| Trial ID: | L6325 |
| Source ID: | NCT01992588
|
| Associated Drug: |
Faster-Acting Insulin Aspart
|
| Title: |
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Faster-acting insulin aspart|DRUG: insulin aspart
|
| Outcome Measures: |
Primary: CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve, From 0 to 30 minutes | Secondary: CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve, From 0 to 1 hour|CSII bolus related baseline corrected area under the glucose infusion rate curve, From 0 to 1 hour
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-11
|
| Completion Date: |
2014-03
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-08
|
| Locations: |
Novo Nordisk Investigational Site, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01992588
|
