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Clinical Trial Details

Trial ID: L6010
Source ID: NCT04460885
Associated Drug: Insulin Icodec
Title: A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before
Acronym: ONWARDS 1
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin icodec|DRUG: Insulin glargine
Outcome Measures: Primary: Change in HbA1c, %-point, From baseline week 0 (V2) to week 52 (V46) | Secondary: Time in target range 3.9-10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6, % of readings, From week 48 (V42) to week 52 (V46)|Change in fasting plasma glucose (FPG), mmol/L, From baseline week 0 (V2) to week 52 (V46)|Number of severe hypoglycaemic episodes (level 3), Number of episodes, From baseline week 0 (V2) to week 52 (V46)|Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter), Number of episodes, From baseline week 0 (V2) to week 52 (V46)|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), Number of episodes, From baseline week 0 (V2) to week 52 (V46)|Number of severe hypoglycaemic episodes (level 3), Number of episodes, From baseline week 0 (V2) to week 83 (V63)|Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter), Number of episodes, From baseline week 0 (V2) to week 83 (V63)|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), Number of episodes, From baseline week 0 (V2) to week 83 (V63)|Mean weekly insulin dose, U, From week 50 (V44) to week 52 (V46)|Change in body weight, kg, From baseline week 0 (V2) to week 52 (V46)|Time spent < 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6, % of readings, From week 48 (V42) to week 52 (V46)|Time spent > 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6, % of readings, From week 48 (V42) to week 52 (V46)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 984
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-11-25
Completion Date: 2022-12-01
Results First Posted:
Last Update Posted: 2024-07-05
Locations: Uni of Alabama at Birmingham, Birmingham, Alabama, 35294, 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|First Valley Medical Group, Lancaster, California, 93534, United States|Desert Oasis Hlthcr Med Group, Palm Springs, California, 92262, United States|Coastal Metabolic Research Center, Ventura, California, 93003, United States|Chase Medical Research LLC, Waterbury, Connecticut, 06708, United States|East Coast Institute for Research, LLC, Jacksonville, Florida, 32216, 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|Metabolic Research Institute Inc, West Palm Beach, Florida, 33401, United States|East West Medical Research Institute_Honolulu, Honolulu, Hawaii, 96814, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Clinical Invest Special_Gurnee, Gurnee, Illinois, 60031, United States|Iowa Diab & Endo Res Center, West Des Moines, Iowa, 50265, United States|Cotton-O'Neil Diab & Endo Ctr, Topeka, Kansas, 66606, United States|Four Rivers Clinical Research Inc, Paducah, Kentucky, 42001, United States|MedStar Hlth Res Institute, Hyattsville, Maryland, 20782, United States|Endo And Metab Cons, Rockville, Maryland, 20852, United States|Arcturus Healthcare, PLC., Troy, Michigan, 48098, United States|Univ of Nebraska Medical CTR, Omaha, Nebraska, 68198-3020, United States|Albuquerque Clin Trials, Inc., Albuquerque, New Mexico, 87102, United States|N.Y. Total Medical Care PC, Brooklyn, New York, 11215, 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, 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|Prestige