A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; semaglutide; sitagliptin
Intervention description: Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks). Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).; Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks) followed by 0.5 mg for 4 weeks. Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).; Daily doses of 100 mg sitagliptin. Total duration of treatment is 30 weeks. Administered as oral tablets.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 308.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing
      of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy
      during 30 weeks of treatment in Japanese subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 20 years or older at the time of signing informed consent

          -  Glycated hemoglobin (HbA1c) between 6.5% and 9.5% (48-80 mmol/mol) (both inclusive)
             for subjects treated with oral antidiabetic drug (OAD) monotherapy and between 7.0%
             and 10.5% (53-91 mmol/mol) (both inclusive) for subjects treated with diet and
             exercise therapy at screening

          -  Japanese subjects diagnosed with type 2 diabetes who are: a) on stable OAD monotherapy
             at a half-maximum dose or below according to the approved Japanese labelling in
             addition to diet and exercise therapy for at least 30 days prior to screening (week
             -8) (For metformin only: the maximum dose of 750 mg/day is allowed except for
             METGLUCO®. For METGLUCO®, the allowable half-max dose of 1125 mg/day must be
             applied.). 'Stable' is defined as unchanged medication and unchanged dose, or b) on
             stable diet and exercise therapy for at least 30 days prior to screening (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, diaphragm, condom [by the partner], intrauterine device, sponge,
             spermicide or oral contraceptives) throughout the trial including the 5-week follow-up
             period

          -  Treatment with once-weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90
             days prior to screening

          -  Treatment with any glucose lowering agent(s) (except for pre-trial OAD for subject
             treated with OAD monotherapy) in a period of 60 days prior to screening. An exception
             is short-term treatment (7 days or less 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 of 50 ng/L (pg/mL) or greater

          -  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) less
             than 60 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

          -  Heart failure, New York Heart Association (NYHA) class IV