dose-response, safety and efficacy of oral semaglutide versus placebo and versus liraglutide, all as monotherapy in japanese subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

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