AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3FLOWNCT03819153

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

A Phase 3 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 413 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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'). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Semaglutide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,533 participants
Where
413 sitesin 28 countries
Study dates
17 Jun 2019to 9 Jan 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

413 sites in 28 countries.

413 sites in 28 countries

United States117 sites

  • Albany Medical College - Endo

    Albany, New York, 12203

  • Renal Medicine Associates

    Albuquerque, New Mexico, 87109

  • Ellipsis Group

    Alpharetta, Georgia, 30022

  • Southeastern Clinical Research Institute, LLC

    Augusta, Georgia, 30904

  • Rocky Mount Reg VA Med-DN

    Aurora, Colorado, 80045

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Texas Diabetes & Endocrinology, P.A._Austin

    Austin, Texas, 78731

  • Research Management, Inc

    Austin, Texas, 78751

  • AM Diabetes And Endocrinology Center

    Bartlett, Tennessee, 38133

  • Heritage Valley Medical Group Inc

    Beaver, Pennsylvania, 15009

  • Metropolitan Cardiovascular Consultants, LLC

    Beltsville, Maryland, 20705

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115-5804

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620

  • UNC Diabetes Care Center_Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Univ Diab & Endo Consultants

    Chattanooga, Tennessee, 37411

  • Apex Medical Research Inc

    Chicago, Illinois, 60607

  • California Inst Of Renal Res

    Chula Vista, California, 91910

  • Cincinnati Veterans Affairs Medical Center

    Cincinnati, Ohio, 45220-2213

  • BayCare Medical Group - Endocrinology

    Clearwater, Florida, 33756

  • John Muir Physician Network

    Concord, California, 94520

  • John Muir Physicians Network

    Concord, California, 94520

  • Horizon Rs Grp, Coral Gbls

    Coral Gables, Florida, 33134

  • Osvaldo A. Brusco MD PA

    Corpus Christi, Texas, 78414

  • West Broadway Clinic

    Council Bluffs, Iowa, 51501

  • Baylor Jack and Jane Hamilton

    Dallas, Texas, 75226

  • Research Institute Of Dallas

    Dallas, Texas, 75231

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302

  • Cesar Figueroa M.D. P.A.

    Delray Beach, Florida, 33445

  • Creekside Endocrine Associates, PC

    Denver, Colorado, 80246

  • MedResearch Inc

    El Paso, Texas, 79902

  • Academy of Diabetes, T&E

    El Paso, Texas, 79935

  • Northeast Research Institute

    Fleming Island, Florida, 32003

  • Aa Mrc Llc

    Flint, Michigan, 48504

  • Elite Research Center

    Flint, Michigan, 48532

  • Valley Research

    Fresno, California, 93720

  • Clinical Invest Special_Gurnee

    Gurnee, Illinois, 60031

  • North Suburban Nephrology LLC

    Gurnee, Illinois, 60031

  • Palmetto Medical General Plaza

    Hialeah, Florida, 33016

  • Encore Medical Research LLC

    Hollywood, Florida, 33021

  • Homestead Associates In Research

    Homestead, Florida, 33032

  • Juno Research, LLC_Houston

    Houston, Texas, 77040

  • Juno Research, LLC_Houston

    Houston, Texas, 77074

  • Southwest Clinical Trials

    Houston, Texas, 77081

  • Southwest Houston Research Ltd

    Houston, Texas, 77099

  • Lycoming Internal Medicine, Inc.

    Jersey Shore, Pennsylvania, 17740

  • Clinical Research Consultants, LLC

    Kansas City, Missouri, 64111

  • California Institute of Renal Research

    La Mesa, California, 91942

  • First Valley Med Grp Lancaster

    Lancaster, California, 93534

  • Clinical Trials Research_Sacramento

    Lincoln, California, 95648

  • Main Street Physician's Care

    Little River, South Carolina, 29566

  • VA Loma Linda Hlthcr Sys

    Loma Linda, California, 92357

  • Long Beach Center For Clinical Research

    Long Beach, California, 90807

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • Advanced Med Res Maumee

    Maumee, Ohio, 43537

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Life Spring Research

    Miami, Florida, 33130

  • Oceane 7 Medical & Research Center, Inc.

