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Clinical Trial Details

Trial ID: L4289
Source ID: NCT04582435
Associated Drug: Insulin Icodec
Title: A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin Icodec
Outcome Measures: Primary: AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state, pmol\*h/L, From 0 to 168 hours after trial product administration (Day 50) | Secondary: AUCGIR,0-36h,SS,Area under the glucose infusion rate-time curve at steady state, mg/kg, From 0 to 36 hours after trial product administration (Day 36)|AUCGIR,40-64h,SS,Area under the glucose infusion rate-time curve at steady state, mg/kg, From 40 to 64 hours after trial product administration (Day 43)|AUCGIR,144-168h,SS,Area under the glucose infusion rate-time curve at steady state, mg/kg, From 144 to 168 hours after trial product administration (Day 50)|AUCGIR,τ,SS,model, Model-based area under the glucose infusion rate-time curve during one dosing interval at steady state, mg/kg, From 0 to 168 hours after trial product administration (Day 50)|AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state, pmol\*h/L, From 0 to 168 hours after trial product administration (Day 36 and 43)|Dose-normalised AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state divided by dose, (pmol\*h/L)/(U/kg), From 0 to 168 hours after trial product administration (Day 50)|Cmax,Ico,SS, Maximum observed serum insulin icodec concentration during one dosing interval at steady state, pmol/L, From 0 to 168 hours after trial product administration (Day 36, 43 and 50)|Dose-normalised Cmax,Ico,SS, Maximum observed serum insulin icodec concentration after the last dose divided by dose, (pmol/L)/(U/kg), From 0 to 168 hours after trial product administration (Day 50)|tmax,Ico,SS, Time to maximum observed serum insulin icodec concentration after the last dose, hours, From 0 to 168 hours after trial product administration (Day 50)|t½,Ico,SS, Terminal half-life for insulin icodec at steady state, hours, Terminal part of the serum insulin icodec concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (Day 50)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 46
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-10-16
Completion Date: 2022-04-22
Results First Posted:
Last Update Posted: 2023-09-18
Locations: Novo Nordisk Investigational Site, Graz, 8010, Austria
URL: https://clinicaltrials.gov/show/NCT04582435