| Trial ID: | L4073 |
| Source ID: | NCT02528396
|
| Associated Drug: |
Biochaperone Insulin Lispro
|
| Title: |
To Investigate the Efficacy and Safety of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: BioChaperone insulin lispro|DRUG: Humalog®
|
| Outcome Measures: |
Primary: AUCΔBG0-2h (timepoint 0 = administration of the meal), Incremental area under the blood glucose (BG) concentration-time curve from 0-2 hours after a meal on day 1-3 \[comparison between treatments Biochaperone insulin lispro vs. lispro (Humalog®)\], 2 hours|AUClispro 0-30min (timepoint 0 = time of dosing), Area under the serum insulin lispro concentration-time curve from 0-30 minutes after bolus dose on one of days 1, 2 or 3 (comparison between treatments BioChaperone insulin lispro vs. lispro (Humalog®)), 30 minutes | Secondary: AUClispro_0-6h, Area under the serum insulin lispro concentration-time curve from 0-6 hours after bolus dose, 6 Hours|Cmax_lispro, Maximum serum insulin lispro concentration, up to 6 Hours|Tmax_lispro, Time to maximum observed serum insulin lispro concentration, up to 6 Hours|AUCBG_0-6h, Area under the curve under the blood glucose (BG) concentration time curve from 0-6 hours, 6 Hours|ΔBGmax, Maximum blood glucose (BG) excursion after a standard meal (0-6 hours), 6 Hours|Adverse events, Number of Adverse events, Up to 3 months|Local tolerability injection site reactions, Injection site reactions over 14 days of exposure, 14 days
|
| Sponsor/Collaborators: |
Sponsor: Adocia | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-08
|
| Completion Date: |
2015-12
|
| Results First Posted: |
|
| Last Update Posted: |
2016-03-16
|
| Locations: |
Profil GmbH, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02528396
|
