Clinical response
Tecan
DISEASE PROGRESSION
Stimulated C-peptide secretion was assessed by the 2-h MMTT method at screening, Week 12, and Week 24. MMTT was performed in fasting patients using Ensure Plus (220 mL; 330 kcal; Abbott Laboratories) as a standardized meal administered between 07:00 h and 10:00 h, with 5 collection time points (before the meal and 30 ± 3 min, 60 ± 3 min, 90 ± 5 min and 120 ± 5 min after the meal). Patients were asked to withhold taking slow-acting insulin on the morning of the test but were allowed to take prandial insulin up to 2 h before the test. An additional clinical parameter was derived based on the difference between the normalized area under the curve (AUC) measured during MMTT tests and the AUC expected values given the general disease progression, as described previously [Antibody levels were assessed using blood samples collected at screening and at Weeks 0, 6, 12, and 24. Autoantibodies directed against insulin, IA-2, and GAD were detected using radioimmunoassays (Euroimmun, Lubeck, Germany) and a gamma counter; autoantibodies directed against ZnT8 were detected using enzyme-linked immunosorbent assay (RSR Limited, Cardiff, UK) and Tecan microplate reader (Tecan Group, Manedorf, Switzerland); all assays were used according to manufacturers’ instructions.