Safety and Effect of Biphasic Insulin Aspart 50 in Patients With Type 2 Diabetes Mellitus.

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: biphasic human insulin

Drug: biphasic insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT00476437

JapicCTI-070408 (Registry Identifier)

BIASP-1864

Details and patient eligibility

About

This trial is conducted in Japan. The purpose of this trial is to investigate the safety and the effect of biphasic insulin aspart 50 compared to biphasic human insulin 50 in patients with type 2 diabetes mellitus.

Enrollment

81 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 diabetes mellitus
Current treatment with pre-mixed human insulin preparation or biphasic/pre-mixed insulin analogue in twice daily treatment for at least 8 weeks.
HbA1C: less than 11.0%
BMI: less than 30.0 kg/m2

Exclusion criteria

Total daily insulin dose: 100 IU/U and more
Treatment with oral hypoglycaemic agents within the last 4 weeks.
Treatment with insulin sensitizer within the last 12 weeks
A lifestyle that is considered unsuitable for this trial (frequent or routine night shift workers etc.)