Status:
ACTIVE_NOT_RECRUITING
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
VA Boston Healthcare System
Conditions:
Cardiovascular Events
Type2 Diabetes
Eligibility:
All Genders
18+ years
Brief Summary
To perform an observational analysis to emulate a target trial (i.e., a hypothetical pragmatic trial that would have answered the causal question of interest) comparing the effectiveness and safety of...
Detailed Description
Aim 1: (1a.) To evaluate the effectiveness of sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide 1 receptor agonists (GLP-1RA), dipeptidyl peptidase-4 inhibitors (DPP-4i), and s...
Eligibility Criteria
Inclusion
- Age ≥ 18 years for Optum Cliniformatics, IBM Marketscan, CPRD, and VHA, and ≥ 65 years for Medicare FFS at cohort entry
- At least 12 months of continuous health plan enrollment (only claims) or registration with a general practitioner (CPRD) before and including cohort entry
- Diagnosis of T2D within 12 months before (or ever before in CPRD) and including cohort entry
- Low or moderate cardiovascular (CV) risk (≤3% risk of CV events/year) at cohort entry \*
- Metformin maintenance therapy, defined as 2 fills (or prescriptions in CPRD) of metformin monotherapy recorded within 6 months before and including cohort entry
Exclusion
- Missing age or gender information
- Nursing care admission within 12 months before and including cohort entry (criteria ignored in CPRD)
- Diagnosis of type 1 diabetes within 12 months before and including cohort entry
- Diagnosis of secondary or gestational diabetes within 12 months before and including cohort entry
- Any insulin fill or prescription within 12 months before and including cohort entry
- Diagnosis of end stage renal disease (stage ≥ 5) within 12 months before and including cohort entry
- Diagnosis of acute or chronic pancreatitis within 12 months before and including cohort entry
- Diagnosis of cirrhosis or acute hepatitis within 12 months before and including cohort entry
- Diagnosis of MEN-2 within 12 months before and including cohort entry
- Recorded solid organ transplant code within 12 months before and including cohort entry
- Patients with recorded initiation of more than one agent within a comparator class at cohort entry
Key Trial Info
Start Date :
August 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
781430 Patients enrolled
Trial Details
Trial ID
NCT05220917
Start Date
August 1 2021
End Date
July 1 2026
Last Update
December 8 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120