Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc

Phase 4 Completed 104 enrolled Novo Nordisk A/S

RandomizedCrossoverQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2019-12-03
Primary completion: 2020-01-29
Completion: 2020-02-27

Outcome

Met primary endpoint

registry analysis (other test); Semaglutide vs Dulaglutide; p <0.0001; Treatment difference -5.9 (95% CI -8.2 to -3.6); ANOVA NCT04189848 ↗

Publications

Results Snitker S, Andersen A, Berg B, van Marle S, Sparre T. Comparison of the injection-site experience of the starting doses with semaglutide and dulaglutide: A randomized, double-blind trial in healthy subjects. Diabetes Obes Metab. 2021 Jun;23(6):1415-1419. doi: 10.1111/dom.14349. Epub 2021 Mar 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dulaglutide	Peptide	0.75 mg	Subcutaneous
Subject	Semaglutide	Peptide	0.25 mg	Subcutaneous