Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Date last updated
25/03/2025
Titles & IDs
Public title
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Query!
Scientific title
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Query!
Secondary ID [1]
0
0
P01148
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
START
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Rate of decline in eGFR
Query!
Assessment method [1]
0
0
Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year
Query!
Timepoint [1]
0
0
24 months
Query!
Secondary outcome [1]
0
0
Urine albumin creatinine ratio
Query!
Assessment method [1]
0
0
Effects of dapagliflozin vs metformin, from baseline to 24 months, on urine albumin creatinine ratio (mg/g)
Query!
Timepoint [1]
0
0
24 months
Query!
Secondary outcome [2]
0
0
Serum creatinine
Query!
Assessment method [2]
0
0
Effects of dapagliflozin vs metformin, from baseline to 24 months, on serum creatinine (umol/L)
Query!
Timepoint [2]
0
0
24 months
Query!
Secondary outcome [3]
0
0
HbA1C
Query!
Assessment method [3]
0
0
Effects of dapagliflozin vs metformin, from baseline to 24 months, on HbA1C (%)
Query!
Timepoint [3]
0
0
24 months
Query!
Secondary outcome [4]
0
0
Fasting blood glucose
Query!
Assessment method [4]
0
0
Effects of dapagliflozin vs metformin, from baseline to 24 months, on fasting blood glucose (mmol/L)
Query!
Timepoint [4]
0
0
24 months
Query!
Secondary outcome [5]
0
0
Systolic and diastolic blood pressure
Query!
Assessment method [5]
0
0
Effects of dapagliflozin vs metformin, from baseline to 24 months, on systolic and diastolic blood pressure (mmHg)
Query!
Timepoint [5]
0
0
24 months
Query!
Secondary outcome [6]
0
0
Body weight
Query!
Assessment method [6]
0
0
Effects of dapagliflozin vs metformin, from baseline to 24 months, on body weight (kg)
Query!
Timepoint [6]
0
0
24 months
Query!
Secondary outcome [7]
0
0
Quality of life measured by EQ-5D-5L
Query!
Assessment method [7]
0
0
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
Query!
Timepoint [7]
0
0
24 months
Query!
Secondary outcome [8]
0
0
Anxiety and depression symptoms measured by HADS
Query!
Assessment method [8]
0
0
Effects of dapagliflozin vs. metformin, from baseline to 24 months, on anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS)
Query!
Timepoint [8]
0
0
24 months
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/06/2026
Query!
Actual
Query!
Sample size
Target
994
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
The George Institute for Global Health - Sydney
Query!
Recruitment hospital [2]
0
0
The George Institute for Global Health - Brisbane
Query!
Recruitment hospital [3]
0
0
Monash University - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2042 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
4000 - Brisbane
Query!
Recruitment postcode(s) [3]
0
0
3004 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
Sri Lanka
Query!
State/province [1]
0
0
Southern Province
Query!
Country [2]
0
0
Sri Lanka
Query!
State/province [2]
0
0
Colombo 10
Query!
Country [3]
0
0
Sri Lanka
Query!
State/province [3]
0
0
Colombo
Query!
Country [4]
0
0
Sri Lanka
Query!
State/province [4]
0
0
Jaffna
Query!
Country [5]
0
0
Sri Lanka
Query!
State/province [5]
0
0
Kandy
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
The George Institute
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
The University of New South Wales
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Monash University
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
University of Sydney
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05345327
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bruce Neal
Query!
Address
0
0
The George Institute for Global Health (Sydney, Australia)
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Emma Zhang
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61 2 8052 4337
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
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
Download to PDF