Stephen Gitelman | University of California San Francisco | San Francisco, CA

Sanford Research | Sioux Falls, SD

The primary objective of the DESIGNATE study is to identify a safe, metabolically favorable, dosing regimen for siplizumab in patients with type 1 diabetes mellitus (T1DM) that induces changes in T cell phenotypes observed with alefacept therapy in new-onset T1DM.

Participants will be age 8-45 and within 18 months of T1DM diagnosis.

DESIGNATE is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in new onset T1DM.

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. 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.

You may be eligible to participate in the DESIGNATE Study if you:

• Are between the ages of 8 and 45
• Have been diagnosed with type 1 diabetes within the last 18 months
• Are in good general health