Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications
Conditions
Interventions
Intervention1: Dapagliflozin
Telmisartan
Levocetirizine: Tablet Telmisartan 40 mg orally once daily plus Tablet Dapagliflozin 10 mg orally once daily plus tablet levocetirizine 2.5 mg orally once dail
Sponsors
Dr Kiran G Piparva
Dr Kiran Piparva
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients of either gender with known case of diabetes nephropathy with persistent proteinuria and on angiotensin receptor blockers (ARBs)/ACE Inhibitors (minimum 3 months of therapy) and other oral antidiabetic medications (excluding the study drug), with or without insulin.
Exclusion criteria
Exclusion criteria: Type 1 diabetes mellitus. Known case of severe renal impairment (eGFR less than 30 mL/min/1.73 m ) or creatinine clearance greater than 80 ml/min or non-diabetic chronic kidney disease (e.g., secondary to autoimmune or other systemic inflammatory disorders). History of chronic urinary tract infection or systemic immunosuppressive/ anti-inflammatory therapy within the past 3 months History of hospitalisation due to myocardial infarction, congestive heart failure or major surgery in the last 3 months. History of uncontrolled hypertension in the last 3 months. History of hypersensitivity to study drugs. Pregnant or lactating women. Participants involved in the operation of heavy machinery requiring continuous vigilance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the change in urinary albumin-to-creatinine ratio (UACR) from baseline to 12 weeks among experimental and control groupTimepoint: 0, 30, 60, and 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the change in estimated glomerular filtration rate (eGFR) 2.To monitor the adverse events between experimental and control group Timepoint: 0, 30, 60, and 90 days | — |
Countries
India
Contacts
Public ContactDr Kiran Piparva
All India Institute of Medical Sciences Rajkot
Outcome results
None listed