Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/insulin aspart; insulin degludec/insulin aspart
Intervention description: Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value. For subcutaneous (s.c., under the skin) administration.; Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values. For subcutaneous (s.c., under the skin) administration.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 272.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

      The aim of the trial is to compare the efficacy and safety of two different titration
      algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes
      mellitus previously treated with insulin glargine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2
             (randomisation)

          -  Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs
             (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase
             inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks
             prior to Visit 2 (randomisation) and doses should have been stable in this period of
             time

          -  Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory
             analysis

          -  Body mass index (BMI) below or equal to 40 kg/m^2

        Exclusion Criteria:

          -  Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones
             (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)

          -  Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial
             infarction; unstable angina pectoris; or coronary arterial bypass graft or
             angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)

          -  Uncontrolled or untreated severe hypertension defined as systolic blood pressure above
             or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg

          -  Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12
             months) or hypoglycaemic unawareness as judged by the investigator

          -  Life-threatening disease (e.g. cancer)