NCT07465926Completed
Early Add-On Combination of GLP-1 Receptor Agonist and SGLT2 Inhibitor in People With Cardiovascular-Kidney-Metabolic Stage 2-3
Associations of Early Add-On GLP-1 Receptor Agonist and SGLT2 Inhibitor Therapy With Mortality and Kidney Outcomes in Adults With Obesity and Type 2 Diabetes Across Cardiovascular-Kidney-Metabolic Stages 2-3: A Target-Trial Emulation
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
This retrospective observational target-trial emulation uses electronic health record data from the TriNetX US Collaborative Network to compare early treatment intensification strategies in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 who initiate a GLP-1 receptor agonist or an SGLT2 inhibitor. The study compares patients who, within 90 days of starting background therapy, add the alternate agent, add a DPP-4 inhibitor or sulfonylurea, or do not receive early add-on therapy. The primary outcome is all-cause mortality over 36 months, with secondary cardiorenal outcomes also evaluated. Propensity-score methods are used to reduce bias from nonrandom treatment selection.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 451036 (actual)
- First submitted
- 8 Mar 2026
- Start date
- 1 Jan 2017
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Chung Shan Medical University
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07465926
What you commit to
- Study type: Observational
- Participants enrolled: 451036
- From 1 Jan 2017 to the primary completion date, 31 Jan 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of GLP-1 receptor agonists, SGLT2 inhibitors, DPP-4 inhibitors, or sulfonylureas within 6 months before cohort entry.
- Major cardiovascular disease or revascularization within 12 months before cohort entry.
- Advanced kidney disease within 12 months before cohort entry, including end-stage kidney disease, dialysis, or estimated glomerular filtration rate less than 15 mL/min/1.73 m2.
- Major cardiovascular or renal events within 6 months before index.
Other illness
- Any history of non-type 2 diabetes, HIV infection, bariatric surgery, or solid-organ transplantation.
Other
- Missing critical baseline covariates.
Who the study is looking for
- Adults aged 20 years or older.
- Obesity, defined by body mass index (BMI) 27 kg/m2 or greater.
- Type 2 diabetes mellitus, defined using electronic health record data, including diagnosis codes and/or hemoglobin A1c 6.5% or greater.
- Met cardiovascular-kidney-metabolic (CKM) stage 2-3 criteria at baseline.
- Initiated a GLP-1 receptor agonist or an SGLT2 inhibitor as background therapy.
- Had treatment strategy classification based on early add-on initiation within 90 days after background therapy initiation, or no early add-on with index at the 90-day landmark.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.