Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes

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 the pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, under single-dose and steady-state conditions in male subjects with type 1 diabetes.

Official Title
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A Single Centre, Open-Label, Multiple Dose Trial Examining the Pharmacodynamic Characteristics of Insulin 454 Under Single-Dose and Steady-State Conditions in Male Subjects With Type 1 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: insulin degludec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive) Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results Exclusion Criteria: History of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator Participation in any other trials involving investigational products within 3 months preceding the start of dosing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 (Once-daily dosing regimen, high concentration)<br> | Drug: insulin degludec<br>* Administered subcutaneously (s.c., under the skin)<br>|
| Experimental: Part 2 (Twice-daily dosing regimen, high concentration)<br> | Drug: insulin degludec<br>* Administered subcutaneously (s.c., under the skin)<br>|
| Experimental: Part 3 (Once-daily dosing regimen, low concentration)<br> | Drug: insulin degludec<br>* 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 |
| --- | --- | --- |
| Area under the glucose infusion rate curve |  | 0-24 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum glucose infusion rate (GIRmax) |  | 0-24 hours after dosing | 
| Time to maximum glucose infusion rate (tGIRmax) |  | 0-24 hours after dosing | 
| Area under the serum insulin degludec curve |  | 0-96 hours after dosing |