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| Name | Class |
|---|---|
| The University of New South Wales | OTHER |
| Monash University | OTHER |
| University of Sydney | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin 10mg | Experimental | 1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years |
|
| Metformin XR 2000mg | Active Comparator | 2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | SGLT2 inhibitor |
| |
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of decline in eGFR | Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Urine albumin creatinine ratio | Effects of dapagliflozin vs metformin, from baseline to 24 months, on urine albumin creatinine ratio (mg/g) | 24 months |
| Serum creatinine | Effects of dapagliflozin vs metformin, from baseline to 24 months, on serum creatinine (umol/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Zhang | Contact | +61 2 8052 4337 | ezhang1@georgeinstitute.org.au | |
| Sarah Stanton | Contact | sstanton@georgeinstitute.org.au |
| Name | Affiliation | Role |
|---|---|---|
| Bruce Neal | The George Institute for Global Health (Sydney, Australia) | Study Chair |
| Clare Arnott | The George Institute for Global Health (Sydney, Australia) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The George Institute for Global Health | Recruiting | Sydney | New South Wales | 2042 | Australia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Drug |
Metformin |
|
| 24 months |
| HbA1C | Effects of dapagliflozin vs metformin, from baseline to 24 months, on HbA1C (%) | 24 months |
| Fasting blood glucose | Effects of dapagliflozin vs metformin, from baseline to 24 months, on fasting blood glucose (mmol/L) | 24 months |
| Systolic and diastolic blood pressure | Effects of dapagliflozin vs metformin, from baseline to 24 months, on systolic and diastolic blood pressure (mmHg) | 24 months |
| Body weight | Effects of dapagliflozin vs metformin, from baseline to 24 months, on body weight (kg) | 24 months |
| Quality of life measured by EQ-5D-5L | 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 | 24 months |
| Anxiety and depression symptoms measured by HADS | Effects of dapagliflozin vs. metformin, from baseline to 24 months, on anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS) | 24 months |
| The George Institute for Global Health | Recruiting | Brisbane | Queensland | 4000 | Australia |
|
| Monash University | Recruiting | Melbourne | Victoria | 3004 | Australia |
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| National Hospital - Galle | Not yet recruiting | Galle | Southern Province | 80000 | Sri Lanka |
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| National Hospital of Sri Lanka 1 | Recruiting | Colombo | 00700 | Sri Lanka |
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| National Hospital of Sri Lanka 2 | Not yet recruiting | Colombo | 00700 | Sri Lanka |
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| Jaffna Teaching Hospital | Recruiting | Jaffna | 40000 | Sri Lanka |
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| Kandy National Hospital | Recruiting | Kandy | 20000 | Sri Lanka |
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