SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
- Registration Number
- NCT05345327
- Lead Sponsor
- The George Institute
- 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 run-in period, eligible participants will be randomised to either dapagliflozin 10mg daily, or metformin XR 2000mg daily in a 1:1 ratio.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 994
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin XR 2000mg Metformin 2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years Dapagliflozin 10mg Dapagliflozin 1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years
- Primary Outcome Measures
Name Time Method Rate of decline in eGFR 24 months Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year
- Secondary Outcome Measures
Name Time Method Urine albumin creatinine ratio 24 months Effects of dapagliflozin vs metformin, from baseline to 24 months, on urine albumin creatinine ratio (mg/g)
Serum creatinine 24 months Effects of dapagliflozin vs metformin, from baseline to 24 months, on serum creatinine (umol/L)
HbA1C 24 months Effects of dapagliflozin vs metformin, from baseline to 24 months, on HbA1C (%)
Fasting blood glucose 24 months Effects of dapagliflozin vs metformin, from baseline to 24 months, on fasting blood glucose (mmol/L)
Systolic and diastolic blood pressure 24 months Effects of dapagliflozin vs metformin, from baseline to 24 months, on systolic and diastolic blood pressure (mmHg)
Body weight 24 months Effects of dapagliflozin vs metformin, from baseline to 24 months, on body weight (kg)
Quality of life measured by EQ-5D-5L 24 months Effects of dapagliflozin vs metformin, from baseline to 24 months, on quality of life measured by European Quality of Life 5-Dimensional Assessment, 5-Level version
Anxiety and depression symptoms measured by HADS 24 months Effects of dapagliflozin vs. metformin, from baseline to 24 months, on anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS)
Trial Locations
- Locations (7)
The George Institute for Global Health
🇦🇺Brisbane, Queensland, Australia
Monash University
🇦🇺Melbourne, Victoria, Australia
Kandy National Hospital
🇱🇰Kandy, Sri Lanka
National Hospital - Galle
🇱🇰Galle, Southern Province, Sri Lanka
National Hospital of Sri Lanka 1
🇱🇰Colombo 10, Sri Lanka
National Hospital of Sri Lanka 2
🇱🇰Colombo, Sri Lanka
Jaffna Teaching Hospital
🇱🇰Jaffna, Sri Lanka