Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart; Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70

Study type: Interventional

Funder types: Industry

Identifiers

NCT01536028

2005-004965-40 (EudraCT Number)

BIASP-1746

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 4 patient groups

BIAsp 30

Active Comparator group

Treatment:

Drug: biphasic insulin aspart 70

Drug: biphasic insulin aspart 30

Drug: insulin aspart

Drug: biphasic insulin aspart 50

BIAsp 50

Experimental group

Treatment:

Drug: biphasic insulin aspart 70

Drug: biphasic insulin aspart 30

Drug: insulin aspart

Drug: biphasic insulin aspart 50

BIAsp 70

Experimental group

Treatment:

Drug: biphasic insulin aspart 70

Drug: biphasic insulin aspart 30

Drug: insulin aspart

Drug: biphasic insulin aspart 50

IAsp

Active Comparator group

Treatment:

Drug: biphasic insulin aspart 70

Drug: biphasic insulin aspart 30

Drug: insulin aspart

Drug: biphasic insulin aspart 50