| 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
|
|
|
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
|
|
|
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. |