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

Primary Purpose

Healthy Volunteers, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Semaglutide

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

DV3396

PDS290

Arm Description

Semaglutide administered with the DV3396 pen-injector (semaglutide D, test formulation)

Semaglutide administered with the PDS290 pen-injector (semaglutide reference formulation)

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

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

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

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

Full Information

NCT ID

NCT04152915

First Posted

November 4, 2019

Last Updated

November 9, 2021

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT04152915

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

November 25, 2019 (Actual)

Primary Completion Date

May 25, 2020 (Actual)

Study Completion Date

May 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DV3396

Arm Type

Experimental

Arm Description

Semaglutide administered with the DV3396 pen-injector (semaglutide D, test formulation)

Arm Title

PDS290

Arm Type

Experimental

Arm Description

Semaglutide administered with the PDS290 pen-injector (semaglutide reference formulation)

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 7 weeks

Primary Outcome Measure Information:

Title

Description

hours*nmol/L

Time Frame

0-840 hours after one dose of s.c. semaglutide 1 mg

Title

Cmax,sema,1mg: Maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period

Description

nmol/L

Time Frame

0-840 hours after one dose of s.c. semaglutide 1 mg

Secondary Outcome Measure Information:

Title

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

Description

hours*nmol/L

Time Frame

0-168 hours after the last dose of s.c. semaglutide 0.25 mg

Title

Cmax,sema,0.25mg,SS: Maximum observed semaglutide concentration at steady state after the last dose of s.c. semaglutide 0.25 mg administration

Description

nmol/L

Time Frame

0-168 hours after the last dose of s.c. semaglutide 0.25 mg

Title

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

Description

hours*nmol/L

Time Frame

0-840 hours after one dose of s.c. semaglutide 1 mg

Title

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

Description

hours

Time Frame

0-840 hours after one dose of s.c. semaglutide 1 mg

Title

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

Description

hours

Time Frame

0-168 hours after the last dose of s.c. semaglutide 0.25 mg

Title

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

Description

hours

Time Frame

0-840 hours after one dose of s.c. semaglutide 1 mg

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Mainz

ZIP/Postal Code

55116

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

IPD Sharing URL

http://novonordisk-trials.com

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

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