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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

Who is this study for? Patients with Myocardial Infarction, Prediabetes Type 2
What treatments are being studied? Metformin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Sweden
Medicinkliniken, Ljungby Hospital
RECRUITING
Ljungby
Contact Information
Primary
Anna Norhammar, MD, Prof.
anna.norhammar@ki.se
+46858701568
Backup
Viveca Ritsinger, MD, PhD
viveca.ritsinger@ki.se
+46372585000
Time Frame
Start Date: 2021-12-02
Estimated Completion Date: 2026-05
Participants
Target number of participants: 5160
Treatments
Active_comparator: Metformin on top of standard care
Metformin will be prescribed by the Investigator at the study site and dispensed at pharmacy of choice by the patient. Metformin will be recommended to be gradually titrated to minimize gastrointestinal side effects with a start dose of 500 mg 1x1 for 1 week and thereafter 500 mg 1x2 with an individualised target dose of 2000 mg daily depending on tolerability. The goal is to a have minimal dose of 500 mg 1x2. Patients will be informed to stop medication in events of sever nausea, vomiting or dehydration according to standard practice. The threshold for metformin titration or adding another drug during follow-up is recommended to be assessed individually by the Investigator at the study site, responsible for the patient. Patients with eGFR \<60 cannot be included in the MIMET study. If GFR is between 30-45 ml/min during the study, metformin should be reduced to 1000 mg daily. Metformin is contraindicated if GFR \<30 ml/min. Standard care will be the same as in the control arm.
No_intervention: Standard care alone
Standard care according to national guidelines. In Sweden there is no pharmacological intervention recommended for individuals with prediabetes at present. Standard care includes diet and life-style advice, which will be given to both groups in the same manner according to local routines, based on the present guidelines. Secondary preventive treatment includes physical activity, participating in exercise program, dietary habits, BMI and or waist circumference, smoking and EQ-5D will be followed in accordance with the routinely reported SWEDEHEART-SEPHIA variables.
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet
Collaborators: Uppsala University, Capio Sankt Görans Hospital, The Swedish Research Council

This content was sourced from clinicaltrials.gov