efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal impairment

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal impairment.


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 * male or female, age above or equal to 18 years at the time of signing informed consent * diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening * hba1c (glycosylated haemoglobin) of 7.0-9.5% (53-80 mmol/mol) (both inclusive) * moderate renal impairment defined as estimated glomerular filtration rate of 30-59 ml/min/1.73 m\^2 as per chronic kidney disease epidemiology collaboration formula * stable daily dose(s) within 90 days prior to the day of screening of any of the following treatment regimens: * 1-2 of the following oral anti-diabetic drugs: * metformin equal or above 1500 mg or maximum tolerated dose documented in the subject medical record), * sulfonylurea (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) * basal insulin alone (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or nph insulin) or * metformin (equal or above 1500 mg or maximum tolerated dose documented in the subject medical record) in combination with basal insulin (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or nph insulin) 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 measure as required by local regulation or practice). for certain specific countries: additional specific requirements apply * 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 or medullary thyroid carcinoma * history of pancreatitis (acute or chronic) * history of major surgical procedures involving the stomach 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 * subjects presently classified as being in new york heart association class iv * planned coronary, carotid or peripheral artery revascularisation known on the day of screening * subjects with alanine aminotransferase above 2.5 x upper normal limit * rapidly progressing renal disease (e.g. such as acute glomerulonephritis) as judged by the investigator or known nephrotic albuminuria (above 2200 mg/24 hours or above 2200 mg/g) * use of systemic immunosuppressive treatment within 90 days prior to screening * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 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 * known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator * 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 carcinoma in situ)