Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in 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 compare insulin degludec and insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high concentration were explorative formulations, not similar to the proposed commercial formulation.

Official Title
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A Randomised, Double-blind, Multiple Period Cross-over Trial Comparing Insulin 454 and Insulin Aspart Fixed Combination Products With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared to Biphasic Insulin Aspart 30 (NovoMix® 30) in Subjects With Type 1 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: insulin degludec
* Drug: insulin degludec/insulin aspart 30
* Drug: insulin degludec/insulin aspart 40
* Drug: insulin degludec/insulin aspart 45
* Drug: insulin degludec/insulin aspart 55
* Drug: insulin aspart
* Drug: biphasic insulin aspart 30
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive) Exclusion Criteria: A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trialproduct, as judged by the Investigator A subject who is known to have hepatitis or who is carrier of the Hepatitis B surface antibodies, or has a positive result to the test for HIV antigen (HBsAg) or Hepatitis C antibodies A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDegAsp 30 + placebo<br> | Drug: insulin degludec/insulin aspart 30<br>* A single dose administered subcutaneously (s.c., under the skin).<br>Drug: placebo<br>* A single dose administered subcutaneously (s.c., under the skin).<br>|
| Experimental: Insulin aspart + insulin degludec - low concentration 1<br> | Drug: insulin degludec<br>* Administered subcutaneously (s.c., under the skin).<br>Drug: insulin aspart<br>* A single dose administered subcutaneously (s.c., under the skin).<br>|
| Experimental: IDegAsp 40 + placebo<br> | Drug: insulin degludec/insulin aspart 40<br>* A single dose administered subcutaneously (s.c., under the skin).<br>Drug: placebo<br>* A single dose administered subcutaneously (s.c., under the skin).<br>|
| Experimental: Insulin aspart + insulin degludec - high concentration 1<br> | Drug: insulin degludec<br>* Administered subcutaneously (s.c., under the skin).<br>Drug: insulin aspart<br>* A single dose administered subcutaneously (s.c., under the skin).<br>|
| Experimental: IDegAsp 45 + placebo<br> | Drug: insulin degludec/insulin aspart 45<br>* A single dose administered subcutaneously (s.c., under the skin).<br>Drug: placebo<br>* A single dose administered subcutaneously (s.c., under the skin).<br>|
| Experimental: Insulin aspart + insulin degludec<br> | Drug: insulin degludec<br>* Administered subcutaneously (s.c., under the skin).<br>Drug: insulin aspart<br>* A single dose administered subcutaneously (s.c., under the skin).<br>|
| Experimental: IDegAsp 55 + placebo<br> | Drug: insulin degludec/insulin aspart 55<br>* A single dose administered subcutaneously (s.c., under the skin).<br>Drug: placebo<br>* A single dose administered subcutaneously (s.c., under the skin).<br>|
| Experimental: Insulin aspart + insulin degludec - high concentration<br> | Drug: insulin degludec<br>* Administered subcutaneously (s.c., under the skin).<br>Drug: insulin aspart<br>* A single dose administered subcutaneously (s.c., under the skin).<br>|
| Active Comparator: BIAsp 30 + placebo<br> | Drug: biphasic insulin aspart 30<br>* A single dose administered subcutaneously (s.c., under the skin).<br>Drug: placebo<br>* A single dose 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 insulin aspart concentration curve |  | 0-2 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve |  | 0-26 hours after dosing | 
| Area under the serum insulin 454 concentration curve |  | 0-120 hours after dosing |