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Massive study compares four diabetes drugs for heart safety

NCT ID NCT05214573

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at health records from over 386,000 adults with type 2 diabetes and moderate heart disease risk. Researchers compared four common second-line diabetes drugs to see which ones were linked to fewer heart attacks, strokes, and other complications. They also asked patients which treatment outcomes mattered most to them. The goal is to help doctors and patients choose the best medication based on real-world data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
glucagon-like peptide-1 receptor agonists, SGLT2 inhibitors, DPP-4 inhibitors, sulfonylureas
What this could lead to
If successful, this could help doctors choose the safest second-line diabetes drug for patients with moderate heart disease risk.
What could go wrong
This is an observational study using past data, not a controlled trial, so results may be less reliable. It cannot prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

386,301 people

The number who actually took part.

Started

Dec 2021

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Aims 1, 2B, 3: De-identified data sets using laboratory results, electronic health record and mortality data from the OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service data. Aim 2A: Adults with Type 2 diabetes receiving care from primary care and endocrinology practices in Mayo Clinic Rochester, MN or Mayo Clinic Health System in Minnesota and Wisconsin.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for all Aims * ≥ 21 years old. * Diagnosis of Type 2 diabetes. * Use of ≥ 1 study drug (GLP-1RA, SGLT2i, DPP-4i, SU). Exclusion Criteria for Aims 1, 2B, 3 * Fill for any study drug during the baseline period or simultaneous (within 30 days) start of ≥2 study drugs * Insulin use * Type 1 diabetes * High risk of CVD * Pregnancy * Metastatic cancer Exclusion Criteria for Aim 2A * Insulin use. * Cognitive impairment. * Terminal or advanced illness. * Non-English speaking. * Residency in a long-term care setting.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder diabetes mellitus heart disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac disease Type 2 diabetes

Contacts and locations

Locations

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.