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 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: Ihecsr/aiimsbpl/July25/213
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief 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

Type 2 Diabetes

Keywords

Type 2 diabetes mellitus, MASLD, Overweight, Glycaemic effectivness

Outcome Measures

Primary Outcomes (2)

• Change in HbA1c from baseline at 6 months

  From enrollment to the end of treatment at 6 months

• Change in weight from baseline at 6 months

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (14)

• Change in HbA1c (%) from baseline at 3 months

  From enrollment to the end of treatment at 3 months

• Change in FBG (mg/dL) from baseline at 6 months

  From enrollment to the end of treatment at 6 months

• Change in ALT from baseline at 6 months

  From enrollment to the end of treatment at 6 months

• Changes in LSM from baseline at 6 months

  From enrollment to the end of treatment at 6 months

• Change in SBP (mmHg) from baseline at 6 months

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Group A

EXPERIMENTAL

Dapagliflozin 10 mg given once daily per orally for 6 months

Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy

Group B

EXPERIMENTAL

Empagliflozin 25mg given once daily per orally for 6 months

Drug: Empagliflozin (25 Mg Tab) along with standard medical therapy

Interventions

Dapagliflozin (10Mg Tab) along with standard medical therapy DRUG

Group A: Dapagliflozin 10 mg once daily + Metformin ± OHAs

Group A

Empagliflozin (25 Mg Tab) along with standard medical therapy DRUG

Group B: Empagliflozin 25 mg once daily + Metformin ± OHAs

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Bhavya Bhavya, MD: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight

Interventions

dapagliflozin; Tablets; empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: SENIOR RESIDENT

Model Details: This will be a prospective, randomized, open-label, parallel-group single-centre clinical trial

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 31, 2025
• Study Start: December 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12