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)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Trial to Compare Pharmacokinetic Properties of Semaglutide Following Subcutaneous Administration of Semaglutide 1 mg by the DV3372 Device and by the PDS290 Semaglutide Pen-injector

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611322
• Other study ID #: NN9535-4429
• Secondary ID: U1111-1206-93722
• Status: Completed
• Phase: Phase 1
• Start date: August 8, 2018
• Est. completion date: January 7, 2019

Study information

• Verified date: January 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 7, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria: - Male or female, aged 18 to 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) and weight between 55.0 and 90.0 kg (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. Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods. - 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 (not allowed within 24 hours before screening), within 14 days prior to the day of screening. - Abuse or intake of alcohol, defined as any of the below: 1) Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than an average intake of 24 g alcohol daily for men and 12 g alcohol daily for women -12 g of alcohol equals about 300 mL of beer or lager, 100 mL of wine, or 25 mL spirits) or 2) Positive alcohol test at screening. - Abuse or intake of drugs, defined as any of the below: 1) Known or suspected drug/chemical substance abuse within 1 year prior to the day of screening or 2) Positive drug of abuse test at screening.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Semaglutide, 0.25 mg
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
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
Semaglutide will be administered s.c. (under the skin) on day 29 in the morning after an overnight fast of at least 8 hours

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

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measured in nmol*h/L	0-840 hours (5 weeks)
Primary	Cmax,sema,Week5: the maximum plasma semaglutide concentration after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period	Measured in nmol/L	0-840 hours (5 weeks)
Secondary	tmax,sema,Week5: time to Cmax of semaglutide after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period	Measured in hours	0-840 hours (5 weeks)
Secondary	t½,sema,Week5: terminal elimination half-life of semaglutide after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period	Measured in hours	0-840 hours (5 weeks)
Secondary	Number of site-initiated technical complaints with or without co-reported adverse events	Number of technical complaints	from first semaglutide dose (day 1) and until the follow-up visit (5 weeks after the last dose of semaglutide)