| Trial ID: | L4608 |
| Source ID: | NCT01697618
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart 30|DRUG: biphasic human insulin 30
|
| Outcome Measures: |
Primary: Area under the serum insulin curve | Secondary: Overall shape of the 24 hour serum insulin profile|Cmax (maximum plasma concentration)|tmax (time to reach maximum)|Area under the curve following each injections derived from 24 hours serum insulin profiles|Overall shape of the 24 hour serum glucose profile|Serum glucose excursions (EXC)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
13
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
1997-04
|
| Completion Date: |
1998-11
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-04
|
| Locations: |
Novo Nordisk Investigational Site, Alphen a/d Rijn, Netherlands|Novo Nordisk Investigational Site, Crawley, RH11 9RT, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT01697618
|
