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Clinical Trial Details

Trial ID: L3916
Source ID: NCT04880850
Associated Drug: Insulin Icodec
Title: A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4)
Acronym: ONWARDS 4
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin icodec|DRUG: Insulin glargine|DRUG: Insulin aspart
Outcome Measures: Primary: Change in Glycated haemoglobin (HbA1c), Measured in %-point, From baseline week 0 (V2) to week 26 (V28) | Secondary: Change in fasting plasma glucose (FPG), Measured in mmol/L, From baseline week 0 (V2) to week 26 (V28)|Time in target-range 3.9-10.0 mmol/L (70-180 mg/dL) (using continuous glucose monitoring (CGM) system, Dexcom G6), Measured in % of readings, From week 22 (V24) to week 26 (V28)|Number of severe hypoglycaemic episodes (level 3), Number of episodes, From baseline week 0 (V2) to week 31 (V30)|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 31 (V30)|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 31 (V30)|Time spent below 3.0 mmol/L (54 mg/dL) (using continuous glucose monitoring (CGM) system, Dexcom G6 ), Measured in % of readings, From week 22 (V24) to week 26 (V28)|Time spent above 10 mmol/L (180 mg/dL) (using continuous glucose monitoring (CGM) system, Dexcom G6), Measured in % of readings, From week 22 (V24) to week 26 (V28)|Mean weekly insulin dose, Measured in U, From week 24 (V26) to week 26 (V28)|Change in body weight, Measured in kg, From baseline week 0 (V2) to week 26 (V28)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 582
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-05-14
Completion Date: 2022-06-16
Results First Posted:
Last Update Posted: 2024-05-29
Locations: John Muir Physicians Network, Concord, California, 94520, United States|Valley Research, Fresno, California, 93720, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Clinical Trials Research_Sacramento_0, Sacramento, California, 95821, United States|Diabetes Research Center, Tustin, California, 92780, United States|Coastal Metabolic Research Center, Ventura, California, 93003, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|MedStar Diabetes Institute, Washington, District of Columbia, 20010, United States|Metabolic Research Institute Inc, West Palm Beach, Florida, 33401, United States|Physicians Research Assoc. LLC, Lawrenceville, Georgia, 30046, United States|Saltzer Medical Group Research, Nampa, Idaho, 83686-6011, United States|Jefferson City Medical Group, PC, Jefferson City, Missouri, 65109, United States|Methodist Physicians Clin, Omaha, Nebraska, 68114, United States|SUNY Upstate Medical University, Syracuse, New York, 13210, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|Physician's East Endocrinology, Greenville, North Carolina, 27834, United States|AM Diabetes And Endocrinology Center, Bartlett, Tennessee, 38133, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Vanderbilt Diab Obes Clin Tri, Nashville, Tennessee, 37212, 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|Osvaldo A. Brusco MD PA, Corpus Christi, Texas, 78414, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|North Texas Endocrine Center, Dallas, Texas, 75231, United States|UT Southwestern Med Cntr, Dallas, Texas, 75390-9302, United States|DCOL Ctr for Clin Res, Longview, Texas, 75605, United States|Imeldaziekenhuis - Bonheiden - Department of Endocrinology, Bonheiden, 2820, Belgium|CHU Helora - Site Warquignies, Boussu, 7300, Belgium|Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie, Bruxelles, 1200, Belgium|UZA - UZ Antwerpen - Department of Endocrinology, Edegem, 2650, Belgium|UZ Leuven - Endocrinology, Leuven, 3000, Belgium|Medanta - The Medicity Multi-Speciality Hospital, Gurugram, Gurgaon, Haryana, 122001, India|Bangalore Clinisearch, Bangalore, Karnataka, 560043, India|Lifecare Hospital and Research Centre, Bangalore, Karnataka, 560092, India|Manipal Hospital, Hebbal, Bengaluru, Bengaluru, Karnataka, 560 024, India|Renai Medicity, Kochi, Kerala, 682025, India|Prince Aly Khan Hospital, Mumbai, Maharashtra, 400010, India|BSES MG hospital, Mumbai, Maharashtra, 400058, India|Grant Medical Foundation, Pune, Maharashtra, 411001, India|Diabetes, Thyroid and Endocrine Centre, Jaipur, Rajasthan, 302006, India|Azienda Ospedaliero-Universitaria Renato Dulbecco, Catanzaro, Cz, 88100, Italy|Istituto Scientifico San Raffaele, Milano, MI, 20132, Italy|A. O. Universitaria S.ORSOLA-MALPIGHI - U. O. Endocrinologia, Bologna, 40138, Italy|Università degli Studi G. D'Annunzio, Chieti, 66100, Italy|A.O.U. Università Studi della Campania "Luigi Vanvitelli", Napoli, 80138, Italy|Policlinico Umberto I La Sapienza V Clinica Medica, Roma, 00161, Italy|Hayashi Diabetes Clinic, Chigasaki-shi, Kanagawa, Japan, 253-0044, Japan|Futata Tetsuhiro Clinic Meinohama, Fukuoka-shi, Fukuoka, 819-0006, Japan|Sasaki Hospital Internal Medicine, Hokkaido, 062-0007, Japan|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|Sugimoto Clinic,Internal Medicine, Kitakyusyu-shi, Fukuoka, 800-0222, Japan|Shimizu Clinic Fusa, Saitama, 336-0967, Japan|Oyama East Clinic, Tochigi, 323-0022, Japan|The Jikei University Hospital Dept of Diabetes, Metabolic, Tokyo, 105-8471, Japan|Noritake Clinic, Ushiku-shi, Ibaraki, 300-1207, Japan|Centro de Investigacion Medica de Occidente S.C., Zapopan, Jalisco, 45116, Mexico|Hospital Universitario Dr. José Eleuterio González_Monterrey, Monterrey, Nuevo León, 64460, Mexico|Unidad Biomedica Avanzada Monterrey, Monterrey, Nuevo León, 64460, Mexico|Rijnstate Ziekenhuis, Arnhem, 6815 AD, Netherlands|Bethesda Diabetes Research Center en Bethesda ziekenhuis, Hoogeveen, 7909 AA, Netherlands|Maastricht Universitair Medisch Centrum, Maastricht, 6229 HX, Netherlands|Ikazia Ziekenhuis, Rotterdam, 3083 AN, Netherlands|Universitair Medisch Centrum Utrecht, Utrecht, 3584 CX, Netherlands|Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila, Bucharest, Bucurestii, 020475, Romania|Spitalul Judetean de Urgenta Targoviste, Targoviste, Dambovita, 130083, Romania|Sc Mediab Srl, Targu Mures, Mures, 540142, Romania|Mariodiab Clinic SRL, Brasov, 500101, Romania|S.C. Medcon S.R.L, Buzau, 120203, Romania|Clinical Emergency Sf. Apostol Andrei Hospital, Galati, 800578, Romania|Tumen State Medical University, Tumen, Russia, 625023, Russian Federation|Arkhangelsk Regional Clinical Hospital, Arkhangelsk, 163045, Russian Federation|City Hospital #5, Barnaul, 656045, Russian Federation|KSFMU, Inrereginal Clinical Diagnostic center, Kazan, 420010, Russian Federation|Kirov Clinical Hospital #7, Kirov, 610014, Russian Federation|Limited Liability Company "AriVa-Med", Kursk, 305016, Russian Federation|City Clinical Hospital №52, Moscow, 123182, Russian Federation|LLC "Centr Targetnoy Terapii", Moscow, 125008, Russian Federation|Limited Law Company "Healthy Family" Medicine Center", Novosibirsk, 630099, Russian Federation|SPb SBHI City Outpatient clinic #37, Saint-Petersburg, 191119, Russian Federation|Regional clinical cardiology dispensary, Saratov, 410039, Russian Federation
URL: https://clinicaltrials.gov/show/NCT04880850

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