Type 2 Diabetes
Conditions
Interventions
Study sites in Sri Lanka:
• The National Hospital of Sri Lanka
• Kandy National Hospital
• Karapitiya Teaching Hospital
• Jaffna Teaching Hospital
Intervention:
Single-blind 4-week active run-in per
Sponsors
The George Institute for Global Health
Eligibility
Inclusion criteria
Inclusion criteria: •Diagnosis of T2D (As this is a pragmatic trial, specific diagnostic criteria for type 2 diabetes are not mandated. Participants diagnosed with type 2 diabetes according to standard clinical practice of the participating clinics will be eligible for this trial) •Males and females 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 >= 30 ml/min/1.73m^2;
Exclusion criteria
Exclusion criteria: •Have an immediate need for rapid intensification of glucose lowering therapy due to marked hyperglycaemia; •There is a definite indication for, or contraindication to, either metformin or SGLT2 inhibitor (as outlined in the current versions of the product information) •They have clearly documented coronary artery disease (defined as a previous acute coronary syndrome, coronary stent or bypass surgery) Clearly documented heart failure (defined on the basis of a hospital admission, specialist diagnosis or an echocardiogram or other imaging modality); •Pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of decline in eGFR (The rate of decline in eGFR, defined as change in eGFR from study baseline to 24 months, in ml/min/1.73m2/year) [Ongoing, up to 24 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in urine albumin creatinine ratio [Ongoing, up to 24 months] Change in serum creatinine [ Ongoing, up to 24 months] HbA1C [ Ongoing, up to 24 months] Fasting blood glucose [ Ongoing, up to 24 months] Systolic and diastolic blood pressure [ Ongoing, up to 24 months] Body weight [ Ongoing, up to 24 months] Quality of life measured by EQ-5D-5L. [ Ongoing, up to 24 months] Anxiety and depression symptoms measured by HADS [Ongoing, up to 24 months] | — |
Countries
Australia,Sri Lanka
Contacts
Public ContactDr. Manilka Sumanatilleke
Consultant Endocrinologist
Outcome results
None listed