NCT03611322

A Trial to Compare Blood Concentration Levels of Semaglutide Following Subcutaneous Injections of Semaglutide 1 mg by 2 Different Devices (the DV3372 Device and by the PDS290 Semaglutide Pen-injector)

A Trial to Compare Pharmacokinetic Properties of Semaglutide Following Subcutaneous Administration of Semaglutide 1 mg by the DV3372 Device and by the PDS290 Semaglutide Pen-injector

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study compares semaglutide in two different injection tools called "PDS290" and "DV3372". The study aims to show similar levels of semaglutide in the blood when using either of the two injection tools. The researchers also want to look at how well the injection tools work. Participants will either receive semaglutide using the PDS290 or the DV3372 injection tool. This is decided by chance, like flipping a coin. This is called randomisation. Semaglutide is an approved medicine (thus available on the market) for people with type 2 diabetes. Semaglutide will be injected subcutaneously (injection under the skin). Participants will get a total of 5 injections with semaglutide. The study will last for a maximum of 86 days. Participants will have 17 scheduled site visits with the study physician or study staff at the study centre. For one of the visits participants will stay at the research unit for 4 days and 3 nights. Participants cannot take part in this study if participants have any disorder that the doctor thinks is a health problem. Only healthy men and women are allowed to take part. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Semaglutide, 0.25 mg	Semaglutide will be administered subcutaneously (s.c., under the skin) on day 1 and 8 in the morning after an overnight fast of at least 8 hours
DRUG	Semaglutide, 0.5 mg	Semaglutide will be administered s.c. (under the skin) on day 15 and 22 in the morning after an overnight fast of at least 8 hours
DRUG	Semaglutide, 1.0 mg	Semaglutide will be administered s.c. (under the skin) on day 29 in the morning after an overnight fast of at least 8 hours
DEVICE	DV3372	DV3372 device will be used for administration of semaglutide
DEVICE	PDS290 pen-injector	PDS290 pen-injector will be used for administration of semaglutide

Timeline

• Start date: 2018-08-08
• Primary completion: 2019-01-07
• Completion: 2019-01-07
• First posted: 2018-08-02
• Last updated: 2020-01-09

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study