About the Study
Struggling with type 2 diabetes? Join this research study to explore a new potential treatment that aims to lower blood sugar and body weight. With type 2 diabetes significantly increasing the risk of cardiovascular disease, finding effective treatments is crucial. This study will compare different doses of a new treatment to see how well they help manage blood sugar and reduce body weight.
Participants will play a vital role in potentially transforming diabetes care while receiving close health monitoring and support. If you have type 2 diabetes, your involvement could help pave the way for better treatments and improved health outcomes. Join researchers in making a difference!
Why Participate?
- Participants will receive a new potential treatment for type 2 diabetes at no cost.
- Participants will be reimbursed for any reasonable travel, parking, meals, and other expenses associated with the research project visits.
- Participants will be contributing valuable information that may benefit those with type 2 diabetes in the future.
- Participants will be helping to advance medical research.
Your Rights
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
- Any information that you provide will be kept strictly confidential, except as required by law.
- Qualified health professionals will monitor your health as it relates to the study.
Who Can Participate?
- People aged 18-75 who are diagnosed with type 2 diabetes mellitus for at least greater than 180 days
- Must have been on a stable daily dose of Metformin with or without SGLT2 inhibitors such as Jardiance, Jardiamet, Forxiga and Xigduo XR, etc.
- Must have HbA1c of 7.5% – 10%
- Must not have been diagnosed with diabetic retinopathy or maculopathy
- Must not have had a weight change of more than 5% in the last 90 days.
- Must not have any of the following medical conditions: pancreatitis, kidney impairment, hypokalemia, known liver disease or a history of gastroparesis
- Must not have any major cardiovascular procedures planned
- Must not have received treatment with any medication for diabetes or obesity within the 90 days prior to screening. Short-term insulin use may be permitted.
- Must not have a scheduled major surgery in the next few months
- Must be able and willing to participate in the study for approximately 42 weeks
More Study Details
The study team will explain the research in its entirety but some details are:
- Participants will inject the study medicine with an easy-to-use injection pen once a week, attend regular study-related health checks and medical tests including having blood samples taken, and maintain a dosing diary and complete questionnaires.
- Participants will keep in contact with the study staff during the study at regularly scheduled visits for a duration of one year, inform the study staff about any health problems, symptoms, new diseases, and medications taken during the research project, and fast for 8 hours before some hospital/clinic visits.
- Participants will return all study medicine at selected visits, follow the study doctor’s instructions, attend all scheduled visits and phone calls, inform the study doctor if unable to attend, fill in a diary and bring it to every visit, inform their local doctor about participation, continue taking usual medicines, report any changes to the study doctor, wear a CGM device, and provide informed consent before any study-related activities.
About the Research Centre:
Macquarie University
Macquarie University is a leading public research university renowned for its commitment to academic excellence and innovative research. Offering a wide range of programs across disciplines such as business, education, law, science and the arts, the university is dedicated to fostering knowledge and embracing different views. They also integrate clinical care with teaching and research, improving patient outcomes and advancing healthcare through its academic health sciences center, MQ Health.
Box Hill Hospital
Box Hill Hospital in Melbourne is one of the seven hospitals that are governed within the Eastern Health network which provides health care services across the Eastern metropolitan area of Victoria. The hospital provides a wide range of healthcare services including: emergency care, general and specialist medicine, intensive care, mental health services, maternity services, post-acute care programs, surgery, teaching and research. Researchers here are focused to help pave the way for better treatments and improved health outcomes for people and communities that are diverse in culture, age, socio-economic status and healthcare needs.
Illawarra Shoalhaven Diabetes Service Clinical trial & Research Unit (ISLHD)
Illawarra Diabetes Service is dedicated to providing comprehensive care and education for individuals with diabetes. The clinic focuses on empowering patients to manage their condition through education on key areas such as glucose monitoring, achieving glycaemic control, and understanding diabetes treatments, including lifestyle adjustments and medications like insulin. The service provides personalized guidance on hypoglycaemia management, sick day protocols, and navigating special situations such as exercise, driving, and pregnancy. Regular screening is emphasized to help patients maintain overall health and prevent long-term complications. By offering expert care and support, Illawarra Diabetes Service helps patients achieve better health outcomes and maintain a balanced lifestyle.
Royal North Shore Hospital
RNSH Hospital is a leading institution in endocrine medicine, renowned for its exceptional team of specialists and cutting-edge research initiatives. The hospital is dedicated to advancing the field of endocrinology through rigorous scientific inquiry and innovative clinical trials.
Currently, RNSH Hospital is at the forefront of a pivotal clinical trial for NNC0519-0130, a promising investigational treatment for Type 2 diabetes. This trial represents a significant step forward in the quest to improve diabetes management and patient outcomes. The highly qualified team at RNSH Hospital is spearheading this research with a focus on precision, safety, and efficacy.
Royal Melbourne Hospital
The Royal Melbourne Hospital (RMH), established in 1848 as Victoria’s first public hospital, has grown into one of the largest healthcare providers in Australia. RMH delivers a wide range of specialist medical, surgical, and mental health services, as well as rehabilitation, aged care, specialist clinics, and community programs. Their commitment to research is an integral part of RMH’s purpose: advancing health for everyone, every day. They remain at the forefront, driving both compassionate care and scientific breakthrough to enhance the wellbeing of Melbourne’s diverse community. Their approach is simple and know as The Melbourne Way. They put people first, lead with kindness and achieve excellence together.
This study has been reviewed and approved by the Monash HREC and Macquarie University HREC.