This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
344
Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.
Novo Nordisk Investigational Site
Hefei, Anhui, China
Novo Nordisk Investigational Site
Hefei, Anhui, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, China
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, China
Novo Nordisk Investigational Site
Guangzhou, Guangdong, China
Novo Nordisk Investigational Site
Shijiazhuang, Hebei, China
...and 12 more locations
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Time frame: Week 0, week 20
Percentage of Subjects Achieving HbA1c Below 7.0%
Time frame: After 20 weeks of treatment
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
Time frame: After 20 weeks of treatment
Change From Baseline in FPG (Fasting Plasma Glucose)
Time frame: Week 0, week 20
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value \< 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms.
Time frame: Week 0 to week 20 (inclusive).
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