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Clinical Trial Details

Trial ID: L5699
Source ID: NCT03179332
Associated Drug: Biochaperone® Insulin Lispro
Title: A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type1 Diabetes Mellitus
Interventions: DRUG: BioChaperone® insulin lispro|DRUG: Fiasp®|DRUG: Novorapid®
Outcome Measures: Primary: AUCGIR(0-60min), Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration, 60 minutes | Secondary: AUCins(0-30min), Baseline corrected area under the insulin concentration time curve from 0 to 30 minutes after bolus administration, 30 minutes|AUCins(0-60min), Baseline corrected area under the insulin concentration time curve from 0 to 60 minutes after bolus administration, 60 minutes|AUCins(0-600min), Baseline corrected area under the insulin concentration time curve from 0 to 600 minutes after bolus administration, 600 minutes|Cmax insulin, Maximum observed baseline corrected insulin concentration, 10 hours|Tmax insulin, Time from bolus administration to baseline corrected Cmax, 10 hours|TmaxGIR, Time from bolus administration to maximum baseline corrected glucose infusion rate, 10 hours|GIRmax, Maximum baseline corrected glucose infusion rate, 10 hours|Adverse Events, Number of Adverse Events in each arm, up to 8 weeks|Clinical safety laboratory, Haematology, biochemistry and urinalysis: changes and findings from Baseline in clinical safety laboratory parameters during the trial duration, from screening, and at follow-up visit., up to 8 weeks
Sponsor/Collaborators: Sponsor: Adocia
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: 2017-06-20
Completion Date: 2017-09-27
Results First Posted:
Last Update Posted: 2017-12-12
Locations: Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT03179332