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Recruiting Phase 3 NCT05182970

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

Trial Parameters

Condition PreDiabetes
Sponsor Karolinska Institutet
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 5,160
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2021-12-02
Completion 2026-05
Interventions
Metformin

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 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 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

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