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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes; Healthy
• Interventions: Drug: Insulin 320; Drug: insulin glargine; Drug: placebo

• Registration Number: NCT02479022
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-19
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-23
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-29
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 84

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Level 1-7 escalating doses	Insulin 320	-
Level 1-7 escalating doses	placebo	-
Level 1-7 escalating doses	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Number of treatment-emergent adverse events	From the time of trial product administration and until 12 days after trial product administration

Secondary Outcome Measures

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