| Trial ID: | L5550 |
| Source ID: | NCT01455142
|
| Associated Drug: |
Insulin Degludec/Insulin Aspart
|
| Title: |
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: insulin degludec/insulin aspart
|
| Outcome Measures: |
Primary: Area under the serum insulin degludec concentration-time curve, From 0 to 120 hours after single-dose (SD)|Maximum observed serum insulin degludec concentration, After single-dose (within 0 to 120 hours after dosing)|Area under the serum insulin aspart concentration-time curve, From 0 to 12 hours after single-dose|Maximum observed serum insulin aspart concentration, After single-dose (within 0 to 12 hours after dosing) | Secondary: Area under the glucose infusion rate curve, From 0 to 26 hours after single-dose|Maximum glucose infusion rate, After single-dose (within 0 to 120 hours after dosing)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-10
|
| Completion Date: |
2012-01
|
| Results First Posted: |
|
| Last Update Posted: |
2015-02-23
|
| Locations: |
Graz, 8010, Austria
|
| URL: |
https://clinicaltrials.gov/show/NCT01455142
|
