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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Diabetes, Healthy

Intervention / Treatment
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* Drug: Insulin 320
* Drug: insulin glargine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |