A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Placebo (semaglutide)
- Registration Number
- NCT03811561
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Semaglutide Semaglutide Participants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care. Placebo Placebo (semaglutide) Participants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care.
- Primary Outcome Measures
Name Time Method Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression. Year 5 Percentage of subjects (yes/no).
- Secondary Outcome Measures
Name Time Method Change in glycosylated haemoglobin (HbA1c). Week 0, Year 5 Measured in %-points.
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy. Week 0-Year 5 Percentage of subjects (yes/no).
Persistent at least 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline. Year 5 Percentage of subjects (yes/no).
Change in body weight. Week 0, Year 5 Measured in kg.
Change in systolic and diastolic blood pressure. Week 0, Year 5 Measured in mmHg.
Presence of at least 3 steps ETDRS subject level improvement. Year 5 Percentage of subjects (yes/no).
Presence of at least 2 steps ETDRS subject level improvement. Year 5 Percentage of subjects (yes/no).
Presence of persistent at least 3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline. Year 5 Percentage of subjects (yes/no).
Time from randomisation to first at least 3 steps ETDRS subject level progression or central involved diabetic macular oedema (ciDME) in either eye. Up to 5 years Measured in months.
Change in visual acuity in the worse seeing eye. Week 0, Year 5 Measured in number of letters using the ETDRS protocol.
Change in visual acuity in the better seeing eye. Week 0, Year 5 Measured in number of letters using the ETDRS protocol.
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with focal/grid laser photocoagulation. Week 0-Year 5 Percentage of subjects (yes/no).
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with steroid. Week 0-Year 5 Percentage of subjects (yes/no).
Presence of at least 2 steps ETDRS subject level progression. Year 5 Percentage of subjects (yes/no).
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with pan-retinal laser photocoagulation. Week 0-Year 5 Percentage of subjects (yes/no).
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with anti-vascular endothelial growth factor (VEGF). Week 0-Year 5 Percentage of subjects (yes/no).
Presence of persistent visual acuity up to 38 ETDRS letters in either eye. Year 5 Percentage of subjects (yes/no).
Presence of persistent at least 2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline. Year 5 Percentage of subjects (yes/no).
Presence of persistent at least 2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline. Year 5 Percentage of subjects (yes/no).
Presence of ciDME in either eye. Year 5 Percentage of subjects (yes/no).
Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides. Week 0, Year 5 Measured in mmol/L
Trial Locations
- Locations (174)
MEDIVASA, s.r.o., Diabetologicka ambulancia
🇸🇰Zilina, Slovakia
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de Bellvitge
🇪🇸Hospitalet de Llobregat, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸La Coruña, Spain
Clinica Universitaria de Navarra
🇪🇸Pamplona, Spain
Hospital Virgen de la Macarena
🇪🇸Sevilla, Spain
Hospital La Fe - EndocrinologÃa y Nutrición
🇪🇸Valencia, Spain
MHAT "Knyaginya Klementina" -Sofia EAD
🇧🇬Sofia, Bulgaria
USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
🇧🇬Sofia, Bulgaria
"Fourth MHAT-Sofia EAD"
🇧🇬Sofia, Bulgaria
"DCC XX - Sofia" EOOD, Endocrinology Consulting Room
🇧🇬Sofia, Bulgaria
Medical centre Vitclinic EOOD
🇧🇬Sofia, Bulgaria
Medivasa s.r.o., Diabetologicka ambulancia
🇸🇰Zilina, Slovakia
Harrogate District Hospital
🇬🇧Harrogate, North Yorkshire, United Kingdom
University Hospital, Queens Medical Centre
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
The Norfolk and Norwich University Hospital
🇬🇧Norfolk, United Kingdom
George Eliot Hospital NHS Trust
🇬🇧Nuneaton, United Kingdom
Clinical Research Unit
🇬🇧Somerset, United Kingdom
Royal Cornwall Hospital (Treliske)
🇬🇧Truro, United Kingdom
Iatriko Psychicou Private Clinic
🇬🇷Athens, Greece
"Laiko" General Hospital of Athens
🇬🇷Athens, Greece
Iatriko Athinon 'Palaiou Falirou'
🇬🇷Athens, Greece
"Ippokrateio" G.H. of Thessaloniki
🇬🇷Thessaloniki, Greece
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
"Thermi" Private Hosital
🇬🇷Thessaloniki, Greece
Del Sol Research Management, LLC
🇺🇸Tucson, Arizona, United States
Southern California Res Ctr
🇺🇸Coronado, California, United States
FDRC
🇺🇸Costa Mesa, 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
Downtown LA Res Ctr. Inc.
