Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes

Inclusion criteria

• Insulin naïve subject (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 an insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitors (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 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-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
• HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
• Body Mass Index (BMI) maximum 45.0 kg/m^2
• Type 2 diabetes (diagnosed clinically) for at least 6 months
• Ability and willingness to adhere to the protocol including performance of self monitored plasma glucose (SMPG) profiles according to the protocol

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 [for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods]
• Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)