| Trial ID: | L3334 |
| Source ID: | NCT01620424
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart 30|DRUG: biphasic insulin aspart 50
|
| Outcome Measures: |
Primary: The maximum insulin aspart concentration | Secondary: The area under the insulin aspart curve|tmax, the time to maximum insulin aspart concentration|t½, terminal half-life|The area under the glucose infusion rate (GIR) profile|GIRmax, maximum glucose infusion rate value|tmaxGIR, time to maximum glucose infusion rate value|The area under the glucose infusion rate profile|Vital signs (blood pressure and pulse)|Adverse events
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
10
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2001-02
|
| Completion Date: |
2001-04
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-05
|
| Locations: |
Novo Nordisk Investigational Site, Tokyo, 1000005, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01620424
|
