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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 55
- Primary Endpoint
- Area under the insulin aspart concentration curve
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
IDegAsp 30 + placebo
Intervention: insulin degludec/insulin aspart 30 (Drug)
IDegAsp 30 + placebo
Intervention: placebo (Drug)
Insulin aspart + insulin degludec - low concentration 1
Intervention: insulin degludec (Drug)
Insulin aspart + insulin degludec - low concentration 1
Intervention: insulin aspart (Drug)
IDegAsp 40 + placebo
Intervention: insulin degludec/insulin aspart 40 (Drug)
IDegAsp 40 + placebo
Intervention: placebo (Drug)
Insulin aspart + insulin degludec - high concentration 1
Intervention: insulin degludec (Drug)
Insulin aspart + insulin degludec - high concentration 1
Intervention: insulin aspart (Drug)
IDegAsp 45 + placebo
Intervention: insulin degludec/insulin aspart 45 (Drug)
IDegAsp 45 + placebo
Intervention: placebo (Drug)
Insulin aspart + insulin degludec
Intervention: insulin degludec (Drug)
Insulin aspart + insulin degludec
Intervention: insulin aspart (Drug)
IDegAsp 55 + placebo
Intervention: insulin degludec/insulin aspart 55 (Drug)
IDegAsp 55 + placebo
Intervention: placebo (Drug)
Insulin aspart + insulin degludec - high concentration
Intervention: insulin degludec (Drug)
Insulin aspart + insulin degludec - high concentration
Intervention: insulin aspart (Drug)
BIAsp 30 + placebo
Intervention: biphasic insulin aspart 30 (Drug)
BIAsp 30 + placebo
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Area under the insulin aspart concentration curve
Time Frame: 0-2 hours after dosing
Secondary Outcomes
- Area under the glucose infusion rate curve(0-26 hours after dosing)
- Area under the serum insulin 454 concentration curve(0-120 hours after dosing)