A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30; insulin glargine; insulin aspart
Intervention description: Injected s.c./subcutaneously once daily with the largest meal Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.; Injected s.c./subcutaneously once daily at the same time every day, with the possibility of treatment intensification with insulin aspart (Basal-bolus arm) Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.; Injected s.c./subcutaneously once daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; 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: 335.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to compare stepwise insulin
      intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin
      glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled
      on oral anti-diabetic therapy.
    

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, age at least 18 years at the time of signing informed consent

          -  Type 2 diabetes subjects clinically diagnosed at least 6 months prior to screening

          -  Treatment with stable daily dose (for at least 90 days prior to screening) of: -
             Metformin (equal or above 1000 mg or maximum tolerated dose documented in the patient
             medical record) and - Sulfonylurea - and willing to discontinue any other oral
             antidiabetic drugs containing insulin secretagogues, DPP4i (dipeptidyl peptidase-4
             inhibitor), SGLT2 (sodium glucose co-transporter 2), colesevelam, bromocriptin and/or
             combination products at randomisation

          -  Insulin-naïve. Short term insulin treatment for acute illnesses for a total of 14 days
             or less is allowed as is prior insulin treatment for gestational diabetes

          -  HbA1c (glycosylated haemoglobin) 7.0-9.5 % (both inclusive) analysed by central
             laboratory

          -  Willing to consume 3 main meals daily (morning, mid-day and evening) throughout the
             entire trial. The definition for 'main meal' will be according to the investigator's
             discretion

        Exclusion Criteria:

          -  Anticipated initiation or change in concomitant medications known to affect weight or
             glucose metabolism, in excess of 14 days (i.e. sibutramine, orlistat, thyroid
             hormones, systemic corticosteroids and other weight loss/modifying agents)

          -  Impaired liver function, defined as ALT (alanine aminotransferase) at least 2.5 times
             upper limit of normal (central laboratory value measured at screening visit)

          -  Inadequately treated high blood pressure defined as Class 2 hypertension or higher
             (i.e. systolic blood pressure equal to or above 160 mm Hg or diastolic equal to or
             above 100 mm Hg) in accordance with the National High Blood Pressure Education
             Program, 7th Joint National Committee1 and ESH/ESC 2013 Guidelines2

          -  Within the past 180 days prior to randomisation, any of the following: Myocardial
             Infarction, stroke or hospitalization for unstable angina and /or transient ischemic
             attack