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)

NCT03611322 · Completed

Last updated 2026-05-28

This clinical trial compares how two different injection devices affect the blood levels of semaglutide (a diabetes medication) in adults with type 2 diabetes after using a 1 mg dose.

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 54 people

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

Timeline Started 2018-08 · est. completion 2019-01

Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT03611322 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide, 0.25 mg Drug

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
Semaglutide, 0.5 mg Drug

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
Semaglutide, 1.0 mg Drug

Semaglutide will be administered s.c. (under the skin) on day 29 in the morning after an overnight fast of at least 8 hours
DV3372 Device

DV3372 device will be used for administration of semaglutide
PDS290 pen-injector Device

PDS290 pen-injector will be used for administration of semaglutide

Main thing measured	AUC0-last,sema,Week5: the area under the plasma semaglutide concentration-time curve from 0 until last quantifiable measurement after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03611322 ↗