Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; lixisenatide
Intervention description: Starting dose of 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day is reached. Administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial metformin (equal to or above 1000 mg/day and up to 3000 mg/day).; Starting dose of 10 microg to be administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (equal to or above 1000mg/day and up to 3000mg/day). Dose escalation to 20 microg s.c. once daily from day 15 after randomization.
Intervention MeSH terms: Liraglutide; Lixisenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 404.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and
      safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2
      diabetes (T2DM).
    

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

          -  Subjects diagnosed with T2DM and on unchanged metformin treatment at the maximum
             tolerated dose (at least 1000 mg/day and up to 3000 mg/day) for at least 90 days prior
             to screening

          -  HbA1c 7.5 - 10.5% (53 mmol/mol - 91 mmol/mol) (both inclusive)

          -  Body Mass Index (BMI) equal to or above 20 kg/m^2

        Exclusion Criteria:

          -  Female of child-bearing potential who is pregnant, breast-feeding or intend to become
             pregnant or is not using adequate contraceptive methods. (Adequate contraceptive
             measures as required by local law or practice)

          -  Treatment with glucose lowering agent(s) other than stated in the inclusion criteria
             in a period of 90 days prior to screening. Exception is short-term treatment (equal to
             or below 7 days in total) with insulin in connection with intercurrent illness

          -  History of chronic pancreatitis or idiopathic acute pancreatitis

          -  Screening calcitonin value equal to or above 50 ng/L

          -  Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine
             neoplasia syndrome type 2 (MEN 2)

          -  Impaired liver function, defined as alanine aminotransferase (ALAT) equal to or above
             2.5 times upper normal limit (UNL)

          -  Impaired renal function defined as estimated glomerular filtration rate (eGFR) below
             60 mL/min/1.73 m^2 per Modification of Diet in Renal Disease (MDRD) formula

          -  Any episode of unstable angina, acute coronary event, cerebral stroke/transient
             ischemic attack (TIA) or other significant cardiovascular event as judged by the
             investigator within 90 days prior to screening

          -  Heart failure, New York Heart Association (NYHA) class IV

          -  Uncontrolled hypertension (defined as systolic blood pressure equal to or above 180
             mmHg and/or diastolic blood pressure equal to or above 100 mmHg)

          -  Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer
             or squamous cell skin cancer)