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

March 27, 2024 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01228-000
        • Cpquali Pesquisa Clinica Ltda
  • Bulgaria
      • Pleven, Bulgaria, 5801
        • DCC I- Pleven EOOD
      • Pleven, Bulgaria, 5806
        • MHAT Sveti Pantaleimon - Pleven, Internal Diseases
      • Plovdiv, Bulgaria, 4003
        • MHAT MC-Sv Ivan Rilski EOOD
      • Plovdiv, Bulgaria, 4000
        • MHAT "Med Line Clinic"
      • Plovdiv, Bulgaria, 4002
        • UMHAT "Sveti Georgi", Clinic of Endocr. and Metab. Diseases
      • Sofia, Bulgaria, 1233
        • "DCC VII - Sofia", Endocrinology Consulting Room
      • Sofia, Bulgaria, 1233
        • MHAT "Knyaginya Klementina" -Sofia EAD
      • Sofia, Bulgaria, 1431
        • USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
      • Sofia, Bulgaria, 1606
        • "Fourth MHAT-Sofia EAD"
      • Sofia, Bulgaria, 1618
        • "DCC XX - Sofia" EOOD, Endocrinology Consulting Room
      • Sofia, Bulgaria, 1618
        • Medical centre Vitclinic EOOD
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • Alberta Diabetes Institute
    • Ontario
      • Concord, Ontario, Canada, L4K 4M2
        • LMC (Thornhill)
      • Etobicoke, Ontario, Canada, M9R 4E1
        • LMC Endo Ctr (Etobicoke) Ltd
      • Toronto, Ontario, Canada, M4G 3E8
        • LMC Endo Centres Ltd.(Bayview)
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Centricity Res Pointe-Claire
      • Saint-Laurent, Quebec, Canada, H4T 1Z9
        • LMC Clin Rsrch Inc. (Montreal)
  • Czechia
      • Brno, Czechia, 62500
        • Fakultní Nemocnice Brno
      • Hradec Kralove, Czechia, 500 05
        • Fakultni Nemocnice Hradec Kralove
      • Praha, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady_Praha
      • Praha 10, Czechia, 100 00
        • Diabetologie Krupska
      • Praha 4, Czechia, 140 00
        • Institut Klinicke A Experimentalni Mediciny
      • Praha 4, Czechia, 140 00
        • MUDr. Michala Pelikanova
  • Germany
      • Friedrichsthal, Germany, 66299
        • Denger, Friedrichsthal
      • Hamburg, Germany, 22607
        • Wendisch/Dahl Hamburg
      • Hamburg, Germany, 21109
        • Diabetes-Zentrum-Wilhelmsburg GbR
      • Münster, Germany, 48145
        • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
      • Münster, Germany, 48153
        • MedicalCenter am Clemenshospital
      • Rehlingen-Siersburg, Germany, 66780
        • Praxis Dr. med. Wenzl-Bauer
      • Saint Ingbert-Oberwürzbach, Germany, 66386
        • Zentrum für klinische Studien Alexander Segner
  • Greece
      • Athens, Greece, 115 25
        • Iatriko Psychicou Private Clinic
      • Athens, Greece, GR-11527
        • "Laiko" General Hospital of Athens
      • Athens, Greece, GR-17562
        • Iatriko Athinon 'Palaiou Falirou'
      • Haidari-Athens, Greece, GR-12462
        • University Hospital of Athens ATTIKON
      • Thessaloniki, Greece, GR-57001
        • "Thermi" Private Hosital
      • Thessaloniki, Greece, GR-54642
        • "Ippokrateio" G.H. of Thessaloniki
  • India
      • Hyderabad, India, 600034
        • Care Hospital
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, 522001
        • Endolife Specialty Hospitals
    • Karnataka
      • Bangalore, Karnataka, India, 560 099
        • Narayana Hrudayalya Institute of Cardiac Sciences
      • Bangalore, Karnataka, India, 560010
        • Diacon Hospital Private Limited
    • Kerala
      • Kochi, Kerala, India, 682041
        • Amrita Institute Of Medical Sciences & Research Centre
      • Thiruvananthapuram, Kerala, India, 695031
        • Indian Institute of Diabetes
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • BYL Nair Hospital and T N Medical College Department of endo
      • Nagpur, Maharashtra, India, 440003
        • Government Medical College and Super Speciality Hospital, Nagpur
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital & Research Centre
    • New Delhi
      • Ansari Nagar, New Delhi 110029, New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • Delhi, New Delhi, India, 110076
        • Apollo Hospital
      • Delhi, New Delhi, India, 110076
        • Indraprastha Apollo Hospital
    • Punjab
      • Ludhiana, Punjab, India, 141008
        • Christian Medical College and Hospital
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Madras Diabetes Research Foundation
      • Madurai, Tamil Nadu, India, 625 020
        • Arthur Asirvatham hospital,
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Apollo Gleneagles Hospital
      • Kolkata, West Bengal, India, 700020
        • SSKM
  • Israel
      • Haifa, Israel, 31096
        • Diabetes and obesity center of excellence, Rambam MC
      • Jerusalem, Israel, 91120
        • Diabetes Unit Hadassah Ein Karem MC
      • Kfar Saba, Israel, 44281
        • Clinical Research Unit Meir Medical Center
      • Petah-Tikva, Israel, 49100
        • Rabin MC Beilinson Campus Endo
      • Tel Hashomer, Israel, 52621
        • Endrocrinolgy Clinic - Sheba Medical Center
      • Tel-Aviv, Israel, 64239
        • Institute of Endocrinology, metabolism and hypertension
  • Latvia
      • Jelgava, Latvia, LV-3001
        • Zemgales diabetes centre
      • Ogre, Latvia, LV-5001
        • Teterovska practice
      • Riga, Latvia, LV-1002
        • P. Stradins Clinical University Hospital
      • Riga, Latvia, LV-1011
        • Medical Centre Pulss 5
      • Riga, Latvia, LV-1024
        • Juglas Medicine Center
  • Mexico
    • México, D.F.
      • Distrito Federal, México, D.F., Mexico, 14080
        • Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario Dr. José Eleuterio González_Monterrey
  • Poland
      • Bydgoszcz, Poland, 85-048
        • In-Vivo Sp. Z o.o.
      • Chorzow, Poland, 41-500
        • B_Serwis Popenda Sp.J.
      • Gdansk, Poland, 80-382
        • Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Gdansk, Poland, 80-858
        • NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.
      • Katowice, Poland, 40-081
        • Centrum Medyczne Pratia Katowice
      • Krakow, Poland, 31-501
        • Krakowskie Centrum Medyczne Sp. z o.o.
      • Lodz, Poland, 90-302
        • Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
      • Lodz, Poland, 94-047 LODZ
        • Prywatny Gabinet Lekarski Jan Ruxer
      • Plonsk, Poland, 09-100
        • SPZZOZ im. Marszalka J. Pilsudskiego w Plonsku
      • Poznan, Poland, 61-251
        • Gaja Poradnie Lekarskie
      • Poznan, Poland, 60-821
        • NZOZ "DiabMed" Poradnia Diabetologiczna
      • Zabrze, Poland, 41-800
        • SPSK nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach, ul. 3-go Maja 13/15 41-800 Zabrze
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Portugal
      • Almada, Portugal, 2805-267
        • Hospital Garcia de Orta
      • Aveiro, Portugal, 3814-501
        • Hospital Infante D. Pedro - Aveiro
      • Coimbra, Portugal, 3000-459
        • Centro Hospitalar e Universitário de Coimbra
      • Guimarães, Portugal, 4835-044
        • Hospital da Senhora da Oliveira - Guimarães
      • Lisboa, Portugal, 1250-230
        • APDP - Associação Protectora dos Diabéticos de Portugal
      • Matosinhos, Portugal, 4464-513
        • Unidade Local de Saúde de Matosinhos
      • Porto, Portugal, 4200-319
        • Centro Hospitalar de São João
      • Setubal, Portugal, 2910-446
        • Centro Hospitalar de Setubal
  • Romania
      • Bucharest, Romania, 011025
        • Sana Monitoring SRL
      • Bucharest, Romania, 010825
        • "Carol Davila" Military Emergency Hospital
      • Bucharest, Romania, 020358
        • SC Clinica Diabnutrimed S.R.L.
    • Bucurestii
      • Bucharest, Bucurestii, Romania, 020475
        • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
    • Cluj
      • Cluj Napoca, Cluj, Romania, 400006
        • Clinic of Diabetes Cluj
    • Timis
      • Timisoara, Timis, Romania, 300736
        • 3rd Clinic for Nutrition-Spitalulul Județean de Urgenta
  • Russian Federation
      • Barnaul, Russian Federation, 656043
        • Multispecialty Medical Clinic Anturium LLC
      • Kazan, Russian Federation, 420012
        • Kazan Federal University
      • Kazan, Russian Federation, 420061
        • PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways
      • Moscow, Russian Federation, 117292
        • National Medical Research Center of Endocrinology
      • Saint-Petersburg, Russian Federation, 194354
        • City Consultative & Diagnostic Centre #1
      • Saint-Petersburg, Russian Federation, 197110
        • Consultative & Diagnostic Center with a Outpatient Hospital
      • Saint-Petersburg, Russian Federation, 196084
        • Diagnistic Centre "Energo"
      • Saratov, Russian Federation, 410031
        • SHI Saratov City Clinical Hospital #9
      • Saratov, Russian Federation, 410039
        • Regional clinical cardiology dispensary
  • Serbia
      • Belgrade, Serbia, 11080
        • Clinical Hospital Center Bezanijska kosa
      • Belgrade, Serbia, 11000
        • Endocrinology, Diabetes and Metabolism Diseases Clinic
      • Belgrade, Serbia, 11000
        • CHC Zvezdara, Clinical department for endocrinology
      • Nis, Serbia, 18000
        • Clinical Centre Nis, Endocrinology, Diabetes and Metabolism
  • Slovakia
      • Bratislava, Slovakia, 833 05
        • Diabetologická ambulancia - Nemocnica akademika L. Derera, UNB
      • Zilina, Slovakia, 01001
        • Medivasa s.r.o., Diabetologicka ambulancia
      • Zilina, Slovakia, 01001
        • Diabetologicka ambulancia, Dia Zilina s.r.o.
      • Zilina, Slovakia, 01001
        • MEDIVASA, s.r.o., Diabetologicka ambulancia
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Hospitalet de Llobregat, Spain, 08907
        • Hospital de Bellvitge
      • La Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra
      • Sevilla, Spain, 41009
        • Hospital Virgen de la Macarena
      • Valencia, Spain, 46026
        • Hospital La Fe - Endocrinología y Nutrición
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • Norfolk, United Kingdom, NR4 7UQ
        • The Norfolk and Norwich University Hospital
      • North Yorkshire, United Kingdom, HG2 7SX
        • Harrogate District Hospital
      • Nuneaton, United Kingdom, CV10 7DJ
        • George Eliot Hospital NHS Trust
      • Somerset, United Kingdom, BA21 4AT
        • Clinical Research Unit
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital (Treliske)
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • University Hospital, Queens Medical Centre
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • Synexus Clinical Research US, Inc./Central Phoenix Medical C
      • Tucson, Arizona, United States, 85715
        • Del Sol Research Management, LLC
      • Tucson, Arizona, United States, 85741
        • Synexus Clinical Research, Inc - Orange Grove Family Practic
    • California
      • Coronado, California, United States, 92118
        • Southern California Res Ctr
      • Costa Mesa, California, United States, 92627
        • FDRC
      • Huntington Beach, California, United States, 92648
        • Diabetes/Lipid Mgmt & Res Ctr
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Inst
      • Lomita, California, United States, 90717
        • Torrance Clin Res Inst, Inc.
      • Los Angeles, California, United States, 90017
        • Downtown LA Res Ctr. Inc.
      • Rancho Cucamonga, California, United States, 91730-3063
        • Rancho Cucamonga Clinical Research
      • Sacramento, California, United States, 95821
        • Clinical Trials Research_Sacramento_0
      • Ventura, California, United States, 93003
        • Coastal Metabolic Research Center
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center
      • Aurora, Colorado, United States, 80045
        • Rocky Mount Reg VA Med-DN
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research LLC
    • Florida
      • Clearwater, Florida, United States, 33756
        • Innovative Research of W Florida Inc.
      • Jacksonville, Florida, United States, 32216
        • Est Cst Inst for Rsrch,Jksnvil
      • Miami, Florida, United States, 33175
        • Reyes Clinical Research, Inc
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Atlanta Diabetes Associates
      • Roswell, Georgia, United States, 30076
        • Endo Res Solutions Inc
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
      • Chicago, Illinois, United States, 60607
        • Apex Medical Research Inc
    • Indiana
      • Avon, Indiana, United States, 46123
        • American Health Network of Indiana, LLC_Avon
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diab & Endo Res Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • The Research Group of Lexington LLC
      • Lexington, Kentucky, United States, 40503
        • Kentucky Diabetes-Endocrinology Center
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
      • Paducah, Kentucky, United States, 42001
        • Four Rivers Clinical Research Inc
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women'S Hospital
      • Boston, Massachusetts, United States, 02215
        • Joslin Center For Diabetes
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center_Cary
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Michigan Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center, Inc.
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Southern New Hampshire Diabetes and Endocrinology
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • New York
      • New York, New York, United States, 10016
        • NYC Research, Inc.
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Mountain Diabetes & Endocrine Center
      • Charlotte, North Carolina, United States, 28226
        • OnSite Clinical Solutions, LLC
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Your Diabetes Endocrine Nutrition Group, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Harold Hamm Diabetes Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Tristar Clin Investigations, PC
    • Tennessee
      • Bristol, Tennessee, United States, 37620-7352
        • Holston Medical Group Pc
