Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin degludec/insulin aspart 30; Drug: insulin degludec/insulin aspart 45; Drug: insulin degludec/insulin aspart 40; Drug: biphasic insulin aspart 30; Drug: insulin degludec/insulin aspart 55; Drug: insulin degludec; Drug: placebo; Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01868568

NN5401-1959

2007-006110-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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55 participants in 9 patient groups

IDegAsp 30 + placebo

Experimental group

Treatment:

Drug: placebo

Drug: insulin degludec/insulin aspart 30

Insulin aspart + insulin degludec - low concentration 1

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin degludec

IDegAsp 40 + placebo

Experimental group

Treatment:

Drug: placebo

Drug: insulin degludec/insulin aspart 40

Insulin aspart + insulin degludec - high concentration 1

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin degludec

IDegAsp 45 + placebo

Experimental group

Treatment:

Drug: placebo

Drug: insulin degludec/insulin aspart 45

Insulin aspart + insulin degludec

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin degludec

IDegAsp 55 + placebo

Experimental group

Treatment:

Drug: placebo

Drug: insulin degludec/insulin aspart 55

Insulin aspart + insulin degludec - high concentration

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin degludec

BIAsp 30 + placebo

Active Comparator group

Treatment:

Drug: placebo

Drug: biphasic insulin aspart 30