DRUG
SGLT2 inhibitor
Any SGLT2i dispensing claim
Status
Active, not recruiting
Phase
Not applicable
Enrollment
781,430
Locations
1
Results
Not posted
Publications
0
Study 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 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).
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 sulfonylureas (SU), at the class and individual agent level, in head-to-head comparisons with respect to cardiovascular (CV) events, mortality, renal events, and other patient-centered outcomes (e.g., time spent at home), in patients with T2D and moderate baseline CV risk (event rate ≤3%/year). (1b.) To examine heterogeneity in treatment effects by age, race/ethnicity, gender, levels of CV risk, including high (≥4%/year) and low risk (\<2%/year), chronic kidney disease (CKD), frailty, and multimorbidity. Aim 2: (2a.) To monitor and quantify the association of the initiation of SGLT2i, GLP-1RA, DPP-4i, or SU, at the class and individual agent level, with previously reported drug-related harms (e.g., diabetic ketoacidosis (DKA), fractures, amputations, pancreatitis, severe hypoglycemia). (2b.) To scan study data sources for signals of potential serious unanticipated drug-related adverse events, using a data-mining approach (tree-based scan statistics). (2c.) By using data generated in Aims 2a and 2b, to build treatment-specific outcome prediction models to identify individual patients' likelihood of drug-related harms, based on specific combinations of patient features.
Interventions
DRUG
Any SGLT2i dispensing claim
DRUG
Any DPP-4 inhibitor claim
DRUG
Any SGLT2i dispensing claim
DRUG
Any 2nd generation SU claim
Timeline
First posted
Feb 2, 2022
Study start
Aug 1, 2021
Primary completion
May 31, 2026
Study completion
Sep 30, 2027
Results posted
Not reported
Registry updated
May 15, 2026
Outcomes
MACE
Time frame · through study completion, an average of 1 year
Myocardial Infarction, Ischemic Stroke, Cardiovascular mortality
Modified MACE
Time frame · through study completion, an average of 1 year
Myocardial Infarction, Ischemic Stroke, All-Cause mortality
Hospitalization for Heart Failure (HHF) Hospitalization for Heart Failure (HHF)
Time frame · through study completion, an average of 1 year
Myocardial Infarction (MI)
Time frame · through study completion, an average of 1 year
Stroke
Time frame · through study completion, an average of 1 year
Cardiovascular Mortality
Time frame · through study completion, an average of 1 year
All-cause mortality
Time frame · through study completion, an average of 1 year
Coronary revascularization
Time frame · through study completion, an average of 1 year
Eligibility
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 locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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