🇺🇸Los Angeles, California, United States
Rancho Cucamonga Clinical Research
🇺🇸Rancho Cucamonga, California, United States
Clinical Trials Research_Sacramento_0
🇺🇸Sacramento, 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
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
Iowa Diab & Endo Res Center
🇺🇸West Des Moines, Iowa, 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
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Boston Medical Center_Cary
🇺🇸Boston, Massachusetts, United States
Joslin Center For Diabetes
🇺🇸Boston, Massachusetts, United States
Michigan Medicine
🇺🇸Ann Arbor, Michigan, 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
OnSite Clinical Solutions, LLC
🇺🇸Charlotte, North Carolina, United States
Harold Hamm Diabetes Center
🇺🇸Oklahoma City, Oklahoma, 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
MultiCare Inst for Res & Innov
🇺🇸Spokane, Washington, United States
CPQuali Pesquisa ClÃnica Ltda
🇧🇷São Paulo, Sao Paulo, Brazil
DCC I- Pleven EOOD
🇧🇬Pleven, Bulgaria
MHAT Sveti Pantaleimon - Pleven, Internal Diseases
🇧🇬Pleven, Bulgaria
MHAT "Med Line Clinic"
🇧🇬Plovdiv, Bulgaria
UMHAT "Sveti Georgi", Clinic of Endocr. and Metab. Diseases
🇧🇬Plovdiv, Bulgaria
MHAT MC-Sv Ivan Rilski EOOD
🇧🇬Plovdiv, Bulgaria
"DCC VII - Sofia", Endocrinology Consulting Room
🇧🇬Sofia, Bulgaria
Alberta Diabetes Institute
🇨🇦Edmonton, Alberta, Canada
LMC Clinical Res Thornhill
🇨🇦Concord, Ontario, Canada
LMC Endo Ctr (Etobicoke) Ltd
🇨🇦Etobicoke, Ontario, Canada
LMC Endo Centres Ltd.(Bayview)
🇨🇦Toronto, Ontario, Canada
Centricity Res Pointe-Claire
🇨🇦Pointe-Claire, Quebec, Canada
LMC Clin Rsrch Inc. (Montreal)
🇨🇦Saint-Laurent, Quebec, Canada
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Diabetologie Krupska
🇨🇿Praha 10, Czechia
Institut klinicke a experimentalni mediciny
🇨🇿Praha 4, Czechia
MUDr. Michala Pelikanova
🇨🇿Praha 4, Czechia
Fakultni nemocnice Kralovske Vinohrady_Praha
🇨🇿Praha, Czechia
Denger, Friedrichsthal
🇩🇪Friedrichsthal, Germany
Diabetes-Zentrum-Wilhelmsburg GbR
🇩🇪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
🇬🇷Haidari-Athens, Greece
Endolife Specialty Hospitals
🇮🇳Guntur, Andhra Pradesh, 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
BYL Nair Hospital and T N Medical College Department of endo
🇮🇳Mumbai, Maharashtra, India
Government Medical College and Super Speciality Hospital, Nagpur
🇮🇳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
Diabetologicka ambulancia, Dia Zilina s.r.o.
🇸🇰Zilina, Slovakia
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
Care Hospital
🇮🇳Hyderabad, India
Diabetes and obesity center of excellence, Rambam MC
🇮🇱Haifa, Israel
Diabetes Unit Hadassah Ein Karem MC
🇮🇱Jerusalem, Israel
Clinical Research Unit Meir Medical Center
🇮🇱Kfar Saba, Israel
Rabin MC Beilinson Campus Endo
🇮🇱Petah-Tikva, Israel
Endrocrinolgy Clinic - Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Institute of Endocrinology, metabolism and hypertension
🇮🇱Tel-Aviv, Israel
Zemgales diabetes centre
🇱🇻Jelgava, Latvia
Teterovska practice
🇱🇻Ogre, Latvia
Medical Centre Pulss 5
🇱🇻Riga, Latvia
P. Stradins Clinical University Hospital
🇱🇻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
Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
🇵🇱Lodz, Poland
In-Vivo Sp. z o.o.
🇵🇱Bydgoszcz, Poland
B_Serwis Popenda Sp.J.
🇵🇱Chorzow, 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
FutureMeds Sp. z o.o.
🇵🇱Kraków, Poland
Prywatny Gabinet Lekarski Jan Ruxer
🇵🇱Lodz, Poland
NZOZ "DiabMed" Poradnia Diabetologiczna
🇵🇱Poznan, Poland
Gaja Poradnie Lekarskie
🇵🇱Poznan, Poland
SPSK nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach, ul. 3-go Maja 13/15 41-800 Zabrze
🇵🇱Zabrze, Poland
Unidade Local De Saude De Matosinhos E.P.E.
🇵🇹Senhora Da Hora, Matosinhos, Matosinhos, Portugal
Unidade Local De Saude De Almada-Seixal E.P.E.
🇵🇹Almada, Portugal
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
🇵🇹Aveiro, Portugal
Unidade Local de Saúde de Coimbra, E.P.E.
🇵🇹Coimbra, Portugal
Unidade Local de Saude do Alto Ave, E.P.E.
🇵🇹Guimarães, Portugal
APDP - Associação Protectora dos Diabéticos de Portugal
🇵🇹Lisboa, Portugal
Centro Hospitalar de São João
🇵🇹Porto, Portugal
Unidade Local de Saude de Sao Joao E.P.E
🇵🇹Porto, Portugal
Unidade Local de Saúde da Arrábida, E.P.E.
🇵🇹Setubal, 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
3rd Clinic for Nutrition-Spitalulul Județean de Urgenta
🇷🇴Timisoara, Timis, 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, Russian Federation
Kazan Federal University
🇷🇺Kazan, Russian Federation
PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways
🇷🇺Kazan, Russian Federation
National Medical Research Center of Endocrinology
🇷🇺Moscow, Russian Federation
City Consultative & Diagnostic Centre #1
🇷🇺Saint-Petersburg, Russian Federation
Diagnistic Centre "Energo"
🇷🇺Saint-Petersburg, Russian Federation
Consultative & Diagnostic Center with a Outpatient Hospital
🇷🇺Saint-Petersburg, Russian Federation
SHI Saratov City Clinical Hospital #9
🇷🇺Saratov, Russian Federation
Regional clinical cardiology dispensary
🇷🇺Saratov, Russian Federation
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
🇷🇸Nis, Serbia
Nemocnica akademika L. Derera, UNB
🇸🇰Bratislava, Slovakia