NCT04007107

A Study Comparing the Injection Site Pain Experience After the Injection of 2 Different Solutions of Semaglutide With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity

A Trial to Compare the Injection Site Pain Experience of 0.25 mg Semaglutide sc Administered by 2 Different Products

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study in healthy men and women compares the injection site experience of the DV3396 pen to that of the PDS290 pens when both pens are used to deliver 0.25 mg semaglutide subcutaneously (sc, under the skin). Participants will receive 2 single doses of semaglutide 0.25 mg on 1 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.

Conditions

• Healthy Volunteers Diabetes Mellitus, Type 2
• Healthy Volunteers Overweight
• Healthy Volunteers Obesity

Interventions

Type	Name	Description
DRUG	Semaglutide (administered by DV3396 pen)	Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day
DRUG	Semaglutide (administered by PDS290 pen)	Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day

Timeline

• Start date: 2019-06-27
• Primary completion: 2019-07-28
• Completion: 2019-09-04
• First posted: 2019-07-05
• Last updated: 2020-08-04
• Results posted: 2020-08-04

Locations

1 site across 1 country: Netherlands