Health Condition 1: -
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult aged 18-75 years diagnosed with type 2 diabetes mellitus diagnosed with chronic kidney disease on stable background therapy initiated with dapagliflozin as per treating physician decision
Exclusion criteria
Exclusion criteria: Type 1 diabetes mellitus Active infection Severe hepatic impairment Pregnant or lactating women Patients are unwilling to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HEMOGLOBIN CHANGETimepoint: 12 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the effect of Dapagliflozin on iron profile parameters, including serum iron, serum total iron binding capacity and transferrin saturation (TSAT). 2. To evaluate changes in renal function parameters, including estimated glomerular filtration rate eGFR, serum creatinine, and urine albumin-to-creatinine ratio (ACR). 3. To determine the impact on glycemic control, as measured by glycated haemoglobin HbA1c and fasting plasma glucose. 4. To compare the level of serum ferritin following treatment with Dapagliflozin. 5. To evaluate the safety and tolerability of Dapagliflozin Timepoint: 6weeks and 12 weeks | — |
Countries
India
Contacts
NIZAM INSTITUTE OF MEDICAL SCIENC