A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese 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 degludec; liraglutide
Intervention description: Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.; Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.; Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
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: None (Open Label)
Enrollment: 819.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety
      of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with
      type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Japanese subjects, age at least 20 years at the time of signing
             informed consent

          -  Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening

          -  HbA1c (glycosylated haemoglobin) 7.0-11.0 % (both inclusive) by central laboratory
             analysis, with the aim of a median of 8.3%. When approximately 50% of the randomised
             subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c
             below or equal to 8.3%; or when approximately 50% of the randomised subjects have a
             HbA1c below or equal to 8.3%, the remaining subjects randomised must have a HbA1c
             above 8.3%

          -  Body-mass index (BMI) above or equal to 20 kg/m^2

          -  Subjects on stable therapy with one OAD (defined as unchanged medication and unchanged
             dose) for at least 60 days (metformin, a-GI, TZD, SU, SGLT2i or glinide) prior to
             screening according to approved Japanese labelling

        Exclusion Criteria:

          -  Previous treatment with insulin (except for short-term treatment in connection with
             intercurrent illness including gestational diabetes)

          -  Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria in a period of 60 days before screening

          -  Anticipated initiation or change in concomitant medications in excess of 14 days known
             to affect weight or glucose metabolism

          -  Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate
             aminotransferase (AST) equal to or above 2.5 times upper limit of normal

          -  Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73m^2 as
             per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

          -  Screening calcitonin equal to or above 50 ng/L

          -  History of pancreatitis (acute or chronic)

          -  Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine
             neoplasia type 2 (MEN 2)

          -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV