Actively Recruiting
SGLT2 Inhibitors as First Treatment to Prevent Kidney Decline in Type 2 Diabetes Comparing Dapagliflozin and Metformin in a Randomized Clinical Trial
Led by The George Institute · Updated on 2024-12-20
994
Participants Needed
8
Research Sites
182 weeks
Total Duration
On this page
Sponsors
T
The George Institute
Lead Sponsor
T
The University of New South Wales
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of the SGLT2 inhibitor dapagliflozin compared to metformin on the annual decline in kidney function measured by eGFR in people with Type 2 Diabetes. This Phase 3 randomized, double-blinded clinical trial is conducted in primary care and community settings in Australia and in tertiary care centers in Sri Lanka. The study aims to determine how these medications perform as first-line therapies to prevent kidney decline in this population. After a 4-week active run-in period, eligible participants will be randomly assigned in equal numbers to receive either dapagliflozin 10 mg daily or metformin extended-release 2000 mg daily. Both medications are taken orally and are compared directly to assess their impact on kidney health over time. Participants will be involved in the study for at least 24 months, during which their kidney function will be regularly monitored to measure the rate of decline in eGFR. The study includes safety assessments and ongoing evaluations to ensure participant well-being and to measure the effectiveness of the treatments in slowing kidney decline associated with Type 2 Diabetes.
CONDITIONS
Official Title
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Type 2 Diabetes
- Aged 18 years or older
- Body mass index greater than 18.5 kg/m2
- Drug naive or managed with metformin monotherapy and willing to be randomized to dapagliflozin or metformin
- Estimated glomerular filtration rate (eGFR) of 45 ml/min/1.73m2 or higher
- Signed informed consent
You will not qualify if you...
- Need for rapid intensification of glucose lowering therapy due to marked hyperglycemia
- Definite indication for or contraindication to either metformin or SGLT2 inhibitor
- Documented coronary artery disease (previous acute coronary syndrome, coronary stent, or bypass surgery)
- Documented heart failure (based on hospital admission, specialist diagnosis, or imaging)
- Pregnant or breastfeeding
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Trial Site Locations
Total: 8 locations
1
The George Institute for Global Health
Sydney, New South Wales, Australia, 2042
Actively Recruiting
2
The George Institute for Global Health
Brisbane, Queensland, Australia, 4000
Actively Recruiting
3
Monash University
Melbourne, Victoria, Australia, 3004
Actively Recruiting
4
National Hospital - Galle
Galle, Southern Province, Sri Lanka, 80000
Not Yet Recruiting
5
National Hospital of Sri Lanka 1
Colombo, Sri Lanka, 00700
Actively Recruiting
6
National Hospital of Sri Lanka 2
Colombo, Sri Lanka, 00700
Not Yet Recruiting
7
Jaffna Teaching Hospital
Jaffna, Sri Lanka, 40000
Actively Recruiting
8
Kandy National Hospital
Kandy, Sri Lanka, 20000
Actively Recruiting
Research Team
E
Emma Zhang
S
Sarah Stanton
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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