A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin degludec/liraglutide; Insulin degludec; Liraglutide
Intervention description: Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.
For 26 weeks.; Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.
For 26 weeks.; Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.
For 26 weeks.
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: 720.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this trial is to confirm the efficacy of insulin
      degludec/liraglutide in controlling glycaemia in Chinese subjects with type 2 diabetes
      mellitus inadequately controlled on oral antidiabetic agents
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. Trial-related
             activities are any procedures that are carried out as part of the trial, including
             activities to determine suitability for the trial

          -  Type 2 diabetes mellitus (clinically diagnosed)

          -  Male or female, age at least 18 years at the time of signing informed consent

          -  HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis, with the aim of a
             median of8.3%. When approximately 50% of the randomised subjects have an HbA1c above
             8.3%, the remaining subjects randomised must have an HbA1c below or equal to 8.3%; or
             when approximately 50% of the randomised subjects have an HbA1c below or equal to
             8.3%, the remaining subjects randomised must have an HbA1c above 8.3%

          -  Current treatment for at least 90 calendar days prior to screening with metformin
             plus/minus one other OAD: α-glucosidase inhibitors, sulphonylureas, glinides or
             thiazolidinediones. For above or equal to 60 calendar days prior to screening subjects
             should be on a stable dose of:

          -  Metformin (above or equal to 1500 mg or max tolerated dose) or

          -  Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above
             or equal to half of the max approved dose according to local label) or

          -  Metformin (above or equal to 1500 mg or max tolerated dose) and glinides (above or
             equal to half of the max approved dose according to local label) or

          -  Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase
             inhibitors (above or equal to half of the max approved dose according to local label)
             or

          -  Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones
             (above or equal to half of the max approved dose according to local label)

        Exclusion Criteria:

          -  Treatment with insulin (except for short-term treatment at the discretion of the
             investigator)

          -  Treatment with glucagon-like-peptide-1 receptor agonists or dipeptidyl-peptidase-4
             inhibitors within 90 days prior to screening

          -  Impaired liver function, defined as alanine aminotransferase above or equal to 2.5
             times upper normal range

          -  Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for
             males and above or equal to 125 μmol/L for females, or as defined according to local
             contraindications for metformin

          -  Screening calcitonin above or equal to 50 ng/L

          -  Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine
             neoplasia type 2 (MEN2)

          -  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 12 months prior to screening and/or planned coronary, carotid or peripheral
             artery revascularisation procedures

          -  Severe uncontrolled treated or untreated hypertension (systolic blood pressure above
             or equal to 180 mmHg or diastolic blood pressure above or equal to 100 mmHg

          -  Proliferative retinopathy or maculopathy (macular oedema), requiring acute treatment

          -  History of pancreatitis (acute or chronic)