Completed

Comparison of Semaglutide Formulations and Injection Tools for Blood Level Consistency

Study Aim

This phase 1 study aims to compare the consistency of blood levels after a single dose of Semaglutide using different formulations and injection tools, by measuring the area under the plasma concentration curve and the maximum plasma concentration.

What is being tested

Semaglutide, 0.5 mg/mL

+ Semaglutide, 1.34 mg/mL

+ DV3372, 0.5 mg/mL

DrugDevice

Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 55 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: July 2018

See protocol details

Summary

Principal SponsorNovo Nordisk A/S

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 23, 2018

Actual date on which the first participant was enrolled.

This study focuses on comparing different versions of a medication called semaglutide, and various injection tools used to administer it. The goal is to demonstrate that these different versions of semaglutide result in similar levels in the bloodstream. This research is important as it aims to ensure that new versions of semaglutide are as effective as the ones currently prescribed by doctors. The study is designed for participants who will receive two versions of semaglutide during two separate dosing visits. One version will be the currently prescribed one, and the other will be a new version. The order in which participants receive these versions is decided randomly. During the study, participants will receive semaglutide as an injection under the skin, with a gap of 7 to 8 weeks between injections. The study will last approximately 16 weeks and will involve 27 visits to the study doctor. For two of these visits, participants will stay at the clinic for 4 days and 3 nights. The study measures the effectiveness of semaglutide by looking at the area under the plasma semaglutide concentration curve from time 0 until the last quantifiable measurement after a single dose. It also measures the maximum plasma semaglutide concentration after a single dose. These measurements help determine how well the body responds to different versions of semaglutide.

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

NCT03598621

Principal SponsorNovo Nordisk A/S

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

3 inclusion criteria required to participate

Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.

Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).

Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

5 exclusion criteria prevent from participating

Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.

Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, within 14 days prior to the day of screening.

Abuse or intake of alcohol, defined as any of the below: a) Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than 24 g alcohol daily for men and 12 g alcohol daily for women. b) Positive alcohol test at screening.

Abuse or intake of drugs, defined as any of the below: a) Known or suspected drug/chemical substance abuse within 1 year prior to the day of screening. b) Positive drug of abuse test at screening.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive a single dose of semaglutide 0.5 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.

Group II

Experimental

Participants will receive a single dose of semaglutide 1.0 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.

Group III

Experimental

Participants will receive a single dose of semaglutide 2.0 mg/mL using NovoPen®4 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Novo Nordisk Investigational Site

Mainz, GermanyOpen Novo Nordisk Investigational Site in Google Maps

Suspended

Novo Nordisk Investigational Site

Neuss, Germany

Completed2 Study Centers