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

Sponsor
The George Institute
Study ID
NCT05345327
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The aim of the trial is to evaluate the effects of the SGLT2 inhibitor, dapagliflozin, compared to metformin on annual decline in eGFR when used as first line therapy in people with Type 2 Diabetes.

Key Dates

Start date
Jan 1, 2023
Status verified
Dec 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
994 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dapagliflozin 10mg
    1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years
  • Active Comparator: Metformin XR 2000mg
    2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years

Primary Outcome Measure

Rate of decline in eGFR [ Time Frame: 24 months ]

Central Contacts

Related Studies