Safety, Tolerability, and Efficacy of Immunomodulation With AT-1501 in Combination With Transplanted Islet Cells in Adults With Brittle T1D

Who can take part

• Men and women 18-65 years of age
• A diagnosis of T1D ≥5 years with onset of disease at <40 years of age
• Involvement in appropriate diabetes management in accordance with the standard of care, 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 unexplained SHEs
• At least 3 unexplained SHEs not secondary to a missed meal or dosing error, in the 12 months prior to Screening
• Glycosylated hemoglobin (HbA1c) level greater than 7% (53 mmol/mol) and less than 9.5% (80 mmol/mol) inclusive
• 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
• Impaired awareness of hypoglycemia (IAH) 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

Who cannot take part

• Any previous solid organ or islet allotransplant
• Body mass index (BMI) >30 kg/m2
• Insulin requirement >1.0 unit/kg/day or <15 units/day