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Completed

NCT Number: NCT02479022

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin 320

Drug

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

Drug

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

Drug

Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.

Primary outcomes

  1. Number of treatment-emergent adverse events

    Time frame: From the time of trial product administration and until 12 days after trial product administration

Secondary outcomes

  1. Area under the serum insulin concentration-time curve

    Time frame: From 0 to 288 hours after a single dose (SD)

  2. Area under the glucose infusion rate-time curve

    Time frame: From 0 to 24 hours after a single dose

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 23, 2015
Registry last updated
Aug 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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