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CTRI Number  CTRI/2025/12/099490 [Registered on: 19/12/2025] Trial Registered Prospectively
Last Modified On: 15/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Use of dapagliflozin in diabetes patients with fatty liver disease 
Scientific Title of Study   Study of Efficacy and Safety of Dapagliflozin on Metabolic Parameters in Patients of Type II Diabetes with Metabolic Dysfunction-Associated Steatotic Liver Disease  
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 Vishal Roy 
Designation  Junior resident 
Affiliation  MGM Medical College and Hospital, Chhatrapati Sambhaji Nagar(Aurangabad), Maharashtra 
Address  MGM Medical College and Hospital, Department of Pharmacology, Chhatrapati Sambhaji Nagar(Aurangabad), Maharashtra Pin Code-431003

Aurangabad
MAHARASHTRA
431003
India 
Phone  8264540699  
Fax    
Email  vishalroy3101998@gamil.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepak Bhosle 
Designation  Professor and Head of Department 
Affiliation  MGM Medical College and Hospital, Chhatrapati Sambhaji Nagar(Aurangabad), Maharashtra 
Address  MGM Medical College and Hospital, Department of Pharmacology, Chhatrapati Sambhaji Nagar(Aurangabad), Maharashtra Pin Code-431003

Aurangabad
MAHARASHTRA
431003
India 
Phone  9422212062  
Fax    
Email  drdeepakbhosle@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishal Roy 
Designation  Junior resident 
Affiliation  MGM Medical College and Hospital, Chhatrapati Sambhaji Nagar(Aurangabad), Maharashtra 
Address  MGM Medical College and Hospital, Department of Pharmacology, Chhatrapati Sambhaji Nagar(Aurangabad), Maharashtra Pin Code-431003

Aurangabad
MAHARASHTRA
431003
India 
Phone  8264540699  
Fax    
Email  vishalroy3101998@gamil.com  
 
Source of Monetary or Material Support  
MGM Medical College and Hospital, Chhatrapati Sambhaji Nagar(Aurangabad),Maharashtra Pin code-431003 
 
Primary Sponsor  
Name  Dr. Vishal Roy 
Address  MGM Medical College and Hospital, Department of Pharmacology, Chhatrapati Sambhaji Nagar(Aurangabad),Maharashtra Pin code-431003 
Type of Sponsor  Other [Self] 
 
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 Vishal Roy  MGM Hospital  MGM Hospital, General Medicine OPD Room no.17
Aurangabad
MAHARASHTRA 
8264540699

vishalroy3101998@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Mission Educational Campus – Institutional Ethics Committee for Human Studies (MGM-ECRHS)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dapagliflozin  10mg once daily for 6 months through oral route. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either gender between age group of 18 to 65 years
2. Individuals with BMI more than 25 kg per square meter
3. Patient with known diabetes with HbA1C between 6.5 to 8.5 percent
4. Patients with FIB 4 score more than 1.4
5. Patient having deranged CAP or LSM value on fibroscan
6. Patient willing to participate in the study and give written informed consent
 
 
ExclusionCriteria 
Details  1. Patients with significant alcohol consumption per day male 30 grams per day female 20 grams per day
2. Patient on any medication known to affect weight in last 3 months
3. Patients having history of hepatic dysfunction
4. Patient having thyroid dysfunction
5. Patients taking any concurrent medications known to affect liver enzymes
6. Patient showing intolerance to dapagliflozin
7. Patients having recurrent urinary tract infection
8. Pregnant and lactating women
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in BMI, HbA1c, lipid profile, FIB-4, CAP, LSM   At baseline and 24 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   02/01/2026 
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)  Not Yet Recruiting 
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  

Background
Metabolic dysfunction associated steatotic liver disease formerly called non alcoholic fatty liver disease is a common condition caused by accumulation of fat in the liver linked to obesity, insulin resistance and type 2 diabetes mellitus. It affects around thirty percent of the global population and nearly one fifth of adults in India. People with metabolic risk factors are more prone to develop this disease. The condition can progress to steatohepatitis, fibrosis and even liver cancer. Dapagliflozin, a sodium glucose cotransporter 2 inhibitor, has shown benefits beyond glucose control by reducing liver enzymes, body weight, triglycerides and improving insulin sensitivity. This suggests its potential role in managing metabolic dysfunction associated steatotic liver disease.

Purpose of the study
The study aims to evaluate the efficacy and safety of dapagliflozin ten milligram once daily on metabolic parameters in patients with type two diabetes and metabolic dysfunction associated steatotic liver disease. It will assess its effect on blood glucose levels, lipid profile, body weight, body mass index, liver fibrosis markers such as FIB four, CAP and LSM, and overall liver function. Adverse effects and tolerability will also be monitored.

In summary, this is a phase four prospective open label single arm interventional study conducted at MGM Medical College and Hospital, Chhatrapati Sambhaji Nagar, to explore the metabolic and liver protective benefits of dapagliflozin in diabetic patients with metabolic dysfunction associated steatotic liver disease.

 
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