| Trial ID: | L3773 |
| Source ID: | NCT04136067
|
| Associated Drug: |
Nnc0268-0965
|
| Title: |
A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: NNC0268-0965|DRUG: insulin glargine
|
| Outcome Measures: |
Primary: Number of treatment-emergent adverse events (AEs), Number of events, From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5) | Secondary: Number of treatment-emergent hypoglycaemic episodes, Number of episodes, From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)|Area under the serum NNC0268-0965 concentration-time curve during one dosing interval at steady state, pmol\*h/l, From 0 to 24 hours after IMP administration at day 6 (visit 2)|Maximum observed serum NNC0268-0965 concentration after the last dose, pmol/l, From 0 to 24 hours after IMP administration at day 6 (visit 2)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-10-29
|
| Completion Date: |
2020-08-23
|
| Results First Posted: |
|
| Last Update Posted: |
2022-09-08
|
| Locations: |
Novo Nordisk Investigational Site, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT04136067
|
