Back to resultsA Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Semaglutide, 0.5 mg/mL
Semaglutide, 1.0 mg/mL
Semaglutide, 1.34 mg/mL
Semaglutide, 2.0 mg/mL
DV3372, 0.5 mg/mL
DV3372, 1.0 mg/mL
PDS290
NovoPen®4
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1: Semaglutide 0.25 mg
Cohort 2: Semaglutide 0.5 mg
Cohort 3: Semaglutide 0.5 mg
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Cmax,sema,SD, the maximum plasma semaglutide concentration after a single dose subcutaneous semaglutide administration
Measured in nmol/L.
Secondary Outcome Measures
AUC0-∞,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until infinity after a single dose subcutaneous semaglutide administration
Measured in nmol·h/L.
tmax,sema,SD, time to Cmax,sema,SD of semaglutide
Measured in hours.
t½,sema,SD, terminal elimination half-life of semaglutide
Measured in hours.
Cl/F,sema,SD, total apparent clearance of semaglutide
Measured in L/h.
Vz/F,sema,SD, apparent volume of distribution of semaglutide
Measured in L.
Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 0.5 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL
Count of technical complaints.
Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 1.0 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL
Count of technical complaints.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03598621
Brief Title
A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools
Official Title
A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations for the DV3372 Device and the Formulation for the PDS290 Semaglutide Pen-injector
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
January 17, 2019 (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
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: Semaglutide 0.25 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2: Semaglutide 0.5 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 3: Semaglutide 0.5 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Semaglutide, 0.5 mg/mL
Intervention Description
A single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours.
Intervention Type
Drug
Intervention Name(s)
Semaglutide, 1.0 mg/mL
Intervention Description
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
Intervention Type
Drug
Intervention Name(s)
Semaglutide, 1.34 mg/mL
Intervention Description
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
Intervention Type
Drug
Intervention Name(s)
Semaglutide, 2.0 mg/mL
Intervention Description
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
Intervention Type
Device
Intervention Name(s)
DV3372, 0.5 mg/mL
Intervention Description
DV3372 device will be used for administration of semaglutide 0.5 mg/mL.
Intervention Type
Device
Intervention Name(s)
DV3372, 1.0 mg/mL
Intervention Description
DV3372 device will be used for administration of semaglutide 1.0 mg/mL.
Intervention Type
Device
Intervention Name(s)
PDS290
Intervention Description
PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.
Intervention Type
Device
Intervention Name(s)
NovoPen®4
Intervention Description
NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL.
Primary Outcome Measure Information:
Title
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
Description
Measured in nmol·h/L.
Time Frame
0-840 hours (5 weeks)
Title
Cmax,sema,SD, the maximum plasma semaglutide concentration after a single dose subcutaneous semaglutide administration
Description
Measured in nmol/L.
Time Frame
0-840 hours (5 weeks)
Secondary Outcome Measure Information:
Title
AUC0-∞,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until infinity after a single dose subcutaneous semaglutide administration
Description
Measured in nmol·h/L.
Time Frame
0-840 hours (5 weeks)
Title
tmax,sema,SD, time to Cmax,sema,SD of semaglutide
Description
Measured in hours.
Time Frame
0-840 hours (5 weeks)
Title
t½,sema,SD, terminal elimination half-life of semaglutide
Description
Measured in hours.
Time Frame
0-840 hours (5 weeks)
Title
Cl/F,sema,SD, total apparent clearance of semaglutide
Description
Measured in L/h.
Time Frame
0-840 hours (5 weeks)
Title
Vz/F,sema,SD, apparent volume of distribution of semaglutide
Description
Measured in L.
Time Frame
0-840 hours (5 weeks)
Title
Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 0.5 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL
Description
Count of technical complaints.
Time Frame
Week 0-5 in both treatment period 1 and 2
Title
Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 1.0 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL
Description
Count of technical complaints.
Time Frame
Week 0-5 in both treatment period 1 and 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
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
Learn more about this trial
A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools
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