The MT-101-101 study is a phase 1 clinical trial (first-time in humans) testing the safety and dosing of a new treatment for autoimmune diseases including type 1 diabetes.
The MT-101-101 study will test the safety and dosing of a potential new treatment for autoimmune diseases, including type 1 diabetes.
Testing of the study medication in the laboratory and animals show it can prevent the immune system’s attack on the body’s insulin-producing cells, which causes type 1 diabetes. Initial studies confirmed its safety in people without type 1 diabetes; it now needs to be tested in those with type 1 diabetes.
The results of this study will assist researchers to determine the optimal dose for future studies with this drug.
Who can get involved
People aged between 18 and 45 years
Diagnosed with type 1 diabetes
Currently using insulin (via injections or by pump)
Living in Victoria or Queensland
Treatment
People with type 1 diabetes will receive two doses of the study medication through a vein in their arm 1 month apart.
Study visits
Study visits
The study will involve 15 visits to the clinic over 6 months. The first (screening) visit will take up to 2 hours and involve a physical examination and blood tests to assess eligibility.
If eligible, participants will be asked to return to the clinic within 60 days to have a meal test and receive the first dose of study medication. This visit will last around 8 hours. It is followed by 3 short visits over the next 3 weeks for further blood samples and health checks.
Participants receive the second dose of study medication at 1 month and then enter a follow-up phase that includes meal tests at months 3 and 6 and additional visits for blood samples and health checks.
Trial sites:
St Vincent’s
Austin
Royal Melbourne Hospital
Risks
The study medication was well-tolerated by 24 people without type 1 diabetes. Comprehensive safety data in patients with type 1 diabetes is not yet available, and as with all medications, side effects may occur. The study team will closely monitor participants and provide treatment for any side effects.
Benefits
Every participant will receive 2 doses of study medication. This is the first study in participants with type 1 diabetes, so it is not yet known if the study drug can delay progression of and/or improve diabetes. Regardless of whether participants receive any direct benefit, involvement in this study will help determine if the study medicine will move to the next stage of clinical testing and will contribute valuable scientific knowledge that may lead to new treatments for type 1 diabetes.
Participants in this trial will be reimbursed for their time and travel.
Find out more
Contact the ATIC team via email, phone 03 9231 2480 or visit the ATIC website.
This study has received ethical approval from the Alfred Hospital Ethics Committee:
