A Trial Comparing Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other Oral Antidiabetic Drug (OAD)
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin degludec/liraglutide; Insulin degludec
Intervention description: Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.; Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 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: Double (Participant, Investigator)
Enrollment: 453.0
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 superiority of
      insulin degludec/liraglutide versus insulin degludec in controlling glycaemia in Chinese
      subjects with type 2 diabetes mellitus after 26 weeks of treatment
    

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 procedures to determine suitability for the trial - Male or female, age at least
        18 years at the time of signing inform consent - Type 2 diabetes mellitus (clinically
        diagnosed) - HbA1c (glycosylated haemoglobin) above or equal to 7.5% by central laboratory
        analysis, with the aim of a median of 8.5%. When approximately 50% of the randomised
        subjects have an HbA1c above 8.5%, the remaining subjects randomised must have an HbA1c
        below or equal to 8.5% or when approximately 50% of the subjects randomised have an HbA1c
        below or equal to 8.5%, the remaining subjects randomised must have an HbA1c above 8.5% -
        Current treatment for at least 90 calendar days prior to screening with basal insulin plus
        metformin plus/minus α-glucosidase inhibitors, sulphonylureas, glinides or
        thiazolidinediones. Subjects should be on a stable dose for at least 60 calendar days prior
        to screening of: Basal insulin 20-50 units (U)/day (both inclusive) ( Individual
        fluctuations of plus/minus 5U during the 60 day period prior to the day of screening are
        acceptable.) on the day of screening in combination with: - 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 glinide
        (at least 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 (AGI) (at least half
        of the max approved dose according to local label) or - Metformin (above or equal to 1500
        mg or max tolerated dose) and thiazolidinediones (at least half of the max approved dose
        according to local label) - Body mass index (BMI) above or equal to 24 kg/m^2 Exclusion
        Criteria: Current use of any antidiabetic drug (except for basal insulin, metformin,
        α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones) or anticipated
        change in concomitant medication, that in the investigator´s opinion could interfere with
        glucose level (e.g. systemic corticosteroids) - Treatment with glucagon like peptide -1
        receptor agonists, or dipeptidyl-peptidase-4 inhibitors or insulin (except for basal
        insulin) within 90 days prior to Visit 1 - 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 mm Hg or diastolic blood pressure above or equal to 100 mm Hg) -
        Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment -
        History of pancreatitis (acute or chronic)