The study is looking at the effect and safety of a new fast-acting insulin (NNC0471 0119) to people with type 1 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters your bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The participants will get each study medicine administered at separate clinic visits. The study will last for about 1-3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
NNC0471-0119 H will be administered subcutaneously.
Insulin aspart will be administered subcutaneously.
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour
Measured in milligram per kilogram (mg/kg).
Time frame: 0 to 1 hour after bolus infusion
AUC(GIR,0-t,basal-corrected): Area under the basal-corrected GIR-time curve from 0 to t
Measured in milligram per kilogram (mg/kg).
Time frame: 0 to 9 hours after bolus infusion
AUC(GIR,0-1h,basal-corrected)/AUC(GIR,0-t,basalcorrected):Ratio of the area under the basal-corrected GIR-time curve from 0 to 1 hour and 0 to t
Measured in percentage (%).
Time frame: 0 to 9 hours after bolus infusion
GIR(max,basal-corrected): Maximum observed basal-corrected GIR
Measured in milligrams per kilogram \*minute (mg/\[kg\*min\]).
Time frame: 0 to 9 hours after bolus infusion
AUC(NNC0471-0119,0-30min,basal corrected)/AUC(NNC0471-0119,0-t,basal-corrected):Ratio of basal-corrected area under serum NNC0471-0119 conc. time curve from 0-30min and 0-t
Measured in percentage (%).
Time frame: 0 to 9 hours after bolus infusion
AUC(NNC0471-0119,0-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t
Measured in hours\*picomole per liter (h\*pmol/L).
Time frame: 0 to 9 hours after bolus infusion
AUC(NNC0471-0119,0-30min,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to 30 minutes
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Measured in h\*pmol/L.
Time frame: 0 to 30 minutes after bolus infusion
AUC(NNC0471-0119,2h-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 2 hours to t, where t is the first time the curve is back to basal level after bolus infusion (at most 9 hours)
Measured in h\*pmol/L.
Time frame: 2 to 9 hours after bolus infusion
AUC(NNC0471-0119,2h-t,basal-corrected)/AUC(NNC0471-0119 H,0-t,basal-corrected):Ratio of basal corrected area under serum NNC0471-0119 conc. time curve from 2hrs-t and 0-t
Measured in percentage (%).
Time frame: 0 to 9 hours after bolus infusion
C(max,NNC0471-0119,basal-corrected): Maximum observed basal-corrected serum NNC0471-0119 concentration
Measured in picomoles per litre (pmol/L).
Time frame: 0 to 9 hours after bolus infusion
t(early50%Cmax,NNC0471-0119,basal-corrected): Time to early 50% maximum observed basal-corrected serum NNC0471-0119 concentration
Measured in minutes (Min).
Time frame: 0 to 9 hours after bolus infusion
t(late50%Cmax,NNC0471-0119,basal-corrected): Time to late 50% maximum observed basal-corrected serum NNC0471-0119 concentration
Measured in minutes (Min).
Time frame: 0 to 9 hours after bolus infusion
Number of adverse events (AEs)
Measure in number of events.
Time frame: From start of first investigational medicinal product (IMP) basal rate infusion (Visit 2, day -1) until completion of post-treatment end of study visit (Visit 4)