Health Trials

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

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe George Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin

    Drug

    SGLT2 inhibitor

  • Metformin

    Drug

    Metformin

Treatment groups

994 Participants
are divided into 2 treatment groups
Group A: Dapagliflozin 10mgExperimental treatment 1 intervention
Group B: Metformin XR 2000mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of decline in eGFR

Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year

Time frame
24 months

Secondary outcomes

1

Urine albumin creatinine ratio

Effects of dapagliflozin vs metformin, from baseline to 24 months, on urine albumin creatinine ratio (mg/g)

Time frame
24 months
2

Serum creatinine

Effects of dapagliflozin vs metformin, from baseline to 24 months, on serum creatinine (umol/L)

Time frame
24 months
3

HbA1C

Effects of dapagliflozin vs metformin, from baseline to 24 months, on HbA1C (%)

Time frame
24 months
4

Fasting blood glucose

Effects of dapagliflozin vs metformin, from baseline to 24 months, on fasting blood glucose (mmol/L)

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The George Institute

Lead sponsor

The University of New South Wales

Collaborator

Monash University

Collaborator

University of Sydney

Collaborator

Source ClinicalTrials.gov
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