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NCT03811561
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
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1500
Sponsor: Novo Nordisk A/S
Location: Synexus Rsch /Cnt Phnx Med C Phoenix Arizona
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
Source: ClinicalTrials.gov (NCT03811561). StuddyBuddy aggregates publicly available trial information.