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Clinical Trial Details

Trial ID: L5831
Source ID: NCT05259033
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 Semaglutide (COMBINE 2)
Acronym: COMBINE 2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT05259033/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: IcoSema|DRUG: Semaglutide 1 mg
Outcome Measures: Primary: Change From Baseline in Glycosylated 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 From Baseline in Fasting Plasma Glucose (FPG), Change from baseline (week 0) to week 52 in FPG 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)|Change From Baseline 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) (<3.0 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 (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., Week 0 to Week 57|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 \< 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 (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., 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 (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., Week 0 to Week 57
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 683
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-04-11
Completion Date: 2024-01-16
Results First Posted: 2025-01-17
Last Update Posted: 2025-01-17
Locations: Univ of AL at Birmingham_BRM, Birmingham, Alabama, 35294, United States|Pri Med Grp dba/Gil Ctr Fam, Gilbert, Arizona, 85296, United States|Clinical Research Institute of Arizona, Sun City West, Arizona, 85375, United States|John Muir Physicians Network, Concord, California, 94520, United States|Velocity Clin Res Wstlke, Los Angeles, California, 90057, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Premier Medical Center, Inc., Toluca Lake, California, 91602, United States|Northeast Research Institute, Fleming Island, Florida, 32003, United States|Northeast Res Inst. Inc., Jacksonville, Florida, 32204, United States|Est Cst Inst for Rsrch,Jksnvil, Jacksonville, Florida, 32216, 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|Florida Institute For Clinical Research, Orlando, Florida, 32825, United States|Oviedo Medical Research, LLC, Oviedo, Florida, 32765, United States|Metabolic Research Institute Inc, West Palm Beach, Florida, 33401, United States|Javara/Privia Med Grp GA,LLC, Albany, Georgia, 31707, United States|East West Med Res Inst, Honolulu, Hawaii, 96814, United States|Saltzer Medical Group Research, Nampa, Idaho, 83686-6011, United States|Endeavor Health, Skokie, Illinois, 60077, United States|Ileana J Tandron APMC, Slidell, Louisiana, 70461-4231, 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|John J Shelmet, MD, Lawrenceville, New Jersey, 08648, United States|Albuquerque Clin Trials, Inc., Albuquerque, New Mexico, 87102, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|PharmQuest Life Sciences LLC, Greensboro, North Carolina, 27408, United States|Diab & Endo Assoc of Stark Co, Canton, Ohio, 44718, United States|New Venture Medical Research, Wadsworth, Ohio, 44281, United States|Thomas Jefferson Univ Di Rsrch Ctr, Philadelphia, Pennsylvania, 19107, United States|Palmetto Clinical Research, Summerville, South Carolina, 29485, United States|AM Diabetes And Endocrinology Center, Bartlett, Tennessee, 38133, United States|Chattanooga Medical Research, LLC, Chattanooga, Tennessee, 37404, United States|Amarillo Med Spec LLP, Amarillo, Texas, 79106, United States|Texas Diab & Endo, P.A., Austin, Texas, 78731, United States|Texas Diabetes & Endocrinology, Austin, Texas, 78749, United States|Osvaldo A. Brusco MD PA, Corpus Christi, Texas, 78414, United States|North Texas Endocrine Center, Dallas, Texas, 75231, United States|UT Southwestern Med Cntr, Dallas, Texas, 75390-9302, United States|Diabetes and Thyroid Ctr of FW, Fort Worth, Texas, 76132, United States|DCOL Ctr for Clin Res, Longview, Texas, 75605, United States|Texas Diabetes & Endocrinology_Round Rock, Round Rock, Texas, 78681, United States|NE Clin Res of San Antonio, San Antonio, Texas, 78233, United States|Sugar Lakes Family Practice PA, Sugar Land, Texas, 77479, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|Javara Inc. / Privia Medical Group LLC_Forest, Forest, Virginia, 24551, United States|Javara Inc/Privia Md GpLLC Fst, Forest, Virginia, 24551, United States|TPMG Clinical Research, Newport News, Virginia, 23606, United States|Centro de Diabetes Metabolismo e Endocrinologia, Fortaleza, Ceara, 60150-162, Brazil|Instituto de Ciências Farmacêuticas de Estudos e Pesquisas, Aparecida de Goiania, Goias, 74935-530, Brazil|Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV, Curitiba, Parana, 80045-170, Brazil|Centro de Diabetes Curitiba, Curitiba, Parana, 80810-040, Brazil|Instituto São José dos Campos em Pesquisas Médicas, São José dos Campos, Sao Paulo, 12243-280, Brazil|BR Trials - Ensaios Clínicos e Consultoria Ltda., São Paulo, Sao Paulo, 01236-030, Brazil|LMC Clinical Res Thornhill, Concord, Ontario, L4K 4M2, Canada|Medical Trust Clinics, Inc., Courtice, Ontario, L1E2J5, Canada|Wharton Med Clin Trials, Hamilton, Ontario, L8L 5G8, Canada|Western Univ. Cnt for Studies in Fam Med, London, Ontario, N6G 2M1, Canada|Bluewater Clin Res Group,Inc, Sarnia, Ontario, N7T 4X3, Canada|LMC Endo Centres Ltd.(Bayview), Toronto, Ontario, M4G 3E8, Canada|Recherche GCP Research, Montreal, Quebec, H1M 1B1, Canada|Recherche GCP Research, Montreal, Quebec, H1Y 3H5, Canada|LMC Clin Rsrch Inc. (Montreal), Montreal, Quebec, H4T 1Z9, Canada|LMC Clin Rsrch Inc. (Montreal), Saint-Laurent, Quebec, H4T 1Z9, Canada|Recherche Clinique Sigma inc, Quebec, G1G 3Y8, Canada|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|Changzhou No.2 People's Hospital, Yanghu Branch, Changzhou, Jiangsu, 213003, China|The Second Affiliated Hospital of Nanjing Medical University-Endocrinology, Nanjing, Jiangsu, 210011, China|Jinan Central Hospital, Ji'nan, Shandong, 250013, China|Huashan Hospital Fudan University-Endocrinology, Shanghai, Shanghai, 200040, China|Shanghai Huashan Hospital, Affiliated to Fudan University, Shanghai, Shanghai, 200040, China|Shanghai Fifth People's Hospital-Endocrinology, Shanghai, Shanghai, 200240, China|General Hospital of Tianjin Medical University-Endocrinology, Tianjin, Tianjin, 300052, China|Zhu Xianyi Memorial Hospital of Tianjin Medical University-Endocrinology, Tianjin, Tianjin, 300070, China|Centre Hospitalier Universitaire de Rouen - Hopital de Bois Guillaume, Bois-Guillaume, 76230, 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|Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1, 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|Iatriko Psychicou Private Clinic, Athens, 115 25, Greece|Evangelismos Hospital, Athens, GR-10676, Greece|'G. Gennimatas' General Hospital of Athens, Athens, GR-115 27, Greece|Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease, Larissa, GR-41110, Greece|General Hospital of Thessaloniki 'G. Gennimatas, Thessaloniki, GR-54635, Greece|"Ippokrateio" G.H. of Thessaloniki, Thessaloniki, GR-54642, Greece|"Thermi" Private Hosital, Thessaloniki, GR-57001, Greece|General Hospital of Thessaloniki "G.Papanikolaou", Thessaloniki, GR-57010, Greece|PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum, Pécs, Baranya Vármegye, 7623, Hungary|Debreceni Egyetem Belgyógyászati Klinika, Debrecen, Hajdu-Bihar, 4032, Hungary|Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület, Debrecen, Hajdu-Bihar, H-4043, Hungary|MED-TIMA Kft., Budapest, 1132, Hungary|Linn clinic - Clalit Health Services, Haifa, 35152, Israel|Clalit sick fund Herzlia, Herzlia, 4630945, Israel|Diabetes Clinic Wolfson MC, Holon, 58100, Israel|Diabetes Unit Hadassah Ein Karem MC, Jerusalem, 91120, Israel|Diabetes Clinic Meir MC, Kfar Saba, 44281, Israel|Endrocrinolgy Clinic - Sheba Medical Center, Tel Hashomer, 52621, Israel|Heiwadai Hospital, Miyazaki-shi, Miyazaki, 880-0034, Japan|The Institute of Medical Science, Asahi Life Foundation, Chuo-ku, Tokyo, 103-0002, Japan|Futata Tetsuhiro Clinic Meinohama, Fukuoka-shi, Fukuoka, 819-0006, Japan|Gifu University Hospital, Gifu, 501-1194, Japan|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|Takatsuki Red Cross Hospital, Osaka, 569-1045, Japan|Shimizu Clinic Fusa, Saitama, 336-0967, Japan|Soka Sugiura Internal Medicine Clinic_Internal Medicine, Saitama, 340-0015, Japan|Shinden Higashi Clinic, Sendai-shi, Miyagi, 983-0039, Japan|Irkutsk State Medical Academy of Postgraduate Education, Irkutsk, 664049, Russian Federation|National Medical Research Center of Endocrinology, Moscow, 117292, Russian Federation|Limited Law Company "Healthy Family" Medicine Center", Novosibirsk, 630099, Russian Federation|BHI of Omsk Region "City Hospital № 3", Omsk, 644029, Russian Federation|Penza Regional Clinical Hospital named after N.N. Burdenko, Penza, 440052, Russian Federation|Rostov State Medical University_Rostov-on-Don, Rostov-on-Don, 344022, Russian Federation|Polyclinic #2 in Yoshkar-Ola, Yoshkar-Ola, 424004, Russian Federation|DIOLI s.r.o., Kosice, 040 01, Slovakia|HUMAN-CARE s.r.o., Kosice, 040 01, Slovakia|Diabetologicka ambulancia DIADAN, s.r.o. Kosice, Kosice, 04011, Slovakia|FNsP L. Pasteura, Kosice, 04190, Slovakia|DIA - KONTROL s.r.o., Levice, 93401, Slovakia|MUDr. Alena Lomencikova, s.r.o, Turcianske Teplice, 039 01, Slovakia|Primary Care Trial Center, PTC ,Gothia Forum, Göteborg, 413 46, Sweden|Centrum for Diabetes, Academical Specialist Centrum, Stockholm, 113 65, Sweden|Enheten för Kliniska Studier (EKS), Örebro, Örebro, 703 62, Sweden|Luzerner Kantonsspital, Luzern 16, 6000, Switzerland|Kantonsspital Olten, Olten, 4600, Switzerland|Diabetes Adipositas Zentrum Zürich, Zollikerberg, 8125, Switzerland|Chung Shan Medical University Hospital, Taichung City, 402, Taiwan|National Cheng Kung University Hospital, Tainan City, 704, Taiwan|Chi Mei Medical Center, Tainan City, 710, Taiwan|Taipei Veterans General Hospital, Taipei, 112, Taiwan|Chang Gung Medical Foundation - Linkou Branch, Taoyuan city, 333, Taiwan
URL: https://clinicaltrials.gov/show/NCT05259033

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress