nctId: NCT06269107 id: NN1535-4988 id: U1111-1283-8648 type: OTHER domain: World Health Organization (WHO) 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 overallStatus: RECRUITING date: 2024-02-15 date: 2025-06-05 date: 2025-07-10 date: 2024-02-21 date: 2024-04-18 name: Novo Nordisk A/S class: INDUSTRY 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). conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 474 type: ESTIMATED name: IcoSema name: Insulin glargine measure: Change in glycated haemoglobin (HbA1c) measure: Change in body weight measure: Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL]) measure: Time spent less than (<) 3.0 mmol/L (54 mg/dL) measure: Time spent greater than (>) 10.0 mmol/L (180 mg/dL) measure: Weekly basal insulin dose measure: Change in fasting plasma glucose (FPG) measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction 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) measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) measure: Number of severe hypoglycaemic episodes (level 3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scripps Whittier Diabetes Inst status: RECRUITING city: La Jolla state: California zip: 92037 country: United States lat: 32.84727 lon: -117.2742 facility: First Valley Med Grp Lancaster status: RECRUITING city: Lancaster state: California zip: 93534 country: United States lat: 34.69804 lon: -118.13674 facility: Clinical Trials Research_Sacramento status: RECRUITING city: Lincoln state: California zip: 95648 country: United States lat: 38.89156 lon: -121.29301 facility: Desert Oasis Hlthcr Med Group status: RECRUITING city: Palm Springs state: California zip: 92262 country: United States lat: 33.8303 lon: -116.54529 facility: Northeast Research Institute status: RECRUITING city: Fleming Island state: Florida zip: 32003 country: United States lat: 30.0933 lon: -81.71898 facility: Clinical Research of Central Florida_Winter Haven status: RECRUITING city: Winter Haven state: Florida zip: 33880 country: United States lat: 28.02224 lon: -81.73286 facility: Atlanta Diabetes Associates status: RECRUITING city: Atlanta state: Georgia zip: 30318 country: United States lat: 33.749 lon: -84.38798 facility: Endo Res Solutions Inc status: RECRUITING city: Roswell state: Georgia zip: 30076 country: United States lat: 34.02316 lon: -84.36159 facility: Elite Clinical Trials status: RECRUITING city: Blackfoot state: Idaho zip: 83221 country: United States lat: 43.19047 lon: -112.34498 facility: Cedar-Crosse Research Center status: RECRUITING city: Chicago state: Illinois zip: 60607 country: United States lat: 41.85003 lon: -87.65005 facility: NorthShore Univ Hlth Sys status: RECRUITING city: Skokie state: Illinois zip: 60077 country: United States lat: 42.03336 lon: -87.73339 facility: Cotton-O'Neil Diab & Endo Ctr status: RECRUITING city: Topeka state: Kansas zip: 66606 country: United States lat: 39.04833 lon: -95.67804 facility: Methodist Phys. 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