Comparing Efficacy and Safety of Thrice Daily Versus Twice Daily NovoMix® 30 (Biphasic Insulin Aspart 30) in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Condition: Diabetes; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30
Intervention description: Administered subcutaneously (s.c., under the skin) thrice daily or twice daily. Subjects will continue with metformin all throughout the trial.
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: 437.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of the trial is to compare efficacy and safety of
      thrice daily versus twice daily NovoMix® 30 (Biphasic insulin aspart 30) in subjects with
      type 2 diabetes inadequately controlled with basal insulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age at least 18 years at the time of signing informed consent. For
             Algeria only: age at least 19 years at the time of signing informed consent

          -  Type 2 diabetes subjects clinically diagnosed for at least 12 months prior to the day
             of screening (Visit 1)

          -  Treated with basal insulin for at least 90 days prior to the day of screening (Visit
             1). The following basal insulin are allowed : insulin analogue once daily (OD) Neutral
             Protamine Hagedorn (NPH) OD or BID (twice daily)

          -  Treatment with metformin with or without one additional OAD (oral antidiabetic drug)
             for at least 90 days prior to the day of screening (Visit 1) Metformin must be at a
             stable dose of at least 1500 mg daily or maximum tolerated dose for at least 60 days
             prior to screening (Visit 1) One additional OAD:Sulphonylurea/Glinides/ a-glucosidase
             inhibitors/Dipeptidyl-peptidase-4 inhibitors/Sodium glucose co-transporter 2 (SGLT2)
             inhibitors (if applicable)

          -  HbA1c (glycosylated haemoglobin) 7.5%-10.0% (both inclusive) by central laboratory
             analysis at screening (Visit 1)

          -  Able and willing to intake three main meals daily (breakfast, lunch and main evening
             meal) throughout the trial. Definition of main meal as judged by the investigator

        Exclusion Criteria:

          -  Previous insulin intensification regimen for more than 14 days: premixed insulin
             thrice daily, basal-bolus regimen or continuous subcutaneous insulin infusion (CSII).
             Treatment during hospitalisation or during gestational diabetes is allowed for periods
             longer than 14 days

          -  Anticipated initiation or change in concomitant medications for more than 14
             consecutive days or on a frequent basis known to affect weight or glucose metabolism
             (e.g. orlistat, thyroid hormones, systemic corticosteroids)

          -  Impaired liver function, defined as alanine aminotransferase (ALT) equal to or above
             2.5 times upper normal limit at screening (Visit 1)