Overview
Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes
Status:
Completed
Completed
Trial end date:
2008-08-01
2008-08-01
Target enrollment:
0
0
Participant gender:
All
All
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 (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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novo Nordisk A/STreatments:
Biphasic InsulinsInsulin
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin degludec, insulin aspart drug combination
Insulin, Globin Zinc
Insulin, Isophane
Insulin, Long-Acting
Criteria
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