safety study of weekly semaglutide in chilean participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study is testing the safety and tolerability of subcutaneous semaglutide in participants with type 2 diabetes (t2d) in chile. participants will get a once-weekly subcutaneous injection of semaglutide in doses decided by the study doctor's criteria, according to participant's personal needs. the study will last for about 24 weeks. participants will have 4 clinic visits and 2 phone calls. participants will have 3 laboratory tests during the study (blood and urine samples).


Eligibility criteria:
inclusion criteria: * participants diagnosed (clinically) with type 2 diabetes greater than equal to (≥) 90 days prior to the screening visit. * stable daily dose of oral antidiabetic drug (oad) and/or insulin treatment for ≥ 60 days prior to the screening visit. * hba1c 7.5-10% (59-86 millimoles per mole \[mmol/mol\]) (both inclusive) in visit 1. * participants in which ozempic is indicated according to approved local label. * fundoscopy/fundus photography record less than equal to (≤) 12 months. exclusion criteria: * known or suspected hypersensitivity to study intervention(s) or related products. * previous participation in this study. participation is defined as signed informed consent. * female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method. * participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before the screening visit, except coronavirus disease 2019 (covid-19) related trials (this is allowed). * treatment with any glucagon-like peptide-1 receptor agonists (glp-1 ra) medication prior to the screening visit. * any disorder which in the investigator's opinion might jeopardise participant'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). * renal impairment defined as estimated glomerular filtration rate (egfr) below 30 milliliters/minute (ml/min)/1.73 meter square (m\^2) as per mdrd-4 (modification of diet in renal disease). * myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening. * participants presently classified as being in new york heart association (nyha) class iv heart failure. * planned coronary, carotid or peripheral artery revascularisation known on the day of screening. * participants with alanine aminotransferase (alt) \> 2.5 x upper normal limit (unl). * 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 ≤ 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 12 months prior to screening. * history or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).