A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin degludec/liraglutide; Insulin degludec
Intervention description: Injected s.c. / subcutaneously (under the skin) once daily; Injected s.c. / 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: 210.0
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 and insulin degludec both in combination with metformin in
      Japanese subjects with type 2 diabetes mellitus inadequately controlled with basal or
      pre-mix/combination insulin therapy and oral anti-diabetic drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Japanese subjects, age at least 20 years at the time of signing
             informed consent

          -  T2DM (type 2 diabetes mellitus) subjects (diagnosed clinically) for at least 6 months
             prior to screening

          -  HbA1c (glycosylated haemoglobin) 7.5-11.0 per cent [58 mmol/mol-97 mmol/mol] (both
             inclusive) by central laboratory analysis

          -  Subjects on stable daily insulin doses for at least 60 days prior to screening
             administered once or twice daily, either as basal insulin (e.g. IDeg, insulin
             glargine, insulin detemir, NPH insulin) or pre-mix/combination insulin (e.g. biphasic
             insulin aspart, insulin degludec/insulin aspart). Total daily insulin dose in the
             previous 60 days should be within 20-50 units, both inclusive, and on the day of
             screening, but fluctuations of plus/minus 20 per cent within the 60 days prior to
             screening are acceptable. The specified insulin treatment should be administered in
             combination with a stable daily dose of metformin within current approved Japanese
             label for at least 60 days prior to screening - additionally, the anti-diabetic
             treatment can be with or without a stable daily dose of one of the following other
             OADs (oral anti-diabetic drug): SU (sulfonylureas), glinides, alpha-glucosidase
             inhibitor, SGLT2i (sodium glucose co-transporter 2 inhibitor) or TZD
             (thiazolidinedione) within current approved Japanese label for at least 60 days prior
             to screening

          -  Body Mass Index (BMI) equal or above 23 kg/m^2

        Exclusion Criteria:

          -  Receipt of any investigational medicinal product (IMP) within 30 days before screening

          -  Use of any anti-diabetic drug in a period of 60 days before screening (except premix/
             combination or basal insulin, metformin, SU, glinides, α-GI, SGLT2i, or TZD) or
             anticipated change in concomitant medication, which in the investigators opinion could
             interfere with glucose metabolism (e.g. systemic corticosteroids or bolus insulin)

          -  Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist during the last 60
             days prior to screening and furthermore, the discontinuation of GLP-1 receptor agonist
             at any point in time must not have been due to safety concerns, tolerability issues or
             lack of efficacy, as judged by the investigator

          -  Treatment with dipetidyl peptidase-4 (DPP-4) inhibitors during the last 60 days prior
             to screening - Impaired liver function, defined as alanine aminotransferase (ALT) or
             aspartate aminotransferase (AST) equal or above 2.5 times upper limit of normal

          -  Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73m^2
             as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

          -  Screening calcitonin equal 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