| Trial ID: | L5532 |
| Source ID: | NCT01464099
|
| Associated Drug: |
Insulin Aspart
|
| Title: |
Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: insulin aspart|DRUG: insulin aspart
|
| Outcome Measures: |
Primary: Area under the insulin aspart bolus concentration-time curve, From 0 and up to 12 hours post bolus dose administration|Maximum plasma concentration (Cmax) of insulin aspart, From 0 and up to 12 hours post bolus dose administration | Secondary: Time to maximum concentration (Tmax) of insulin aspart, From 0-12 hours post bolus dose administration|AUC (area under the curve) of insulin aspart, From -4 to 0 hours after dose administration
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-06
|
| Completion Date: |
2008-11
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-28
|
| Locations: |
Novo Nordisk Investigational Site, Chula Vista, California, 91911, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01464099
|
