| Trial ID: | L5011 |
| Source ID: | NCT01682902
|
| Associated Drug: |
Faster-Acting Insulin Aspart
|
| Title: |
A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® 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: Faster-acting insulin aspart|DRUG: insulin aspart
|
| Outcome Measures: |
Primary: Mean change in plasma glucose concentration, From 0-2 hours after administration of standardised meal after the first, the second, and the third 14-day treatment period | Secondary: Self-measured plasma glucose (SMPG) 7-point profile, After the first, the second, and the third 14-day treatment period|Self-measured plasma glucose (SMPG) 9-point profile, After the first, the second, and the third 14-day treatment period|Number of adverse events (AEs) (including infusion site reactions/infections), Days 0-14 for each treatment periods|Number of hypoglycaemic episodes, Days 0-14 for each treatment period|Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG), Days 0-14 for each treatment period|Number of episodes of infusion set occlusions, Days 0-14 for each treatment period
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
43
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-09
|
| Completion Date: |
2013-03
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-09
|
| Locations: |
Novo Nordisk Investigational Site, Atlanta, Georgia, 30318, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01682902
|
