| Trial ID: | L3467 |
| Source ID: | NCT03611322
|
| Associated Drug: |
Semaglutide, 0.25 Mg
|
| Title: |
A Trial to Compare Blood Concentration Levels of Semaglutide Following Subcutaneous Injections of Semaglutide 1 mg by 2 Different Devices (the DV3372 Device and by the PDS290 Semaglutide Pen-injector)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Semaglutide, 0.25 mg|DRUG: Semaglutide, 0.5 mg|DRUG: Semaglutide, 1.0 mg|DEVICE: DV3372|DEVICE: PDS290 pen-injector
|
| Outcome Measures: |
Primary: AUC0-last,sema,Week5: the area under the plasma semaglutide concentration-time curve from 0 until last quantifiable measurement after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period, Measured in nmol\*h/L, 0-840 hours (5 weeks)|Cmax,sema,Week5: the maximum plasma semaglutide concentration after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period, Measured in nmol/L, 0-840 hours (5 weeks) | Secondary: tmax,sema,Week5: time to Cmax of semaglutide after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period, Measured in hours, 0-840 hours (5 weeks)|t½,sema,Week5: terminal elimination half-life of semaglutide after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period, Measured in hours, 0-840 hours (5 weeks)|Number of site-initiated technical complaints with or without co-reported adverse events, Number of technical complaints, from first semaglutide dose (day 1) and until the follow-up visit (5 weeks after the last dose of semaglutide)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
54
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-08-08
|
| Completion Date: |
2019-01-07
|
| Results First Posted: |
|
| Last Update Posted: |
2020-01-09
|
| Locations: |
Novo Nordisk Investigational Site, Berlin, 10117, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT03611322
|
