Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; placebo
Intervention description: 1.8 mg administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.; Administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 279.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and the United States of America (USA). The aim of this
      trial is to investigate the efficacy and safety of liraglutide in subjects with type 2
      diabetes and moderate renal impairment.

      The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin
      regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged
             medication and unchanged dose) for 90 days prior to the screening visit including:
             Monotherapy or any duo-combinations of metformin and/or SUs and/or pioglitazone.
             Metformin should be used with caution in subjects with moderate renal failure and must
             be used in accordance with local metformin labelling or guidelines. Or Monotherapy or
             any combinations of metformin and/or pioglitazone and/or basal or premix insulin.
             Insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to
             the screening visit as confirmed by the investigator are acceptable. Metformin should
             be used with caution in subjects with moderate renal failure and must be used in
             accordance with local metformin labelling or guidelines. Combination of pioglitazone
             and insulin should be used with caution and according to local labelling or guidelines

          -  HbA1c 7-10% (both inclusive)

          -  Moderate renal impairment diagnosed more than 90 days prior to the screening visit and
             confirmed by an eGFR (glomerular filtration rate) of 30-59 mL/min/1.73 m2 per MDRD
             (modification of diet in renal disease) formula at the screening visit

          -  Body Mass Index (BMI) 20-45 kg/m^2 (both inclusive)

        Exclusion Criteria:

          -  Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the
             investigator

          -  Treatment with antidiabetic medication(s) other than stated in the inclusion criteria
             in a period of 90 days prior to screening. Previous short-term (below or equal to 7
             days in total) treatment with rapid-or short-acting insulin in connection with
             intercurrent illness is allowed at the discretion of the investigator

          -  Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to
             2.5 times upper normal limit

          -  History of chronic pancreatitis or idiopathic acute pancreatitis

          -  Within the past 180 days any of the following: Episode of unstable angina, acute
             coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant
             cardiovascular event (including e.g. arrhythmias or conduction delays on ECG
             (electrocardiogram))

          -  Heart failure defined as New York Heart Association (NYHA) class IV

          -  A systolic blood pressure above or equal to 180 mmHg or a diastolic blood pressure
             above or equal to 100 mmHg

          -  Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion
             of the investigator

          -  Use of immunosuppressive treatment within 90 days prior to screening

          -  Diagnosis or treatment for cancer in the previous 5 years (except basal cell skin
             cancer or squamous cell skin cancer)

          -  Proliferative retinopathy or maculopathy requiring acute treatment as judged by the
             investigator