A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens

A Trial to Demonstrate Bioequivalence Between Semaglutide D Formulations for the DV3396 Pen-Injector and the Formulation for the PDS290 Semaglutide Pen-Injector

The study will look at how two different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide. Which version participants get is decided by chance. One version is the one that doctors already can prescribe and the other is the new version. Participants will get the medicines as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two versions of semaglutide. The study will last for about 80-99 days. Participants will have 24 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Healthy Volunteers
• Intervention / Treatment: Drug: Semaglutide

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55116
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent.
• Body mass index between 25.0 and 34.9 kg/m^2 (both inclusive) and
• Body weight between 65.0 and 130.0 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, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid (the two latter are 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:
• 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)
• Positive alcohol test at screening
• Abuse or intake of drugs, defined as any of the below:
• Known or suspected drug/chemical substance abuse within 1 year prior to the day of screening
• Positive drug of abuse test at screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DV3396; Semaglutide administered with the DV3396 pen-injector (semaglutide D, test formulation)	Drug: Semaglutide; Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 7 weeks
Experimental: PDS290; Semaglutide administered with the PDS290 pen-injector (semaglutide reference formulation)	Drug: Semaglutide; Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 7 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-last,sema,1mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period	hours*nmol/L	0-840 hours after one dose of s.c. semaglutide 1 mg
Cmax,sema,1mg: Maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period	nmol/L	0-840 hours after one dose of s.c. semaglutide 1 mg

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-168h,sema,0.25mg,SS: Area under the semaglutide concentration time curve from time 0 until 168 hours at steady state after the last dose of s.c. semaglutide 0.25 mg administration	hours*nmol/L	0-168 hours after the last dose of s.c. semaglutide 0.25 mg
Cmax,sema,0.25mg,SS: Maximum observed semaglutide concentration at steady state after the last dose of s.c. semaglutide 0.25 mg administration	nmol/L	0-168 hours after the last dose of s.c. semaglutide 0.25 mg
AUC0-∞,sema,1mg: Area under the semaglutide concentration time curve from time 0 until infinity after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period	hours*nmol/L	0-840 hours after one dose of s.c. semaglutide 1 mg
tmax,sema,1mg: Time of maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period	hours	0-840 hours after one dose of s.c. semaglutide 1 mg
tmax,sema,0.25mg,SS: Time of maximum observed semaglutide concentration at steady state after the last dose of s.c. semaglutide 0.25 mg administration	hours	0-168 hours after the last dose of s.c. semaglutide 0.25 mg
t½,sema,1mg: terminal elimination half-life of semaglutide after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period	hours	0-840 hours after one dose of s.c. semaglutide 1 mg

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): May 25, 2020
• Study Completion (Actual): May 25, 2020

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9535-4588; U1111-1235-3506 (Other Identifier: World Health Organization (WHO)); 2019-002588-92 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No