NCT03598621

A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools

A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations for the DV3372 Device and the Formulation for the PDS290 Semaglutide Pen-injector

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will compare four different semaglutide versions and different injection tools. The study aims to show similar levels of semaglutide in the blood using different versions of semaglutide. The researchers also want to look at how well the injection tools work. Participants will get two versions of semaglutide at two separate dosing visits. One of them is a version that doctors already can prescribe and the other will be one of the new versions. Which version participants get first is decided by chance. Participants will get semaglutide as an injection under the skin. The time between injections is 7 to 8 weeks. The study will last for about 16 weeks. Participants will have 27 study visits with the study doctor. For two of the visits, participants will stay at the clinic for 4 days and 3 nights.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Semaglutide, 0.5 mg/mL	A single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours.
DRUG	Semaglutide, 1.0 mg/mL	A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
DRUG	Semaglutide, 1.34 mg/mL	A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
DRUG	Semaglutide, 2.0 mg/mL	A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
DEVICE	DV3372, 0.5 mg/mL	DV3372 device will be used for administration of semaglutide 0.5 mg/mL.
DEVICE	DV3372, 1.0 mg/mL	DV3372 device will be used for administration of semaglutide 1.0 mg/mL.
DEVICE	PDS290	PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.
DEVICE	NovoPen®4	NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL.

Timeline

• Start date: 2018-07-23
• Primary completion: 2019-01-17
• Completion: 2019-01-17
• First posted: 2018-07-26
• Last updated: 2020-01-09

Locations

2 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study