A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects
3 other identifiers
interventional
84
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 320 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 19, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 1, 2016
July 1, 2016
6 months
June 19, 2015
July 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of treatment-emergent adverse events
From the time of trial product administration and until 12 days after trial product administration
Secondary Outcomes (2)
Area under the serum insulin concentration-time curve
From 0 to 288 hours after a single dose (SD)
Area under the glucose infusion rate-time curve
From 0 to 24 hours after a single dose
Study Arms (1)
Level 1-7 escalating doses
EXPERIMENTALInterventions
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.
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.
Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.
Eligibility Criteria
You may qualify if:
- Male, aged 18-55 years (both inclusive) at the time of signing informed consent
- 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
You may not qualify if:
- Known or suspected hypersensitivity to trial products or related products
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Neuss, 41460, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2015
First Posted
June 23, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
August 1, 2016
Record last verified: 2016-07