SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
NCT ID: NCT05345327
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
994 participants
INTERVENTIONAL
2023-01-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Dapagliflozin 10mg
1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years
Dapagliflozin
SGLT2 inhibitor
Metformin XR 2000mg
2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years
Metformin
Metformin
Interventions
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Dapagliflozin
SGLT2 inhibitor
Metformin
Metformin
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
* Pregnant or breast-feeding.
18 Years
ALL
No
Sponsors
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The University of New South Wales
OTHER
Monash University
OTHER
University of Sydney
OTHER
The George Institute
OTHER
Responsible Party
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Principal Investigators
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Bruce Neal
Role: STUDY_CHAIR
The George Institute for Global Health (Sydney, Australia)
Clare Arnott
Role: STUDY_CHAIR
The George Institute for Global Health (Sydney, Australia)
Locations
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The George Institute for Global Health
Sydney, New South Wales, Australia
The George Institute for Global Health
Brisbane, Queensland, Australia
Monash University
Melbourne, Victoria, Australia
National Hospital - Galle
Galle, Southern Province, Sri Lanka
National Hospital of Sri Lanka 1
Colombo, , Sri Lanka
National Hospital of Sri Lanka 2
Colombo, , Sri Lanka
Jaffna Teaching Hospital
Jaffna, , Sri Lanka
Kandy National Hospital
Kandy, , Sri Lanka
Countries
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Central Contacts
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Facility Contacts
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Emma Zhang
Role: primary
Sarah Stanton
Role: backup
Emma Zhang
Role: primary
Sarah Stanton
Role: backup
Simone Spark
Role: primary
Zachary Flanagan
Role: backup
Muditha Weerakkody
Role: primary
Manilka Sumanatilleke
Role: primary
Uditha Bulugahapitiya
Role: primary
Mahalingam Ararinthan
Role: primary
Charles Antonypillai
Role: primary
Other Identifiers
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P01148
Identifier Type: -
Identifier Source: org_study_id