Clinical Research, Franklin, Ohio, 45005, United States|Intend Research, Norman, Oklahoma, 73069, United States|The Diabetes Center, LLC, Murrells Inlet, South Carolina, 29576, United States|Hillcrest Clinical Research, Simpsonville, South Carolina, 29681-1538, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Texas Diab & Endo, P.A., Austin, Texas, 78731, 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, Houston, Texas, 77040, United States|Fmc Science, Llc, Lampasas, Texas, 76550, 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|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|TPMG Clinical Research, Newport News, Virginia, 23606, United States|Rainier Clin Res Ctr Inc, Renton, Washington, 98057, United States|Poliklinika SLAVONIJA OSIJEK, Osijek, Osječko - Baranjska Županija, 31000, Croatia|Opca bolnica Karlovac, Karlovac, 47000, Croatia|KBC Rijeka, Endokrinologija, Rijeka, 51000, Croatia|Opca bolnica Varazdin, Varazdin, 42 000, Croatia|PGIMS Rohtak, Rohtak, Haryana, 124001, India|TOTALL Diabetes Hormone Institute, Indore, Madhya Pradesh, 452010, India|BYL Nair Hospital and T N Medical College Department of endo, Mumbai, Maharashtra, 400008, India|chelleram Diabetes Institute, Pune, Maharashtra, 411021, India|Madras Diabetes Research Foundation, Chennai, Tamil Nadu, 600086, India|Christian Medical College Hospital, Vellore, Vellore, Tamil Nadu, 632004, India|Ramdev Rao Hospital, Hyderabad, Telangana, 500072, India|Osmania General Hospital, Hyderabad, Telengana, 500 012, India|Gandhi Hospital & Medical college, Hyderabad, Telengana, 500003, India|Diabetes Clinic Wolfson MC, Holon, 58100, Israel|Diabetes Unit Hadassah Ein Karem MC, Jerusalem, 91120, Israel|Diabetes Clinic Meir MC, Kfar Saba, 44281, Israel|Rabin Medical Center, Petach Tikva, 49100, Israel|Kaplan MC, Rehovot, 76100, Israel|Policlinico Umberto I Seconda Clinica Medica, Roma, RM, 00161, Italy|Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, 24127, Italy|Policlinico Mater Domini Università di Catanzaro, Catanzaro, 88100, Italy|Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia, Milano, 20122, Italy|Unità Funzionale di nutrizione clinica cod 58.01.3, Palermo, 90127, Italy|Hayashi Diabetes Clinic, Chigasaki-shi, Kanagawa, Kanagawa, Japan, 253-0044, Japan|Hayashi Diabetes Clinic, Chigasaki-shi, Kanagawa, Japan, 253-0044, Japan|Heiwadai Hospital, Miyazaki-shi, Miyazaki, 880-0034, Japan|The University of Tokyo Hospital, Diabetes and Metabolic, Bunkyo-ku, Tokyo, 113-8655, Japan|Tokuyama clinic, Chiba, 261-0004, Japan|Futata Tetsuhiro Clinic Meinohama, Fukuoka-shi, Fukuoka, 819-0006, Japan|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|Sugimoto Clinic,Internal Medicine, Kitakyusyu-shi, Fukuoka, 800-0222, Japan|Toranomon Hospital, Endocrinology and Metabolism, Minato-ku, Tokyo, 105-8470, Japan|Shinden Higashi Clinic_Miyagi, Miyagi, 983-0039, Japan|Takatsuki Red Cross Hospital, Osaka, 569-1045, Japan|Shimizu Clinic Fusa, Saitama, 336-0967, Japan|Wakakusa Clinic, Shimotsuke-shi, Tochigi, 329-0433, Japan|Oyama East Clinic, Tochigi, 323-0022, Japan|Noritake Clinic, Ushiku-shi, Ibaraki, 300-1207, Japan|InstitutoJalisciense de Investigación en Diabetes y Obesidad, Guadalajara, Jalisco, 44600, Mexico|Clínica Omega Diabetes, S.C., Mexico City, México, D.F., 06700, Mexico|Hospital Universitario Dr. José Eleuterio González, Monterrey, Nuevo León, 64460, Mexico|Investigación Médica Sonora S.C., Hermosillo, Sonora, 