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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: insulin degludec/insulin aspart 30; Drug: placebo; Drug: insulin degludec; Drug: insulin aspart; Drug: insulin degludec/insulin aspart 40; Drug: insulin degludec/insulin aspart 45; Drug: insulin degludec/insulin aspart 55; Drug: biphasic insulin aspart 30

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDegAsp 30 + placebo	Drug: insulin degludec/insulin aspart 30; A single dose administered subcutaneously (s.c., under the skin).; Drug: placebo; A single dose administered subcutaneously (s.c., under the skin).
Experimental: Insulin aspart + insulin degludec - low concentration 1	Drug: insulin degludec; Administered subcutaneously (s.c., under the skin).; Drug: insulin aspart; A single dose administered subcutaneously (s.c., under the skin).
Experimental: IDegAsp 40 + placebo	Drug: placebo; A single dose administered subcutaneously (s.c., under the skin).; Drug: insulin degludec/insulin aspart 40; A single dose administered subcutaneously (s.c., under the skin).
Experimental: Insulin aspart + insulin degludec - high concentration 1	Drug: insulin degludec; Administered subcutaneously (s.c., under the skin).; Drug: insulin aspart; A single dose administered subcutaneously (s.c., under the skin).
Experimental: IDegAsp 45 + placebo	Drug: placebo; A single dose administered subcutaneously (s.c., under the skin).; Drug: insulin degludec/insulin aspart 45; A single dose administered subcutaneously (s.c., under the skin).
Experimental: Insulin aspart + insulin degludec	Drug: insulin degludec; Administered subcutaneously (s.c., under the skin).; Drug: insulin aspart; A single dose administered subcutaneously (s.c., under the skin).
Experimental: IDegAsp 55 + placebo	Drug: placebo; A single dose administered subcutaneously (s.c., under the skin).; Drug: insulin degludec/insulin aspart 55; A single dose administered subcutaneously (s.c., under the skin).
Experimental: Insulin aspart + insulin degludec - high concentration	Drug: insulin degludec; Administered subcutaneously (s.c., under the skin).; Drug: insulin aspart; A single dose administered subcutaneously (s.c., under the skin).
Active Comparator: BIAsp 30 + placebo	Drug: placebo; A single dose administered subcutaneously (s.c., under the skin).; Drug: biphasic insulin aspart 30; A single dose administered subcutaneously (s.c., under the skin).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the insulin aspart concentration curve	0-2 hours after dosing

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: May 30, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Estimate): October 22, 2015
• Last Update Submitted That Met QC Criteria: October 21, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
• Other Study ID Numbers: NN5401-1959; 2007-006110-42 (EudraCT Number)