Patients with acute myocardial infarction or unstable angina pectoris and newly detected impaired glucose tolerance or type 2 diabetes (without any previous pharmacological glucose-lowering treatment) MedDRA version: 9.1 Level: HLGT Classification code 10018424 Term: Glucose metabolism disorders (incl diabetes mellitus) MedDRA version: 9.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome
Conditions
Interventions
Trade Name: JANUVIA
Product Name: JANUVIA
Product Code: Sitagliptin
Pharmaceutical Form: Tablet
Other descriptive name: sitagliptin
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. No informed consent. 2. Previous known type 2 diabetes. 3. Admission plasma glucose >12 mmol/L. 4. Impaired renal function (S-creatinine = 130 µmol/L or need of renal dialysis). 5. BMI>30. 6. Known Type 1 diabetes, GAD positive or C-peptide<0.30. 7. Patients with severe concomitant disease (i.e. malignancy, liver failure). 8. Patients who at discharge are planned for Coronary Artery Bypass Grafting or percutaneous coronary intervention. 9. Congestive heart failure (NYHA III-IV). 10. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception. 11. 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). 12. Age<18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 pectoris and newly discovered glucose abnormalities (IGT or T2DM).;Secondary Objective: To evaluate the effect of sitagliptin (Januvia™) on 1. glucometabolic classification by means of a glucose tolerance tested with an OGTT after three months of treatment. 2. endothelial function (measured with Endo-PAT2000, Itamar) after three months of treatment. 3. GLP-1 independent beta-cell function after three months measured as the ?AIRG obtained from a “Frequently sampled intravenous glucose tolerance test” (FSIGT). ;Primary end point(s): The primary endpoint is improvement in beta-cell function after three months treatment measured by means of insulinogenic index (?I30/?G30) obtained from an oral glucose tolerance test (OGTT). | — |
Countries
Sweden
Outcome results
None listed