Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; oral anti-diabetic drug
Intervention description: 0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).; An additional oral anti-diabetic drug (OAD) with a different mechanism of action than the pre-trial OAD. The type and dosage of the additional OAD should be chosen by the investigator within the Japanese labelled dose.
Intervention MeSH terms: Liraglutide; Hypoglycemic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 363.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial was conducted in Japan. The aim of this trial was to evaluate the safety and
      efficacy of once daily administration of liraglutide in combination with an oral
      anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently
      controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either
      glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at
      unchanged type and dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities (trial-related
             activities are any procedures that would not have been performed during normal
             management of the subject.)

          -  Japanese subjects with type 2 diabetes on monotherapy with an OAD (either glinide,
             metformin, a-glucosidase inhibitor or thiazolidinedione) within approved Japanese
             labelling in addition to diet and exercise therapy. Total daily dose and type of drug
             should have remained unchanged for at least 8 weeks prior to Visit 1

          -  Type 2 diabetes mellitus (clinically diagnosed) for at least 6 months

          -  HbA1c between 7.0-10.0% (both inclusive)

          -  Body Mass Index (BMI) below 40.0 kg/m^2

          -  Outpatients who have no plans for an educational hospitalisation for the purpose of
             glycaemic control. However, hospitalisation for training of self-injection from Visit
             2 that is for no longer than one week is allowed

          -  Subjects able and willing to perform self-monitoring of plasma glucose (SMPG)

        Exclusion Criteria:

          -  Subjects with known or previous malignant tumor and are strongly suspected of
             recurrence (except basal cell skin cancer or squamous cell skin cancer)

          -  Calcitonin above or equal to 160 pg/mL

          -  Personal history of non-familial medullary thyroid carcinoma

          -  Family or personal history of multiple endocrine neoplasia type 2 (MEN-2) or familial
             medullary thyroid carcinoma (FMTC)

          -  History of chronic pancreatitis or idiopathic acute pancreatitis

          -  Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last
             12 months) or hypoglycaemic unawareness as judged by the investigator or
             hospitalisation for diabetic ketoacidosis during the previous 6 months

          -  Treatment with GLP-1 receptor agonist or dipeptidyl peptidase 4 (DPP-4) inhibitor
             within 12 weeks prior to Visit 1

          -  Having contraindications to liraglutide and any of the OADs (according to Japanese
             labelling)