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HomeTrials › NCT05220917

Type 2 diabetes · Not applicable · Active, not recruiting

Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study

NCT05220917 · Sponsor: Brigham and Women's Hospital

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 SGLT2 inhibitor, DPP-4 inhibitor, GLP-1RA, 2nd generation SU for cardiovascular events, type2 diabetes, renal disease.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeSGLT2 inhibitor, DPP-4 inhibitor, GLP-1RA, 2nd generation SU
Study length~4.8 years overall
Planned participants781,430
TypeObservational (no assigned treatment)

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

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 sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide 1 receptor agonists (GLP-1RA), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU), at the class and individual agent level, in head-to-head comparisons in patients with type 2 diabetes (T2D).

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)

Inclusion Criteria: * 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 Criteria: * 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

Study sites by state

Massachusetts

  • Brigham and Women's Hospital — Boston

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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