Type 2 DiabetesPhase 3STARTNCT05345327
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
A Phase 3 study testing Dapagliflozin and Metformin in people with Type 2 Diabetes, run by The George Institute at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dapagliflozin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 994 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Jan 2023to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Sarah Stanton contact
8 sites in 2 countries
Sri Lanka5 sites, 5 recruiting
- Recruiting
National Hospital of Sri Lanka 1
Colombo, 00700
Manilka Sumanatilleke, +94 777 440 208, manilkasumana@gmail.com
Manilka Sumanatilleke
- Not yet recruiting
National Hospital of Sri Lanka 2
Colombo, 00700
Uditha Bulugahapitiya, +94 777 440 208, udithakaush@gmail.com
Uditha Bulugahapitiya
- Not yet recruiting
National Hospital - Galle
Galle, Southern Province, 80000
Muditha Weerakkody, +94 714 050 524, mudithaweerakkody@gmail.com
Muditha Weerakkody
- Recruiting
Jaffna Teaching Hospital
Jaffna, 40000
Mahalingam Ararinthan, 0772619589, ara.jho@gmail.com
Mahalingam Aravinthan
- Recruiting
Kandy National Hospital
Kandy, 20000
Charles Antonypillai, +94773417639, cantonypillai@gmail.com
Charles Antonypillai
Australia3 sites, 3 recruiting
- Recruiting
The George Institute for Global Health
Brisbane, Queensland, 4000
Emma Zhang, +61 2 8052 4337, ezhang1@georgeinstitute.org.au
Sarah Stanton, sstanton@georgeinstitute.org.au
- Recruiting
Monash University
Melbourne, Victoria, 3004
Simone Spark, simone.spark@monash.edu
Zachary Flanagan, Zachary.Flanagan@monash.edu
- Recruiting
The George Institute for Global Health
Sydney, New South Wales, 2042
Emma Zhang, +61 2 8052 4337, ezhang1@georgeinstitute.org.au
Sarah Stanton, sstanton@georgeinstitute.org.au
About this study
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.
Read the detailed description
This study is a randomised, double blinded clinical trial and will be undertaken in primary care and community sites across Australia and tertiary care centres in Sri Lanka. Following a 4-week active run-in period, eligible participants will be randomised to either dapagliflozin 10mg daily, or metformin XR 2000mg daily in a 1:1 ratio.
- Conditions
- Type 2 Diabetes
- Being tested
- Dapagliflozin, Metformin
- Keywords
- Diabetes, Renal decline, Metformin, Sodium Glucose Co-Transporter 2 inhibitor
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
SGLT2 inhibitor
MetforminDrug
Metformin
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10mg | Experimental | 1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years Receives: Drug: Dapagliflozin |
| Metformin XR 2000mg | Active comparator | 2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of decline in eGFR
Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year
Measured: 24 months
Secondary outcomes (8)
Urine albumin creatinine ratio
Effects of dapagliflozin vs metformin, from baseline to 24 months, on urine albumin creatinine ratio (mg/g)
Measured: 24 months
Serum creatinine
Effects of dapagliflozin vs metformin, from baseline to 24 months, on serum creatinine (umol/L)
Measured: 24 months
HbA1C
Effects of dapagliflozin vs metformin, from baseline to 24 months, on HbA1C (%)
Measured: 24 months
Fasting blood glucose
Effects of dapagliflozin vs metformin, from baseline to 24 months, on fasting blood glucose (mmol/L)
Measured: 24 months
Systolic and diastolic blood pressure
Effects of dapagliflozin vs metformin, from baseline to 24 months, on systolic and diastolic blood pressure (mmHg)
Measured: 24 months
Body weight
Effects of dapagliflozin vs metformin, from baseline to 24 months, on body weight (kg)
Measured: 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
Measured: 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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Jan 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 994 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The University of New South Wales, Monash University, University of Sydney
- Responsible party
- Sponsor
- Investigators
- Bruce Neal, Study chair, The George Institute for Global Health (Sydney, Australia)Clare Arnott, Study chair, The George Institute for Global Health (Sydney, Australia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345327
- Sponsor's protocol ID
- P01148
- Acronym
- START
- Status last verified
- Dec 2024
- First submitted
- 19 Apr 2022
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05345327
- Acronym / sponsor ID
- START / P01148
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Renal decline, Metformin, Sodium Glucose Co-Transporter 2 inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 994 participants (estimated)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- The University of New South Wales, Monash University, University of Sydney
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomised, double blinded clinical trial and will be undertaken in primary care and community sites across Australia and tertiary care centres in Sri Lanka. Following a 4-week active run-in period, eligible participants will be randomised to either dapagliflozin 10mg daily, or metformin XR 2000mg daily in a 1:1 ratio.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10mg | Experimental | Drug: Dapagliflozin1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years |
| Metformin XR 2000mg | Active comparator | Drug: Metformin2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinSGLT2 inhibitor | Drug | Dapagliflozin 10mg |
| MetforminMetformin | Drug | Metformin XR 2000mg |
Primary outcome
Rate of decline in eGFR
Time frame: 24 months
Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year
8 secondary outcomes
Urine albumin creatinine ratio
Time frame: 24 months
Serum creatinine
Time frame: 24 months
HbA1C
Time frame: 24 months
Fasting blood glucose
Time frame: 24 months
Systolic and diastolic blood pressure
Time frame: 24 months
Body weight
Time frame: 24 months
Quality of life measured by EQ-5D-5L
Time frame: 24 months
Anxiety and depression symptoms measured by HADS
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Stanton contact
Bruce Neal study chair
The George Institute for Global Health (Sydney, Australia)
Clare Arnott study chair
The George Institute for Global Health (Sydney, Australia)
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin and Metformin in people with Type 2 Diabetes, run by The George Institute at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sri Lanka, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Zhang (+61 2 8052 4337, ezhang1@georgeinstitute.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of decline in eGFR (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.