FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071087 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 10/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Dapagliflozin and Pioglitazone for Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes 
Scientific Title of Study   A Comparitive study of Dapagliflozin Vs Pioglitazone in Patients of Non Alcoholic Fatty liver disease with Type 2 Diabetes Mellitus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Babra 
Designation  Junior Resident 
Affiliation  Eras Lucknow Medical College 
Address  Department Of Pharmacology 5th floor Eras Lucknow Medical College Sarfarazganj Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9469892171  
Fax    
Email  babrashafi0109@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Fardan Qadeer 
Designation  Associate Professor 
Affiliation  Eras Lucknow Medical College 
Address  Department of Pharmacology 5th floor Eras Lucknow Medical College Sarfarazganj Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9936671891  
Fax    
Email  fardan.lko@gmail.com  
 
Details of Contact Person
Public Query  
Name  Babra 
Designation  Junior Resident 
Affiliation  Eras Lucknow Medical College 
Address  Department Of Pharmacology 5th floor Eras Lucknow Medical College Sarfarazganj Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9469892171  
Fax    
Email  babrashafi0109@gmail.com  
 
Source of Monetary or Material Support  
Eras Lucknow Medical College and Hospital Sarfarazganj Lucknow Uttar Pradesh India 226003 
 
Primary Sponsor  
Name  Babra 
Address  Department of Pharmacology 5th floor Eras Lucknow Medical College Sarfarazganj Lucknow Uttar Pradesh India 226003 
Type of Sponsor  Other [Self] 
 
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 Babra  Eras Lucknow Medical College and Hospital  Department Of Pharmacology 5th floor Sarfarazganj Lucknow
Lucknow
UTTAR PRADESH 		 9469892171

babrashafi0109@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ELMCH,Era University,Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, (2) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DAPAGLIFLOZIN  An inhibitor of sodium glucose co transporter 2, and is responsible for reducing renal tubular glucose reabsorption. DOSE : 10 mg/day OD  
Comparator Agent  PIOGLITAZONE  Is an oral drug that is a part of thiazolidinedione class and approved to treat type 2 diabetes mellitus, works by stimulating nuclear receptor known as PPAR-gamma DOSE : 7.5 mg/day OD 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 NAFLD Fibrosis Score(Stage 1 to Stage 3)
2 USG (Grade 2 & Grade 3 fatty liver)
3 HbA1C 6.5% & above
4 BMI 23 kg/m² & above
5 Type 2 diabetes mellitus patient on treatment of metformin (upto 2g/day)
 
 
ExclusionCriteria 
Details  1 Patient with heart failure, kidney failure, malignancy
2 Pregnant & Lactating mothers
3 Habitual drinkers
4 Contraindication to dapagliflozin and pioglitazone
5 Use of steroid &/ or other immunosuppressor
6 H/o mental illness or inability to co operate
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Achieving the target level of HbA1C 6.5%


 		 3 week 6 week 12 week


 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome:
• Assessment of glycemic control (HbA1c) in participants.
• Adverse events of Dapagliflozin and Pioglitazone in study population.
 		 3,6,12th week 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   01/08/2024 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [BABRASHAFI0109@GMAIL.COM].

  6. For how long will this data be available start date provided 01-08-2024 and end date provided 29-03-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

TITLE: A COMPARATIVE STUDY OF  DAPAGLIFLOZIN VS PIOGLITAZONE IN PATIENTS OF NON ALCOHOLIC FATTY LIVER DISEASE WITH TYPE 2 DIABETES MELLITUS
BACKGROUND: NAFLD Is a condition in which excess fat builds up in the liver.This buildup of fat is not caused by heavy alcohol use. DAPAGLIFLOZIN
An inhibitor of sodium-glucose co-transporter 2 (SGLT2),decreases blood glucose levels without the use of insulin by improving renal glucose excretion. PIOGLITAZONE Is an oral drug It works by stimulating nuclear receptors known as peroxisome proliferator-activated receptor gamma(PPAR-γ) and modifies gene expression through binding to PPAR-γ, which has several consequences.
MATERIAL AND METHODS: The study employed a prospective, randomized, open-label design and was conducted at ERA’S Lucknow Medical College & Hospital, with collaboration from the Department of Pharmacology, Medicine, and Radiology. It involved a total sample size of 108 patients, evenly distributed with 54 patients in each group. The study continued for a duration of 18 months

 
Close