A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; DPP-4 inhibitor
Intervention description: Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.; Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.
Intervention MeSH terms: Dipeptidyl-Peptidase IV Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 601.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy
      of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic
      drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on
      diet/exercise therapy or OAD monotherapy.

      All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD
      monotherapy in addition to diet and exercise therapy) during the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age at least 20 years at the time of signing informed consent

          -  HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.5% (53-91 mmol/mol) (both
             inclusive)

          -  Japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable
             treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and
             exercise therapy for at least 30 days before Visit 1 (week -2). or b) on OAD
             monotherapy (either of SU (sulfonylurea), glinide, a-GI (a-glucosidase inhibitor) or
             TZD (thiazolidinediones)) within approved Japanese labelling in addition to diet and
             exercise therapy for at least 60 days before Visit 1 (week -2)

        Exclusion Criteria:

          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of
             child-bearing potential and not using an adequate contraceptive method (e.g.,
             abstinence [not having sex], diaphragm, condom [by the partner], intrauterine device,
             sponge, spermicide or oral contraceptives) throughout the trial including the 5 week
             follow-up period

          -  Treatment with glucose lowering agent(s) other than stated in the inclusion criteria
             within 60 days before Visit 1 (week -2) and treatment with once weekly glucagon-like
             peptide-1 (GLP-1) receptor agonists within 90 days before Visit 1 (week -2). An
             exception is short-term treatment (below or equal to 7 days in total) with insulin in
             connection with inter-current illness

          -  Any disorder which, in the opinion of the investigator, might jeopardise subject's
             safety or compliance with the protocol

          -  History of chronic or idiopathic acute pancreatitis

          -  Screening calcitonin value above or equal to 50 ng/L (pg/mL)

          -  Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine
             neoplasia syndrome type 2 (MEN2)

          -  Impaired renal function defined as estimated glomerular filtration rate (eGFR) below
             30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4
             variable version)

          -  Acute coronary or cerebrovascular event within 90 days before randomisation (Visit 2
             [week 0])

          -  Heart failure, New York Heart Association (NYHA) class IV