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

Last updated: December 17, 2024
Sponsor: The George Institute
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

Dapagliflozin

Metformin

Clinical Study ID

NCT05345327
P01148
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 toeither dapagliflozin or metformin;

  • eGFR ≥45 ml/min/1,73m2; and

  • Signed informed consent.

Exclusion

Exclusion Criteria:

  • Have an immediate need for rapid intensification of glucose lowering therapy due tomarked hyperglycaemia; or

  • There is a definite indication for, or contraindication to, either metformin orSGLT2 inhibitor; or

  • They have clearly documented coronary artery disease (defined as a previous acutecoronary syndrome, coronary stent or bypass surgery) or clearly documented heartfailure (defined on the basis of a hospital admission, specialist diagnosis or anechocardiogram or other imaging modality); or

  • Pregnant or breast-feeding.

Study Design

Total Participants: 994
Treatment Group(s): 2
Primary Treatment: Dapagliflozin
Phase: 3
Study Start date:
January 01, 2023
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • The George Institute for Global Health

    Sydney, New South Wales 2042
    Australia

    Active - Recruiting

  • The George Institute for Global Health

    Brisbane, Queensland 4000
    Australia

    Active - Recruiting

  • Monash University

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • National Hospital - Galle

    Galle, Southern Province 80000
    Sri Lanka

    Site Not Available

  • National Hospital of Sri Lanka 2

    Colombo, 00700
    Sri Lanka

    Site Not Available

  • National Hospital of Sri Lanka 1

    Colombo 10, 00700
    Sri Lanka

    Active - Recruiting

  • Jaffna Teaching Hospital

    Jaffna, 40000
    Sri Lanka

    Active - Recruiting

  • Kandy National Hospital

    Kandy, 20000
    Sri Lanka

    Active - Recruiting

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