A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects
NCT ID: NCT02479022
Last Updated: 2016-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
84 participants
INTERVENTIONAL
2015-06-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Level 1-7 escalating doses
Insulin 320
Subjects will be randomised to receive a single dose of Insulin 320 orally, at 7 escalating dose levels from 300 nmol to 21600 nmol. Progression to next dose level will be based on a safety evaluation.
insulin glargine
As an open label active comparator, subjects will be randomised to receive a single dose of insulin glargine subcutaneously (s.c., under the skin), at all dose levels. The insulin glargine dose will be the same at all dose levels.
placebo
Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.
Interventions
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Insulin 320
Subjects will be randomised to receive a single dose of Insulin 320 orally, at 7 escalating dose levels from 300 nmol to 21600 nmol. Progression to next dose level will be based on a safety evaluation.
insulin glargine
As an open label active comparator, subjects will be randomised to receive a single dose of insulin glargine subcutaneously (s.c., under the skin), at all dose levels. The insulin glargine dose will be the same at all dose levels.
placebo
Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.
Eligibility Criteria
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Inclusion Criteria
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)
* Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion Criteria
* Previous participation in this trial. Participation is defined as signed informed consent
* Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
* Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) as judged by the investigator
18 Years
55 Years
MALE
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Neuss, , Germany
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2014-003918-92
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1161-6716
Identifier Type: OTHER
Identifier Source: secondary_id
NN1957-4195
Identifier Type: -
Identifier Source: org_study_id
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