Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; sitagliptin; placebo; placebo
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 subcutaneously (s.c., under the skin) once daily + metformin tablets (at least 1000 mg/day); 100 mg/day sitagliptin tablets once-daily + metformin (at least 1000 mg/day); Sitagliptin placebo tablets once-daily; Sitagliptin placebo tablets once-daily
Intervention MeSH terms: Sitagliptin Phosphate; Liraglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and North America. The aim of the trial is to
      investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects
      with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.
    

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 type 2 diabetes and treated with metformin equal to or above
             1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin
             100 mg/day, both at a stable dose for at least 90 days prior to screening. Stable is
             defined as unchanged medication and dose

          -  - HbA1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive)

          -  - Body mass index equal to or above 20 kg/m^2

        Exclusion Criteria:

          -  - Any chronic disorder or severe disease which at the discretion of the investigator
             might jeopardise subject's safety or compliance with the protocol

          -  - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria
             in a period of 90 days prior to screening. An exception is short-term treatment (equal
             to or less than 7 days in total) with insulin in connection with intercurrent illness

          -  - Female who is pregnant, breast-feeding, intends to become pregnant or of
             child-bearing potential not using adequate contraceptive methods (adequate
             contraceptive measures as required by local regulations or practice)

          -  - 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 or multiple endocrine
             neoplasia syndrome type 2

          -  - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin
             cancer or squamous cell skin cancer)

          -  - Impaired liver function, defined as alanine aminotransferase equal to or above 2.5
             times upper normal limit

          -  - Impaired renal function defined as estimated glomerular filtration rate 60
             mL/min/1.73 m^2 per modification of diet in renal disease formula

          -  - Any episode of unstable angina, acute coronary event, cerebral stroke/transient
             ischemic attack or other significant cardiovascular event as judged by the
             investigator within 90 days prior to screening

          -  - Heart failure, New York Heart Association class IV

          -  - Uncontrolled treated or untreated hypertension (systolic blood pressure equal to or
             above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)