A Double-blind, Randomised, Four-Period Crossover Trial Comparing the Pharmacodynamics and Pharmacokinetics After Single Dose of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Insulin Aspart in Subjects With Type 1 Diabetes
Overview
- Phase
- Phase 1
- Intervention
- biphasic insulin aspart 50
- Conditions
- Diabetes
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 1 diabetes for at least 12 months
- •Serum C-peptide maximum 0.4 ng/mL
- •Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine
- •BMI (Body Mass Index) maximum 32 kg/m\^2
- •HbA1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory
- •Non-smoker
Exclusion Criteria
- •The receipt of any investigational drug within the last 30 days prior to this trial
- •Total daily insulin dose at least 1.8 U/kg/day
- •Current treatment with IAsp (insulin aspart) products
- •A history of drug or alcohol abuse within the last 5 years
- •Impaired hepatic function
- •Impaired renal function
- •Cardiac problems
- •Severe, uncontrolled hypertension
Arms & Interventions
BIAsp 30
Intervention: biphasic insulin aspart 50
BIAsp 30
Intervention: biphasic insulin aspart 30
BIAsp 50
Intervention: biphasic insulin aspart 50
BIAsp 30
Intervention: biphasic insulin aspart 70
BIAsp 30
Intervention: insulin aspart
BIAsp 50
Intervention: biphasic insulin aspart 30
BIAsp 50
Intervention: biphasic insulin aspart 70
BIAsp 50
Intervention: insulin aspart
BIAsp 70
Intervention: biphasic insulin aspart 30
BIAsp 70
Intervention: biphasic insulin aspart 50
BIAsp 70
Intervention: biphasic insulin aspart 70
BIAsp 70
Intervention: insulin aspart
IAsp
Intervention: biphasic insulin aspart 30
IAsp
Intervention: biphasic insulin aspart 50
IAsp
Intervention: biphasic insulin aspart 70
IAsp
Intervention: insulin aspart
Outcomes
Primary Outcomes
Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing
Secondary Outcomes
- Hypoglycaemic episodes
- Maximum GIR value
- Maximum drug concentration for insulin aspart (IAsp)
- Time to maximum IAsp concentration
- Area under the GIR-curves
- Area under the curve of the IAsp profiles
- Minimum drug concentration in NEFA (Nonesterified fatty acids)
- Time to minimum plasma concentration, NEFA
- Area under the curve of the NEFA profiles
- Adverse events
- Time to maximum GIR value