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Clinical Trial Details

Trial ID: L5062
Source ID: NCT06809621
Associated Drug: Nnc0471-0119 H
Title: A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 1 Diabetes When Given by an Insulin Pump
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: NNC0471-0119 H|DRUG: Insulin aspart
Outcome Measures: Primary: 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)., 0 to 1 hour after bolus infusion | Secondary: 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)., 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 (%)., 0 to 9 hours after bolus infusion|GIR(max,basal-corrected): Maximum observed basal-corrected GIR, Measured in milligrams per kilogram \*minute (mg/\[kg\*min\])., 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 (%)., 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)., 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, Measured in h\*pmol/L., 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., 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 (%)., 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)., 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)., 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)., 0 to 9 hours after bolus infusion|Number of adverse events (AEs), Measure in number of events., 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)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 43
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-28
Completion Date: 2025-07-31
Results First Posted:
Last Update Posted: 2025-02-05
Locations: Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT06809621