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ACTIVE NOT RECRUITING
NCT03811561
PHASE3

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Official title: Long-term Effects of Semaglutide on Diabetic Retinopathy in Subjects With Type 2 Diabetes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2019-05-08

Completion Date

2027-11-07

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DRUG

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).

DRUG

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).

Locations (229)

Synexus Rsch /Cnt Phnx Med C

Phoenix, Arizona, United States

Del Sol Research Management, LLC

Tucson, Arizona, United States

South Arizona VA Healthcare System

Tucson, Arizona, United States

Synexus Cln Rsrch Inc - Orange Gro FP

Tucson, Arizona, United States

Southern California Res Ctr

Coronado, California, United States

FDRC

Costa Mesa, California, United States

Advanced Investigative Medicine, Inc.

Hawthorne, California, United States

Diabetes/Lipid Mgmt & Res Ctr

Huntington Beach, California, United States

Scripps Whittier Diabetes Inst

La Jolla, California, United States

Torrance Clin Res Inst, Inc.

Lomita, California, United States

Angel City Research, Inc.

Los Angeles, California, United States

Downtown LA Res Ctr. Inc.

Los Angeles, California, United States

Riverside University Health System Medical Center

Moreno Valley, California, United States

Rancho Cucamonga Clinical Research

Rancho Cucamonga, California, United States

Clinical Trials Research_Sacramento_0

Sacramento, California, United States

UCLA Diabetes Center at Santa Monica

Santa Monica, California, United States

Coastal Metabolic Research Center

Ventura, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Barbara Davis Center

Aurora, Colorado, United States

Rocky Mount Reg VA Med-DN

Aurora, Colorado, United States

Chase Medical Research LLC

Waterbury, Connecticut, United States

Innovative Research of W FL

Clearwater, Florida, United States

Est Cst Inst for Rsrch,Jksnvil

Jacksonville, Florida, United States

Reyes Clinical Research, Inc

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Endo Res Solutions Inc

Roswell, Georgia, United States

Apex Medical Research Inc

Chicago, Illinois, United States

The University Of Chicago

Chicago, Illinois, United States

American Health Network of Indiana, LLC_Avon

Avon, Indiana, United States

American Health Network of Indiana, LLC_Greenfield

Greenfield, Indiana, United States

Iowa Diab & Endo Res Center

West Des Moines, Iowa, United States

VA Medical Center

Lexington, Kentucky, United States

Kentucky Diabetes-Endocrinology Center

Lexington, Kentucky, United States

The Research Group of Lexington LLC

Lexington, Kentucky, United States

L-MARC Research Center

Louisville, Kentucky, United States

Four Rivers Clinical Research Inc

Paducah, Kentucky, United States

MedStar Hlth Res Institute

Hyattsville, Maryland, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Boston Medical Center_Cary

Boston, Massachusetts, United States

Joslin Center For Diabetes

Boston, Massachusetts, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

Michigan Medicine

Ann Arbor, Michigan, United States

Synexus Clinical Research US, Inc._Tempe_0

Richfield, Minnesota, United States

Diabetes & Endo Specialists Inc

Chesterfield, Missouri, United States

Palm Research Center Inc-Vegas

Las Vegas, Nevada, United States

Southern New Hampshire Diabete

Nashua, New Hampshire, United States

Lovelace Scientific Resources Inc

Albuquerque, New Mexico, United States

University of New Mexico

Albuquerque, New Mexico, United States

NYC Research, Inc.

New York, New York, United States

Mountain Diabetes & Endocrine Center

Asheville, North Carolina, United States

University of North Carolina

Chapel Hill, North Carolina, United States

OnSite Clinical Solutions, LLC

Charlotte, North Carolina, United States

Your Diabetes Endocrine Nutrition Group, Inc.

