| 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
|
|
|
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
|
|
|
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.
|