A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools

Sponsor
Novo Nordisk A/S
Study ID
NCT03598621
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Semaglutide, 0.5 mg/mL — DRUG
    A single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours.
  • Semaglutide, 1.0 mg/mL — DRUG
    A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
  • Semaglutide, 1.34 mg/mL — DRUG
    A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
  • Semaglutide, 2.0 mg/mL — DRUG
    A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
  • DV3372, 0.5 mg/mL — DEVICE
    DV3372 device will be used for administration of semaglutide 0.5 mg/mL.
  • DV3372, 1.0 mg/mL — DEVICE
    DV3372 device will be used for administration of semaglutide 1.0 mg/mL.
  • PDS290 — DEVICE
    PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.
  • NovoPen®4 — DEVICE
    NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL.

Study Details

This study will compare four different semaglutide versions and different injection tools. The study aims to show similar levels of semaglutide in the blood using different versions of semaglutide. The researchers also want to look at how well the injection tools work. Participants will get two versions of semaglutide at two separate dosing visits. One of them is a version that doctors already can prescribe and the other will be one of the new versions. Which version participants get first is decided by chance. Participants will get semaglutide as an injection under the skin. The time between injections is 7 to 8 weeks. The study will last for about 16 weeks. Participants will have 27 study visits with the study doctor. For two of the visits, participants will stay at the clinic for 4 days and 3 nights.

Key Dates

Start date
Jul 23, 2018
Status verified
Jan 2020
Primary completion
Jan 17, 2019
Completion
Jan 17, 2019

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Semaglutide 0.25 mg
    Participants will receive a single dose of semaglutide 0.5 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
  • Experimental: Cohort 2: Semaglutide 0.5 mg
    Participants will receive a single dose of semaglutide 1.0 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
  • Experimental: Cohort 3: Semaglutide 0.5 mg
    Participants will receive a single dose of semaglutide 2.0 mg/mL using NovoPen®4 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.

Primary Outcome Measure

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

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