| Trial ID: | L5452 |
| Source ID: | NCT01269606
|
| Associated Drug: |
Insulin Aspart
|
| Title: |
Comparing Insulin Aspart With Fast-acting Insulin Human 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 human|DRUG: insulin aspart|DRUG: insulin human
|
| Outcome Measures: |
Primary: Clearance at steady state (CLss) for IV treatment group, from 180 min to 240 min|Area under the curve (AUC) for IM treatment group, from 0 to 480 min after intramuscular injection | Secondary: Area under the curve (AUC) for IM treatment group, from 0 minutes to infinite time after intramuscular injection|Steady state concentration (Css) for IV treatment group, from 180 min to 240 min|Hypoglycaemic episodes, from screening (visit 1) to follow-up visit (2-21 days after last trial product administration)|Adverse Events (AEs), from first trial related activity to follow-up visit (2-21 days after last trial product administration)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
13
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-01
|
| Completion Date: |
2011-03
|
| Results First Posted: |
|
| Last Update Posted: |
2014-06-16
|
| Locations: |
Fukuoka, 812-0025, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01269606
|
