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

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Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Healthy
Diabetes
Diabetes Mellitus, Type 2

Treatments

Drug: insulin glargine
Drug: Insulin 320
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02479022
2014-003918-92 (EudraCT Number)
NN1957-4195
U1111-1161-6716 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

84 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

84 participants in 1 patient group

Level 1-7 escalating doses
Experimental group
Treatment:
Drug: placebo
Drug: Insulin 320
Drug: insulin glargine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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