Mentor, Ohio, United States

University of Toledo Medical Center

Toledo, Ohio, United States

Harold Hamm Diabetes Center

Oklahoma City, Oklahoma, United States

Aria Endocrine Metabolic Assoc

Philadelphia, Pennsylvania, United States

Tristar Clin Investigations, PC

Philadelphia, Pennsylvania, United States

Holston Medical Group Pc

Bristol, Tennessee, United States

Univ Diab & Endo Consultants

Chattanooga, Tennessee, United States

Holston Medical Group

Kingsport, Tennessee, United States

Vanderbilt Diab Obes Clin Tri

Nashville, Tennessee, United States

Central Texas Clinical Research

Austin, Texas, United States

Texas Diab & Endo, P.A.

Austin, Texas, United States

Velocity Clinical Res-Dallas

Dallas, Texas, United States

UT Southwestern Med Cntr

Dallas, Texas, United States

Clinical Trials of Texas, LLC

San Antonio, Texas, United States

VIP Trials

San Antonio, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Simcare Medical Research, LLC

Sugar Land, Texas, United States

Synexus Clinical Research US, INC.

Murray, Utah, United States

MultiCare Inst for Res & Innov

Spokane, Washington, United States

CPQuali Pesquisa Clínica Ltda

São Paulo, São Paulo, Brazil

DCC I- Pleven EOOD Endocrinology

Pleven, Bulgaria

MHAT Sveti Pantaleimon - Pleven, Internal Diseases

Pleven, Bulgaria

MHAT Med Line Clinic

Plovdiv, Bulgaria

UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Endocrinology

Plovdiv, Bulgaria

MHAT MC-Sv Ivan Rilski EOOD

Plovdiv, Bulgaria

"DCC VII - Sofia", Endocrinology Consulting Room

Sofia, Bulgaria

DCC VII - Sofia EOOD, Endocrinology

Sofia, Bulgaria

MHAT Knyaginya Klementina - Sofia EAD

Sofia, Bulgaria

USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology

Sofia, Bulgaria

IV MHAT - Sofia EAD

Sofia, Bulgaria

DCC XX - Sofia EOOD, Endocrinology

Sofia, Bulgaria

Medical centre Vitclinic EOOD

Sofia, Bulgaria

Alberta Diabetes Institute

Edmonton, Alberta, Canada

LMC Clinical Res Thornhill

Concord, Ontario, Canada

LMC Endo Ctr (Etobicoke) Ltd

Etobicoke, Ontario, Canada

LMC Oakville

Oakville, Ontario, Canada

The Ottawa Hospital_Riverside

Ottawa, Ontario, Canada

LMC Endo Centres Ltd.(Bayview)

Toronto, Ontario, Canada

LMC Clinical Research, Inc. (Montreal Glen)

Montreal, Quebec, Canada

Centricity Res Pointe-Claire

Pointe-Claire, Quebec, Canada

LMC Clin Rsrch Inc. (Montreal)

Saint-Laurent, Quebec, Canada

Fakultni nemocnice Brno

Brno, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Diabetologie Krupska

Prague, Czechia

Fakultni nemocnice Kralovske Vinohrady_Praha

Prague, Czechia

Institut klinicke a experimentalni mediciny

Prague, Czechia

MUDr. Michala Pelikanova

Prague, Czechia

Praxis Denger/Pfitzner, Friedrichsthal

Friedrichsthal, Germany

Diabetologische Schwerpunktpraxis Harburg- Dr. med.Paschen,

Hamburg, Germany

Diabetes-Zentrum-Wilhelmsburg GbR

Hamburg, Germany

Wendisch - Dahl Hamburg - DZHW

Hamburg, Germany

Wendisch/Dahl Hamburg

Hamburg, Germany

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

Münster, Germany

MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

Münster, Germany

Praxis Dr. med. Wenzl-Bauer

Rehlingen-Siersburg, Germany

Zentrum für klinische Studien Alexander Segner

Saint Ingbert-Oberwürzbach, Germany

University Hospital of Athens ATTIKON

Athens, Attica, Greece

Iatriko Psychicou Private Clinic

Athens, Greece

"Laiko" General Hospital of Athens

Athens, Greece

"Laiko" General Hospital of Athens

Athens, Greece

Iatriko Athinon 'Palaiou Falirou'

Athens, Greece

University Hospital of Athens ATTIKON

Haidari-Athens, Greece

"Ippokrateio" G.H. of Thessaloniki

Thessaloniki, Greece

"Thermi" Private Hosital

Thessaloniki, Greece

"Thermi" Private Hosital

Thessaloniki, Greece

Endolife Specialty Hospitals

Guntur, Andhra Pradesh, India

Nirmal Hospital Pvt. Ltd.

Surat, Gujarat, India

Narayana Hrudayalya Institute of Cardiac Sciences

Bangalore, Karnataka, India

Diacon Hospital Private Limited

Bangalore, Karnataka, India

Amrita Institute Of Medical Sciences & Research Centre

Kochi, Kerala, India

Indian Institute of Diabetes

Thiruvananthapuram, Kerala, India

Indian Institute of Diabetes

Thiruvnanthapuram, Kerala, India

BYL Nair Hospital and T N Medical College Department of endo

Mumbai, Maharashtra, India

Seth GS medical college and KEM Hospital

Mumbai, Maharashtra, India

Government Medical College and Super Speciality Hospital, Nagpur

Nagpur, Maharashtra, India

DEW Medicare & Trinity hospital

Nagpur, Maharashtra, India

Deenanath Mangeshkar Hospital & Research Centre

Pune, Maharashtra, India

All India Institute of Medical Sciences

Ansari Nagar, New Delhi 110029, New Delhi, India

Apollo Hospital

Delhi, New Delhi, India

Indraprastha Apollo Hospital

Delhi, New Delhi, India

All India Institute of Medical Sciences

New Dehli, New Delhi, India

Dayanand Medical College & Hospital_Ludhiana

Ludhiana, Punjab, India

Christian Medical College and Hospital

Ludhiana, Punjab, India

Madras Diabetes Research Foundation

Chennai, Tamil Nadu, India

Arthur Asirvatham hospital,

Madurai, Tamil Nadu, India

SSKM

Kolkata, West Bengal, India

Apollo Gleneagles Hospital

Kolkata, West Bengal, India

Apollo Multispeciality Hospital, Kolkata

Kolkata, West Bengal, India

Care Hospital

Hyderabad, India

Aditya Jyot Hospital

Mumbai, India

Rambam MC - Diabetes and obesity center of excellence

Haifa, Israel

Hadassah Ein Karam MC - Diabetes Unit

Jerusalem, Israel

Meir MC - Diabetes unit

Kfar Saba, Israel

Rabin MC Beilinson - Endo unit

Petah Tikva, Israel

Sourasky MC - Institute of Endocrinology, metabolism and hypertension

Tel Aviv, Israel

Sheba MC - Endocrinology Clinic

Tel Litwinsky, Israel

Zemgales diabetes centre

Jelgava, Latvia

Teterovska practice

Ogre, Latvia

P. Stradins Clinical University Hospital

Riga, Latvia

Medical Centre Pulss 5

Riga, Latvia

Juglas Medicine Center

Riga, Latvia

Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab

Distrito Federal, México, D.F., Mexico

Hospital Universitario Dr. José Eleuterio González_Monterrey

Monterrey, Nuevo León, Mexico

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Podlaskie Voivodeship, Poland

In-Vivo Sp. z o.o.

Bydgoszcz, Poland

B_Serwis Popenda Sp.J.

Chorzów, Poland

Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gdansk, Poland

NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.

Gdansk, Poland

Centrum Medyczne Pratia Katowice

Katowice, Poland

Clinical Medical Research Korfantego - Ambulatoryjna Opieka

Katowice, Poland

FutureMeds Sp. z o.o.

Krakow, Poland

Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia

Lodz, Poland

Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

Lodz, Poland

Prywatny Gabinet Lekarski Jan Ruxer

Lodz, Poland

NZOZ "DiabMed" Poradnia Diabetologiczna

Poznan, Poland

Gaja Poradnie Lekarskie

Poznan, Poland

SPZZOZ im. Marszalka J. Pilsudskiego w Plonsku

Płońsk, Poland

SPSK nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach, ul. 3-go Maja 13/15 41-800 Zabrze

Zabrze, Poland

Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia

Lodz, Łódź Voivodeship, Poland

ULS De Matosinhos E.P.E.- Hospital Pedro Hispano

Senhora Da Hora, Matosinhos, Matosinhos, Portugal

ULS Almada-Seixal E.P.E. - Hospital Garcia de Orta

Almada, Portugal

ULS Da Regiao De Aveiro E.P.E. - Hospital Infante D. Pedro

Aveiro, Portugal

Unidade Local De Saúde De Coimbra, E.P.E.

Coimbra, Portugal

ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães

Guimarães, Portugal

APDP - Associação Protectora dos Diabéticos de Portugal

Lisbon, Portugal

Centro Hospitalar de São João

Porto, Portugal

ULS De São João, E.P.E. - Hospital de São João

Porto, Portugal

ULS Da Arrábida, E.P.E._Hospital de São Bernardo

Setúbal, Portugal

Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila

Bucharest, București, Romania

Clinic of Diabetes Cluj

Cluj-Napoca, Cluj, Romania

SC Centru Medical Dr. Negrisanu SRL

Timișoara, Timiș County, Romania

3rd Clinic for Nutrition-Spitalulul Județean de Urgenta

Timișoara, Timiș County, Romania

"Carol Davila" Military Emergency Hospital

Bucharest, Romania

Sana Monitoring SRL

Bucharest, Romania

SC Clinica Diabnutrimed S.R.L.

Bucharest, Romania

Multispecialty Medical Clinic Anturium LLC

Barnaul, Russia

Kazan Federal University

Kazan', Russia

PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways

Kazan', Russia

Kazan Federal University

Kazan', Russia

FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia

Moscow, Russia

National Medical Research Center of Endocrinology

Moscow, Russia

Branch of limited liability company "Hadassah Medical LTD"

Moscow, Russia

State Novosibirsk regional clinical hospital

Novosibirsk, Russia

City Consultative & Diagnostic Centre #1

Saint Petersburg, Russia

Diagnistic Centre "Energo"

Saint Petersburg, Russia

Consultative & Diagnostic Center with a Outpatient Hospital

Saint Petersburg, Russia

Llc "International Medical Center "Time"

Saint-Peterburg, Russia

SHI Saratov City Clinical Hospital #9

Saratov, Russia

Regional clinical cardiology dispensary

Saratov, Russia

Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, Russia

Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.

Novi Sad, Vojvodina, Serbia

CHC Zvezdara, Clinical department for endocrinology

Belgrade, Serbia

Endocrinology, Diabetes and Metabolism Diseases Clinic

Belgrade, Serbia

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia

Clinical Centre Nis, Endocrinology, Diabetes and Metabolism

Niš, Serbia

V. interna klinika LF UK a UNB

Bratislava, Slovakia

Nemocnica akademika L. Derera, UNB

Bratislava, Slovakia

Diabetologicka ambulancia, Dia Zilina s.r.o.

Žilina, Slovakia

Medivasa s.r.o., Diabetologicka ambulancia

Žilina, Slovakia

MEDIVASA, s.r.o., Diabetologicka ambulancia

Žilina, Slovakia

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Hospital de Bellvitge

L'Hospitalet de Llobregat, Spain

Clinica Universitaria de Navarra

Pamplona, Spain

Hospital Virgen de la Macarena

Seville, Spain

Hospital La Fe - Endocrinología y Nutrición

Valencia, Spain

Harrogate District Hospital

Harrogate, North Yorkshire, United Kingdom

Queen's Medical Centre University Hospital

Nottingham, Nottinghamshire, United Kingdom

University Hospital, Queens Medical Centre

Nottingham, Nottinghamshire, United Kingdom

Yeovil District Hospital - Clinical Research Unit

Yeovil, Somerset, United Kingdom

Kings College Hospital

London, United Kingdom

Norfolk and Norwich University Hospital

Norfolk, United Kingdom

George Eliot Hospital NHS Trust

Nuneaton, United Kingdom

George Eliot Hospital

Nuneaton, United Kingdom

Clinical Research Unit

Somerset, United Kingdom

Royal Cornwall Hospital (Treliske)

Truro, United Kingdom