Overview

Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes

Status:
Completed
Trial end date:
1999-06-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Biphasic Insulins
Insulin
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Insulin, Globin Zinc
Insulin, Long-Acting
Criteria
Inclusion Criteria:

- Type 2 diabetes

- Duration of diabetes for longer than 12 months

- Body mass index (BMI) below 35.0 kg/m^2

- HbA1c below 11.0 %

- Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three
months and in the last month as sole anti-diabetic treatment (i.e., no additional oral
hypoglycaemic medication or daily use of short-acting insulin supplement)

Exclusion Criteria:

- Current treatment with agents affecting glucose metabolism

- History of drug or alcohol dependence

- Impaired hepatic function

- Impaired renal function

- Cardiac disease

- Proliferative retinopathy

- Recurrent severe hypoglycaemia or advanced neuropathy