    Miami, Florida, 33144

  • International Physicians Research

    Miami, Florida, 33173

  • San Marcus Res Clin Miami Lakes

    Miami Lakes, Florida, 33014

  • Floridian Clinical Research, LLC

    Miami Lakes, Florida, 33016

  • NYU Langone Neph Associates

    Mineola, New York, 11501

  • South Broward Research LLC

    Miramar, Florida, 33027

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Burke Primary Care

    Morganton, North Carolina, 28655

  • The Diabetes Center, LLC

    Murrells Inlet, South Carolina, 29576

  • Family Medicine of SayeBrook LLC

    Myrtle Beach, South Carolina, 29588

  • Saltzer Medical Group Research

    Nampa, Idaho, 83686-6011

  • Vanderbilt Medical Center_Nashville

    Nashville, Tennessee, 37232

  • Eastern Nephr Assoc, PLLC

    New Bern, North Carolina, 28562

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • NYU Nephrology Associates

    New York, New York, 10016

  • York Clinical Research LLC

    Norfolk, Virginia, 23504

  • Alliance for Multispec Res

    Norman, Oklahoma, 73069

  • Valley Renal Medical Group Research

    Northridge, California, 91324

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502

  • Univ of Nebraska Medical CTR

    Omaha, Nebraska, 68198

  • SC Nephrology and Hypertension

    Orangeburg, South Carolina, 29118

  • Four Rivers Clinical Research Inc

    Paducah, Kentucky, 42001

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California, 92262

  • Northeast Endocrine Metabolic Associates

    Philadelphia, Pennsylvania, 19114

  • Hanson Clinical Research Center

    Port Charlotte, Florida, 33952

  • Saviers Medical Group

    Port Hueneme, California, 93041

  • Inland Empire Clin Trials LLC

    Rialto, California, 92377

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Mayo Clinic

    Rochester, Minnesota, 55905-0001

  • Carlos Arauz-Pacheco Md, Pa

    Rockwall, Texas, 75032

  • Sierra Clinical Research

    Roseville, California, 95661

  • Endocrine Research Solutions

    Roswell, Georgia, 30076

  • Northeast Research Institute

    Saint Augustine, Florida, 32080

  • VA Medical Center_Salem

    Salem, Virginia, 24153-6404

  • University of Utah School of Medicine

    Salt Lake City, Utah, 84108

  • Univ Of Texas Hlth Science Cntr

    San Antonio, Texas, 78207

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Briggs Clinical Research, LLC

    San Antonio, Texas, 78224

  • VIP Trials

    San Antonio, Texas, 78230

  • NE Clin Res of San Antonio

    San Antonio, Texas, 78233

  • California Research Foundation

    San Diego, California, 92123

  • N America Res Inst - San Dimas

    San Dimas, California, 91773

  • NorCal Endocrinology and Internal Medicine

    San Ramon, California, 94583

  • Cardiovascular Ctr of Sarasota

    Sarasota, Florida, 34239

  • Endeavor Health

    Skokie, Illinois, 60077

  • University of Vermont Medical Center

    South Burlington, Vermont, 05403

  • MultiCare Inst for Res & Innov

    Spokane, Washington, 99202

  • Washington University_St. Louis_0

    St Louis, Missouri, 63110

  • Simcare Medical Research, LLC

    Sugar Land, Texas, 77478

  • Universal Research Group

    Tacoma, Washington, 98405

  • Lundquist Inst-Biomed Innovtn

    Torrance, California, 90502

  • Dr. Terence Hart

    Tuscumbia, Alabama, 35674

  • Velocity Clin. Res Valparaiso

    Valparaiso, Indiana, 46383

  • San Fernando Valley Hlth Inst

    West Hills, California, 91304

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224

  • Whiteville Medical Associates

    Whiteville, North Carolina, 28472

  • Accellacare

    Wilmington, North Carolina, 28401

  • Amherst Family Practice P.C.

    Winchester, Virginia, 22601

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina, 27103

  • Clinical Research of Cent FL

    Winter Haven, Florida, 33880

Other trials in United States

Canada32 sites

  • Dr. Harpreet Bajaj

    Brampton, Ontario, L6S 0C6

  • Aggarwal and Assoc Ltd.

    Brampton, Ontario, L6T 0G1

  • JBN Medical Diagnostic Services Inc.

    Burlington, Ontario, L7M 4Y1

  • LMC Clin Res Inc. Calgary

    Calgary, Alberta, T2H 2G4

  • University of Calgary

    Calgary, Alberta, T2T 5C7

  • LMC Clin Res Inc. Thornhill

    Concord, Ontario, L4K 4M2

  • LMC Endo Ctr (Etobicoke) Ltd

    Etobicoke, Ontario, M9R 4E1

  • QE II Health - Pharmacy

    Halifax, Nova Scotia, B3H 1V8

  • Hamilton Med Res Group

    Hamilton, Ontario, L8M 1K7

  • Premier Clinical Trial Research Network (PCTRN)

    Hamilton, Ontario, L8M 1K7

  • Ctr de rech Clin de Laval

    Laval, Quebec, H7T 2P5

  • Milestone Research

    London, Ontario, N5W 6A2

  • Clinique de Recherche Medpharmgene Inc.

