Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.

• Phase: Phase 2
• 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:

• Subjects with Type 2 diabetes

• Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months

• HbA1c maximum 10.0%

• BMI (Body Mass Index) maximum 35.0 kg/m2

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

Exclusion Criteria:

• The receipt of any investigational drug within the last 30 days prior to this trial

• Total daily insulin dose minimum 2.0 U/(kg·day)

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

• Impaired hepatic function

• Impaired renal function

• Cardiac disease

• Severe, uncontrolled hypertension