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)

Sponsor
Novo Nordisk A/S
Study ID
NCT03611322
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Semaglutide, 0.25 mg — DRUG
    Semaglutide will be administered subcutaneously (s.c., under the skin) on day 1 and 8 in the morning after an overnight fast of at least 8 hours
  • Semaglutide, 0.5 mg — DRUG
    Semaglutide will be administered s.c. (under the skin) on day 15 and 22 in the morning after an overnight fast of at least 8 hours
  • Semaglutide, 1.0 mg — DRUG
    Semaglutide will be administered s.c. (under the skin) on day 29 in the morning after an overnight fast of at least 8 hours
  • DV3372 — DEVICE
    DV3372 device will be used for administration of semaglutide
  • PDS290 pen-injector — DEVICE
    PDS290 pen-injector will be used for administration of semaglutide

Study Details

This study compares semaglutide in two different injection tools called "PDS290" and "DV3372". The study aims to show similar levels of semaglutide in the blood when using either of the two injection tools. The researchers also want to look at how well the injection tools work. Participants will either receive semaglutide using the PDS290 or the DV3372 injection tool. This is decided by chance, like flipping a coin. This is called randomisation. Semaglutide is an approved medicine (thus available on the market) for people with type 2 diabetes. Semaglutide will be injected subcutaneously (injection under the skin). Participants will get a total of 5 injections with semaglutide. The study will last for a maximum of 86 days. Participants will have 17 scheduled site visits with the study physician or study staff at the study centre. For one of the visits participants will stay at the research unit for 4 days and 3 nights. Participants cannot take part in this study if participants have any disorder that the doctor thinks is a health problem. Only healthy men and women are allowed to take part. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Key Dates

Start date
Aug 8, 2018
Status verified
Jan 2020
Primary completion
Jan 7, 2019
Completion
Jan 7, 2019

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DV3372 device
    Participants will receive semaglutide on day 1, 8, 15, 22 and 29. The treatment period from first treatment (Day 1) to end of the treatment (Day 29) will be 4 weeks.
  • Active Comparator: PDS290 semaglutide pen-injector
    Participants will receive semaglutide on day 1, 8, 15, 22 and 29. The treatment period from first treatment (Day 1) to end of the treatment (Day 29) will be 4 weeks.

Primary Outcome Measure

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 [ Time Frame: 0-840 hours (5 weeks) ]

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