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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05345327




Registration number
NCT05345327
Ethics application status
Date submitted
19/04/2022
Date registered
25/04/2022

Titles & IDs
Public title
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Scientific title
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Secondary ID [1] 0 0
P01148
Universal Trial Number (UTN)
Trial acronym
START
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of decline in eGFR
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Urine albumin creatinine ratio
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Serum creatinine
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
HbA1C
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Fasting blood glucose
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Systolic and diastolic blood pressure
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Body weight
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
Quality of life measured by EQ-5D-5L
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Anxiety and depression symptoms measured by HADS
Timepoint [8] 0 0
24 months

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 =45 ml/min/1,73m2; and
* Signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
994
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
The George Institute for Global Health - Sydney
Recruitment hospital [2] 0 0
The George Institute for Global Health - Brisbane
Recruitment hospital [3] 0 0
Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
2042 - Sydney
Recruitment postcode(s) [2] 0 0
4000 - Brisbane
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Sri Lanka
State/province [1] 0 0
Southern Province
Country [2] 0 0
Sri Lanka
State/province [2] 0 0
Colombo 10
Country [3] 0 0
Sri Lanka
State/province [3] 0 0
Colombo
Country [4] 0 0
Sri Lanka
State/province [4] 0 0
Jaffna
Country [5] 0 0
Sri Lanka
State/province [5] 0 0
Kandy

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Sydney
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bruce Neal
Address 0 0
The George Institute for Global Health (Sydney, Australia)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Emma Zhang
Address 0 0
Country 0 0
Phone 0 0
+61 2 8052 4337
Fax 0 0
Email 0 0
ezhang1@georgeinstitute.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05345327