A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease (FLOW)
March 13, 2025 updated by: Novo Nordisk A/S
Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease
The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes.
Participants will get semaglutide (active medicine) or placebo ('dummy medicine').
This is known as participants' study medicine - which treatment participants get is decided by chance.
Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes.
Participants will get the study medicine in a pen.
Participants will use the pen to inject the medicine in a skin fold once a week.
The study will close when there is enough information collected to show clear result of the study.
The total time participants will be in this study is about 3 to 5 years, but it could be longer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3533
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 Locations
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Buenos Aires, Argentina, C1425AGC
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
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Buenos Aires, Argentina, C1250AAN
- Centro Diabetológico y Nuticional Dr Alejandro Chertkoff
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Caba, Argentina, C1430CKE
- Glenny Corp. S.A
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Caba, Argentina, C1440AAD
- Medical Center of Diabetes and Nutrition
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Caba, Argentina, 1429
- FEPREVA
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Caba, Argentina, C1060ABA
- Centro de Investigación Clínica
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Buenos Aires
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Villa Dominico, Buenos Aires, Argentina, B1872EEA
- Centro de Estudios Renales e Hipertensión Arterial
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New South Wales
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Gosford, New South Wales, Australia, 2250
- Gosford Renal Research
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St Leonards, New South Wales, Australia, 2065
- Royal North Shore Hospital
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Westmead, New South Wales, Australia, 2145
- Westmead Hospital_Northmead
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Queensland
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Milton, Queensland, Australia, 4064
- Core Research Centre
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Health Nephrology
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Fitzroy, Victoria, Australia, 3065
- St Vincent's Hospital_Fitzroy_0
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Melbourne, Victoria, Australia, 3004
- Monash University Clinical Trial Centre
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Parkville, Victoria, Australia, 3050
- The Royal Melbourne Hospital
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Bonheiden, Belgium, 2820
- Imeldaziekenhuis - Bonheiden - Department of Endocrinology
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Brussel, Belgium, 1090
- Universitair Ziekenhuis Brussel - Diabeteskliniek
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Brussel, Belgium, 1090
- UZ Brussel - Universitair Ziekenhuis Brussel
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Bruxelles, Belgium, 1200
- Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
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Edegem, Belgium, 2650
- UZA - UZ Antwerpen - Department of Endocrinology
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Gent, Belgium, 9000
- UZ Gent - Endocrinologie - Diabetologie
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Leuven, Belgium, 3000
- UZ Leuven - Endocrinology
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Liège, Belgium, 4000
- Centre hospitalier universitaire de Liège (CHU de Liège)
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Roeselare, Belgium, 8800
- AZ Delta - Roeselare
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Bahia, Brazil, 41810-011
- Centro Médico Hospital da Bahia
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Ceara
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Fortaleza, Ceara, Brazil, 60125-058
- Instituto de Ensino e Pesquisa Clínica do Ceará Ltda
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Parana
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Curitiba, Parana, Brazil, 80440-020
- Instituto Pró-Renal Brasil
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
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Sao Paulo
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Santo André, Sao Paulo, Brazil, 09030-010
- Hospital e Maternidade Dr. Christovão da Gama S.A.
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São Paulo, Sao Paulo, Brazil, 01228-000
- Cpquali Pesquisa Clinica Ltda
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São Paulo, Sao Paulo, Brazil, 01228-200
- CPCLIN - Centro de Pesquisas Clinicas
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São Paulo, Sao Paulo, Brazil, 01223-001
- Instituto de Pesquisa Clinica (IPEC)
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Kozloduy, Bulgaria, 3320
- Medical centre "Zdrave 1" OOD
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Plovdiv, Bulgaria, 4001
- UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases
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Sliven, Bulgaria, 8800
- MHAT "Dr. Ivan Seliminski"-Sliven
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Smolyan, Bulgaria, 4700
- "Nader Yabrudi - ASMPVBE Individual practice"
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Sofia, Bulgaria, 1431
- UMHAT Aleksandrovska
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Sofia, Bulgaria, 1784
- Medical Center Synexus Sofia
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Stara Zagora, Bulgaria, 6001
- Medical Center "Nov Rehabilitatsionen center" EOOD
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Quebec, Canada, G1W 4R4
- Centre de Recherche Saint-Louis
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Alberta
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Calgary, Alberta, Canada, T2T 5C7
- University Of Calgary
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Calgary, Alberta, Canada, T2H 2G4
- LMC Clin Res Inc. Calgary
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Red Deer, Alberta, Canada, T4N 6V7
- The Bailey Clinic
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British Columbia
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Vancouver, British Columbia, Canada, V5Y 3W2
- BC Diabetes Canada
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Newfoundland and Labrador
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Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
- Commonwealth Medical Clinic
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Eastern Health Authority
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V8
- QE II Health - Pharmacy
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Ontario
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Brampton, Ontario, Canada, L6S 0C6
- Dr. Harpreet Bajaj
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Brampton, Ontario, Canada, L6T 0G1
- Aggarwal and Assoc Ltd.
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Burlington, Ontario, Canada, L7M 4Y1
- JBN Medical Diagnostic Services Inc.
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Concord, Ontario, Canada, L4K 4M2
- LMC Clin Res Inc. Thornhill
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Etobicoke, Ontario, Canada, M9R 4E1
- LMC Endo Ctr (Etobicoke) Ltd
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Hamilton, Ontario, Canada, L8M 1K7
- Hamilton Med Res Group
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Hamilton, Ontario, Canada, L8M 1K7
- Premier Clinical Trial Research Network (PCTRN)
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London, Ontario, Canada, N5W 6A2
- Milestone Research
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Nepean, Ontario, Canada, K2J 0V2
- LMC Research Inc. Ottawa
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Oshawa, Ontario, Canada, L1G 2B9
- Lakeridge Health
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Oshawa, Ontario, Canada, L1J 2K1
- Dr. James Cha
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Oshawa, Ontario, Canada, L1J 2K1
- King Street Research
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Sarnia, Ontario, Canada, N7T 4X3
- Bluewater Clin Res Group, Inc.
