Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin

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)