a research study to look at how semaglutide compared to placebo affects diabetic eye disease in people with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). the study will be performed in people with type 2 diabetes. participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. participants will inject the study medicine using a pen-injector. the medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. the study will last for 5 years.


Eligibility criteria:
inclusion criteria: * male or female, age greater than or equal to 18 years at the time of signing informed consent * diagnosed with type 2 diabetes mellitus. * hba1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive). * eye inclusion criteria (both eyes must meet all criteria): * early treatment diabetic retinopathy study (etdrs) level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by central reading centre * no ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema six months prior to the day of screening. * no anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation. * best-corrected visual acuity greater than or equal to 30 letters using the etdrs visual acuity protocol * no previous treatment with pan-retinal laser photocoagulation * no substantial non-diabetic ocular condition that, in the opinion of the ophthalmologist, would impact diabetic retinopathy or diabetic macular oedema progression during the trial * no substantial media opacities that would preclude successful imaging exclusion criteria: * any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening * planned coronary, carotid or peripheral artery revascularisation known on the day of screening * subjects presently classified as being in new york heart association (nyha) class iv * renal impairment measured as estimated glomerular filtration rate (egfr) value of egfr less than 30 ml/min/1.73 m\^2 * personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma * presence or history of malignant neoplasms within the past 5 years prior to the day of screening. basal and squamous cell skin cancer and any carcinoma in-situ are allowed * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods * concurrent treatment with any glp-1 receptor agonist or dpp-4 inhibitor from randomisation. * receipt of any investigational medicinal product within 30 days before screening * previous participation in this trial. participation is defined as randomisation * known or suspected hypersensitivity to trial products or related products * any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol