This study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Aurora St Luke's Medical Center, Endocrine & Diabetes Center
Milwaukee, Wisconsin, United States
LMC Endocrinology Centres (Barrie) Ltd
Barrie, Ontario, Canada
LMC Endocrinology Centres (Bayview) Ltd
Toronto, Ontario, Canada
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months
Time frame: at 13 months
Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 4, 7, 10, 18, 24, 30 and 36 months
Time frame: 36 months
Measure: Change from baseline of fasted C-peptide at 4, 7, 10, 13, 18, 24, 30 and 36 months
Time frame: 36 months
Measure: number of hypoglycemic events
Time frame: 36 months
Measure: daily insulin dose
Time frame: 36 months
Measure: anti-ACZ885 antibodies
Time frame: 36 months
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