A Comparison of Effectiveness, Safety, and Cost-effectiveness of Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes Mellitus and High Body Mass Index (BMI)
NCT07311551 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112
Last updated 2025-12-31
Summary
This study aims to compare the effect of two drugs used to treat diabetes, that is, Dapagliflozin and Empagliflozin on HbA1c (which is an indicator of blood sugar over the last 3 months) body weight, liver and kidney function, blood pressure, and overall cost-effectiveness in patients with type 2 diabetes and high body mass index (23kg/m2). The results will help us determine which drug is more effective, safer, and economical for Indian patients and improve future treatment options.
Conditions
Interventions
- DRUG
-
Dapagliflozin (10Mg Tab) along with standard medical therapy
Group A: Dapagliflozin 10 mg once daily + Metformin ± OHAs
- DRUG
-
Empagliflozin (25 Mg Tab) along with standard medical therapy
Group B: Empagliflozin 25 mg once daily + Metformin ± OHAs
Sponsors & Collaborators
-
Bhavya Bhavya, MD
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-24
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
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