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

The George Institute

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin; Drug: Dapagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT05345327

P01148

Details and patient eligibility

About

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.

Full 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.

Enrollment: 994 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

994 participants in 2 patient groups

Dapagliflozin 10mg

Experimental group

Description:

1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years

Treatment:

Drug: Dapagliflozin

Metformin XR 2000mg

Active Comparator group

Description:

2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years

Treatment:

Drug: Metformin