SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapagliflozin, Metformin.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Sri Lanka
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Dapagliflozin
SGLT2 inhibitor - Drug Metformin
Metformin
Primary outcome measures
- Rate of decline in eGFR [Time frame: 24 months]
Secondary outcome measures (8)
- Urine albumin creatinine ratio [Time frame: 24 months]
- Serum creatinine [Time frame: 24 months]
- HbA1C [Time frame: 24 months]
- Fasting blood glucose [Time frame: 24 months]
- Systolic and diastolic blood pressure [Time frame: 24 months]
- Body weight [Time frame: 24 months]
- Quality of life measured by EQ-5D-5L [Time frame: 24 months]
- Anxiety and depression symptoms measured by HADS [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Sri Lanka · 5 centers
- National Hospital - Galle — Galle
- National Hospital of Sri Lanka 1 — Colombo
- National Hospital of Sri Lanka 2 — Colombo
- Jaffna Teaching Hospital — Jaffna
- Kandy National Hospital — Kandy
Australia · 3 centers
- The George Institute for Global Health — Sydney
- The George Institute for Global Health — Brisbane
- Monash University — Melbourne
Identifiers
NCT: NCT05345327 · P01148