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Clinical Trial Details

Trial ID: L5786
Source ID: NCT05352815
Associated Drug: Icosema
Title: A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec
Acronym: COMBINE 1
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT05352815/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: IcoSema|DRUG: Insulin icodec
Outcome Measures: Primary: Change in Glycated Haemoglobin (HbA1c), Change from baseline (week 0) to week 52 in HbA1c is presented. The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above., Baseline (Week 0), Week 52 | Secondary: Change in Body Weight, Change from baseline (week 0) to week 52 in body weight is presented. The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above., Baseline (Week 0), Week 52|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre [mmol/L] (54 Milligram Per Decilitre [mg/dL]), Confirmed by Blood Glucose [BG] Meter) or Severe Hypoglycaemic Episodes (Level 3), Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was less than (\<) 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit ; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets., From baseline week 0 to week 57|Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6, Time in range was defined as 100 times the number of recorded measurements in glycemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above., From week 48 to week 52|Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6, Time spent below threshold was defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above., From week 48 to week 52|Percentage of Time Spent > 10.0 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6, Time spent above threshold is defined as 100 times the number of recorded measurements above the threshold, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above., From week 48 to week 52|Change in Fasting Plasma Glucose (FPG), Change in FPG from baseline (week 0) to week 52 is presented. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above., Baseline (Week 0), Week 52|Weekly Basal Insulin Dose, Estimated mean average weekly basal insulin dose from week 50 to week 52 of treatment is presented. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit (V56); 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets., From week 50 to week 52|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter), Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was less than (\<) 3.0 mmol/L (54 mg/dL). The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit ; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets., From baseline week 0 to week 57|Number of Severe Hypoglycaemic Episodes (Level 3), Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 3 had no specific glucose threshold. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets., From baseline week 0 to week 57
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1291
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-06-01
Completion Date: 2024-04-23
Results First Posted: 2025-04-03
Last Update Posted: 2025-04-03
Locations: Pri Med Grp dba/Gil Ctr Fam, Gilbert, Arizona, 85296, United States|Medical Investigations, Inc., Little Rock, Arkansas, 72211, United States|John Muir Physicians Network, Concord, California, 94520, United States|Headlands Research California, LLC, Escondido, California, 92025, United States|Scripps Whittier Diabetes Inst, La Jolla, California, 92037, United States|Torrance Clin Res Inst, Inc., Lomita, California, 90717, United States|Pacific Clinical Studies, Los Alamitos, California, 90720, United States|Downtown LA Res Ctr. Inc., Los Angeles, California, 90017, United States|Velocity Clin Res Wstlke, Los Angeles, California, 90057, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|NorCal Endocrinology and Internal Medicine, San Ramon, California, 94583, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|Creekside Endocrine Associates, PC, Denver, Colorado, 80246, United States|Clinical Res Of W Florida Inc, Clearwater, Florida, 33765, United States|Northeast Research Institute, Fleming Island, Florida, 32003, United States|Suncoast Clin Res Port Richey, New Port Richey, Florida, 34652, United States|Metabolic Research Institute Inc, West Palm Beach, Florida, 33401, United States|Javara/Privia Med Grp GA,LLC, Albany, Georgia, 31707, United States|Javara Inc., Fayetteville, Georgia, 30214, United States|Physicians Research Assoc. LLC, Lawrenceville, Georgia, 30046, United States|Endeavor Health, Skokie, Illinois, 60077, United States|Iowa Diab & Endo Res Center, West Des Moines, Iowa, 50266, United States|Cotton O'Neil Clin Research Ctr, Topeka, Kansas, 66606, United States|The Research Group of Lexington LLC, Lexington, Kentucky, 40503, United States|New Orleans Center for Clinical Research, New Orleans, Louisiana, 70119, United States|Ileana J Tandron APMC, Slidell, Louisiana, 70461-4231, United States|MedStar Hlth Res Institute, Hyattsville, Maryland, 20782, United States|Brigham & Women's Hospital, Boston, Massachusetts, 02115-5804, United States|Northern Pines Hlth Ctr, PC, Buckley, Michigan, 49620, United States|Elite Research Center, Flint, Michigan, 48532, United States|International Diabetes Center, Minneapolis, Minnesota, 55416, United States|Jefferson City Medical Group, PC, Jefferson City, Missouri, 65109, United States|Methodist Phys. Clinic, Omaha, Nebraska, 68114, United States|University of NE Med Ctr, Omaha, Nebraska, 68198, United States|Palm Research Center Inc., Las Vegas, Nevada, 89148, United States|Southern New Hampshire Diabete, Nashua, New Hampshire, 03063, United States|Albuquerque Clin Trials, Inc., Albuquerque, New Mexico, 87102, United States|Mid Hudson Medical Research, PLLC, New Windsor, New York, 12553, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|PharmQuest Life Sciences LLC, Greensboro, North Carolina, 27408, United States|Central Ohio Clinical Research LLC, Columbus, Ohio, 43213, United States|New Venture Medical Research, Wadsworth, Ohio, 44281, United States|AM Diabetes And Endocrinology Center, Bartlett, Tennessee, 38133, United States|Holston Medical Group_Bristol, Bristol, Tennessee, 37620, United States|HealthStar Physicians PC, Morristown, Tennessee, 37813, United States|Amarillo Med Spec LLP, Amarillo, Texas, 79106, United States|Texas Diabetes & Endocrinology, P.A._Austin, Austin, Texas, 78731, United States|Texas Diabetes & Endocrinology, P.A._Austin, Austin, Texas, 78749, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|Univ of TX SW Med Ctr Dallas, Dallas, Texas, 75390-9302, United States|PrimeCare Medical Group, Houston, Texas, 77024, United States|Javara Inc. / Privia Medical Group Gulf Coast PLLC, Houston, Texas, 77054, United States|PlanIt Research, PLLC, Houston, Texas, 77079, United States|Protenium Clinical Research, Hurst, Texas, 76054, United States|Andres Garcia-Zuniga, MD, P.A, Laredo, Texas, 78041, United States|Milton Haber, M.D., Laredo, Texas, 78041, United States|DCOL Ctr for Clin Res, Longview, Texas, 75605, United States|Texas Diabetes &Endocrinology, Round Rock, Texas, 78681, United States|Sun Research Institute, San Antonio, Texas, 78215, United States|Briggs Clinical Research, LLC, San Antonio, Texas, 78224, United States|Javara Inc Privia Grp Gulf Cst, San Marcos, Texas, 78666, United States|SimCare, PLLC, Sugar Land, Texas, 77478, United States|Javara Inc/Privia Md GpLLC Fst, Forest, Virginia, 24551, United States|Eastern Virginia Medical School, Norfolk, Virginia, 23510, United States|Amherst Family Practice P.C., Winchester, Virginia, 22601, United States|Holdsworth House Clinical Research, Darlinghurst, New South Wales, 2010, Australia|Momentum Clinical Research Darlinghurst, Darlinghurst, New South Wales, 2010, Australia|Novatrials, Kotara, New South Wales, 2289, Australia|Illawarra Diabetes Service Clinical Trials & Research Unit, Wollongong, New South Wales, 2500, Australia|Royal Brisbane and Women's Hospital, Herston, Queensland, 4029, Australia|Southern Adelaide Diabetes & Endocrine Services, Oaklands Park, South Australia, 5046, Australia|Launceston General Hospital, Launceston, Tasmania, 7250, Australia|Barwon Health (The Geelong Hospital), Geelong, Victoria, 3220, Australia|The Alfred Hospital, Melbourne, Victoria, 3004, Australia|Imeldaziekenhuis - Bonheiden - Department of Endocrinology, Bonheiden, 2820, 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|AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie, Kortrijk, 8500, Belgium|UZ Leuven - Endocrinology, Leuven, 3000, Belgium|"IPSMC - d-r Nikolay Kostadinov" EOOD, Burgas, 8000, Bulgaria|'Medical center Medi city 21' OOD, Kyustendil, 2500, Bulgaria|DCC I- Pleven EOOD, Pleven, 5801, Bulgaria|UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases, Plovdiv, 4001, Bulgaria|MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases, Sofia, 1606, Bulgaria|Anhui Provincial Hospital-Endocrinology, Hefei, Anhui, 230001, China|Peking University People's Hospital-Endocrinology, Beijing, Beijing, 100044, China|Chongqing University Three Gorges Hospital, ChongQing, Chongqing, 404000, China|Huizhou Central People's Hospital-Endocrinology, Huizhou, Guangdong, 516001, China|Harrison International Peace Hospital-Endocrinology, Hengshui, Hebei, 053000, China|Harrison International Peace Hospital, Hengshui, Hebei, 053000, China|Huaihe Hospital of Henan University-Endocrinology, Kaifeng, Henan, 475000, China|Changzhou No.2 People's Hospital, Yanghu Branch, Changzhou, Jiangsu, 213003, China|The First People's Hospital of Changzhou, Changzhou, Jiangsu, 213003, China|The Second Affiliated Hospital of Nanjing Medical University-Endocrinology, Nanjing, Jiangsu, 210011, China|The Second Affiliated Hospital of Nanjing Medical University_Nanjing, Nanjing, Jiangsu, 210011, China|The Second Affiliated Hospital of Soochow University-Endocrinology, Suzhou, Jiangsu, 215004, China|The Affiliated Hospital of Jiangsu University-Endocrinology, Zhenjiang, Jiangsu, 212001, China|Jinan Central Hospital, Ji'nan, Shandong, 250013, China|Shanghai Fifth People's Hospital-Endocrinology, Shanghai, Shanghai, 200240, China|General Hospital of Tianjin Medical University-Endocrinology, Tianjin, Tianjin, 300052, China|The Second Hospital of Tianjin Medical University, Tianjin, Tianjin, 300211, China|Poliklinika Solmed, Zagreb, Grad Zagreb, 10000, Croatia|Poliklinika SLAVONIJA OSIJEK, Osijek, Osječko - Baranjska Županija, 31000, Croatia|Klinicki bolnicki centar Osijek, Osijek, 31 000, Croatia|Opca bolnica Pula, Pula, 52100, Croatia|KBC Rijeka, Endokrinologija, Rijeka, 51000, Croatia|Health Step Finland Oy, Kuopio, 70210, Finland|Raision sosiaali- ja terveyskeskus, Raisio, 21200, Finland|Tampereen diabetesvastaanotto, Tampere, 33900, Finland|Turku University Hospital, Turku, 20520, Finland|Ähtärin terveysasema, Ähtäri, 63700, Finland|Gujarat Endocrine Centre, Ahmedabad, Gujarat, 380052, India|Government Medical College, Kozhikode, Kozhikode, Kerala, 673008, India|Jothydev's Diabetes & Research Center, Thriruvananthapuram, Kerala, 695 032, India|TOTALL Diabetes Hormone Institute, Indore, Madhya Pradesh, 452010, India|Excel Endocrine Centre, Kolhapur, Maharashtra, 416008, India|Seth GS medical college and KEM Hospital, Mumbai, Maharashtra, 400012, India|Post Graduate Institute of Medical Education & Research, Chandigarh, Punjab, 160012, India|M.V.Hospital for Diabetes Pvt. Ltd., Chennai, Tamil Nadu, 600 013, India|Arthur Asirvatham hospital,, Madurai, Tamil Nadu, 625020, India|Osmania General Hospital, Hyderabad, Telangana, 500012, India|Ramdev Rao Hospital, Hyderabad, Telangana, 500072, India|Lady Hardinge Medical College, New Delhi, 110001, India|A.O.U. Consorziale Policlinico di Bari, Bari, BA, 70124, Italy|Policlinico Mater Domini Università di Catanzaro, Catanzaro, 88100, Italy|ASL 4 Chiavarese, Chiavari (genova), 16043, Italy|ASST Grande Ospedale Metropolitano Niguarda, Milano, 20162, Italy|Seino Internal Medicine Clinic, Koriyama-shi, Fukushima, Japan, 963-8851, Japan|Manda Memorial Hospital, Sapporo-shi, Hokkaido, Hokkaido, Japan, 060-0062, Japan|Hayashi Diabetes Clinic, Chigasaki-shi, Kanagawa, Kanagawa, Japan, 253-0044, Japan|Hayashi Diabetes Clinic, Chigasaki-shi, Kanagawa, Japan, 253-0044, Japan|Jinnouchi Hospital, Kumamoto-shi, Kumamoto, Japan, 862-0976, Japan|Heiwadai Hospital, Miyazaki-shi, Miyazaki, 880-0034, Japan|Kumanomae Nishimura Internal Medical Clinic, Arakawa-ku, Tokyo, 116-0012, Japan|Akaicho Clinic, Chiba-shi, Chiba, 260-0804, Japan|Futata Tetsuhiro Clinic Meinohama, Fukuoka-shi, Fukuoka, 819-0006, Japan|Kunisaki Makoto Clinic, Fukuoka-shi, Fukuoka, 819-0168, Japan|Sasaki Internal Medicine, Hokkaido, 062-0007, Japan|Yoshimura clinic, Kumamoto, 861-8039, Japan|Hisatomi Clinic, Saga-shi, Saga, 840-0937, Japan|Tokyo-Eki Center-building Clinic, Tokyo, 103-0027, Japan|Fukuwa Clinic, Tokyo, 104-0031, Japan|Yokohama City University Hospital, Endocrinology, Metabolism, Yokohama-shi, Kanagawa, 236-0004, Japan|Soonchunhyang University Hospital, Cheonan, Chungcheongnam-do, 31151, Korea, Republic of|Korea University Ansan Hospital, Ansan, Gyeonggi-do, 15355, Korea, Republic of|Seoul National University Bundang Hospital_Seongnam-si, Seongnam-si, 463-707, Korea, Republic of|Korea University Anam Hospital, Seoul, 02841, Korea, Republic of|Seoul National University Hospital, Seoul, 03080, Korea, Republic of|Kangbuk Samsung Hospital, Seoul, 03181, Korea, Republic of|Severance Hospital, Yonsei University Health System, Seoul, 03722, Korea, Republic of|Asan Medical Center, Seoul, 05505, Korea, Republic of|Seoul Saint Mary's Hospital, Seoul, 06591, Korea, Republic of|Nowon Eulji Medical Center, Eulji University, Seoul, 139-827, Korea, Republic of|Wonju Severance Christian Hospital, Wonju, 26426, Korea, Republic of|Hospital Universitario Dr. José Eleuterio González_Monterrey, Monterrey, Nuevo León, 64460, Mexico|Centro de Investigación Cardiometabólica de Aguascalientes, Aguascalientes, 20230, Mexico|Clínicos Asociados BOCM, S.C., Mexico City, 03300, Mexico|Nordlandssykehuset Bodø, Bodø, 8005, Norway|Drammen sykehus - Vestre Viken HF, Drammen, 3004, Norway|Sykehuset Innlandet HF Hamar, Hamar, 2318, Norway|Oslo universitetssykehus Aker, Oslo, 0586, Norway|St. Olavs Hospital HF, Trondheim, NO-7030, Norway|NZOZ Przychodnia Specjalistyczna Medica, Lublin, Lubelski, 20-538, Poland|Uniwersyteckie Centrum Kliniczne (UCK), Gdansk, 80-214, Poland|NZOZ "CenterMed Lublin" Sp. z o.o., Lublin, 20-044, Poland|Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji, Warszawa, 02-507, Poland|Unidade Local De Saude De Matosinhos E.P.E., Senhora Da Hora, Matosinhos, Matosinhos, 4464-513, Portugal|Unidade Local De Saude De Almada-Seixal E.P.E., Almada, 2805-267, Portugal|Unidade Local De Saude Da Regiao De Aveiro E.P.E., Aveiro, 3814-501, Portugal|Hospital de Braga, Braga, 4710-243, Portugal|Centro Hospitalar Lisboa Ocidental, Lisboa, 1349-019, Portugal|Hospital Da Luz S.A., Lisboa, 1500-650, Portugal|Unidade Local de Saúde de Matosinhos, Matosinhos, 4464-513, Portugal|Hospital Luz Arrabida, S.A., Vila Nova de Gaia, 4400-346, Portugal|Advanced Clinical Research LLC, Bayamon, 00959, Puerto Rico|Manati Ctr For Clin Research, Manati, 00674, Puerto Rico|Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila, Bucharest, Bucurestii, 020475, Romania|CMI Diabet, Nutritie, Boli Metabolice "Dr Pop Lavinia", Baia Mare, Maramures, 430222, Romania|Mariodiab Clinic SRL, Brasov, 500101, Romania|SC Consultmed SRL, Iasi, 700547, Romania|Clinica Korall S.R.L. Satu Mare, Satu-Mare, 440055, Romania|Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava, Suceava, 720237, Romania|Tumen State Medical University, Tumen, Russia, 625023, Russian Federation|Arkhangelsk Regional Clinical Hospital, Arkhangelsk, 163045, Russian Federation|Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg, 620102, Russian Federation|Irkutsk State Medical Academy of Postgraduate Education, Irkutsk, 664049, Russian Federation|Limited Liability Company "AriVa-Med", Kursk, 305016, Russian Federation|City Consultative & Diagnostic Centre #1, Saint-Petersburg, 194354, Russian Federation|Saratov regional clinical hospital, Saratov, 410053, Russian Federation|Endocrinology, Diabetes and Metabolism Diseases Clinic, Belgrade, 11000, Serbia|Deepak Lakha, Johannesburg, Gauteng, 1820, South Africa|Hemant Makan, Johannesburg, Gauteng, 1827, South Africa|Wits Bara Clinical Trial Site, Johannesburg, Gauteng, 2013, South Africa|Dr Pillay's Rooms, Durban, KwaZulu-Natal, 4450, South Africa|Armansis Medical Centre, Brits, North West, 0250, South Africa|Langeberg Clinical Trials, Cape Town, Western Cape, 7572, South Africa|Netcare Alberton Hospital, Alberton, 1449, South Africa|Changhua Christian Hospital, Changhua City, 500, Taiwan|China Medical University Hospital, Taichung, 404, Taiwan|National Cheng Kung University Hospital, Tainan City, 704, Taiwan|Chi Mei Medical Center, Tainan City, 710, Taiwan|Taipei Medical University Hospital, Taipei city, 110, Taiwan|Ankara Universitesi Ibni Sina Hastanesi, Ankara, Altindag, 06230, Turkey|Cukurova Universitesi Tip Fakultesi, Adana, 01150, Turkey|Gulhane Egitim Arastirma Hastanesi, Ankara, 06010, Turkey|Haseki Sultangazi, Istanbul, 34098, Turkey|T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, 34722, Turkey|T.C. S.B. Ist Il SagMud Pendik Egitim ve Arastirma Hastanesi, Istanbul, 34899, Turkey|Tekirdag Namık Kemal UTF, Tekirdag, 59030, Turkey
URL: https://clinicaltrials.gov/show/NCT05352815