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NCT Number: NCT01868568

Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected 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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin degludec

Drug

Administered subcutaneously (s.c., under the skin).

insulin degludec/insulin aspart 30

Drug

A single dose administered subcutaneously (s.c., under the skin).

insulin degludec/insulin aspart 40

Drug

A single dose administered subcutaneously (s.c., under the skin).

insulin degludec/insulin aspart 45

Drug

A single dose administered subcutaneously (s.c., under the skin).

insulin degludec/insulin aspart 55

Drug

A single dose administered subcutaneously (s.c., under the skin).

insulin aspart

Drug

A single dose administered subcutaneously (s.c., under the skin).

biphasic insulin aspart 30

Drug

A single dose administered subcutaneously (s.c., under the skin).

Placebo

Drug

A single dose administered subcutaneously (s.c., under the skin).

Primary outcomes

  1. Area under the insulin aspart concentration curve

    Time frame: 0-2 hours after dosing

Secondary outcomes

  1. Area under the glucose infusion rate curve

    Time frame: 0-26 hours after dosing

  2. Area under the serum insulin 454 concentration curve

    Time frame: 0-120 hours after dosing

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2013
Registry last updated
Oct 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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