A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine 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: Insulin degludec/liraglutide is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.; Insulin glargine is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.
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: 557.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to compare the efficacy and safety
      of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes
      mellitus.
    

Eligibility criteria:

        Inclusion Criteria: - Type 2 diabetes mellitus - HbA1c 7.0-10.0% [53-86 mmol/mol] (both
        inclusive) by central laboratory analysis - Current treatment with insulin glargine for at
        least 90 days prior to screening - Stable daily dose of insulin glargine between 20 units
        and 50 units (both inclusive) for at least 56 days prior to screening. Total daily dose
        should be within the range of 20-50 units, both inclusive, on the day of screening, but
        individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are
        acceptable - Stable daily dose of metformin (above or equal to 1500 mg or max tolerated
        dose) for at least 90 days prior to screening - Body mass index (BMI) below or equal to 40
        kg/m^2 Exclusion Criteria: - Any use of oral antidiabetic agents (OADs) (except for
        metformin) within 90 days prior to Visit 1 (screening) - Current use of any drug (except
        metformin and insulin glargine) or anticipated change inconcomitant medication, which in
        the investigator's opinion could interfere with the glucose metabolism (e.g. systemic
        corticosteroids) - Previous and/or current treatment with any insulin regimen other than
        basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent
        illness includinggestational diabetes is allowed at the discretion of the investigator) -
        Previous and/or current treatment with glucagon-like peptide-1 (GLP-1) receptor agonists
        (e.g. exenatide, liraglutide) - Impaired liver function, defined as ALAT (alanine
        aminotransferase) above or equal to 2.5 times upper normal range (UNR) - Impaired renal
        function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to
        1.5 mg/dL) for males and above or equal to 125 micromol/L (1.4 mg/dL) for females, or as
        allowed 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) - History of chronic pancreatitis or idiopathic
        acute pancreatitis