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

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