Status:
RECRUITING
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Lead Sponsor:
The George Institute
Collaborating Sponsors:
The University of New South Wales
Monash University
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
This study is a randomised, double blinded clinical trial and will be undertaken in primary care and community sites across Australia and tertiary care centres in Sri Lanka. Following a 4-week active ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Have an immediate need for rapid intensification of glucose lowering therapy due to marked hyperglycaemia; or
- There is a definite indication for, or contraindication to, either metformin or SGLT2 inhibitor; or
- They have clearly documented coronary artery disease (defined as a previous acute coronary syndrome, coronary stent or bypass surgery) or clearly documented heart failure (defined on the basis of a hospital admission, specialist diagnosis or an echocardiogram or other imaging modality); or
- Pregnant or breast-feeding.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
994 Patients enrolled
Trial Details
Trial ID
NCT05345327
Start Date
January 1 2023
End Date
June 30 2026
Last Update
December 20 2024
Active Locations (8)
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1
The George Institute for Global Health
Sydney, New South Wales, Australia, 2042
2
The George Institute for Global Health
Brisbane, Queensland, Australia, 4000
3
Monash University
Melbourne, Victoria, Australia, 3004
4
National Hospital - Galle
Galle, Southern Province, Sri Lanka, 80000