| Trial ID: | L2817 |
| Source ID: | NCT02964104
|
| Associated Drug: |
Insulin Icodec
|
| Title: |
A Trial Investigating the Safety, Tolerability, Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Pharmacodynamics (the Effect of the Investigated Drug on the Body) of Insulin 287 in Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin icodec|DRUG: placebo|DRUG: insulin degludec|DRUG: placebo
|
| Outcome Measures: |
Primary: Number of treatment emergent adverse events (TEAE), From the first trial product administration at day 1 until completion of the post-treatment follow-up visit (day 68 - 79) | Secondary: AUCI287,τ,SS, area under the steady-state serum insulin 287 concentration-time curve, During one dosing interval at steady-state from 0 to 168 hours after last dose (day 29)|AUCGIR,0-24h,SS, area under the glucose infusion rate-time curve at steady state, At day 30 and day 35
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-11-15
|
| Completion Date: |
2017-12-12
|
| Results First Posted: |
|
| Last Update Posted: |
2021-08-27
|
| Locations: |
Novo Nordisk Investigational Site, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02964104
|
