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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05345327
Registration number
NCT05345327
Ethics application status
Date submitted
19/04/2022
Date registered
25/04/2022
Date last updated
24/08/2023
Titles & IDs
Public title
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
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Scientific title
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
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Secondary ID [1]
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P01148
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Universal Trial Number (UTN)
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Trial acronym
START
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dapagliflozin
Treatment: Drugs - Metformin
Experimental: Dapagliflozin 10mg - 1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years
Active Comparator: Metformin XR 2000mg - 2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years
Treatment: Drugs: Dapagliflozin
SGLT2 inhibitor
Treatment: Drugs: Metformin
Metformin
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of decline in eGFR
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Assessment method [1]
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Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year
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Timepoint [1]
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24 months
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Secondary outcome [1]
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Urine albumin creatinine ratio
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Assessment method [1]
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Effects of dapagliflozin vs metformin, from baseline to 24 months, on urine albumin creatinine ratio (mg/g)
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Timepoint [1]
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24 months
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Secondary outcome [2]
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Serum creatinine
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Assessment method [2]
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Effects of dapagliflozin vs metformin, from baseline to 24 months, on serum creatinine (umol/L)
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Timepoint [2]
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24 months
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Secondary outcome [3]
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HbA1C
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Assessment method [3]
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Effects of dapagliflozin vs metformin, from baseline to 24 months, on HbA1C (%)
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Timepoint [3]
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24 months
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Secondary outcome [4]
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Fasting blood glucose
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Assessment method [4]
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Effects of dapagliflozin vs metformin, from baseline to 24 months, on fasting blood glucose (mmol/L)
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Timepoint [4]
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24 months
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Secondary outcome [5]
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Systolic and diastolic blood pressure
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Assessment method [5]
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Effects of dapagliflozin vs metformin, from baseline to 24 months, on systolic and diastolic blood pressure (mmHg)
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Timepoint [5]
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24 months
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Secondary outcome [6]
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Body weight
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Assessment method [6]
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Effects of dapagliflozin vs metformin, from baseline to 24 months, on body weight (kg)
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Timepoint [6]
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24 months
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Secondary outcome [7]
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Quality of life measured by EQ-5D-5L
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Assessment method [7]
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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
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Timepoint [7]
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24 months
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Eligibility
Key inclusion criteria
- 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 =30 ml/min/1,73m2; and
- Signed informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Have an immediate need for rapid intensification of glucose lowering therapy due to
marked hyperglycaemia; or
- 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2026
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Actual
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Sample size
Target
994
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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The George Institute for Global Health - Sydney
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Recruitment hospital [2]
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The George Institute for Global Health - Brisbane
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Recruitment hospital [3]
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Monash University - Melbourne
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Recruitment postcode(s) [1]
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2042 - Sydney
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Recruitment postcode(s) [2]
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4000 - Brisbane
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The University of New South Wales
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Monash University
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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University of Sydney
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05345327
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bruce Neal
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Address
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The George Institute for Global Health (Sydney, Australia)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Rachel McGrath
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Address
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Country
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Phone
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+61 2 8052 4300
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05345327
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