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Sarnia, Ontario, Canada, N7T 4X3
- Bluewater Clin Res Group,Inc
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Stoney Creek, Ontario, Canada, L8J 0B6
- Winterberry Family Medicine
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Toronto, Ontario, Canada, M5T 3L9
- Mount Sinai Hospital
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Toronto, Ontario, Canada, M9V 4B4
- Dr. Anil K Gupta Med Prof Corp
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Toronto, Ontario, Canada, M5G 2N2
- UHN-Toronto General Hospital
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Toronto, Ontario, Canada, M4G 3E8
- LMC Endo Centres Ltd.(Bayview)
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Toronto, Ontario, Canada, M9V 4B4
- Dr Anil K Gupta Med Prof Corp
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Quebec
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Laval, Quebec, Canada, H7T 2P5
- Ctr de rech Clin de Laval
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Montreal, Quebec, Canada, H4N 2W2
- Centre Medical Acadie
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Montreal, Quebec, Canada, H4A 3T2
- Applied Med Inf Res
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Montreal, Quebec, Canada, H2K 1H2
- Clinique de Recherche Medpharmgene Inc.
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Beijing
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Beijing, Beijing, China, 100044
- Peking University People's Hospital
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Beijing, Beijing, China, 100044
- Peking University People's Hospital-Endocrinology
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Beijing, Beijing, China, 101200
- Beijing Pinggu Hospital-Endocrinology
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Jiangsu
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Zhenjiang, Jiangsu, China, 212001
- The Affiliated Hospital of Jiangsu University-Endocrinology
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Shandong
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Ji'nan, Shandong, China, 250013
- Jinan Central Hospital
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Annonay cedex, France, 07103
- Centre Hospitalier Ardeche Nord
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BRON cedex, France, 69677
- Hospices Civils de Lyon-Hopital Cardiologique Louis Pradel-2
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Caen, France, 14033
- Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre-1
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Grenoble - Cédex 09, France, 38043
- Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-2
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La Roche-sur-yon, France, 85925
- Centre Hospitalier Departemental Vendee- La Roche Sur Yon
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Le Coudray, France, 28630
- Les Hopitaux de Chartres-Hopital Louis Pasteur
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Le Creusot, France, 71200
- Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1
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Le Creusot, France, 71200
- Groupe SOS Santé Hôtel Dieu
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Paris, France, 75019
- Fondation Rothschild
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Reims, France, 51092
- Centre Hospitalier Universitaire Reims-Hopital Maison Blanche
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Saint Herblain, France, 44800
- Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
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Saint Herblain, France, 44800
- Hôpital Nord Laënnec- Service D'Endocrinologie
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Toulouse, France, 31054
- Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2
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Venissieux, France, 69200
- Centre de Recherche Clinique Portes Du Sud
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Bad Mergentheim, Germany, 97980
- Diabetespraxis Mergentheim
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Bad Oeynhausen, Germany, 32545
- Herz- und Diabeteszentrum NRW - Bad Oeynhausen
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Düsseldorf, Germany, 40210
- DaVita Clinical Research Deutschland GmbH
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Erlangen, Germany, 91054
- Medizinische Klinik 4, Universitätsklinikum Erlangen
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Essen, Germany, 45136
- InnoDiab Forschung Gmbh
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Essen, Germany, 45219
- Praxis Dr. med. M. Esser
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Hamburg, Germany, 22607
- Wendisch/Dahl Hamburg
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Münster, Germany, 48145
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
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Saint Ingbert-Oberwürzbach, Germany, 66386
- Zentrum für klinische Studien Alexander Segner
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Athens, Greece, 115 25
- Iatriko Psychicou Private Clinic
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Athens, Greece, GR-11527
- General Hospital of Athens "Laiko", Nephrology Clinic
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Athens, Greece, 17562
- Iatriko Athinon 'Palaiou Falirou'
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Athens, Greece, 11527
- General hospital of Athens 'G.Gennimatas'
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Lamia, Greece, 35100
- General Hospital of Lamia
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Rio, Patra, Greece, 26504
- General University Hospital of Patras,Nephrology clinic
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Thessaloniki, Greece, 54642
- General Hospital of Thessaloniki "Ippokrateio"
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Thessaloniki, Greece, GR-564 29
- Genl Hosp of Thessaloniki, Papageorgiou ,Nephrology clinic
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Thessaloniki, Greece, 54636
- AHEPA General University Hospital
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Thessaloniki, Greece, 54643
- EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
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Thessaloniki, Greece, 57001
- "Thermi" Private Hosital
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Thessaloniki, Greece, 54642
- "Ippokrateio" G.H. of Thessaloniki
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Attica
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Athens, Attica, Greece, 12462
- University Hospital of Athens ATTIKON
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Budapest, Hungary, 1076
- Péterfy Sándor utcai Kórház
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Budapest, Hungary, 1132
- MED-TIMA Kft.
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Debrecen, Hungary, 4025
- Belinus Bt.
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Debrecen, Hungary, H-4032
- Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
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Debrecen, Hungary, 4043
- Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület
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Gyula, Hungary, H-5700
- Békés Megyei Központi Kórház
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Siófok, Hungary, 8600
- Siófoki Kórház, Diabetológiai Szakrendelés
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Szombathely, Hungary, 9700
- Markusovszky Egyetemi Oktatokorhaz
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Szombathely, Hungary, H-9700
- Markusovszky Egyetemi Oktatokorhaz
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Baranya Vármegye
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Pécs, Baranya Vármegye, Hungary, 7623
- PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
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Bács-Kiskun Vármegye
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Baja, Bács-Kiskun Vármegye, Hungary, 6500
- Lausmed Kft.
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Hajdu-Bihar Varmegye
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Debrecen, Hajdu-Bihar Varmegye, Hungary, 4025
- Belinus Bt.
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Somogy Vármegye
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Siófok, Somogy Vármegye, Hungary, 8600
- Siófoki Kórház, Diabetológiai Szakrendelés
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Szabolcs-Szatmar Varmegye
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Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary, 4405
- Borbánya Praxis E.Ü. Kft.
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New Delhi, India, 110060
- Sir Ganga Ram Hospital
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Andhra Pradesh
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Guntur, Andhra Pradesh, India, 522001
- Endolife Specialty Hospitals
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Delhi
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New Delhi, Delhi, India, 110017
- Max Super Speciality Hospital, Saket
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Karnataka
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Bangalore, Karnataka, India, 560054
- Ramaiah Memorial Hospital
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Bangalore, Karnataka, India, 560092
- Lifecare Hospital and Research Centre
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Bangalore, Karnataka, India, 560060
- BGS Global Hospitals
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Kerala
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Kochi, Kerala, India, 682041
- Amrita Institute Of Medical Sciences & Research Centre
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Kozhikode, Kerala, India, 673008
- Calicut Medical College
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Maharashtra
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Mumbai, Maharashtra, India, 400012
- Seth GS medical college and KEM Hospital
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Pune, Maharashtra, India, 411030
- Poona hospital and research centre
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Tamil Nadu
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Chennai, Tamil Nadu, India, 600037
- The Madras Medical Mission
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Telangana
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Hyderabad, Telangana, India, 500012
- Osmania General Hospital
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226014
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
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Lucknow, Uttar Pradesh, India, 226003
- MV Hospital and Research Centre
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Lucknow, Uttar Pradesh, India, 226005
- Ajanta ResearchCentre
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Lucknow, Uttar Pradesh, India, 226014
- Sanjay Gandhi Postgraduate Institute of Medical Science
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West Bengal
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Kolkata, West Bengal, India, 700054
- Apollo Multispeciality Hospital, Kolkata
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Holon, Israel, 58100
- Diabetes Clinic Wolfson MC
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Jerusalem, Israel, 91120
- Diabetes Unit Hadassah Ein Karem MC
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Kfar Saba, Israel, 4428164
- Meir Medical Center
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Rehovot, Israel, 7661041
- Kaplan Medical Center_Rehovot
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Bergamo, Italy, 24127
- Azienda Ospedaliera Papa Giovanni XXIII
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Bergamo, Italy, 24127
- AO Papa Giovanni XXIII UOC malattie Endocrine 1-Diabetologia
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Milano, Italy, 20157
- Azienda Ospedaliera Luigi Sacco
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Milano, Italy, 20122
- Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia
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Roma, Italy, 00161
- Azienda Ospealiero Universitaria Policlinico Umberto I
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Roma, Italy, 00189
- Azienda Ospedaliero - Universitaria Sant'Andrea
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MI
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Milano, MI, Italy, 20132
- Istituto Scientifico San Raffaele
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PA
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Palermo, PA, Italy, 90127
- AOUPol.Giaccone UOC Malattie Endocrine,Ricambio e Nutrizione
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PI
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Pisa, PI, Italy, 56124
- Presidio Ospedaliero Cisanello
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Chiba, Japan, 271-0077
- New Tokyo Heart Clinic
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Fukui, Japan, 910-8526
- Fukui Prefectural Hospital_Fukui
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Fukuoka, Japan, 816-0864
- Fukuoka Tokushukai Hospital
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Gunma, Japan, 373-0036
- Kawada Clinic
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Hokkaido, Japan, 062-0007
- Sasaki Hospital Internal Medicine
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Hokkaido, Japan, 062-0007
- Sasaki Internal Medicine
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Ibaraki, Japan, 311-0113
- Naka Kinen Clinic
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Ibaraki,, Japan, 331-0133
- Nishiyamado Keiwa Hospital
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Ishikawa, Japan, 920-0293
- Kanazawa Medical University Hospital
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Kanagawa, Japan, 235-0045
- H.E.C Science Clinic
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Kanagawa, Japan, 232-0064
- Yokohama Minoru Clinic
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Kanagawa, Japan, 247-0055
- Shonan Takai Clinic
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Kyoto, Japan, 611-0041
- Uji Tokushukai Medical Center
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Okayama, Japan, 701-0192
- Kawasaki Medical School Hospital
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Osaka, Japan, 569-1045
- Takatsuki Red Cross Hospital
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Saitama, Japan, 336-0967
- Shimizu Clinic Fusa
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Tochigi, Japan, 323-0022
- Oyama East Clinic
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Tokyo, Japan, 113-8655
- The University of Tokyo Hospital
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Tokyo, Japan, 103-0028
- Tokyo Center Clinic
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Tokyo, Japan, 104-0031
- Fukuwa Clinic
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Tokyo, Japan, 113-8431
- Juntendo University Hospital_Tokyo
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Tokyo, Japan, 125-0054
- Kato Clinic of Internal Medicine
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Tokyo, Japan, 177-0041
- Sugawara Clinic
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Fukushima, Japan
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Koriyama-shi, Fukushima, Japan, Japan, 963-8851
- Seino Internal Medicine Clinic
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Hokkaido, Japan
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Sapporo-shi, Hokkaido, Hokkaido, Japan, Japan, 060-0062
- Manda Memorial Hospital
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Kumamoto, Japan
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Kumamoto-shi, Kumamoto, Japan, Japan, 862-0976
- Jinnouchi Hospital
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Miyazaki
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Miyazaki-shi, Miyazaki, Japan, 880-0034
- Heiwadai Hospital
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Alor Setar, Malaysia, 05460
- Hospital Sultanah Bahiyah
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Ipoh, Perak, Malaysia, 30450
- Hospital Raja Permaisuri Bainun Ipoh
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Kuching, Malaysia, 93586
- Sarawak General Hospital
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Pulau Pinang, Malaysia, 10990
- Hospital Pulau Pinang
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Serdang, Malaysia, 43000
- Hospital Serdang
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Wilayah Persekutuan Kuala Lumpur
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Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
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Hidalgo
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Actopan, Hidalgo, Mexico, 42500
- Centro de Atención al Diabetico
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Jalisco
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Guadalajara, Jalisco, Mexico, 44600
- Inst. Jaliscience de Investigacion en Diabetes y Obesidad SC
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México, D.F.
