| CTRI Number |
CTRI/2025/03/082781 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Can the Combination of Dapagliflozin and Pioglitazone in Non Alcoholic Fatty Liver Disease with Type2 Diabetes Mellitus patients will have similar effect as Dapagliflozin or Pioglitazone alone? |
|
Scientific Title of Study
|
A Comparative study on the effect of Dapagliflozin, Pioglitazone and a combination of Dapagliflozin and Pioglitazone in Non Alcoholic Fatty Lliver Disease patients 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 |
Dr Bolisetty Tulasi Devi |
| Designation |
Post Graduate student |
| Affiliation |
IMS and SUM hospital |
| Address |
Demo room (near opd), Department of General Medicine, Ground floor, IMS and SUM Hospital, K8, Kalinganagar, Bhubaneswar, Khordha, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9618676365 |
| Fax |
9937063390 |
| Email |
lassy.bolisetty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandan Das |
| Designation |
Professor, Department of General Medicine |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
Department of General Medicine, fourth floor, IMS and SUM Hospital, K8, Kalinga nagar, Bhubaneswar, Khordha, Odisha, India.
Khordha
ORISSA
751003
India |
| Phone |
9937063390 |
| Fax |
9937063390 |
| Email |
drchandan1204@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bolisetty Tulasi Devi |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
Demo room (near Out Patient Department) Department of General Medicine, Ground floor, IMS and SUM Hospital, K8, Kalinga nagar, Bhubaneswar, Khordha, Odisha, India.
Khordha
ORISSA
751003
India |
| Phone |
9618676365 |
| Fax |
|
| Email |
lassy.bolisetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF GENERAL MEDICINE AND DEPARTMENT OF GASTROENTEROLOGY, 4th floor, IMS and SUM Hospital, K8, Kalinga nagar, Bhubaneshwar, Khordha, Odisha, India 751003 |
|
|
Primary Sponsor
|
| Name |
BOLISETTY TULASI DEVI |
| Address |
Demo room (near opd), Department of General Medicine, Ground floor, IMS and SUM Hospital, K8, Kalinga nagar, Bhubaneswar, Khordha, Odisha, India 751003 |
| 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 |
| Dr Bolisetty Tulasi Devi |
IMS and SUM HOSPITAL |
Discussion room (near Out Patient Department), Ground floor, Department of General Medicine, K8, Kalinga nagar, Bhubaneswar, Khordha, Odisha 751003
Khordha
ORISSA |
9618676365
lassy.bolisetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K742||Hepatic fibrosis with hepatic sclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DAPAGLIFLOZIN and PIOGLITAZONE |
patients of non alcoholic fatty live disease with type 2 diabetes will be divided into 3 groups by randomisation. After randomisation, one study group will receive Dapagliflozin, one group will receive Pioglitazone, one study group will receive both Dapagliflozin and Pioglitazone of dose 10mg and 15mg respectively |
| Comparator Agent |
DAPAGLIFLOZINE |
Dose of 10mg frequency- once daily, route of administration- oral, duration- 3 months |
| Comparator Agent |
PIOGLITAZONE |
dose 15mg, frequency- once daily, route of administration- oral, duration- 3months. Effect of these drugs through various liver parameters and HbA1c will be studied in all the 3 groups after 3 months and compared with each other |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
presence of fatty liver on ultrasound with deranged liver enzymes who are known cases of non alcoholic fatty liver disease spectrum
with type 2DM and HbA1c of more than 6.5 |
|
| ExclusionCriteria |
| Details |
patients of chronic or viral hepatitis B or C infection, significant alcohol intake of more than 30g in males and 20g per day in females after converting to ethanol, cases with history of hepatotoxic drugs, drugs leading to hepatic fibrosis or drugs supposed to decrease hepatic fibrosis like omega 3 fatty acids, vitamin E, UDCA, saroglitazar, pioglitazone, GLP1 agonists, documented cases of autoimmune hepatitis, hepatic storage or hereditary diseases, Wilsons, hemochromatosis will be excluded. patients with severe renal dysfunction, ischemic heart disease, heart failure with NYHA grade 3 at present or past, complicated UTI or pyelonephritis, Pregnant and lactating females will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Liver stiffness measurement score by Transient elastography, SGOT, SGPT, TPC, APRI, FIB 4, NAFLD FIBROSIS SCORE |
once before initiating the drug and once after completion of 3 months course |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HbA1c |
3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
31/03/2025 |
| 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="0"
Months="5"
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
|
aim- TO COMPARE THE EFFECT OF DAPAGLIFLOZIN, PIOGLITAZONE AND A COMBINATION OF DAPAGLIFLOZIN AND PIOGLITAZONE ON STEATOSIS AND FIBROSIS IN NON ALCOHOLIC FATTY LIVER DISEASE PATIENTS WITH TYPE 2 DIABETES MELLITUS
objective- to evaluate and compare the effect of dapagliflozin, pioglitazone, and combination of both these drugs in patients of non alcoholic fatty liver disease with type 2 diabetes
drug- Dapagliflozin 10mg which is a SGLT2 inhibitor, Pioglitazone 15mg which is Thiazolinedione
patients of NAFLD with type 2 diabetes are taken and they are randomised into 3 groups. one group will receive dapagliflozin 10mg once daily, the 2nd group will receive pioglitazone 15mg once daily, 3rd group will receive a combination of both dapagliflozin 10mg and pioglitazone 15mg once daily for 3 months. The effect of drugs in the 3 groups will be evaluated and compared after 3 months using different liver parameters |