Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5040
Source ID: NCT03598621
Associated Drug: Semaglutide, 0.5 Mg/Ml
Title: A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide, 0.5 mg/mL|DRUG: Semaglutide, 1.0 mg/mL|DRUG: Semaglutide, 1.34 mg/mL|DRUG: Semaglutide, 2.0 mg/mL|DEVICE: DV3372, 0.5 mg/mL|DEVICE: DV3372, 1.0 mg/mL|DEVICE: PDS290|DEVICE: NovoPen®4
Outcome Measures: Primary: AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until last quantifiable measurement after a single dose subcutaneous semaglutide administration, Measured in nmol·h/L., 0-840 hours (5 weeks)|Cmax,sema,SD, the maximum plasma semaglutide concentration after a single dose subcutaneous semaglutide administration, Measured in nmol/L., 0-840 hours (5 weeks) | Secondary: AUC0-∞,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until infinity after a single dose subcutaneous semaglutide administration, Measured in nmol·h/L., 0-840 hours (5 weeks)|tmax,sema,SD, time to Cmax,sema,SD of semaglutide, Measured in hours., 0-840 hours (5 weeks)|t½,sema,SD, terminal elimination half-life of semaglutide, Measured in hours., 0-840 hours (5 weeks)|Cl/F,sema,SD, total apparent clearance of semaglutide, Measured in L/h., 0-840 hours (5 weeks)|Vz/F,sema,SD, apparent volume of distribution of semaglutide, Measured in L., 0-840 hours (5 weeks)|Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 0.5 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL, Count of technical complaints., Week 0-5 in both treatment period 1 and 2|Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 1.0 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL, Count of technical complaints., Week 0-5 in both treatment period 1 and 2
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 68
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-07-23
Completion Date: 2019-01-17
Results First Posted:
Last Update Posted: 2020-01-09
Locations: Novo Nordisk Investigational Site, Mainz, 55116, Germany|Novo Nordisk Investigational Site, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT03598621