      • Chattanooga, Tennessee, United States, 37411
        • Univ Diab & Endo Consultants
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt Diab Obes Clin Tri
    • Texas
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • Austin, Texas, United States, 78731
        • Texas Diab & Endo, P.A.
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Res-Dallas
      • Dallas, Texas, United States, 75390-9302
        • UT Southwestern Med Cntr
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, LLC
      • San Antonio, Texas, United States, 78230
        • VIP Trials
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
      • Sugar Land, Texas, United States, 77478
        • Simcare Medical Research, LLC
    • Utah
      • Murray, Utah, United States, 84107
        • Synexus Clinical Research US, Inc.
    • Washington
      • Spokane, Washington, United States, 99202
        • MultiCare Inst for Res & Innov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semaglutide
Participants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care.
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).
Placebo Comparator: Placebo
Participants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression.
Time Frame: Year 5
Percentage of subjects (yes/no).
Year 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from randomisation to first at least 3 steps ETDRS subject level progression or central involved diabetic macular oedema (ciDME) in either eye.
Time Frame: Up to 5 years
Measured in months.
Up to 5 years
Change in visual acuity in the worse seeing eye.
Time Frame: Week 0, Year 5
Measured in number of letters using the ETDRS protocol.
Week 0, Year 5
Change in visual acuity in the better seeing eye.
Time Frame: Week 0, Year 5
Measured in number of letters using the ETDRS protocol.
Week 0, Year 5
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with focal/grid laser photocoagulation.
Time Frame: Week 0-Year 5
Percentage of subjects (yes/no).
Week 0-Year 5
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with pan-retinal laser photocoagulation.
Time Frame: Week 0-Year 5
Percentage of subjects (yes/no).
Week 0-Year 5
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with anti-vascular endothelial growth factor (VEGF).
Time Frame: Week 0-Year 5
Percentage of subjects (yes/no).
Week 0-Year 5
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with steroid.
Time Frame: Week 0-Year 5
Percentage of subjects (yes/no).
Week 0-Year 5
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy.
Time Frame: Week 0-Year 5
Percentage of subjects (yes/no).
Week 0-Year 5
Presence of at least 3 steps ETDRS subject level improvement.
Time Frame: Year 5
Percentage of subjects (yes/no).
Year 5
Presence of at least 2 steps ETDRS subject level progression.
Time Frame: Year 5
Percentage of subjects (yes/no).
Year 5
Presence of at least 2 steps ETDRS subject level improvement.
Time Frame: Year 5
Percentage of subjects (yes/no).
Year 5
Presence of persistent visual acuity up to 38 ETDRS letters in either eye.
Time Frame: Year 5
Percentage of subjects (yes/no).
Year 5
Presence of persistent at least 2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline.
Time Frame: Year 5
Percentage of subjects (yes/no).
Year 5
Presence of persistent at least 3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline.
Time Frame: Year 5
Percentage of subjects (yes/no).
Year 5
Presence of persistent at least 2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline.
Time Frame: Year 5
Percentage of subjects (yes/no).
Year 5
Persistent at least 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline.
Time Frame: Year 5
Percentage of subjects (yes/no).
Year 5
Presence of ciDME in either eye.
Time Frame: Year 5
Percentage of subjects (yes/no).
Year 5
Change in glycosylated haemoglobin (HbA1c).
Time Frame: Week 0, Year 5
Measured in %-points.
Week 0, Year 5
Change in body weight.
Time Frame: Week 0, Year 5
Measured in kg.
Week 0, Year 5
Change in systolic and diastolic blood pressure.
Time Frame: Week 0, Year 5
Measured in mmHg.
Week 0, Year 5
Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides.
Time Frame: Week 0, Year 5
Measured in mmol/L
Week 0, Year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2019

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

November 7, 2027

Study Registration Dates

First Submitted

January 18, 2019

First Submitted That Met QC Criteria

January 18, 2019

First Posted (Actual)

January 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9535-4352
  • U1111-1201-6256 (Other Identifier: World Health Organization (WHO))
  • 2017-003619-20 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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