What this trial means for you
This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Semaglutide, Placebo (semaglutide) for diabetes mellitus, type 2.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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
Study sites by state
Arizona
- Synexus Rsch /Cnt Phnx Med C — Phoenix
- Del Sol Research Management, LLC — Tucson
- South Arizona VA Healthcare System — Tucson
- Synexus Cln Rsrch Inc - Orange Gro FP — Tucson
California
- Southern California Res Ctr — Coronado
- FDRC — Costa Mesa
- Advanced Investigative Medicine, Inc. — Hawthorne
- Diabetes/Lipid Mgmt & Res Ctr — Huntington Beach
- Scripps Whittier Diabetes Inst — La Jolla
- Torrance Clin Res Inst, Inc. — Lomita
- Angel City Research, Inc. — Los Angeles
- Downtown LA Res Ctr. Inc. — Los Angeles
- Riverside University Health System Medical Center — Moreno Valley
- Rancho Cucamonga Clinical Research — Rancho Cucamonga
- Clinical Trials Research_Sacramento_0 — Sacramento
- UCLA Diabetes Center at Santa Monica — Santa Monica
- Coastal Metabolic Research Center — Ventura
- Diablo Clinical Research, Inc. — Walnut Creek
Colorado
- Barbara Davis Center — Aurora
- Rocky Mount Reg VA Med-DN — Aurora
Connecticut
- Chase Medical Research LLC — Waterbury
Florida
- Innovative Research of W FL — Clearwater
- Est Cst Inst for Rsrch,Jksnvil — Jacksonville
- Reyes Clinical Research, Inc — Miami
- Renstar Medical Research — Ocala
Georgia
- Atlanta Diabetes Associates — Atlanta
- Endo Res Solutions Inc — Roswell
Illinois
- Apex Medical Research Inc — Chicago
- The University Of Chicago — Chicago
Indiana
- American Health Network of Indiana, LLC_Avon — Avon
- American Health Network of Indiana, LLC_Greenfield — Greenfield
Iowa
- Iowa Diab & Endo Res Center — West Des Moines
Kentucky
- VA Medical Center — Lexington
- Kentucky Diabetes-Endocrinology Center — Lexington
- The Research Group of Lexington LLC — Lexington
- L-MARC Research Center — Louisville
- Four Rivers Clinical Research Inc — Paducah
Maryland
- MedStar Hlth Res Institute — Hyattsville
Massachusetts
- Brigham & Women's Hospital — Boston
- Boston Medical Center_Cary — Boston
- Joslin Center For Diabetes — Boston
- Joslin Diabetes Center — Boston
Michigan
- Michigan Medicine — Ann Arbor
Minnesota
- Synexus Clinical Research US, Inc._Tempe_0 — Richfield
Missouri
- Diabetes & Endo Specialists Inc — Chesterfield
Nevada
- Palm Research Center Inc-Vegas — Las Vegas
New Hampshire
- Southern New Hampshire Diabete — Nashua
New Mexico
- Lovelace Scientific Resources Inc — Albuquerque
- University of New Mexico — Albuquerque
New York
- NYC Research, Inc. — New York
North Carolina
- Mountain Diabetes & Endocrine Center — Asheville
- University of North Carolina — Chapel Hill
- OnSite Clinical Solutions, LLC — Charlotte
Ohio
- Your Diabetes Endocrine Nutrition Group, Inc. — Mentor
- University of Toledo Medical Center — Toledo
Oklahoma
- Harold Hamm Diabetes Center — Oklahoma City
Pennsylvania
- Aria Endocrine Metabolic Assoc — Philadelphia
- Tristar Clin Investigations, PC — Philadelphia
Tennessee
- Holston Medical Group Pc — Bristol
- Univ Diab & Endo Consultants — Chattanooga
- Holston Medical Group — Kingsport
- Vanderbilt Diab Obes Clin Tri — Nashville
Texas
- Central Texas Clinical Research — Austin
- Texas Diab & Endo, P.A. — Austin
- Velocity Clinical Res-Dallas — Dallas
- UT Southwestern Med Cntr — Dallas
- Clinical Trials of Texas, LLC — San Antonio
- VIP Trials — San Antonio
- Consano Clinical Research, LLC — Shavano Park
- Simcare Medical Research, LLC — Sugar Land
Utah
- Synexus Clinical Research US, INC. — Murray
Washington
- MultiCare Inst for Res & Innov — Spokane
View the official record on ClinicalTrials.gov →
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