Date

2025-03-11

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

Study sites in Sri Lanka: • The National Hospital of Sri Lanka • Kandy National Hospital • Karapitiya Teaching Hospital • Jaffna Teaching Hospital Intervention: Single-blind 4-week active run-in period to assess adherence and tolerability of study medication. Following completion of run-in, participants who tolerated and adhered to the run-in medication will be randomized. Randomization: Participants will be randomly allocated (via a web-based system) in a 1:1 ratio to either metformin XR or dapagliflozin, stratified by site and baseline renal function. Study arms: 1. Experimental: 10mg Dapagliflozin and Metformin placebo daily for 2 years. 2. Active Comparator: 2000mg Metformin XR and Dapagliflozin placebo daily for 2 years. Randomized study medication will be provided in identical packaging such that participants and study staff are masked to treatment allocation.

Next Version

Study sites • National Hospital of Sri Lanka, Colombo 10. • Colombo South Teaching Hospital, Dehiwala. • Kandy National Hospital, Kandy. • National Hospital - Galle. • Jaffna Teaching Hospital, Jaffna.