A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease

Diabetes Mellitus, Type 2 Clinical Trial

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Official title:

Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03819153
• Other study ID #: NN9535-4321
• Secondary ID: U1111-1217-62592
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 17, 2019
• Est. completion date: August 19, 2024

Study information

• Verified date: June 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3508
• Est. completion date: August 19, 2024
• Est. primary completion date: August 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. 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

2. 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Semaglutide
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 (semaglutide)
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.

Locations

Country	Name	City	State
Argentina	Centro Diabetológico y Nuticional Dr Alejandro Chertkoff	Buenos Aires
Argentina	Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli	Buenos Aires
Argentina	Centro de Investigación Clínica	Caba
Argentina	FEPREVA	Caba
Argentina	Glenny Corp. S.A	Caba
Argentina	Medical Center of Diabetes and Nutrition	Caba
Argentina	Centro de Estudios Renales e Hipertensión Arterial	Villa Dominico	Buenos Aires
Australia	Monash Health Nephrology	Clayton	Victoria
Australia	St Vincent's Hospital_Fitzroy_0	Fitzroy	Victoria
Australia	Gosford Renal Research	Gosford	New South Wales
Australia	Monash University Clinical Trial Centre	Melbourne	Victoria
Australia	Core Research Centre	Milton	Queensland
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Westmead Hospital_Northmead	Westmead	New South Wales
Belgium	Imeldaziekenhuis - Bonheiden - Department of Endocrinology	Bonheiden
Belgium	Universitair Ziekenhuis Brussel - Diabeteskliniek	Brussel
Belgium	Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie	Bruxelles
Belgium	UZA - UZ Antwerpen - Department of Endocrinology	Edegem
Belgium	UZ Gent - Endocrinologie - Diabetologie	Gent
Belgium	UZ Leuven - Endocrinology	Leuven
Belgium	Centre hospitalier universitaire de Liège (CHU de Liège)	Liège
Belgium	AZ Delta - Roeselare - Diabeteskliniek	Roeselare
Brazil	Centro Médico Hospital da Bahia	Bahia
Brazil	Instituto Pró-Renal Brasil	Curitiba	Parana
Brazil	Instituto de Ensino e Pesquisa Clínica do Ceará Ltda	Fortaleza	Ceara
Brazil	Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital e Maternidade Dr. Christovão da Gama S.A.	Santo André	Sao Paulo
Brazil	CPCLIN - Centro de Pesquisas Clínicas	São Paulo	Sao Paulo
Brazil	CPQuali Pesquisa Clínica Ltda	São Paulo	Sao Paulo
Brazil	Instituto de Pesquisa Clinica (IPEC)	São Paulo	Sao Paulo
Bulgaria	Medical centre "Zdrave 1" OOD	Kozloduy
Bulgaria	UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases	Plovdiv
Bulgaria	MHAT "Dr. Ivan Seliminski"-Sliven	Sliven
Bulgaria	"Nader Yabrudi - ASMPVBE Individual practice"	Smolyan
Bulgaria	Medical Center Synexus Sofia	Sofia
Bulgaria	UMHAT Aleksandrovska	Sofia
Bulgaria	Medical Center "Nov Rehabilitatsionen center" EOOD	Stara Zagora
Canada	Aggarwal and Assoc Ltd.	Brampton	Ontario
Canada	Dr. Harpreet Bajaj	Brampton	Ontario
Canada	JBN Medical Diagnostic Services Inc.	Burlington	Ontario
Canada	LMC Clin Res Inc. Calgary	Calgary	Alberta
Canada	University of Calgary	Calgary	Alberta
Canada	LMC Clin Res Inc. Thornhill	Concord	Ontario
Canada	LMC Endo Ctr (Etobicoke) Ltd	Etobicoke	Ontario
Canada	QE II Health - Pharmacy	Halifax	Nova Scotia
Canada	Hamilton Med Res Group	Hamilton	Ontario
Canada	Ctr de rech Clin de Laval	Laval	Quebec
Canada	Milestone Research	London	Ontario
Canada	Applied Med Inf Res	Montreal	Quebec
Canada	Centre Medical Acadie	Montreal	Quebec
Canada	Clinique de Recherche Medpharmgene Inc.	Montreal	Quebec
Canada	Commonwealth Medical Clinic	Mount Pearl	Newfoundland and Labrador
Canada	LMC Research Inc. Ottawa	Nepean	Ontario
Canada	Dr. James Cha	Oshawa	Ontario
Canada	King Street Research	Oshawa	Ontario
Canada	Lakeridge Health	Oshawa	Ontario
Canada	Centre de Recherche Saint-Louis	Quebec
Canada	The Bailey Clinic	Red Deer	Alberta
Canada	Bluewater Clin Res Group, Inc.	Sarnia	Ontario
Canada	Bluewater Clin Res Group,Inc	Sarnia	Ontario
Canada	Eastern Health Authority	St. Johns	Newfoundland and Labrador
Canada	Winterberry Family Medicine	Stoney Creek	Ontario
Canada	Dr Anil K Gupta Med Prof Corp	Toronto	Ontario
Canada	Dr. Anil K Gupta Med Prof Corp	Toronto	Ontario
Canada	LMC Endo Centres Ltd.(Bayview)	Toronto	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	UHN-Toronto General Hospital	Toronto	Ontario
Canada	BC Diabetes Canada	Vancouver	British Columbia
China	Beijing Pinggu Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Jinan Central Hospital	Ji'nan	Shandong
China	The Affiliated Hospital of Jiangsu University_Zhenjiang	Zhenjiang	Jiangsu
France	Centre Hospitalier Ardeche Nord	Annonay cedex
France	Hospices Civils de Lyon-Hopital Cardiologique Louis Pradel-2	BRON cedex
France	Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre-1	Caen
France	Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-2	Grenoble - Cédex 09
France	Centre Hospitalier Departemental Vendee- La Roche Sur Yon	La Roche-sur-yon
France	Les Hopitaux de Chartres-Hopital Louis Pasteur	Le Coudray
France	Groupe SOS Santé Hôtel Dieu	Le Creusot
France	Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1	Le Creusot
France	Fondation Rothschild	Paris
France	Centre Hospitalier Universitaire Reims-Hopital Maison Blanche	Reims
France	Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1	Saint Herblain
France	Hôpital Nord Laënnec- Service D'Endocrinologie	Saint Herblain
France	Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2	Toulouse
France	Groupe Hospitalier Mutualiste Des Portes Du Sud	Venissieux
Germany	Diabetespraxis Mergentheim	Bad Mergentheim
Germany	Dr. med. Young Hee Lee Barkey	Bad Oeynhausen
Germany	DaVita Clinical Research Deutschland GmbH	Düsseldorf
Germany	Medizinische Klinik 4, Universitätsklinikum Erlangen	Erlangen
Germany	InnoDiab Forschung GmbH	Essen
Germany	Praxis Dr. med. M. Esser	Essen
Germany	Wendisch/Dahl Hamburg	Hamburg
Germany	Institut für Diabetesforschung GmbH Münster - Dr. med. Rose	Münster
Germany	Zentrum für klinische Studien Alexander Segner	Saint Ingbert-Oberwürzbach
Greece	General Hospital of Athens "Laiko", Nephrology Clinic	Athens
Greece	General hospital of Athens 'G.Gennimatas'	Athens
Greece	Iatriko Athinon 'Palaiou Falirou'	Athens
Greece	Iatriko Psychicou Private Clinic	Athens
Greece	University Hospital of Athens ATTIKON	Haidari-Athens	Attica
Greece	General Hospital of Lamia	Lamia
Greece	General University Hospital of Patras,Nephrology clinic	Rio, Patra
Greece	"Ippokrateio" G.H. of Thessaloniki	Thessaloniki
Greece	"Thermi" Private Hosital	Thessaloniki
Greece	AHEPA General University Hospital	Thessaloniki
Greece	EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes	Thessaloniki
Greece	General Hospital of Thessaloniki "Ippokrateio"	Thessaloniki
Greece	Genl Hosp of Thessaloniki, Papageorgiou ,Nephrology clinic	Thessaloniki
Hungary	Lausmed Kft.	Baja	Bács-Kiskun Vármegye
Hungary	MED-TIMA Kft.	Budapest
Hungary	Péterfy Sándor utcai Kórház	Budapest
Hungary	Belinus Bt.	Debrecen
Hungary	Belinus Bt.	Debrecen	Hajdu-Bihar Varmegye
Hungary	Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika	Debrecen
Hungary	Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület	Debrecen
Hungary	Békés Megyei Központi Kórház	Gyula
