| CTRI Number |
CTRI/2023/12/060736 [Registered on: 26/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Drug trial between Dapagliflozin with existing drug Saroglitazar in patients with Non alcoholic fatty liver disease and diabetes |
|
Scientific Title of Study
|
Prospective randomised study of therapeutic effects of Saroglitazar and Dapagliflozin in patients with type 2 diabetes mellitus and Non Alcoholic Fatty 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 Deepthi V |
| Designation |
Post Graduate General medicine |
| Affiliation |
Saveetha medical college |
| Address |
Room number LC 341
Department of General medicine Saveetha medical college
Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9003952904 |
| Fax |
|
| Email |
vakatideepthi@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kannan R |
| Designation |
Professor General Medicine |
| Affiliation |
Saveetha medical college |
| Address |
Department of General Medicine
Saveetha medical college
Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9710071284 |
| Fax |
|
| Email |
endork@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepthi V |
| Designation |
Post Graduate General medicine |
| Affiliation |
Saveetha medical college |
| Address |
Room number LC 341
Department of General Medicine Saveetha medical college
Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9003952904 |
| Fax |
|
| Email |
vakatideepthi@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Deepthi v |
| Address |
Saveetha medical college Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai-602105 |
| Type of Sponsor |
Other [Primary investigator ] |
|
|
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 Deepthi V |
Saveetha Medical college |
Department of General medicine
Saveetha medical college
Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU |
9003952904
vakatideepthi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical college and hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dapagliflozin |
10 mg OD for 14 weeks |
| Comparator Agent |
Saroglitazar |
4 mg OD for 14 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with NAFLD diagnosed on ultrasonography
2.HbA1C>6.5%
3.BMI>25
4.Willingness to comply with all protocol required evaluations
|
|
| ExclusionCriteria |
| Details |
1.Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilsons disease, hemochromatosis, etc.).
2. Average alcohol consumption greater than equal to 21 drinks per week formen, greater than
equal to 14 drinks per week for women in the 6 months before enrollment.
3.The patients who already used medications known to cause hepatic steatosis for more than two weeks in the past year such as mipomersen, lomitapide, amiodarone, methotrexate, tamoxifen, corticosteroid, valproate,
antiretroviral medicines.
4.Presence of alternative cause of fatty liver, including Total Parenteral Nutrition,
Starvation, Lipodystrophy, -Abetalipoproteinemia, Acute fatty liver of pregnancy, HELLP syndrome, Reye’s syndrome. Clinical, imaging, or histological evidence of cirrhosis.
5.Use of drugs with a potential effect on NASH such as ursodeoxycholic acid, vitamin E, pioglitazone.
6.Pregnant or lactating female. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NAFLD fibrosis score |
0,14 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum lipid profile |
0,14 weeks |
| AST,ALT |
0,14 weeks |
| Liver shear wave elastography |
0,14 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/01/2024 |
| 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="1"
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
|
NAFLD has become a major cause of chronic liver disease and is treated as public health priority. NAFLD is often observed in patients with type 2 DM and NAFLD. Therapeutic options for management of NAFLD are limited and include lifestyle modifications, antioxidants and insulin sensitizers. Saroglitazar is a dual peroxisome proliferator activated receptors activator. Saroglitazar is the first drug approved in India for management of diabetic dyslipedemia. Dapagliflozin is a Sodium glucose cotransporter 2 inhibitor. Body weight reduction is the first line recommendation in NAFLD patients. Dapagliflizin has a strong potential to reduce body weight. We plan to study the efficacy of Saroglitazar in comparison to Dapagliflozin in NAFLD patients having type 2 DM.
Materials and methods : A prospective randomised study on therapeutic effects of saraglitazar and dapagliflozin in patients having NAFLD with type 2 Diabetes presenting to Saveetha Medical College Hospital between June 1, 2023 and June 1, 2024. NAFLD patients having Type 2 diabetes mellitus will be divided into 2 groups: A) Will be administered Saroglitazar 4mg/day for 14 weeks
B) Will be administered Dapogliflozin 10 mg/day for 14 weeks The participants will be subjected to the following tests Blood tests: AST, ALT, serum lipid profile, HbA1C, FBS,PPBS, platelet count, albumin Liver shear wave elastography
Anthropometry – Body weight, BMI, Waist circumference
A comparison of therapeutic effects of saroglitazar and dapagliflozin will be made by assessing above mentioned parameters at baseline and after 14 weeks
To our knowledge, this study works to adds a new indication for dapagliflozinnin the treatment of NAFLD. Our current work aims to compare the associations of the (Nonalcoholic fatty liver disease) NAFLD with Type 2 Diabetes Mellitus and dyslipidemia (DL). The factors associated with Type 2 DM, DL, NAFLD are to be analyzed. Also, the safety of both drugs (Dapagliflozinnand Saroglitazar) are compared on NAFLD in diabetes dyslipidemic patients. The efficacies of both the drugs in lowering the lipid profile and glucose levels will be monitored. This study investigates biomarkers for glycemic control (hemoglobin A1c and random blood glucose, insulin), lipid metabolism (triglycerides, total cholesterol, high-density lipoprotein [HDL], and low-density lipoprotein [LDL]), albumin, and hepatic cholestasis (gamma-glutamyl transferase [GGT]) in NAFLD. Its mean purpose was to determine whether these biomarkers could detect improvement in progression of NAFLD in Diabetic dyslipidemic patients receiving Dapagliflozin and Saroglitazar.
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