Back to resultsA Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2, Healthy
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Insulin 320
insulin glargine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Level 1-7 escalating doses
Arm Description
Outcomes
Primary Outcome Measures
Number of treatment-emergent adverse events
Secondary Outcome Measures
Area under the serum insulin concentration-time curve
Area under the glucose infusion rate-time curve
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02479022
Brief Title
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects
Official Title
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Level 1-7 escalating doses
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Insulin 320
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.
Primary Outcome Measure Information:
Title
Number of treatment-emergent adverse events
Time Frame
From the time of trial product administration and until 12 days after trial product administration
Secondary Outcome Measure Information:
Title
Area under the serum insulin concentration-time curve
Time Frame
From 0 to 288 hours after a single dose (SD)
Title
Area under the glucose infusion rate-time curve
Time Frame
From 0 to 24 hours after a single dose
10. Eligibility
Sex
Male
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, 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects
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