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Clinical Trial Details

Trial ID: L1599
Source ID: NCT03819153
Associated Drug: Semaglutide
Title: A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
Acronym: FLOW
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03819153/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide|DRUG: Placebo (semaglutide)
Outcome Measures: Primary: 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., From Week 0 up to Week 234 | Secondary: 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., From Week 0 up to Week 234|Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI), Number of participants from time of randomization to time to occurrence of onset of persistent ≥50% reduction in eGFR (CKD-EPI) were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., From Week 0 up to Week 234|Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2, Number of participants from time of randomization to time to occurrence of onset of persistent eGFR (CKD-EPI) \<15 mL/min/1.73m\^2 were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., From Week 0 up to Week 234|Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy, Number of participants from time of randomization to time to occurrence of initiation of chronic renal replacement therapy (dialysis or kidney transplantation) were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., From Week 0 up to Week 234|Number of Participants From Time of Randomization to Occurrence of Renal Death, Number of participants from time of randomization to time to occurrence of renal death were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., From Week 0 up to Week 234|Number of Participants From Time of Randomization to Occurrence of CV Death, Number of participants from time of randomization to time to occurrence of CV death were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., From Week 0 up to Week 234|Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope), Annual rate of change in eGFR in terms of chronic kidney disease CKD-EPI were reported from Week 12 to Week 234 in-trial period. eGFR was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., Week 12, Week 234|Change From Baseline in eGFR (CKD-EPI) at Week 12, Change from baseline in eGFR at Week 12 during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., Baseline (Week 0), Week 12|Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104, Changes from baseline in eGFR (cystatin C) at Week 104 in-trial period were reported. Cystatin C was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., Baseline (Week 0), Week 104|Change From Baseline in Urinary Albumin-to-creatinine Ratio (UACR) at Week 104: Ratio to Baseline, Change from baseline in UACR (ratio to baseline) at Week 104 in-trial period were reported. For UACR, the baseline assessment is defined as the mean of the two assessments from the randomization visit. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., Baseline (Week 0), Week 104|Number of Participants From Time of Randomization to Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Acute Myocardial Infarction (Non Fatal); Non-fatal Stroke; and CV Death, Number of participants who reported first occurence of non-fatal acute myocardial infarction, non-fatal stroke, and CV death combined data were presented from Week 0 up to Week 234 during on-treatment period. MACE consisted of non-fatal acute myocardial infarction, cardiovascular death and non-fatal stroke. First on-treatment period is defined as period from date of first dose until first time where no dose had been administered within 5 weeks (35 days) or end of the in-trial period, whichever came first., From Week 0 up to Week 234|Number of Participants From Time of Randomization to Time to Occurrence of All-cause Death, Number of participants who reported occurence of deaths from Week 0 up to Week 234 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., From Week 0 up to Week 234|Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Myocardial Infarction, Number of participants who reported occurrence of non-fatal acute myocardial infarction from Week 0 up to Week 234 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., From Week 0 up to Week 234|Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Stroke, Number of participants who reported occurrence of non-fatal stroke from Week 0 up to Week 234 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., From Week 0 up to Week 234|Number of Participants From Time of Randomization to Time to First Occurrence of Major Adverse Limb Events (MALE): Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization, Number of participants with combined data of first occurence of acute limb ischaemia hospitalization and chronic limb ischaemia hospitalization from Week 0 up to Week 234 during on-treatment period were presented. MALE consisted of acute and chronic limb ischaemia hospitalisation., From Week 0 up to Week 234|Number of Participants With Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization, Number of participants of acute limb ischaemia hospitalization and chronic limb ischaemia hospitalization from Week 0 up to Week 234 during in-trial period were presented. MALE consisted of acute and chronic limb ischaemia hospitalisation. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., From Week 0 up to Week 234|Change From Baseline in Body Weight at Week 104, Change in body weight from Week 0 up to Week 104 during in-trial period, measured in kilograms, were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., Baeline (Week 0), Week 104|Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 104, Change in HbA1c from Week 0 to Week 104 during in-trial period, measured in percentage point of HbA1c, were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., Baseline (Week 0), Week 104|Change From Baseline in Systolic Blood Pressure at Week 104, Change in systolic blood pressure from Week 0 to Week 104 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., Baseline (Week 0), Week 104|Change From Baseline in Diastolic Blood Pressure at Week 104, Change in diastolic blood pressure from Week 0 to Week 104 during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., Baseline (Week 0), Week 104|Number of Severe Hypoglycaemic Episodes, The number of severe hypoglycaemic episodes (such as the seriousness of hypoglycaemia, contributing factors, seizures, and unconsciousness; classified by American Diabetes Association) observed during the in-trial period were reported in this endpoint. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death., From Week 0 up to Week 234
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 3533
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-06-17
Completion Date: 2024-01-09
Results First Posted: 2025-03-20
Last Update Posted: 2025-03-20
Locations: Dr. Terence Hart, Tuscumbia, Alabama, 35674, United States|California Inst Of Renal Res, Chula Vista, California, 91910, United States|John Muir Physician Network, Concord, California, 94520, United States|John Muir Physicians Network, Concord, California, 94520, United States|Valley Research, Fresno, California, 93720, United States|California Institute of Renal Research, La Mesa, California, 91942, United States|First Valley Med Grp Lancaster, Lancaster, California, 93534, United States|Clinical Trials Research_Sacramento, Lincoln, California, 95648, United States|VA Loma Linda Hlthcr Sys, Loma Linda, California, 92357, United States|Long Beach Center For Clinical Research, Long Beach, California, 90807, United States|VA Long Beach Healthcare System, Long Beach, California, 90822, United States|Academic Medical Research Institute, Los Angeles, California, 90022, United States|Valley Renal Medical Group Research, Northridge, California, 91324, United States|Desert Oasis Hlthcr Med Group, Palm Springs, California, 92262, United States|Saviers Medical Group, Port Hueneme, California, 93041, United States|Inland Empire Clin Trials LLC, Rialto, California, 92377, United States|Sierra Clinical Research, Roseville, California, 95661, United States|California Research Foundation, San Diego, California, 92123, United States|N America Res Inst - San Dimas, San Dimas, California, 91773, United States|NorCal Endocrinology and Internal Medicine, San Ramon, California, 94583, United States|Lundquist Inst-Biomed Innovtn, Torrance, California, 90502, United States|San Fernando Valley Hlth Inst, West Hills, California, 91304, United States|Rocky Mount Reg VA Med-DN, Aurora, Colorado, 80045, United States|Creekside Endocrine Associates, PC, Denver, Colorado, 80246, United States|BayCare Medical Group - Endocrinology, Clearwater, Florida, 33756, United States|Horizon Rs Grp, Coral Gbls, Coral Gables, Florida, 33134, United States|Cesar Figueroa M.D. P.A., Delray Beach, Florida, 33445, United States|Northeast Research Institute, Fleming Island, Florida, 32003, United States|Palmetto Medical General Plaza, Hialeah, Florida, 33016, United States|Encore Medical Research LLC, Hollywood, Florida, 33021, United States|Homestead Associates In Research, Homestead, Florida, 33032, United States|San Marcus Res Clin Miami Lakes, Miami Lakes, Florida, 33014, United States|Floridian Clinical Research, LLC, Miami Lakes, Florida, 33016, United States|Life Spring Research, Miami, Florida, 33130, United States|Oceane 7 Medical & Research Center, Inc., Miami, Florida, 33144, United States|International Physicians Research, Miami, Florida, 33173, United States|South Broward Research LLC, Miramar, Florida, 33027, United States|Suncoast Clinical Research, Inc., New Port Richey, Florida, 34652, United States|Hanson Clinical Research Center, Port Charlotte, Florida, 33952, United States|Northeast Research Institute, Saint Augustine, Florida, 32080, United States|Cardiovascular Ctr of Sarasota, Sarasota, Florida, 34239, United States|Clinical Research of Cent FL, Winter Haven, Florida, 33880, United States|Ellipsis Group, Alpharetta, Georgia, 30022, United States|Southeastern Clinical Research Institute, LLC, Augusta, Georgia, 30904, United States|Endocrine Research Solutions, Roswell, Georgia, 30076, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|Saltzer Medical Group Research, Nampa, Idaho, 83686-6011, United States|Apex Medical Research Inc, Chicago, Illinois, 60607, United States|Clinical Invest Special_Gurnee, Gurnee, Illinois, 60031, United States|North Suburban Nephrology LLC, Gurnee, Illinois, 60031, United States|Endeavor Health, Skokie, Illinois, 60077, United States|Velocity Clin. Res Valparaiso, Valparaiso, Indiana, 46383, United States|West Broadway Clinic, Council Bluffs, Iowa, 51501, United States|Four Rivers Clinical Research Inc, Paducah, Kentucky, 42001, United States|Metropolitan Cardiovascular Consultants, LLC, Beltsville, Maryland, 20705, United States|Brigham & Women's Hospital, Boston, Massachusetts, 02115-5804, United States|Northern Pines Hlth Ctr, PC, Buckley, Michigan, 49620, United States|Aa Mrc Llc, Flint, Michigan, 48504, United States|Elite Research Center, Flint, Michigan, 48532, United States|Mayo Clinic, Rochester, Minnesota, 55905-0001, United States|Clinical Research Consultants, LLC, Kansas City, Missouri, 64111, United States|Washington University_St. Louis_0, Saint Louis, Missouri, 63110, United States|Univ of Nebraska Medical CTR, Omaha, Nebraska, 68198, United States|Renal Medicine Associates, Albuquerque, New Mexico, 87109, United States|Albany Medical College - Endo, Albany, New York, 12203, United States|NYU Langone Neph Associates, Mineola, New York, 11501, United States|NYU Nephrology Associates, New York, New York, 10016, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|UNC Diabetes Care Center_Chapel Hill, Chapel Hill, North Carolina, 27514, United States|Carteret Medical Group, Morehead City, North Carolina, 28557, United States|Burke Primary Care, Morganton, North Carolina, 28655, United States|Eastern Nephr Assoc, PLLC, New Bern, North Carolina, 28562, United States|Whiteville Medical Associates, Whiteville, North Carolina, 28472, United States|Accellacare, Wilmington, North Carolina, 28401, United States|Brookview Hills Research Associates, LLC, Winston-Salem, North Carolina, 27103, United States|Cincinnati Veterans Affairs Medical Center, Cincinnati, Ohio, 45220-2213, United States|Advanced Med Res Maumee, Maumee, Ohio, 43537, United States|Alliance for Multispec Res, Norman, Oklahoma, 73069, United States|Heritage Valley Medical Group Inc, Beaver, Pennsylvania, 15009, United States|Lycoming Internal Medicine, Inc., Jersey Shore, Pennsylvania, 17740, United States|Northeast Endocrine Metabolic Associates, Philadelphia, Pennsylvania, 19114, United States|Main Street Physician's Care, Little River, South Carolina, 29566, United States|The Diabetes Center, LLC, Murrells Inlet, South Carolina, 29576, United States|Family Medicine of SayeBrook LLC, Myrtle Beach, South Carolina, 29588, United States|SC Nephrology and Hypertension, Orangeburg, South Carolina, 29118, United States|AM Diabetes And Endocrinology Center, Bartlett, Tennessee, 38133, United States|Univ Diab & Endo Consultants, Chattanooga, Tennessee, 37411, United States|Vanderbilt Medical Center_Nashville, Nashville, Tennessee, 37232, United States|Central Texas Clinical Research, Austin, Texas, 78705, United States|Texas Diabetes & Endocrinology, P.A._Austin, Austin, Texas, 78731, United States|Research Management, Inc, Austin, Texas, 78751, United States|Osvaldo A. Brusco MD PA, Corpus Christi, Texas, 78414, United States|Baylor Jack and Jane Hamilton, Dallas, Texas, 75226, United States|Research Institute Of Dallas, Dallas, Texas, 75231, United States|UT Southwestern Med Cntr, Dallas, Texas, 75390-9302, United States|MedResearch Inc, El Paso, Texas, 79902, United States|Academy of Diabetes, T&E, El Paso, Texas, 79935, United States|Juno Research, LLC_Houston, Houston, Texas, 77040, United States|Juno Research, LLC_Houston, Houston, Texas, 77074, United States|Southwest Clinical Trials, Houston, Texas, 77081, United States|Southwest Houston Research Ltd, Houston, Texas, 77099, United States|Carlos Arauz-Pacheco Md, Pa, Rockwall, Texas, 75032, United States|Univ Of Texas Hlth Science Cntr, San Antonio, Texas, 78207, United States|Sun Research Institute, San Antonio, Texas, 78215, United States|Briggs Clinical Research, LLC, San Antonio, Texas, 78224, United States|VIP Trials, San Antonio, Texas, 78230, United States|NE Clin Res of San Antonio, San Antonio, Texas, 78233, United States|Simcare Medical Research, LLC, Sugar Land, Texas, 77478, United States|University of Utah School of Medicine, Salt Lake City, Utah, 84108, United States|University of Vermont Medical Center, South Burlington, Vermont, 05403, United States|York Clinical Research LLC, Norfolk, Virginia, 23504, United States|McGuire VA Medical Center, Richmond, Virginia, 23249, United States|VA Medical Center_Salem, Salem, Virginia, 24153-6404, United States|Amherst Family Practice P.C., Winchester, Virginia, 22601, United States|Capital Clin Res Ctr,LLC, Olympia, Washington, 98502, United States|MultiCare Inst for Res & Innov, Spokane, Washington, 99202, United States|Universal Research Group, Tacoma, Washington, 98405, United States|Centro de Estudios Renales e Hipertensión Arterial, Villa Dominico, Buenos Aires, B1872EEA, Argentina|Centro Diabetológico y Nuticional Dr Alejandro Chertkoff, Buenos Aires, C1250AAN, Argentina|Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli, Buenos Aires, C1425AGC, Argentina|FEPREVA, Caba, 1429, Argentina|Centro de Investigación Clínica, Caba, C1060ABA, Argentina|Glenny Corp. S.A, Caba, C1430CKE, Argentina|Medical Center of Diabetes and Nutrition, Caba, C1440AAD, Argentina|Gosford Renal Research, Gosford, New South Wales, 2250, Australia|Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia|Westmead Hospital_Northmead, Westmead, New South Wales, 2145, Australia|Core Research Centre, Milton, Queensland, 4064, Australia|Monash Health Nephrology, Clayton, Victoria, 3168, Australia|St Vincent's Hospital_Fitzroy_0, Fitzroy, Victoria, 3065, Australia|Monash University Clinical Trial Centre, Melbourne, Victoria, 3004, Australia|The Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia|Imeldaziekenhuis - Bonheiden - Department of Endocrinology, Bonheiden, 2820, Belgium|Universitair Ziekenhuis Brussel - Diabeteskliniek, Brussel, 1090, Belgium|UZ Brussel - Universitair Ziekenhuis Brussel, Brussel, 1090, Belgium|Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie, Bruxelles, 1200, Belgium|UZA - UZ Antwerpen - Department of Endocrinology, Edegem, 2650, Belgium|UZ Gent - Endocrinologie - Diabetologie, Gent, 9000, Belgium|UZ Leuven - Endocrinology, Leuven, 3000, Belgium|Centre hospitalier universitaire de Liège (CHU de Liège), Liège, 4000, Belgium|AZ Delta - Roeselare, Roeselare, 8800, Belgium|Instituto de Ensino e Pesquisa Clínica do Ceará Ltda, Fortaleza, Ceara, 60125-058, Brazil|Instituto Pró-Renal Brasil, Curitiba, Parana, 80440-020, Brazil|Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda., Porto Alegre, Rio Grande Do Sul, 90430-001, Brazil|Hospital e Maternidade Dr. Christovão da Gama S.A., Santo André, Sao Paulo, 09030-010, Brazil|Instituto de Pesquisa Clinica (IPEC), São Paulo, Sao Paulo, 01223-001, Brazil|CPQuali Pesquisa Clínica Ltda, São Paulo, Sao Paulo, 01228-000, Brazil|CPCLIN - Centro de Pesquisas Clínicas, São Paulo, Sao Paulo, 01228-200, Brazil|Centro Médico Hospital da Bahia, Bahia, 41810-011, Brazil|Medical centre "Zdrave 1" OOD, Kozloduy, 3320, Bulgaria|UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases, Plovdiv, 4001, Bulgaria|MHAT "Dr. Ivan Seliminski"-Sliven, Sliven, 8800, Bulgaria|"Nader Yabrudi - ASMPVBE Individual practice", Smolyan, 4700, Bulgaria|UMHAT Aleksandrovska, Sofia, 1431, Bulgaria|Medical Center Synexus Sofia, Sofia, 1784, Bulgaria|Medical Center "Nov Rehabilitatsionen center" EOOD, Stara Zagora, 6001, Bulgaria|LMC Clin Res Inc. Calgary, Calgary, Alberta, T2H 2G4, Canada|University of Calgary, Calgary, Alberta, T2T 5C7, Canada|The Bailey Clinic, Red Deer, Alberta, T4N 6V7, Canada|BC Diabetes Canada, Vancouver, British Columbia, V5Y 3W2, Canada|Commonwealth Medical Clinic, Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada|Eastern Health Authority, St. Johns, Newfoundland and Labrador, A1B 3V6, Canada|QE II Health - Pharmacy, Halifax, Nova Scotia, B3H 1V8, Canada|Dr. Harpreet Bajaj, Brampton, Ontario, L6S 0C6, Canada|Aggarwal and Assoc Ltd., Brampton, Ontario, L6T 0G1, Canada|JBN Medical Diagnostic Services Inc., Burlington, Ontario, L7M 4Y1, Canada|LMC Clin Res Inc. Thornhill, Concord, Ontario, L4K 4M2, Canada|LMC Endo Ctr (Etobicoke) Ltd, Etobicoke, Ontario, M9R 4E1, Canada|Hamilton Med Res Group, Hamilton, Ontario, L8M 1K7, Canada|Premier Clinical Trial Research Network (PCTRN), Hamilton, Ontario, L8M 1K7, Canada|Milestone Research, London, Ontario, N5W 6A2, Canada|LMC Research Inc. Ottawa, Nepean, Ontario, K2J 0V2, Canada|Lakeridge Health, Oshawa, Ontario, L1G 2B9, Canada|Dr. James Cha, Oshawa, Ontario, L1J 2K1, Canada|King Street Research, Oshawa, Ontario, L1J 2K1, Canada|Bluewater Clin Res Group, Inc., Sarnia, Ontario, N7T 4X3, Canada|Bluewater Clin Res Group,Inc, Sarnia, Ontario, N7T 4X3, Canada|Winterberry Family Medicine, Stoney Creek, Ontario, L8J 0B6, Canada|LMC Endo Centres Ltd.(Bayview), Toronto, Ontario, M4G 3E8, Canada|UHN-Toronto General Hospital, Toronto, Ontario, M5G 2N2, Canada|Mount Sinai Hospital, Toronto, Ontario, M5T 3L9, Canada|Dr Anil K Gupta Med Prof Corp, Toronto, Ontario, M9V 4B4, Canada|Dr. Anil K Gupta Med Prof Corp, Toronto, Ontario, M9V 4B4, Canada|Ctr de rech Clin de Laval, Laval, Quebec, H7T 2P5, Canada|Clinique de Recherche Medpharmgene Inc., Montreal, Quebec, H2K 1H2, Canada|Applied Med Inf Res, Montreal, Quebec, H4A 3T2, Canada|Centre Medical Acadie, Montreal, Quebec, H4N 2W2, Canada|Centre de Recherche Saint-Louis, Quebec, G1W 4R4, Canada|Peking University People's Hospital-Endocrinology, Beijing, Beijing, 100044, China|Peking University People's Hospital, Beijing, Beijing, 100044, China|Beijing Pinggu Hospital-Endocrinology, Beijing, Beijing, 101200, China|The Affiliated Hospital of Jiangsu University-Endocrinology, Zhenjiang, Jiangsu, 212001, China|Jinan Central Hospital, Ji'nan, Shandong, 250013, China|Centre Hospitalier Ardeche Nord, Annonay cedex, 07103, France|Hospices Civils de Lyon-Hopital Cardiologique Louis Pradel-2, BRON cedex, 69677, France|Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre-1, Caen, 14033, France|Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-2, Grenoble - Cédex 09, 38043, France|Centre Hospitalier Departemental Vendee- La Roche Sur Yon, La Roche-sur-yon, 85925, France|Les Hopitaux de Chartres-Hopital Louis Pasteur, Le Coudray, 28630, France|Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1, Le Creusot, 71200, France|Groupe SOS Santé Hôtel Dieu, Le Creusot, 71200, France|Fondation Rothschild, Paris, 75019, France|Centre Hospitalier Universitaire Reims-Hopital Maison Blanche, Reims, 51092, France|Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1, Saint Herblain, 44800, France|Hôpital Nord Laënnec- Service D'Endocrinologie, Saint Herblain, 44800, France|Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2, Toulouse, 31054, France|Centre de Recherche Clinique Portes Du Sud, Venissieux, 69200, France|Diabetespraxis Mergentheim, Bad Mergentheim, 97980, Germany|Herz- und Diabeteszentrum NRW - Bad Oeynhausen, Bad Oeynhausen, 32545, Germany|DaVita Clinical Research Deutschland GmbH, Düsseldorf, 40210, Germany|Medizinische Klinik 4, Universitätsklinikum Erlangen, Erlangen, 91054, Germany|InnoDiab Forschung GmbH, Essen, 45136, Germany|Praxis Dr. med. M. Esser, Essen, 45219, Germany|Wendisch/Dahl Hamburg, Hamburg, 22607, Germany|Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster, 48145, Germany|Zentrum für klinische Studien Alexander Segner, Saint Ingbert-Oberwürzbach, 66386, Germany|University Hospital of Athens ATTIKON, Athens, Attica, 12462, Greece|Iatriko Psychicou Private Clinic, Athens, 115 25, Greece|General hospital of Athens 'G.Gennimatas', Athens, 11527, Greece|Iatriko Athinon 'Palaiou Falirou', Athens, 17562, Greece|General Hospital of Athens "Laiko", Nephrology Clinic, Athens, GR-11527, Greece|General Hospital of Lamia, Lamia, 35100, Greece|General University Hospital of Patras,Nephrology clinic, Rio, Patra, 26504, Greece|AHEPA General University Hospital, Thessaloniki, 54636, Greece|"Ippokrateio" G.H. of Thessaloniki, Thessaloniki, 54642, Greece|General Hospital of Thessaloniki "Ippokrateio", Thessaloniki, 54642, Greece|EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes, Thessaloniki, 54643, Greece|"Thermi" Private Hosital, Thessaloniki, 57001, Greece|Genl Hosp of Thessaloniki, Papageorgiou ,Nephrology clinic, Thessaloniki, GR-564 29, Greece|PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum, Pécs, Baranya Vármegye, 7623, Hungary|Lausmed Kft., Baja, Bács-Kiskun Vármegye, 6500, Hungary|Belinus Bt., Debrecen, Hajdu-Bihar Varmegye, 4025, Hungary|Siófoki Kórház, Diabetológiai Szakrendelés, Siófok, Somogy Vármegye, 8600, Hungary|Borbánya Praxis E.Ü. Kft., Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405, Hungary|Péterfy Sándor utcai Kórház, Budapest, 1076, Hungary|MED-TIMA Kft., Budapest, 1132, Hungary|Belinus Bt., Debrecen, 4025, Hungary|Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület, Debrecen, 4043, Hungary|Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika, Debrecen, H-4032, Hungary|Békés Megyei Központi Kórház, Gyula, H-5700, Hungary|Siófoki Kórház, Diabetológiai Szakrendelés, Siófok, 8600, Hungary|Markusovszky Egyetemi Oktatókórház, Szombathely, 9700, Hungary|Markusovszky Egyetemi Oktatókórház, Szombathely, H-9700, Hungary|Endolife Specialty Hospitals, Guntur, Andhra Pradesh, 522001, India|Max Super Speciality Hospital, Saket, New Delhi, Delhi, 110017, India|Ramaiah Memorial Hospital, Bangalore, Karnataka, 560054, India|BGS Global Hospitals, Bangalore, Karnataka, 560060, India|Lifecare Hospital and Research Centre, Bangalore, Karnataka, 560092, India|Amrita Institute Of Medical Sciences & Research Centre, Kochi, Kerala, 682041, India|Calicut Medical College, Kozhikode, Kerala, 673008, India|Seth GS medical college and KEM Hospital, Mumbai, Maharashtra, 400012, India|Poona hospital and research centre, Pune, Maharashtra, 411030, India|The Madras Medical Mission, Chennai, Tamil Nadu, 600037, India|Osmania General Hospital, Hyderabad, Telangana, 500012, India|MV Hospital and Research Centre, Lucknow, Uttar Pradesh, 226003, India|Ajanta ResearchCentre, Lucknow, Uttar Pradesh, 226005, India|Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, 226014, India|Sanjay Gandhi Postgraduate Institute of Medical Science, Lucknow, Uttar Pradesh, 226014, India|Apollo Multispeciality Hospital, Kolkata, Kolkata, West Bengal, 700054, India|Sir Ganga Ram Hospital, New Delhi, 110060, India|Diabetes Clinic Wolfson MC, Holon, 58100, Israel|Diabetes Unit Hadassah Ein Karem MC, Jerusalem, 91120, Israel|Meir Medical Center, Kfar Saba, 4428164, Israel|Kaplan Medical Center_Rehovot, Rehovot, 7661041, Israel|Istituto Scientifico San Raffaele, Milano, MI, 20132, Italy|AOUPol.Giaccone UOC Malattie Endocrine,Ricambio e Nutrizione, Palermo, PA, 90127, Italy|Presidio Ospedaliero Cisanello, Pisa, PI, 56124, Italy|AO Papa Giovanni XXIII UOC malattie Endocrine 1-Diabetologia, Bergamo, 24127, Italy|Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, 24127, Italy|Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia, Milano, 20122, Italy|Azienda Ospedaliera Luigi Sacco, Milano, 20157, Italy|Azienda Ospealiero Universitaria Policlinico Umberto I, Roma, 00161, Italy|Azienda Ospedaliero - Universitaria Sant'Andrea, Roma, 00189, Italy|Seino Internal Medicine Clinic, Koriyama-shi, Fukushima, Japan, 963-8851, Japan|Manda Memorial Hospital, Sapporo-shi, Hokkaido, Hokkaido, Japan, 060-0062, Japan|Jinnouchi Hospital, Kumamoto-shi, Kumamoto, Japan, 862-0976, Japan|Heiwadai Hospital, Miyazaki-shi, Miyazaki, 880-0034, Japan|New Tokyo Heart Clinic, Chiba, 271-0077, Japan|Fukui Prefectural Hospital_Fukui, Fukui, 910-8526, Japan|Fukuoka Tokushukai Hospital, Fukuoka, 816-0864, Japan|Kawada Clinic, Gunma, 373-0036, Japan|Sasaki Hospital Internal Medicine, Hokkaido, 062-0007, Japan|Sasaki Internal Medicine, Hokkaido, 062-0007, Japan|Nishiyamado Keiwa Hospital, Ibaraki,, 331-0133, Japan|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|Kanazawa Medical University Hospital, Ishikawa, 920-0293, Japan|Yokohama Minoru Clinic, Kanagawa, 232-0064, Japan|H.E.C Science Clinic, Kanagawa, 235-0045, Japan|Shonan Takai Clinic, Kanagawa, 247-0055, Japan|Uji Tokushukai Medical Center, Kyoto, 611-0041, Japan|Kawasaki Medical School Hospital, Okayama, 701-0192, Japan|Takatsuki Red Cross Hospital, Osaka, 569-1045, Japan|Shimizu Clinic Fusa, Saitama, 336-0967, Japan|Oyama East Clinic, Tochigi, 323-0022, Japan|Tokyo Center Clinic, Tokyo, 103-0028, Japan|Fukuwa Clinic, Tokyo, 104-0031, Japan|Juntendo University Hospital_Tokyo, Tokyo, 113-8431, Japan|The University of Tokyo Hospital, Tokyo, 113-8655, Japan|Kato Clinic of Internal Medicine, Tokyo, 125-0054, Japan|Sugawara Clinic, Tokyo, 177-0041, Japan|University Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia|Hospital Sultanah Bahiyah, Alor Setar, 05460, Malaysia|Hospital Raja Permaisuri Bainun Ipoh, Ipoh, Perak, 30450, Malaysia|Sarawak General Hospital, Kuching, 93586, Malaysia|Hospital Pulau Pinang, Pulau Pinang, 10990, Malaysia|Hospital Serdang, Serdang, 43000, Malaysia|Centro de Atención al Diabetico, Actopan, Hidalgo, 42500, Mexico|Inst. Jaliscience de Investigacion en Diabetes y Obesidad SC, Guadalajara, Jalisco, 44600, Mexico|Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab, Distrito Federal, México, D.F., 14080, Mexico|Instituto Nacional de Ciencias Médicas y Nutrición_Mexico City, Mexico City, México, D.F., 14080, Mexico|Centro para el Desarrollo de la Medicina y la Asistencia, Culiacán, Sinaloa, 80230, Mexico|Centro de Estudios de Investigación Metabólicos y Cardio, Ciudad Madero, Tamaulipas, 89440, Mexico|Noordwest Ziekenhuisgroep, Alkmaar, 1815 JD, Netherlands|Ziekenhuis Groep Twente Almelo, Almelo, 7609 PP, Netherlands|EB Flevo Research BV, Almere, 1311RL, Netherlands|Meander Medisch Centrum, Amersfoort, 3813 TZ, Netherlands|OLVG West, Amsterdam, 1061 AE, Netherlands|Amsterdam UMC Lokatie VUMC, Amsterdam, 1081 HV, Netherlands|Rijnstate Ziekenhuis, Arnhem, 6815 AD, Netherlands|Tergooi, locatie Hilversum, Hilversum, 1213 XZ, Netherlands|Universitair Medisch Centrum Utrecht, Utrecht, 3584 CX, Netherlands|Osteo Medic s.c. Artur Racewicz Jerzy Supronik, Bialystok, 15-351, Poland|NZOZ WITAMED Poradnia Diabetologiczna, Kielce, 25-035, Poland|Wojewodzki Szpital Specjalistyczny w Olsztynie, Olsztyn, 10-561, Poland|Centrum Medyczne "Diabetika", Radom, 26-600, Poland|Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie, Szczecin, 70-111, Poland|Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa, 01-192, Poland|Miedzyleski Szpital Specjalistyczny, Oddzial Nefrologiczny, Warszawa, 04-749, Poland|Prywatny Gabinet Janusz Gumprecht, Zabrze, 41-800, Poland|Reg. State Budget Healthc. Inst. Regional Clinical Hospital, Barnaul, 656024, Russian Federation|City Hospital #5, Barnaul, 656045, Russian Federation|Road Clinical Hospital at station Chelyabinsk, Chelyabinsk, 454048, Russian Federation|PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways, Kazan, 420061, Russian Federation|SAHI Kuzbass Hospital(former Regional clinical hospital), Kemerovo, 650066, Russian Federation|National Medical Research Center of Endocrinology, Moscow, 117292, Russian Federation|LLC RC Medical, Novosibirsk, 630005, Russian Federation|Limited Law Company "Healthy Family" Medicine Center", Novosibirsk, 630099, Russian Federation|Penza Regional Clinical Hospital named after N.N. Burdenko, Penza, 440026, Russian Federation|Aurora MedFort LLC, Saint Petersburg, 194156, Russian Federation|Joint Stock Company "Modern Medical Technologies", Saint-Petersburg, 190121, Russian Federation|Limited Liability Company "Energiya Zdoroviya", Saint-Petersburg, 194156, Russian Federation|Medinet LLC, Saint-Petersburg, 194356, Russian Federation|LLC "Endocrinolog", Samara, 443031, Russian Federation|SHI Saratov City Clinical Hospital #9, Saratov, 410031, Russian Federation|Regional clinical cardiology dispensary, Saratov, 410039, Russian Federation|Regional Endocrinological Dispensary, Stavropol, 355035, Russian Federation|Ulianovsk Regional Clinical Hospital, Ulianovsk, 432063, Russian Federation|Voronezh Regional Clinical Consultive-diagnostic Centre, Voronezh, 394018, Russian Federation|Solovyev Clinical Emergency Hospital, Yaroslavl, 150003, Russian Federation|Polyclinic #2 in Yoshkar-Ola, Yoshkar-Ola, 424004, Russian Federation|MEDISPEKTRUM s.r.o., Bratislava, 851 01, Slovakia|FMC - dialyzacne sluzby, s.r.o., Kosice, 04011, Slovakia|Narodny Endokrinologicky a diabetologicky ustav, Lubochna, 03491, Slovakia|IN-DIA s.r.o., Lucenec, 984 01, Slovakia|DIABETIK s.r.o., Nitra, 94901, Slovakia|Diabetologicka ambulancia MEDIKARD, s.r.o., Presov, 08001, Slovakia|ARETEUS s.r.o., Trebisov, 07501, Slovakia|MUDr. Jana Rociakova s.r.o., ambulancia vnutorneho lekarstva, Zilina, 010 01, Slovakia|FMC- dialyzacne sluzby, s.r.o., Zilina, 010 08, Slovakia|MEDIVASA, s.r.o., Diabetologicka ambulancia, Zilina, 01001, Slovakia|Diabetes Care Centre & CDE Centre, Benoni, Gauteng, 1501, South Africa|LCS Clinical Research Unit, Cosmo City, Gauteng, 2188, South Africa|Soweto Clinical Trial Centre, Johannesburg, Gauteng, 1818, South Africa|Hemant Makan, Johannesburg, Gauteng, 1827, South Africa|Wits Bara Clinical Trial Site, Johannesburg, Gauteng, 2013, South Africa|Dr A Amod, Durban, KwaZulu-Natal, 4092, South Africa|Precise Clinical Solutions (Pty) Ltd, Durban, KwaZulu-Natal, 4092, South Africa|Tiervlei Trial Centre, Cape Town, Western Cape, 7530, South Africa|Prof Rayner_Division of Nephrology, Cape Town, Western Cape, 7925, South Africa|Hospital del Mar, Barcelona, 08003, Spain|Hospital Vall d'Hebron, Barcelona, 08035, Spain|Hospital Público da Mariña, Burela, 27880, Spain|Hospital Universitario de Getafe, Getafe, 28909, Spain|Hospital Ribera Polusa, Lugo, 27004, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain|Hospital Universitario Doctor Peset, Valencia, 46017, Spain|Siriraj Hospital_Bangkoknoi, Bangkok, Bangkoknoi, Bangkok, Bangkok, 10700, Thailand|Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, Mueang Chiang Mai District, 50200, Thailand|Phramongkutklao Hospital-nephrology, Bangkok, Rajathewee, 10400, Thailand|King Chulalongkorn Memorial Hospital-Division of Nephrology, Bangkok, 10330, Thailand|King Chulalongkorn Memorial Hospital_Bangkok, Bangkok, 10330, Thailand|Phramongkutklao Hospital-nephrology, Bangkok, 10400, Thailand|Siriraj Hospital-Nephro, Bangkok, 10700, Thailand|Ankara Universitesi Ibni Sina Hastanesi, Ankara, 06100, Turkey|Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali, Ankara, 06230, Turkey|Gazi University Medical Faculty- Nephrology, Ankara, 06500, Turkey|Akdeniz Universitesi Hastanesi Nefroloji Bilim Dali, Antalya, 07058, Turkey|Aydin Adnan Menderes University Nephrology, Aydin, 09100, Turkey|Istanbul University Cerrahpasa Medical Faculty, Istanbul, 34098, Turkey|Istanbul Universitesi Istanbul Tip Fakultesi- Nefroloji, Istanbul, 34390, Turkey|Goztepe Egitim Arastirma Hastanesi Nefroloji, Istanbul, 34722, Turkey|T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi, Istanbul, 34899, Turkey|Ege University Medical Faculty, Izmir, 35100, Turkey|Kahramanmaras Sutcu Imam University, Kahramanmaras, 46040, Turkey|Kocaeli University Nephrology Department, Kocaeli, 41380, Turkey|SI "Institute of Medical and Social Problems of Disability", Dnipro, 49000, Ukraine|Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk, 76008, Ukraine|CNPI "Kharkiv City Clinical Hospital #27", Kharkiv, 61002, Ukraine|SI "National Institute of Therapy n.a. L.T. Malaya of NAMSU", Kharkiv, 61039, Ukraine|Institute of Endocrinology and Metabolism of AMSU, Kyiv, 04114, Ukraine|CI "1st City Clinical Hospital of Poltava City Council", Poltava, 36039, Ukraine|CI "Zaporizhia city clinical hospital #10", Zaporizhia, 69001, Ukraine|Aberdeen Royal Infirmary, Aberdeen, AB25 2ZN, United Kingdom|Diabetes Centre, Heartlands Hospital, Birmingham, Birmingham, B9 5SS, United Kingdom|Ely Bridge Surgery, Cardiff, CF5 4AD, United Kingdom|Ninewells Hospital, Dundee, DD1 9SY, United Kingdom|Western General Hospital, Edinburgh, EH4 2XU, United Kingdom|Glasgow Clinical Research Facility, Glasgow, G31 2ER, United Kingdom|The Diabetes Centre, Ipswich, IP4 5PD, United Kingdom|North Middlesex Hospital, London, N18 1QX, United Kingdom|Royal Free - Diabetes, London, NW3 2QG, United Kingdom|Lister Hospital, Stevenage, SG1 4AB, United Kingdom|St Georges Hospital, Tooting, SW17 0RE, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03819153