Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; insulin glargine
Intervention description: Will be injected subcutaneously (under the skin) once daily three times weekly.; Will be injected subcutaneously (under the skin) once daily administered at the same time each day.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 467.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial was conducted in Europe and North America. The aim of this clinical trial was to
      compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with
      insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or
      DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with
      oral anti-diabetic drugs (OADs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes (diagnosed clinically) for at least 6 months

          -  Insulin naïve subjects (allowed are: previous short term insulin treatment up to 14
             days; treatment during hospitalisation or during gestational diabetes is allowed for
             periods longer than 14 days)

          -  Current treatment: metformin monotherapy or metformin in any combination with insulin
             secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor,
             alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months
             prior to visit 1 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 (sulfonylurea (SU) or glinide): minimum half of the
             daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the
             daily maximal dose according to local labelling -alpha-glucosidase-inhibitor
             (acarbose): minimum half of the daily maximal dose or maximum tolerated dose

          -  HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis

          -  BMI (Body Mass Index) below or equal to 45.0 kg/m^2

        Exclusion Criteria:

          -  Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), Exenatide
             or Liraglutide

          -  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 hereof (except basal cell skin cancer or squamous
             cell skin cancer)