Metformin and Prevention of Cardiovascular Events in Patients With Acute Myocardial Infarction and Prediabetes (MIMET)
The Myocardial Infarction and New Treatment With Metformin Study (MIMET) - a R-RCT to Study Metformin and the Prevention of Cardiovascular Events in Patients With Acute Myocardial Infarction and Newly Detected Prediabetes
Karolinska Institutet
5,160 participants
Dec 2, 2021
INTERVENTIONAL
Conditions
Summary
Prediabetes is associated to an increased risk of cardiovascular disease and mortality. Although metformin can delay progression to diabetes there is a lack of RCTs evaluating the effect of metformin on cardiovascular outcomes. MIMET aims to investigate if addition of metformin to standard care has effects on the occurrence of cardiovascular events after acute myocardial infarction in patients with newly detected prediabetes (identified by oral glucose tolerance test, HbA1c or fasting glucose levels).
Eligibility
Inclusion Criteria10
- I. AMI
- II. Swedish citizens with a personal ID number ≥18 years and ≤80 years
- III. Newly diagnosed prediabetes:
- HbA1c 42-47 mmol/mol or
- Capillary or venous fasting plasma glucose concentration 6.1-6.9 mmol/L or
- 2-hour post-load capillary glucose concentration 8.9-12.1 mmol/L or
- 2-h post-load venous plasma glucose concentration 7.8-11.0 mmol/L
- HbA1c <48 mmol/mol and 2-hour post-load capillary glucose concentration >12.1 mmol/L or 2-h post-load venous plasma glucose concentration >11.0 mmol/L (thus elevated 2-hour glucose levels in the diabetes range but without HbA1c levels diagnostic for diabetes)
- IV. Naïve to metformin and other glucose lowering therapy
- V. Signed informed consent
Exclusion Criteria14
- I. Type 1 diabetes
- II. Known type 2 diabetes
- III. Indication for glucose lowering treatment
- IV. Acute condition with high risk for volume depletion, circulatory shock, hypoxia
- V. Serious illness, other than cardiovascular, with short life expectancy
- VI. Renal failure (eGFR <60ml/min)
- VII. Hepatic failure
- VIII. Malignancy within the last year
- IX. Contraindication or hypersensitivity to the study drug
- X. Alcohol or drug abuse
- XI. Pregnancy or breastfeeding
- XII. Women of childbearing potential without adequate anticonception during any part of the study period
- XIII. Previous hospitalisation for lactic acidosis
- XIV. Predicted inability to comply with the study protocol
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Interventions
Individualised target dose of 2000 mg daily depending on tolerability.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05182970