Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type 1Diabetes
- Interventions
- Drug: biphasic insulin aspart 50Drug: biphasic insulin aspart 70
- Registration Number
- NCT01536028
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BIAsp 30 biphasic insulin aspart 30 - BIAsp 30 biphasic insulin aspart 70 - BIAsp 50 biphasic insulin aspart 30 - BIAsp 70 biphasic insulin aspart 30 - IAsp biphasic insulin aspart 50 - IAsp biphasic insulin aspart 70 - BIAsp 30 biphasic insulin aspart 50 - BIAsp 50 biphasic insulin aspart 50 - BIAsp 70 biphasic insulin aspart 50 - BIAsp 70 biphasic insulin aspart 70 - BIAsp 50 biphasic insulin aspart 70 - IAsp biphasic insulin aspart 30 - BIAsp 30 insulin aspart - BIAsp 50 insulin aspart - BIAsp 70 insulin aspart - IAsp insulin aspart -
- Primary Outcome Measures
Name Time Method Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing
- Secondary Outcome Measures
Name Time Method Hypoglycaemic episodes Maximum drug concentration for insulin aspart (IAsp) Time to maximum IAsp concentration Maximum GIR value 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
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Neuss, Germany