Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; sitagliptin
Intervention description: Injected under the skin once daily for 26 weeks. The doses will be individually adjusted.; Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 458.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial will be conducted in Africa, Asia, North America and South America. The aim of
      this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to
      subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes
      inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes (diagnosed clinically) for at least 6 months

          -  Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue
             (sulphonylurea or glinides) or pioglitazone) in any combination 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 or maximum tolerated dose
             (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half
             of the maximal daily dose according to local labelling -Pioglitazone: minimum half of
             the maximal daily dose according to local labelling or maximum tolerated dose

          -  Body Mass Index (BMI) below or equal to 40.0 kg/m^2

          -  HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

        Exclusion Criteria:

          -  Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide,
             rosiglitazone or acarbose

          -  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)

          -  Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last
             12 months) or hypoglycaemic unawareness as judged by the Investigator or
             hospitalisation for diabetic ketoacidosis during the previous 6 months

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate

          -  Cancer and medical history hereof (except basal cell skin cancer or squamous cell skin
             cancer)