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PreDiabetesPhase 3MIMETNCT05182970

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

A Phase 3 study testing Metformin in people with PreDiabetes and Acute Myocardial Infarction, run by Karolinska Institutet at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,160 participants
Where
1 siteSweden
Study dates
2 Dec 2021to May 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • AMI
  • Swedish citizens with a personal ID number ≥18 years and ≤80 years
  • 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
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  • 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)
  • Naïve to metformin and other glucose lowering therapy
  • Signed informed consent

Who cannot join

  • Type 1 diabetes
  • Known type 2 diabetes
  • Indication for glucose lowering treatment
  • Acute condition with high risk for volume depletion, circulatory shock, hypoxia
  • Serious illness, other than cardiovascular, with short life expectancy
  • Renal failure (eGFR <60ml/min)
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  • Hepatic failure
  • Malignancy within the last year
  • Contraindication or hypersensitivity to the study drug
  • Alcohol or drug abuse
  • Pregnancy or breastfeeding
  • Women of childbearing potential without adequate anticonception during any part of the study period
  • Previous hospitalisation for lactic acidosis
  • Predicted inability to comply with the study protocol

Trial locations and contacts

1 site in 1 country.

Anna Norhammar, MD, Prof. contact

+46858701568

anna.norhammar@ki.se

Viveca Ritsinger, MD, PhD contact

+46372585000

viveca.ritsinger@ki.se

Sweden1 site, 1 recruiting

  • Medicinkliniken, Ljungby Hospital

    Ljungby, 341 35

    Thomas Aronsson, Head of Clinic

    Viveca Ritsinger, MD PhD

    Recruiting

Other trials in Sweden

About this study

Official title: 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

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).

Read the 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 (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.

Being tested
Metformin
Medical subject headings
Prediabetic State, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Individualised target dose of 2000 mg daily depending on tolerability.

Study groups in NCT05182970
Study groupRoleWhat they receive
Metformin on top of standard careActive comparatorMetformin 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.
Receives: Drug: Metformin
Standard care aloneNo interventionStandard 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to major CV event

    Major CV event; a composite endpoint of first of all-cause death or main diagnosis of MI, heart failure or stroke (reported in SWEDEHEART, the National Patient Register and the Cause of Death Register).

    Measured: Estimated follow-up for each patient is 1-4 years

Secondary outcomes (10)

  1. Time to the composite endpoint CV death, main diagnosis of MI, heart failure or stroke.

    Time to first event included in the composite endpoint CV death, main diagnosis of MI, heart failure or stroke.

    Measured: Estimated follow-up for each patient is 1-4 years

  2. Time to the composite endpoint of all-cause death, main diagnosis of MI, stroke and revascularisation (CABG or PCI >4 months after the index AMI).

    Time to first event included in the composite endpoint of all-cause death, main diagnosis of MI, stroke and revascularisation (CABG or PCI >4 months after the index AMI).

    Measured: Estimated follow-up for each patient is 1-4 years

  3. All-cause death

    Time to all-cause death

    Measured: Estimated follow-up for each patient is 1-4 years

  4. CV death

    Time to CV death

    Measured: Estimated follow-up for each patient is 1-4 years

  5. Hospitalisation with MI

    Time to readmission for MI. Hospital admission for MI during day 0-30 after index AMI will be excluded

    Measured: Estimated follow-up for each patient is 1-4 years

  6. Hospitalisation with stroke

    Time to hospitalisation for stroke (main diagnosis)

    Measured: Estimated follow-up for each patient is 1-4 years

  7. Hospitalisation with heart failure

    Time to hospitalisation for heart failure (main diagnosis)

    Measured: Estimated follow-up for each patient is 1-4 years

  8. New cancer diagnosis

    Time to new cancer diagnosis defined as the first occurrence of any cancer in the National Patient Register

    Measured: Estimated follow-up for each patient is 1-4 years

  9. Initiation of any glucose lowering therapy

    Time to initiation of any glucose lowering therapy (ATC code A10 in the Prescribed Drug Register, excluding randomisation to metformin)

    Measured: Estimated follow-up for each patient is 1-4 years

  10. Diabetes diagnosis

    Defined as diabetes diagnosis in National Patient Register and/or prescribed glucose lowering treatment in the Prescribed Drug Register excluding randomisation to metformin in the active treatment arm

    Measured: Estimated follow-up for each patient is 1-4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2022
  2. Study start2 Dec 2021
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05182970
Sponsor's protocol ID
2019-05382
Other IDs
2019
Acronym
MIMET
Status last verified
Apr 2024
First submitted
21 Dec 2021
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ritsinger V, Hagstrom E, Hambraeus K, James S, Jernberg T, Lagerqvist B, Leosdottir M, Lundman P, Pernow J, Ostlund O, Norhammar A. Design and rationale of the myocardial infarction and new treatment with metformin study (MIMET) - Study protocol for a registry-based randomised clinical trial. J Diabetes Complications. 2023 Oct;37(10):108599. doi: 10.1016/j.jdiacomp.2023.108599. Epub 2023 Aug 30.

    PubMed 37683518

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin in people with PreDiabetes and Acute Myocardial Infarction, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anna Norhammar, MD, Prof. (+46858701568, anna.norhammar@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to major CV event (time frame: Estimated follow-up for each patient is 1-4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05182970, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.

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