| Trial ID: | L5125 |
| Source ID: | NCT01865279
|
| Associated Drug: |
Insulin Degludec
|
| Title: |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin degludec|DRUG: placebo|DRUG: insulin degludec|DRUG: isophane human insulin
|
| Outcome Measures: |
Primary: Frequency of adverse events (trial part 1 only), From day prior to dosing and until 10-14 days after dosing|Area under the glucose infusion rate curve (trial part 2 only), 0-24 hours after dosing | Secondary: Area under the serum insulin concentration curve, 0-72 hours after dosing
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
64
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2005-12
|
| Completion Date: |
2006-04
|
| Results First Posted: |
|
| Last Update Posted: |
2015-10-23
|
| Locations: |
Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01865279
|
