About the study
TRIUMPH-2 is a weight loss drug trial for the treatment of excess weight in people with Diabetes Type 2 and Obstructive Sleep Apnoea.
What's involved
You will be provided with a complete participant information sheet and will have the opportunity to discuss the study with doctors prior to making any decisions about enrolling in this trial.
If you are eligible for this study you will be asked to attend a screening visit and sign a consent form after speaking with one of the study doctors. There will also be screening eye photography. If you are eligible to continue you will be randomised to either drug or placebo, given dietary advice and be given a diary to fill in and a glucometer to take your own blood glucose at home.
During the study you will visit the Woolcock Institute of Medical Research monthly for approximately 1 year and 9 months. This will be to undergo test and pick up further drug or placebo. Some of these appointments can be done via Telehealth. You will be given dietary counselling by an Accredited Practicing Dietitian (APD) throughout the study and your weight will be taken at each visit.
A complete list of procedures and visits will be available in the participant information sheet.
Visits required
Approximately 24 visits over 84 weeks. Some of these are via Telehealth.
Eligibility criteria
- Aged 18 years or older
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Have overweight or obesity or a BMI of 27 or higher
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Have type 2 diabetes
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Possible obstructive sleep apnoea
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Have been unable to lose bodyweight on your own
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Are willing to give yourself weekly injections
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Are ready to take part for the full length of the study (1 year and 9 months)
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Note: this is a summary and a complete list of inclusion and exclusion criteria is available on request.
Chief investigator: Professor Ron Grunstein
Ethics approvals:
The Monash Health Human Research Ethics Committee has reviewed and approved this clinical trial (Reference Number: RES-23-0000-295A) which is a registered human ethics committee in accordance with the National Statement on Ethical Conduct of Human Research (2007) incorporating all updates.
Find out more
Contact: Dr Claudia Harper (PhD)
Call: (02) 9805 3297
Email: claudia.harper@woolcock.org.au