    Montreal, Quebec, H2K 1H2

  • Applied Med Inf Res

    Montreal, Quebec, H4A 3T2

  • Centre Medical Acadie

    Montreal, Quebec, H4N 2W2

  • Commonwealth Medical Clinic

    Mount Pearl, Newfoundland and Labrador, A1N 1W7

  • LMC Research Inc. Ottawa

    Nepean, Ontario, K2J 0V2

  • Lakeridge Health

    Oshawa, Ontario, L1G 2B9

  • Dr. James Cha

    Oshawa, Ontario, L1J 2K1

  • King Street Research

    Oshawa, Ontario, L1J 2K1

  • Centre de Recherche Saint-Louis

    Québec, G1W 4R4

  • The Bailey Clinic

    Red Deer, Alberta, T4N 6V7

  • Bluewater Clin Res Group, Inc.

    Sarnia, Ontario, N7T 4X3

  • Bluewater Clin Res Group,Inc

    Sarnia, Ontario, N7T 4X3

  • Eastern Health Authority

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Winterberry Family Medicine

    Stoney Creek, Ontario, L8J 0B6

  • LMC Endo Centres Ltd.(Bayview)

    Toronto, Ontario, M4G 3E8

  • UHN-Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Mount Sinai Hospital

    Toronto, Ontario, M5T 3L9

  • Dr Anil K Gupta Med Prof Corp

    Toronto, Ontario, M9V 4B4

  • Dr. Anil K Gupta Med Prof Corp

    Toronto, Ontario, M9V 4B4

  • BC Diabetes Canada

    Vancouver, British Columbia, V5Y 3W2

Other trials in Canada

Japan27 sites

  • New Tokyo Heart Clinic

    Chiba, 271-0077

  • Fukui Prefectural Hospital_Fukui

    Fukui, 910-8526

  • Fukuoka Tokushukai Hospital

    Fukuoka, 816-0864

  • Kawada Clinic

    Gunma, 373-0036

  • Sasaki Hospital Internal Medicine

    Hokkaido, 062-0007

  • Sasaki Internal Medicine

    Hokkaido, 062-0007

  • Naka Kinen Clinic

    Ibaraki, 311-0113

  • Nishiyamado Keiwa Hospital

    Ibaraki, 331-0133

  • Kanazawa Medical University Hospital

    Ishikawa, 920-0293

  • Yokohama Minoru Clinic

    Kanagawa, 232-0064

  • H.E.C Science Clinic

    Kanagawa, 235-0045

  • Shonan Takai Clinic

    Kanagawa, 247-0055

  • Seino Internal Medicine Clinic

    Koriyama-shi, Fukushima, Japan, 963-8851

  • Jinnouchi Hospital

    Kumamoto, Kumamoto, Japan, 862-0976

  • Uji Tokushukai Medical Center

    Kyoto, 611-0041

  • Heiwadai Hospital

    Miyazaki, Miyazaki, 880-0034

  • Kawasaki Medical School Hospital

    Okayama, 701-0192

  • Takatsuki Red Cross Hospital

    Osaka, 569-1045

  • Shimizu Clinic Fusa

    Saitama, 336-0967

  • Manda Memorial Hospital

    Sapporo-shi, Hokkaido, Hokkaido, Japan, 060-0062

  • Oyama East Clinic

    Tochigi, 323-0022

  • Tokyo Center Clinic

    Tokyo, 103-0028

  • Fukuwa Clinic

    Tokyo, 104-0031

  • Juntendo University Hospital_Tokyo

    Tokyo, 113-8431

  • The University of Tokyo Hospital

    Tokyo, 113-8655

  • Kato Clinic of Internal Medicine

    Tokyo, 125-0054

  • Sugawara Clinic

    Tokyo, 177-0041

Other trials in Japan

Russia21 sites

  • Reg. State Budget Healthc. Inst. Regional Clinical Hospital

    Barnaul, 656024

  • City Hospital #5

    Barnaul, 656045

  • Road Clinical Hospital at station Chelyabinsk

    Chelyabinsk, 454048

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

    Kazan', 420061

  • SAHI Kuzbass Hospital(former Regional clinical hospital)

    Kemerovo, 650066

  • National Medical Research Center of Endocrinology

    Moscow, 117292

  • LLC RC Medical

    Novosibirsk, 630005

  • Limited Law Company "Healthy Family" Medicine Center"

    Novosibirsk, 630099

  • Penza Regional Clinical Hospital named after N.N. Burdenko

    Penza, 440026

  • Joint Stock Company "Modern Medical Technologies"

    Saint Petersburg, 190121

  • Aurora MedFort LLC

    Saint Petersburg, 194156

  • Limited Liability Company "Energiya Zdoroviya"

