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: Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.; Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
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: 460.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in South Africa, Europe and North America. The aim of this trial is
      to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine
      (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4
      (DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic
      drugs (OADs) qualifying for intensified treatment.
    

Eligibility criteria:

        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)