| Outcome Measures: |
Primary: AUCI287τ,SS - Area under the serum insulin 287 concentration-time curve during one dosing interval at steady state, Measured in pmol\*h/L, From 0 to 168 hours after trial product administration (day 50) | Secondary: Number of adverse events (AEs), Number of events, From first trial product administration (day 1) to end of last dosing interval (day 57 for insulin 287, day 15 for IGlar)|Number of hypoglycaemic episodes, Number of episodes, From first trial product administration (day 1) to end of last dosing interval (day 57 for insulin 287, day 15 for IGlar) excluding clamp days|Change in antiinsulin 287 antibody level, Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer), From first insulin 287 administration (day 1) to follow-up visit (day 106)|Change in antiinsulin 287 antibody titres, Number of dilutions. The antibody titer is calculated by diluting the blood serum sample containing antibody in serial ratios (1:2, 1:4, 1:8, 1:16... and so on). Using an appropriate detection method (e.g., colorimetric, chromatographic, etc.), each dilution is tested for the presence of detectable levels of antibody. The assigned titer value is indicative of the last dilution in which the antibody was detected., From first insulin 287 administration (day 1) to follow-up visit (day 106)|Positive cross-reactive anti-human insulin antibodies, Yes/no. Number of participants who developed/not developed positive cross-reactive anti-human insulin antibodies., At follow-up visit (day 106)|AUCI287,0-168,FD - Area under the serum insulin 287 concentration-time curve after the first dose, Measured in pmol\*h/L, From 0 to 168 hours after trial product administration (day 1)|tmax,I287,FD - Time to maximum observed serum insulin 287 concentration after the first dose, Measured in hours, From 0 to 168 hours after trial product administration (day 1)|Cmax,I287,FD - Maximum observed serum insulin 287 concentration after the first dose, Measured in pmol/L, From 0 to 168 hours after trial product administration (day 1)|tmax,I287,SS - Time to maximum observed serum insulin 287 concentration after the last dose, Measured in hours, From 0 to 168 hours after trial product administration (day 50)|Cmax,I287,SS - Maximum observed serum insulin 287 concentration after the last dose, Measured in pmol/L, From 0 to 168 hours after trial product administration (day 50)|t1/2,I287,SS - Terminal half-life for insulin 287 at steady state, Measured in hours, Terminal part of the serum insulin 287 concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (day 50)|CI287,trough - Serum insulin 287 trough concentration, Measured in pmol/L, Measured at the end of each dosing interval 168 hours after dosing (day 8, 15, 22, 29, 36, 43, 50 and 57)|AUCIGlar,τ,SS - Area under the serum IGlar concentration-time curve during one dosing interval at steady state, Measured in pmol\*h/L, From 0 to 24 hours after trial product administration (day 14)|Cmax,IGlar,SS - Maximum observed serum IGlar concentration at steady state, Measured in pmol/L, From 0 to 24 hours after trial product administration (day 14)|tmax,IGlar,SS - Time to maximum observed serum IGlar concentration at steady state, Measured in hours, From 0 to 24 hours from trial product administration (day 14)|CIGlar,trough - Serum IGlar trough concentration, Measured in pmol/L, Measured at the end of each dosing interval 24 hours after trial product administration (day 7, 14 and 15)|AUCGIR,24-48h,SS - Area under the glucose infusion rate-time curve at steady state, Measured in mg/kg, From 24 to 48 hours after trial product administration (day 51)|GIRmax,24-48h, SS - Maximum observed glucose infusion rate at steady state, Measured in mg/(kg\*min), From 24 to 48 hours after trial product administration (day 51)|AUCGIR,150-168h,SS - Area under the glucose infusion rate-time curve at steady state, Measured in mg/kg, From 150 to 168 hours after trial product administration (day 57)|GIRmax,150-168h,SS - Maximum observed glucose infusion rate at steady state, Measured in mg/(kg\*min), From 150 to 168 hours after trial product administration (day 57)|AUCGIR,0-24h,SS - Area under the glucose infusion rate-time curve at steady state, Measured in mg/kg, From 0 to 24 hours after trial product administration (day 14)|GIRmax,0-24h,SS - Maximum observed glucose infusion rate at steady state, Measured in mg/(kg\*min), From 0 to 24 hours after trial product administration (day 14)
|
