| Trial ID: | L2623 |
| Source ID: | NCT02344992
|
| Associated Drug: |
Biochaperone Insulin Lispro
|
| Title: |
Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
|
| 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 blood glucose time curve: AUCbg(0-2h), Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal, 2 hours | Secondary: Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h), 8 hours|Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax, 8 hours|Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h), 8 hours|Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp), 8 hours|Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters, Up to 7 weeks
|
| Sponsor/Collaborators: |
Sponsor: Adocia
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
38
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-01
|
| Completion Date: |
2015-06
|
| Results First Posted: |
|
| Last Update Posted: |
2017-06-01
|
| Locations: |
Profil GmbH, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02344992
|
