| CTRI Number |
CTRI/2025/08/093475 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Compare the Efficacy of Dapagliflozin and Teneligliptin on Liver Fat and Metabolism in People with Type 2 Diabetes and Fatty Liver Disease. |
|
Scientific Title of Study
|
A Open-label Randomized controlled trial to compare the efficacy of Dapagliflozin and Teneligliptin on liver fat reduction and on Metabolic Parameters in type 2 Diabetes patients with MAFLD" |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaideep CK |
| Designation |
Junior resident |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
AIIMS Bibinagar
Department of Pharmacology.
4th floor Academic block
BIBINAGAR.
NALGONDA.
Nalgonda
TELANGANA
508126
India |
| Phone |
8921153422 |
| Fax |
|
| Email |
ckjaideep198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debasis Bisoi |
| Designation |
Associate professor |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
AIIMS Bibinagar
Department of Pharmacology
4th floor,Academic block
BIBINAGAR
NALGONDA.
Nalgonda
TELANGANA
508126
India |
| Phone |
9437213656 |
| Fax |
|
| Email |
bisoidebasis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaideep CK |
| Designation |
Junior resident |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
AIIMS Bibinagar.
Department of pharmacology
BIBINAGAR
NALGONDA.
Nalgonda
TELANGANA
508126
India |
| Phone |
8921153422 |
| Fax |
|
| Email |
ckjaideep198@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Jaideep CK |
| Address |
AIIMS Bibinagar
Department of Pharmacology
4th floor Admin block
HYDERABAD METROPOLITAN REGION
TELANGANA 508126 |
| 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 |
| Jaideep CK |
AIIMS Bibinagar |
Department of pharmacology and general medicine,radiology.
Hyderabad metropolitan region
Telangana 508126
Nalgonda
TELANGANA |
08921153422
ckjaideep198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BIBINAGAR IEC |
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.
|
Dapagliflozin OD for 12 week
|
| Comparator Agent |
Teneligliptin |
Teneligliptin 20 mg OD for 12 weeek |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults Patients aged 20–65 years diagnosed with MAFLD giving written informed
consent .
T2DM patient with MAFLD eligible for treatment with Dapagliflozin or Teneligliptin .
Diagnosed with MAFLD based on imaging evidence of hepatic steatosis and metabolic dysfunction. |
|
| ExclusionCriteria |
| Details |
Type 1 diabetic mellitus
History of other chronic liver disease Eg Viral hepatitis autoimmune hepatitis alcohol related liver disease.
History of chronic kideny disease, eGFR less than 30 ml per min per 1.73m2.
History of alcohol intake more than 30 mg/day in men,more than 20mg/day in women.
Pregnancy or lactation
History of ischemic heart disease.
Cognitively impaired.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the liver fat content measured by USG. |
12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in glycemic parameter.LFT,Lipid profile,BP,BMI. |
12 week |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
11/09/2025 |
| 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)
|
Open to Recruitment |
| 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
|
This Open-label, randomized controlled trial will compare the efficacy of dapagliflozin and teneligliptin on liver fat reduction and metabolic parameters in patients with Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD). MAFLD is a prevalent liver condition strongly associated with metabolic disorders such as diabetes, obesity, and hypertension. While both dapagliflozin (SGLT2 inhibitor) and teneligliptin (DPP-4 inhibitor) are used for diabetes, emerging evidence suggests they may have additional benefits on liver health. This study aims to evaluate and compare the impact of these drugs on liver fat content, blood sugar levels, body mass index, liver enzymes, and blood pressure over three months. The findings could guide better treatment strategies for MAFLD in the Indian population. |