Metformin and Prevention of Cardiovascular Events in Patients With Acute Myocardial Infarction and Prediabetes (MIMET)

Launched by KAROLINSKA INSTITUTET · Dec 21, 2021

Keywords

ClinConnect Summary

The MIMET clinical trial is studying whether adding metformin, a medication commonly used to manage blood sugar levels, can help prevent heart-related problems in patients who have recently experienced a heart attack and have been newly diagnosed with prediabetes. Prediabetes means that blood sugar levels are higher than normal but not high enough to be classified as diabetes. This trial aims to find out if metformin can improve heart health in these patients when given alongside standard medical care.

To participate in this study, individuals must be Swedish citizens aged between 18 and 80, have had an acute heart attack, and have a recent diagnosis of prediabetes. Participants should not have diabetes or be currently taking medication to lower blood sugar. Those who join the trial will receive either metformin or a placebo (a substance with no active medication) and will be monitored to see if there are any differences in heart health outcomes. It’s important for potential participants to understand the eligibility criteria and that this trial is currently looking for volunteers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • I. AMI
• • II. Swedish citizens with a personal ID number ≥18 years and ≤80 years
• III. Newly diagnosed prediabetes:
• • 1. HbA1c 42-47 mmol/mol or
• • 2. Capillary or venous fasting plasma glucose concentration 6.1-6.9 mmol/L or
• • 3. 2-hour post-load capillary glucose concentration 8.9-12.1 mmol/L or
• • 4. 2-h post-load venous plasma glucose concentration 7.8-11.0 mmol/L
• • 5. 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 Criteria:
• • 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