Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Semaglutide; Placebo; Liraglutide
Intervention description: Oral administration once daily; Oral administration once daily; Subcutaneous (s.c., under the skin) injection once daily
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 243.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this trial is to investigate the dose-response
      relationship of once-daily dosing of three dose levels (3, 7 and 14 mg) of oral semaglutide
      versus placebo as monotherapy on glycaemic control in Japanese subjects with type 2 diabetes
      mellitus
    

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

          -  Japanese male or female, age above or equal to 20 years at the time of signing
             informed consent

          -  Diagnosed with type 2 diabetes mellitus for at least 30 days prior to day of screening

          -  HbA1c 6.5%-9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral
             antidiabetic drug as monotherapy and 7.0%-10.0% (53-86 mmol/mol) (both inclusive) for
             subjects treated with diet and exercise therapy alone

          -  Treatment for at least 30 days prior to day of screening with;- stable daily dose of
             oral anti-diabetic drug as monotherapy (allowed oral anti-diabetic drugs are:
             metformin, sulphonylurea, glinide, α-glucosidase inhibitor, dipeptidyl peptidase-4
             inhibitor and sodium-glucose cotransporter-2 inhibitor) at a half-maximum approved
             dose or below according to Japanese labelling in addition to diet and exercise
             therapy. or - diet and exercise therapy alone

        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. Adequate
             contraceptive measures are abstinence (not having sex), diaphragm, condom (by the
             partner), intrauterine device, sponge, spermicide or oral contraceptives

          -  Any disorder, which in the investigator's opinion might jeopardise subject's safety or
             compliance with the protocol

          -  Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary
             thyroid carcinoma (MTC)

          -  History of pancreatitis (acute or chronic)

          -  History of major surgical procedures involving the stomach and potentially affecting
             absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,
             gastric bypass surgery)

          -  Any of the following: myocardial infarction, stroke or hospitalisation for unstable
             angina or transient ischaemic attack within the past 180 days prior to the day of
             screening and randomisation

          -  Subject presently classified as being in New York Heart Association (NYHA) Class IV

          -  Planned coronary, carotid or peripheral artery revascularisation known on the day of
             screening

          -  Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL)

          -  Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 30
             mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula
             (CKD-EPI)

          -  Treatment with once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA), once
             weekly dipeptidyl peptidase-4 (DPP-4) inhibitor or thiazolidinedione in a period of 90
             days before the day of screening

          -  Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria in a period of 60 days before the day of screening.
             An exception is short-term insulin treatment for acute illness for a total of below or
             equal to 14 days

          -  Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus
             photography or dilated fundoscopy performed within 90 days prior to randomisation

          -  History or presence of malignant neoplasms within the last 5 years (except basal and
             squamous cell skin cancer and in-situ carcinomas)

          -  Initiation of anti-diabetic medication between the day of screening and the day of
             randomisation