A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
NCT ID: NCT03819153
Last Updated: 2025-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3533 participants
INTERVENTIONAL
2019-06-17
2024-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Dr. Terence Hart
Tuscumbia, Alabama, United States
California Inst Of Renal Res
Chula Vista, California, United States
John Muir Physician Network
Concord, California, United States
John Muir Physicians Network
Concord, California, United States
Valley Research
Fresno, California, 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
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
Valley Renal Medical Group Research
Northridge, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
Saviers Medical Group
Port Hueneme, California, United States
Inland Empire Clin Trials LLC
Rialto, California, United States
Sierra Clinical Research
Roseville, California, 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
Lundquist Inst-Biomed Innovtn
Torrance, California, United States
San Fernando Valley Hlth Inst
West Hills, California, United States
Rocky Mount Reg VA Med-DN
Aurora, Colorado, United States
Creekside Endocrine Associates, PC
Denver, Colorado, United States
BayCare Medical Group - Endocrinology
Clearwater, Florida, United States
Horizon Rs Grp, Coral Gbls
Coral Gables, Florida, United States
Cesar Figueroa M.D. P.A.
Delray Beach, Florida, United States
Northeast Research Institute
Fleming Island, Florida, 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
Life Spring Research
Miami, Florida, United States
Oceane 7 Medical & Research Center, Inc.
Miami, Florida, United States
International Physicians Research
Miami, Florida, United States
San Marcus Res Clin Miami Lakes
Miami Lakes, Florida, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Hanson Clinical Research Center
Port Charlotte, Florida, United States
Northeast Research Institute
Saint Augustine, Florida, United States
Cardiovascular Ctr of Sarasota
Sarasota, Florida, United States
Clinical Research of Cent FL
Winter Haven, Florida, United States
Ellipsis Group
Alpharetta, Georgia, United States
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, United States
Endocrine Research Solutions
Roswell, Georgia, United States
Solaris Clinical Research
Meridian, Idaho, United States
Saltzer Medical Group Research
Nampa, Idaho, United States
Apex Medical Research Inc
Chicago, Illinois, United States
Clinical Invest Special_Gurnee
Gurnee, Illinois, United States
North Suburban Nephrology LLC
Gurnee, Illinois, United States
Endeavor Health
Skokie, Illinois, United States
Velocity Clin. Res Valparaiso
Valparaiso, Indiana, United States
West Broadway Clinic
Council Bluffs, Iowa, United States
Four Rivers Clinical Research Inc
Paducah, Kentucky, 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
Aa Mrc Llc
Flint, Michigan, United States
Elite Research Center
Flint, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, United States
Washington University_St. Louis_0
St Louis, Missouri, United States
Univ of Nebraska Medical CTR
Omaha, Nebraska, United States
Renal Medicine Associates
Albuquerque, New Mexico, United States
Albany Medical College - Endo
Albany, New York, United States
NYU Langone Neph Associates
Mineola, New York, United States
NYU Nephrology Associates
New York, New York, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
UNC Diabetes Care Center_Chapel Hill
Chapel Hill, North Carolina, United States
Carteret Medical Group
Morehead City, North Carolina, United States
Burke Primary Care
Morganton, North Carolina, United States
Eastern Nephr Assoc, PLLC
New Bern, North Carolina, United States
Whiteville Medical Associates
Whiteville, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, United States
Cincinnati Veterans Affairs Medical Center
Cincinnati, Ohio, United States
Advanced Med Res Maumee
Maumee, Ohio, United States
Alliance for Multispec Res
Norman, Oklahoma, United States
Heritage Valley Medical Group Inc
Beaver, Pennsylvania, United States
Lycoming Internal Medicine, Inc.
Jersey Shore, Pennsylvania, United States
Northeast Endocrine Metabolic Associates
Philadelphia, Pennsylvania, United States
Main Street Physician's Care
Little River, South Carolina, United States
The Diabetes Center, LLC
Murrells Inlet, South Carolina, United States
Family Medicine of SayeBrook LLC
Myrtle Beach, South Carolina, United States
SC Nephrology and Hypertension
Orangeburg, South Carolina, United States
AM Diabetes And Endocrinology Center
Bartlett, Tennessee, United States
Univ Diab & Endo Consultants
Chattanooga, Tennessee, United States
Vanderbilt Medical Center_Nashville
Nashville, Tennessee, United States
Central Texas Clinical Research
Austin, Texas, United States
Texas Diabetes & Endocrinology, P.A._Austin
Austin, Texas, United States
Research Management, Inc
Austin, Texas, United States
Osvaldo A. Brusco MD PA
Corpus Christi, Texas, 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
MedResearch Inc
El Paso, Texas, United States
Academy of Diabetes, T&E
El Paso, Texas, 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
Carlos Arauz-Pacheco Md, Pa
Rockwall, Texas, United States
Univ Of Texas Hlth Science Cntr
San Antonio, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Briggs Clinical Research, LLC
San Antonio, Texas, United States
VIP Trials
San Antonio, Texas, United States
NE Clin Res of San Antonio
San Antonio, Texas, United States
Simcare Medical Research, LLC
Sugar Land, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
University of Vermont Medical Center
South Burlington, Vermont, United States
York Clinical Research LLC
Norfolk, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
VA Medical Center_Salem
Salem, Virginia, United States
Amherst Family Practice P.C.
Winchester, Virginia, United States
Capital Clin Res Ctr,LLC
Olympia, Washington, United States
MultiCare Inst for Res & Innov
Spokane, Washington, United States
Universal Research Group
Tacoma, Washington, United States
Centro de Estudios Renales e Hipertensión Arterial
Villa Domínico, Buenos Aires, Argentina
Centro Diabetológico y Nuticional Dr Alejandro Chertkoff
Buenos Aires, , Argentina
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
Buenos Aires, , Argentina
FEPREVA
CABA, , Argentina
Centro de Investigación Clínica
CABA, , Argentina
Glenny Corp. S.A
CABA, , Argentina
Medical Center of Diabetes and Nutrition
CABA, , Argentina
Gosford Renal Research
Gosford, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Westmead Hospital_Northmead
Westmead, New South Wales, Australia
Core Research Centre
Milton, Queensland, Australia
Monash Health Nephrology
Clayton, Victoria, Australia
St Vincent's Hospital_Fitzroy_0
Fitzroy, Victoria, Australia
Monash University Clinical Trial Centre
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Imeldaziekenhuis - Bonheiden - Department of Endocrinology
Bonheiden, , Belgium
Universitair Ziekenhuis Brussel - Diabeteskliniek
Brussels, , Belgium
UZ Brussel - Universitair Ziekenhuis Brussel
Brussels, , Belgium
Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
Brussels, , Belgium
UZA - UZ Antwerpen - Department of Endocrinology
Edegem, , Belgium
UZ Gent - Endocrinologie - Diabetologie
Ghent, , Belgium
UZ Leuven - Endocrinology
Leuven, , Belgium
Centre hospitalier universitaire de Liège (CHU de Liège)
Liège, , Belgium
AZ Delta - Roeselare
Roeselare, , Belgium
Instituto de Ensino e Pesquisa Clínica do Ceará Ltda
Fortaleza, Ceará, Brazil
Instituto Pró-Renal Brasil
Curitiba, Paraná, 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, São Paulo, Brazil
Instituto de Pesquisa Clinica (IPEC)
São Paulo, São Paulo, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, Brazil
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, São Paulo, Brazil
Centro Médico Hospital da Bahia
Bahia, , Brazil
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
UMHAT Aleksandrovska
Sofia, , Bulgaria
Medical Center Synexus Sofia
Sofia, , Bulgaria
Medical Center "Nov Rehabilitatsionen center" EOOD
Stara Zagora, , Bulgaria
LMC Clin Res Inc. Calgary
Calgary, Alberta, Canada
University of Calgary
Calgary, Alberta, Canada
The Bailey Clinic
Red Deer, Alberta, Canada
BC Diabetes Canada
Vancouver, British Columbia, Canada
Commonwealth Medical Clinic
Mount Pearl, Newfoundland and Labrador, Canada
Eastern Health Authority
St. John's, Newfoundland and Labrador, Canada
QE II Health - Pharmacy
Halifax, Nova Scotia, Canada
Dr. Harpreet Bajaj
Brampton, Ontario, Canada
Aggarwal and Assoc Ltd.
Brampton, Ontario, Canada
JBN Medical Diagnostic Services Inc.
Burlington, Ontario, Canada
LMC Clin Res Inc. Thornhill
Concord, Ontario, Canada
LMC Endo Ctr (Etobicoke) Ltd
Etobicoke, Ontario, Canada
Hamilton Med Res Group
Hamilton, Ontario, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
Milestone Research
London, Ontario, Canada
LMC Research Inc. Ottawa
Nepean, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, Canada
Dr. James Cha
Oshawa, Ontario, Canada
King Street Research
Oshawa, Ontario, Canada
Bluewater Clin Res Group, Inc.
Sarnia, Ontario, Canada
Bluewater Clin Res Group,Inc
Sarnia, Ontario, Canada
Winterberry Family Medicine
Stoney Creek, Ontario, Canada
LMC Endo Centres Ltd.(Bayview)
Toronto, Ontario, Canada
UHN-Toronto General Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Dr Anil K Gupta Med Prof Corp
Toronto, Ontario, Canada
Dr. Anil K Gupta Med Prof Corp
Toronto, Ontario, Canada
Ctr de rech Clin de Laval
Laval, Quebec, Canada
Clinique de Recherche Medpharmgene Inc.
Montreal, Quebec, Canada
Applied Med Inf Res
Montreal, Quebec, Canada
Centre Medical Acadie
Montreal, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, , Canada
Peking University People's Hospital-Endocrinology
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Pinggu Hospital-Endocrinology
Beijing, Beijing Municipality, China
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, China
Jinan Central Hospital
Ji'nan, Shandong, China
Centre Hospitalier Ardeche Nord
Annonay, , France
Hospices Civils de Lyon-Hopital Cardiologique Louis Pradel-2
Bron, , 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 Sante-Hopital Le Creusot-Hotel Dieu-1
Le Creusot, , France
Groupe SOS Santé Hôtel Dieu
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
Centre de Recherche Clinique Portes Du Sud
Vénissieux, , France
Diabetespraxis Mergentheim
Bad Mergentheim, , Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
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, , Germany
University Hospital of Athens ATTIKON
Athens, Attica, Greece
Iatriko Psychicou Private Clinic
Athens, , Greece
General hospital of Athens 'G.Gennimatas'
Athens, , Greece
Iatriko Athinon 'Palaiou Falirou'
Athens, , Greece
General Hospital of Athens "Laiko", Nephrology Clinic
Athens, , Greece
General Hospital of Lamia
Lamia, , Greece
General University Hospital of Patras,Nephrology clinic
Rio, Patra, , Greece
AHEPA General University Hospital
Thessaloniki, , Greece
"Ippokrateio" G.H. of Thessaloniki
Thessaloniki, , Greece
General Hospital of Thessaloniki "Ippokrateio"
Thessaloniki, , Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, , Greece
"Thermi" Private Hosital
Thessaloniki, , Greece
Genl Hosp of Thessaloniki, Papageorgiou ,Nephrology clinic
Thessaloniki, , Greece
PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
Pécs, Baranya Vármegye, Hungary
Lausmed Kft.
Baja, Bács-Kiskun county, Hungary
Belinus Bt.
Debrecen, Hajdú-Bihar, Hungary
Siófoki Kórház, Diabetológiai Szakrendelés
Siófok, Somogy County, Hungary
Borbánya Praxis E.Ü. Kft.
Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary
Péterfy Sándor utcai Kórház
Budapest, , Hungary
MED-TIMA Kft.
Budapest, , Hungary
Belinus Bt.
