Researchers test if Real-World data can replicate major diabetes trial
NCT ID NCT07417631
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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300,000 people
The number who actually took part.
- Started
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Feb 2026
- Finished
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Jun 2026
- Lead sponsor
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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
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Brigham and Women's Hospital
Boston, Massachusetts, 02120, United States
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