Status:

COMPLETED

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

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes

Diabetes Mellitus, Type 1

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

Brief Summary

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 (i...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2008

Estimated Enrollment :

55 Patients enrolled

Trial Details

Trial ID

NCT01868568

Start Date

April 1 2008

End Date

August 1 2008

Last Update

October 22 2015

Active Locations (1)

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1

Neuss, Germany, 41460