| Trial ID: | L6466 |
| Source ID: | NCT02148861
|
| Associated Drug: |
Insulin Icodec
|
| Title: |
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin icodec|DRUG: insulin degludec|DRUG: placebo
|
| Outcome Measures: |
Primary: Number of treatment emergent adverse events, From the first trial product administration at Day 1 until completion of the post-treatment follow-up visit (3-14 days after Visit 9, Day 65) | Secondary: Area under the steady-state serum insulin 287 concentration-time curve, During one dosing interval at steady-state from 0 to 168 h after last dose (Day 29)|area under the glucose infusion rate - time curve at steady-state, At Day 31 and day 35
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
49
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-05-26
|
| Completion Date: |
2015-06-01
|
| Results First Posted: |
|
| Last Update Posted: |
2021-03-08
|
| Locations: |
Novo Nordisk Investigational Site, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02148861
|
