Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications
Conditions
Interventions
Intervention1: Dapagliflozin: Tablet Dapagliflozin 10 mg would be used in the intervention arm along with ongoing anti-diabetic medications for 12 weeks
Control Intervention1: Placebo: Matching placeb
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men aged 40-75 years, duration of T2D more than 2 years, HbA1c at screening 7-10% 2. Urinary albumin-to-creatinine ratio (ACR) more than 30 mg/g, eGFR more than 45 ml/min/1.73 m2 3. On metformin 2000 mg and/or glimepiride 2-4 mg/gliclazide 60-120 mg and/or stable doses of insulin for the last 3 months 4. Non-hypertensive or controlled hypertension on stable dose of anti-hypertensives for the last 6 month
Exclusion criteria
Exclusion criteria: 1. Coronary artery disease, heart failure, peripheral vascular disease 2. Severe NPDR or PDR or CSME 3. History of urinary tract infection in the past 6 months 4. Prior history of SLGT2i use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change in circulating miR-192, miR-200a/200b and miR-191 levelsTimepoint: At the end of 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the change in urinary albumin-to-creatinine ratio (ACR) and flow-mediated dilation (FMD)Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactRimesh Pal
Postgraduate Institute of Medical Education and Research (PGIMER)
Outcome results
None listed