Hungary	Borbánya Praxis E.Ü. Kft.	Nyíregyháza	Szabolcs-Szatmar Varmegye
Hungary	PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum	Pécs	Baranya Vármegye
Hungary	Siófoki Kórház, Diabetológiai Szakrendelés	Siófok	Somogy Vármegye
Hungary	Siófoki Kórház, Diabetológiai Szakrendelés	Siófok
Hungary	Markusovszky Egyetemi Oktatókórház	Szombathely
India	BGS Global Hospitals	Bangalore	Karnataka
India	Lifecare Hospital and Research Centre	Bangalore	Karnataka
India	Ramaiah Memorial Hospital	Bangalore	Karnataka
India	The Madras Medical Mission	Chennai	Tamil Nadu
India	Endolife Specialty Hospitals	Guntur	Andhra Pradesh
India	Osmania General Hospital	Hyderabad	Telengana
India	Amrita Institute Of Medical Sciences & Research Centre	Kochi	Kerala
India	Apollo Multispeciality Hospital, Kolkata	Kolkata	West Bengal
India	Calicut Medical College	Kozhikode	Kerala
India	Ajanta ResearchCentre	Lucknow	Uttar Pradesh
India	MV Hospital and Research Centre	Lucknow	Uttar Pradesh
India	Sanjay Gandhi Postgraduate Institute of Medical Science	Lucknow	Uttar Pradesh
India	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Lucknow	Uttar Pradesh
India	Seth GS medical college and KEM Hospital	Mumbai	Maharashtra
India	Max Super Speciality Hospital, Saket	New Delhi	Delhi
India	Sir Ganga Ram Hospital	New Delhi
India	Poona hospital and research centre	Pune	Maharashtra
Israel	Diabetes Clinic Wolfson MC	Holon
Israel	Diabetes Unit Hadassah Ein Karem MC	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Kaplan Medical Center_Rehovot	Rehovot
Italy	AO Papa Giovanni XXIII UOC malattie Endocrine 1-Diabetologia	Bergamo
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	Azienda Ospedaliera Luigi Sacco	Milano
Italy	Istituto Scientifico San Raffaele	Milano	MI
Italy	Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia	Milano
Italy	AOUPol.Giaccone UOC Malattie Endocrine,Ricambio e Nutrizione	Palermo	PA
Italy	Presidio Ospedaliero Cisanello	Pisa	PI
Italy	Azienda Ospealiero Universitaria Policlinico Umberto I	Roma
Italy	Azienda Ospedaliero - Universitaria Sant'Andrea	Roma
Japan	New Tokyo Heart Clinic	Chiba
Japan	Fukui Prefectural Hospital_Fukui	Fukui
Japan	Fukuoka Tokushukai Hospital	Fukuoka
Japan	Kawada Clinic	Gunma
Japan	Sasaki Hospital Internal Medicine	Hokkaido
Japan	Naka Kinen Clinic	Ibaraki
Japan	Nishiyamado Keiwa Hospital	Ibaraki,
Japan	Kanazawa Medical University Hospital	Ishikawa
Japan	H.E.C Science Clinic	Kanagawa
Japan	Shonan Takai Clinic	Kanagawa
Japan	Yokohama Minoru Clinic	Kanagawa
Japan	Seino Internal Medicine Clinic	Koriyama-shi	Fukushima, Japan
Japan	Jinnouchi Hospital	Kumamoto-shi	Kumamoto, Japan
Japan	Uji Tokushukai Medical Center	Kyoto
Japan	Heiwadai Hospital	Miyazaki-shi	Miyazaki
Japan	Kawasaki Medical School Hospital	Okayama
Japan	Takatsuki Red Cross Hospital	Osaka
Japan	Shimizu Clinic Fusa	Saitama
Japan	Manda Memorial Hospital	Sapporo-shi, Hokkaido	Hokkaido, Japan
Japan	Oyama East Clinic	Tochigi
Japan	Fukuwa Clinic	Tokyo
Japan	Juntendo University Hospital_Tokyo	Tokyo
Japan	Kato Clinic of Internal Medicine	Tokyo
Japan	Sugawara Clinic	Tokyo
Japan	The University of Tokyo Hospital	Tokyo
Japan	Tokyo Center Clinic	Tokyo
Malaysia	Hospital Sultanah Bahiyah	Alor Setar
Malaysia	Hospital Raja Permaisuri Bainun Ipoh	Ipoh, Perak
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	Sarawak General Hospital	Kuching
Malaysia	Hospital Pulau Pinang	Pulau Pinang
Malaysia	Hospital Serdang	Serdang
Mexico	Centro de Atención al Diabetico	Actopan	Hidalgo
Mexico	Centro de Estudios de Investigación Metabólicos y Cardio	Ciudad Madero	Tamaulipas
Mexico	Centro para el Desarrollo de la Medicina y la Asistencia	Culiacán	Sinaloa
Mexico	Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab	Distrito Federal	México, D.F.
Mexico	Inst. Jaliscience de Investigacion en Diabetes y Obesidad SC	Guadalajara	Jalisco
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición_Mexico City	Mexico City	México, D.F.
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Ziekenhuis Groep Twente Almelo	Almelo
Netherlands	EB Flevo Research BV	Almere
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	Amsterdam UMC Lokatie VUMC	Amsterdam
Netherlands	OLVG West	Amsterdam
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	Tergooi, locatie Hilversum	Hilversum
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Poland	Osteo Medic s.c. Artur Racewicz Jerzy Supronik	Bialystok
Poland	NZOZ WITAMED Poradnia Diabetologiczna	Kielce
Poland	Wojewodzki Szpital Specjalistyczny w Olsztynie	Olsztyn
Poland	Centrum Medyczne "Diabetika"	Radom
Poland	Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie	Szczecin
Poland	Miedzyleski Szpital Specjalistyczny, Oddzial Nefrologiczny	Warszawa
Poland	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa
Poland	Prywatny Gabinet Janusz Gumprecht	Zabrze
Russian Federation	City Hospital #5	Barnaul
Russian Federation	Reg. State Budget Healthc. Inst. Regional Clinical Hospital	Barnaul
Russian Federation	Road Clinical Hospital at station Chelyabinsk	Chelyabinsk
Russian Federation	PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways	Kazan
Russian Federation	SAHI Kuzbass Hospital(former Regional clinical hospital)	Kemerovo
Russian Federation	National Medical Research Center of Endocrinology	Moscow
Russian Federation	Limited Law Company "Healthy Family" Medicine Center"	Novosibirsk
Russian Federation	LLC RC Medical	Novosibirsk
Russian Federation	Penza Regional Clinical Hospital named after N.N. Burdenko	Penza
Russian Federation	Aurora MedFort LLC	Saint Petersburg
Russian Federation	Joint Stock Company "Modern Medical Technologies"	Saint-Petersburg
Russian Federation	Limited Liability Company "Energiya Zdoroviya"	Saint-Petersburg
Russian Federation	Medinet LLC	Saint-Petersburg
Russian Federation	LLC "Endocrinolog"	Samara
Russian Federation	Regional clinical cardiology dispensary	Saratov
Russian Federation	SHI Saratov City Clinical Hospital #9	Saratov
Russian Federation	Regional Endocrinological Dispensary	Stavropol
Russian Federation	Ulianovsk Regional Clinical Hospital	Ulianovsk
Russian Federation	Voronezh Regional Clinical Consultive-diagnostic Centre	Voronezh
Russian Federation	Solovyev Clinical Emergency Hospital	Yaroslavl
Russian Federation	Polyclinic #2 in Yoshkar-Ola	Yoshkar-Ola
Slovakia	MEDISPEKTRUM s.r.o.	Bratislava
Slovakia	FMC - dialyzacne sluzby, s.r.o.	Kosice
Slovakia	Narodny Endokrinologicky a diabetologicky ustav	Lubochna
Slovakia	IN-DIA s.r.o.	Lucenec
Slovakia	DIABETIK s.r.o.	Nitra
Slovakia	Diabetologicka ambulancia MEDIKARD, s.r.o.	Presov
Slovakia	ARETEUS s.r.o.	Trebisov
Slovakia	FMC- dialyzacne sluzby, s.r.o.	Zilina
Slovakia	MEDIVASA, s.r.o., Diabetologicka ambulancia	Zilina
Slovakia	MUDr. Jana Rociakova s.r.o., ambulancia vnutorneho lekarstva	Zilina
South Africa	Diabetes Care Centre & CDE Centre	Benoni	Gauteng
South Africa	FARMOVS (Pty) LTD	Bloemfontein	Free State
South Africa	Prof Rayner	Cape Town	Western Cape
South Africa	Tiervlei Trial Centre	Cape Town	Western Cape
South Africa	LCS Clinical Research Unit	Cosmo City	Gauteng
South Africa	Dr A Amod	Durban	KwaZulu-Natal
South Africa	Precise Clinical Solutions (Pty) Ltd	Durban	KwaZulu-Natal
South Africa	Hemant Makan	Johannesburg	Gauteng
South Africa	Soweto Clinical Trial Centre	Johannesburg	Gauteng
South Africa	Wits Bara Clinical Trial Site	Johannesburg	Gauteng
Spain	Hospital del Mar	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Público da Mariña	Burela
Spain	Hospital Universitario de Getafe	Getafe
Spain	Hospital Ribera Polusa	Lugo
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario Doctor Peset	Valencia
