Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes
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This trial is conducted in Africa and Middle East. The objective of the study is to compare glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30 twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.
Comparison of Biphasic Insulin Aspart 30 Twice Daily With Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart, in Combination With or Without Metformin (for Both Treatment Groups) in Subjects With Type 2 Diabetes. A Multi-center, Randomized, Open-labeled, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70
Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
18 Years to 18 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Type 2 diabetic subjects
Current treatment with Biphasic Human Insulin 30/70 twice daily alone or in combination with any oral hypoglycaemic agent for at least 3 months prior to entering the trial
HbA1c at least 12%
Willing and able to perform self blood glucose monitoring (SMBG)
History of drug or alcohol dependence
Receipt of any investigational drug within the last month prior to this trial
Anticipated change in dose of prescription medication, which may influence glucose regulation (Mono Amino Oxidase-inhibitors, non selective beta-adrenergic agents, anabolic steroids and systemic glucocorticoids)
Severe uncontrolled hypertension
Recurrent severe hypoglycemia as judged by investigator
Any disease or condition, which the Investigator feels, would interfere with the trial