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Clinical Trial Details

Trial ID: L2673
Source ID: NCT05013229
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 Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: IcoSema|DRUG: Insulin glargine|DRUG: insulin aspart
Outcome Measures: Primary: Change in HbA1c, Percent-points, From baseline week 0 (V2) to week 52 (V54) | Secondary: Change in body weight, Kg, From baseline week 0 (V2) to week 52 (V54)|Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3), Number of episodes, From week 0 (V52) to week 52 (V54)|Time in range 3.9 - 10.0 mmol/L (70 - 180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6, Percentage of readings, From week 48 (V50) to week 52 (V54)|Time spent more than 10.0 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6, Percentage of readings, From week 48 (V50) to week 52 (V54)|Time spent less than 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6, Percentage of readings, From week 48 (V50) to week 52 (V54)|Change in fasting plasma glucose (FPG), mmol/L, From baseline week 0 (V2) to week 52 (V54)|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction, Score 0-36. The higher the score the greater the satisfaction with treatment., From baseline week 0 (V2) to week 52 (V54)|Number of severe hypoglycaemic episodes (level 3), Number of episodes, From baseline week 0 (V2) to week 57 (V56)|Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter), Number of episodes, From baseline week 0 (V2) to week 57 (V56)|Weekly insulin dose (total), Units, From week 50 (V52) to week 52 (V54)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 679
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-11-30
Completion Date: 2023-11-14
Results First Posted:
Last Update Posted: 2024-11-14
Locations: Scripps Wht Diab Inst La Jolla, La Jolla, California, 92037, United States|Downtown LA Res Ctr. Inc., Los Angeles, California, 90017, United States|San Diego Family Care, San Diego, California, 92111, United States|Creekside Endocrine Associates, Denver, Colorado, 80209, United States|Northeast Research Institute, Fleming Island, Florida, 32003, United States|Northeast Res Inst. Inc., Jacksonville, Florida, 32204, United States|South Broward Research LLC, Miramar, Florida, 33027, United States|Adult Medicine of Lake County, Inc., Mount Dora, Florida, 32757, United States|Florida Inst For Clin Res, Orlando, Florida, 32825, United States|Endo Res Solutions Inc, Roswell, Georgia, 30076, United States|Saltzer Medical Group Research, Nampa, Idaho, 83686-6011, United States|Endeavor Health, Skokie, Illinois, 60077, United States|Iowa Diab & Endo Res Center, West Des Moines, Iowa, 50265, United States|The Research Group of Lexington LLC, Lexington, Kentucky, 40503, United States|MedStar Hlth Res Institute, Hyattsville, Maryland, 20782, United States|Northern Pines Hlth Ctr, PC, Buckley, Michigan, 49620, United States|Palm Research Center Inc-Vegas, Las Vegas, Nevada, 89148, United States|Southern NH Diabetes and Endocrinology, Nashua, New Hampshire, 03060, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|Piedmont Healthcare/Research, Statesville, North Carolina, 28625, United States|Accellacare, Wilmington, North Carolina, 28401, United States|Diab & Endo Assoc of Stark Co, Canton, Ohio, 44718, United States|Prestige Clinical Research, Franklin, Ohio, 45005, United States|New Venture Medical Research, Wadsworth, Ohio, 44281, United States|Hillcrest Clinical Research, Simpsonville, South Carolina, 29681-1538, United States|AM