Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc

Sponsor
Novo Nordisk A/S
Study ID
NCT04189848
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Semaglutide — DRUG
    Subjects will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day.
  • Dulaglutide — DRUG
    Subjects will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day.

Study Details

This study in healthy men and women looks at the injection site experience of semaglutide and dulaglutide given subcutaneously (s.c., under the skin). Participants will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day. The 2 injections will be given at least 30 minutes apart, one in each side of the stomach. Participants will be in the clinic research center for 1 day. A follow-up phone call will take place between 4 and 5 weeks after the injections were given.

Key Dates

Start date
Dec 3, 2019
Status verified
Nov 2022
Primary completion
Jan 29, 2020
Completion
Feb 27, 2020

Study Design

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

Arms

  • Experimental: Semaglutide followed by dulaglutide
    The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach
  • Experimental: Dulaglutide followed by semaglutide
    The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach

Primary Outcome Measure

Intensity of Injection Site Pain [ Time Frame: 1 minute after each injection (Day 1) ]

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