protocolSection identificationModule nctId: NCT06340854, orgStudyIdInfo id: NN1436-7724, secondaryIdInfos id: U1111-1292-6151, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: 2023-506084-34, type: OTHER, domain: European Medical Agency (EMA), briefTitle: A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2025-05-16, completionDateStruct date: 2025-06-20, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months., conditionsModule conditions: Diabetes, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 404, type: ESTIMATED, armsInterventionsModule interventions name: Insulin icodec, interventions name: Insulin glargine, outcomesModule primaryOutcomes measure: Change in glycated hemoglobin (HbA1c), secondaryOutcomes measure: Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL)), secondaryOutcomes measure: Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction, secondaryOutcomes measure: Number of severe hypoglycaemic episodes (level 3), secondaryOutcomes measure: Number of clinically significant hypoglycaemic episodes (level 2) (less than (<) 3.0 millimoles per litre (mmol/L) (54 mg/dL), confirmed by blood glucose (BG) meter), secondaryOutcomes measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL),confirmed by BG meter) or severe hypoglycaemic episodes (level 3), secondaryOutcomes measure: Time spent < 3.0 mmol/L (54 mg/dL), secondaryOutcomes measure: Change in time spent > 10.0 mmol/L (180 mg/dL), secondaryOutcomes measure: Mean weekly insulin dose, secondaryOutcomes measure: Change in body weight, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Advanced Investigative Medicine, Inc., status: RECRUITING, city: Hawthorne, state: California, zip: 90250, country: United States, geoPoint lat: 33.9164, lon: -118.35257, 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: Clinical Trials Research, status: RECRUITING, city: Lincoln, state: California, zip: 95648, country: United States, geoPoint lat: 38.89156, lon: -121.29301, locations facility: Northeast Research Institute of Florida, status: RECRUITING, city: Fleming Island, state: Florida, zip: 32003, country: United States, geoPoint lat: 30.0933, lon: -81.71898, locations facility: South Broward Research LLC, status: RECRUITING, city: Miramar, state: Florida, zip: 33027, country: United States, geoPoint lat: 25.98731, lon: -80.23227, 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: Cotton-Oneill Diabetes and End, status: RECRUITING, city: Topeka, state: Kansas, zip: 66606-2806, country: United States, geoPoint lat: 39.04833, lon: -95.67804, locations facility: International Diabetes Center, status: RECRUITING, city: Minneapolis, state: Minnesota, zip: 55416, country: United States, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Jefferson City Medical Group, PC, status: RECRUITING, city: Jefferson City, state: Missouri, zip: 65109, country: United States, geoPoint lat: 38.5767, lon: -92.17352, locations facility: Univ of Nebraska Medical CTR, status: NOT_YET_RECRUITING, city: Omaha, state: Nebraska, zip: 68198-3020, country: United States, geoPoint lat: 41.25626, lon: -95.94043, locations facility: Palm Research Center Inc-Vegas, status: RECRUITING, city: Las Vegas, state: Nevada, zip: 89148, country: United States, geoPoint lat: 36.17497, lon: -115.13722, locations facility: Southern NH Diabetes and Endo_Nashua, status: RECRUITING, city: Nashua, state: New Hampshire, zip: 03060, country: United States, geoPoint lat: 42.76537, lon: -71.46757, locations facility: PharmQuest Life Sciences LLC, status: RECRUITING, city: Greensboro, state: North Carolina, zip: 27408, country: United States, geoPoint lat: 36.07264, lon: -79.79198, locations facility: Accellacare Wilmington, status: RECRUITING, city: Wilmington, state: North Carolina, zip: 28401, country: United States, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Trial Management Associates, status: RECRUITING, city: Myrtle Beach, state: South Carolina, zip: 29572, country: United States, geoPoint lat: 33.68906, lon: -78.88669, locations facility: Amarillo Medical Specialists, status: RECRUITING, city: Amarillo, state: Texas, zip: 79106, country: United States, geoPoint lat: 35.222, lon: -101.8313, 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: Victorium Clinical Research, status: RECRUITING, city: Houston, state: Texas, zip: 77024, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: PlanIt Research, PLLC, status: RECRUITING, city: Houston, state: Texas, zip: 77079, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Chrysalis Clinical Research, status: RECRUITING, city: Saint George, state: Utah, zip: 84790, country: United States, geoPoint lat: 37.10415, lon: -113.58412, locations facility: Rainier Clin Res Ctr Inc, status: RECRUITING, city: Renton, state: Washington, zip: 98057, country: United States, geoPoint lat: 47.48288, lon: -122.21707, locations facility: "Medical Center Viva Feniks" Ood, status: RECRUITING, city: Dobrich, zip: 9300, country: Bulgaria, geoPoint lat: 43.56667, lon: 27.83333, locations facility: MHAT "Knyaginya Klementina" -Sofia EAD, status: RECRUITING, city: Sofia, zip: 1233, country: Bulgaria, geoPoint lat: 42.69751, lon: 23.32415, locations facility: UMHAT Aleksandrovska, status: RECRUITING, city: Sofia, zip: 1431, country: Bulgaria, geoPoint lat: 42.69751, lon: 23.32415, locations facility: Medical Institute of Ministry of interior, status: RECRUITING, city: Sofia, zip: 1606, country: Bulgaria, geoPoint lat: 42.69751, lon: 23.32415, locations facility: InnoDiab Forschung GmbH, status: RECRUITING, city: Essen, zip: 45136, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, locations facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, status: NOT_YET_RECRUITING, city: Münster, zip: 48145, country: Germany, geoPoint lat: 51.96236, lon: 7.62571, locations facility: MedicalCenter am Clemenshospital, status: NOT_YET_RECRUITING, city: Münster, zip: 48153, country: Germany, geoPoint lat: 51.96236, lon: 7.62571, locations facility: RED-Institut für medizinische Forschung und Fortbildung GmbH, status: RECRUITING, city: Oldenburg in Holstein, zip: 23758, country: Germany, geoPoint lat: 54.29576, lon: 10.90156, locations facility: Institut für Diabetesforschung Osnabrück, status: NOT_YET_RECRUITING, city: Osnabrück, zip: 49080, country: Germany, geoPoint lat: 52.27264, lon: 8.0498, locations facility: Zentrum für klinische Studien Allgäu Oberschwaben, status: NOT_YET_RECRUITING, city: Wangen, zip: 88239, country: Germany, geoPoint lat: 48.72933, lon: 9.61175, locations facility: Lifecare Hospital and Research Centre, status: NOT_YET_RECRUITING, city: Bangalore, state: Karnataka, zip: 560092, country: India, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Belgaum Diabetes Centre, status: NOT_YET_RECRUITING, city: Belgaum, state: Karnataka, zip: 590001, country: India, geoPoint lat: 15.85212, lon: 74.50447, locations facility: Manipal Hospital, Old Airport Road, Bengaluru, status: NOT_YET_RECRUITING, city: Bengaluru, state: Karnataka, zip: 560017, country: India, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Amrita Institute Of Medical Sciences & Research Centre, status: NOT_YET_RECRUITING, city: Kochi, state: Kerala, zip: 682041, country: India, geoPoint lat: 9.93988, lon: 76.26022, 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: Grant Medical Foundation Ruby Hall Clinic, status: NOT_YET_RECRUITING, city: Pune, state: Maharashtra, zip: 411001, country: India, geoPoint lat: 18.51957, lon: 73.85535, locations facility: Malla Reddy Narayana Multispeciality Hospital, status: NOT_YET_RECRUITING, city: Hyderabad, state: Telangana, zip: 500055, country: India, geoPoint lat: 17.38405, lon: 78.45636, locations facility: Gandhi Hospital & Medical college, status: NOT_YET_RECRUITING, city: Hyderabad, state: Telengana, zip: 500003, country: India, geoPoint lat: 17.38405, lon: 78.45636, locations facility: Government Institute of Medical Sciences, status: NOT_YET_RECRUITING, city: Noida, state: Uttar Pradesh, zip: 201310, country: India, geoPoint lat: 28.58, lon: 77.33, locations facility: Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, status: NOT_YET_RECRUITING, city: Chandigarh, zip: 160012, country: India, geoPoint lat: 30.73629, lon: 76.7884, locations facility: Christian Medical College and Hospital, status: NOT_YET_RECRUITING, city: Ludhiana, zip: 141008, country: India, geoPoint lat: 30.91204, lon: 75.85379, locations facility: Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), status: NOT_YET_RECRUITING, city: Puducherry, zip: 605006, country: India, geoPoint lat: 11.93381, lon: 79.82979, 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: Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology, status: NOT_YET_RECRUITING, city: Shinjuku-ku, state: Tokyo, zip: 1600023, country: Japan, geoPoint lat: 35.2946, lon: 139.57059, locations facility: Futata Tetsuhiro Clinic Meinohama, status: RECRUITING, city: Fukuoka-shi, Fukuoka, zip: 819-0006, country: Japan, geoPoint lat: 33.6, lon: 130.41667, locations facility: Oyama East Clinic, status: RECRUITING, city: Tochigi, zip: 323-0022, country: Japan, geoPoint lat: 36.38333, lon: 139.73333, locations facility: Noritake Clinic, status: RECRUITING, city: Ushiku-shi, Ibaraki, zip: 300-1207, country: Japan, locations facility: Uniwersytecki Szpital Kliniczny w Opolu, status: RECRUITING, city: Opole, state: Opolskie, zip: 45-401, country: Poland, geoPoint lat: 50.67211, lon: 17.92533, locations facility: Uniwersytecki Szpital Kliniczny w Opolu, status: NOT_YET_RECRUITING, city: Opole, state: Opolskie, zip: 45-401, country: Poland, geoPoint lat: 50.67211, lon: 17.92533, locations facility: NZOZ Vita-Diabetica Malgorzata Buraczyk, status: RECRUITING, city: Bialystok, state: Podlaskie Voivodeship, zip: 15-879, country: Poland, geoPoint lat: 53.13333, lon: 23.16433, locations facility: NZOZ Vita-Diabetica Malgorzata Buraczyk, status: NOT_YET_RECRUITING, city: Bialystok, state: Podlaskie Voivodeship, zip: 15-879, country: Poland, geoPoint lat: 53.13333, lon: 23.16433, 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: Centrum Medyczne Pratia Gdynia, status: NOT_YET_RECRUITING, city: Gdynia, state: Pomorskie, zip: 81-338, country: Poland, geoPoint lat: 54.51889, lon: 18.53188, locations facility: Centrum Medyczne Pratia Katowice, status: RECRUITING, city: Katowice, zip: 40-081, country: Poland, geoPoint lat: 50.25841, lon: 19.02754, locations facility: Centrum Medyczne Pratia Katowice, status: NOT_YET_RECRUITING, city: Katowice, zip: 40-081, country: Poland, geoPoint lat: 50.25841, lon: 19.02754, locations facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji, status: RECRUITING, city: Warszawa, zip: 02-507, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji, status: NOT_YET_RECRUITING, city: Warszawa, zip: 02-507, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Trialmed CRS, status: RECRUITING, city: Piotrków Trybunalski, state: Łódzkie, zip: 97-300, country: Poland, geoPoint lat: 51.40547, lon: 19.70321, locations facility: Advanced Clinical Research LLC, status: RECRUITING, city: Bayamon, zip: 00959, country: Puerto Rico, geoPoint lat: 18.39856, lon: -66.15572, locations facility: Manati Ctr For Clin Research, status: RECRUITING, city: Manati, zip: 00674, country: Puerto Rico, geoPoint lat: 18.42745, lon: -66.49212, locations facility: Hemant Makan, status: NOT_YET_RECRUITING, city: Johannesburg, state: Gauteng, zip: 1827, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Dr Moosa's Rooms, status: NOT_YET_RECRUITING, city: Lenasia, state: Gauteng, zip: 1827, country: South Africa, geoPoint lat: -26.32052, lon: 27.83564, locations facility: Botho ke Bontle Health Services, status: NOT_YET_RECRUITING, city: Pretoria, state: Gauteng, zip: 0184, country: South Africa, geoPoint lat: -25.74486, lon: 28.18783, locations facility: Dr Mahesh Duki Research And Trial Site, status: NOT_YET_RECRUITING, city: Durban, state: KwaZulu Natal, zip: 4339, country: South Africa, geoPoint lat: -29.8579, lon: 31.0292, locations facility: Dr A Amod, status: NOT_YET_RECRUITING, city: Durban, state: KwaZulu-Natal, zip: 4092, country: South Africa, geoPoint lat: -29.8579, lon: 31.0292, locations facility: Dr MB Moosa's Practice, status: NOT_YET_RECRUITING, city: Durban, state: KwaZulu-Natal, zip: 4092, country: South Africa, geoPoint lat: -29.8579, lon: 31.0292, locations facility: Hospital de Basurto, status: NOT_YET_RECRUITING, city: Bilbao, state: Vizcaya, zip: 48013, country: Spain, geoPoint lat: 43.26271, lon: -2.92528, locations facility: Hospital Clinic i Provincial, status: RECRUITING, city: Barcelona, zip: 08036, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: ABS La Roca del Vallés, status: RECRUITING, city: La Roca del Vallés, zip: 08430, country: Spain, geoPoint lat: 41.58333, lon: 2.33333, locations facility: Hospital Clínico Virgen de la Victoria, status: RECRUITING, city: Málaga, zip: 29010, country: Spain, geoPoint lat: 36.72016, lon: -4.42034, locations facility: Hospital Quirón, status: NOT_YET_RECRUITING, city: Pozuelo de Alarcón, zip: 28223, country: Spain, geoPoint lat: 40.43293, lon: -3.81338, hasResults: False