Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Characteristics of Explorative Formulations of Insulin Degludec and IDegAsp 50 in Healthy Japanese Subjects

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM), both explorative formulations, not similar to the proposed commercial formulation, in healthy male Japanese subjects.

Official Title
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A Randomised, Double-blind, Placebo-controlled, Single-dose, Parallel Group Trial With Insulin 454 and SIAM 50 in Healthy Male Japanese Subjects

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: insulin degludec
* Drug: placebo
* Drug: insulin degludec/insulin aspart 50


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese passport holder Japanese-born parents Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive) Fasting blood glucose of below or equal to 6 mmol/L Healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data at screening, as assessment of medical history, physical exjudged by the Investigator Exclusion Criteria: The receipt of any investigational drug within 3 months prior to this trial Subjects with a history of significant multiple drug allergies or with a known allergy to the trialproduct or any medicine chemically related to the trial product, 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose, insulin degludec<br> | Drug: insulin degludec<br>* Single dose administered subcutaneously (s.c., under the skin).<br>Drug: placebo<br>* Administered subcutaneously (s.c., under the skin)<br>|
| Experimental: Medium dose, insulin degludec<br> | Drug: insulin degludec<br>* Single dose administered subcutaneously (s.c., under the skin).<br>Drug: placebo<br>* Administered subcutaneously (s.c., under the skin)<br>|
| Experimental: High dose, insulin degludec<br> | Drug: insulin degludec<br>* Single dose administered subcutaneously (s.c., under the skin).<br>Drug: placebo<br>* Administered subcutaneously (s.c., under the skin)<br>|
| Experimental: IDegAsp 50<br> | Drug: placebo<br>* Administered subcutaneously (s.c., under the skin)<br>Drug: insulin degludec/insulin aspart 50<br>* Single dose of IDegAsp 50 administered subcutaneously (s.c., under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events (AEs) |  | From dosing visit and until follow-up 7-21 days after last dosing visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin concentration curve |  | 0-96 hours after dosing | 
| Area under the glucose infusion rate curve |  | 0-24 hours after dosing |