Thailand	King Chulalongkorn Memorial Hospital-Division of Nephrology	Bangkok
Thailand	King Chulalongkorn Memorial Hospital_Bangkok	Bangkok
Thailand	Phramongkutklao Hospital-nephrology	Bangkok
Thailand	Siriraj Hospital-Nephro	Bangkok
Thailand	Siriraj Hospital_Bangkoknoi, Bangkok	Bangkoknoi, Bangkok	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai	Mueang Chiang Mai District
Turkey	Ankara Universitesi Ibni Sina Hastanesi	Ankara
Turkey	Gazi University Medical Faculty- Nephrology	Ankara
Turkey	Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali	Ankara
Turkey	Akdeniz Universitesi Hastanesi Nefroloji Bilim Dali	Antalya
Turkey	Aydin Adnan Menderes University Nephrology	Aydin
Turkey	Goztepe Egitim Arastirma Hastanesi Nefroloji	Istanbul
Turkey	Istanbul Universitesi Istanbul Tip Fakultesi- Nefroloji	Istanbul
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul
Turkey	T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Ege University Medical Faculty	Izmir
Turkey	Kahramanmaras Sutcu Imam University	Kahramanmaras
Turkey	Kocaeli University Nephrology Department	Kocaeli
Ukraine	SI "Institute of Medical and Social Problems of Disability"	Dnipro
Ukraine	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivsk
Ukraine	CNPI "Kharkiv City Clinical Hospital #27"	Kharkiv
Ukraine	SI "National Institute of Therapy n.a. L.T. Malaya of NAMSU"	Kharkiv
Ukraine	Institute of Endocrinology and Metabolism of AMSU	Kyiv
Ukraine	CI "1st City Clinical Hospital of Poltava City Council"	Poltava
Ukraine	CI "Zaporizhia city clinical hospital #10"	Zaporizhia
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Diabetes Centre, Heartlands Hospital, Birmingham	Birmingham
United Kingdom	Ely Bridge Surgery	Cardiff
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Glasgow Clinical Research Facility	Glasgow
United Kingdom	The Diabetes Centre	Ipswich
United Kingdom	North Middlesex Hospital	London
United Kingdom	Royal Free - Diabetes	London
United Kingdom	Lister Hospital	Stevenage
United Kingdom	St Georges Hospital	Tooting
United States	Albany Medical College - Endo	Albany	New York
United States	Renal Medicine Associates	Albuquerque	New Mexico
United States	Ellipsis Group	Alpharetta	Georgia
United States	Southeastern Clinical Research Institute, LLC	Augusta	Georgia
United States	Rocky Mount Reg VA Med-DN	Aurora	Colorado
United States	Central Texas Clinical Research	Austin	Texas
United States	Research Management, Inc	Austin	Texas
United States	Texas Diabetes & Endocrinology, P.A._Austin	Austin	Texas
United States	AM Diabetes And Endocrinology Center	Bartlett	Tennessee
United States	Heritage Valley Medical Group Inc	Beaver	Pennsylvania
United States	Metropolitan Cardiovascular Consultants, LLC	Beltsville	Maryland
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Northern Pines Hlth Ctr, PC	Buckley	Michigan
United States	UNC Diabetes Care Center_Chapel Hill	Chapel Hill	North Carolina
United States	Univ Diab & Endo Consultants	Chattanooga	Tennessee
United States	Apex Medical Research Inc	Chicago	Illinois
United States	California Inst Of Renal Res	Chula Vista	California
United States	Cincinnati Veterans Affairs Medical Center	Cincinnati	Ohio
United States	BayCare Medical Group - Endocrinology	Clearwater	Florida
United States	John Muir Physician Network	Concord	California
United States	John Muir Physicians Network	Concord	California
United States	Horizon Rs Grp, Coral Gbls	Coral Gables	Florida
United States	Osvaldo A. Brusco MD PA	Corpus Christi	Texas
United States	West Broadway Clinic	Council Bluffs	Iowa
United States	Baylor Jack and Jane Hamilton	Dallas	Texas
United States	Research Institute Of Dallas	Dallas	Texas
United States	UT Southwestern Med Cntr	Dallas	Texas
United States	Cesar Figueroa M.D. P.A.	Delray Beach	Florida
United States	Creekside Endocrine Associates, PC	Denver	Colorado
United States	Academy of Diabetes, Thyroid & Endocrine, P.A.	El Paso	Texas
United States	MedResearch Inc	El Paso	Texas
United States	Northeast Research Institute	Fleming Island	Florida
United States	Aa Mrc Llc	Flint	Michigan
United States	Elite Research Center	Flint	Michigan
United States	Valley Research	Fresno	California
United States	Clinical Invest Special_Gurnee	Gurnee	Illinois
United States	North Suburban Nephrology LLC	Gurnee	Illinois
United States	Palmetto Medical General Plaza	Hialeah	Florida
United States	Encore Medical Research LLC	Hollywood	Florida
United States	Homestead Associates In Research	Homestead	Florida
United States	Juno Research, LLC_Houston	Houston	Texas
United States	Juno Research, LLC_Houston	Houston	Texas
United States	Southwest Clinical Trials	Houston	Texas
United States	Southwest Houston Research Ltd	Houston	Texas
United States	Lycoming Internal Medicine, Inc.	Jersey Shore	Pennsylvania
United States	Clinical Research Consultants, LLC	Kansas City	Missouri
United States	California Institute of Renal Research	La Mesa	California
United States	First Valley Med Grp Lancaster	Lancaster	California
United States	Clinical Trials Research_Sacramento	Lincoln	California
United States	Main Street Physician's Care	Little River	South Carolina
United States	VA Loma Linda Hlthcr Sys	Loma Linda	California
United States	Long Beach Center For Clinical Research	Long Beach	California
United States	VA Long Beach Healthcare System	Long Beach	California
United States	Academic Medical Research Institute	Los Angeles	California
United States	Advanced Med Res Maumee	Maumee	Ohio
United States	Solaris Clinical Research	Meridian	Idaho
United States	International Physicians Research	Miami	Florida
United States	Life Spring Research	Miami	Florida
United States	Oceane 7 Medical & Research Center, Inc.	Miami	Florida
United States	Floridian Clinical Research, LLC	Miami Lakes	Florida
United States	San Marcus Res Clin Miami Lakes	Miami Lakes	Florida
United States	NYU Langone Neph Associates	Mineola	New York
United States	South Broward Research LLC	Miramar	Florida
United States	Carteret Medical Group	Morehead City	North Carolina
United States	Burke Primary Care	Morganton	North Carolina
United States	The Diabetes Center, LLC	Murrells Inlet	South Carolina
United States	Family Medicine of SayeBrook LLC	Myrtle Beach	South Carolina
United States	Saltzer Medical Group Research	Nampa	Idaho
United States	Vanderbilt Medical Center_Nashville	Nashville	Tennessee
United States	Eastern Nephr Assoc, PLLC	New Bern	North Carolina
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	NYU Nephrology Associates	New York	New York
United States	York Clinical Research LLC	Norfolk	Virginia
United States	Alliance for Multispec Res	Norman	Oklahoma
United States	Valley Renal Medical Group Research	Northridge	California
United States	Capital Clin Res Ctr,LLC	Olympia	Washington
United States	Univ of Nebraska Medical CTR	Omaha	Nebraska
United States	SC Nephrology and Hypertension	Orangeburg	South Carolina
United States	Four Rivers Clinical Research Inc	Paducah	Kentucky
United States	Desert Oasis Hlthcr Med Group	Palm Springs	California
United States	Northeast Endocrine Metabolic Associates	Philadelphia	Pennsylvania
United States	Hanson Clinical Research Center	Port Charlotte	Florida
United States	Saviers Medical Group	Port Hueneme	California
United States	Inland Empire Clin Trials LLC	Rialto	California
United States	McGuire VA Medical Center	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Carlos Arauz-Pacheco Md, Pa	Rockwall	Texas
United States	Sierra Clinical Research	Roseville	California
United States	Endocrine Research Solutions	Roswell	Georgia
United States	Northeast Research Institute	Saint Augustine	Florida
United States	Washington University_St. Louis_0	Saint Louis	Missouri
United States	VA Medical Center_Salem	Salem	Virginia
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	Briggs Clinical Research, LLC	San Antonio	Texas
