A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/insulin aspart
Intervention description: Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued.
Intervention MeSH terms: Insulin; Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 394.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the
      efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart
      30) in insulin naïve subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. (Trial-related
             activities are any procedure that would not have been performed during normal
             management of the subject)

          -  Type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to
             screening

          -  Current treatment: metformin monotherapy or metformin in any combination with one of
             the following oral anti-diabetic drugs (OADs): insulin secretagogue (sulfonylurea or
             glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alpha-glucosidase inhibitors for
             at least 12 weeks prior to randomisation (Visit 2) with the minimum doses stated: -
             Metformin: alone or in combination (including fixed combination) 1500 mg daily, or
             maximum tolerated dose (at least 1000 mg daily), - Insulin secretagogue (sulphonylurea
             or glinide): minimum half of the daily maximum dose according to local labelling, -
             DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, -
             Alpha-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum
             tolerated dose

          -  Insulin naïve subject; allowed is: Previous short term insulin treatment up to 14 days

          -  Insulin naïve subject; allowed is: Treatment during hospitalization or during
             gestational diabetes is allowed for periods longer than 14 days)

          -  HbA1c (glycosylated haemoglobin) between 7.0-10.0 % (both inclusive) by central
             laboratory analysis

          -  Body mass index (BMI) below or equal to 40.0 kg/m^2

        Exclusion Criteria:

          -  Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor
             agonists within 12 weeks prior to visit 1 (screening)

          -  Anticipated change in concomitant medication known to interfere significantly with
             glucose metabolism, such as systemic corticosteroids, beta-blockers and MAO inhibitors

          -  Anticipated significant lifestyle changes during the trial according to the discretion
             of the trial physician, e.g. shift work (including permanent night/evening shift
             workers), as well as highly variable eating habits

          -  Cardiovascular disease, within the last 24 weeks prior to trial start, defined as:
             stroke; decompensated heart failure NYHA (New York Heart Association) 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 trial physician's opinion could interfere with the
             results of the trial

          -  Previous participation in this trial. Participation is defined as randomised.
             Re-screening of screening failures is allowed only once within the limits of the
             recruitment period

          -  Known or suspected hypersensitivity to trial products or related products