Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT04189848
- Phase
- PHASE4
- Status
- Completed
Conditions
- Diabetes Mellitus, Type 2
- Healthy Volunteers
- Obesity
- Overweight
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- Semaglutide — DRUGSubjects will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day.
- Dulaglutide — DRUGSubjects 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 dulaglutideThe 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach
- Experimental: Dulaglutide followed by semaglutideThe 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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