A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/liraglutide; insulin glargine; insulin aspart
Intervention description: Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.; Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.; Injected s.c./subcutaneously (under the skin) before each main meal.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Liraglutide; Xultophy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 506.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to compare efficacy and safety of
      insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with
      metformin in subjects with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age at least 18 years at the time of signing informed consent

          -  Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening

          -  HbA1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by
             central laboratory analysis

          -  Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to
             screening

          -  Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least
             56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within
             the 56 calendar days prior to screening are acceptable, however on the day of
             screening total daily dose should be within the range of 20 units-50 units both
             inclusive

          -  Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least
             90 calendar days prior to screening

          -  Body mass index (BMI) below or equal to 40 kg/m^2

        Exclusion Criteria:

          -  Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria in a period of 90 calendar days before screening

          -  Anticipated initiation or change in concomitant medications in excess of 14 calendar
             days known to affect weight or glucose metabolism, such as weight loss/modifying
             (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)

          -  Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times
             upper limit of normal

          -  Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per
             CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)

          -  Screening calcitonin at least 50 ng/L

          -  History of pancreatitis (acute or chronic)

          -  Personal or family history of medullary thyroid carcinoma or multiple endocrine
             neoplasia type 2