| Trial ID: | L5421 |
| Source ID: | NCT03965013
|
| Associated Drug: |
Nnc0268-0965
|
| Title: |
A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1|Healthy Volunteers
|
| Interventions: |
DRUG: NNC0268-0965|DRUG: Placebo|DRUG: insulin glargine
|
| Outcome Measures: |
Primary: Number of treatment-emergent adverse events, Number of events, From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10 | Secondary: Number of treatment-emergent hypoglycaemic episodes, Number of episodes, From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10|Area under the serum NNC0268-0965 concentration-time curve after a single dose, pmol\*h/L, From 0 hours until infinity after trial product administration (day 1)|Maximum observed serum NNC0268-0965 concentration after a single dose, pmol/L, From 0 hours until last measurement time after trial product administration (day 1)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
78
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-06-05
|
| Completion Date: |
2019-12-14
|
| Results First Posted: |
|
| Last Update Posted: |
2021-01-14
|
| Locations: |
Novo Nordisk Investigational Site, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT03965013
|
