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Clinical Trial Details

Trial ID: L2967
Source ID: NCT03723772
Associated Drug: Insulin Icodec
Title: A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Insulin icodec|DRUG: IGlar U100
Outcome Measures: Primary: AUCI287,τ,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: AUCGIR,16-52h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state, Measured in mg/kg, From 16 to 52 hours after trial product administration (Day 50)|AUCGIR,138-168h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state, Measured in mg/kg, From 138 to 168 hours after trial product administration (Day 50)|GIRmax,16-52h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state, Measured in mg/(kg\*min), From 16 to 52 hours after trial product administration (Day 50)|GIRmax,138-168h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state, Measured in mg/(kg\*min), From 138 to 168 hours after trial product administration (Day 50)|AUCGIR,0-24h,SS (for insulin glargine) - 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 (for insulin glargine) - Maximum observed glucose infusion rate at steady state, Measured in mg/(kg\*min), From 0 to 24 hours after trial product administration (Day 14)|AUCI287,0-168h,FD (from insulin 287) - 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)|Cmax,I287,FD (for insulin 287) - 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,FD (for insulin 287) - 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,SS (for insulin 287) - 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)|tmax,I287,SS (for insulin 287) - 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)|t½,I287,SS (for insulin 287) - 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 (for insulin 287) - Serum insulin 287 trough concentration, Measured in pmol/L, Measured at the end of each dosing interval 168 hours after trial product administration (Day 8, 15, 22, 29, 36, 43, 50 and 57)|AUCIGlar,τ,SS (for insulin glargine) - Area under the serum insulin glargine 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 (for insulin glargine) - Maximum observed serum insulin glargine concentration at steady state, Measured in pmol/L, From 0 to 24 hours after trial product administration (Day 14)|tmax,IGlar,SS (for insulin glargine) - Time to maximum observed serum insulin glargine concentration at steady state, Measured in hours, From 0 to 24 hours after trial product administration (Day 14)|CIGlar,trough (for insulin glargine) - Serum insulin glargine trough concentration, Measured in pmol/L, Measured at the end of each dosing interval 24 hours after trial product administration (Day 4, 7, 14 and 15)|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)|Change in anti-insulin 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 (visit 25, day 106)|Change in anti-insulin 287 antibody titres, Number of dilutions, From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106)|Positive cross-reactive anti-human insulin antibodies, Number of patients with/without positive cross-reactive anti-human insulin antibodies, At the follow-up visit (Visit 25, day 106)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 66
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-11-29
Completion Date: 2020-06-26
Results First Posted:
Last Update Posted: 2025-03-11
Locations: Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT03723772