Comparison of Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes

• Status: Completed
• Trial end date: 2001-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of this trial is to compare the single dose and steady state pharmacodynamics 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 basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily

• BMI (Body Mass Index) maximum 35 kg/m^2

• Able and willing to perform self-blood glucose monitoring

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

• Currently being treated with insulin aspart products

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

• Impaired hepatic function

• Impaired renal function

• Blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory

• Cardiac problems

• Severe, uncontrolled hypertension