Debrecen, , Hungary
Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület
Debrecen, , Hungary
Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika
Debrecen, , Hungary
Békés Megyei Központi Kórház
Gyula, , Hungary
Siófoki Kórház, Diabetológiai Szakrendelés
Siófok, , Hungary
Markusovszky Egyetemi Oktatókórház
Szombathely, , Hungary
Markusovszky Egyetemi Oktatókórház
Szombathely, , Hungary
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, India
Ramaiah Memorial Hospital
Bangalore, Karnataka, India
BGS Global Hospitals
Bangalore, Karnataka, India
Lifecare Hospital and Research Centre
Bangalore, Karnataka, India
Amrita Institute Of Medical Sciences & Research Centre
Kochi, Kerala, India
Calicut Medical College
Kozhikode, Kerala, India
Seth GS medical college and KEM Hospital
Mumbai, Maharashtra, India
Poona hospital and research centre
Pune, Maharashtra, India
Max Super Speciality Hospital, Saket
New Delhi, National Capital Territory of Delhi, India
The Madras Medical Mission
Chennai, Tamil Nadu, India
Osmania General Hospital
Hyderabad, Telangana, India
MV Hospital and Research Centre
Lucknow, Uttar Pradesh, India
Ajanta ResearchCentre
Lucknow, Uttar Pradesh, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India
Sanjay Gandhi Postgraduate Institute of Medical Science
Lucknow, Uttar Pradesh, India
Apollo Multispeciality Hospital, Kolkata
Kolkata, West Bengal, India
Sir Ganga Ram Hospital
New Delhi, , India
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, , Israel
Istituto Scientifico San Raffaele
Milan, MI, Italy
AOUPol.Giaccone UOC Malattie Endocrine,Ricambio e Nutrizione
Palermo, PA, Italy
Presidio Ospedaliero Cisanello
Pisa, PI, Italy
AO Papa Giovanni XXIII UOC malattie Endocrine 1-Diabetologia
Bergamo, , Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia
Milan, , Italy
Azienda Ospedaliera Luigi Sacco
Milan, , Italy
Azienda Ospealiero Universitaria Policlinico Umberto I
Roma, , Italy
Azienda Ospedaliero - Universitaria Sant'Andrea
Roma, , Italy
Seino Internal Medicine Clinic
Koriyama-shi, Fukushima, Japan, Japan
Manda Memorial Hospital
Sapporo-shi, Hokkaido, Hokkaido, Japan, Japan
Jinnouchi Hospital
Kumamoto, Kumamoto, Japan, Japan
Heiwadai Hospital
Miyazaki, Miyazaki, 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
Sasaki Internal Medicine
Hokkaido, , Japan
Naka Kinen Clinic
Ibaraki, , Japan
Nishiyamado Keiwa Hospital
Ibaraki, , Japan
Kanazawa Medical University Hospital
Ishikawa, , Japan
Yokohama Minoru Clinic
Kanagawa, , Japan
H.E.C Science Clinic
Kanagawa, , Japan
Shonan Takai Clinic
Kanagawa, , Japan
Uji Tokushukai Medical Center
Kyoto, , Japan
Kawasaki Medical School Hospital
Okayama, , Japan
Takatsuki Red Cross Hospital
Osaka, , Japan
Shimizu Clinic Fusa
Saitama, , Japan
Oyama East Clinic
Tochigi, , Japan
Tokyo Center Clinic
Tokyo, , Japan
Fukuwa Clinic
Tokyo, , Japan
Juntendo University Hospital_Tokyo
Tokyo, , Japan
The University of Tokyo Hospital
Tokyo, , Japan
Kato Clinic of Internal Medicine
Tokyo, , Japan
Sugawara Clinic
Tokyo, , Japan
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Sultanah Bahiyah
Alor Star, , Malaysia
Hospital Raja Permaisuri Bainun Ipoh
Ipoh, Perak, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Hospital Pulau Pinang
Pulau Pinang, , Malaysia
Hospital Serdang
Serdang, , Malaysia
Centro de Atención al Diabetico
Actopan, Hidalgo, Mexico
Inst. Jaliscience de Investigacion en Diabetes y Obesidad SC
Guadalajara, Jalisco, Mexico
Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab
Distrito Federal, México, D.F., Mexico
Instituto Nacional de Ciencias Médicas y Nutrición_Mexico City
Mexico City, México, D.F., Mexico
Centro para el Desarrollo de la Medicina y la Asistencia
Culiacán, Sinaloa, Mexico
Centro de Estudios de Investigación Metabólicos y Cardio
Ciudad Madero, Tamaulipas, Mexico
Noordwest Ziekenhuisgroep
Alkmaar, , Netherlands
Ziekenhuis Groep Twente Almelo
Almelo, , Netherlands
EB Flevo Research BV
Almere Stad, , Netherlands
Meander Medisch Centrum
Amersfoort, , Netherlands
OLVG West
Amsterdam, , Netherlands
Amsterdam UMC Lokatie VUMC
Amsterdam, , Netherlands
Rijnstate Ziekenhuis
Arnhem, , Netherlands
Tergooi, locatie Hilversum
Hilversum, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
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
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, , Poland
Miedzyleski Szpital Specjalistyczny, Oddzial Nefrologiczny
Warsaw, , Poland
Prywatny Gabinet Janusz Gumprecht
Zabrze, , Poland
Reg. State Budget Healthc. Inst. Regional Clinical Hospital
Barnaul, , Russia
City Hospital #5
Barnaul, , Russia
Road Clinical Hospital at station Chelyabinsk
Chelyabinsk, , Russia
PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways
Kazan', , Russia
SAHI Kuzbass Hospital(former Regional clinical hospital)
Kemerovo, , Russia
National Medical Research Center of Endocrinology
Moscow, , Russia
LLC RC Medical
Novosibirsk, , Russia
Limited Law Company "Healthy Family" Medicine Center"
Novosibirsk, , Russia
Penza Regional Clinical Hospital named after N.N. Burdenko
Penza, , Russia
Joint Stock Company "Modern Medical Technologies"
Saint Petersburg, , Russia
Aurora MedFort LLC
Saint Petersburg, , Russia
Limited Liability Company "Energiya Zdoroviya"
Saint Petersburg, , Russia
Medinet LLC
Saint Petersburg, , Russia
LLC "Endocrinolog"
Samara, , Russia
SHI Saratov City Clinical Hospital #9
Saratov, , Russia
Regional clinical cardiology dispensary
Saratov, , Russia
Regional Endocrinological Dispensary
Stavropol, , Russia
Ulianovsk Regional Clinical Hospital
Ulyanovsk, , Russia
Voronezh Regional Clinical Consultive-diagnostic Centre
Voronezh, , Russia
Solovyev Clinical Emergency Hospital
Yaroslavl, , Russia
Polyclinic #2 in Yoshkar-Ola
Yoshkar-Ola, , Russia
MEDISPEKTRUM s.r.o.
Bratislava, , Slovakia
FMC - dialyzacne sluzby, s.r.o.
Košice, , Slovakia
IN-DIA s.r.o.
Lučenec, , Slovakia
Narodny Endokrinologicky a diabetologicky ustav
Ľubochňa, , Slovakia
DIABETIK s.r.o.
Nitra, , Slovakia
Diabetologicka ambulancia MEDIKARD, s.r.o.
Prešov, , Slovakia
ARETEUS s.r.o.
Trebišov, , Slovakia
MUDr. Jana Rociakova s.r.o., ambulancia vnutorneho lekarstva
Žilina, , Slovakia
FMC- dialyzacne sluzby, s.r.o.
Žilina, , Slovakia
MEDIVASA, s.r.o., Diabetologicka ambulancia
Žilina, , Slovakia
Diabetes Care Centre & CDE Centre
Benoni, Gauteng, South Africa
LCS Clinical Research Unit
Cosmo City, Gauteng, South Africa
Soweto Clinical Trial Centre
Johannesburg, Gauteng, South Africa
Hemant Makan
Johannesburg, Gauteng, South Africa
Wits Bara Clinical Trial Site
Johannesburg, Gauteng, South Africa
Dr A Amod
Durban, KwaZulu-Natal, South Africa
Precise Clinical Solutions (Pty) Ltd
Durban, KwaZulu-Natal, South Africa
Tiervlei Trial Centre
Cape Town, Western Cape, South Africa
Prof Rayner_Division of Nephrology
Cape Town, Western Cape, South Africa
Hospital del Mar
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Público da Mariña
Burela de Cabo, , Spain
Hospital Universitario de Getafe
Getafe, , Spain
Hospital Ribera Polusa
Lugo, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Siriraj Hospital_Bangkoknoi, Bangkok
Bangkoknoi, Bangkok, Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Mueang Chiang Mai District, Thailand
Phramongkutklao Hospital-nephrology
Bangkok, Rajathewee, 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
Ankara Universitesi Ibni Sina Hastanesi
Ankara, , Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty- Nephrology
Ankara, , Turkey (Türkiye)
Akdeniz Universitesi Hastanesi Nefroloji Bilim Dali
Antalya, , Turkey (Türkiye)
Aydin Adnan Menderes University Nephrology
Aydin, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi- Nefroloji
Istanbul, , Turkey (Türkiye)
Goztepe Egitim Arastirma Hastanesi Nefroloji
Istanbul, , Turkey (Türkiye)
T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Kahramanmaras Sutcu Imam University
Kahramanmaraş, , Turkey (Türkiye)
Kocaeli University Nephrology Department
Kocaeli, , Turkey (Türkiye)
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, , Ukraine
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 Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
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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.
