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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00564668

NN2000-1611

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind