Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; insulin glargine
Intervention description: Individually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks; Subjects continue their pre-trial insulin glargine once daily plus OAD (oral anti-diabetic drug) treatment for four weeks before switch to insulin degludec
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in the United States of America (USA). The aim of this clinical trial
      is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec
      (IDeg) in subjects with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months

          -  HbA1c maximum 10 % by central laboratory analysis

          -  Current treatment with basal-oral therapy (BOT) (no prandial insulin ever) consisting
             of: at least three months with insulin glargine once daily (average prescribed dose
             must have been unchanged (within plus/minus 10%) for four weeks prior to Visit 1 as
             confirmed by patient records or verbal confirmation by the subject) in combination
             with stable (unchanged doses for at least 3 months prior to Visit 1) OAD (metformin,
             insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor)
             treatment in any approved (according to label) dose or combination

        Exclusion Criteria:

          -  Use within the last three months prior to Visit 1 of: Exenatide, Liraglutide or
             Thiazoledinediones (TZDs) other than Pioglitazone

          -  Cardiovascular disease (CVD) 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 within the last six months
             prior to Visit 1

          -  Recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the
             last 12 months), or hypoglycaemic unawareness as judged by the Investigator, or
             hospitalisation for diabetic ketoacidosis during the previous six months

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures according to local requirements

          -  Previous participation in this trial. Participation is defined as started on trial
             medication. Rescreening of screening failures is allowed only once within the limits
             of the recruitment period

          -  Known or suspected hypersensitivity to trial products or related products