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Researchers test if Real-World data can replicate major diabetes trial

NCT ID NCT07417631

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study looks at health insurance claims from about 30,000 people with type 2 diabetes to see if real-world data can produce similar results to a large clinical trial called REWIND. The goal is to learn when and how to trust real-world data for answering medical questions. No new treatments are given; instead, researchers analyze existing records to compare two diabetes drugs, dulaglutide and sitagliptin.

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

300,000 people

The number who actually took part.

Started

Feb 2026

Finished

Jun 2026

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

Two populations: (1) Individuals with T2DM, who are either aged 50 years or above with an established cardiovascular disease, aged 55 years or above with a subclinical cardiovascular disease, or aged 60 years or above with at least two cardiovascular risk factors; and (2) individuals typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with T2DM.

Ages

50 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.

Eligible Cohort Entry Dates: The study will use three data sources: Optum Clinformatics, Merative MarketScan, and Medicare. Optum: Eligible cohort entry period between September 18, 2014 to August 31, 2025. MarketScan: Eligible cohort entry period between October 1, 2016 to October 31, 2023. Medicare: Eligible cohort entry period between September 18, 2014 to October 31, 2020. FOLLOWING ELIGIBILITY OF THE REWIND TRIAL: Inclusion Criteria: * MI, Stroke, Revascularization procedure, Diagnosis of coronary/carotid/peripheral artery disease, diagnosis of hypertensive heart disease * BMI \>= 23.0kg/m2 * Type 2 Diabetes Mellitus * Chronic Kidney Disease (CKD) Stage 3/4 * Albuminuria * Tobacco use * Hypercholesterolemia/-lipidemia * Stable dose of glucose-lowering drugs, use lipid-lowering drugs, use of blood pressure medication Exclusion Criteria: * MEN syndrome or medullary thyroid carcinoma, organ transplant, malignancy * Severe hypoglycemic episode * CKD stage 5 or dialysis * Gastric emptying abnormality or bariatric surgery * Pregnancy * Craniocervical Instability (CCI) * Pancreatitis * Liver disease * Weight loss drug * Uncontrolled diabetes * Acute coronary/cerebrovascular event * Concurrent use of both study drugs EXPANDED POPULATION: Inclusion Criteria: * History of MI, stroke, any surgical or percutaneous revascularization procedure, use of antihypertensive/ lipid-lowering drugs, coronary / carotid / peripheral artery disease * BMI \>= 25.0kg/m2 * Type 2 Diabetes Exclusion Criteria: * Medullary thyroid carcinoma, * MEN syndrome type 2 * Malignancy * Type 1 diabetes or secondary diabetes * End-stage renal disease or dialysis * Uncontrolled diabetic retinopathy or maculopathy * Pregnancy * Bariatric surgery * Prior use of pramlintide or any GLP-1-RA except dulaglutide, or any DPP4i except sitagliptin

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120, United States

More trials for these conditions

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