A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/liraglutide; insulin degludec
Intervention description: IDeg/Lira treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDegLira is injected subcutaneously (under the skin) once daily.; IDeg treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDeg is injected subcutaneously (under the skin) once daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Liraglutide; Insulin, Long-Acting; Xultophy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 413.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
      this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira)
      and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their
      pre-trial treatment with metformin throughout the entire trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with type 2 diabetes

          -  HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)

          -  Subjects on stable daily doses for at least 90 days prior to trial start of: Basal
             insulin (total daily basal insulin dose within the range of 20-40U in combination
             with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more
             or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max.
             approved dose according to local label) or metformin and glinides (equal to or more
             than half of the max. approved dose according to local label)

          -  BMI (Body Mass Index) more than or equal to 27 kg/m^2

        Exclusion Criteria:

          -  Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide,
             liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones
             within 90 days prior to trial start

          -  Impaired liver function

          -  Impaired renal function

          -  Screening calcitonin equal to or above 50 ng/l

          -  Subjects with personal or family history of medullary thyroid carcinoma (MTC) or
             multiple endocrine neoplasia type 2 (MEN 2)

          -  Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis
             of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the
             last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral
             artery revascularisation procedures

          -  Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal
             to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg)

          -  Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
             according to physician's opinion

          -  History of chronic pancreatitis or idiopathic acute pancreatitis