Comparison of NN5401 With Insulin Glargine, 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: insulin degludec/insulin aspart; insulin glargine
Intervention description: Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily with main meal. Dose was individually adjusted.; Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 465.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

      The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with
      insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and
      oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the
      trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months

          -  Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral
             protamine Hagedorn [NPH] insulin) once daily (OD), for at least 3 months

          -  Ongoing treatment with: metformin with or without other oral antidiabetic drugs (OADs)
             for at least 3 months prior to randomisation

          -  HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis

          -  BMI maximum 40.0 kg/m^2

        Exclusion Criteria:

          -  Treatment with insulin regimens other than a basal insulin regimen (insulin detemir or
             insulin glargine or NPH insulin) OD within 3 months prior to Visit 1

          -  Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within 3 months prior
             to visit 1

          -  Current rosiglitazone users

          -  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)

          -  Impaired liver function, defined as alanine aminotransferase (ALAT) at least 2.5 times
             upper limit of normal (one retest analysed at the central laboratory within a week of
             receipt of the result is permitted with the result of the last sample being
             conclusive)

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures according to local requirements

          -  Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous
             cell skin cancer)