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

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 A
    Dapagliflozin 10 mg given once daily per orally for 6 months
  • Experimental: Group B
    Empagliflozin 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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