Effect of sodium glucose cotransporter 2 inhibitors on diabetic macular edema in patient with type 2 diabetes mellitus-a prospective randomnized control trial.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- To Assess the changes in Diabetic Macular Edema in patients of Type 2 Diabetes Mellitus with Sodium Glucose Co-transporter 2 inhibitor (Dapagliflozin)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 0.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Outcomes
Primary Outcomes
To Assess the changes in Diabetic Macular Edema in patients of Type 2 Diabetes Mellitus with Sodium Glucose Co-transporter 2 inhibitor (Dapagliflozin)
Time Frame: 3 Months
Secondary Outcomes
- 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)