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
Mendonca L, Moura H, Chaves PC, Neves JS, Ferreira JP. The Impact of Glucagon-Like Peptide-1 Receptor Agonists on Kidney Outcomes: A Meta-Analysis of Randomized Placebo-Controlled Trials. Clin J Am Soc Nephrol. 2024 Oct 8;20(2):159-68. doi: 10.2215/CJN.0000000584. Online ahead of print.
Kosiborod MN, Deanfield J, Pratley R, Borlaug BA, Butler J, Davies MJ, Emerson SS, Kahn SE, Kitzman DW, Lingvay I, Mahaffey KW, Petrie MC, Plutzky J, Rasmussen S, Ronnback C, Shah SJ, Verma S, Weeke PE, Lincoff AM; SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM Trial Committees and Investigators. Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials. Lancet. 2024 Sep 7;404(10456):949-961. doi: 10.1016/S0140-6736(24)01643-X. Epub 2024 Aug 30.
Pratley RE, Tuttle KR, Rossing P, Rasmussen S, Perkovic V, Nielsen OW, Mann JFE, MacIsaac RJ, Kosiborod MN, Kamenov Z, Idorn T, Hansen MB, Hadjadj S, Bakris G, Baeres FMM, Mahaffey KW; FLOW Trial Committees and Investigators. Effects of Semaglutide on Heart Failure Outcomes in Diabetes and Chronic Kidney Disease in the FLOW Trial. J Am Coll Cardiol. 2024 Oct 22;84(17):1615-1628. doi: 10.1016/j.jacc.2024.08.004. Epub 2024 Aug 30.
Mann JFE, Rossing P, Bakris G, Belmar N, Bosch-Traberg H, Busch R, Charytan DM, Hadjadj S, Gillard P, Gorriz JL, Idorn T, Ji L, Mahaffey KW, Perkovic V, Rasmussen S, Schmieder RE, Pratley RE, Tuttle KR. Effects of semaglutide with and without concomitant SGLT2 inhibitor use in participants with type 2 diabetes and chronic kidney disease in the FLOW trial. Nat Med. 2024 Oct;30(10):2849-2856. doi: 10.1038/s41591-024-03133-0. Epub 2024 Jun 24.
De La Flor JC, Moral E, Deira J, Monzon T, Valga F, Albarracin C, Rodeles M. Response to "Experience with dulaglutide in an obese diabetic patient on incremental peritoneal dialysis". Response to related letter. Nefrologia (Engl Ed). 2024 May-Jun;44(3):444-446. doi: 10.1016/j.nefroe.2023.10.010. Epub 2024 Jun 10. No abstract available.
Perkovic V, Tuttle KR, Rossing P, Mahaffey KW, Mann JFE, Bakris G, Baeres FMM, Idorn T, Bosch-Traberg H, Lausvig NL, Pratley R; FLOW Trial Committees and Investigators. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. N Engl J Med. 2024 Jul 11;391(2):109-121. doi: 10.1056/NEJMoa2403347. Epub 2024 May 24.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1217-6259
Identifier Type: OTHER
Identifier Source: secondary_id
2018-002878-50
Identifier Type: REGISTRY
Identifier Source: secondary_id
JapicCTI-194843
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN9535-4321
Identifier Type: -
Identifier Source: org_study_id
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