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CTRI Number  CTRI/2024/11/076387 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of oral Semaglutide vs Dapagliflozin on liver fat in patients with Type 2 Diabetes. 
Scientific Title of Study   Effect of oral Semaglutide vs Dapagliflozin on hepatic steatosis in patients with Type 2 Diabetes mellitus and Metabolic dysfunction-associated steatotic liver disease – a pilot 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  Surbhi gupta  
Designation  DNB RESIDENT YEAR 1 
Affiliation  max hospital saket 
Address  ENDOCRINE DEPARTMENT MAX hospital, superspeciality hospital, saket, new delhi
max hospital,superspeciality hospital, saket, new delhi
South
DELHI
110017
India 
Phone  09306007419  
Fax    
Email  surbhigupta20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ambrish Mithal 
Designation  principal director and head, department of endocrinology 
Affiliation  max hospital saket 
Address  ENDOCRINE DEPARTMENT EAST BLOCK max hospital, superspeciality hospital, saket, new delhi max hospital,superspeciality hospital, saket, new delhi
max hospital, superspeciality hospital, saket, new delhi max hospital,superspeciality hospital, saket, new delhi
South
DELHI
110017
India 
Phone  9811019093  
Fax    
Email  ambrishmithal@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ambrish Mithal 
Designation  principal director and head, department of endocrinology 
Affiliation  max hospital saket 
Address  ENDOCRINE DEPARTMENT EAST BLOCK. max hospital, superspeciality hospital, saket, new delhi max hospital,superspeciality hospital, saket, new delhi
max hospital, superspeciality hospital, saket, new delhi max hospital,superspeciality hospital, saket, new delhi
South
DELHI
110017
India 
Phone  9811019093  
Fax    
Email  ambrishmithal@hotmail.com  
 
Source of Monetary or Material Support  
max hospital superspeciality, saket, new delhi, INDIA. 110017 
 
Primary Sponsor  
Name  surbhi gupta  
Address  max hospital, superspeciality hospital, saket, new delhi max hospital,superspeciality hospital, saket, new delhi, INDIA 110017 
Type of Sponsor  Other [self- SURBHI GUPTA] 
 
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 Ambrish Mithal  max hospital saket  ENDOCRINE DEPARTMENT EAST BLOCK max hospital, superspeciality hospital, saket, new delhi max hospital,superspeciality hospital, saket, new delhi
South
DELHI 
9811019093

ambrishmithal@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
instiution ethic committee, devki devi foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  dapagliflozin  10 mg once a day orally for 6 months 
Intervention  rybelsus  rybelsus 14 mg once a day orally for 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  both male and female are eligible
Non pregnant patients with T2D above the age of 18 years with documented hepatic steatosis transient elastography CAP more than 275 db per m with the following criteria
T2D patients with Hba1c more than 7 percent
Ability and willingness to provide informed consent

 
 
ExclusionCriteria 
Details  age less than 18 years and more than 100 age
Hba1c more than 10 percent
Current treatment with GLP1RA Pioglitazone SGLT2i Saroglitazar
History of congestive heart failure NYHA class 1 to 4
Irreversible medical conditions with predicted survival less than1 year
Alcohol consumption more than 14 units per week for women and more than 21 units per week for men
Severe hepatic impairment of any cause AST or ALT
more than 5 times the upper limit of normal
Evidence of other forms of liver disease including hepatitis B hepatitis C and autoimmune hepatitis
History of use of drugs known to cause hepatic steatosis methotrexate amiodarone valproate steroids
History of pancreatitis
Family history of thyroid cancer
Pregnant patients
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study and compare the effect of semaglutide and dapagliflozin over 6 months in reducing liver fat and fibrosis in patients with T2D and MASLD by using TE.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study and compare the effect of semaglutide and dapagliflozin on changes in liver indices: FIB-4, FAST, AGILE 3+score.
2. To study and compare the effect of semaglutide and dapagliflozin on changes in laboratory parameters (transaminases, FPG, HbA1c, UACR, lipid profile).
3. To study and compare the effect of semaglutide and dapagliflozin on changes in Body Composition Analysis (BCA).
 
6 months 
1. To study and compare the effect of semaglutide and dapagliflozin on changes in liver indices: FIB-4, FAST, AGILE 3+score.
2. To study and compare the effect of semaglutide and dapagliflozin on changes in laboratory parameters (transaminases, FPG, HbA1c, UACR, lipid profile).
3. To study and compare the effect of semaglutide and dapagliflozin on changes in Body Composition Analysis (BCA).
 
6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   30/11/2024 
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="6"
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  

Metabolic dysfunction-associated steatotic liver disease (MASLD) and Metabolic dysfunction-associated steatohepatitis (MASH) have recently replaced the terms Non-alcoholic fatty liver disease (NAFLD) and Non-alcoholic steatohepatitis (NASH) (1). Studies suggest a nearly complete overlap (99%) between the MASLD-defined population and the historical NAFLD-defined population (2, 3). All recommendations in the American Association for the Study of Liver Diseases (AASLD) Practice Guidance on the clinical assessment and management of NAFLD can be applied to patients with MASLD (1). So, both the terms MASLD and MASH have been interchangeably used with NAFLD and NASH, respectively, in our study paper. MASLD is the most common chronic liver disease, affecting 17-47% of the population worldwide (4). MASLD/MASH has now become one of the most common indications for liver transplantation worldwide. Type 2 diabetes mellitus (T2D) is a major risk factor for MASLD and MASH since the prevalence of MASLD is as high as 30-75% among these patients (5-7). Patients with MASH have an increased risk of morbidity and mortality related to liver and cardiovascular disease compared with patients who have simple steatosis and the general population (8-10). Early detection of severe steatosis and significant fibrosis by noninvasive methods would be useful to allow early treatment of MASLD in high-risk patients with T2D. The strong association of MASH with metabolic syndrome provides a compelling rationale for the investigation of Glucagon-like peptide-1 receptor agonists (GLP1RA) that induce weight loss and insulin sensitivity. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are oral antidiabetic drugs that reduce hyperglycemia independently of insulin secretion by promoting glucosuria and weight loss (11). In animal studies, SGLT2i have been found to suppress the development of NAFLD /NASH (12).  Few human trials have investigated the effect of SGLT-2i on hepatic steatosis in patients with T2D and NAFLD (13, 14). In March 2024, a drug named Resmetirom was approved by the Food and Drugs Administration (FDA) for the treatment of patients with non-cirrhotic MASH and moderate to advanced hepatic fibrosis (15).  However, there has been a significant unmet medical need for effective and accessible treatment for MASLD.  Our study is an attempt to explore two drugs thatare routinely used in the treatment of T2D for the treatment of MASLD.

 

 
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