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.
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 →
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