Comparison of effect of different blood sugar lowering agent combinations (metformin and dapagliflozin vs metformin and semaglutide) on body fat percentage and muscle strength in patients with diabetes: A Randomized Controlled study

Comparison of effect of metformin plus Dapagliflozin Vs Metformin plus semaglutide on lean body mass and muscle strength in T2DM: A Randomized Controlled Trial. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079703

Enrollment

Registered

2025-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Metformin + Dapagliflozin: Metformin 1000 mg OD plus dapagliflozin 10 mg BD for 3 months as per the standard treatment guidelines in patients of T2DM Control Intervention1: Metformin +

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed case of T2DM with HbA1C between 7% and 10%, and taking metformin but blood sugar uncontrolled and requires addition of another oral hypoglycemic agent (dapagliflozin or semaglutide)

Exclusion criteria

Exclusion criteria: Pregnancy, type 1 diabetes mellitus, Malignancy patients on steroids or immune suppressants over long duration that is for more than 3 months, patients on exogenous insulin, patients previously on SGLT2 inhibitors or GLP1 analogues, patients having T2DM for more than 15 years, patients with chronic kidney disease that is with eGFR less than 30, patients with eating OR autoimmune OR thyroid OR muscle disorders, patients with Human Immunodeficiency Virus infection

Design outcomes

Primary

Measure	Time frame
To compare the change in lean body mass and muscle strength assessed by DEXA Scan and hand grip dynamometer between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months	—

Secondary

Measure	Time frame
To compare the change in HbA1c between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in fasting blood glucose between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in postprandial blood glucose between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in liver function tests between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in renal function tests between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in serum creatinine to cystatin C ratio between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in anthropometrical measurements between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline, at 1 month, 2 months and 3 months;To compare the change in BMI between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in calf muscle circumference between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the incidence of side effects between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in lean body mass composition assessed by bioelectric impedance analysis between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months	—

Measure

Time frame

To compare the change in HbA1c between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in fasting blood glucose between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in postprandial blood glucose between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in liver function tests between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in renal function tests between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in serum creatinine to cystatin C ratio between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in anthropometrical measurements between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline, at 1 month, 2 months and 3 months;To compare the change in BMI between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in calf muscle circumference between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the incidence of side effects between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months;To compare the change in lean body mass composition assessed by bioelectric impedance analysis between metformin plus dapagliflozin group and metformin plus semaglutide groupTimepoint: Baseline and at 3 months

—

Countries

India

Contacts

Public ContactDr Yuvan Shankar S P

AIIMS Jodhpur

sidhurimple@yahoo.com09784525975

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026