| Trial ID: | L1983 |
| Source ID: | NCT05345327
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
|
| Acronym: |
START
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Dapagliflozin|DRUG: Metformin
|
| Outcome Measures: |
Primary: 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 | Secondary: 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), 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
|
| Sponsor/Collaborators: |
Sponsor: The George Institute | Collaborators: The University of New South Wales|Monash University|University of Sydney
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
994
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2023-01-01
|
| Completion Date: |
2026-06-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-12-20
|
| Locations: |
The George Institute for Global Health, Sydney, New South Wales, 2042, Australia|The George Institute for Global Health, Brisbane, Queensland, 4000, Australia|Monash University, Melbourne, Victoria, 3004, Australia|National Hospital - Galle, Galle, Southern Province, 80000, Sri Lanka|National Hospital of Sri Lanka 1, Colombo 10, 00700, Sri Lanka|National Hospital of Sri Lanka 2, Colombo, 00700, Sri Lanka|Jaffna Teaching Hospital, Jaffna, 40000, Sri Lanka|Kandy National Hospital, Kandy, 20000, Sri Lanka
|
| URL: |
https://clinicaltrials.gov/show/NCT05345327
|
