Compares dapagliflozin and metformin to protect kidneys in type 2 diabetes
Compares dapagliflozin with metformin as first treatment in adults with type 2 diabetes.
Key facts
- Who runs it
- The George Institute
- Where
- Colombo, Galle, Jaffna, and Kandy, Sri LankaSee the 5 sitesAlso in 1 other country, 3 sites
- Trial code
- Registry title
- SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 994 people, planned
- Started
- 1 Jan 2023
- Planned end
- 30 Jun 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Dapagliflozin
- Metformin
- Record updated
- 20 December 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 2 diabetes who have not taken diabetes drugs yet, or who take only metformin. It compares dapagliflozin with metformin on kidney function decline.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes with eGFR of 45 ml/min/1,73m2 or higher and body mass index above 18.5 kg/m2.
- Earlier treatment
- No earlier diabetes drugs, or metformin alone. They must be willing to be randomised to dapagliflozin or metformin.
- Biomarker or test result
- eGFR of 45 ml/min/1,73m2 or higher.
Main reasons for not taking part
- Immediate need for rapid stronger glucose lowering because of marked hyperglycaemia
- A clear reason for, or against, using metformin or an SGLT2 inhibitor
- Documented coronary artery disease (previous acute coronary syndrome, coronary stent or bypass surgery)
- Documented heart failure
- Pregnant or breast-feeding
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Sri Lanka
Also in 1 other country, 3 sites
- National Hospital of Sri Lanka 1Colombo, Sri LankaContact: Manilka SumanatillekeTaking people
- National Hospital of Sri Lanka 2Colombo, Sri LankaContact: Uditha BulugahapitiyaNot yet recruiting
- National Hospital GalleGalle, Sri LankaContact: Muditha WeerakkodyNot yet recruiting
- Jaffna Teaching HospitalJaffna, Sri LankaContact: Mahalingam ArarinthanTaking people
- Kandy National HospitalKandy, Sri LankaContact: Charles AntonypillaiTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Dapagliflozin 10mgTreatment being tested
1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years
Treatment: Dapagliflozin
- Metformin XR 2000mgExisting treatment, for comparison
2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years
Treatment: Metformin
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
- Plain-language title
- Compares dapagliflozin and metformin to protect kidneys in type 2 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 20 December 2024