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Design and rationale of the myocardial infarction and new treatment with metformin study (MIMET) - Study protocol for a registry-based randomised clinical trial

Ritsinger, Viveca ; Hagström, Emil ; Hambraeus, Kristina ; James, Stefan ; Jernberg, Tomas ; Lagerqvist, Bo ; Leosdottir, Margrét LU ; Lundman, Pia ; Pernow, John and Östlund, Ollie , et al. (2023) In Journal of Diabetes and its Complications 37(10).
Abstract

Aims: To investigate if addition of metformin to standard care (life-style advice) reduces the occurrence of cardiovascular events and death after myocardial infarction (MI) in patients with newly detected prediabetes. Methods: The Myocardial Infarction and new treatment with Metformin study (MIMET) is a large multicentre registry-based randomised clinical trial (R-RCT) within the SWEDEHEART registry platform expected to include 5160 patients with MI and newly detected prediabetes (identified with fasting blood glucose, HbA1c or 2-h glucose on oral glucose tolerance test) at ∼20 study sites in Sweden. Patients 18–80 years, without known diabetes and naïve to glucose lowering therapy, will be randomised 1:1 to open-label metformin... (More)

Aims: To investigate if addition of metformin to standard care (life-style advice) reduces the occurrence of cardiovascular events and death after myocardial infarction (MI) in patients with newly detected prediabetes. Methods: The Myocardial Infarction and new treatment with Metformin study (MIMET) is a large multicentre registry-based randomised clinical trial (R-RCT) within the SWEDEHEART registry platform expected to include 5160 patients with MI and newly detected prediabetes (identified with fasting blood glucose, HbA1c or 2-h glucose on oral glucose tolerance test) at ∼20 study sites in Sweden. Patients 18–80 years, without known diabetes and naïve to glucose lowering therapy, will be randomised 1:1 to open-label metformin therapy plus standard care or standard care alone. Outcomes: Patients will be followed for 2 years for the primary outcome new cardiovascular event (first of death, non-fatal MI, hospitalisation for heart failure or non-fatal stroke). Secondary endpoints include individual components of the primary endpoint, diabetes diagnosis, initiation of any glucose lowering therapy, cancer, and treatment safety. Events will be collected from national healthcare registries. Conclusions: The MIMET study will investigate if metformin is superior to standard care after myocardial infarction in preventing cardiovascular events in patients with prediabetes (Clinicaltrials.gov identifier: NCT05182970; EudraCT No: 2019-001487-30).

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Metformin, Myocardial infarction, Prediabetes, Prognosis, Registry-based randomised clinical trials
in
Journal of Diabetes and its Complications
volume
37
issue
10
article number
108599
publisher
Elsevier
external identifiers
  • pmid:37683518
  • scopus:85170406789
ISSN
1056-8727
DOI
10.1016/j.jdiacomp.2023.108599
language
English
LU publication?
yes
id
bc75b341-5716-45a1-93fb-62e0262d203c
date added to LUP
2024-01-12 15:15:07
date last changed
2024-04-13 08:42:08
@article{bc75b341-5716-45a1-93fb-62e0262d203c,
  abstract     = {{<p>Aims: To investigate if addition of metformin to standard care (life-style advice) reduces the occurrence of cardiovascular events and death after myocardial infarction (MI) in patients with newly detected prediabetes. Methods: The Myocardial Infarction and new treatment with Metformin study (MIMET) is a large multicentre registry-based randomised clinical trial (R-RCT) within the SWEDEHEART registry platform expected to include 5160 patients with MI and newly detected prediabetes (identified with fasting blood glucose, HbA1c or 2-h glucose on oral glucose tolerance test) at ∼20 study sites in Sweden. Patients 18–80 years, without known diabetes and naïve to glucose lowering therapy, will be randomised 1:1 to open-label metformin therapy plus standard care or standard care alone. Outcomes: Patients will be followed for 2 years for the primary outcome new cardiovascular event (first of death, non-fatal MI, hospitalisation for heart failure or non-fatal stroke). Secondary endpoints include individual components of the primary endpoint, diabetes diagnosis, initiation of any glucose lowering therapy, cancer, and treatment safety. Events will be collected from national healthcare registries. Conclusions: The MIMET study will investigate if metformin is superior to standard care after myocardial infarction in preventing cardiovascular events in patients with prediabetes (Clinicaltrials.gov identifier: NCT05182970; EudraCT No: 2019-001487-30).</p>}},
  author       = {{Ritsinger, Viveca and Hagström, Emil and Hambraeus, Kristina and James, Stefan and Jernberg, Tomas and Lagerqvist, Bo and Leosdottir, Margrét and Lundman, Pia and Pernow, John and Östlund, Ollie and Norhammar, Anna}},
  issn         = {{1056-8727}},
  keywords     = {{Metformin; Myocardial infarction; Prediabetes; Prognosis; Registry-based randomised clinical trials}},
  language     = {{eng}},
  number       = {{10}},
  publisher    = {{Elsevier}},
  series       = {{Journal of Diabetes and its Complications}},
  title        = {{Design and rationale of the myocardial infarction and new treatment with metformin study (MIMET) - Study protocol for a registry-based randomised clinical trial}},
  url          = {{http://dx.doi.org/10.1016/j.jdiacomp.2023.108599}},
  doi          = {{10.1016/j.jdiacomp.2023.108599}},
  volume       = {{37}},
  year         = {{2023}},
}