| CTRI Number |
CTRI/2020/02/023250 [Registered on: 11/02/2020] Trial Registered Prospectively |
| Last Modified On: |
31/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness and Safety of the drug Remogliflozin in diabetic patients with fat accumulation in liver |
|
Scientific Title of Study
|
Efficacy and Safety of Remogliflozin on Non-alcoholic fatty liver disease in diabetic patients on background Metformin therapy-A Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kshirsagar Shivani Prakash |
| Designation |
Post graduate student |
| Affiliation |
SRMMCH and RC |
| Address |
Department of Pharmacology SRMMCH and RC Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7875400129 |
| Fax |
|
| Email |
shivanikshirsagar22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Melvin George |
| Designation |
Associate professor |
| Affiliation |
SRM MCH and RC |
| Address |
Department of Clinical Pharmacology SRM MCH and RC Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894133697 |
| Fax |
|
| Email |
melvingeorge2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R Jamuna Rani |
| Designation |
Head of Department |
| Affiliation |
SRMMCH and RC |
| Address |
Department of Pharmacology SRMMCH and RC Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9840279010 |
| Fax |
|
| Email |
jrs_durai@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SRM MCH and RC Potheri Kattankulathur Kancheepuram district Tamilnadu India 603203
|
|
|
Primary Sponsor
|
| Name |
Kshirsagar Shivani Prakash |
| Address |
Department of Pharmacology SRMMCH & RC Kattankulathur |
| 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 |
| Kshirsagar Shivani Prakash |
SRM Medical college Hospital and Research centre |
Male and Female wards Deparment of Medicine First floor SRM hospital Kattankulathur
Kancheepuram
TAMIL NADU |
7875400129
shivanikshirsagar22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tablet Metformin |
Dose 500 mg
Twice daily
Oral route
6 weeks duration |
| Comparator Agent |
Tablet Metformin |
Dose 500 mg
Twice daily
Oral route
6 weeks duration |
| Intervention |
Tablet Remogliflozin Etabonate |
Dose 100 mg
Twice daily
Oral route
6 week duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Controlled Type 2 Diabetes Mellitus on Metformin therapy
Diagnosed with Non-Alcoholic Fatty liver disease
Fasting plasma glucose less than than 250 mg/dl
Willing to participate in the study and comply with it procedures by signing a written informed consent
|
|
| ExclusionCriteria |
| Details |
age less than 18 years and more than 75 years
Uncontrolled Diabetes Mellitus
Diabetic patients on Insulin therapy
Fasting plasma glucose more than 250 mg/dl
Viral Hepatitis
Autoimmune Hepatitis
Primary Billiary Cirrhosis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Aspartate transaminase
Alanine Transaminase |
0 week and 6 weeks
0 week and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fasting blood glucose |
0 week and 6 weeks |
| Body weight |
0 week and 6 weeks |
| Adverse drug reactions |
6 weeks |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/02/2020 |
| 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
|
The study details will be published in an indexed journal after the completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Drugs of the class SGLT2 inhibitors have shown to be efficacious in improving liver profile in non-alcoholic fatty liver disease. Preclinical studies of efficacy of Remogliflozin in Non alcoholic fatty liver disesase are available.Hence this study is being done to study the efficacy and safety of Remogliflozin on Non alcoholic fatty liver disease in diabetic patients on metformin therapy. |