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

NCT03598621 · Completed

Last updated 2026-05-28

This study is testing whether different versions of semaglutide, a diabetes medication, produce similar levels in the blood when injected using different tools.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 68 people

Who can join Ages 18–55 · all sexes Healthy volunteers accepted.

Timeline Started 2018-07 · est. completion 2019-01

Where 2 sites · Germany

What this study is testing ClinicalTrials.gov NCT03598621 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide, 0.5 mg/mL Drug

A single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours.
Semaglutide, 1.0 mg/mL Drug

A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
Semaglutide, 1.34 mg/mL Drug

A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
Semaglutide, 2.0 mg/mL Drug

A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
DV3372, 0.5 mg/mL Device

DV3372 device will be used for administration of semaglutide 0.5 mg/mL.
DV3372, 1.0 mg/mL Device

DV3372 device will be used for administration of semaglutide 1.0 mg/mL.
PDS290 Device

PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.
NovoPen®4 Device

NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL.

Main thing measured	AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until last quantifiable measurement after a single dose subcutaneous semaglutide administration
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03598621 ↗