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Clinical Trial Details

Trial ID: L1857
Source ID: NCT04760626
Associated Drug: Insulin Icodec
Title: A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before
Acronym: ONWARDS 5
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin icodec|DRUG: Insulin Glargine 100U/mL|DRUG: Insulin Degludec|DRUG: Insulin Glargine 300U/mL
Outcome Measures: Primary: Change in HbA1c (glycated haemoglobin), %-point, From baseline week 0 (V2) to week 52 (V6) | Secondary: Time from baseline to treatment discontinuation or intensification, Days, From baseline week 0 (V2) to week 52 (V6)|Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction, Score of 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment., From baseline week 0 (V2) to week 52 (V6)|Trim-D (Treatment Related Impact Measure for Diabetes) compliance domain, Score of 4-20. 4 items scored on a scale of 1 to 5 Transformed to a 0-100 scale with higher scores corresponding to better compliance., At end of treatment week 52 (V6)|Number of severe hypoglycaemic episodes (level 3), Number of episodes, From baseline week 0 (V2) to week 57 (V8)|Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter), Number of episodes, From baseline week 0 (V2) to week 57 (V8)|Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3), Number of episodes, From baseline week 0 (V2) to week 57 (V8)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1085
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-03-01
Completion Date: 2022-08-29
Results First Posted:
Last Update Posted: 2024-08-07
Locations: Univ of Alabama Birmingham, Birmingham, Alabama, 35233, United States|Lakeview Clinical Research, LLC, Guntersville, Alabama, 35976, United States|American Clinical Trials, Buena Park, California, 90620, United States|Valley Research, Fresno, California, 93720, United States|Advanced Investigative Medicine, Inc., Hawthorne, California, 90250, United States|Diabetes/Lipid Mgmt & Res Ctr, Huntington Beach, California, 92648, United States|Scripps Whittier Diabetes Inst, La Jolla, California, 92037, United States|First Valley Medical Group, Lancaster, California, 93534, United States|Torrance Clin Res Inst, Inc., Lomita, California, 90717, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Desert Oasis Hlthcr Med Group, Palm Springs, California, 92262, United States|Clinical Trials Research_Sacramento, Sacramento, California, 95821, United States|San Diego Family Care, San Diego, California, 92111, United States|NorCal Endocrinology and Internal Medicine, San Ramon, California, 94583, United States|Encompass Clinical Research_Spring Valley, Spring Valley, California, 91978, United States|Coastal Metabolic Research Center, Ventura, California, 93003, United States|San Fernando Valley Hlth Inst, West Hills, California, 91304, United States|Est Cst Inst for Rsrch,Jksnvil, Jacksonville, Florida, 32216, United States|Adult Medicine of Lake County, Inc., Mount Dora, Florida, 32757, United States|Suncoast Clin Res Port Richey, New Port Richey, Florida, 34652, United States|Florida Inst For Clin Res, Orlando, Florida, 32825, United States|Palm Harbor Medical Associates, Palm Harbor, Florida, 34684-3609, United States|Suncoast Clinical Research, Inc., Palm Harbor, Florida, 34684, United States|Metabolic Research Institute Inc, West Palm Beach, Florida, 33401, United States|Clinical Research