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HomeTrials › NCT03811561

Type 2 diabetes · Phase 3 · Active, not recruiting

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

NCT03811561 · Sponsor: Novo Nordisk A/S

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.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeSemaglutide, Placebo (semaglutide)
Study length~8.5 years overall
Planned participants1,500
TypeInterventional (you receive treatment)

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 →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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