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Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)

NCT07188545 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 23280000

Last updated 2025-09-23

No results posted yet for this study

Summary

Complex pathophysiological interactions among obesity, metabolic risk factors, chronic kidney disease (CKD), and the cardiovascular system lead to poor cardiovascular-kidney-metabolic health (CKMH), which is a major determinant of premature morbidity and mortality. Poor CKMH may lead to cardiovascular-kidney-metabolic syndrome (CKMS) - the five-stage framework introduced by The American Heart Association (AHA) which accounts for the critical overlap between cardiorenal syndrome and cardiometabolic disease.

Evidence from randomized controlled trials shows glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose co-transporter-2 inhibitors (SGLT2is) may improve CKMH in individuals with Type 2 Diabetes (T2D) and/ or obesity. However, there is modest evidence suggesting differential effectiveness of GLP-1RA and SGLT2i drugs between males and females. The extent of these sex-based differences is currently unknown. In part, this may be due to underrepresentation of females in clinical trials. Exploring sex-based differences in GLP-1RA and SGLT2i treatment on CKMH outcomes is important to inform CKMS treatment and equity in CKMH.

Robust secondary data sources present the opportunity to elucidate sex heterogeneity in GLP-1RA and SGLT2i treatment on CKMH outcomes. Using a target-trial emulation design, this study aims to observe differences in long-term CKMH outcomes between patients treated by GLP-1RA and SGLT2i medications versus those treated with active comparator medications, and whether there is an observed interaction between sex and treatment.

Conditions

  • Cardiovascular Kidney Metabolic Syndrome

Interventions

DRUG

Intervention

GLP-1RA and/or SGLT2i adult users with ≥1 prescription for the intervention GLP-1RA or SGLT2i medications (including combination drugs or mixed therapies with comparator medications). GLP-1RAs include: Exenatide, Liraglutide, Semaglutide, Dulaglutide, Lixisenatide, Albiglutide, Tirzepatide. SGLT2is include: Canagliflozin, Dapagliflozin, Bexagliflozin, Empagliflozin, Ertugliflozin, Sotagliflozin.

DRUG

Active Comparator

DPP4i or Oral Obesity Agent adult users with ≥1 prescription for the comparator DPP4i or Oral Obesity Agent medications AND no intervention GLP-1RA or SGLT2i prescriptions in first 30 days of follow up. DPP4is include: Alogliptin, Saxagliptin, Linagliptin, Sitagliptin. Oral Obesity Agents include: Orlistat, Naltrexone-bupropion, Phentermine-topiramate, Phentermine, Diethylpropion, Bupropion (off-label), Topiramate (off-label)

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2029-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07188545 on ClinicalTrials.gov