| CTRI Number |
CTRI/2019/03/017915 [Registered on: 05/03/2019] Trial Registered Prospectively |
| Last Modified On: |
01/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of a drug,dapagliflozin in type 2 diabetic mellitus patient having diabetic macular edema |
|
Scientific Title of Study
|
Effect of sodium glucose cotransporter 2 inhibitors on diabetic macular edema in patient with type 2 diabetes mellitus-a prospective randomnized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Bhansali |
| Designation |
Professor & Head , Department of Endocrinology |
| Affiliation |
Postgraduate Institute of Medical Education and Research,Chandigarh-12. |
| Address |
Department of Endocrinology ,Postgraduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9478111956 |
| Fax |
01722744401 |
| Email |
anilbhansaliendocrine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Bhansali |
| Designation |
Professor & Head , Department of Endocrinology |
| Affiliation |
Postgraduate Institute of Medical Education and Research,Chandigarh-12. |
| Address |
Department of Endocrinology ,Postgraduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9478111956 |
| Fax |
01722744401 |
| Email |
anilbhansaliendocrine@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ningombam Sashikanta Singh |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research,Chandigarh-12. |
| Address |
Department of Endocrinology, Postgraduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8414825032 |
| Fax |
|
| Email |
sashizden@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh - 12 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| Address |
Postgraduate Institute of Medical Education and Research ,Sector 12 ,Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Bhansali |
Advance Eye Centre OPD and Department of Endocrinology OPD |
Postgraduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH |
9478111956
anilbhansaliendocrine@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tablet Dapagliflozin |
Tab Dapagliflozin 10 mg once daily orally X 3 Months
|
| Comparator Agent |
Tablet Placebo |
Tablet Placebo once daily X 3 Months |
| Comparator Agent |
Tablet Torsemide |
Tablet Torsemide 20 mg once daily X 3 Months |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting to Advance Eye Centre and Endocrinology Out Patient Department with Type 2 Diabetes Mellitus > 5 years treated with insulin/ oral hypoglycemic agents except Pioglitazone
2.Patients with Diabetic Macular Edema and Non Proliferative Diabetic Retinopathy detected either with Fundus Fluorescein Angiography or Optical Coherence Tomography
3.Patients with HbA1c between 7% - 10%
4.Patients with Estimated Glomerular Filtration rate > 45 ml/min |
|
| ExclusionCriteria |
| Details |
1.Patients with Type 1 Diabetes Mellitus
2.Patients with proliferative diabetic retinopathy
3.Patients with history of treatment for Diabetic Macular Edema in the last 3 Months
4.Patients with Macular Edema due to any other cause
5.Patients with Tractional Macular Edema on OCT or those requiring surgery
6.Patients with Human Immunodeficiency Virus,Hepatitis B or C Virus, Coronary Artery Disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess the changes in Diabetic Macular Edema in patients of Type 2 Diabetes Mellitus with Sodium Glucose Co-transporter 2 inhibitor (Dapagliflozin) |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess changes in HbA1c ,fasting and postprandial blood glucose , Serum lipid profile, Serum creatinine and Estimated Glomerular Filtration rate in patients of Type 2 Diabetes Mellitus with Sodium Glucose Co-Transporter 2 Inhibitor (Dapagliflozin) |
3 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
04/03/2019 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is randomnized, double blind, parallel group, placebo controlled trial to analyse the effect of Sodium Glucose Co-Transporter 2 inhibitor (Dapagliflozin). After a detailed informed consent, patients blood sugar will be stabilised for 6 weeks with either oral hypoglycemic agents or insulin or both.At baseline, fundus assessment will be done which would include best corrected visual acuity, slit lamp examination ,IOP measurement, optical coherence tomography and fundus fluorescien angiography.blood pressure assessment will be done.sample will be send for fasting and post prandial blood sugar, HbA1c, serum lipid profile and Serum creatinine. Fundus assesment with coherence tomography and flourecein angiograpy will be repeated at 6 weeks.Patient will be randomly assigned using simple randomisation(lottery method) to one of the following groups.One group will be given Tab Dapagliflozin 10 mg once daily x 3 months ,second group will be given Tab placebo once daily x 3 months and third group will be given Tab Torsemide 20 mg once daily x 3 months. Final follow up will be done at 4&1/2 months from baseline which would include repeating the same investigations done at baseline to compare with the baseline reports. |