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

NCT03598621 | Completed Phase 1 FDA Drug

• 3 other identifiers: NN9535-4387U1111-1200-80752017-003437-29
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until last quantifiable measurement after a single dose subcutaneous semaglutide administration

  Measured in nmol·h/L.

  0-840 hours (5 weeks)

• Cmax,sema,SD, the maximum plasma semaglutide concentration after a single dose subcutaneous semaglutide administration

  Measured in nmol/L.

  0-840 hours (5 weeks)

Secondary Outcomes (7)

• AUC0-∞,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until infinity after a single dose subcutaneous semaglutide administration

  0-840 hours (5 weeks)

• tmax,sema,SD, time to Cmax,sema,SD of semaglutide

  0-840 hours (5 weeks)

• t½,sema,SD, terminal elimination half-life of semaglutide

  0-840 hours (5 weeks)

• Cl/F,sema,SD, total apparent clearance of semaglutide

  0-840 hours (5 weeks)

• Vz/F,sema,SD, apparent volume of distribution of semaglutide

  0-840 hours (5 weeks)

Study Arms (3)

Cohort 1: Semaglutide 0.25 mg

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.

Drug: Semaglutide, 0.5 mg/mL; Drug: Semaglutide, 1.34 mg/mL; Device: DV3372, 0.5 mg/mL; Device: PDS290

Cohort 2: Semaglutide 0.5 mg

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.

Drug: Semaglutide, 1.0 mg/mL; Drug: Semaglutide, 1.34 mg/mL; Device: DV3372, 1.0 mg/mL; Device: PDS290

Cohort 3: Semaglutide 0.5 mg

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.

Drug: Semaglutide, 1.34 mg/mL; Drug: Semaglutide, 2.0 mg/mL; Device: PDS290; Device: NovoPen®4

Interventions

Semaglutide, 0.5 mg/mL DRUG

A single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours.

Cohort 1: Semaglutide 0.25 mg

Semaglutide, 1.0 mg/mL DRUG

A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.

Cohort 2: Semaglutide 0.5 mg

Semaglutide, 1.34 mg/mL DRUG

A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.

Cohort 1: Semaglutide 0.25 mg; Cohort 2: Semaglutide 0.5 mg; Cohort 3: Semaglutide 0.5 mg

Semaglutide, 2.0 mg/mL DRUG

A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.

Cohort 3: Semaglutide 0.5 mg

DV3372, 0.5 mg/mL DEVICE

DV3372 device will be used for administration of semaglutide 0.5 mg/mL.

Cohort 1: Semaglutide 0.25 mg

DV3372, 1.0 mg/mL DEVICE

DV3372 device will be used for administration of semaglutide 1.0 mg/mL.

Cohort 2: Semaglutide 0.5 mg

PDS290 DEVICE

PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.

Cohort 1: Semaglutide 0.25 mg; Cohort 2: Semaglutide 0.5 mg; Cohort 3: Semaglutide 0.5 mg

NovoPen®4 DEVICE

NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL.

Cohort 3: Semaglutide 0.5 mg

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly affective contraceptive methods.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Novo Nordisk Investigational Site

Mainz, 55116, Germany

Location

Novo Nordisk Investigational Site

Neuss, 41460, 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
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: July 23, 2018
• Primary Completion: January 17, 2019
• Study Completion: January 17, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)