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

A Single-Centre, Randomised, Open-Labelled, Two-Period, Crossover Trial In Subjects With Type 2 Diabetes Comparing the Glycaemic Control of Two Treatment Regimens: A Thrice Daily Regimen With Biphasic Insulin Aspart 70 and - 30 and a Twice Daily Regimen With Biphasic Human Insulin 30

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.

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