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Clinical Trial Details

Trial ID: L2552
Source ID: NCT02213146
Associated Drug: Biochaperone Human Insulin
Title: A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 1
Interventions: DRUG: BioChaperone human insulin|DRUG: Huminsulin® Normal|DRUG: Humalog®
Outcome Measures: Primary: Area under the curve (AUCins(0-1h)), Area under the human insulin serum concentration - time curve from t=0 to 1 hour, 1 hour | Secondary: Pharmacokinetics: Early t0.5max ins/lisp, Time to first observed half maximum serum human insulin / insulin lispro concentration, up to 10 hours post administration|Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours, Area under the glucose infusion rate - time curve from t=0 to 10 hours, 10 hours|Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax), Time to first observed half maximum glucose infusion rate, 10 hours|Glucodynamics: GIRmax - Maximum glucose infusion rate, Maximum glucose infusion rate, 10 hours|Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration, Area under the human insulin / insulin lispro serum concentration - Time curve from t=0 to 10 hours, 10 hours|Pharmacokinetics: Tmax(ins/lisp) - Time to maximum observed serum human insulin concentration and insulin lispro concentration, Time to maximum observed serum human insulin concentration and insulin lispro concentration, 10 hours|Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters, Adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters, up to 7 weeks|Pharmacokinetics: Cmax(ins/lisp), Maximum observed human insulin / insulin lispro serum concentration, up to 10 hours|Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours, Area under the glucose infusion rate - time curve from t=0 to 2 hours, 2 hours post administration
Sponsor/Collaborators: Sponsor: Adocia
Gender: MALE
Age: ADULT
Phases: PHASE1|PHASE2
Enrollment: 38
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-08
Completion Date: 2015-06
Results First Posted:
Last Update Posted: 2017-06-01
Locations: Profil GmbH, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT02213146