| Trial ID: | L7028 |
| Source ID: | NCT04857398
|
| Associated Drug: |
Insulin Icodec
|
| Title: |
A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People From China With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin icodec
|
| Outcome Measures: |
Primary: Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state, pmol\*h/L, From 0 to 168 hours after trial product administration (Day 36) | Secondary: Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state divided by dose, (pmol\*h/L)/(U/kg), From 0 to 168 hours after trial product administration (Day 36)|Maximum observed serum insulin icodec concentration after the last dose, pmol/L, From 0 to 168 hours after trial product administration (Day 36)|Maximum observed serum insulin icodec concentration after the last dose divided by dose, (pmol/L)/(U/kg), From 0 to 168 hours after trial product administration (Day 36)|Time to maximum observed serum insulin icodec concentration after the last dose, hours, From 0 to 168 hours after trial product administration (Day 36)|Terminal half-life for insulin icodec at steady state, hours, Terminal part of the serum insulin icodec concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (Day 36)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-04-28
|
| Completion Date: |
2022-04-06
|
| Results First Posted: |
|
| Last Update Posted: |
2023-05-17
|
| Locations: |
Novo Nordisk Investigational Site, Beijing, Beijing, 100853, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04857398
|
