| Trial ID: | L6641 |
| Source ID: | NCT01538511
|
| Associated Drug: |
Biphasic Insulin Aspart 70
|
| Title: |
Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy Volunteers
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart 70|DRUG: biphasic insulin aspart 30
|
| Outcome Measures: |
Primary: Area under the plasma insulin concentration curve from 0 to 24 hours | Secondary: Area under the concentration curve of plasma insulin from 0 to 4 hours after meals|Maximum plasma insulin concentration observed from 0 to 4 hours after meals|Time to reach the maximum plasma insulin concentration from 0 to 4 hours after meals|The 24-hour plasma insulin profile deviances in Japanese type 2 diabetic subjects|Pre-meal plasma glucose concentration before meals|Postprandial plasma glucose (PPPG) excursion from 0 to 4 hours after meals|The maximum plasma glucose concentration observed from 0 to 4 hours after meals|The time to reach the maximum plasma glucose concentration of observed from 0 to 4 hours after meals|Average of plasma glucose concentration from 0 to 24 hours|The area under the plasma C-peptide concentration curve from 0 to 24 hours derived from the 24-hour plasma C-peptide profile|Frequency of hypoglycaemic episodes|Frequency of adverse events
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
59
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-06-05
|
| Completion Date: |
2007-03-13
|
| Results First Posted: |
|
| Last Update Posted: |
2017-10-06
|
| Locations: |
Novo Nordisk Investigational Site, Tokyo, 1000005, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01538511
|
