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

Phase 1

Completed

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

• Registration Number: NCT01868568
• Lead Sponsor: Novo Nordisk A/S

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 (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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-06-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IDegAsp 30 + placebo	placebo	-
IDegAsp 40 + placebo	insulin degludec/insulin aspart 40	-
IDegAsp 30 + placebo	insulin degludec/insulin aspart 30	-
IDegAsp 40 + placebo	placebo	-
IDegAsp 45 + placebo	insulin degludec/insulin aspart 45	-
IDegAsp 45 + placebo	placebo	-
IDegAsp 55 + placebo	insulin degludec/insulin aspart 55	-
IDegAsp 55 + placebo	placebo	-
BIAsp 30 + placebo	biphasic insulin aspart 30	-
BIAsp 30 + placebo	placebo	-
Insulin aspart + insulin degludec - high concentration 1	insulin aspart	-
Insulin aspart + insulin degludec	insulin degludec	-
Insulin aspart + insulin degludec - low concentration 1	insulin degludec	-
Insulin aspart + insulin degludec - low concentration 1	insulin aspart	-
Insulin aspart + insulin degludec - high concentration 1	insulin degludec	-
Insulin aspart + insulin degludec - high concentration	insulin aspart	-
Insulin aspart + insulin degludec	insulin aspart	-
Insulin aspart + insulin degludec - high concentration	insulin degludec	-

Primary Outcome Measures

Name	Time	Method
Area under the insulin aspart concentration curve	0-2 hours after dosing

Secondary Outcome Measures

Name	Time	Method
Area under the serum insulin 454 concentration curve	0-120 hours after dosing
Area under the glucose infusion rate curve	0-26 hours after dosing