protocolSection identificationModule nctId: NCT06269107, orgStudyIdInfo id: NN1535-4988, secondaryIdInfos id: U1111-1283-8648, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: 2022-502484-38-00, type: OTHER, domain: European Medicines Agency (EMA), briefTitle: 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-06-05, completionDateStruct date: 2025-07-10, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks)., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 474, type: ESTIMATED, armsInterventionsModule interventions name: IcoSema, interventions name: Insulin glargine, outcomesModule primaryOutcomes measure: Change in glycated haemoglobin (HbA1c), secondaryOutcomes measure: Change in body weight, secondaryOutcomes measure: Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL]), secondaryOutcomes measure: Time spent less than (<) 3.0 mmol/L (54 mg/dL), secondaryOutcomes measure: Time spent greater than (>) 10.0 mmol/L (180 mg/dL), secondaryOutcomes measure: Weekly basal insulin dose, secondaryOutcomes measure: Change in fasting plasma glucose (FPG), secondaryOutcomes measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction, secondaryOutcomes measure: 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), secondaryOutcomes measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter), secondaryOutcomes measure: Number of severe hypoglycaemic episodes (level 3), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scripps Whittier Diabetes Inst, status: RECRUITING, city: La Jolla, state: California, zip: 92037, country: United States, geoPoint lat: 32.84727, lon: -117.2742, locations facility: First Valley Med Grp Lancaster, status: RECRUITING, city: Lancaster, state: California, zip: 93534, country: United States, geoPoint lat: 34.69804, lon: -118.13674, locations facility: Clinical Trials Research_Sacramento, status: RECRUITING, city: Lincoln, state: California, zip: 95648, country: United States, geoPoint lat: 38.89156, lon: -121.29301, locations facility: Desert Oasis Hlthcr Med Group, status: RECRUITING, city: Palm Springs, state: California, zip: 92262, country: United States, geoPoint lat: 33.8303, lon: -116.54529, locations facility: Northeast Research Institute, status: RECRUITING, city: Fleming Island, state: Florida, zip: 32003, country: United States, geoPoint lat: 30.0933, lon: -81.71898, locations facility: Clinical Research of Central Florida_Winter Haven, status: RECRUITING, city: Winter Haven, state: Florida, zip: 33880, country: United States, geoPoint lat: 28.02224, lon: -81.73286, locations facility: Atlanta Diabetes Associates, status: RECRUITING, city: Atlanta, state: Georgia, zip: 30318, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Endo Res Solutions Inc, status: RECRUITING, city: Roswell, state: Georgia, zip: 30076, country: United States, geoPoint lat: 34.02316, lon: -84.36159, locations facility: Elite Clinical Trials, status: RECRUITING, city: Blackfoot, state: Idaho, zip: 83221, country: United States, geoPoint lat: 43.19047, lon: -112.34498, locations facility: Cedar-Crosse Research Center, status: RECRUITING, city: Chicago, state: Illinois, zip: 60607, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: NorthShore Univ Hlth Sys, status: RECRUITING, city: Skokie, state: Illinois, zip: 60077, country: United States, geoPoint lat: 42.03336, lon: -87.73339, locations facility: Cotton-O'Neil Diab & Endo Ctr, status: RECRUITING, city: Topeka, state: Kansas, zip: 66606, country: United States, geoPoint lat: 39.04833, lon: -95.67804, locations facility: Methodist Phys. Clinic, status: RECRUITING, city: Omaha, state: Nebraska, zip: 68114, country: United States, geoPoint lat: 41.25626, lon: -95.94043, locations facility: Albuquerque Clin Trials, Inc., status: RECRUITING, city: Albuquerque, state: New Mexico, zip: 87102, country: United States, geoPoint lat: 35.08449, lon: -106.65114, locations facility: Albany Medical College - Endo, status: RECRUITING, city: Albany, state: New York, zip: 12206, country: United States, geoPoint lat: 42.65258, lon: -73.75623, locations facility: Southgate Medical Group, LLP, status: RECRUITING, city: West Seneca, state: New York, zip: 14224, country: United States, geoPoint lat: 42.85006, lon: -78.79975, locations facility: Physician's East Endocrinology, status: RECRUITING, city: Greenville, state: North Carolina, zip: 27834, country: United States, geoPoint lat: 35.61266, lon: -77.36635, locations facility: Diab & Endo Assoc of Stark Co, status: RECRUITING, city: Canton, state: Ohio, zip: 44718, country: United States, geoPoint lat: 40.79895, lon: -81.37845, locations facility: Advanced Medical Research, status: RECRUITING, city: Maumee, state: Ohio, zip: 43537, country: United States, geoPoint lat: 41.56283, lon: -83.65382, locations facility: New Venture Medical Research, status: RECRUITING, city: Wadsworth, state: Ohio, zip: 44281-9236, country: United States, geoPoint lat: 41.02561, lon: -81.72985, locations facility: Holston Medical Group, status: RECRUITING, city: Kingsport, state: Tennessee, zip: 37660, country: United States, geoPoint lat: 36.54843, lon: -82.56182, locations facility: Amarillo Med Spec LLP, status: RECRUITING, city: Amarillo, state: Texas, zip: 79106, country: United States, geoPoint lat: 35.222, lon: -101.8313, locations facility: Velocity Clinical Research- Cedar Park, status: RECRUITING, city: Cedar Park, state: Texas, zip: 78613, country: United States, geoPoint lat: 30.5052, lon: -97.82029, locations facility: Velocity Clinical Res-Dallas, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: North Texas Endocrine Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75231, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Diabetes and Thyroid Ctr of FW, status: RECRUITING, city: Fort Worth, state: Texas, zip: 76132, country: United States, geoPoint lat: 32.72541, lon: -97.32085, locations facility: Fmc Science, Llc, status: RECRUITING, city: Lampasas, state: Texas, zip: 76550, country: United States, geoPoint lat: 31.06378, lon: -98.1817, locations facility: Consano Clinical Research, LLC, status: RECRUITING, city: Shavano Park, state: Texas, zip: 78231, country: United States, geoPoint lat: 29.58495, lon: -98.55252, locations facility: Wade Family Medicine, status: RECRUITING, city: Bountiful, state: Utah, zip: 84010, country: United States, geoPoint lat: 40.88939, lon: -111.88077, locations facility: Peking University People's Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100044, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Friendship Hospital, Capital Medical University, status: RECRUITING, city: Beijing, state: Beijing, zip: 100050, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Chongqing University Three Gorges Hospital, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 404000, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Huizhou Central People's Hospital, status: RECRUITING, city: Huizhou, state: Guangdong, zip: 516001, country: China, geoPoint lat: 23.11147, lon: 114.41523, locations facility: The Second Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210011, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Second Affiliated Hospital of Nanjing Medical University, status: NOT_YET_RECRUITING, city: Nanjing, state: Jiangsu, zip: 210011, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Hospital of Jiangsu University, status: RECRUITING, city: Zhenjiang, state: Jiangsu, zip: 212001, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: Jinan Central Hospital, status: RECRUITING, city: Jinan, state: Shandong, zip: 250013, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Jinan Central Hospital, status: NOT_YET_RECRUITING, city: Jinan, state: Shandong, zip: 250013, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shanghai Pudong New Area People's Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 201200, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Harrison International Peace Hospital, status: WITHDRAWN, city: Hengshui, zip: 053000, country: China, geoPoint lat: 37.73222, lon: 115.70111, locations facility: Evangelismos Hospital, status: RECRUITING, city: Athens, zip: GR-10676, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: 'G. Gennimatas' General Hospital of Athens, status: RECRUITING, city: Athens, zip: GR-115 27, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: "Laiko" General Hospital of Athens, status: RECRUITING, city: Athens, zip: GR-11527, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: General Hospital of Kalamata, status: RECRUITING, city: Kalamata, zip: 24100, country: Greece, geoPoint lat: 37.03913, lon: 22.11265, locations facility: Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease, status: RECRUITING, city: Larissa, zip: GR-41110, country: Greece, geoPoint lat: 39.63689, lon: 22.41761, locations facility: "Thermi" Private Hosital, status: RECRUITING, city: Thessaloniki, zip: GR-57001, country: Greece, geoPoint lat: 40.64361, lon: 22.93086, locations facility: Ramaiah Memorial Hospital, status: RECRUITING, city: Bangalore, state: Karnataka, zip: 560054, country: India, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Ramaiah Memorial Hospital, status: NOT_YET_RECRUITING, city: Bangalore, state: Karnataka, zip: 560054, country: India, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Mysore Medical College and Research Institute, status: NOT_YET_RECRUITING, city: Mysore, state: Karnataka, zip: 570001, country: India, geoPoint lat: 12.29791, lon: 76.63925, locations facility: BYL Nair Hospital and T N Medical College Department of endo, status: RECRUITING, city: Mumbai, state: Maharashtra, zip: 400008, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: BYL Nair Hospital and T N Medical College Department of endo, status: NOT_YET_RECRUITING, city: Mumbai, state: Maharashtra, zip: 400008, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: Seth GS Medical College & KEM Hospital, status: RECRUITING, city: Mumbai, state: Maharashtra, zip: 400012, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: Seth GS Medical College & KEM Hospital, status: NOT_YET_RECRUITING, city: Mumbai, state: Maharashtra, zip: 400012, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: BSES MG hospital, status: RECRUITING, city: Mumbai, state: Maharashtra, zip: 400058, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: BSES MG hospital, status: NOT_YET_RECRUITING, city: Mumbai, state: Maharashtra, zip: 400058, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: Chellaram Diabetes Institute, status: RECRUITING, city: Pune, state: Maharashtra, zip: 411021, country: India, geoPoint lat: 18.51957, lon: 73.85535, locations facility: SMS Medical College & Hospital, status: NOT_YET_RECRUITING, city: Jaipur, state: Rajasthan, zip: 302004, country: India, geoPoint lat: 26.91962, lon: 75.78781, locations facility: Diabetes, Thyroid and Endocrine Centre, status: RECRUITING, city: Jaipur, state: Rajasthan, zip: 302006, country: India, geoPoint lat: 26.91962, lon: 75.78781, locations facility: Madras Diabetes Research Foundation, status: RECRUITING, city: Chennai, state: Tamil Nadu, zip: 600086, country: India, geoPoint lat: 13.08784, lon: 80.27847, locations facility: Madras Diabetes Research Foundation, status: NOT_YET_RECRUITING, city: Chennai, state: Tamil Nadu, zip: 600086, country: India, geoPoint lat: 13.08784, lon: 80.27847, locations facility: Udyaan Health Care, status: RECRUITING, city: Lucknow, state: Uttar Pradesh, zip: 226002, country: India, geoPoint lat: 26.83928, lon: 80.92313, locations facility: Post Graduate Institute of Medical Education & Research, status: NOT_YET_RECRUITING, city: Chandigarh, zip: 160012, country: India, geoPoint lat: 30.73629, lon: 76.7884, locations facility: IPGME&R and SSKM Hospital, status: NOT_YET_RECRUITING, city: Kolkata, zip: 700020, country: India, geoPoint lat: 22.56263, lon: 88.36304, locations facility: Ospedale San Salvatore, Dipartimento Medico ASL1 Abruzzo, UOC Diabetologia, status: RECRUITING, city: L'Aquila, state: Abbruzzo, zip: 67100, country: Italy, geoPoint lat: 42.35055, lon: 13.39954, locations facility: Casa Sollievo della Sofferenza reparto endocrinologia, status: RECRUITING, city: San Giovanni Rotondo, state: FG, zip: 71013, country: Italy, geoPoint lat: 41.70643, lon: 15.7277, locations facility: I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli Anziani, status: NOT_YET_RECRUITING, city: Ancona, zip: 60127, country: Italy, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Casa della Salute di Ceccano (FR), status: RECRUITING, city: Ceccano (Frosinone), zip: 03023, country: Italy, locations facility: ASL 4 Chiavarese, status: NOT_YET_RECRUITING, city: Chiavari (genova), zip: 16034, country: Italy, locations facility: ASST Grande Ospedale Metropolitano Niguarda, status: RECRUITING, city: Milano, zip: 20162, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser, status: RECRUITING, city: Perugia, zip: 06129, country: Italy, geoPoint lat: 43.1122, lon: 12.38878, locations facility: A.O.U. Policlinico Umberto I, status: RECRUITING, city: Rome, zip: 00161, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Heiwadai Hospital, status: RECRUITING, city: Miyazaki-shi, state: Miyazaki, zip: 880-0034, country: Japan, geoPoint lat: 31.91667, lon: 131.41667, locations facility: Tokuyama clinic, status: RECRUITING, city: Chiba, zip: 261-0004, country: Japan, geoPoint lat: 35.6, lon: 140.11667, locations facility: Oodouri Diabetes, Internal medicine