Study Comparing Dapagliflozin and Metformin to Protect Kidney Function in Adults with Type 2 Diabetes

What this Trial Is About

Researchers are evaluating the effects of the SGLT2 inhibitor dapagliflozin compared to metformin on the annual decline in kidney function, measured by eGFR, in people with Type 2 Diabetes. This Phase 3, randomized, double-blind trial is conducted in primary care and community sites in Australia and tertiary care centers in Sri Lanka. The purpose is to understand which first-line therapy may better prevent kidney decline in this population. After a 4-week active run-in period, participants will be randomly assigned to one of two groups one group will take dapagliflozin 10 mg once daily with placebo metformin tablets, and the other group will take metformin XR 2000 mg once daily with placebo dapagliflozin tablets. Treatment will continue for 2 years under quadruple masking to maintain study integrity. During the study, participants will undergo assessments including kidney function tests eGFR, serum creatinine, urine albumin creatinine ratio, blood sugar measurements HbA1C, fasting glucose, blood pressure monitoring, body weight check, and quality of life evaluations using the EQ-5D-5L. Mental health symptoms such as anxiety and depression will also be measured with the HADS questionnaire. The primary outcome is the rate of eGFR decline over 24 months, with safety and other health indicators monitored throughout the study period.

SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes