Siplizumab for Type 1 Diabetes
(DESIGNATE Trial)
Trial Summary
What is the purpose of this trial?
This is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in individuals aged 8-45 years with a Type 1 diabetes mellitus (T1DM) diagnosis. within 18 months of V0. Participants will be randomized 1:1:1:1 to one of four possible siplizumab dosing arms. All dosing arms will receive weekly siplizumab doses for a total of 12 weeks. After the completion of treatment, participants will undergo follow-up visits at weeks 12, 24, 36 and 52 which include longitudinal MMTTs. If indicated, participants will enter into long-term safety monitoring for up to an additional 48 weeks. Blood samples for mechanistic analyses will be obtained during the treatment phase and thereafter. Adults aged 18- 45 will be enrolled initially at the study sites. The primary objective is to identify a safe, metabolically favorable, dosing regimen for siplizumab in patients with type 1 diabetes that induces changes in T cell phenotypes observed with alefacept therapy in new-onset T1DM. The secondary objectives are to: 1. Assess the safety profile of siplizumab in recently diagnosed T1DM. 2. Assess the effects of siplizumab on residual beta cell function in recently diagnosed T1DM participants.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it excludes those who have used certain medications that affect glucose tolerance or insulin resistance recently. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the drug Siplizumab for Type 1 Diabetes?
There is no direct data on the effectiveness of Siplizumab for Type 1 Diabetes in the provided research. However, similar treatments like anti-CD3 monoclonal antibodies have shown promise in preserving beta-cell function in Type 1 Diabetes, suggesting potential for Siplizumab, which is also an anti-CD3 monoclonal antibody.12345
How is the drug Siplizumab unique for treating Type 1 Diabetes?
Siplizumab is unique because it targets the CD2 receptor on T cells, which is different from other treatments that focus on different immune pathways or cell types. This approach aims to modulate the immune system's attack on insulin-producing cells in the pancreas, offering a novel mechanism compared to existing therapies.13467
Research Team
Stephen Gitelman, M.D.
Principal Investigator
University of California San Francisco, School of Medicine: Diabetes Center
Eligibility Criteria
This trial is for individuals aged 8-45 with Type 1 diabetes diagnosed within the last 18 months. They must have completed their primary COVID-19 vaccination series, not be on certain diabetes or immunosuppressive medications, and cannot have a history of severe reactions to monoclonal antibodies or significant cardiovascular disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly siplizumab doses for a total of 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including longitudinal MMTTs
Long-term safety monitoring
Participants may enter into long-term safety monitoring for up to an additional 48 weeks if indicated
Treatment Details
Interventions
- Siplizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor