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Clinical Trial Details

Trial ID: L4204
Source ID: NCT02967224
Associated Drug: Insulin Glargine (U300)
Title: A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulins in Insulin Naïve Patients Initiating Insulin
Acronym: Reach-Control
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: insulin glargine (U300)|DRUG: insulin glargine (U100)|DRUG: NPH insulin|DRUG: insulin detemir|DRUG: insulin degludec
Outcome Measures: Primary: Change in HbA1c (percentage %), Baseline to 6 Months | Secondary: Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy), At Month 6 and Month 12|Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not, At Month 6 and Month 12|Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%,<8.0%), At Month 6 and Month 12|Proportion of patients with HbA1c target (thresholds listed above; attainment of metabolic benefit) without documented (blood glucose (BG) ≤70 mg/dL [3.9 mmol/L]) symptomatic or severe hypoglycemia, At Month 6 and Month 12|Proportion of patients with HbA1c target (thresholds listed above; attainment of metabolic benefit) without documented (BG <54 mg/dL [3.0 mmol/L]) symptomatic or severe hypoglycemia, At Month 6 and Month 12|Change in HbA1c (percentage %), Baseline to Month 12|Percentage of patients whose HbA1c decreased at least 1%, At Month 6 and Month 12|Percentage of patients whose HbA1c decreased at least 1%, At Month 6 and maintained at Month 12|Percentage of patients requiring intensification, At Month 6 and Month 12|Time to intensification, At Month 6 and Month 12|Change in fasting plasma glucose, Baseline to Month 6 and Month 12
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 705
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-11-05
Completion Date: 2017-10-16
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 076-001, Curitiba, 80810-140, Brazil|Investigational Site Number 076005, Fortaleza, 60115-282, Brazil|Investigational Site Number 076004, Fortaleza, Brazil|Investigational Site Number 076009, Rio de Janeiro, 202110340, Brazil|Investigational Site Number 076008, Sao Paulo, 01244-030, Brazil|Investigational Site Number 076011, São José dos Campos, 12243-280, Brazil|Investigational Site Number 076007, São paulo, 01223-001, Brazil|Investigational Site Number 076003, São Paulo, 04024-002, Brazil|Investigational Site Number 076010, Taguatinga, 72155000, Brazil|Investigational Site Number 250060, Alencon Cedex, 61014, France|Investigational Site Number 250023, Amiens Cedex 1, 80054, France|Investigational Site Number 250057, Bar le Duc, France|Investigational Site Number 250050, BETHUNE Cedex, 62408, France|Investigational Site Number 250008, BOIS GUILLAUME Cedex, 76233, France|Investigational Site Number 250024, Bordeaux, 33000, France|Investigational Site Number 250028, Brest, 29000, France|Investigational Site Number 250014, Caen, 14000, France|Investigational Site Number 250003, CAHORS Cedex 9, 46005, France|Investigational Site Number 250064, CHALONS EN CHAMPAGNE Cedex, 51005, France|Investigational Site Number 250026, Cholet, 49300, France|Investigational Site Number 250025, Corbeil Essonnes, 91100, France|Investigational Site Number 250011, Eaubonne, France|Investigational Site Number 250013, La Roche Sur Yon, 85025, France|Investigational Site Number 250058, La Rochelle Cedex 1, 17019, France|Investigational Site Number 250027, La Seyne sur Mer, France|Investigational Site Number 250034, Lamagistere, 82360, France|Investigational Site Number 250017, Le Puy En Velay Cedex, 43012, France|Investigational Site Number 250012, Marseille, 13008, France|Investigational Site Number 250054, Maubeuge, 59600, France|Investigational Site Number 250045, Montpellier, 34059, France|Investigational Site Number 250020, Montpellier, 34295, France|Investigational Site Number 250016, Montpellier, France|Investigational Site Number 250035, Mulhouse, France|Investigational Site Number 250004, NARBONNE Cedex, 11018, France|Investigational Site Number 250046, Nevers, 58000, France|Investigational Site Number 250041, Nimes, 30029, France|Investigational Site Number 250044, Orleans, 45100, France|Investigational Site Number 250063, Paris, 75012, France|Investigational Site Number 250053, Paris, 75014, France|Investigational Site Number 250005, Paris, 75018, France|Investigational Site Number 250032, Paris, 75020, France|Investigational Site Number 250021, Pierre-Bénite, 69310, France|Investigational Site Number 250030, Pierre-Bénite, 69310, France|Investigational Site Number 250052, POITIERS Cedex, 86021, France|Investigational Site Number 250051, PRINGY Cedex, 74374, France|Investigational Site Number 250039, Reims Cedex, 51092, France|Investigational Site Number 250022, Roubaix, 59100, France|Investigational Site Number 250033, Saint-Mandé, 94160, France|Investigational Site Number 250055, Sete, 34200, France|Investigational Site Number 250031, Strasbourg Cedex 2, 67098, France|Investigational Site Number 250056, Strasbourg, 67000, France|Investigational Site Number 250001, Strasbourg, 67091, France|Investigational Site Number 250043, Tarbes, 65013, France|Investigational Site Number 250002, Toulouse Cedex 3, 31076, France|Investigational Site Number 250029, Vandoeuvre Les Nancy Cedex, 54511, France|Investigational Site Number 250009, Venissieux, 69200, France|Investigational Site Number 250007, VICHY Cedex, 03201, France|Investigational Site Number 250006, Vichy, 03200, France|Investigational Site Number 250059, Villeneuve sur Lot, 47300, France|Investigational Site Number 276013, Bornheim, 53332, Germany|Investigational Site Number 276002, Dresden, 01279, Germany|Investigational Site Number 276001, Dresden, 01307, Germany|Investigational Site Number 276016, Hamburg, 22607, Germany|Investigational Site Number 276014, Hohenmölsen, 06679, Germany|Investigational Site Number 276017, Münster, 48153, Germany|Investigational Site Number 276012, Neumünster, 24534, Germany|Investigational Site Number 276009, Neuwied, 56564, Germany|Investigational Site Number 276008, Oldenburg, 26133, Germany|Investigational Site Number 276006, Pirna, 01796, Germany|Investigational Site Number 276010, Rehlingen-Siersburg, 66780, Germany|Investigational Site Number 276005, Riesa, 01587, Germany|Investigational Site Number 276011, Schweinfurt, 97421, Germany|Investigational Site Number 276007, Sulzbach-Rosenberg, 92237, Germany|Investigational Site Number 372003, Dublin 4, Ireland|Investigational Site Number 327002, Dublin 7, Ireland|Investigational Site Number 642001, Bucuresti, 010825, Romania|Investigational Site Number 642002, Bucuresti, 022441, Romania|Investigational Site Number 642007, Bucuresti, Romania|Investigational Site Number 642004, Cluj-Napoca, 400006, Romania|Investigational Site Number 642005, Galati, 800291, Romania|Investigational Site Number 642009, Iasi, Romania|Investigational Site Number 642006, Oradea, 410169, Romania|Investigational Site Number 642008, Targoviste, 130083, Romania|Investigational Site Number 724013, Almansa, 02640, Spain|Investigational Site Number 724024, Badalona, 08915, Spain|Investigational Site Number 724016, Barakaldo, 48903, Spain|Investigational Site Number 724005, Barcelona, 08025, Spain|Investigational Site Number 724019, Barcelona, 08035, Spain|Investigational Site Number 724017, Barcelona, Spain|Investigational Site Number 724008, Burgos, Spain|Investigational Site Number 724018, Donostia, 20014, Spain|Investigational Site Number 724026, Ferrol, 15405, Spain|Investigational Site Number 724021, Gerona, 17007, Spain|Investigational Site Number 724027, Huelva, 21005, Spain|Investigational Site Number 724014, La Coruña, 15006, Spain|Investigational Site Number 724001, LLeida, Spain|Investigational Site Number 724025, Madrid, 28040, Spain|Investigational Site Number 724028, Madrid, 28041, Spain|Investigational Site Number 724006, Majadahonda, 28222, Spain|Investigational Site Number 724030, Málaga, 29004, Spain|Investigational Site Number 724020, Málaga, 29010, Spain|Investigational Site Number 724012, Sabadell, 08208, Spain|Investigational Site Number 724009, Santiago de Compostela, 15706, Spain|Investigational Site Number 724010, Sevilla, 41010, Spain|Investigational Site Number 724011, Sevilla, 41013, Spain|Investigational Site Number 724002, Valencia, 46009, Spain|Investigational Site Number 724022, Valencia, 46014, Spain|Investigational Site Number 724007, Vitoria, 1009, Spain|Investigational Site Number 826033, Atherstone, CV91EU, United Kingdom|Investigational Site Number 826016, Ayr, KA66DX, United Kingdom|Investigational Site Number 826008, Bradford on Avon, BA151DQ, United Kingdom|Investigational Site Number 826004, Chertsey, KT160PZ, United Kingdom|Investigational Site Number 826011, Chesterfield, S404TF, United Kingdom|Investigational Site Number 826028, Chippenham, SN152SB, United Kingdom|Investigational Site Number 826038, Cornwall, PL143XA, United Kingdom|Investigational Site Number 826027, Cornwall, PL231DT, United Kingdom|Investigational Site Number 826031, Coventry, CV22DX, United Kingdom|Investigational Site Number 826003, Craigavon, BT635QQ, United Kingdom|Investigational Site Number 826035, Dudley, DY1 2HQ, United Kingdom|Investigational Site Number 826015, Larbert, FK54WR, United Kingdom|Investigational Site Number 826002, Liverpool, L97AL, United Kingdom|Investigational Site Number 826018, Manchester, M239LT, United Kingdom|Investigational Site Number 826019, Manchester, M85RB, United Kingdom|Investigational Site Number 826009, Nuneaton, CV107DJ, United Kingdom|Investigational Site Number 826021, Plymouth, PL53JB, United Kingdom|Investigational Site Number 826006, Portsmouth, PO63LY, United Kingdom|Investigational Site Number 826020, Southampton, SO303JB, United Kingdom|Investigational Site Number 826013, Taunton, TA15DA, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02967224

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress