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

PHASE3RECRUITING

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Diagnosis of T2D
  2. Aged ≥18 years
  3. Body mass index > 18.5 kg/m2
  4. Drug naïve, or managed with metformin monotherapy and willing to be randomised to either dapagliflozin or metformin
  5. eGFR ≥45 ml/min/1,73m2
  6. Signed informed consent

Exclusion criteria

  1. Have an immediate need for rapid intensification of glucose lowering therapy due to marked hyperglycaemia
  2. There is a definite indication for, or contraindication to, either metformin or SGLT2 inhibitor
  3. 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)
  4. Pregnant or breast-feeding

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

PREVENTION

phase

Phase

    PHASE3

trial

Study ID

NCT05345327

Intervention or treatment

DRUG: Dapagliflozin

DRUG: Metformin

Conditions

  • Type 2 Diabetes

  • Condition: Type 2 Diabetes

  • DRUG: Dapagliflozin and other drugs

  • Sydney, New South Wales, Australia and more

  • Sponsor: The George Institute

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

The George Institute for Global Health

Select from list below to view details:

  • The George Institute for Global Health

    Sydney, New South Wales, Australia

  • The George Institute for Global Health

    Brisbane, Queensland, Australia

  • Monash University

    Melbourne, Victoria, Australia

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Who is running the clinical trial?

TGI

The George Institute

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Dapagliflozin 10mg
  • 1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years
Drug: Dapagliflozin
    ACTIVE_COMPARATOR: Metformin XR 2000mg
    • 2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years
    Drug: Metformin

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      Rate of decline in eGFRChange in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year24 months

      Secondary Outcome

      MeasureDescriptionTime Frame
      Urine albumin creatinine ratioEffects of dapagliflozin vs metformin, from baseline to 24 months, on urine albumin creatinine ratio (mg/g)24 months
      Serum creatinineEffects of dapagliflozin vs metformin, from baseline to 24 months, on serum creatinine (umol/L)24 months
      HbA1CEffects of dapagliflozin vs metformin, from baseline to 24 months, on HbA1C (%)24 months
      Fasting blood glucoseEffects of dapagliflozin vs metformin, from baseline to 24 months, on fasting blood glucose (mmol/L)24 months
      Systolic and diastolic blood pressureEffects of dapagliflozin vs metformin, from baseline to 24 months, on systolic and diastolic blood pressure (mmHg)24 months
      Body weightEffects of dapagliflozin vs metformin, from baseline to 24 months, on body weight (kg)24 months
      Quality of life measured by EQ-5D-5LEffects of dapagliflozin vs metformin, from baseline to 24 months, on quality of life measured by European Quality of Life 5-Dimensional Assessment, 5-Level version24 months
      Anxiety and depression symptoms measured by HADSEffects of dapagliflozin vs. metformin, from baseline to 24 months, on anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS)24 months
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes

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