START Trial: Evaluating SGLT2 Inhibitors as First-Line Therapy in Type 2 Diabetes

The START trial, led by The George Institute for Global Health and Monash University, is a NHMRC-funded clinical trial evaluating whether sodium-glucose cotransporter 2 (SGLT2) inhibitors, specifically dapagliflozin can more effectively slow kidney function decline compared to metformin in individuals newly diagnosed with type 2 diabetes (T2D).

Why is the START Trial Important?

Type 2 diabetes is a leading cause of chronic kidney disease (CKD) and cardiovascular complications. While metformin is the current first-line therapy for T2D, emerging evidence suggests that SGLT2 inhibitors (like dapagliflozin) may offer superior kidney and heart protection.

The START trial aims to determine whether initiating dapagliflozin early—instead of metformin—can better preserve kidney function, reduce complications, and improve long-term outcomes in T2D patients.

Trial Design & Methodology

• Pragmatic, multicenter, double-blind, randomized controlled trial

• 994 participants (497 per arm) across Australia and Sri Lanka (400 from Sri Lanka)

• Intervention:

  • Dapagliflozin (10mg) + Metformin placebo vs.

  • Metformin XR (2000mg) + Dapagliflozin placebo

• Primary Outcome: Rate of eGFR decline over 24 months

• Secondary Outcomes: Changes in albuminuria, HbA1c, blood pressure, weight, and quality of life

RemediumOne is proud to be part of this international effort, ensuring high-quality trial execution in Sri Lanka.

The currently recruiting sites include :

• National Hospital of Sri Lanka

• Kandy National Hospital

• Karapitiya Teaching Hospital

• Jaffna Teaching Hospital

Dr. Manilka Sumanatilleke, Consultant Endocrinologist at the National Hospital of Sri Lanka is the Coordinating Principal Investigator of the study in Sri Lanka.

The study is actively recruiting eligible participants

Find more information about the trial: ClinicalTrials.gov ID: NCT05345327

Stay tuned for updates as the START trial progresses.