of Central Florida_Winter Haven, Winter Haven, Florida, 33880, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|Endo Res Solutions, Inc, Roswell, Georgia, 30076, United States|Elite Clinical Trials, Blackfoot, Idaho, 83221, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Central Illinois Diabetes and Clinical Research, Springfield, Illinois, 62711, United States|Cotton O'Neil Clin Research Ctr, Topeka, Kansas, 66606, United States|MedStar Community Clin Res Ctr, Hyattsville, Maryland, 20782, United States|Endo and Metab Consultants, Rockville, Maryland, 20852, United States|Northern Pines Hlth Ctr, PC, Buckley, Michigan, 49620, United States|Arcturus Healthcare, PLC., Troy, Michigan, 48098, United States|Jefferson City Medical Group, PC, Jefferson City, Missouri, 65109, United States|Methodist Physicians Clin, Omaha, Nebraska, 68114, United States|Univ of Nebraska Medical CTR, Omaha, Nebraska, 68198-3020, United States|Palm Research Center Inc-Vegas, Las Vegas, Nevada, 89148, United States|Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire, 03060, United States|Albuquerque Clin Trials, Inc., Albuquerque, New Mexico, 87102, United States|Albany Medical College - Endo, Albany, New York, 12203, United States|N.Y. Total Medical Care PC, Brooklyn, New York, 11215, United States|Mid Hudson Medical Research, PLLC, New Windsor, New York, 12553, United States|Endocrine Associates of Long Island, PC, Smithtown, New York, 11787, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|Physicians East Endocrinology, Greenville, North Carolina, 27834, United States|Medication Management, LLC, Raleigh, North Carolina, 27609, United States|Accellacare, Wilmington, North Carolina, 28401, United States|Plains Clinical Research Center, LLC_Fargo, Fargo, North Dakota, 58104, United States|Diab & Endo Assoc of Stark Co, Canton, Ohio, 44718, United States|Providence Health Partners Ctr, Dayton, Ohio, 45439, United States|New Venture Medical Research, Wadsworth, Ohio, 44281, United States|The Diabetes Center, LLC, Murrells Inlet, South Carolina, 29576, United States|Hillcrest Clinical Research, Simpsonville, South Carolina, 29681-1538, United States|AM Diabetes And Endocrinology Center, Bartlett, Tennessee, 38133, United States|Chattanooga Medical Research, LLC, Chattanooga, Tennessee, 37404, United States|Univ Diab & Endo Consultants, Chattanooga, Tennessee, 37411, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|HealthStar Physicians PC, Morristown, Tennessee, 37813, 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|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|UT Southwestern Med Cntr, Dallas, Texas, 75390-9302, United States|PrimeCare Medical Group, Houston, Texas, 77024, United States|Juno Research, LLC, Houston, Texas, 77074, United States|Protenium Clinical Research, Hurst, Texas, 76054, United States|Medical Colleagues-Texas LLP, Katy, Texas, 77450, United States|Fmc Science, Llc, Lampasas, Texas, 76550, United States|Andres Garcia-Zuniga, MD, P.A, Laredo, Texas, 78041, United States|Texas Diab & Endo, P.A., Round Rock, Texas, 78681, United States|Clinical Trials of Texas, LLC, San Antonio, Texas, 78229, United States|NE Clin Res of San Antonio, San Antonio, Texas, 78233, United States|Simcare Medical Research, LLC, Sugar Land, Texas, 77478, United States|Wade Family Medicine, Bountiful, Utah, 84010, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|TPMG