A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes
NCT ID: NCT03811561
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1500 participants
INTERVENTIONAL
2019-05-08
2027-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Semaglutide
Participants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care.
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
Participants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with type 2 diabetes mellitus.
* HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
* 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
* 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
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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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 Consulting Room
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
Unidade Local de Saude de Sao Joao E.P.E
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, Bucurestii, 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
Countries
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Other Identifiers
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U1111-1201-6256
Identifier Type: OTHER
Identifier Source: secondary_id
2017-003619-20
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN9535-4352
Identifier Type: -
Identifier Source: org_study_id