| CTRI Number |
CTRI/2025/12/098255 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of effect of Dapagliflozin and Saroglitazar on FIB-4 score in patients with non- alcoholic fatty liver disease and Type 2 diabetes mellitus |
|
Scientific Title of Study
|
Impact of Dapagliflozin in comparison with Saroglitazar on FIB-4 Score in Patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Type 2 Diabetes Mellitus: A Open-Label, Randomized controlled Study |
| 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 J S Kumar |
| Designation |
Associate Dean, PG academics, Professor & Head of General Medicine |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur 603203, Chengalpattu dist., India
Chennai
TAMIL NADU
603203
India |
| Phone |
9840047678 |
| Fax |
|
| Email |
kumarj1@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Jagadeesan |
| Designation |
Assistant professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur 603203, Chengalpattu dist., India
Chennai
TAMIL NADU
603203
India |
| Phone |
7449277556 |
| Fax |
|
| Email |
jagadeem1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Pooja C |
| Designation |
Pharm D, PG Student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur 603203, Chengalpattu dist., India
Chennai
TAMIL NADU
603203
India |
| Phone |
8946062956 |
| Fax |
|
| Email |
pc5409@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpattu District, Tamil Nadu - 603203, India |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpattu District, Tamil Nadu - 603203, India |
| Type of Sponsor |
Private medical college |
|
|
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 M Jagadeesan |
SRM Medical College Hospital and Research Centre |
Unit- 1, OPD, Department of General Medicine, SRM Institute of Science and Technology, Kattankulathur 603203, Chengalpattu dist., India
Chennai
TAMIL NADU |
74492 77556
jagadeem1@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Students, SRM Medical College Hospital & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dapagliflozin |
Dapagliflozin 10 mg once a day (Morning; after food) is given to the test group. |
| Comparator Agent |
Saroglitazar |
Saroglitazar 4 mg once a day (Morning; after food) is given to the control group. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Willing participants with
1. Age greater than 18 years
2. Newly diagnosed or previously diagnosed with type 2 diabetes mellitus (According to American Diabetes Association, HbA1c greater than 6.5 percentage, FBS greater than 126 mg/dl, PPBS greater than 200 mg/dl)
3. Evidence of fatty liver on ultrasound
4. BMI greater than or equal to 25 kg/m2 or waist circumference greater than 94 cm in men and greater than 80 cm in women
5. No history of alcohol consumption |
|
| ExclusionCriteria |
| Details |
1. Chronic hepatitis B or C
2. Individuals having type- 1 diabetes mellitus or individuals on insulin therapy
3. Drugs affecting MASLD such as vitamin E, pioglitazone, SGLT2 inhibitors, Saroglitazar and glucagon-like peptide 1 analogues
4. Patients on pharmacological or non-pharmacological treatment for weight loss and patients on intentional weight losing program
5. Liver diseases due to other etiologies like autoimmune liver disease, Wilsons’ disease etc., uncontrolled thyroid disease, active cardio-pulmonary disease or chronic kidney disease
6. Cirrhotic patients
7. Lactating and pregnant women
8. Patients who were known to have cardiac and renal disorders after medical history interview
9. History of mental illness or inability to cooperate with the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To assess the efficacy of Dapagliflozin in comparison with Saroglitazar.
•Reduction in FIB- 4 score. |
Baseline and at 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved Fatty liver index (FLI) score. |
Baseline & at 12th week |
| Reduction Controlled Attenuation Parameter (CAP) & Liver Stiffness Measurement (LSM). |
Baseline & at 12th week |
Improvement in the metabolic parameters mentioned as follows: -
1. Anthropometric measurements- Height (cm), weight (kg), BMI (kg/m2), waist circumference (cm).
2. Blood glucose level- Fasting blood sugar (mg/dl), HbA1c (percentage).
3. Liver function test- Aspartate Aminotransferase/ Serum Glutamate-Oxaloacetate Transaminase (AST/SGOT) (U/L), Alanine Aminotransferase/ Serum Glutamate-Pyruvate Transaminase (ALT/SGPT) (U/L), Gamma-Glutamyl Transferase (GGT) (U/L).
4. Lipid profile- Low-density lipoprotein cholesterol (LDL-C) (mg/dl), High-density lipoprotein cholesterol (HDL-C) (mg/dl), Triglycerides (TG) (mg/dl) |
Baseline & at 12th week |
| Improved health related quality of life of patients measured by the validated CLDQ-NAFLD questionnaires |
Baseline & at 12th week |
| Adherence/compliance to the medications with follow-up every month |
Baseline & at 12th week |
| Documenting the frequency of adverse events occurring during the study period |
Baseline & at 12th week |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
25/02/2026 |
| Date of First Enrollment (Global) |
15/12/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
1. Patients will be recruited from the hospital using the inclusion and exclusion criteria. 2. Patients meeting the inclusion criteria and giving voluntary consent will be included in the study. 3. Patients will randomly (Simple randomization) be allocated to either of the groups Dapagliflozin 10 mg once daily (Moming: after food) (Test group) or Saroglitazar 4 mg once daily (Morning; after food) (Control group). 4. The following laboratory parameters will be measured at baseline (Visit 0) and after l2 weeks (Visit l): -
a. Anthropometric measurements: Height (cm), weight (kg), BMI (kg/m2), waist circumference (cm) b. Blood glucose c. Liver function test d. Lipid profile e. Platelets count f. Fibroscan- Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM)
5. Using those values, Fibrosis-4 (FIB-4) index and FLI (Fatty liver index) will be calculated at baseline and at follow-up. 6. Quality of life will be assessed using a validated questionnaire CLDQ NAFLD (Chronic Liver Discase Questionnaire - Non-Alcoholic Fatty Liver Discase version) at baseline and at follow-up. 7. The compliance to medications will be measured by call or by face-to-face interview during the follow up. 8. If any adverse events are identified during the study, it will be reported. |