Status:
RECRUITING
Metformin and Prevention of Cardiovascular Events in Patients With Acute Myocardial Infarction and Prediabetes (MIMET)
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Capio Sankt Görans Hospital
Uppsala University
Conditions:
PreDiabetes
Acute Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
The study is a national multicenter R-RCT associated to the The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
5160 Patients enrolled
Trial Details
Trial ID
NCT05182970
Start Date
December 2 2021
End Date
May 1 2026
Last Update
April 2 2024
Active Locations (1)
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1
Medicinkliniken, Ljungby Hospital
Ljungby, Sweden, 341 35