Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/insulin aspart
Intervention description: Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Intervention MeSH terms: Insulin; Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia and North America. The aim of this trial is to compare the
      efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve
      subjects with type 2 diabetes mellitus when using two different titration algorithms (dose
      individually adjusted) as add-on to subject's ongoing treatment with metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation
             (visit 2)

          -  Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer
             than or equal to 14 days in total; Treatment during hospitalisation or during
             gestational diabetes is allowed for periods longer than 14 days in total)

          -  Current treatment: Metformin alone or metformin in any combination of 1 or 2
             additional OADs (oral anti-diabetic drug) including an insulin secretagogue
             (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors,
             alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing
             for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in
             combination (including fixed combination), must be at least 1000 mg daily

          -  HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)

          -  BMI (Body Mass Index) below or equal to 45 kg/m^2

          -  Ability and willingness to adhere to the protocol including self measurement of plasma
             glucose

        Exclusion Criteria:

          -  Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12
             weeks prior to randomisation (visit 2)

          -  Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the
             last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial
             physician)

          -  Previous participation in this trial. Participation is defined as randomised.
             Re-screening is allowed once during the recruitment period

          -  Known or suspected hypersensitivity to trial products or related products

          -  The receipt of any investigational drug within 4 weeks prior to randomisation (visit
             2)

          -  Anticipated significant lifestyle changes during the study, e.g. shift work (including
             permanent night/evening shift workers) as well as highly variable eating habits