Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30
Intervention description: Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 344.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

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

          -  Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months

          -  Currently treated with premixed/self-mixed human insulin (proportion of short-acting
             insulin is equal to or lower than 30%) BID (twice daily) combined with metformin with
             or without alpha-glucosidase inhibitor for at least 3 months prior to screening visit
             (Visit 1) with the minimum dose stated: Metformin: at least 1500 mg/day or maximum
             tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to
             Visit 1) OR alpha-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or
             voglibose at least 0.6 mg/day

          -  Total daily insulin dose below 1.4 IU/Kg

          -  HbA1c above or equal to 7.0% and below or equal to 9.5% (central laboratory)

          -  Body Mass Index (BMI) below or equal to 35.0 kg/m^2

        Exclusion Criteria:

          -  Treatment with any insulin secretagogue, thiazolidinedione (TZD), dipeptidyl
             peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists
             within the last 3 months prior to Visit 1

          -  Previous use of insulin intensification treatment (premixed insulin thrice daily,
             basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more
             than 14 days

          -  Previous use of any insulin other than premixed/self-mixed human insulin (proportion
             of short acting insulin equal to or lower than 30%) BID within 3 month prior to Visit
             1

          -  Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the
             last 12 months) or hypoglycaemic unawareness as judged by the investigator or
             hospitalisation for diabetic ketoacidosis during the previous 6 months

          -  Known proliferative retinopathy or maculopathy requiring treatment