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Distrito Federal, México, D.F., Mexico, 14080
- Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab
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Mexico City, México, D.F., Mexico, 14080
- Instituto Nacional de Ciencias Médicas y Nutrición_Mexico City
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Sinaloa
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Culiacán, Sinaloa, Mexico, 80230
- Centro para el Desarrollo de la Medicina y la Asistencia
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Tamaulipas
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Ciudad Madero, Tamaulipas, Mexico, 89440
- Centro de Estudios de Investigación Metabólicos y Cardio
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Alkmaar, Netherlands, 1815 JD
- Noordwest Ziekenhuisgroep
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Almelo, Netherlands, 7609 PP
- Ziekenhuis Groep Twente Almelo
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Almere, Netherlands, 1311RL
- EB Flevo Research BV
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Amersfoort, Netherlands, 3813 TZ
- Meander Medisch Centrum
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Amsterdam, Netherlands, 1061 AE
- OLVG West
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Amsterdam, Netherlands, 1081 HV
- Amsterdam UMC Lokatie VUMC
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Arnhem, Netherlands, 6815 AD
- Rijnstate Ziekenhuis
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Hilversum, Netherlands, 1213 XZ
- Tergooi, locatie Hilversum
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Utrecht, Netherlands, 3584 CX
- Universitair Medisch Centrum Utrecht
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Bialystok, Poland, 15-351
- Osteo Medic s.c. Artur Racewicz Jerzy Supronik
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Kielce, Poland, 25-035
- NZOZ WITAMED Poradnia Diabetologiczna
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Olsztyn, Poland, 10-561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
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Radom, Poland, 26-600
- Centrum Medyczne "Diabetika"
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Szczecin, Poland, 70-111
- Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
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Warszawa, Poland, 01-192
- Synexus Polska Sp. z o.o. Oddzial w Warszawie
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Warszawa, Poland, 04-749
- Miedzyleski Szpital Specjalistyczny, Oddzial Nefrologiczny
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Zabrze, Poland, 41-800
- Prywatny Gabinet Janusz Gumprecht
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Barnaul, Russian Federation, 656045
- City Hospital #5
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Barnaul, Russian Federation, 656024
- Reg. State Budget Healthc. Inst. Regional Clinical Hospital
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Chelyabinsk, Russian Federation, 454048
- Road Clinical Hospital at station Chelyabinsk
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Kazan, Russian Federation, 420061
- PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways
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Kemerovo, Russian Federation, 650066
- SAHI Kuzbass Hospital(former Regional clinical hospital)
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Moscow, Russian Federation, 117292
- National Medical Research Center of Endocrinology
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Novosibirsk, Russian Federation, 630005
- LLC RC Medical
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Novosibirsk, Russian Federation, 630099
- Limited Law Company "Healthy Family" Medicine Center"
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Penza, Russian Federation, 440026
- Penza Regional Clinical Hospital named after N.N. Burdenko
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Saint Petersburg, Russian Federation, 194156
- Aurora MedFort LLC
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Saint-Petersburg, Russian Federation, 190121
- Joint Stock Company "Modern Medical Technologies"
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Saint-Petersburg, Russian Federation, 194156
- Limited Liability Company "Energiya Zdoroviya"
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Saint-Petersburg, Russian Federation, 194356
- Medinet LLC
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Samara, Russian Federation, 443031
- LLC "Endocrinolog"
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Saratov, Russian Federation, 410031
- SHI Saratov City Clinical Hospital #9
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Saratov, Russian Federation, 410039
- Regional clinical cardiology dispensary
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Stavropol, Russian Federation, 355035
- Regional Endocrinological Dispensary
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Ulianovsk, Russian Federation, 432063
- Ulianovsk Regional Clinical Hospital
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Voronezh, Russian Federation, 394018
- Voronezh Regional Clinical Consultive-diagnostic Centre
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Yaroslavl, Russian Federation, 150003
- Solovyev Clinical Emergency Hospital
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Yoshkar-Ola, Russian Federation, 424004
- Polyclinic #2 in Yoshkar-Ola
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Bratislava, Slovakia, 851 01
- MEDISPEKTRUM s.r.o.
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Kosice, Slovakia, 04011
- FMC - dialyzacne sluzby, s.r.o.
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Lubochna, Slovakia, 03491
- Narodny Endokrinologicky a diabetologicky ustav
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Lucenec, Slovakia, 984 01
- IN-DIA s.r.o.
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Nitra, Slovakia, 94901
- DIABETIK s.r.o.
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Presov, Slovakia, 08001
- Diabetologicka ambulancia MEDIKARD, s.r.o.
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Trebisov, Slovakia, 07501
- ARETEUS s.r.o.
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Zilina, Slovakia, 010 01
- MUDr. Jana Rociakova s.r.o., ambulancia vnutorneho lekarstva
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Zilina, Slovakia, 010 08
- FMC- dialyzacne sluzby, s.r.o.
