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Clinical Trial Details

Trial ID: L6729
Source ID: NCT04501107
Associated Drug: Administration Of Biochaperone Insulin Lispro Reconstituted With Humalog® (Imp1)
Title: A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Administration of BioChaperone insulin lispro reconstituted with Humalog® (IMP1)|DRUG: Administration of Ready-to-use BioChaperone insulin lispro (IMP2)|DRUG: Administration of US-approved Humalog® (IMP3)|DRUG: Administration of EU-approved Humalog® (IMP4)
Outcome Measures: Primary: AUCGIR.0-12h, Area under the glucose infusion rate-time curve from time 0 until end of clamp, From t=0 to t=12 hours after IMP administration|AUCGIR.0-1h, Area under the glucose infusion rate-time curve from time 0 to 1 hour after IMP administration, From t=0 to t=1 hour after IMP administration|AUCLIS.0-12h, Area under the insulin lispro concentration-time curve from 0 hours to 12 hours after dose administration, From t=0 to t=12 hours after IMP administration|AUCLIS.0-1h, Area under the insulin lispro concentration-time curve from 0 hours to 1 hour after dose administration, From t=0 to t=1 hour after IMP administration | Secondary: tmax.LIS, Time to maximum observed insulin lispro concentration, From t=0 to t=12 hours after IMP administration|Cmax.LIS, Maximum observed insulin lispro concentration, From t=0 to t=12 hours after IMP administration|AUCLIS.2-6h, Area under the insulin lispro concentration-time curve from 2 hour to 6 hour after dose administration, From t=2 to t=6hours after IMP administration|t50%-LIS (early), Time to half-maximum before Cmax.LIS, From t=0 to t=12 hours after IMP administration|tmax.GIR, Time to maximum glucose infusion rate, From t=0 to t=12 hours after IMP administration|GIRmax, Maximum glucose infusion rate, From t=0 to t=12 hours after IMP administration|AUCGIR.4-8h, Area under the glucose infusion rate-time curve from 4 to 8 hours after dose administration, From t=4 to t=8 hours after IMP administration
Sponsor/Collaborators: Sponsor: Adocia
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 32
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-08-03
Completion Date: 2020-11-03
Results First Posted:
Last Update Posted: 2020-11-30
Locations: Profil GmbH, Mainz, D-55116, Germany
URL: https://clinicaltrials.gov/show/NCT04501107