Clinic, status: RECRUITING, city: Hokkaido, zip: 060-0001, country: Japan, geoPoint lat: 43.41104, lon: 142.88878, locations facility: Oyama East Clinic, status: RECRUITING, city: Tochigi, zip: 323-0022, country: Japan, geoPoint lat: 36.38333, lon: 139.73333, locations facility: Tokyo-Eki Center-building Clinic, status: RECRUITING, city: Tokyo, zip: 103-0027, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Fukuwa Clinic, status: RECRUITING, city: Tokyo, zip: 104-0031, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Juntendo University Hospital, status: RECRUITING, city: Tokyo, zip: 113-8431, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska, status: RECRUITING, city: Bialystok, state: Podlaskie, zip: 15-435, country: Poland, geoPoint lat: 53.13333, lon: 23.16433, locations facility: SNZOZ Lege Artis, status: RECRUITING, city: Bialystok, zip: 15-404, country: Poland, geoPoint lat: 53.13333, lon: 23.16433, locations facility: Uniwersyteckie Centrum Kliniczne Regionalne Centrum Diabetologii, status: RECRUITING, city: Gdansk, zip: 80-214, country: Poland, geoPoint lat: 54.35205, lon: 18.64637, locations facility: Grazyna Pulka Specjalistyczny Osrodek "All-Med", status: RECRUITING, city: Krakow, zip: 30-033, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Gabinet Lekarski Malgorzata Saryusz-Wolska, status: RECRUITING, city: Lodz, zip: 90-132, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Centrum Terapii Wspolczesnej, status: RECRUITING, city: Lodz, zip: 90-338, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Ko-Med Nova Sp.zo.o. Lublin II, status: RECRUITING, city: Lublin, zip: 20-362, country: Poland, geoPoint lat: 51.25, lon: 22.56667, locations facility: Ko-Med Nova Sp.zo.o. STASZOW, status: RECRUITING, city: Staszow, zip: 28-200, country: Poland, geoPoint lat: 50.56307, lon: 21.16593, locations facility: NBR Polska Tomasz Klodawski, status: RECRUITING, city: Warszawa, zip: 00-710, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: PANSTWOWY INSTYTUT MEDYCZNY MSWiA, status: RECRUITING, city: Warszawa, zip: 02-507, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Clinhouse Centrum Medyczne, status: RECRUITING, city: Zabrze, zip: 41-807, country: Poland, geoPoint lat: 50.32492, lon: 18.78576, locations facility: Advanced Clinical Research LLC, status: RECRUITING, city: Bayamon, zip: 00959, country: Puerto Rico, geoPoint lat: 18.39856, lon: -66.15572, locations facility: Dr R Dulabh, status: RECRUITING, city: Johannesburg, state: Gauteng, zip: 1812, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Dr R Dulabh, status: NOT_YET_RECRUITING, city: Johannesburg, state: Gauteng, zip: 1812, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Newtown Clinical Research, status: RECRUITING, city: Johannesburg, state: Gauteng, zip: 2001, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Roodepoort Medicross Clinical Research Centre, status: RECRUITING, city: Roodepoort, state: Gauteng, zip: 1724, country: South Africa, geoPoint lat: -26.1625, lon: 27.8725, locations facility: Clinical Research Institute of South Africa, status: RECRUITING, city: KwaDukuza, state: KwaZulu Natal, zip: 4449, country: South Africa, geoPoint lat: -29.32816, lon: 31.28954, locations facility: Dr Pillay's Rooms, status: RECRUITING, city: Durban, state: KwaZulu-Natal, zip: 4450, country: South Africa, geoPoint lat: -29.8579, lon: 31.0292, locations facility: Dr Pillay's Rooms, status: NOT_YET_RECRUITING, city: Durban, state: KwaZulu-Natal, zip: 4450, country: South Africa, geoPoint lat: -29.8579, lon: 31.0292, locations facility: Langeberg Clinical Trials, status: RECRUITING, city: Cape Town, state: Western Cape, zip: 7572, country: South Africa, geoPoint lat: -33.92584, lon: 18.42322, locations facility: Akdeniz University Tip Fakultesi Hastanesi, status: RECRUITING, city: Antalya, zip: 07058, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, locations facility: Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi, status: RECRUITING, city: Istanbul, zip: 34371, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji, status: RECRUITING, city: Istanbul, zip: 34390, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, locations facility: T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi, status: RECRUITING, city: Istanbul, zip: 34899, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Tekirdag Namık Kemal UTF, status: RECRUITING, city: Tekirdag, zip: 59030, country: Turkey, geoPoint lat: 40.9781, lon: 27.51101, hasResults: False