A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine 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
Intervention description: Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.; Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Liraglutide; Xultophy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1012.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose
      is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus
      insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately
      controlled with oral anti diabetics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age greater than or equal to 18 years at the time of signing informed
             consent

          -  Subjects diagnosed with type 2 diabetes mellitus

          -  HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis

          -  Body mass index greater than or equal to 20 kg/m^2

          -  Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days
             prior to the day of screening is allowed, as is prior insulin treatment for
             gestational diabetes

          -  Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens
             within 90 days prior to the day of screening: a) Biguanides (metformin greater than or
             equal to 1500 mg or maximum tolerated dose documented in the subject medical record),
             b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors
             (greater than or equal to half of the maximum approved dose according to local label
             or maximum tolerated dose as documented in subjects medical record)

        Exclusion Criteria:

          -  Screening calcitonin greater than or equal to 50 ng/L

          -  Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73
             m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using
             IDMS for serum creatinine measurement on the day of screening

          -  Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times
             upper limit of normal

          -  Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid
             Carcinoma

          -  History of pancreatitis (acute or chronic)

          -  Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria in a period of 90 days before the day of screening

          -  Anticipated initiation or change in concomitant medications for more than 14
             consecutive days or on a frequent basis known to affect weight or glucose metabolism
             (e.g. orlistat, thyroid hormones, corticosteroids)