    Saint Petersburg, 194156

  • Medinet LLC

    Saint Petersburg, 194356

  • LLC "Endocrinolog"

    Samara, 443031

  • SHI Saratov City Clinical Hospital #9

    Saratov, 410031

  • Regional clinical cardiology dispensary

    Saratov, 410039

  • Regional Endocrinological Dispensary

    Stavropol, 355035

  • Ulianovsk Regional Clinical Hospital

    Ulyanovsk, 432063

  • Voronezh Regional Clinical Consultive-diagnostic Centre

    Voronezh, 394018

  • Solovyev Clinical Emergency Hospital

    Yaroslavl, 150003

  • Polyclinic #2 in Yoshkar-Ola

    Yoshkar-Ola, 424004

Other trials in Russia

India17 sites

  • Ramaiah Memorial Hospital

    Bangalore, Karnataka, 560054

  • BGS Global Hospitals

    Bangalore, Karnataka, 560060

  • Lifecare Hospital and Research Centre

    Bangalore, Karnataka, 560092

  • The Madras Medical Mission

    Chennai, Tamil Nadu, 600037

  • Endolife Specialty Hospitals

    Guntur, Andhra Pradesh, 522001

  • Osmania General Hospital

    Hyderabad, Telangana, 500012

  • Amrita Institute Of Medical Sciences & Research Centre

    Kochi, Kerala, 682041

  • Apollo Multispeciality Hospital, Kolkata

    Kolkata, West Bengal, 700054

  • Calicut Medical College

    Kozhikode, Kerala, 673008

  • MV Hospital and Research Centre

    Lucknow, Uttar Pradesh, 226003

  • Ajanta ResearchCentre

    Lucknow, Uttar Pradesh, 226005

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    Lucknow, Uttar Pradesh, 226014

  • Sanjay Gandhi Postgraduate Institute of Medical Science

    Lucknow, Uttar Pradesh, 226014

  • Seth GS medical college and KEM Hospital

    Mumbai, Maharashtra, 400012

  • Max Super Speciality Hospital, Saket

    New Delhi, National Capital Territory of Delhi, 110017

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Poona hospital and research centre

    Pune, Maharashtra, 411030

Other trials in India

France14 sites

  • Centre Hospitalier Ardeche Nord

    Annonay, 07103

  • Hospices Civils de Lyon-Hopital Cardiologique Louis Pradel-2

    Bron, 69677

  • Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre-1

    Caen, 14033

  • Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-2

    Grenoble - Cédex 09, 38043

  • Centre Hospitalier Departemental Vendee- La Roche Sur Yon

    La Roche-sur-Yon, 85925

  • Les Hopitaux de Chartres-Hopital Louis Pasteur

    Le Coudray, 28630

  • Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1

    Le Creusot, 71200

  • Groupe SOS Santé Hôtel Dieu

    Le Creusot, 71200

  • Fondation Rothschild

    Paris, 75019

  • Centre Hospitalier Universitaire Reims-Hopital Maison Blanche

    Reims, 51092

  • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1

    Saint-Herblain, 44800

  • Hôpital Nord Laënnec- Service D'Endocrinologie

    Saint-Herblain, 44800

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2

    Toulouse, 31054

  • Centre de Recherche Clinique Portes Du Sud

    Vénissieux, 69200

Other trials in France

Hungary14 sites

  • Lausmed Kft.

    Baja, Bács-Kiskun county, 6500

  • Péterfy Sándor utcai Kórház

    Budapest, 1076

  • MED-TIMA Kft.

    Budapest, 1132

  • Belinus Bt.

    Debrecen, Hajdú-Bihar, 4025

  • Belinus Bt.

    Debrecen, 4025

  • Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület

    Debrecen, 4043

  • Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika

    Debrecen, H-4032

  • Békés Megyei Központi Kórház

    Gyula, H-5700

  • Borbánya Praxis E.Ü. Kft.

    Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405

  • PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum

    Pécs, Baranya Vármegye, 7623

  • Siófoki Kórház, Diabetológiai Szakrendelés

    Siófok, Somogy County, 8600

  • Siófoki Kórház, Diabetológiai Szakrendelés

    Siófok, 8600

  • Markusovszky Egyetemi Oktatókórház

    Szombathely, 9700

  • Markusovszky Egyetemi Oktatókórház

    Szombathely, H-9700

Other trials in Hungary

Greece13 sites

  • University Hospital of Athens ATTIKON

    Athens, Attica, 12462

  • Iatriko Psychicou Private Clinic

    Athens, 115 25

  • General hospital of Athens 'G.Gennimatas'

    Athens, 11527

  • Iatriko Athinon 'Palaiou Falirou'

