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

  • STATUS
    Recruiting
  • End date
    May 23, 2026
  • participants needed
    5160
  • sponsor
    Karolinska Institutet
Updated on 23 March 2022
diabetes
cardiovascular disease
fasting
metformin
hemoglobin a1c
plasma glucose
acute myocardial infarction

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).

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 (SWEDEHEART registry) where participants, after informed consent, will be randomly assigned to either open treatment with standard care + metformin or standard care alone in a 1:1 ratio. Standard care consists of diet and life-style advice according to national guidelines but does not include metformin. Baseline data for individual patients will be collected from the SWEDEHEART registry. Patients will be followed per routine care at 2 and 12 months post index AMI and in addition at a final study visit at 24 months. Laboratory measurements and collection of SAE will be performed yearly. In total n=5150 patients is expected to be followed for major CV event (all-cause mortality, myocardial infarction, heart failure and stroke) by linkage with SWEDEHEART and national health registries.

Details
Condition PreDiabetes, Acute Myocardial Infarction, Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction
Treatment Metformin
Clinical Study IdentifierNCT05182970
SponsorKarolinska Institutet
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 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
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