Clinical Trial Details
| Trial ID: | L4231 |
| Source ID: | NCT02029924 |
| Associated Drug: | Biochaperone Insulin Lispro |
| Title: | A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro 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 insulin lispro|DRUG: Humalog® |
| Outcome Measures: | Primary: Area under the curve (AUC), Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes, 30 minutes | Secondary: Pharmacokinetics: Early t0.5max(Lisp), Time to first observed half maximum observed insulin lispro concentration, up to 6 hours post administration of study drug|Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours, 6 hours|Glucodynamics: Early t0.5(GIRmax), Time to first observed half maximum glucose infusion rate, 6 hours|Glucodynamic: GIRmax (Maximum glucose infusion rate), 6 hours|Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours, 6 hours|Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration, 6 hours|Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters, 8 weeks |
| Sponsor/Collaborators: | Sponsor: Adocia |
| Gender: | MALE |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 37 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2013-12 |
| Completion Date: | 2014-08 |
| Results First Posted: | |
| Last Update Posted: | 2017-06-01 |
| Locations: | Neuss, 41460, Germany |
| URL: | https://clinicaltrials.gov/show/NCT02029924 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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