A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools
NCT ID: NCT03598621
Last Updated: 2020-01-09
Study Results
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Basic Information
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COMPLETED
PHASE1
68 participants
INTERVENTIONAL
2018-07-23
2019-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1: Semaglutide 0.25 mg
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.
Semaglutide, 0.5 mg/mL
A single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours.
Semaglutide, 1.34 mg/mL
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
DV3372, 0.5 mg/mL
DV3372 device will be used for administration of semaglutide 0.5 mg/mL.
PDS290
PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.
Cohort 2: Semaglutide 0.5 mg
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.
Semaglutide, 1.0 mg/mL
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
Semaglutide, 1.34 mg/mL
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
DV3372, 1.0 mg/mL
DV3372 device will be used for administration of semaglutide 1.0 mg/mL.
PDS290
PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.
Cohort 3: Semaglutide 0.5 mg
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.
Semaglutide, 1.34 mg/mL
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
Semaglutide, 2.0 mg/mL
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
PDS290
PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.
NovoPen®4
NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL.
Interventions
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Semaglutide, 0.5 mg/mL
A single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours.
Semaglutide, 1.0 mg/mL
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
Semaglutide, 1.34 mg/mL
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
Semaglutide, 2.0 mg/mL
A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
DV3372, 0.5 mg/mL
DV3372 device will be used for administration of semaglutide 0.5 mg/mL.
DV3372, 1.0 mg/mL
DV3372 device will be used for administration of semaglutide 1.0 mg/mL.
PDS290
PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.
NovoPen®4
NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Mainz, , Germany
Novo Nordisk Investigational Site
Neuss, , Germany
Countries
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Other Identifiers
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U1111-1200-8075
Identifier Type: OTHER
Identifier Source: secondary_id
2017-003437-29
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN9535-4387
Identifier Type: -
Identifier Source: org_study_id
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