| Trial ID: | L5785 |
| Source ID: | NCT01524809
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: biphasic insulin aspart 30|DRUG: biphasic insulin aspart 70
|
| Outcome Measures: |
Primary: Area under the serum insulin curve 6-14 hours after dinner at day 15 | Secondary: Area under the serum insulin curve 6-14 hours after dinner at day 1|Area under the serum insulin curve 0-6 hours after dinner|Area under the curve 0-24 hours|Serum insulin|Apparent t½ (apparent elimination half life)|Cmax, maximum concentration|tmax, time to reach Cmax|Adverse events
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
26
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2001-01
|
| Completion Date: |
2001-06
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-05
|
| Locations: |
Novo Nordisk Investigational Site, Århus C, 8000, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT01524809
|
