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Clinical Trial Details

Trial ID: L6318
Source ID: NCT06269107
Associated Drug: Icosema
Title: A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4)
Acronym: COMBINE 4
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: IcoSema|DRUG: Insulin glargine
Outcome Measures: Primary: Change in glycated haemoglobin (HbA1c), Measured in percentage (%)-point., From baseline (week 0) to week 40 | Secondary: Change in body weight, Measured in kilogram (kg)., From baseline (week 0) to week 40|Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL]), Measured in % of readings., From week 36 to week 40|Time spent less than (<) 3.0 mmol/L (54 mg/dL), Measured in % of readings., From week 36 to week 40|Time spent greater than (>) 10.0 mmol/L (180 mg/dL), Measured in % of readings., From week 36 to week 40|Weekly basal insulin dose, Measured in units of insulin., From week 38 to week 40|Change in fasting plasma glucose (FPG), Measured in mmol/l., From baseline (week 0) to week 40|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction, The DTSQs items are scored on a 7-point graded response scale ranging from 0 to 6. Score ranges from 0 to 36. Higher scores indicate greater the satisfaction with medication., From baseline (week 0) to week 40|Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose meter) or severe hypoglycaemic episodes (level 3), Measured in number of episodes., From baseline (week 0) to week 45|Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter), Measured in number of episodes., From baseline (week 0) to week 45|Number of severe hypoglycaemic episodes (level 3), Measured in number of episodes., From baseline (week 0) to week 45
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 474
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-15
Completion Date: 2025-06-30
Results First Posted:
Last Update Posted: 2025-01-14
Locations: Scripps Whittier Diabetes Inst, La Jolla, California, 92037, United States|First Valley Med Grp Lancaster, Lancaster, California, 93534, United States|Desert Oasis Hlthcr Med Group, Palm Springs, California, 92262, United States|Clinical Trials Research_Sacramento, Sacramento, California, 95821, United States|Northeast Research Institute, Fleming Island, Florida, 32003, United States|Clinical Research of Cent FL, Winter Haven, Florida, 33880, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|Elite Clinical Trials, Blackfoot, Idaho, 83221, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Endeavor Health, Skokie, Illinois, 60077, United States|Cotton-O'Neil Diab & Endo Ctr, Topeka, Kansas, 66606, United States|Methodist Phys. Clinic, Omaha, Nebraska, 68114, United States|Albuquerque Clin Trials, Inc., Albuquerque, New Mexico, 87102, United States|Albany Medical College - Endo, Albany, New York, 12206, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|Physician's East Endocrinology, Greenville, North Carolina, 27834, United States|Diab & Endo Assoc of Stark Co, Canton, Ohio, 44718, United States|Advanced Medical Research, Maumee, Ohio, 43537, United States|New Venture Medical Research, Wadsworth, Ohio, 44281-9236, United States|Amarillo Med Spec LLP, Amarillo, Texas, 79106, United States|Velocity Clinical Research- Cedar Park, Austin, Texas, 78759, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|North Texas Endocrine Center, Dallas, Texas, 75231, United States|Diabetes and Thyroid Ctr of FW, Fort Worth, Texas, 76132, United States|Fmc Science, Llc, Lampasas, Texas, 76550, United States|Quality Research Inc, San Antonio, Texas, 78209, United States|Flourish Research, San Antonio, Texas, 78229, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|TPMG Clinical Research, Newport News, Virginia, 23606, United States|Peking University People's Hospital-Endocrinology, Beijing, Beijing, 100044, China|Beijing Friendship Hospital, Capital Medical University-Endocrinology, Beijing, Beijing, 100050, China|Chongqing University Three Gorges Hospital, Chongqing, Chongqing, 404000, China|Huizhou