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 Phase 1 FDA Drug

• 3 other identifiers: NN9535-4429U1111-1206-93722017-005127-25
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• tmax,sema,Week5: time to Cmax of semaglutide after first maintenance dose of subcutaneous semaglutide 1 mg administration following a four week escalation period

  0-840 hours (5 weeks)

• 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

  0-840 hours (5 weeks)

• Number of site-initiated technical complaints with or without co-reported adverse events

  from first semaglutide dose (day 1) and until the follow-up visit (5 weeks after the last dose of semaglutide)

Study Arms (2)

DV3372 device

EXPERIMENTAL

Participants will receive semaglutide on day 1, 8, 15, 22 and 29. The treatment period from first treatment (Day 1) to end of the treatment (Day 29) will be 4 weeks.

Drug: Semaglutide, 0.25 mg; Drug: Semaglutide, 0.5 mg; Drug: Semaglutide, 1.0 mg; Device: DV3372

PDS290 semaglutide pen-injector

ACTIVE COMPARATOR

Participants will receive semaglutide on day 1, 8, 15, 22 and 29. The treatment period from first treatment (Day 1) to end of the treatment (Day 29) will be 4 weeks.

Drug: Semaglutide, 0.25 mg; Drug: Semaglutide, 0.5 mg; Drug: Semaglutide, 1.0 mg; Device: PDS290 pen-injector

Interventions

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

DV3372 device; PDS290 semaglutide pen-injector

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

DV3372 device; PDS290 semaglutide pen-injector

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; PDS290 semaglutide pen-injector

DV3372 DEVICE

DV3372 device will be used for administration of semaglutide

DV3372 device

PDS290 pen-injector DEVICE

PDS290 pen-injector will be used for administration of semaglutide

PDS290 semaglutide pen-injector

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 2, 2018
• Study Start: August 8, 2018
• Primary Completion: January 7, 2019
• Study Completion: January 7, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)