| Trial ID: | L6934 |
| Source ID: | NCT01865305
|
| Associated Drug: |
Insulin Degludec/Insulin Aspart 30
|
| Title: |
Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin degludec/insulin aspart 30|DRUG: insulin degludec/insulin aspart 40|DRUG: insulin degludec/insulin aspart 50|DRUG: insulin degludec|DRUG: insulin aspart|DRUG: biphasic insulin aspart 30|DRUG: insulin degludec/insulin aspart 40|DRUG: insulin degludec/insulin aspart 50|DRUG: biphasic insulin aspart 30
|
| Outcome Measures: |
Primary: Area under the insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes), 0-2 hours after dosing|Maximum glucose infusion rate divided by the average glucose infusion rate (for subjects with type 2 diabetes), 0-24 hours after dosing | Secondary: Area under the glucose infusion rate curve, 0-24 hours after dosing|Area under the serum insulin degludec concentration curve, 0-96 hours after dosing
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
59
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-09
|
| Completion Date: |
2007-02
|
| Results First Posted: |
|
| Last Update Posted: |
2015-10-23
|
| Locations: |
Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01865305
|
