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Benefits and side effects of Dapagliflozin medicine in diabetic patients with kidney disease.

Efficacy and Safety of Dapagliflozin in progression of Chronic Kidney Disease in patients with type 2 Diabetes Mellitus: A Randomised Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045596
Enrollment
60
Registered
2022-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 2: E112- Type 2 diabetes mellitus with kidney complications

Interventions

Intervention1: SGLT 2 Inhibitors (Sodium Glucose Co-transporter): SGLT 2 Inhibitors given for retarding the progression of chronic kidney disease in Diabetic patients. Control Intervention1: Tab Dapag

Sponsors

Maulana Azad Medical College Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with diagnosis of CKD with type 2 Diabetes Mellitus with HbA1c eGFR of 30-60ml/min/1.73m2 Urinary Albumin to Creatinine ratio 200-5000mg/g 2. Patients who are on ACE inhibitors or ARBs for at least 4 weeks before screening.

Exclusion criteria

Exclusion criteria: 1. Patients with Type 1 diabetes, lupus nephritis, Rheumatoid arthritis, Cancer and Neurodegenerative disorders 2. Patients have received immunosuppressive therapy within 6 months. 3. Pregnant patients and nursing mothers.

Design outcomes

Primary

MeasureTime frame
Change in eGFR Change in UACRTimepoint: 0, 3, 6 months after starting drug therapy—

Secondary

MeasureTime frame
Change in HbA1c levelsTimepoint: 0, 3, 6 months after starting drug therapy;Change in IL-6 levels Timepoint: 0, 6 months after starting drug therapy;Frequency of hypoglycemic episodes Timepoint: 0, 3, 6 months after starting drug therapy ;Safety Profile in both groupsTimepoint: 0, 3, 6 months after starting drug therapy—

Countries

India

Contacts

Public ContactDr Kritika

Maulana Azad Medical College, Delhi

drbskalra@gmail.com9810785004

Outcome results

None listed

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