The study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell regeneration. The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and insulin production.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
Unnamed facility
Basel, Switzerland
Unnamed facility
Zurich, Switzerland
Change in beta-cell function as measured by change in C-peptide level during thd MMTT (Mixed meal tolerance test) at Day 112 compared to baseline (Day 0 pre-dose)
Time frame: Day 0 pre-dose and Day 112
Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.
Time frame: Day 0 (baseline) through Day 364
Change in insulin requirements
Time frame: Day -3 through Day 0 pre-dose and Day 109 through Day 112)
Change in HbA1c levels
Time frame: Day 0 pre-dose and Day 112
Change in fasting glucose
Time frame: Day 0 pre-dose and Day 112
Change in fasting glucagon and cortisol
Time frame: Day 0 pre-dose and Day 112
Change in systemic inflammation markers
Time frame: Day 0 pre-dose and Day 112
Change in meal-stimulated GLP-1 and GIP
Time frame: Day 0 pre-dose and Day 112
Change in lipids profile
Time frame: Day 0 pre-dose and Day 112
Measurement of serum concentrations of XOMA 052
Time frame: Day 0 pre-dose, Day 28, Day 56, Day 84, Day 112, Day 182, and Day 364
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