Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05345327

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

Led by The George Institute · Updated on 2024-12-20

994

Participants Needed

8

Research Sites

182 weeks

Total Duration

On this page

Sponsors

T

The George Institute

Lead Sponsor

T

The University of New South Wales

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Type 2 Diabetes
  • Aged 18 years or older
  • Body mass index greater than 18.5 kg/m2
  • Drug naive or managed with metformin monotherapy and willing to be randomized to dapagliflozin or metformin
  • Estimated glomerular filtration rate (eGFR) of 45 ml/min/1.73m2 or higher
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Need for rapid intensification of glucose lowering therapy due to marked hyperglycemia
  • Definite indication for or contraindication to either metformin or SGLT2 inhibitor
  • Documented coronary artery disease (previous acute coronary syndrome, coronary stent, or bypass surgery)
  • Documented heart failure (based on hospital admission, specialist diagnosis, or imaging)
  • Pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

The George Institute for Global Health

Sydney, New South Wales, Australia, 2042

Actively Recruiting

2

The George Institute for Global Health

Brisbane, Queensland, Australia, 4000

Actively Recruiting

3

Monash University

Melbourne, Victoria, Australia, 3004

Actively Recruiting

4

National Hospital - Galle

Galle, Southern Province, Sri Lanka, 80000

Not Yet Recruiting

5

National Hospital of Sri Lanka 1

Colombo, Sri Lanka, 00700

Actively Recruiting

6

National Hospital of Sri Lanka 2

Colombo, Sri Lanka, 00700

Not Yet Recruiting

7

Jaffna Teaching Hospital

Jaffna, Sri Lanka, 40000

Actively Recruiting

8

Kandy National Hospital

Kandy, Sri Lanka, 20000

Actively Recruiting

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Research Team

E

Emma Zhang

CONTACT

S

Sarah Stanton

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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