| Outcome Measures: |
Primary: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period, Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs led to study treatment discontinuation, and SAEs. On-treatment period is defined as from date of first administration of study treatment to 98 days after date of last administration of study treatment (including start and stop date)., Adverse events were reported from first dose of study treatment to 98 days after last dose, up to a maximum duration of approximately 65 weeks.|Normalized Stimulated C-peptide Area Under the Curve (AUC) at Week 52, The mixed meal tolerance test (MMTT) has appropriate sensitivity to detect residual insulin secretion and beta cell function. In the MMTT, following an 8-10 hour overnight fast, a weight-based liquid meal provided as 6 mL/kg (maximum 360 mL) of mixed meal, ingested over 5 min with timed blood samples for glucose and C peptide determination obtained 10 min prior to ingestion (t = -10), at baseline (t = 0), and at 15, 30, 60, 90, and 120 min after consumption of the liquid meal. The time collections for post load samples are based on the start time of the mixed meal. Stimulated C-peptide AUC by the standard MMTT, normalized by the duration of measurements, was analyzed with a mixed model repeated measures analysis., At Week 52, 10 min prior to ingestion, at start of ingestion, and at 15, 30, 60, 90, and 120 min after consumption of the liquid meal. | Secondary: Maximum Plasma Concentration (Cmax) of CFZ533 After Intravenous (IV) Administration, Cmax is defined as the maximum (peak) observed concentration following a dose. Free CFZ533 plasma concentrations were determined using a validated target-based sandwich enzyme-linked immunosorbent assay (ELISA) method., Day 1: Pre-dose and 90 minutes after the start of the IV infusion (duration of the infusion is 30 minutes).|Trough Plasma Concentration (Ctrough) of CFZ533, Ctrough is the observed plasma concentration that is just prior to the beginning of, or at the end of a dosing interval. Free CFZ533 plasma concentrations were determined using a validated target-based sandwich ELISA method., Pre-dose at: Day 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56, Week 60, Week 64, Week 68, Week 72.|Time to Reach Maximum Plasma Concentration (Tmax) of CFZ533 After IV Administration, Tmax is the time to reach maximum (peak) drug concentration after single-dose administration (time). Free CFZ533 plasma concentrations were determined using a validated target-based sandwich ELISA method. Theoretical sampling time points were used to report Tmax., Day 1: Pre-dose and 90 minutes after the start of the IV infusion (duration of the infusion is 30 minutes).|Number of Participants With Full or Partial Remission, Full remission is defined by HbA1c ≤ 6.5% (48 mmol/mol) and no exogenous insulin use at Week 52. Partial remission 1 is defined by Insulin Dose Adjusted HbA1c (IDAA1c) ≤ 9.0 at Week 52. Partial remission 2 is defined by HbA1c \< 7.0% (53 mmol/mol) and total daily insulin dose \<0.5 units per kg per day at Week 52. Two different criteria for partial remission were considered, and patients were assessed separately according to each criterion., Week 52|Normalized Stimulated C-peptide Area Under the Curve (AUC) at Week 72, The mixed meal tolerance test (MMTT) has appropriate sensitivity to detect residual insulin secretion and beta cell function. In the MMTT, following an 8-10 hour overnight fast, a weight-based liquid meal provided as 6 mL/kg (maximum 360 mL) of mixed meal, ingested over 5 min with timed blood samples for glucose and C peptide determination obtained 10 min prior to ingestion (t = -10), at baseline (t = 0), and at 15, 30, 60, 90, and 120 min after consumption of the liquid meal. The time collections for post load samples are based on the start time of the mixed meal. Stimulated C-peptide AUC by the standard MMTT, normalized by the duration of measurements, was analyzed with a mixed model repeated measures analysis., At Week 72, 10 min prior to ingestion, at start of ingestion, and at 15, 30, 60, 90, and 120 min after consumption of the liquid meal.
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| Locations: |
Novartis Investigative Site, Brussel, 1090, Belgium|Novartis Investigative Site, Edegem, 2650, Belgium|Novartis Investigative Site, Leuven, 3000, Belgium|Novartis Investigative Site, Liege, 4000, Belgium|Novartis Investigative Site, Augsburg, 86179, Germany|Novartis Investigative Site, Firenze, FI, 50139, Italy|Novartis Investigative Site, Milano, MI, 20132, Italy|Novartis Investigative Site, Ljubljana, 1525, Slovenia|Novartis Investigative Site, Malaga, Andalucia, 29010, Spain|Novartis Investigative Site, Esplugues De Llobregat, Barcelona, 08950, Spain|Novartis Investigative Site, La Coruna, Galicia, 15006, Spain|Novartis Investigative Site, Nottingham, NG7 2UH, United Kingdom
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