83280, Mexico|NZOZ "CenterMed Lublin" Sp. z o.o., Lublin, Lubelskie, 20-044, Poland|NZOZ Przychodnia Specjalistyczna Medica, Lublin, Lubelski, 20-538, Poland|Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski, Gorzow Wielkopolski, Lubuskie, 66-400, Poland|NBR Polska Tomasz Klodawski, Warsaw, Mazowieckie, 00-710, Poland|NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska, Bialystok, Podlaskie, 15-435, Poland|Centrum Medyczne "Diabetika", Radom, 26-600, Poland|Centrum Zdrowia Tuchow Sp z o.o., Wierzchoslawice, 33-122, Poland|Prywatny Gabinet Janusz Gumprecht, Zabrze, 41-800, Poland|Advanced Clinical Research LLC, Bayamon, 00959, Puerto Rico|Manati Ctr For Clin Research, Manati, 00674, Puerto Rico|SAHI Kuzbass Hospital(former Regional clinical hospital), Kemerovo, 650066, Russian Federation|National Medical Research Center of Endocrinology, Moscow, 117292, Russian Federation|Setchenov First Moscow State Medical University, Moscow, 119435, Russian Federation|Limited Law Company "Healthy Family" Medicine Center", Novosibirsk, 630099, Russian Federation|Scientifc Institute of Clinical and Experimental Lymphology, Novosibirsk, 630117, Russian Federation|Penza Regional Clinical Hospital named after N.N. Burdenko, Penza, 440052, Russian Federation|Leningrad Regional Clinical Hospital, Saint Petersburg, 194291, Russian Federation|Limited Liability Company "Energiya Zdoroviya", Saint-Petersburg, 194156, Russian Federation|Medinet LLC, Saint-Petersburg, 194356, Russian Federation|Consultative & Diagnostic Center with a Outpatient Hospital, Saint-Petersburg, 197110, Russian Federation|Regional clinical cardiology dispensary, Saratov, 410039, Russian Federation|Siberian State Medical University, Tomsk, 634050, Russian Federation|Voronezh Regional Clinical Consultive-diagnostic Centre, Voronezh, 394018, Russian Federation|Polyclinic #2 in Yoshkar-Ola, Yoshkar-Ola, 424004, Russian Federation|Peter Farkas MD, s.r.o., Sahy, Slovak Republic, 93601, Slovakia|Diabetologicka a endokrinologicka ambulancia, Bratislava, 84102, Slovakia|MEDISPEKTRUM s.r.o., Bratislava, 851 01, Slovakia|MediVet s.r.o., Malacky, 901 01, Slovakia|SIN AZUCAR s.r.o., Malacky, 901 01, Slovakia|Diabetologicka ambulancia SchronerMED, s.r.o., Moldava nad Bodvou, 045 01, Slovakia|ARETEUS s.r.o., Trebisov, 07501, Slovakia|Complejo Hospitalario Universitario A Coruña, La Coruña, 15006, Spain|ABS La Roca del Vallés, La Roca del Vallés, 08430, Spain|Hospital Universitario de la Princesa, Madrid, 28006, Spain|Centro de Especialidades José Marva, Madrid, 28020, Spain|Hospital Quirón, Pozuelo de Alarcon, 28223, Spain|Layton Medical Centre, Blackpool, FY3 7EN, United Kingdom|Bollington Medical Centre, Bollington, SK10 5JH, United Kingdom|The Health Centre, Bradford-on-Avon, BA15 1DQ, United Kingdom|Southmead Hospital, Bristol, BS10 5NB, United Kingdom|Addenbrooke's Hospital_Cambridge, Cambridge, CB2 0QQ, United Kingdom|The Adam Practice, Dorset, BH16 5PW, United Kingdom|Western General Hospital, Edinburgh, EH4 2XU, United Kingdom|Burbage Surgery, Hinckley, LE10 2SE, United Kingdom|The Staploe Medical Centre, Soham, CB7 5JD, United Kingdom|Joint Clinical Research Facility - Swansea, Swansea, SA2 8PP, United Kingdom|Royal Cornwall Hospital (Treliske), Truro, TR1 3LJ, United Kingdom|Albany House Medical Centre, Wellingborough, NN8 4RW, United Kingdom
URL: https://clinicaltrials.gov/show/NCT04460885

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress