UST1D2 Study

Global News | B.C. researchers looking for participants in potentially life-changing diabetes research

Summary

UST1D2 is randomized controlled trial of the effectiveness of a new medication in people with type 1 diabetes (T1D) aged 18 to 35 years, within 100 days of diagnosis.

Aim 

We are looking for young adults to help study the effects of a new study medication called ustekinumab in young adults recently diagnosed with type 1 diabetes. Ustekinumab is currently used for the treatment of psoriasis (which affects the skin), Crohn’s disease (an inflammatory bowel disease), and other autoimmune conditions.

Help us learn if this medication can delay or halt the damage to the pancreas of people recently diagnosed with type 1 diabetes, making it easier to achieve optimal diabetes control in the early years following diagnosis.

For this study, we are looking for:

  • Male or female participants aged 18 to 35 years, diagnosed with T1D
  • Ability to receive the first dose of study drug within 100 days of diagnosis of T1D
  • Evidence of body still making some insulin (we will measure this)
  • Ability to attend 11 study visits over 1.5 years

Treatment course and duration

Before being included in the study, we will perform a screening visit to test if your body is still able to make some insulin. If you choose to participate in the study, you will be randomized to receive either the study medication or a placebo. Odds of receiving the study drug is 2/3 (67%)

You will be asked to come for a totally of 11 study visits, including the screening visit. 

Study medication or placebo will be administered via IV infusion at a loading given at week 0. Thereafter, study medication or placebo will be injected under the skin at weeks 8, 16, 24, 32, 40 and 48 (7 doses total). Total duration of study is 78 weeks. In order to determine if your body is still able to produce some insulin a 2 hour Mixed Meal Tolerance Test (MMTT) will be conducted at screening, week 28, 52 and 78. You will also be asked to provide blood samples at study visits, and you will be asked to complete some questionnaires.

Other notes

All subjects will be provided Continuous Glucose Monitor (CGM - Dexcom G6) at no charge for the first 12 months of the study.  Grants to help cover the costs of accommodation and travel to Vancouver or Toronto may be available. (Note: participants local to the Vancouver or Toronto area are not eligible for these grants, but reasonable reimbursement for their other expenses will be provided).

Study locations 

Vancouver, B.C.

Principal Investigator:
Dr. Tom Elliott
BCDiabetes
400-210 West Broadway 
Vancouver B.C., V5Y 3W2

Study coordinator & primary contact:
Dr. Marla Inducil 
P: 604-628-7253 x 7011 
Email: minducil@bcdiabetes.ca  

BC Diabetes
 
Toronto, ON

Principal Investigator:
Dr. Bruce Perkins
Mount Sinai Hospital/UHN
60 Murray St, L5-253
Toronto, ON, M5T 3L9

Study coordinator and primary contact:
Andrej Orszag
P: (416)-586-4800 ext. 7625
Email: Andrej.Orszag@uhn.ca

Sinai Health