Diabetes And Endocrinology Center, Bartlett, Tennessee, 38133, United States|Univ Diab & Endo Consultants, Chattanooga, Tennessee, 37411, United States|HealthStar Physicians PC, Morristown, Tennessee, 37813, United States|Amarillo Med Spec LLP, Amarillo, Texas, 79106, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, 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|Clinical Investigations Of Texas, Plano, Texas, 75075, United States|Briggs Clinical Research, LLC, San Antonio, Texas, 78224, United States|NE Clin Res of San Antonio, San Antonio, Texas, 78233, United States|Simcare Medical Research, LLC, Sugar Land, Texas, 77478, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|Rainier Clin Res Ctr Inc, Renton, Washington, 98057, United States|Fakultni nemocnice Plzen, Plzen, Czech Republic, 304 60, Czechia|Fakultni nemocnice Plzen, Plzen, Czech Republic, 323 00, Czechia|University Hospital U sv. Anny, Brno, 602 00, Czechia|University Hospital U sv. Anny, Brno, 656 91, Czechia|FN Hradec Kralove, Hradec Kralove, 500 05, Czechia|Diabet2 s.r.o., Praha 1, 110 00, Czechia|Diabetologická a interní ambulance Diabet2, Praha 1, 110 00, Czechia|Fledip s.r.o., Praha 6, 160 00, Czechia|ResTrial s.r.o., Praha 8, 18100, Czechia|III. interni klinika VFN a 1. LK UK v Praze, Praha, 12000, Czechia|Institut klinicke a experimentalni mediciny_Praha, Praha, 14021, Czechia|Fledip s.r.o., Praha, 160 00, Czechia|Centre Hospitalier Departemental Vendee- La Roche Sur Yon, LA ROCHE-sur-YON cedex 9, 85295, France|Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-2, Le Creusot, 71200, France|Aphp-Hopital Lariboisiere-1, Paris, 75010, France|Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2, Pessac, 33600, France|Centre de Recherche Clinique Portes Du Sud, Venissieux, 69200, France|InnoDiab Forschung GmbH, Essen, 45136, Germany|Wendisch/Dahl Hamburg, Hamburg, 22607, Germany|Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster, 48145, Germany|RED-Institut für medizinische Forschung und Fortbildung GmbH, Oldenburg in Holstein, 23758, Germany|Zentrum für klinische Studien Alexander Segner, Saint Ingbert-Oberwürzbach, 66386, Germany|Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft., Budapest, 1036, Hungary|Szőcs Depot Egészségügyi Szolgáltató Kft., Budapest, 1042, Hungary|Semmelweis Egyetem II. Belgyógyászati Klinika, Budapest, 1088, Hungary|ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft., Budapest, 1089, Hungary|Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház, Békéscsaba, 5600, Hungary|Apollo Hospital, Ahmedabad, Ahmedabad, Gujarat, 382428, India|Apollo Hospital International Ltd, Gandhinagar, Gujarat, 382428, India|Diacon Hospital Private Limited, Bangalore, Karnataka, 560010, India|TOTALL Diabetes Hormone Institute, Indore, Madhya Pradesh, 452010, India|Sahyadri Speciality Hospital, Pune, Maharashtra, 411004, India|Sahyadri Super Speciality Hospital, Pune, Maharashtra, 411004, India|chelleram Diabetes Institute, Pune, Maharashtra, 411021, India|Post Graduate Institute of Medical Education & Research, Chandigarh, Punjab, 160012, India|Christian Medical College and Hospital, Ludhiana, Punjab, 141008, India|Fortis Heart Institute and Multispeciality Hospital, Mohali, Punjab, 160062, India|Diabetes, Thyroid and Endocrine Centre, Jaipur, Rajasthan, 302006, India|Madras Diabetes Research Foundation, Chennai, Tamil Nadu, 600086, India|Christian Medical College Hospital, Vellore, Vellore, Tamil Nadu, 632004, India|Medanta Lucknow Hospital, Lucknow, Uttar Pradesh, 