A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects

July 29, 2016 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Level 1-7 escalating doses
Drug: 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.
Drug: 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.
Drug: placebo
Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of treatment-emergent adverse events
Time Frame: From the time of trial product administration and until 12 days after trial product administration
From the time of trial product administration and until 12 days after trial product administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the serum insulin concentration-time curve
Time Frame: From 0 to 288 hours after a single dose (SD)
From 0 to 288 hours after a single dose (SD)
Area under the glucose infusion rate-time curve
Time Frame: From 0 to 24 hours after a single dose
From 0 to 24 hours after a single dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 19, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1957-4195
  • 2014-003918-92 (EudraCT Number)
  • U1111-1161-6716 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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