-
Zilina, Slovakia, 01001
- MEDIVASA, s.r.o., Diabetologicka ambulancia
-
-
-
-
Gauteng
-
Benoni, Gauteng, South Africa, 1501
- Diabetes Care Centre & CDE Centre
-
Cosmo City, Gauteng, South Africa, 2188
- LCS Clinical Research Unit
-
Johannesburg, Gauteng, South Africa, 1827
- Hemant Makan
-
Johannesburg, Gauteng, South Africa, 2013
- Wits Bara Clinical Trial Site
-
Johannesburg, Gauteng, South Africa, 1818
- Soweto Clinical Trial Centre
-
-
KwaZulu-Natal
-
Durban, KwaZulu-Natal, South Africa, 4092
- Dr A Amod
-
Durban, KwaZulu-Natal, South Africa, 4092
- Precise Clinical Solutions (Pty) Ltd
-
-
Western Cape
-
Cape Town, Western Cape, South Africa, 7530
- Tiervlei Trial Centre
-
Cape Town, Western Cape, South Africa, 7925
- Prof Rayner_Division of Nephrology
-
-
-
-
-
Barcelona, Spain, 08003
- Hospital del Mar
-
Barcelona, Spain, 08035
- Hospital Vall d'Hebron
-
Burela, Spain, 27880
- Hospital Público da Mariña
-
Getafe, Spain, 28909
- Hospital Universitario de Getafe
-
Lugo, Spain, 27004
- Hospital Ribera Polusa
-
Valencia, Spain, 46010
- Hospital Clinico Universitario de Valencia
-
Valencia, Spain, 46017
- Hospital Universitario Doctor Peset
-
-
-
-
-
Bangkok, Thailand, 10330
- King Chulalongkorn Memorial Hospital_Bangkok
-
Bangkok, Thailand, 10330
- King Chulalongkorn Memorial Hospital-Division of Nephrology
-
Bangkok, Thailand, 10400
- Phramongkutklao Hospital-nephrology
-
Bangkok, Thailand, 10700
- Siriraj Hospital-Nephro
-
-
Bangkok
-
Bangkoknoi, Bangkok, Bangkok, Thailand, 10700
- Siriraj Hospital_Bangkoknoi, Bangkok
-
-
Mueang Chiang Mai District
-
Chiang Mai, Mueang Chiang Mai District, Thailand, 50200
- Maharaj Nakorn Chiang Mai Hospital
-
-
Rajathewee
-
Bangkok, Rajathewee, Thailand, 10400
- Phramongkutklao Hospital-nephrology
-
-
-
-
-
Ankara, Turkey, 06100
- Ankara Universitesi Ibni Sina Hastanesi
-
Ankara, Turkey, 06230
- Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali
-
Ankara, Turkey, 06500
- Gazi University Medical Faculty- Nephrology
-
Antalya, Turkey, 07058
- Akdeniz Universitesi Hastanesi Nefroloji Bilim Dali
-
Aydin, Turkey, 09100
- Aydin Adnan Menderes University Nephrology
-
Istanbul, Turkey, 34098
- Istanbul University Cerrahpasa Medical Faculty
-
Istanbul, Turkey, 34899
- T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi
-
Istanbul, Turkey, 34390
- Istanbul Universitesi Istanbul Tip Fakultesi- Nefroloji
-
Istanbul, Turkey, 34722
- Goztepe Egitim Arastirma Hastanesi Nefroloji
-
Izmir, Turkey, 35100
- Ege University Medical Faculty
-
Kahramanmaras, Turkey, 46040
- Kahramanmaras Sutcu Imam University
-
Kocaeli, Turkey, 41380
- Kocaeli University Nephrology Department
-
-
-
-
-
Dnipro, Ukraine, 49000
- SI "Institute of Medical and Social Problems of Disability"
-
Ivano-Frankivsk, Ukraine, 76008
- Ivano-Frankivsk Regional Clinical Hospital
-
Kharkiv, Ukraine, 61002
- CNPI "Kharkiv City Clinical Hospital #27"
-
Kharkiv, Ukraine, 61039
- SI "National Institute of Therapy n.a. L.T. Malaya of NAMSU"
-
Kyiv, Ukraine, 04114
- Institute of Endocrinology and Metabolism of AMSU
-
Poltava, Ukraine, 36039
- CI "1st City Clinical Hospital of Poltava City Council"
-
Zaporizhia, Ukraine, 69001
- CI "Zaporizhia city clinical hospital #10"
-
-
-
-
-
Aberdeen, United Kingdom, AB25 2ZN
- Aberdeen Royal Infirmary
-
Birmingham, United Kingdom, B9 5SS
- Diabetes Centre, Heartlands Hospital, Birmingham
-
Cardiff, United Kingdom, CF5 4AD
- Ely Bridge Surgery
-
Dundee, United Kingdom, DD1 9SY
- Ninewells Hospital
-
Edinburgh, United Kingdom, EH4 2XU
- Western General Hospital
-
Glasgow, United Kingdom, G31 2ER
- Glasgow Clinical Research Facility
-
Ipswich, United Kingdom, IP4 5PD
- The Diabetes Centre
-
London, United Kingdom, N18 1QX
- North Middlesex Hospital
-
London, United Kingdom, NW3 2QG
- Royal Free - Diabetes
-
Stevenage, United Kingdom, SG1 4AB
- Lister Hospital
-
Tooting, United Kingdom, SW17 0RE
- St Georges Hospital
-
-
-
-
Alabama
-
Tuscumbia, Alabama, United States, 35674
- Dr. Terence Hart
-
-
California
-
Chula Vista, California, United States, 91910
- California Inst Of Renal Res
-
Concord, California, United States, 94520
- John Muir Physician Network
-
Concord, California, United States, 94520
- John Muir Physicians Network
-
Fresno, California, United States, 93720
- Valley Research
-
La Mesa, California, United States, 91942
- California Institute of Renal Research
-
Lancaster, California, United States, 93534
- First Valley Med Grp Lancaster
-
Lincoln, California, United States, 95648
- Clinical Trials Research_Sacramento
-
Loma Linda, California, United States, 92357
- VA Loma Linda Hlthcr Sys
-
Long Beach, California, United States, 90807
- Long Beach Center For Clinical Research
-
Long Beach, California, United States, 90822
- VA Long Beach Healthcare System
-
Los Angeles, California, United States, 90022
- Academic Medical Research Institute
-
Northridge, California, United States, 91324
- Valley Renal Medical Group Research
-
Palm Springs, California, United States, 92262
- Desert Oasis Hlthcr Med Group
-
Port Hueneme, California, United States, 93041
- Saviers Medical Group
-
Rialto, California, United States, 92377
- Inland Empire Clin Trials LLC
-
Roseville, California, United States, 95661
- Sierra Clinical Research
-
San Diego, California, United States, 92123
- California Research Foundation
-
San Dimas, California, United States, 91773
- N America Res Inst - San Dimas
-
San Ramon, California, United States, 94583
- NorCal Endocrinology and Internal Medicine
-
Torrance, California, United States, 90502
- Lundquist Inst-Biomed Innovtn
-
West Hills, California, United States, 91304
- San Fernando Valley Hlth Inst
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Rocky Mount Reg VA Med-DN
-
Denver, Colorado, United States, 80246
- Creekside Endocrine Associates, PC
-
-
Florida
-
Clearwater, Florida, United States, 33756
- BayCare Medical Group - Endocrinology
-
Coral Gables, Florida, United States, 33134
- Horizon Rs Grp, Coral Gbls
-
Delray Beach, Florida, United States, 33445
- Cesar Figueroa M.D. P.A.
-
Fleming Island, Florida, United States, 32003
- Northeast Research Institute
-
Hialeah, Florida, United States, 33016
- Palmetto Medical General Plaza
-
Hollywood, Florida, United States, 33021
- Encore Medical Research LLC
-
Homestead, Florida, United States, 33032
- Homestead Associates in Research
-
Miami, Florida, United States, 33130
- Life Spring Research
-
Miami, Florida, United States, 33144
- Oceane 7 Medical & Research Center, Inc.
-
Miami, Florida, United States, 33173
- International Physicians Research
-
Miami Lakes, Florida, United States, 33016
- Floridian Clinical Research, LLC
-
Miami Lakes, Florida, United States, 33014
- San Marcus Res Clin Miami Lakes
-
Miramar, Florida, United States, 33027
- South Broward Research LLC
-
New Port Richey, Florida, United States, 34652
- Suncoast Clinical Research, Inc.
-
Port Charlotte, Florida, United States, 33952
- Hanson Clinical Research Center
-
Saint Augustine, Florida, United States, 32080
- Northeast Research Institute
-
Sarasota, Florida, United States, 34239
- Cardiovascular Ctr of Sarasota
-
Winter Haven, Florida, United States, 33880
- Clinical Research of Cent FL
-
-
Georgia
-
Alpharetta, Georgia, United States, 30022
- Ellipsis Group
-
Augusta, Georgia, United States, 30904
- Southeastern Clinical Research Institute, LLC
-
Roswell, Georgia, United States, 30076
- Endocrine Research Solutions
-
-
Idaho
-
Meridian, Idaho, United States, 83646
- Solaris Clinical Research
-
Nampa, Idaho, United States, 83686-6011
- Saltzer Medical Group Research
-
-
Illinois
-
Chicago, Illinois, United States, 60607
- Apex Medical Research Inc
-
Gurnee, Illinois, United States, 60031
- Clinical Invest Special_Gurnee
-
Gurnee, Illinois, United States, 60031
- North Suburban Nephrology LLC
-
Skokie, Illinois, United States, 60077
- Endeavor Health
-
-
Indiana
-
Valparaiso, Indiana, United States, 46383
- Velocity Clin. Res Valparaiso
-
-
Iowa
-
Council Bluffs, Iowa, United States, 51501
- West Broadway Clinic
-
-
Kentucky
-
Paducah, Kentucky, United States, 42001
- Four Rivers Clinical Research Inc
-
-
Maryland
-
Beltsville, Maryland, United States, 20705
- Metropolitan Cardiovascular Consultants, LLC
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115-5804
- Brigham & Women's Hospital
-
-
Michigan
-
Buckley, Michigan, United States, 49620
- Northern Pines Hlth Ctr, PC
-
Flint, Michigan, United States, 48504
- Aa Mrc Llc
-
Flint, Michigan, United States, 48532
- Elite Research Center
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905-0001
- Mayo Clinic
-
-
Missouri
-
Kansas City, Missouri, United States, 64111
- Clinical Research Consultants, LLC
-
Saint Louis, Missouri, United States, 63110
- Washington University_St. Louis_0
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198
- Univ of Nebraska Medical CTR
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87109
- Renal Medicine Associates
-
-
New York
-
Albany, New York, United States, 12203
- Albany Medical College - Endo
-
Mineola, New York, United States, 11501
- NYU Langone Neph Associates
-
New York, New York, United States, 10016
- NYU Nephrology Associates
-
West Seneca, New York, United States, 14224
- Southgate Medical Group, LLP
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- UNC Diabetes Care Center_Chapel Hill
-
Morehead City, North Carolina, United States, 28557
- Carteret Medical Group
-
Morganton, North Carolina, United States, 28655
- Burke Primary Care
-
New Bern, North Carolina, United States, 28562
- Eastern Nephr Assoc, PLLC
-
Whiteville, North Carolina, United States, 28472
- Whiteville Medical Associates
-
Wilmington, North Carolina, United States, 28401
- Accellacare
-
Winston-Salem, North Carolina, United States, 27103
- Brookview Hills Research Associates, LLC
-
-
Ohio
-
Cincinnati, Ohio, United States, 45220-2213
- Cincinnati Veterans Affairs Medical Center
-
Maumee, Ohio, United States, 43537
- Advanced Med Res Maumee
-
-
Oklahoma
-
Norman, Oklahoma, United States, 73069
- Alliance for Multispec Res
-
-
Pennsylvania
-
Beaver, Pennsylvania, United States, 15009
- Heritage Valley Medical Group Inc
-
Jersey Shore, Pennsylvania, United States, 17740
- Lycoming Internal Medicine, Inc.
-
Philadelphia, Pennsylvania, United States, 19114
- Northeast Endocrine Metabolic Associates
-
-
South Carolina
-
Little River, South Carolina, United States, 29566
- Main Street Physician's Care
-
Murrells Inlet, South Carolina, United States, 29576
- The Diabetes Center, LLC
-
Myrtle Beach, South Carolina, United States, 29588
- Family Medicine of SayeBrook LLC
-
Orangeburg, South Carolina, United States, 29118
- SC Nephrology and Hypertension
-
-
Tennessee
-
Bartlett, Tennessee, United States, 38133
- AM Diabetes And Endocrinology Center
-
Chattanooga, Tennessee, United States, 37411
- Univ Diab & Endo Consultants
-
Nashville, Tennessee, United States, 37232
- Vanderbilt Medical Center_Nashville
-
-
Texas
-
Austin, Texas, United States, 78705
- Central Texas Clinical Research
-
Austin, Texas, United States, 78731
- Texas Diabetes & Endocrinology, P.A._Austin
-
Austin, Texas, United States, 78751
- Research Management, Inc
-
Corpus Christi, Texas, United States, 78414
- Osvaldo A. Brusco MD PA
-
Dallas, Texas, United States, 75231
- Research Institute Of Dallas
-
Dallas, Texas, United States, 75390-9302
- UT Southwestern Med Cntr
-
Dallas, Texas, United States, 75226
- Baylor Jack and Jane Hamilton
-
El Paso, Texas, United States, 79902
- Medresearch Inc
-
El Paso, Texas, United States, 79935
- Academy of Diabetes, T&E
-
Houston, Texas, United States, 77081
- Southwest Clinical Trials
-
Houston, Texas, United States, 77099
- Southwest Houston Research Ltd
-
Houston, Texas, United States, 77074
- Juno Research, LLC_Houston
-
Houston, Texas, United States, 77040
- Juno Research, LLC_Houston
-
Rockwall, Texas, United States, 75032
- Carlos Arauz-Pacheco Md, Pa
-
San Antonio, Texas, United States, 78215
- Sun Research Institute
-
San Antonio, Texas, United States, 78230
- VIP Trials
-
San Antonio, Texas, United States, 78224
- Briggs Clinical Research, LLC
-
San Antonio, Texas, United States, 78207
- Univ Of Texas Hlth Science Cntr
-
San Antonio, Texas, United States, 78233
- NE Clin Res of San Antonio
-
Sugar Land, Texas, United States, 77478
- Simcare Medical Research, LLC
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- University of Utah School of Medicine
-
-
Vermont
-
South Burlington, Vermont, United States, 05403
- University of Vermont Medical Center
-
-
Virginia
-
Norfolk, Virginia, United States, 23504
- York Clinical Research LLC
-
Richmond, Virginia, United States, 23249
- McGuire VA Medical Center
-
Salem, Virginia, United States, 24153-6404
- VA Medical Center_Salem
-
Winchester, Virginia, United States, 22601
- Amherst Family Practice P.C.
-
-
Washington
-
Olympia, Washington, United States, 98502
- Capital Clin Res Ctr,LLC
-
Spokane, Washington, United States, 99202
- MultiCare Inst for Res & Innov
-
Tacoma, Washington, United States, 98405
- Universal Research Group
-
-
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 above or equal to 18 years at the time of signing informed consent. Japan: Male or female, age above or equal to 20 years at the time of signing informed consent
- Diagnosed with type 2 diabetes mellitus
- HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol)
Renal impairment defined either by:
- serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or
- serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g
- Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening
Exclusion Criteria:
- Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations
- Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening
- Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
- Planned coronary, carotid or peripheral artery revascularisation
- Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
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 are to receive semglutide for up to 5 years or more (event driven).
The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.
|
Participants are to inject semaglutide with a needle in the stomach, thigh or upper arm.
Participants will use a pen to inject semaglutide under their skin.
Participants will inject semaglutide 1 time a week on the same day of the week.
Participants' dose of semaglutide will be changed over time.
Participants start by taking a smaller amount (0.25 mg).
After 4 weeks the dose will be increased to 0.5 mg.
It will be increased more (to 1 mg) at 8 weeks.
Participants will then stay on the same dose for the rest of the study.
|
|
Placebo Comparator: Placebo
Participants are to receive placebo (semglutide) for up to 5 years or more (event driven).
The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.
|
Participants are to inject placebo (semaglutide) with a needle in the stomach, thigh or upper arm.
Participants will use a pen to inject placebo (semaglutide) under their skin.
Participants will inject placebo (semaglutide) 1 time a week on the same day of the week.
Participants' dose of placebo (semaglutide) will be changed over time.
Participants start by taking a smaller amount (0.25 mg).
After 4 weeks the dose will be increased to 0.5 mg.
It will be increased more (to 1 mg) at 8 weeks.
Participants will then stay on the same dose for the rest of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death
Time Frame: From Week 0 up to Week 234
|
Number of participants with first composite renal event i.e., from time of randomization to first occurrence of an onset of persistent greater than or equal to (≥) 50 percent (%) reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease - epidemiology collaboration [CKD-EPI]), onset of persistent eGFR (CKD-EPI) <15 milliliter per minute per 1.73 meter square (mL/min/1.73m^2),
initiation of chronic renal replacement therapy (dialysis or kidney transplantation), renal death, and cardiovascular (CV) death combined data were reported in this outcome measure.
|
From Week 0 up to Week 234
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)
Time Frame: From Week 0 up to Week 234
|
Annual rate of change in Total eGFR slope CKD-EPI were reported from baseline at Week 234 in-trial period.
eGFR was calculated using the CKD-EPI formula.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
From Week 0 up to Week 234
|
|
Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI)
Time Frame: From Week 0 up to Week 234
|
Number of participants from time of randomization to time to occurrence of onset of persistent ≥50% reduction in eGFR (CKD-EPI) were reported.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
From Week 0 up to Week 234
|
|
Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2
Time Frame: From Week 0 up to Week 234
|
Number of participants from time of randomization to time to occurrence of onset of persistent eGFR (CKD-EPI) <15 mL/min/1.73m^2
were reported.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
From Week 0 up to Week 234
|
|
Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy
Time Frame: From Week 0 up to Week 234
|
Number of participants from time of randomization to time to occurrence of initiation of chronic renal replacement therapy (dialysis or kidney transplantation) were reported.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
From Week 0 up to Week 234
|
|
Number of Participants From Time of Randomization to Occurrence of Renal Death
Time Frame: From Week 0 up to Week 234
|
Number of participants from time of randomization to time to occurrence of renal death were reported.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
From Week 0 up to Week 234
|
|
Number of Participants From Time of Randomization to Occurrence of CV Death
Time Frame: From Week 0 up to Week 234
|
Number of participants from time of randomization to time to occurrence of CV death were reported.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
From Week 0 up to Week 234
|
|
Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope)
Time Frame: Week 12, Week 234
|
Annual rate of change in eGFR in terms of chronic kidney disease CKD-EPI were reported from Week 12 to Week 234 in-trial period.
eGFR was calculated using the CKD-EPI formula.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
Week 12, Week 234
|
|
Change From Baseline in eGFR (CKD-EPI) at Week 12
Time Frame: Baseline (Week 0), Week 12
|
Change from baseline in eGFR at Week 12 during in-trial period were reported.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
Baseline (Week 0), Week 12
|
|
Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104
Time Frame: Baseline (Week 0), Week 104
|
Changes from baseline in eGFR (cystatin C) at Week 104 in-trial period were reported.
Cystatin C was calculated using the CKD-EPI formula.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
Baseline (Week 0), Week 104
|
|
Change From Baseline in Urinary Albumin-to-creatinine Ratio (UACR) at Week 104: Ratio to Baseline
Time Frame: Baseline (Week 0), Week 104
|
Change from baseline in UACR (ratio to baseline) at Week 104 in-trial period were reported.
For UACR, the baseline assessment is defined as the mean of the two assessments from the randomization visit.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
Baseline (Week 0), Week 104
|
|
Number of Participants From Time of Randomization to Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Acute Myocardial Infarction (Non Fatal); Non-fatal Stroke; and CV Death
Time Frame: From Week 0 up to Week 234
|
Number of participants who reported first occurence of non-fatal acute myocardial infarction, non-fatal stroke, and CV death combined data were presented from Week 0 up to Week 234 during on-treatment period.
MACE consisted of non-fatal acute myocardial infarction, cardiovascular death and non-fatal stroke.
First on-treatment period is defined as period from date of first dose until first time where no dose had been administered within 5 weeks (35 days) or end of the in-trial period, whichever came first.
|
From Week 0 up to Week 234
|
|
Number of Participants From Time of Randomization to Time to Occurrence of All-cause Death
Time Frame: From Week 0 up to Week 234
|
Number of participants who reported occurence of deaths from Week 0 up to Week 234 during in-trial period were presented.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
From Week 0 up to Week 234
|
|
Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Myocardial Infarction
Time Frame: From Week 0 up to Week 234
|
Number of participants who reported occurrence of non-fatal acute myocardial infarction from Week 0 up to Week 234 during in-trial period were presented.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
From Week 0 up to Week 234
|
|
Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Stroke
Time Frame: From Week 0 up to Week 234
|
Number of participants who reported occurrence of non-fatal stroke from Week 0 up to Week 234 during in-trial period were presented.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
From Week 0 up to Week 234
|
|
Number of Participants From Time of Randomization to Time to First Occurrence of Major Adverse Limb Events (MALE): Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization
Time Frame: From Week 0 up to Week 234
|
Number of participants with combined data of first occurence of acute limb ischaemia hospitalization and chronic limb ischaemia hospitalization from Week 0 up to Week 234 during on-treatment period were presented.
MALE consisted of acute and chronic limb ischaemia hospitalisation.
|
From Week 0 up to Week 234
|
|
Number of Participants With Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization
Time Frame: From Week 0 up to Week 234
|
Number of participants of acute limb ischaemia hospitalization and chronic limb ischaemia hospitalization from Week 0 up to Week 234 during in-trial period were presented.
MALE consisted of acute and chronic limb ischaemia hospitalisation.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
From Week 0 up to Week 234
|
|
Change From Baseline in Body Weight at Week 104
Time Frame: Baeline (Week 0), Week 104
|
Change in body weight from Week 0 up to Week 104 during in-trial period, measured in kilograms, were presented.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
Baeline (Week 0), Week 104
|
|
Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 104
Time Frame: Baseline (Week 0), Week 104
|
Change in HbA1c from Week 0 to Week 104 during in-trial period, measured in percentage point of HbA1c, were presented.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
Baseline (Week 0), Week 104
|
|
Change From Baseline in Systolic Blood Pressure at Week 104
Time Frame: Baseline (Week 0), Week 104
|
Change in systolic blood pressure from Week 0 to Week 104 during in-trial period were presented.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
Baseline (Week 0), Week 104
|
|
Change From Baseline in Diastolic Blood Pressure at Week 104
Time Frame: Baseline (Week 0), Week 104
|
Change in diastolic blood pressure from Week 0 to Week 104 during in-trial period were reported.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
Baseline (Week 0), Week 104
|
|
Number of Severe Hypoglycaemic Episodes
Time Frame: From Week 0 up to Week 234
|
The number of severe hypoglycaemic episodes (such as the seriousness of hypoglycaemia, contributing factors, seizures, and unconsciousness; classified by American Diabetes Association) observed during the in-trial period were reported in this endpoint.
In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.
|
From Week 0 up to Week 234
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cohen S, Sternlicht H, Bakris GL. Mineralocorticoid Receptor Antagonists in the Treatment of Diabetic Kidney Disease: Their Application in the Era of SGLT2 Inhibitors and GLP-1 Receptor Agonists. Curr Diab Rep. 2022 May;22(5):213-218. doi: 10.1007/s11892-022-01461-4. Epub 2022 Apr 20.
- Rossing P, Baeres FMM, Bakris G, Bosch-Traberg H, Gislum M, Gough SCL, Idorn T, Lawson J, Mahaffey KW, Mann JFE, Mersebach H, Perkovic V, Tuttle K, Pratley R. The rationale, design and baseline data of FLOW, a kidney outcomes trial with once-weekly semaglutide in people with type 2 diabetes and chronic kidney disease. Nephrol Dial Transplant. 2023 Aug 31;38(9):2041-2051. doi: 10.1093/ndt/gfad009. Erratum In: Nephrol Dial Transplant. 2024 Mar 27;39(4):724. doi: 10.1093/ndt/gfad252.
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)
June 17, 2019
Primary Completion (Actual)
January 9, 2024
Study Completion (Actual)
January 9, 2024
Study Registration Dates
First Submitted
January 18, 2019
First Submitted That Met QC Criteria
January 25, 2019
First Posted (Actual)
January 28, 2019
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 13, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Endocrine System Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Metabolic Diseases
- Glucose Metabolism Disorders
- Renal Insufficiency
- Diabetes Mellitus, Type 2
- Diabetes Mellitus
- Kidney Diseases
- Renal Insufficiency, Chronic
- Glucagon-Like Peptide-1 Receptor Agonists
- Physiological Effects of Drugs
- Hypoglycemic Agents
- Semaglutide
Other Study ID Numbers
- NN9535-4321
- U1111-1217-6259 (Other Identifier: World Health Organization (WHO))
- 2018-002878-50 (Registry Identifier: European Medicines Agency (EudraCT))
- JapicCTI-194843 (Registry Identifier: JAPIC (Japan))
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.