| Trial ID: | L4274 |
| Source ID: | NCT02220296
|
| Associated Drug: |
Insulin 338
|
| Title: |
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0123-0338 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Healthy|Diabetes|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Insulin 338|DRUG: placebo|DRUG: Insulin 338|DRUG: insulin glargine
|
| Outcome Measures: |
Primary: Incidence of adverse events, Day 1 - day 22 | Secondary: Incidence of hypoglycaemic episodes, Day 1 - day 22|Area under the serum insulin 338 concentration-time curve from zero to infinity, Day 1- day 22|Maximum serum insulin 338 concentration observed, Day 1- day 22|Time for maximum serum insulin 338 concentration, Day 1- day 22|t1/2, the terminal half-life of insulin 338, Day 1- day 22
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
62
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-08-20
|
| Completion Date: |
2015-03-31
|
| Results First Posted: |
|
| Last Update Posted: |
2017-12-08
|
| Locations: |
Novo Nordisk Investigational Site, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02220296
|
