unstable Angina Pectoris
Diabetes Mellitus
Impaired Glucose Tolerance
Drug: Sitagliptin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study Evaluating the Effect of Sitagliptin (Januvia™) on Beta-cell Function in Patients With Acute Myocardial Infarction or Unstable Angina Pectoris and Newly Detected Impaired Glucose Tolerance or Type 2 Diabetes.

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Improvement in beta-cell function measured by means of the insulinogenic index (ΔI30/ΔG30) obtained from an oral glucose tolerance test (OGTT) [ Time Frame: By the end of the study as stated ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement of glucose tolerance by means of an OGTT [ Time Frame: As stated for the study ] [ Designated as safety issue: Yes ]
  • Improvement in endothelial function [ Time Frame: As stated for the study ] [ Designated as safety issue: Yes ]
  • Improvement in incretin-independent beta-cell function measured as the Acute Insulin Response (ΔAIRG) during an intravenous glucose tolerance test. [ Time Frame: As stated for the study ] [ Designated as safety issue: Yes ]

Enrollment: 85
Study Start Date: May 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: BE 1
Patients in this arm are randomly assigned to treatment with placebo
Drug: Sitagliptin
BE 1 receives Placebo tablets od during 12 weeks BE 2 receives Sitagliptin tablets 100 mg od during 12 weeks
Other Name: Active drug is Januvia produced by Merck
Active Comparator: BE 2
Patients in this arm are randomly assigned to treatment with Sitagliptin
Drug: Sitagliptin
BE 1 receives Placebo tablets od during 12 weeks BE 2 receives Sitagliptin tablets 100 mg od during 12 weeks
Other Name: Active drug is Januvia produced by Merck

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627744

Locations
Sweden
Karolinska University Hospital Solna
171 76 Stockholm, N.a., Sweden, n.a.
Karolinska Institutet
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska Institutet
Investigators
Study Chair: Lars Rydén, Professor Karolinska Institutet, Stockholm, Sweden
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lars Rydén MD, FRCP, FACC, FESC, Cardiology Unit, Department of Medicine, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00627744     History of Changes
Other Study ID Numbers: BEGAMI, N.a.
Study First Received: February 22, 2008
Last Updated: June 24, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
Type 2 diabetes, IGT, Myocardial infarction, Incretins

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Diabetes Mellitus
Glucose Intolerance
Infarction
Myocardial Infarction
Cardiovascular Diseases
Chest Pain
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Hyperglycemia
Ischemia
Metabolic Diseases
Myocardial Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014