Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 Diabetes

• Status: Completed
• Trial end date: 2005-04-12
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Japan. The aim of this trial was to investigate the safety and efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced by current process in Japanese 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, Long-Acting

Criteria

Inclusion Criteria:

• Subjects with type 2 diabetes

• Subjects with insulin treatment for at least 24 weeks

• Current treatment with premixed biphasic human insulin preparation for at least 12 weeks

• HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

• Recurrent severe hypoglycaemia

• Proliferative retinopathy or maculopathy requiring acute treatment

• Impaired renal function

• Cardiac diseases

• Uncontrolled hypertension

• Subjects with known malignant tumour

• Total daily insulin dose greater than or equal to 100 IU