| Trial ID: | L4853 |
| Source ID: | NCT01542450
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: insulin detemir|DRUG: insulin NPH
|
| Outcome Measures: |
Primary: The ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours | Secondary: AUCGIR, area under the glucose infusion rate value curve|GIRmax, the maximum GIR value|tmax GIR, time to maximum GIR value|Cmax, maximum concentration|Area under the curve|tmax, time to maximum concentration|MRT, mean residence time|t½, terminal half-life|Adverse events
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
23
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2002-08
|
| Completion Date: |
2003-02
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-27
|
| Locations: |
Novo Nordisk Investigational Site, Tokyo, 1000005, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01542450
|