Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 Diabetes
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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.
A 24-week, Randomised, Multi-centre, Double-blind, Parallel-group Trial to Investigate the Safety and the Efficacy of NN2000-Mix30 Compared to NN-X14Mix30 NovoRapid®30Mix) in Subjects With Type 2 Diabetes Mellitus on a Twice Daily Regimen
Actual Study Start Date
June 19, 2004
Primary Completion Date
April 12, 2005
Study Completion Date
April 12, 2005
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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%
Recurrent severe hypoglycaemia
Proliferative retinopathy or maculopathy requiring acute treatment
Impaired renal function
Subjects with known malignant tumour
Total daily insulin dose greater than or equal to 100 IU