Beta-cell Function in Glucose Abnormalities and Acute Myocardial Infarction (BEGAMI)
This study has been completed.
Sponsor:
Karolinska Institutet
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00627744
First received: February 22, 2008
Last updated: June 24, 2011
Last verified: October 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
- Improvement of glucose tolerance by means of an OGTT
- Improvement in endothelial function
- 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:
- 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.
Exclusion criteria:
- 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).
Contacts and Locations
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
| 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 Infarction Myocardial Infarction Glucose Intolerance Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Ischemia Pathologic Processes Necrosis Hyperglycemia Sitagliptin Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013