Clinical Research, Newport News, Virginia, 23606, United States|Clinical Inv Spec, Inc.Kenosha, Kenosha, Wisconsin, 53144, United States|LMC Clin Res Inc. Calgary, Calgary, Alberta, T2H 2G4, Canada|The Bailey Clinic, Red Deer, Alberta, T4N 6V7, Canada|Dr. M.B. Jones Inc, Victoria, British Columbia, V8V 4A1, Canada|Rivergrove Medical Clinic, Winnipeg, Manitoba, R2V 4W3, Canada|Winnipeg Clinic, Winnipeg, Manitoba, R3C 0N2, Canada|G.A. Research Associates Ltd., Moncton, New Brunswick, E1G 1A7, Canada|Commonwealth Medical Clinic, Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada|Eastern Health Authority, St. Johns, Newfoundland and Labrador, A1B 3V6, Canada|LMC Diabetes & Endocrinology (Barrie), Barrie, Ontario, L4N 7L3, Canada|Centricity Research LMC, Brampton, Ontario, L6S 0C6, Canada|LMC (Thornhill), Concord, Ontario, L4K 4M2, Canada|Medical Trust Clinics, Inc., Courtice, Ontario, L1E2J5, Canada|LMC Endo Ctr (Etobicoke) Ltd, Etobicoke, Ontario, M9R 4E1, Canada|Wharton Med Clin Trials, Hamilton, Ontario, L8L 5G8, Canada|Hamilton Med Res Group, Hamilton, Ontario, L8M 1K7, Canada|Milestone Research, London, Ontario, N5W 6A2, Canada|Western Univ. Cnt for Studies in Fam Med, London, Ontario, N6G 2M1, Canada|LMC Research Inc. Ottawa, Nepean, Ontario, K2J 0V2, Canada|LMC Oakville, Oakville, Ontario, L6M 1M1, Canada|Bluewater Clin Res Group,Inc, Sarnia, Ontario, N7T 4X3, Canada|Winterberry Family Medicine, Stoney Creek, Ontario, L8J 0B6, Canada|LMC Endo Centres Ltd.(Bayview), Toronto, Ontario, M4G 3E8, Canada|Dr. Anil K Gupta Medicine Professional Corporation, Toronto, Ontario, M9V 4B4, Canada|ViaCar Recherche Clinique Inc, Brossard, Quebec, J4Z 2K9, Canada|Ecogene-21, Chicoutimi, Quebec, G7H 7K9, Canada|Ctr de rech Clin de Laval, Laval, Quebec, H7T 2P5, Canada|Manna Research Mirabel, Mirabel, Quebec, J7J 2K8, Canada|Applied Med Inf Res, Montreal, Quebec, H4A 3T2, Canada|Diex Recherche Joliette, Saint-Charles-Borromee, Quebec, J6E 2B4, Canada|LMC Clin Rsrch Inc. (Montreal), Saint-Laurent, Quebec, H4T 1Z9, Canada|Ctr Méd. et pro d l'Ost d port, St-Marc-des-Carrières, Quebec, G0A 4B0, Canada|Diex Recherche Victoriaville, Victoriaville, Quebec, G6P 6P6, Canada|Recherche Clinique Sigma inc, Quebec, G1G 3Y8, Canada|Diex Recherche Quebec Inc., Quebec, G1V 4T3, Canada|Centre de Recherche Saint-Louis, Quebec, G1W 4R4, Canada|Diabetespraxis Mergentheim, Bad Mergentheim, 97980, Germany|Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR, Berlin, 13597, Germany|InnoDiab Forschung GmbH, Essen, 45136, Germany|Zentrum für klinische Forschung, Dr. med. Lüdemann, Falkensee, 14612, Germany|Wendisch/Dahl Hamburg, Hamburg, 22607, Germany|Milek, Hohenmölsen, Hohenmölsen, 06679, Germany|Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster, 48145, Germany|MedicalCenter am Clemenshospital, Münster, 48153, Germany|RED-Institut für medizinische Forschung und Fortbildung GmbH, Oldenburg in Holstein, 23758, Germany|Praxis Dr. med. Wenzl-Bauer, Rehlingen-Siersburg, 66780, Germany|Bieler, Riesa, Riesa, 01587, Germany|Zentrum für klinische Studien Alexander Segner, Saint Ingbert-Oberwürzbach, 66386, Germany|Erlinger, Stuttgart, 70378, Germany|Zentrum für klinische Studien Allgäu Oberschwaben, Wangen, 88239, Germany|Iatriko Psychicou Private Clinic, Athens, 115 25, Greece|'G. Gennimatas' General Hospital of Athens, Athens, GR-115 27, Greece|Korgiallenio - Benakio