SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of T2D;
• Aged ≥18 years;
• Body mass index \> 18.5 kg/m2;
• Drug naïve, or managed with metformin monotherapy and willing to be randomised to either dapagliflozin or metformin;
• eGFR ≥45 ml/min/1,73m2; and
• Signed informed consent.
Locations
Other Locations
Australia
The George Institute for Global Health
RECRUITING
Brisbane
Monash University
RECRUITING
Melbourne
The George Institute for Global Health
RECRUITING
Sydney
Sri Lanka
National Hospital of Sri Lanka 1
RECRUITING
Colombo
National Hospital of Sri Lanka 2
NOT_YET_RECRUITING
Colombo
National Hospital - Galle
NOT_YET_RECRUITING
Galle
Jaffna Teaching Hospital
RECRUITING
Jaffna
Kandy National Hospital
RECRUITING
Kandy
Contact Information
Primary
Emma Zhang
ezhang1@georgeinstitute.org.au
+61 2 8052 4337
Backup
Sarah Stanton
sstanton@georgeinstitute.org.au
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 994
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Monash University, The University of New South Wales, University of Sydney
Leads: The George Institute