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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05345327

Acronym

START

Enrollment

994

Registered

2022-04-25

Start date

2023-01-01

Completion date

2026-06-30

Last updated

2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Diabetes, Renal decline, Metformin, Sodium Glucose Co-Transporter 2 inhibitor

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 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.

Interventions

DRUGDapagliflozin

SGLT2 inhibitor

DRUGMetformin

Metformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Rate of decline in eGFR	24 months	Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year

Secondary

Measure	Time frame	Description
Serum creatinine	24 months	Effects of dapagliflozin vs metformin, from baseline to 24 months, on serum creatinine (umol/L)
HbA1C	24 months	Effects of dapagliflozin vs metformin, from baseline to 24 months, on HbA1C (%)
Fasting blood glucose	24 months	Effects of dapagliflozin vs metformin, from baseline to 24 months, on fasting blood glucose (mmol/L)
Urine albumin creatinine ratio	24 months	Effects of dapagliflozin vs metformin, from baseline to 24 months, on urine albumin creatinine ratio (mg/g)
Body weight	24 months	Effects of dapagliflozin vs metformin, from baseline to 24 months, on body weight (kg)
Quality of life measured by EQ-5D-5L	24 months	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
Anxiety and depression symptoms measured by HADS	24 months	Effects of dapagliflozin vs. metformin, from baseline to 24 months, on anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS)
Systolic and diastolic blood pressure	24 months	Effects of dapagliflozin vs metformin, from baseline to 24 months, on systolic and diastolic blood pressure (mmHg)

Countries

Australia, Sri Lanka

Contacts

Primary ContactEmma Zhang

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

Backup ContactSarah Stanton

sstanton@georgeinstitute.org.au

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026