Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/insulin aspart; biphasic insulin aspart
Intervention description: Twice daily subcutaneous (sc, under the skin) injection.; Twice daily subcutaneous (sc, under the skin) injection.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 543.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of
      insulin degludec/insulin aspart and BIAsp 30 in subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. Trial-related
             activities are any procedures that are carried out as part of the trial, including
             activities to determine suitability for the trial

          -  Male or female at least 18 years of age

          -  Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months

          -  Insulin treated subjects on current treatment: basal insulin, premixed insulin or a
             self-mixed insulin regimen, all administered once daily (OD) or BID with or without
             metformin. The treatment regimen should have remained unchanged for at least 8 weeks
             prior to randomisation

          -  HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis

          -  Body mass index (BMI) equal or below 40.0 kg/m^2

        Exclusion Criteria:

          -  Treatment with sulphonylureas, meglitinides, DPP-4 inhibitors, alpha-glycosidase
             inhibitors within 8 weeks prior to screening (Visit 1) or thiazolidinediones (TZDs) or
             GLP-1 receptor agonists within 12 weeks prior to screening (Visit 1)

          -  Anticipated change in concomitant medication known to interfere significantly with
             glucose metabolism, such as systemic corticosteroids, beta-blockers and monoamine
             oxidase (MAO) inhibitors

          -  Anticipated significant lifestyle changes during the trial according to the discretion
             of the investigator, e.g. shift work (including permanent night/evening shift
             workers), as well as highly variable eating habits

          -  Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined
             as: stroke; decompensated heart failure NYHA1 class III or IV; myocardial infarction;
             unstable angina pectoris; or coronary arterial bypass graft or angioplasty

          -  Any clinically significant disease or disorder, except for conditions associated with
             type 2 diabetes, which in the investigator's opinion could interfere with the results
             of the trial

          -  Previous participation in this trial. Participation is defined as screened.

          -  Known or suspected hypersensitivity to trial products or related products