Safety and Effect of Biphasic Insulin Aspart 50 in Patients With Type 2 Diabetes Mellitus.
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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.
Condition or disease
DiabetesDiabetes Mellitus, Type 2
Drug: biphasic insulin aspartDrug: biphasic human insulin
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Ages Eligible for Study:
20 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.)