A clinical trial to study the effect of a drug,dapagliflozin in type 2 diabetic mellitus patient having diabetic macular edema

Phase 3

Not yet recruiting

Conditions: Retinal disorders in diseases classified elsewhere,

Registration Number: CTRI/2019/03/017915

Lead Sponsor: Postgraduate Institute of Medical Education and Research

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Advance Eye Centre OPD and Department of Endocrinology OPD
🇮🇳
Chandigarh, CHANDIGARH, India
Advance Eye Centre OPD and Department of Endocrinology OPD
🇮🇳Chandigarh, CHANDIGARH, India
Dr Anil Bhansali
Principal investigator
9478111956
anilbhansaliendocrine@gmail.com