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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2008

Interventions

  • Drug: insulin degludec
    • Administered subcutaneously (s.c., under the skin).
  • Drug: insulin degludec/insulin aspart 30
    • 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).
  • Drug: insulin degludec/insulin aspart 45
    • 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).
  • Drug: insulin aspart
    • 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).
  • Drug: placebo
    • A single dose administered subcutaneously (s.c., under the skin).

Arms, Groups and Cohorts

  • Experimental: IDegAsp 30 + placebo
  • Experimental: Insulin aspart + insulin degludec – low concentration 1
  • Experimental: IDegAsp 40 + placebo
  • Experimental: Insulin aspart + insulin degludec – high concentration 1
  • Experimental: IDegAsp 45 + placebo
  • Experimental: Insulin aspart + insulin degludec
  • Experimental: IDegAsp 55 + placebo
  • Experimental: Insulin aspart + insulin degludec – high concentration
  • Active Comparator: BIAsp 30 + placebo

Clinical Trial Outcome Measures

Primary Measures

  • Area under the insulin aspart concentration curve
    • Time Frame: 0-2 hours after dosing

Secondary Measures

  • Area under the glucose infusion rate curve
    • Time Frame: 0-26 hours after dosing
  • Area under the serum insulin 454 concentration curve
    • Time Frame: 0-120 hours after dosing

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novo Nordisk A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S

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