Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2Diabetes
- Registration Number
- NCT00564668
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety During 24 weeks of treatment
- Secondary Outcome Measures
Name Time Method HbA1c
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Tokyo, Japan