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Clinical Trials in the UK / NCT03811561
Active, not recruiting Phase 3

A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes

NCT03811561 · tracked via the Priya Life Science UK tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2019-05-08
Last updated
2026-09-09

Condition(s) studied

Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

SemaglutidePlacebo (semaglutide)

Semaglutide: Participants will get one dose of semaglutide once weekly in addition to their diabetes medicines - which treatment they get is decided by chance. Participants will inject the study medicine using a pre-filled PDS290 pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. Participants will start with once-weekly doses of 0.25 mg for 4 weeks, then the dose will be gradually increased to 0.5 mg once weekly for 4 weeks, and finally to 1.0 mg once weekly (maximum dose) up to 260 weeks (5 years).

Placebo (semaglutide): Participants will get one dose of placebo (semaglutide) once weekly in addition to their diabetes medicines - which treatment they get is decided by chance. Participants will inject the study medicine using a pre-filled PDS290 pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. Participants will start with once-weekly doses of 0.25 mg for 4 weeks, then the dose will be gradually increased to 0.5 mg once weekly for 4 weeks, and finally to 1.0 mg once weekly (maximum dose) up to 260 weeks (5 years).

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (230)

FacilityCityRegionStatus
Synexus Rsch /Cnt Phnx Med C Phoenix Arizona
Del Sol Research Management, LLC Tucson Arizona
South Arizona VA Healthcare System Tucson Arizona
Synexus Cln Rsrch Inc - Orange Gro FP Tucson Arizona
Southern California Res Ctr Coronado California
FDRC Costa Mesa California
Advanced Investigative Medicine, Inc. Hawthorne California
Diabetes/Lipid Mgmt & Res Ctr Huntington Beach California
Scripps Whittier Diabetes Inst La Jolla California
Torrance Clin Res Inst, Inc. Lomita California
Angel City Research, Inc. Los Angeles California
Downtown LA Res Ctr. Inc. Los Angeles California
Riverside University Health System Medical Center Moreno Valley California
Rancho Cucamonga Clinical Research Rancho Cucamonga California
Clinical Trials Research_Sacramento_0 Sacramento California
UCLA Diabetes Center at Santa Monica Santa Monica California
Coastal Metabolic Research Center Ventura California
Diablo Clinical Research, Inc. Walnut Creek California
Barbara Davis Center Aurora Colorado
Rocky Mount Reg VA Med-DN Aurora Colorado
Chase Medical Research LLC Waterbury Connecticut
Innovative Research of W FL Clearwater Florida
Est Cst Inst for Rsrch,Jksnvil Jacksonville Florida
Reyes Clinical Research, Inc Miami Florida
Renstar Medical Research Ocala Florida
Atlanta Diabetes Associates Atlanta Georgia
Endo Res Solutions Inc Roswell Georgia
Apex Medical Research Inc Chicago Illinois
The University Of Chicago Chicago Illinois
American Health Network of Indiana, LLC_Avon Avon Indiana
American Health Network of Indiana, LLC_Greenfield Greenfield Indiana
Iowa Diab & Endo Res Center West Des Moines Iowa
VA Medical Center Lexington Kentucky
Kentucky Diabetes-Endocrinology Center Lexington Kentucky
The Research Group of Lexington LLC Lexington Kentucky
L-MARC Research Center Louisville Kentucky
Four Rivers Clinical Research Inc Paducah Kentucky
MedStar Hlth Res Institute Hyattsville Maryland
Brigham & Women's Hospital Boston Massachusetts
Boston Medical Center_Cary Boston Massachusetts

+ 190 more sites — see the full list on the official registry below.

On this site

📄 Ozempic (semaglutide) drug profile →

More Novo Nordisk A/S trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03811561 on ClinicalTrials.gov ↗ ← All trials in the UK