Clinical Trial Details
| Trial ID: | L4551 |
| Source ID: | NCT02562313 |
| Associated Drug: | Biochaperone Insulin Lispro |
| Title: | A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog® |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 1 Diabetes Mellitus |
| Interventions: | DRUG: BioChaperone insulin lispro|DRUG: Humalog® |
| Outcome Measures: | Primary: Pharmacodynamics: ΔAUCBG 0-2h, Incremental Area Under the Blood Glucose concentration-time Curve from 0-2 hours after the start of the meal., 2 Hours|Pharmacokinetics: AUClis 0-30min, Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes, 30 minutes | Secondary: AUClis_0-6h, Area Under the baseline adjusted insulin Lispro Curve from 0-6h following a bolus dose, up to 6 Hours|Cmax, Maximum insulin Concentration following a bolus dose, up to 6 Hours|tCmax, Time to Maximum insulin Concentration following a bolus dose, up to 6 Hours|BGmax, Maximum Blood Glucose after start of an individualised standardised meal intake, up to 6 Hours|tBGmax, Time to Maximum Blood Glucose concentration, up to 6 Hours|Compatibility, Number of suspected episodes of infusion set occlusion or leakage, up to 14 days|Adverse Events, Number of Adverse Events, up to 12 weeks|Local tolerability, Number of injection site reactions, up to 12 weeks |
| Sponsor/Collaborators: | Sponsor: Adocia | Collaborators: Eli Lilly and Company |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 80 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2015-09 |
| Completion Date: | 2016-11 |
| Results First Posted: | |
| Last Update Posted: | 2016-11-22 |
| Locations: | Profil GmbH, Neuss, 41460, Germany |
| URL: | https://clinicaltrials.gov/show/NCT02562313 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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