Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.

NCT07417631 | Completed FDA Drug

• 1 other identifier: 2018P002966-REWIND
• Study Type: observational
• Target: 300,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Time to first occurrence of myocardial infarction, stroke, or all-cause mortality

  The primary outcome is the time from cohort entry to the first occurrence of any component of the composite endpoint: myocardial infarction, stroke, or all-cause mortality in patients with T2DM with and without previous CVD, comparing dulaglutide versus sitagliptin, when following the eligibility criteria of the REWIND trial.

  From cohort entry through first occurrence of outcome, disenrollment, end of the study period, treatment discontinuation +45-day grace/risk window, treatment switch between arms, nursing home admission, start of another GLP-1 RA, assessed up to 1 year.

• Time to first occurrence of myocardial infarction, stroke, or all-cause mortality

  The outcome is the time from cohort entry to the first occurrence of any component of the composite endpoint: myocardial infarction, stroke, or all-cause mortality in patients with T2DM with and without previous CVD, comparing dulaglutide versus sitagliptin, when expanding the eligibility criteria of the REWIND trial.

  From cohort entry through first occurrence of outcome, disenrollment, end of the study period, treatment discontinuation +45-day grace/risk window, treatment switch between arms, nursing home admission, start of another GLP-1 RA, assessed up to 1 year.

Secondary Outcomes (3)

• Time to first occurrence of myocardial infarction, stroke, or all-cause mortality, assessed as individual components

  From cohort entry through first occurrence of outcome, disenrollment, end of the study period, treatment discontinuation +45-day grace/risk window, treatment switch between arms, nursing home admission, start of another GLP-1 RA, assessed up to 1 year.

• Time to first occurrence of a heart failure event

  From cohort entry through first occurrence of outcome, disenrollment, end of the study period, treatment discontinuation +45-day grace/risk window, treatment switch between arms, nursing home admission, start of another GLP-1 RA, assessed up to 1 year.

• Time to first occurrence of unstable angina

  From cohort entry through first occurrence of outcome, disenrollment, end of the study period, treatment discontinuation +45-day grace/risk window, treatment switch between arms, nursing home admission, start of another GLP-1 RA, assessed up to 1 year.

Other Outcomes (2)

• Time to first occurrence of hernia

  From cohort entry through first occurrence of outcome, disenrollment, end of the study period, treatment discontinuation +45-day grace/risk window, treatment switch between arms, nursing home admission, start of another GLP-1 RA, assessed up to 1 year.

• Time to first occurrence of lumbar radiculopathy

  From cohort entry through first occurrence of outcome, disenrollment, end of the study period, treatment discontinuation +45-day grace/risk window, treatment switch between arms, nursing home admission, start of another GLP-1 RA, assessed up to 1 year.

Study Arms (2)

Initiation of dulaglutide

Exposure group

Drug: Dulaglutide

Initiation of sitagliptin

Reference group

Drug: Sitagliptin

Interventions

Dulaglutide DRUG

Initiation of dulaglutide dispensing claim is used as the exposure.

Initiation of dulaglutide

Sitagliptin DRUG

Initiation of sitagliptin dispensing claim is used as the reference.

Initiation of sitagliptin

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Nils Krüger, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: February 3, 2026
• Primary Completion: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-02

Locations

US (1)