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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,500

Participants

Timeline

Start Date

May 8, 2019

Primary Completion Date

December 25, 2026

Study Completion Date

November 7, 2027

Conditions
Diabetes Mellitus, Type 2
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).

Trial Locations (183)

1011

Medical Centre Pulss 5, Riga

1233

"DCC VII - Sofia, Endocrinology Consulting Room", Sofia

"MHAT Knyaginya Klementina -Sofia EAD", Sofia

1431

"USHATE Akad. Ivan Penchev Second Clinic of Endocrinology", Sofia

1606

"Fourth MHAT-Sofia EAD", Sofia

1618

"DCC XX - Sofia EOOD, Endocrinology Consulting Room", Sofia

Medical centre Vitclinic EOOD, Sofia

3001

Zemgales diabetes centre, Jelgava

4000

"MHAT Med Line Clinic", Plovdiv

4002

"UMHAT Sveti Georgi, Clinic of Endocr. and Metab. Diseases", Plovdiv

4003

MHAT MC-Sv Ivan Rilski EOOD, Plovdiv

5001

Teterovska practice, Ogre

5801

DCC I- Pleven EOOD, Pleven

5806

MHAT Sveti Pantaleimon - Pleven, Internal Diseases, Pleven

10016

NYC Research, Inc., New York

11000

CHC Zvezdara, Clinical department for endocrinology, Belgrade

Endocrinology, Diabetes and Metabolism Diseases Clinic, Belgrade

11080

Clinical Hospital Center Bezanijska Kosa, Belgrade

11527

"Laiko General Hospital of Athens", Athens

12462

University Hospital of Athens ATTIKON, Athens

14080

Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab, Distrito Federal

15006

Complejo Hospitalario Universitario A Coruña, A Coruña

18000

Clinical Centre Nis, Endocrinology, Diabetes and Metabolism, Niš

19114

Tristar Clin Investigations, PC, Philadelphia

21109

Diabetes-Zentrum-Wilhelmsburg GbR, Hamburg

22607

Wendisch/Dahl Hamburg (DZHW), Hamburg

Wendisch/Dahl Hamburg, Hamburg

28226

OnSite Clinical Solutions, LLC, Charlotte

28803

Mountain Diabetes & Endocrine Center, Asheville

30076

Endo Res Solutions Inc, Roswell

30318

Atlanta Diabetes Associates, Atlanta

31008

Clinica Universitaria de Navarra, Pamplona

31096

Rambam MC - Diabetes and obesity center of excellence, Haifa

32216

Est Cst Inst for Rsrch,Jksnvil, Jacksonville

33756

Innovative Research of W FL, Clearwater

34471

Renstar Medical Research, Ocala

37212

Vanderbilt Diab Obes Clin Tri, Nashville

37411

Univ Diab & Endo Consultants, Chattanooga

37660

Holston Medical Group, Kingsport

40213

L-MARC Research Center, Louisville

40503

Kentucky Diabetes-Endocrinology Center, Lexington

The Research Group of Lexington LLC, Lexington

41009

Hospital Virgen de la Macarena, Seville

42001

Four Rivers Clinical Research Inc, Paducah

44281

Meir MC - Diabetes unit, Kfar Saba

46026

Hospital La Fe - Endocrinología y Nutrición, Valencia

46123

American Health Network of Indiana, LLC_Avon, Avon

48109

Michigan Medicine, Ann Arbor

48145

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster

48153

MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin, Münster

49100

Rabin MC Beilinson - Endo unit, Petah Tikva

50266

Iowa Diab & Endo Res Center, West Des Moines

52621

Sheba MC - Endocrinology Clinic, Tel Litwinsky

54642

"Ippokrateio G.H. of Thessaloniki", Thessaloniki

57001

"Thermi Private Hosital", Thessaloniki

60607

Apex Medical Research Inc, Chicago

60637

The University Of Chicago, Chicago

62500

Fakultni nemocnice Brno, Brno

64239

Institute of Endocrinology, metabolism and hypertension, Tel Aviv

64460

Hospital Universitario Dr. José Eleuterio González_Monterrey, Monterrey

66299

Praxis Denger/Pfitzner, Friedrichsthal, Friedrichsthal

66386

Zentrum für klinische Studien Alexander Segner, Saint Ingbert-Oberwürzbach

66780

Praxis Dr. med. Wenzl-Bauer, Rehlingen-Siersburg

73104

Harold Hamm Diabetes Center, Oklahoma City

75230

Velocity Clinical Res-Dallas, Dallas

77478

Simcare Medical Research, LLC, Sugar Land

78229

Clinical Trials of Texas, LLC, San Antonio

78230

VIP Trials, San Antonio

78231

Consano Clinical Research, LLC, Shavano Park

78705

Central Texas Clinical Research, Austin

78731

Texas Diab & Endo, P.A., Austin

80045

Barbara Davis Center, Aurora

Rocky Mount Reg VA Med-DN, Aurora

85715

Del Sol Research Management, LLC, Tucson

87131

University of New Mexico, Albuquerque

90017

Downtown LA Res Ctr. Inc., Los Angeles

90717

Torrance Clin Res Inst, Inc., Lomita

91120

Hadassah Ein Karam MC - Diabetes Unit, Jerusalem

92037

Scripps Whittier Diabetes Inst, La Jolla

92118

Southern California Res Ctr, Coronado

92627

FDRC, Costa Mesa

92648

Diabetes/Lipid Mgmt & Res Ctr, Huntington Beach

93003

Coastal Metabolic Research Center, Ventura

94598

Diablo Clinical Research, Inc., Walnut Creek

95821

Clinical Trials Research_Sacramento_0, Sacramento

99202

MultiCare Inst for Res & Innov, Spokane

110029

All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029

All India Institute of Medical Sciences, New Dehli

110076

Apollo Hospital, Delhi

Indraprastha Apollo Hospital, Delhi

117292

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

National Medical Research Center of Endocrinology, Moscow

141008

Christian Medical College and Hospital, Ludhiana

194354

City Consultative & Diagnostic Centre #1, Saint Petersburg

196084

"Diagnistic Centre Energo", Saint Petersburg

197110

Consultative & Diagnostic Center with a Outpatient Hospital, Saint Petersburg

300736

3rd Clinic for Nutrition-Spitalulul Județean de Urgenta, Timișoara

400006

Clinic of Diabetes Cluj, Cluj-Napoca

400008

BYL Nair Hospital and T N Medical College Department of endo, Mumbai

410031

SHI Saratov City Clinical Hospital #9, Saratov

410039

Regional clinical cardiology dispensary, Saratov

411004

Deenanath Mangeshkar Hospital & Research Centre, Pune

420012

Kazan Federal University, Kazan'

420061

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

440009

Government Medical College and Super Speciality Hospital, Nagpur, Nagpur

522001

Endolife Specialty Hospitals, Guntur

560010

Diacon Hospital Private Limited, Bangalore

600034

Care Hospital, Hyderabad

600086

Madras Diabetes Research Foundation, Chennai

656043

Multispecialty Medical Clinic Anturium LLC, Barnaul

682041

Amrita Institute Of Medical Sciences & Research Centre, Kochi

695031

Indian Institute of Diabetes, Thiruvananthapuram

695033

Indian Institute of Diabetes, Thiruvnanthapuram

700054

Apollo Gleneagles Hospital, Kolkata

91730-3063

Rancho Cucamonga Clinical Research, Rancho Cucamonga

06708

Chase Medical Research LLC, Waterbury

02115

Brigham & Women's Hospital, Boston

02118

Boston Medical Center_Cary, Boston

02215

Joslin Center For Diabetes, Boston

Joslin Diabetes Center, Boston

37620-7352

Holston Medical Group Pc, Bristol

75390-9302

UT Southwestern Med Cntr, Dallas

01228-000

CPQuali Pesquisa Clínica Ltda, São Paulo

T6G 2E1

Alberta Diabetes Institute, Edmonton

L4K 4M2

LMC Clinical Res Thornhill, Concord

M9R 4E1

LMC Endo Ctr (Etobicoke) Ltd, Etobicoke

M4G 3E8

LMC Endo Centres Ltd.(Bayview), Toronto

H9R 4S3

Centricity Res Pointe-Claire, Pointe-Claire

H4T 1Z9

LMC Clin Rsrch Inc. (Montreal), Saint-Laurent

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

100 00

Diabetologie Krupska, Prague

100 34

Fakultni nemocnice Kralovske Vinohrady_Praha, Prague

140 00

Institut klinicke a experimentalni mediciny, Prague

MUDr. Michala Pelikanova, Prague

115 25

Iatriko Psychicou Private Clinic, Athens

GR-11527

"Laiko General Hospital of Athens", Athens

GR-17562

Iatriko Athinon 'Palaiou Falirou', Athens

GR-12462

University Hospital of Athens ATTIKON, Haidari-Athens

GR-57001

"Thermi Private Hosital", Thessaloniki

560 099

Narayana Hrudayalya Institute of Cardiac Sciences, Bangalore

625 020

Arthur Asirvatham hospital,, Madurai

LV-1002

P. Stradins Clinical University Hospital, Riga

LV-1024

Juglas Medicine Center, Riga

15-276

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

85-048

In-Vivo Sp. z o.o., Bydgoszcz

41-500

B_Serwis Popenda Sp.J., Chorzów

80-382

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

80-858

NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o., Gdansk

40-081

Centrum Medyczne Pratia Katowice, Katowice

31-501

FutureMeds Sp. z o.o., Krakow

90-302

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

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

94-047

Prywatny Gabinet Lekarski Jan Ruxer, Lodz

60-821

"NZOZ DiabMed Poradnia Diabetologiczna", Poznan

61-251

Gaja Poradnie Lekarskie, Poznan

41-800

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

4464-513

Unidade Local De Saude De Matosinhos E.P.E., Senhora Da Hora, Matosinhos

2805-267

Unidade Local De Saude De Almada-Seixal E.P.E. - Hospital Garcia de Orta, Almada

3814-501

Unidade Local De Saude Da Regiao De Aveiro E.P.E., Aveiro

3000-561

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

4835-044

Unidade Local de Saude do Alto Ave, E.P.E., Guimarães

1250-230

APDP - Associação Protectora dos Diabéticos de Portugal, Lisbon

4200-319

Centro Hospitalar de São João, Porto

Unidade Local de Saude de Sao Joao E.P.E, Porto

2910-446

Unidade Local de Saúde da Arrábida, E.P.E., Setúbal

020475

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

010825

"Carol Davila Military Emergency Hospital", Bucharest

011025

Sana Monitoring SRL, Bucharest

020358

SC Clinica Diabnutrimed S.R.L., Bucharest

833 05

Nemocnica akademika L. Derera, UNB, Bratislava

01001

Diabetologicka ambulancia, Dia Zilina s.r.o., Žilina

Medivasa s.r.o., Diabetologicka ambulancia, Žilina

MEDIVASA, s.r.o., Diabetologicka ambulancia, Žilina

08035

Hospital Vall d'Hebron, Barcelona

08907

Hospital de Bellvitge, L'Hospitalet de Llobregat

HG2 7SX

Harrogate District Hospital, Harrogate

NG7 2UH

University Hospital, Queens Medical Centre, Nottingham

BA21 4AT

Yeovil District Hospital - Clinical Research Unit, Yeovil

Clinical Research Unit, Somerset

SE5 9RS

Kings College Hospital, London

NR4 7UQ

The Norfolk and Norwich University Hospital, Norfolk

CV10 7DJ

George Eliot Hospital NHS Trust, Nuneaton

TR1 3LJ

Royal Cornwall Hospital (Treliske), Truro

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT03811561 - A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes | Biotech Hunter | Biotech Hunter