226030, India|Swasthya Diabetes Care, Ahmedabad, 390013, India|Azienda Ospedaliero-Universitaria Renato Dulbecco, Catanzaro, CZ, 88100, Italy|Pol. Uni. Campus Biomedico UOC Endocrinologia e Diabetologia, Roma, RM, 00128, Italy|Azienda Ospedaliera Luigi Sacco, Milano, 20157, Italy|Ospedale Civico Partinico di Palermo, Partinico, 90047, Italy|IRCCS Multimedica, Sesto San Giovanni (MI), 20099, Italy|Heiwadai Hospital, Miyazaki-shi, Miyazaki, 880-0034, Japan|Asano Clinic, Kawagoe-shi, Saitama, Japan, 350-0851, Japan|Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology, Shinjuku-ku, Tokyo, 1600023, Japan|TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology, Aichi, 468-0009, Japan|Akaicho Clinic, Chiba-shi, Chiba, 260-0804, Japan|The Institute of Medical Science, Asahi Life Foundation, Chuo-ku, Tokyo, 103-0002, Japan|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|Minami Akatsuka Clinic, Mito-shi, Ibaraki, 311-4153, Japan|Takatsuki Red Cross Hospital, Osaka, 569-1045, Japan|Tokyo-Eki Center-building Clinic, Tokyo, 103-0027, Japan|Fukuwa Clinic, Tokyo, 104-0031, Japan|Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan, Kota Bharu, Kelantan, 16150, Malaysia|Hospital Universiti Kebangsaan Malaysia, Cheras, Kuala Lumpur, 56000, Malaysia|Hospital Seri Manjung, Seri Manjung, Perak, 32040, Malaysia|University Technology MARA (UiTM) - Puncak Alam, Sungai Buloh, Selangor, 47000, Malaysia|University Technology MARA (UiTM) - Sg Buloh, Sungai Buloh, Selangor, 47000, Malaysia|University Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia|Klinik Kesihatan Simpang Kuala, Alor Setar, 05400, Malaysia|Miri Hospital, Miri, Sarawak, 98000, Malaysia|NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska, Bialystok, Podlaskie, 15-435, Poland|Centrum Medyczne Pratia Gdynia, Gdynia, Pomorskie, 81-338, Poland|SNZOZ Lege Artis, Bialystok, 15-404, Poland|Gabinet Lekarski Malgorzata Saryusz-Wolska, Lodz, 90-132, Poland|Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A., Lodz, 90-338, Poland|NBR Polska Tomasz Klodawski, Warszawa, 00-710, Poland|Healthcare centre Kocevje, Kocevje, 1330, Slovenia|Healthcare Centre Koper, Koper, SI-6000, Slovenia|UKC Ljubljana, Endocrinology and Diabetes, Ljubljana, SI-1000, Slovenia|General Hospital Murska Sobota, Murska Sobota, SI-9000, Slovenia|General Hospital Nova Gorica_Diabetes, Nova Gorica, SI-5290, Slovenia|Medi-Clinic Bloemfontein, Bloemfontein, Free State, 9301, South Africa|Lenasia Clinical Trial Centre, Lenasia, Gauteng, 1827, South Africa|Prof P. Joshi, Pretoria, Gauteng, 0181, South Africa|Spoke Research Inc, Cape Town, Western Cape, 7441, South Africa|Siriraj Hospital_Bangkoknoi, Bangkok, Bangkoknoi, Bangkok, Bangkok, 10700, Thailand|Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, Mueang Chiang Mai District, 50200, Thailand|Rajavithi Hospital, Bangkok, 10400, Thailand|Srinagarind Hospital, Khon Kaen, 40002, Thailand|Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima, 30000, Thailand|Baskent Universitesi Adana, Adana, 01250, Turkey|Gulhane Egitim Arastirma Hastanesi, Ankara, 06010, Turkey|Akdeniz University Tip Fakultesi Hastanesi, Antalya, 07058, Turkey|Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi, Aydin, 09010, Turkey|Pamukkale Universitesi Tip Fakultesi, Denizli, 20070, Turkey|TC SB Ist.İl Sag.Müd.Prof.Dr.Cemil Tascioglu Sehir Hastanesi, Istanbul, 34400, Turkey|Dokuz Eylul University Medical Faculty, Izmir, 35340, Turkey
URL: https://clinicaltrials.gov/show/NCT05013229

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress