Safety, Tolerability and Efficacy of Immunomodulation With AT-1501 in Islet Cell Transplantation

Inclusion Criteria

• •1. Men and women 18-65 years of age
• •2. A diagnosis of T1D ≥5 years with onset of disease at \<40 years of age
• •3. Involvement in intensive diabetes management as directed by an endocrinologist or diabetologist with at least 3 clinical evaluations within the 12 months prior to Screening; using an insulin pump or multiple daily injection (MDI) insulin therapy; and, unable to achieve acceptable metabolic control because of the occurrence of severe hypoglycemia
• •4. At least 2 unexplained SHEs not secondary to a missed meal or dosing error, etc., in the 12 months prior to Screening
• •5. Glycosylated hemoglobin (HbA1c) level greater than 7% (53 mmol/mol) and less than 9.5% (80 mmol/mol) inclusive
• •6. Absence of stimulated C peptide (\< 0.3 ng/mL) in response to a mixed meal tolerance test (MMTT) measured at 60 and 90 minutes after the start of consumption
• •7. Reduced awareness of hypoglycemia as defined by a Clarke Score \[Clarke 1995\] of 4 or more at the time of Screening, during the Screening period and within the last 6 months prior to the transplant