| Outcome Measures: |
Primary: Percentage of Patients With ADA, Percentage of the combined results of treatment-induced ADA-positive patients and treatment-boosted ADA-positive patients out of the total number of evaluable patients. ADA = antidrug antibodies., 104 days after the first dose | Secondary: Percentage of Patients With Treatment-induced ADA, Percentage of the total number of evaluable patients that were ADA negative at baseline and ADA positive after drug administration out of the total number of evaluable patients. ADA = antidrug antibodies, 104 days after the first dose|Percentage of Patients With Treatment-boosted ADA, Percentage of baseline ADA-positive patients with significant increases (≥5-fold) in ADA titre after drug administration out of the total number of evaluable patients. ADA = antidrug antibodies, 104 days after the first dose|Characterization of ADA Response - Neutralizing Activity, Percentage of ADA positive patients with ADA neutralizing activity. ADA = antidrug antibodies., 104 days after the first dose|Characterization of ADA Response - Titer of Neutralizing Activity, Titre of neutralizing activity of ADA positive patients. ADA = antidrug antibodies., 104 days after the first dose|Characterization of ADA Response - Cross-reactivity, Percentage of ADA positive patients with cross-reactivity towards endogenous glucagon. ADA = antidrug antibodies., 104 days after the first dose|Characterization of ADA Response - Timing, The timing of detected ADA response. ADA = antidrug antibodies., 104 days after the first dose|Characterization of ADA Response - Duration, The Duration of detected ADA response. ADA = antidrug antibodies., 104 days after the first dose|Pharmacokinetics - Area Under the Plasma Concentration Curve, Area under the plasma concentration curve (AUC) 0-30 minutes at visit 2 and 4 (days 0 and 14). Plasma PK concentrations were measured before dosing and at 5, 10 and 30 minutes after dosing., 0-30 minutes|Pharmacokinetics - Area Under the Plasma Concentration Curve, Area under the plasma concentration curve (AUC) 0-90 minutes at visit 2 and 4 (days 0 and 14). Plasma PK concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing., 0-90 minutes|Pharmacokinetics - Maximum Plasma Concentration, Maximum plasma concentration (Cmax) at visit 2 and 4 (days 0 and 14). Plasma PK concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing., 90 minutes|Pharmacokinetics - Time to Maximum Plasma Concentration, Time to maximum plasma concentration (Tmax) at visit 2 and 4 (days 0 and 14). Plasma PK concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing., 90 minutes|Pharmacodynamics - Area Under the Effect Curve, Plasma glucose profiles, area under the effect curve (AUE) 0-30 minutes at visit 2 and 4 (days 0 and 14). Plasma glucose concentrations were measured before dosing and at 5, 10 and 30 minutes after dosing., 0-30 minutes|Pharmacodynamics - Area Under the Effect Curve, Plasma glucose profiles, area under the effect curve (AUE) 0-90 minutes at visit 2 and 4 (days 0 and 14). Plasma glucose concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing., 0-90 minutes|Pharmacodynamics - Change From Baseline Plasma Glucose, Change from baseline plasma glucose to maximum plasma glucose (CEmax) at visit 2 and 4 (days 0 and 14). Plasma glucose concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing., 90 minutes|Pharmacodynamics - Time to Maximum Plasma Glucose Concentration, Time to maximum plasma glucose concentration (Tmax) at visit 2 and 4 (days 0 and 14). Plasma glucose concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing., 90 minutes|Pharmacodynamics - An Increase in the Plasma Glucose Concentration of ≥20 mg/dL Within 30 Minutes After Treatment, An increase in the plasma glucose concentration of ≥20 mg/dL within 30 minutes after treatment at visit 2 and visit 4. Plasma glucose concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing., 30 minutes
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| Locations: |
Compass Research, Orlando, Florida, 32806, United States|Advanced Clinical Research, Meridian, Idaho, 83642, United States|CRC - Clinical Research Center, Medizinische Universität Graz, Graz, Austria|LMC Manna Research, Barrie, Canada|LMC Calgary, Calgary, Canada|LMC Diabetes & Manna Research, Toronto, Canada|Diabeteszentrum Hamburg West, Gemeinschaftspraxis für Innere Medizin, Hamburg, Germany
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