Hospital (Red Cross Hosp.), Athens, GR-11526, Greece|"Laiko" General Hospital of Athens, Athens, GR-11527, Greece|Iatriko Athinon 'Palaiou Falirou', Athens, GR-17562, Greece|Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease, Larissa, GR-41110, Greece|General Hospital of Thessaloniki 'G. Gennimatas, Thessaloniki, GR-54635, Greece|AHEPA General University Hospital, Thessaloniki, GR-54636, Greece|"Ippokrateio" G.H. of Thessaloniki, Thessaloniki, GR-54642, Greece|"Ippokrateio" General Hosp Thessaloniki, A' Internal Med, Thessaloniki, GR-54642, Greece|EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes, Thessaloniki, GR-54643, Greece|"Thermi" Private Hosital, Thessaloniki, GR-57001, Greece|General Hospital of Thessaloniki "G.Papanikolaou", Thessaloniki, GR-57010, Greece|Belinus Bt., Debrecen, Hajdu-Bihar Varmegye, 4025, Hungary|Selye János Kórház és Rendelőintézet, Komárom, Komárom-Esztergom, 2900, Hungary|Szent Margit Kórház, Budapest, 1032, Hungary|Óbudai Egészségügyi Centrum, Budapest, 1036, Hungary|Szőcs Depot Egészségügyi Szolgáltató Kft., Budapest, 1042, Hungary|ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft., Budapest, 1089, Hungary|MED-TIMA Kft., Budapest, 1132, Hungary|MH Egészségügyi Központ, Budapest, 1134, Hungary|Uno Medical Trials Eü. Szolgáltató és Kereskedelmi Kft., Budapest, 1152, Hungary|Kaposi Mór Oktató Kórház, Kaposvár, 7400, Hungary|Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ, Szeged, H-6725, Hungary|Markusovszky Egyetemi Oktatókórház, Szombathely, H-9700, Hungary|Zala Megyei Szent Rafael Kórház, Zalaegerszeg, 8900, Hungary|Centrum Medyczne Pratia Gdynia, Gdynia, Pomorskie, 81-338, Poland|NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o., Gdansk, 80-858, Poland|Centrum Medyczne Pratia Katowice, Katowice, 40-081, Poland|Gabinet Lekarski Malgorzata Saryusz-Wolska, Lodz, 90-132, Poland|Pro Salus Centrum Medyczne, Lodz, 91-473, Poland|Katedra i Klinika Chorob Wewnetrznych AM w Lublinie, Lublin, 20-081, Poland|Oddzial Chorób - Wewn., Poznan, 60-834, Poland|Velocity Nova Sp. z o.o., Pulawy, 24-100, Poland|Velocity Nova Sp. z o.o., Staszow, 28-200, Poland|Lubelskie Centrum Diagnostyczne Tomasz Blicharski, Swidnik, 21-040, Poland|Poradnia dla Chorych na Cukrzycę, Zabrze, 41-800, Poland|Manati Ctr For Clin Research, Manati, 00674, Puerto Rico|T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan, Adana, 01000, Turkey|Baskent Universitesi Adana, Adana, 01250, Turkey|Ankara Universitesi Ibni Sina Hastanesi, Ankara, 06100, Turkey|Gaziantep Universitesi Tip Fakultesi Hastanesi, Gaziantep, 27070, Turkey|Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm, Hatay, 31060, Turkey|Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi, Istanbul, 34303, Turkey|Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi, Istanbul, 34371, Turkey|Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji, Istanbul, 34390, Turkey|Haydarpasa Numune Hastanesi, Istanbul, 34718, Turkey|T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, 34722, Turkey|Umraniye Egitim ve Arastirma Hastanesi, Istanbul, 34760, Turkey|T.C. S.B. Ist Il SagMud Pendik Egitim ve Arastirma Hastanesi, Istanbul, 34899, Turkey|Dokuz Eylul University Medical Faculty, Izmir, 35340, Turkey|Erciyes Universitesi Tip Fakultesi, Kayseri, 38039, Turkey
URL: https://clinicaltrials.gov/show/NCT04760626

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress