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

Phase 3RecruitingNCT05345327

The George Institute994 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

994

Conditions

Type 2 Diabetes

Interventions

DapagliflozinDRUG

SGLT2 inhibitor

MetforminDRUG

Metformin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

The George Institute for Global Health

Sydney, New South Wales, Australia

RECRUITING

The George Institute for Global Health

Brisbane, Queensland, Australia

RECRUITING

Monash University

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

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

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

Serum creatinine

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

Time frame: 24 months

HbA1C

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

Time frame: 24 months

Fasting blood glucose

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

Time frame: 24 months

Systolic and diastolic blood pressure

Effects of dapagliflozin vs metformin, from baseline to 24 months, on systolic and diastolic blood pressure (mmHg)

Time frame: 24 months

Body weight

Effects of dapagliflozin vs metformin, from baseline to 24 months, on body weight (kg)

Time frame: 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

Central Contacts

Emma Zhang

CONTACT

+61 2 8052 4337 ezhang1@georgeinstitute.org.au

Sarah Stanton

CONTACT

sstanton@georgeinstitute.org.au

Data from ClinicalTrials.gov

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