Comparison of NN5401 With Biphasic Insulin Aspart 30 in 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 30
Intervention description: Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.; Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 447.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to
      compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects
      with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months

          -  Subjects on premixed human or analogue insulin or self-mixed insulin regimen,
             containing 20-40 % fast/rapid-acting component, once daily (OD) or twice daily (BID),
             with or without oral antidiabetic drugs) (OADs) (metformin, sulphonylurea (SU),
             glinides, alpha-glucosidase inhibitor, DPP-4 (dipeptidyl peptidase-4) inhibitor and
             pioglitazone), for at least 3 months before Visit 1

          -  HbA1c 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 other insulin regimens than those listed in key inclusion criterion no.
             2 within 3 months

          -  Treatment with rosiglitazone or glucagon-like peptide-1 (GLP-1) receptor agonists
             (exenatide, liraglutide) within 3 months prior to visit 1

          -  Cardiovascular disease within the last 6 months prior to visit 1, defined as: stroke;
             decompensated heart failure New York Heart Association (NYHA) class III or IV;
             myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or
             angioplasty

          -  Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least
             180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures according to local requirements

          -  Cancer and medical history of cancer (except basal cell skin cancer and squamous cell
             skin cancer