Suspended

Metformin vs SGLT2-Inhibitor: Cardiovascular Effects in Diabetes Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This observational study aims to compare the effects of Metformin and SGLT2-Inhibitor on cardiovascular health in diabetes patients, focusing on events such as stroke, myocardial infarction, and heart failure.

What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2018
See protocol details

Summary

Principal SponsorBrigham and Women's Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2018

Actual date on which the first participant was enrolled.

The MACES study focuses on comparing the effectiveness of two diabetes medications, Metformin and SGLT2-inhibitors, in relation to cardiovascular health. This research targets individuals with diabetes and pre-existing heart conditions, aiming to understand which drug better reduces the risk of heart-related complications. The study takes into account various factors like existing medical conditions, diabetes severity, healthcare usage, prescriber characteristics, and other medications. The potential findings of this study could help improve treatment strategies for diabetic patients with heart disease, ensuring they receive the most effective care. In this observational study, participants are matched based on their likelihood of receiving either Metformin or an SGLT2-inhibitor, taking into account numerous baseline factors. This matching process helps to balance the comparison between the two treatment groups. The study's primary outcome measures the incidence of cardiovascular events, such as stroke, myocardial infarction, and heart failure, using ICD9 and ICD10 codes. These events will only be analyzed individually if there are more than 30 instances of a specific event. The study also conducts sensitivity analyses and may assess the primary risk in patients with a history of cardiovascular disease, if a sufficient sample size is available. To ensure the accuracy of the results, researchers will also conduct a tracer analysis using cellulitis as an outcome, as it is unrelated to both SGLT2s and Metformin.

Official TitleMetformin And Cardiovascular Effectiveness vs SGLT2 (MACES)
Principal SponsorBrigham and Women's Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

INCLUSION: \- all patients newly prescribed an SGLT2 or metformin between March 29, 2013 to January 1st, 2017 with at least 6 months of continuous enrollment (1 year in a sensitivity analysis) EXCLUSION: * age \< 18 years * previous use of any diabetes medication * lack of a diagnosis of type 2 diabetes mellitus * history of malignant neoplasm * dialysis * type 1 diabetes

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Division of Pharmacoepidemiology and Pharmacoeconomics

Boston, United StatesOpen Division of Pharmacoepidemiology and Pharmacoeconomics in Google Maps
SuspendedOne Study Center