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CTRI Number  CTRI/2025/01/079703 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 05/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   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 
Scientific Title of 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. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rimple Jeet Kaur 
Designation  Associate Professor, Pharmacology 
Affiliation  AIIMS Jodhpur 
Address  Department of pharmacology, second floor, AIIMS college, gate no:5 AIIMS Jodhpur Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9784525975  
Fax    
Email  sidhurimple@yahoo.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Rimple Jeet Kaur 
Designation  Associate Professor, Pharmacology 
Affiliation  AIIMS Jodhpur 
Address  Department of pharmacology, second floor, AIIMS college, gate no:5 AIIMS Jodhpur Rajasthan 342005


RAJASTHAN
342005
India 
Phone  09784525975  
Fax    
Email  sidhurimple@yahoo.com   
 
Details of Contact Person
Public Query  
Name  Dr Yuvan Shankar S P 
Designation  Junior Resident, Pharmacology 
Affiliation  AIIMS Jodhpur 
Address  Department of pharmacology, second floor, AIIMS college, gate no:5 AIIMS Jodhpur Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  09445044902  
Fax    
Email  yuvanshankar35@hotmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Jodhpur, Basni, Jodhpur, Rajasthan 342 005, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur, Rajasthan 
Address  AIIMS college gate no: 5, Basni Phase 2 Rajasthan 342005 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yuvan Shankar S P  All India Institute of Medical Sciences Jodhpur, Rajasthan  Room no: 250, Department of pharmacology, AIIMS Medical college building, AIIMS Jodhpur, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN 		 9445044902

yuvanshankar35@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Metformin + Dapagliflozin  Metformin 1000 mg OD plus dapagliflozin 10 mg BD for 3 months as per the standard treatment guidelines in patients of T2DM 
Comparator Agent  Metformin + Semaglutide  Metformin 1000 mg OD plus semaglutide 3mg OD (if tolerated, can be increased up to 14 mg in 2-4 weeks) for 3 months as per the treating physician 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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) 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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 group  Baseline and at 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the change in HbA1c between metformin plus dapagliflozin group and metformin plus semaglutide group  Baseline and at 3 months 
To compare the change in fasting blood glucose between metformin plus dapagliflozin group and metformin plus semaglutide group  Baseline and at 3 months 
To compare the change in postprandial blood glucose between metformin plus dapagliflozin group and metformin plus semaglutide group  Baseline and at 3 months 
To compare the change in liver function tests between metformin plus dapagliflozin group and metformin plus semaglutide group  Baseline and at 3 months 
To compare the change in renal function tests between metformin plus dapagliflozin group and metformin plus semaglutide group  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 group  Baseline and at 3 months 
To compare the change in anthropometrical measurements between metformin plus dapagliflozin group and metformin plus semaglutide group  Baseline, at 1 month, 2 months and 3 months 
To compare the change in BMI between metformin plus dapagliflozin group and metformin plus semaglutide group  Baseline and at 3 months 
To compare the change in calf muscle circumference between metformin plus dapagliflozin group and metformin plus semaglutide group  Baseline and at 3 months 
To compare the incidence of side effects between metformin plus dapagliflozin group and metformin plus semaglutide group  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 group  Baseline and at 3 months 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   12/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Title of study is “Comparison of Effect of Metformin Plus Dapagliflozin Vs. Metformin Plus Semaglutide on Lean Body Mass And Muscle Strength In T2DM” It aims to compare the effects of two treatment regimens—metformin plus dapagliflozin versus metformin plus semaglutide—on lean body mass (LBM) and muscle strength in patients with type 2 diabetes mellitus (T2DM). 
PICOT Population: Adults (40-60 years) diagnosed with T2DM Intervention: Metformin + dapagliflozin Comparison: Metformin + semaglutide 
Outcome: Changes in lean body mass and muscle strength, and other biochemical parameters. 
Timeframe: 3 months 
Research Question: How do metformin combined with dapagliflozin versus metformin combined with semaglutide affect lean body mass and muscle strength in patients with T2DM over 3 months? 
Aims and Objectives: 
The primary aim is to compare lean body mass and muscle strength between the two treatment groups with DEXA scan.
Secondary objectives include comparing biochemical and physical parameters ((HbA1c, fasting and postprandial blood glucose levels, LFT, RFT, serum creatinine:cystatin C ratio, anthropometry, BMI, calf muscle measure) side effects, muscle strength using RMS of surface EMG and handgrip dynamometry, and muscle thickness using USG guided method between same 2 groups. 
Inclusion and Exclusion Criteria Inclusion: Patients aged 40-60 with T2DM, HbA1C between 7% and 10%, on metformin. Exclusion: Patients with type 1 diabetes, chronic kidney disease, steroid use, pregnancy, malignancy, or other muscle-affecting disorders, previously on SGLT-2i or GLP-1 analogues, patients with diabetes for >15 years. 
Expected Outcomes The study anticipates significant differences in LBM and muscle strength between the two groups. It is hypothesized that metformin with GLP-1 analogues may better preserve LBM and muscle strength compared to the metformin and SGLT-2 inhibitor combination, which may lead to LBM reduction. The results will guide more holistic treatment approaches for T2DM patients.
 
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