Using metformin to prevent heart problems in patients with prediabetes after a heart attack
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
This study is testing if adding metformin to regular care can help prevent heart problems in people with prediabetes who have just had a heart attack.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 5160 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Ljungby) |
| Trial ID | NCT05182970 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of adding metformin to standard care in patients who have experienced an acute myocardial infarction and have newly diagnosed prediabetes. It is a national multicenter randomized controlled trial where participants will be assigned to receive either standard care alone or standard care plus metformin. The study aims to evaluate the impact of this intervention on the occurrence of major cardiovascular events over a follow-up period of 24 months. Data will be collected from the SWEDEHEART registry and patients will be monitored for various cardiovascular outcomes.
Who should consider this trial
Good fit: Ideal candidates are Swedish citizens aged 18 to 80 who have experienced an acute myocardial infarction and have newly diagnosed prediabetes.
Not a fit: Patients with type 1 diabetes, known type 2 diabetes, or those requiring glucose-lowering treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular outcomes for patients with prediabetes following a heart attack.
How similar studies have performed: Other studies have suggested potential benefits of metformin in cardiovascular outcomes, but this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ljungby
- Medicinkliniken, Ljungby Hospital — Ljungby, Sweden (Recruiting)
Study contacts
- Principal investigator: Anna Norhammar, MD, Prof. — Karolinska Institutet
- Study coordinator: Anna Norhammar, MD, Prof.
- Email: anna.norhammar@ki.se
- Phone: +46858701568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.