Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes

• Status: Completed
• Trial end date: 2001-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of this trial is to investigate steady state pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Type 1 diabetes for at least 12 months

• Currently on a multiple dose insulin regimen

• HbA1c maximum 12.0%

• BMI (body mass index) below 35 kg/m^2

• Able and willing to perform self-blood glucose monitoring (SBGM)

Exclusion Criteria:

• Treatment with insulin aspart within the last 14 days prior to this trial

• 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

• A history of drug abuse or alcohol dependence within the last 5 years

• Impaired hepatic function

• Impaired renal function

• Blood donation within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory

• Cardiac disease

• Severe, uncontrolled hypertension