| Trial ID: | L3167 |
| Source ID: | NCT01981031
|
| Associated Drug: |
Biochaperone® Combo
|
| Title: |
A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: BioChaperone® Combo|DRUG: Humalog® Mix25
|
| Outcome Measures: |
Primary: End of action of 0.8 U/kg BioChaperone® Combo (time from administration until blood glucose concentration is consistently above 8.3 mmol/L during the glucose clamp procedure), from 0 to 30 hours after a single-dose administration | Secondary: Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25, from 0 to 30 hours after a single-dose administration|Number of Adverse Events, hypoglycemic events, local tolerability, adverse reactions, Weeks 0-10
|
| Sponsor/Collaborators: |
Sponsor: Adocia
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
21
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-11
|
| Completion Date: |
2014-08
|
| Results First Posted: |
|
| Last Update Posted: |
2017-06-01
|
| Locations: |
Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01981031
|
