A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve 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: Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.; Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.
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: 833.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the
      trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin
      naïve subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months

          -  Insulin naïve subjects (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), dipeptidyl peptidase IV (DPP-IV)
             inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3
             months prior to randomisation (Visit 2) 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-IV
             inhibitor: minimum 100 mg daily or according to local labelling,
             alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or
             maximum tolerated dose

          -  HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory
             analysis

          -  BMI (Body Mass Index) below or equal to 40.0 kg/m^2

        Exclusion Criteria:

          -  Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor
             agonists within the last 3 months prior to Visit 1 (screening)

          -  Anticipated change in concomitant medication known to interfere significantly with
             glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine
             oxidase) inhibitors

          -  Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined
             as stroke; decompensated heart failure NYHA (New York Heart Association) class III or
             IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft
             or angioplasty

          -  Any clinically significant disease or disorder, except for conditions associated with
             type 2 diabetes mellitus, which in the Investigator's opinion could interfere with the
             results of the trial

          -  Previous participation in this trial. Participation is defined as randomised.
             Re-screening of screening failures is allowed only once within the limits of the
             recruitment period

          -  Known or suspected hypersensitivity to trial product(s) or related products