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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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 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.)