The START trial is a NHMRC-funded community-based clinical trial that will evaluate the comparative effects of the Sodium Glucose Co-Transporter 2 (SGLT2) inhibitor dapagliflozin compared to metformin, on annual decline in eGFR, when used as first-line therapy in people with type 2 diabetes.
The intervention will be evaluated by a pragmatic, multi-centre, double-blind, randomised trial involving at least 60 primary health care practices across NSW, VIC and QLD. The sample size of 994 participants (497 intervention and 497 control groups) will detect a difference in eGRF slope between dapagliflozin and metformin over a 24-month period. Changes in urine albumin creatinine ratio, serum creatinine, HbA1c, fasting blood glucose, systolic and diastolic blood pressure, body weight, quality of life and anxiety and depression will be monitored.
Geographic location the project wishes to recruit from (State/Area):
Sydney and surrounds, Melbourne and surrounds, Brisbane and surrounds, regional NSW, VIC, QLD
Name of investigators/Contact person.
Lead Investigator: Professor Bruce Neal, The George Institute for Global Health, Sydney, Australia
Principal Investigator: Associate Professor Clare Arnott, The George Institute for Global Health, Australia
Principal Investigator: Professor Sophia Zoungas, Monash University, Melbourne, Australia
GP Principal Investigator: Professor Tim Usherwood, University of Sydney, Sydney, Australia
Contact details:
Dr Lauren Houston, The George Institute for Global Health, Sydney, Australia.
Telephone: +61 2 8052 4343
Email: START-trial@georgeinstitute.org.au
Brief Description of participants/practices sought (inclusion and exclusion criteria, or a hyperlink to this):
GP Practices based in Sydney, Melbourne, Brisbane and their surrounds who can assist START trial staff to identify potentially eligible participants from their GP Practice who meet the following eligibility criteria:
Inclusion criteria:
- Diagnosis of type 2 diabetes;
- Aged ≥18 years;
- Body mass index > 18.5 kg/m2;
- Drug naïve, or managed with metformin monotherapy and willing to be randomised;
- eGFR ≥30 ml/min/1.73m2; and
- Signed informed consent.
Exclusion criteria:
- Immediate need for rapid intensification of glucose lowering therapy due to marked hyperglycaemia;
- There is a definite indication for, or contraindication to, either metformin or SGLT2 inhibitor;
- Established coronary artery disease or heart failure; or
- Pregnant or breast-feeding.
Commencement date of the project: 20 June 2022
Closing date for recruitment: 30 June 2025, depending on the rate of recruitment.
Time involvement of GPs and/or practice staff, and/or patients:
The role of your GP practice in the START Trial is minimal. The GP practice/GPs main trial responsibilities include assisting START trial staff to identify potential participants and to confirm their patients are suitable to participate in the START trial. Trial participants will attend follow-up visits every 16-20 weeks: four face-to-face and five telephone or video conference visits over a period of approximately 2 years.
Compensation offered:
$150 per randomised participant to support administrative costs at GP Practice.
Availability of CPD points:
GPs can self-record their participation in START as a GP Co-Investigator under a Professional Leadership Activity and claim CPD hours.