Central People's Hospital-Endocrinology, Huizhou, Guangdong, 516001, China|The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210011, China|The Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212001, China|Jinan Central Hospital, Jinan, Shandong, 250013, China|Shanghai Pudong New Area People's Hospital-Endocrinology, Shanghai, Shanghai, 201200, China|Evangelismos Hospital, Athens, GR-10676, Greece|'G. Gennimatas' General Hospital of Athens, Athens, GR-115 27, Greece|"Laiko" General Hospital of Athens, Athens, GR-11527, Greece|General Hospital of Kalamata, Kalamata, 24100, Greece|Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease, Larissa, GR-41110, Greece|"Thermi" Private Hosital, Thessaloniki, GR-57001, Greece|Ramaiah Memorial Hospital, Bangalore, Karnataka, 560054, India|Mysore Medical College and Research Institute, Mysore, Karnataka, 570001, India|BYL Nair Hospital and T N Medical College Department of endo, Mumbai, Maharashtra, 400008, India|Seth GS Medical College & KEM Hospital, Mumbai, Maharashtra, 400012, India|BSES MG hospital, Mumbai, Maharashtra, 400058, India|Chellaram Diabetes Institute, Pune, Maharashtra, 411021, India|SMS Medical College & Hospital, Jaipur, Rajasthan, 302004, India|Diabetes, Thyroid and Endocrine Centre, Jaipur, Rajasthan, 302006, India|Madras Diabetes Research Foundation, Chennai, Tamil Nadu, 600086, India|Udyaan Health Care, Lucknow, Uttar Pradesh, 226002, India|Post Graduate Institute of Medical Education & Research, Chandigarh, 160012, India|Ospedale San Salvatore, Dipartimento Medico ASL1 Abruzzo, UOC Diabetologia, L'Aquila, Abbruzzo, 67100, Italy|Casa Sollievo della Sofferenza reparto endocrinologia, San Giovanni Rotondo, FG, 71013, Italy|I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli Anziani, Ancona, 60127, Italy|Casa della Salute di Ceccano (FR), Ceccano (Frosinone), 03023, Italy|ASL 4 Chiavarese, Chiavari (genova), 16043, Italy|ASST Grande Ospedale Metropolitano Niguarda, Milano, 20162, Italy|Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia, Perugia, 06129, Italy|A.O.U. Policlinico Umberto I, Rome, 00161, Italy|Heiwadai Hospital, Miyazaki-shi, Miyazaki, 880-0034, Japan|Tokuyama clinic, Chiba, 261-0004, Japan|Oodouri Diabetes, Internal medicine Clinic, Hokkaido, 060-0001, Japan|Oyama East Clinic, Tochigi, 323-0022, Japan|Tokyo-Eki Center-building Clinic, Tokyo, 103-0027, Japan|Fukuwa Clinic, Tokyo, 104-0031, Japan|Juntendo University Hospital, Tokyo, 113-8431, Japan|NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska, Bialystok, Podlaskie, 15-435, Poland|SNZOZ Lege Artis, Bialystok, 15-404, Poland|Uniwersyteckie Centrum Kliniczne Regionalne Centrum Diabetologii, Gdansk, 80-214, Poland|Grazyna Pulka Specjalistyczny Osrodek "All-Med", Krakow, 30-033, Poland|Gabinet Lekarski Malgorzata Saryusz-Wolska, Lodz, 90-132, Poland|Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A., Lodz, 90-338, Poland|Velocity Nova Sp. z o.o., Lublin, 20-362, Poland|Velocity Nova Sp. z o.o., Staszow, 28-200, Poland|NBR Polska Tomasz Klodawski, Warszawa, 00-710, Poland|PANSTWOWY INSTYTUT MEDYCZNY MSWiA, Warszawa, 02-507, Poland|Clinhouse Centrum Medyczne, Zabrze, 41-807, Poland|Advanced Clinical Research LLC, Bayamon, 00959, Puerto Rico|Dr R Dulabh, Johannesburg, Gauteng, 1812, South Africa|Newtown Clinical Research, Johannesburg, Gauteng, 2001, South Africa|Roodepoort Medicross Clinical Research Centre, Roodepoort, Gauteng, 1724, South Africa|Clinical Research Institute of South Africa, KwaDukuza, KwaZulu Natal, 4449, South Africa|Dr Pillay's Rooms, Durban, KwaZulu-Natal, 4450, South Africa|Langeberg Clinical Trials, Cape Town, Western Cape, 7572, South Africa|Akdeniz University Tip Fakultesi Hastanesi, Antalya, 07058, Turkey|Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi, Istanbul, 34371, Turkey|T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi, Istanbul, 34899, Turkey|Tekirdag Namık Kemal UTF, Tekirdag, 59030, Turkey
URL: https://clinicaltrials.gov/show/NCT06269107

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