| Outcome Measures: |
Primary: PK endpoint, AUCins. 0 - 24h, area under the serum insulin concentration curve from 0 to 24. hours, Up to 24 hours|PK endpoint, Cins.max, maximum observed insulin concentration., Up to 30 hrs|PD endpoint, AUC GIR.0-24h, area under the glucose infusion rate curve from 0 to 24 hours., Up to 24 hours|PD endpoint, GIR max, maximum observed glucose infusion rate, Up to 30 hrs | Secondary: Secondary PK endpoint, AUC ins.0-12h, AUC ins.12 - 24h, AUC ins.0 -inf., areas under the serum insulin concentration curve in the indicated time intervals, Up to 24 hrs|Secondary PK endpoint, tmax.ins, time to maximum observed serum insulin concentration, Up to 30 hrs|Exploratory PK endpoint, t½, terminal serum elimination half-life calculated as t½=ln2/λz and, Up to 30 hrs|Exploratory PK endpoint, λz, terminal elimination rate constant, Up to 30 hrs|Secondary PD endpoint, AUC GIR.0 - 12h, AUC GIR.12 - 24h, areas under the glucose infusion rate curve in the indicated time-intervals, Up to 24 hrs|Secondary PD endpoint, AUC GIR.0 - last, area under the glucose infusion rate curve from 0 hours until the end of clamp, Up to 30 hrs|Secondary PD endpoint, t max.GIR, time to maximum glucose infusion rate, Up to 30 hrs|Exploratory PD endpoint, Duration of action, time until blood glucose levels is consistently above 150 mg/dL, Up to 30 hrs|Exploratory PD endpoint, Time to onset of action, time from trial product administration until blood glucose concentration has decreased at least 5 mg/dL from baseline, where baseline is defined as the mean of blood glucose levels from - 6 to - 2 minutes before trial product administration as measured by ClampArt., Up to 30 hrs|Safety endpoints, As measured by treatment-emergent adverse events, Up to 12 Weeks
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