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

NCT03598621 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2020-01-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Reporting Anchor and Disclosure (1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-23
Primary Completion
2019-01-17
Completion
2019-01-17
FDA Drug
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03598621 on ClinicalTrials.gov