SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— START  

Official title:

SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345327
• Other study ID #: P01148
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: August 2023
• Source: The George Institute
• Contact: Rachel McGrath
• Phone: +61 2 8052 4300
• Email: rmcgrath[@]georgeinstitute.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 994
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Dapagliflozin
SGLT2 inhibitor
• Metformin
Metformin

Locations

Country	Name	City	State
Australia	The George Institute for Global Health	Brisbane	Queensland
Australia	Monash University	Melbourne	Victoria
Australia	The George Institute for Global Health	Sydney	New South Wales

Sponsors (4)

Lead Sponsor	Collaborator
The George Institute	Monash University, The University of New South Wales, University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of decline in eGFR	Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year	24 months
Secondary	Urine albumin creatinine ratio	Effects of dapagliflozin vs metformin, from baseline to 24 months, on urine albumin creatinine ratio (mg/g)	24 months
Secondary	Serum creatinine	Effects of dapagliflozin vs metformin, from baseline to 24 months, on serum creatinine (umol/L)	24 months
Secondary	HbA1C	Effects of dapagliflozin vs metformin, from baseline to 24 months, on HbA1C (%)	24 months
Secondary	Fasting blood glucose	Effects of dapagliflozin vs metformin, from baseline to 24 months, on fasting blood glucose (mmol/L)	24 months
Secondary	Systolic and diastolic blood pressure	Effects of dapagliflozin vs metformin, from baseline to 24 months, on systolic and diastolic blood pressure (mmHg)	24 months
Secondary	Body weight	Effects of dapagliflozin vs metformin, from baseline to 24 months, on body weight (kg)	24 months
Secondary	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	24 months