Status:
COMPLETED
Beta-cell Function in Glucose Abnormalities and Acute Myocardial Infarction
Lead Sponsor:
Karolinska Institutet
Conditions:
Myocardial Infarction
Unstable Angina Pectoris
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 abnormalit...
Detailed Description
GENERAL AIM / PRIMARY OBJECTIVE The primary objective is to show that sitagliptin (Januvia™) 100 mg once daily for three months improves beta-cell function in patients with AMI or unstable angina pect...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00627744
Start Date
May 1 2008
End Date
November 1 2010
Last Update
February 12 2021
Active Locations (2)
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1
Karolinska Institutet
Stockholm, Sweden, 171 76
2
Karolinska University Hospital Solna
Stockholm, Sweden