    Athens, 17562

  • General Hospital of Athens "Laiko", Nephrology Clinic

    Athens, GR-11527

  • General Hospital of Lamia

    Lamia, 35100

  • General University Hospital of Patras,Nephrology clinic

    Rio, Patra, 26504

  • AHEPA General University Hospital

    Thessaloniki, 54636

  • "Ippokrateio" G.H. of Thessaloniki

    Thessaloniki, 54642

  • General Hospital of Thessaloniki "Ippokrateio"

    Thessaloniki, 54642

  • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes

    Thessaloniki, 54643

  • "Thermi" Private Hosital

    Thessaloniki, 57001

  • Genl Hosp of Thessaloniki, Papageorgiou ,Nephrology clinic

    Thessaloniki, GR-564 29

Other trials in Greece

Turkey (Türkiye)12 sites

  • Ankara Universitesi Ibni Sina Hastanesi

    Ankara, 06100

  • Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali

    Ankara, 06230

  • Gazi University Medical Faculty- Nephrology

    Ankara, 06500

  • Akdeniz Universitesi Hastanesi Nefroloji Bilim Dali

    Antalya, 07058

  • Aydin Adnan Menderes University Nephrology

    Aydin, 09100

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Istanbul Universitesi Istanbul Tip Fakultesi- Nefroloji

    Istanbul, 34390

  • Goztepe Egitim Arastirma Hastanesi Nefroloji

    Istanbul, 34722

  • T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34899

  • Ege University Medical Faculty

    Izmir, 35100

  • Kahramanmaras Sutcu Imam University

    Kahramanmaraş, 46040

  • Kocaeli University Nephrology Department

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

United Kingdom11 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • Diabetes Centre, Heartlands Hospital, Birmingham

    Birmingham, B9 5SS

  • Ely Bridge Surgery

    Cardiff, CF5 4AD

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Glasgow Clinical Research Facility

    Glasgow, G31 2ER

  • The Diabetes Centre

    Ipswich, IP4 5PD

  • North Middlesex Hospital

    London, N18 1QX

  • Royal Free - Diabetes

    London, NW3 2QG

  • Lister Hospital

    Stevenage, SG1 4AB

  • St Georges Hospital

    Tooting, SW17 0RE

Other trials in United Kingdom

Slovakia10 sites

  • MEDISPEKTRUM s.r.o.

    Bratislava, 851 01

  • FMC - dialyzacne sluzby, s.r.o.

    Košice, 04011

  • Narodny Endokrinologicky a diabetologicky ustav

    Ľubochňa, 03491

  • IN-DIA s.r.o.

    Lučenec, 984 01

  • DIABETIK s.r.o.

    Nitra, 94901

  • Diabetologicka ambulancia MEDIKARD, s.r.o.

    Prešov, 08001

  • ARETEUS s.r.o.

    Trebišov, 07501

  • MUDr. Jana Rociakova s.r.o., ambulancia vnutorneho lekarstva

    Žilina, 010 01

  • FMC- dialyzacne sluzby, s.r.o.

    Žilina, 010 08

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

    Žilina, 01001

Other trials in Slovakia

Belgium9 sites

  • Imeldaziekenhuis - Bonheiden - Department of Endocrinology

    Bonheiden, 2820

  • Universitair Ziekenhuis Brussel - Diabeteskliniek

    Brussels, 1090

  • UZ Brussel - Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie

    Brussels, 1200

  • UZA - UZ Antwerpen - Department of Endocrinology

    Edegem, 2650

  • UZ Gent - Endocrinologie - Diabetologie

    Ghent, 9000

  • UZ Leuven - Endocrinology

    Leuven, 3000

  • Centre hospitalier universitaire de Liège (CHU de Liège)

    Liège, 4000

  • AZ Delta - Roeselare

    Roeselare, 8800

Other trials in Belgium

Germany9 sites

  • Diabetespraxis Mergentheim

    Bad Mergentheim, 97980

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, 32545

  • DaVita Clinical Research Deutschland GmbH

    Düsseldorf, 40210

  • Medizinische Klinik 4, Universitätsklinikum Erlangen

    Erlangen, 91054

  • InnoDiab Forschung GmbH

    Essen, 45136

  • Praxis Dr. med. M. Esser

    Essen, 45219

  • Wendisch/Dahl Hamburg

    Hamburg, 22607

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

    Münster, 48145

  • Zentrum für klinische Studien Alexander Segner

    Saint Ingbert-Oberwürzbach, 66386

Other trials in Germany

Italy9 sites

  • AO Papa Giovanni XXIII UOC malattie Endocrine 1-Diabetologia

    Bergamo, 24127

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Istituto Scientifico San Raffaele

    Milan, MI, 20132

  • Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia

    Milan, 20122

  • Azienda Ospedaliera Luigi Sacco

    Milan, 20157

  • AOUPol.Giaccone UOC Malattie Endocrine,Ricambio e Nutrizione

    Palermo, PA, 90127

  • Presidio Ospedaliero Cisanello

    Pisa, PI, 56124

  • Azienda Ospealiero Universitaria Policlinico Umberto I

    Roma, 00161

  • Azienda Ospedaliero - Universitaria Sant'Andrea

    Roma, 00189

Other trials in Italy

Netherlands9 sites

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815 JD

  • Ziekenhuis Groep Twente Almelo

    Almelo, 7609 PP

  • EB Flevo Research BV

    Almere Stad, 1311RL

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

  • OLVG West

    Amsterdam, 1061 AE

  • Amsterdam UMC Lokatie VUMC

    Amsterdam, 1081 HV

  • Rijnstate Ziekenhuis

    Arnhem, 6815 AD

  • Tergooi, locatie Hilversum

    Hilversum, 1213 XZ

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

South Africa9 sites

  • Diabetes Care Centre & CDE Centre

    Benoni, Gauteng, 1501

  • Tiervlei Trial Centre

    Cape Town, Western Cape, 7530

  • Prof Rayner_Division of Nephrology

    Cape Town, Western Cape, 7925

  • LCS Clinical Research Unit

    Cosmo City, Gauteng, 2188

  • Dr A Amod

    Durban, KwaZulu-Natal, 4092

  • Precise Clinical Solutions (Pty) Ltd

    Durban, KwaZulu-Natal, 4092

  • Soweto Clinical Trial Centre

    Johannesburg, Gauteng, 1818

  • Hemant Makan

    Johannesburg, Gauteng, 1827

  • Wits Bara Clinical Trial Site

    Johannesburg, Gauteng, 2013

Other trials in South Africa

Australia8 sites

  • Monash Health Nephrology

    Clayton, Victoria, 3168

  • St Vincent's Hospital_Fitzroy_0

    Fitzroy, Victoria, 3065

  • Gosford Renal Research

    Gosford, New South Wales, 2250

  • Monash University Clinical Trial Centre

    Melbourne, Victoria, 3004

  • Core Research Centre

    Milton, Queensland, 4064

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Westmead Hospital_Northmead

    Westmead, New South Wales, 2145

Other trials in Australia

Brazil8 sites

  • Centro Médico Hospital da Bahia

    Bahia, 41810-011

  • Instituto Pró-Renal Brasil

    Curitiba, Paraná, 80440-020

  • Instituto de Ensino e Pesquisa Clínica do Ceará Ltda

    Fortaleza, Ceará, 60125-058

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

    Porto Alegre, Rio Grande do Sul, 90430-001

  • Hospital e Maternidade Dr. Christovão da Gama S.A.

    Santo André, São Paulo, 09030-010

  • Instituto de Pesquisa Clinica (IPEC)

    São Paulo, São Paulo, 01223-001

  • CPQuali Pesquisa Clínica Ltda

    São Paulo, São Paulo, 01228-000

  • CPCLIN - Centro de Pesquisas Clínicas

    São Paulo, São Paulo, 01228-200

Other trials in Brazil

Poland8 sites

  • Osteo Medic s.c. Artur Racewicz Jerzy Supronik

    Bialystok, 15-351

  • NZOZ WITAMED Poradnia Diabetologiczna

    Kielce, 25-035

  • Wojewodzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, 10-561

  • Centrum Medyczne "Diabetika"

    Radom, 26-600

  • Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie

    Szczecin, 70-111

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw, 01-192

  • Miedzyleski Szpital Specjalistyczny, Oddzial Nefrologiczny

    Warsaw, 04-749

  • Prywatny Gabinet Janusz Gumprecht

    Zabrze, 41-800

Other trials in Poland

Argentina7 sites

  • Centro Diabetológico y Nuticional Dr Alejandro Chertkoff

    Buenos Aires, C1250AAN

  • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

    Buenos Aires, C1425AGC

  • FEPREVA

    CABA, 1429

  • Centro de Investigación Clínica

    CABA, C1060ABA

  • Glenny Corp. S.A

    CABA, C1430CKE

  • Medical Center of Diabetes and Nutrition

    CABA, C1440AAD

  • Centro de Estudios Renales e Hipertensión Arterial

    Villa Domínico, Buenos Aires, B1872EEA

Other trials in Argentina

Bulgaria7 sites

  • Medical centre "Zdrave 1" OOD

    Kozloduy, 3320

  • UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases

    Plovdiv, 4001

  • MHAT "Dr. Ivan Seliminski"-Sliven

    Sliven, 8800

  • "Nader Yabrudi - ASMPVBE Individual practice"

    Smolyan, 4700

  • UMHAT Aleksandrovska

    Sofia, 1431

  • Medical Center Synexus Sofia

    Sofia, 1784

  • Medical Center "Nov Rehabilitatsionen center" EOOD

    Stara Zagora, 6001

Other trials in Bulgaria

Spain7 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Público da Mariña

    Burela de Cabo, 27880

  • Hospital Universitario de Getafe

    Getafe, 28909

  • Hospital Ribera Polusa

    Lugo, 27004

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Doctor Peset

    Valencia, 46017

Other trials in Spain

Thailand7 sites

  • Phramongkutklao Hospital-nephrology

    Bangkok, Rajathewee, 10400

  • King Chulalongkorn Memorial Hospital-Division of Nephrology

    Bangkok, 10330

  • King Chulalongkorn Memorial Hospital_Bangkok

    Bangkok, 10330

  • Phramongkutklao Hospital-nephrology

    Bangkok, 10400

  • Siriraj Hospital-Nephro

    Bangkok, 10700

  • Siriraj Hospital_Bangkoknoi, Bangkok

    Bangkoknoi, Bangkok, Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, Mueang Chiang Mai District, 50200

Other trials in Thailand

Ukraine7 sites

  • SI "Institute of Medical and Social Problems of Disability"

    Dnipro, 49000

  • Ivano-Frankivsk Regional Clinical Hospital

    Ivano-Frankivsk, 76008

  • CNPI "Kharkiv City Clinical Hospital #27"

    Kharkiv, 61002

  • SI "National Institute of Therapy n.a. L.T. Malaya of NAMSU"

    Kharkiv, 61039

  • Institute of Endocrinology and Metabolism of AMSU

    Kyiv, 04114

  • CI "1st City Clinical Hospital of Poltava City Council"

    Poltava, 36039

  • CI "Zaporizhia city clinical hospital #10"

    Zaporizhia, 69001

Other trials in Ukraine

Malaysia6 sites

  • Hospital Sultanah Bahiyah

    Alor Star, 05460

  • Hospital Raja Permaisuri Bainun Ipoh

    Ipoh, Perak, 30450

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

  • Sarawak General Hospital

    Kuching, 93586

  • Hospital Pulau Pinang

    Pulau Pinang, 10990

  • Hospital Serdang

    Serdang, 43000

Other trials in Malaysia

Mexico6 sites

  • Centro de Atención al Diabetico

    Actopan, Hidalgo, 42500

  • Centro de Estudios de Investigación Metabólicos y Cardio

    Ciudad Madero, Tamaulipas, 89440

  • Centro para el Desarrollo de la Medicina y la Asistencia

    Culiacán, Sinaloa, 80230

  • Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab

    Distrito Federal, México, D.F., 14080

  • Inst. Jaliscience de Investigacion en Diabetes y Obesidad SC

    Guadalajara, Jalisco, 44600

  • Instituto Nacional de Ciencias Médicas y Nutrición_Mexico City

    Mexico City, México, D.F., 14080

Other trials in Mexico

China5 sites

  • Peking University People's Hospital-Endocrinology

    Beijing, Beijing Municipality, 100044

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Pinggu Hospital-Endocrinology

    Beijing, Beijing Municipality, 101200

  • Jinan Central Hospital

    Ji'nan, Shandong, 250013

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang, Jiangsu, 212001

Other trials in China

Israel4 sites

  • Diabetes Clinic Wolfson MC

    Holon, 58100

  • Diabetes Unit Hadassah Ein Karem MC

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 4428164

  • Kaplan Medical Center_Rehovot

    Rehovot, 7661041

Other trials in Israel

About this study

Official title: 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.

Being tested
Semaglutide, Placebo (semaglutide)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    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)Drug

    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.

Study groups in NCT03819153
Study groupRoleWhat they receive
SemaglutideExperimentalParticipants 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.
Receives: Drug: Semaglutide
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo (semaglutide)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: From Week 0 up to Week 234

Secondary outcomes (21)

  1. Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)

    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.

    Measured: From Week 0 up to Week 234

  2. Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI)

    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.

    Measured: From Week 0 up to Week 234

  3. Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2

    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.

    Measured: From Week 0 up to Week 234

  4. Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy

    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.

    Measured: From Week 0 up to Week 234

  5. Number of Participants From Time of Randomization to Occurrence of Renal Death

    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.

    Measured: From Week 0 up to Week 234

  6. Number of Participants From Time of Randomization to Occurrence of CV Death

    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.

    Measured: From Week 0 up to Week 234

  7. Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope)

    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.

    Measured: Week 12, Week 234

  8. Change From Baseline in eGFR (CKD-EPI) at 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.

    Measured: Baseline (Week 0), Week 12

  9. Change From Baseline in eGFR (Cystatin C CKD-EPI) at 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.

    Measured: Baseline (Week 0), Week 104

  10. Change From Baseline in Urinary Albumin-to-creatinine Ratio (UACR) at Week 104: Ratio to Baseline

    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.

    Measured: Baseline (Week 0), Week 104

  11. 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

    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.

    Measured: From Week 0 up to Week 234

  12. Number of Participants From Time of Randomization to Time to Occurrence of All-cause Death

    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.

    Measured: From Week 0 up to Week 234

  13. 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

    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.

    Measured: From Week 0 up to Week 234

  14. 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

    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.

    Measured: From Week 0 up to Week 234

  15. 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

    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.

    Measured: From Week 0 up to Week 234

  16. Number of Participants With Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization

    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.

    Measured: From Week 0 up to Week 234

  17. Change From Baseline in Body Weight at 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.

    Measured: Baeline (Week 0), Week 104

  18. Change From Baseline in Glycosylated Haemoglobin (HbA1c) at 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.

    Measured: Baseline (Week 0), Week 104

  19. Change From Baseline in Systolic Blood Pressure at 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.

    Measured: Baseline (Week 0), Week 104

  20. Change From Baseline in Diastolic Blood Pressure at 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.

    Measured: Baseline (Week 0), Week 104

  21. Number of Severe Hypoglycaemic Episodes

    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.

    Measured: From Week 0 up to Week 234

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2019
  2. Study start17 Jun 2019
  3. Primary completion9 Jan 2024
  4. Study completion9 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,533 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03819153
Sponsor's protocol ID
NN9535-4321
Other IDs
U1111-1217-6259, 2018-002878-50, JapicCTI-194843, 2018
Acronym
FLOW
Status last verified
Mar 2025
First submitted
18 Jan 2019
Last updated
20 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • 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.

    PubMed 36651820

  • Tuttle KR, Bakris GL, Baeres FMM, Bang CN, Bax WA, Belmar N, Musinga D, Cherney DZI, Chernin G, Lim SK, Mann JFE, Perkovic V, Pratley R, Ridker PM, Rossing P, Schmieder R, Shamkhalova MS, Sreenivasamurthy L, Mahaffey KW. Kidney and Survival Benefits of Semaglutide in Diabetes With Chronic Kidney Disease: FLOW Trial Cardiovascular Subgroup Analyses. J Am Coll Cardiol. 2026 Jun 2;87(21):2996-3012. doi: 10.1016/j.jacc.2026.02.5125.

    PubMed 42233552

  • Rayner B, Mahaffey KW, Mann JFE, Pratley RE, Rossing P, Belmar N, Bosch-Traberg H, Jeppesen OK, Tran MC, Chernin G, Tuttle KR. Effect of semaglutide on COVID-19 and other infections: an analysis from the FLOW randomized clinical trial. Nephrol Dial Transplant. 2026 Feb 23:gfag036. doi: 10.1093/ndt/gfag036. Online ahead of print.

    PubMed 41728915

  • Tuttle KR, Mann JFE, Mayrdorfer MM, Rayner B, Pugliese G, Pratley RE, Perkovic V, Mahaffey KW, Kashihara N, Jeppesen OK, Gumprecht J, Correa-Rotter R, Cherney DZI, Bosch-Traberg H, Arici M, Rossing P; FLOW Trial Investigators. Kidney and Survival Outcomes with Semaglutide by CKD Severity in the FLOW Trial. Clin J Am Soc Nephrol. 2026 Feb 18;21(5):841-51. doi: 10.2215/CJN.0000000974. Online ahead of print.

    PubMed 41706532

  • Rossing P, Lindhardt M, Tikkanen CK, Menon J, Cattin J, Hunt B, Malkin SJP, Chubb B, Damgaard T, Borg R. Once-weekly semaglutide versus placebo for the treatment of type 2 diabetes and chronic kidney disease in Denmark: A long-term cost-effectiveness analysis based on FLOW. Cardiovasc Diabetol. 2025 Dec 20;25(1):32. doi: 10.1186/s12933-025-03002-1.

    PubMed 41422027

  • Pruijm M, Belmar N, Bjornstad P, Cherney DZI, Das V, Gunnarsson T, Hodgin JB, Schytz PA, Tuttle KR, Kretzler M. REMODELing mechanistic trials for kidney disease: a multimodal, tissue-centered approach to understand the renal mechanism of action of semaglutide. Kidney Int. 2026 Jan;109(1):6-16. doi: 10.1016/j.kint.2025.10.005. Epub 2025 Nov 7.

    PubMed 41207620

  • 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.

    PubMed 39963952

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 413 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 413 sites in United States, Canada, Japan, Russia, India and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03819153, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

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