| Trial ID: | L4264 |
| Source ID: | NCT01526941
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Comparison of Single Dose and Steady State Pharmacodynamics 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: Steady state area under the glucose infusion rate profile, 6-12 hours | Secondary: GIRmax, the maximal glucose infusion rate value|tmax, time to maximum glucose infusion rate value|area under the glucose infusion rate profile|Time to 50% of area under the glucose infusion rate profile, 0-12 hours|Cmax, maximum concentration|tmax, time to reach Cmax|Area under the curve|t½, terminal half-life|Adverse events
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
27
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2001-05
|
| Completion Date: |
2001-07
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-05
|
| Locations: |
Novo Nordisk Investigational Site, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01526941
|
