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Clinical Trial Details

Trial ID: L3854
Source ID: NCT05262595
Associated Drug: Nnc0471-0119 A
Title: A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin Pump
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: NNC0471-0119 A|DRUG: NNC0471-0119 B|DRUG: NNC0471-0119 D|DRUG: Faster aspart
Outcome Measures: Primary: AUC (NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected), Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 0 to 30 minutes and 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours). Measured in percentage, 0 to 12 hours after bolus infusion | Secondary: AUC (NNC0471-0119,0-t,basal-corrected), Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours). Measured in h\*pmol/L, 0 to 12 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 12 hours). Measured in h\*pmol/L, 2 to 12 hours after bolus infusion|AUC (NNC0471-0119,2h-t,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected), Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 2 hours to t and 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours). Measured in percentage, 0 to 12 hours after bolus infusion|Cmax,NNC0471-0119,basal-corrected: Maximum observed basal-corrected serum NNC0471-0119 concentration, pmol/L, 0 to 12 hours after bolus infusion|Number of adverse events (AEs), 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 6)|AUC (GIR,0-t,basal-corrected), Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to t, where t is the first time the GIR curve is back to basal level after bolus infusion (at most 12 hours). Measured in mg/kg, 0 to 12 hours after bolus infusion|AUC (GIR,0-1h,basal-corrected), Area under the basal-corrected GIR-time curve from 0 to 1 hour. Measured in mg/kg, 0 to 1 hour after bolus infusion|AUC (GIR,0-1h,basal-corrected/AUC (GIR,0-t,basal-corrected), Ratio of the area under the basal-corrected GIR-time curve from 0 to 1 hour and 0 to t, where t is the first time the GIR curve is back to basal level after bolus infusion (at most 12 hours). Measured in percentage, 0 to 12 hours after bolus infusion|GIRmax,basal-corrected: Maximum observed basal-corrected GIR, mg/(kg\*min), 0 to 12 hours after bolus infusion
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 19
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-03-03
Completion Date: 2022-09-05
Results First Posted:
Last Update Posted: 2023-10-12
Locations: Novo Nordisk Investigational Site, Graz, 8010, Austria
URL: https://clinicaltrials.gov/show/NCT05262595