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

PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-01-01

Primary completion: 2026-06-30

Study completion finish: 2026-06-30

Study type

PREVENTION

Phase

PHASE3

Trial ID

NCT05345327

Intervention or treatment

DRUG: Dapagliflozin

DRUG: Metformin

Conditions

• Type 2 Diabetes

Condition: Type 2 Diabetes
DRUG: Dapagliflozin and other drugs
Sydney, New South Wales, Australia and more
Sponsor: The George Institute

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

The George Institute for Global Health

Research sites nearby

Select from list below to view details:

The George Institute for Global Health
Sydney, New South Wales, Australia
The George Institute for Global Health
Brisbane, Queensland, Australia
Monash University
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dapagliflozin 10mg 1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years	DRUG: Dapagliflozin SGLT2 inhibitor
ACTIVE_COMPARATOR: Metformin XR 2000mg 2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years	DRUG: Metformin Metformin

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Urine albumin creatinine ratio	Effects of dapagliflozin vs metformin, from baseline to 24 months, on urine albumin creatinine ratio (mg/g)	24 months
Serum creatinine	Effects of dapagliflozin vs metformin, from baseline to 24 months, on serum creatinine (umol/L)	24 months
HbA1C	Effects of dapagliflozin vs metformin, from baseline to 24 months, on HbA1C (%)	24 months
Fasting blood glucose	Effects of dapagliflozin vs metformin, from baseline to 24 months, on fasting blood glucose (mmol/L)	24 months
Systolic and diastolic blood pressure	Effects of dapagliflozin vs metformin, from baseline to 24 months, on systolic and diastolic blood pressure (mmHg)	24 months
Body weight	Effects of dapagliflozin vs metformin, from baseline to 24 months, on body weight (kg)	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	24 months

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes