Back to resultsSGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes (START)
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Dapagliflozin
Metformin
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes focused on measuring Diabetes, Renal decline, Metformin, Sodium Glucose Co-Transporter 2 inhibitor
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of T2D within the last 4 years;
- Aged ≥18 years;
- Body mass index between 18.5 and 45 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.
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.
Sites / Locations
- The George Institute for Global HealthRecruiting
- The George Institute for Global HealthRecruiting
- Monash UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dapagliflozin 10mg
Metformin XR 2000mg
Arm Description
1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years
2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years
Outcomes
Primary Outcome Measures
Rate of decline in eGFR
Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year
Secondary Outcome Measures
Urine albumin creatinine ratio
Effects of dapagliflozin vs metformin, from baseline to 24 months, on urine albumin creatinine ratio (mg/g)
Serum creatinine
Effects of dapagliflozin vs metformin, from baseline to 24 months, on serum creatinine (umol/L)
HbA1C
Effects of dapagliflozin vs metformin, from baseline to 24 months, on HbA1C (%)
Fasting blood glucose
Effects of dapagliflozin vs metformin, from baseline to 24 months, on fasting blood glucose (mmol/L)
Systolic and diastolic blood pressure
Effects of dapagliflozin vs metformin, from baseline to 24 months, on systolic and diastolic blood pressure (mmHg)
Body weight
Effects of dapagliflozin vs metformin, from baseline to 24 months, on body weight (kg)
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
Full Information
NCT ID
NCT05345327
First Posted
April 19, 2022
Last Updated
August 21, 2023
Sponsor
The George Institute
Collaborators
The University of New South Wales, Monash University, University of Sydney
1. Study Identification
Unique Protocol Identification Number
NCT05345327
Brief Title
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Acronym
START
Official Title
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The George Institute
Collaborators
The University of New South Wales, Monash University, University of Sydney
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This study is a randomised, double blinded, community-based clinical trial and will be undertaken in primary care sites across Victoria, New South Wales and Queensland, Australia. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes, Renal decline, Metformin, Sodium Glucose Co-Transporter 2 inhibitor
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
994 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin 10mg
Arm Type
Experimental
Arm Description
1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years
Arm Title
Metformin XR 2000mg
Arm Type
Active Comparator
Arm Description
2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
SGLT2 inhibitor
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin
Primary Outcome Measure Information:
Title
Rate of decline in eGFR
Description
Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Urine albumin creatinine ratio
Description
Effects of dapagliflozin vs metformin, from baseline to 24 months, on urine albumin creatinine ratio (mg/g)
Time Frame
24 months
Title
Serum creatinine
Description
Effects of dapagliflozin vs metformin, from baseline to 24 months, on serum creatinine (umol/L)
Time Frame
24 months
Title
HbA1C
Description
Effects of dapagliflozin vs metformin, from baseline to 24 months, on HbA1C (%)
Time Frame
24 months
Title
Fasting blood glucose
Description
Effects of dapagliflozin vs metformin, from baseline to 24 months, on fasting blood glucose (mmol/L)
Time Frame
24 months
Title
Systolic and diastolic blood pressure
Description
Effects of dapagliflozin vs metformin, from baseline to 24 months, on systolic and diastolic blood pressure (mmHg)
Time Frame
24 months
Title
Body weight
Description
Effects of dapagliflozin vs metformin, from baseline to 24 months, on body weight (kg)
Time Frame
24 months
Title
Quality of life measured by EQ-5D-5L
Description
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
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel McGrath
Phone
+61 2 8052 4300
Email
rmcgrath@georgeinstitute.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Stanton
Email
sstanton@georgeinstitute.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Neal
Organizational Affiliation
The George Institute for Global Health (Sydney, Australia)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Clare Arnott
Organizational Affiliation
The George Institute for Global Health (Sydney, Australia)
Official's Role
Study Chair
Facility Information:
Facility Name
The George Institute for Global Health
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2042
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel McGrath
Phone
61 2 8052 4597
Email
rmcgrath@georgeinstitute.org.au
First Name & Middle Initial & Last Name & Degree
Sarah Stanton
Email
sstanton@georgeinstitute.org.au
First Name & Middle Initial & Last Name & Degree
Bruce Neal
First Name & Middle Initial & Last Name & Degree
Clare Arnott
Facility Name
The George Institute for Global Health
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel McGrath
Phone
61 2 8052 4597
Email
rmcgrath@georgeinstitute.org.au
First Name & Middle Initial & Last Name & Degree
Sarah Stanton
Email
sstanton@georgeinstitute.org.au
First Name & Middle Initial & Last Name & Degree
Bruce Neal
First Name & Middle Initial & Last Name & Degree
Clare Arnott
Facility Name
Monash University
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Spark
Email
simone.spark@monash.edu
First Name & Middle Initial & Last Name & Degree
Zachary Flanagan
Email
Zachary.Flanagan@monash.edu
First Name & Middle Initial & Last Name & Degree
Sophia Zoungas
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
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