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

Effect of sodium glucose cotransporter 2 inhibitors on diabetic macular edema in patient with type 2 diabetes mellitus-a prospective randomnized control trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/03/017915

Enrollment

Registered

2019-03-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H36- Retinal disorders in diseases classified elsewhere

Interventions

Intervention1: Tablet Dapagliflozin: Tab Dapagliflozin 10 mg once daily orally X 3 Months Control Intervention1: Tablet Placebo: Tablet Placebo once daily X 3 Months Control Intervention2: Tablet Tor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To Assess the changes in Diabetic Macular Edema in patients of Type 2 Diabetes Mellitus with Sodium Glucose Co-transporter 2 inhibitor (Dapagliflozin)Timepoint: 3 Months	—

Secondary

Measure	Time frame
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)Timepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Ningombam Sashikanta Singh

Postgraduate Institute of Medical Education and Research,Chandigarh-12.

anilbhansaliendocrine@gmail.com9478111956

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026