Comparison of NN1250 Versus 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: Insulin degludec injected subcutaneously (under the skin) once daily. The doses will be individually adjusted; Insulin glargine injected subcutaneously (under the skin) once daily. The doses will be 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: 435.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia and Japan. The aim of this trial is to compare insulin
      degludec (NN1250) with insulin glargine both combined with oral antidiabetic drugs (OADs) in
      subjects with type 2 diabetes never treated with insulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For Japan only: minimum age is 20 years

          -  Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months

          -  Current treatment with monotherapy or combination of an insulin secretagouge
             (sulfonylurea or glinide) and metformin, with or without addition of
             alfa-glucosidase-inhibitors or a DPP-4 inhibitor with unchanged dosing for at least 3
             months prior to visit 1. The dose(s) should as minimum be as stated: -Insulin
             secretagogue (sulfonylurea or glinide): Minimum half of the daily maximal dose
             according to local labelling -Metformin: alone or in combination (including fixed
             combination): Maximum tolerated dose - alfa-glucosidase-inhibitors: Minimum half of
             the daily maximal dose or maximum tolerated dose -DPP-4 (dipeptyl peptidase 4)
             inhibitor: According to local labelling

          -  HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis

          -  Body Mass Index (BMI) no higher than 35.0 kg/m^2

        Exclusion Criteria:

          -  Use within the last 3 months prior to Visit 1 of: TZDs (thiazolidinediones), 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, or the intention of becoming pregnant or not using adequate
             contraceptive measures according to local requirements (for Thailand: adequate
             contraceptive measures are: diaphragm, condom (by the partner), intrauterine device in
             place for last three months before trial starts, sponge, cap with spermicide,
             contraceptive patch, approved hormonal implant (i.e. Norplant), oral contraceptives
             taken without difficulty for the last three months before trial starts, post
             menopausal state or sterilisation.)

          -  Cancer and medical history of cancer (except basal cell skin cancer or squamous cell
             skin cancer)