United States	NE Clin Res of San Antonio	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Univ Of Texas Hlth Science Cntr	San Antonio	Texas
United States	VIP Trials	San Antonio	Texas
United States	California Research Foundation	San Diego	California
United States	N America Res Inst - San Dimas	San Dimas	California
United States	NorCal Endocrinology and Internal Medicine	San Ramon	California
United States	Cardiovascular Ctr of Sarasota	Sarasota	Florida
United States	NorthShore Univ Hlth Sys	Skokie	Illinois
United States	University of Vermont Medical Center	South Burlington	Vermont
United States	MultiCare Inst for Res & Innov	Spokane	Washington
United States	Simcare Medical Research, LLC	Sugar Land	Texas
United States	Universal Research Group	Tacoma	Washington
United States	Lundquist Inst-Biomed Innovtn	Torrance	California
United States	Dr. Terence Hart	Tuscumbia	Alabama
United States	Velocity Clin. Res Valparaiso	Valparaiso	Indiana
United States	San Fernando Valley Hlth Inst	West Hills	California
United States	Southgate Medical Group, LLP	West Seneca	New York
United States	Whiteville Medical Associates	Whiteville	North Carolina
United States	Accellacare	Wilmington	North Carolina
United States	Amherst Family Practice P.C.	Winchester	Virginia
United States	Brookview Hills Research Associates, LLC	Winston-Salem	North Carolina
United States	Clinical Research of Central Florida_Winter Haven	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Malaysia,  Mexico,  Netherlands,  Poland,  Russian Federation,  Slovakia,  South Africa,  Spain,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first occurrence of a composite primary outcome event defined as persistent eGFR decline of greater than or equal to 50 percentage from trial start, reaching ESRD, death from kidney disease or death from cardiovascular disease	Measured in month(s). End Stage Renal Disease (ESRD) is defined as the following individual components: Persistent estimated glomerular filtration rate (eGFR) less than 15 mL/min/1.73m^2 or, Chronic dialysis treatment or receiving a kidney transplantation.	Week 0 to month 61
Secondary	Annual rate of change in eGFR (chronic kidney disease - epidemiology collaboration (CKD-EPI)) (total eGFR slope)	Measured in (mL/min/1.73 m^2)/year.	Week 0 to month 61
Secondary	Time to first occurrence of a composite cardiovascular major adverse cardiovascular event (MACE) endpoint consisting of: Non-fatal myocardial infarction, non-fatal stroke, and cardiovascular (CV) death	Measured in month(s).	Week 0 to month 61
Secondary	Time to occurrence of all-cause death	Measured in month(s).	Week 0 to month 61
Secondary	Time to occurrence of each of the individual components of the primary composite endpoint and of the confirmatory secondary MACE endpoint	Measured in month(s).	Week 0 to month 61
Secondary	Time to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of: Acute limb ischemia hospitalisation and chronic limb ischemia hospitalisation	Measured in month(s).	Week 0 to month 61
Secondary	Annual rate of change in eGFR (CKD-EPI) (chronic eGFR slope)	Measured in (mL/min/1.73 m^2)/year.	Week 12 to month 61
Secondary	Change in eGFR (CKD-EPI)	Measured in mL/min/1.73 m^2.	Week 0, Week 12
Secondary	Change in eGFR (cystatin C CKD-EPI)	Measured in mL/min/1.73 m^2.	Week 0, Year 3
Secondary	Relative change in urinary albumin-to-creatinine ratio (UACR)	Measured in percentage.	Week 0, Year 3
Secondary	Change in body weight	Measured in kilogram.	Week 0, Year 3
Secondary	Change in glycosylated haemoglobin (HbA1c)	Measured in percentage point.	Week 0, Year 3
Secondary	Change in systolic blood pressure	Measured in mmHg.	Week 0, Year 3
Secondary	Change in diastolic blood pressure	Measured in mmHg.	Week 0, Year 3
Secondary	Number of severe hypoglycaemic episodes	Number of events.	Week 0 to month 61