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Clinical Trial NCT05220917 (CER-4-T2D) for Cardiovascular Events, Type2 Diabetes, Renal Disease is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Brigham and Women's HospitalComparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study (CER-4-T2D) 781,430 Head-to-Head Comparison Observational
Clinical Trial NCT05220917 (CER-4-T2D) is an observational study for Cardiovascular Events, Type2 Diabetes, Renal Disease that is active, not recruiting. It started on August 1, 2021 with plans to enroll 781,430 participants. Led by Brigham and Women's Hospital, it is expected to complete by July 1, 2026. The latest data from ClinicalTrials.gov was last updated on December 8, 2025.
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 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 he...Show More
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 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),...Show More
Official Title
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
Conditions
Cardiovascular EventsType2 DiabetesRenal DiseaseOther Study IDs
- CER-4-T2D
- 2021P001784
NCT ID Number
Start Date (Actual)
2021-08-01
Last Update Posted
2025-12-08
Completion Date (Estimated)
2026-07-01
Enrollment (Estimated)
781,430
Study Type
Observational
Status
Active, not recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
SGLT-2i (Comparison 1) For SGLT-2i vs. DPP4i SGLT-2i - exposure group DPP4i - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
DPP-4i (Comparison 1) For SGLT-2i vs. DPP4i SGLT-2i - exposure group DPP-4i - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
SGLT-2i (Comparison 2) For SGLT-2i vs GLP-1 RA SGLT-2i - exposure group GLP-1 RA - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
GLP-1 RA (Comparison 2) For SGLT-2i vs GLP-1 RA SGLT-2i - exposure group GLP-1 RA - referent group | GLP-1RA Any SGLT2i dispensing claim |
GLP-1 RA (Comparison 3) For GLP-1 RA vs DPP-4i GLP-1 RA - exposure group DPP-4i - referent group | GLP-1RA Any SGLT2i dispensing claim |
DPP-4i (Comparison 3) For GLP-1 RA vs DPP-4i GLP-1 RA - exposure group DPP-4i - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
SGLT-2i (Comparison 4) For SGLT-2i vs SU SGLT-2i - exposure group SU - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
SU (Comparison 4) For SGLT-2i vs SU SGLT-2i - exposure group SU - referent group | 2nd generation SU Any 2nd generation SU claim |
GLP-1 RA (Comparison 5) For GLP-1 RA vs SU GLP-1 RA - exposure group SU - referent group | GLP-1RA Any SGLT2i dispensing claim |
SU (Comparison 5) For GLP-1 RA vs SU GLP-1 RA - exposure group SU - referent group | 2nd generation SU Any 2nd generation SU claim |
DPP-4i (Comparison 6) For DPP-4i vs SU DPP-4i - exposure group SU - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
SU (Comparison 6) For DPP-4i vs SU DPP-4i - exposure group SU - referent group | 2nd generation SU Any 2nd generation SU claim |
SGLT2i (Comparison 7) For SGLT2i vs. GLP-1RA vs. DPP-4i vs. SU (4-way comparison) SGLT2i, GLP-1 RA, and SU - exposure groups DPP-4i - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
GLP-1 RA (Comparison 7) For SGLT2i vs. GLP-1RA vs. DPP-4i vs. SU (4-way comparison) SGLT2i, GLP-1 RA, and SU - exposure groups DPP-4i - referent group | GLP-1RA Any SGLT2i dispensing claim |
DPP-4i (Comparison 7) For SGLT2i vs. GLP-1RA vs. DPP-4i vs. SU (4-way comparison) SGLT2i, GLP-1 RA, and SU - exposure groups DPP-4i - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
SU (Comparison 7) For SGLT2i vs. GLP-1RA vs. DPP-4i vs. SU (4-way comparison) SGLT2i, GLP-1 RA, and SU - exposure groups DPP-4i - referent group | 2nd generation SU Any 2nd generation SU claim |
SGLT2i (Comparison 8) For SGLT2i vs. GLP-1RA vs. DPP-4i (3-way comparison) SGLT2i and GLP-1 RA - exposure groups DPP-4i - referent group | SGLT2 inhibitor Any SGLT2i dispensing claim |
GLP-1 RA (Comparison 8) For SGLT2i vs. GLP-1RA vs. DPP-4i (3-way comparison) SGLT2i and GLP-1 RA - exposure groups DPP-4i - referent group | GLP-1RA Any SGLT2i dispensing claim |
DPP-4i (Comparison 8) For SGLT2i vs. GLP-1RA vs. DPP-4i (3-way comparison) SGLT2i and GLP-1 RA - exposure groups DPP-4i - referent group | DPP-4 inhibitor Any DPP-4 inhibitor claim |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
MACE | Myocardial Infarction, Ischemic Stroke, Cardiovascular mortality | through study completion, an average of 1 year |
Modified MACE | Myocardial Infarction, Ischemic Stroke, All-Cause mortality | through study completion, an average of 1 year |
Hospitalization for Heart Failure (HHF) Hospitalization for Heart Failure (HHF) | through study completion, an average of 1 year |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Myocardial Infarction (MI) | through study completion, an average of 1 year | |
Stroke | through study completion, an average of 1 year | |
Cardiovascular Mortality | through study completion, an average of 1 year | |
All-cause mortality | through study completion, an average of 1 year | |
Coronary revascularization | through study completion, an average of 1 year |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Brigham and Women's Hospital398 active studies to exploreStudy Responsible Party
Elisabetta Patorno, Principal Investigator, Associate Professor of Medicine, Brigham and Women's Hospital
No contact data.
1 Study Locations in 1 Countries
Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts, 02120, United States