What this trial means for you
This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Dulaglutide, Sitagliptin for type 2 diabetes.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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
Study sites by state
Massachusetts
- Brigham and Women's Hospital — Boston
View the official record on ClinicalTrials.gov →
Follow this trial
Get an email when our monthly digest covers enrollment changes and results for trials like this one.
Newsletter signup launches soon. (Site owner: set PUBLIC_BUTTONDOWN_USERNAME in
.env to activate this form.)