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)
- Sponsor
- Bhavya Bhavya, MD
- Study ID
- NCT07311551
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin (10Mg Tab) along with standard medical therapy — DRUGGroup A: Dapagliflozin 10 mg once daily + Metformin ± OHAs
- Empagliflozin (25 Mg Tab) along with standard medical therapy — DRUGGroup B: Empagliflozin 25 mg once daily + Metformin ± OHAs
Study Details
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.
Key Dates
- Start date
- Dec 24, 2025
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 112 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Group ADapagliflozin 10 mg given once daily per orally for 6 months
- Experimental: Group BEmpagliflozin 25mg given once daily per orally for 6 months
Primary Outcome Measure
Change in HbA1c from baseline at 6 months [ Time Frame: From enrollment to the end of treatment at 6 months ]
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