Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.

Official Title
-----------------
A Randomised, Double-Blind, Single Dose, Six-Period Cross-over Dose Response Trial Comparing the Pharmacodynamics and Pharmacokinetics of Insulin 454 With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin degludec
* Drug: insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results Specific inclusion criteria for subject with type 1 diabetes: Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive) Specific inclusion criteria for subject with type 2 diabetes: Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening Treated with insulin for the past 3 months prior to screening Body Mass Index (BMI) between 22.0 and 35.0 kg/ m^2 (both inclusive) Exclusion Criteria: Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator. Subject with a history of or presence of cancer Any condition that the Investigator and/or Sponsor feels would interfere with study Specific exclusion criteria for subject with type 2 diabetes: Therapy with oral antidiabetic drugs within the past 3 months prior to screening

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin degludec<br> | Drug: insulin degludec<br>* Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.<br>|
| Active Comparator: Insulin glargine<br> | Drug: insulin glargine<br>* Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.<br>|

What is the study measuring?
-----------------
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 |
| --- | --- | --- |
| Area under the insulin degludec/insulin glargine curve |  | 0-96 hours after dosing |