Compares dapagliflozin and metformin to protect kidneys in type 2 diabetes
Compares dapagliflozin with metformin as first treatment in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Key facts
- Where
- Colombo, Galle, Jaffna, and Kandy, Sri LankaSee the 5 sites
- Phase
- Phase 3
Where in Sri Lanka
- National Hospital of Sri Lanka 1Colombo, Sri LankaTaking people
- National Hospital of Sri Lanka 2Colombo, Sri LankaNot yet recruiting
- National Hospital GalleGalle, Sri LankaNot yet recruiting
- Jaffna Teaching HospitalJaffna, Sri LankaTaking people
- Kandy National HospitalKandy, Sri LankaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The George Institute
- Trial code
- NCT05345327
- Record updated
- 20 December 2024
- Original description
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.Read full original descriptionShow less
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
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.
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: 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; Have an immediate need for rapid intensification of glucose lowering therapy due to marked hyperglycaemia; or; Pregnant or breast-feeding.