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Clinical Trial Details

Trial ID: L6639
Source ID: NCT02967211
Associated Drug: Insulin Glargine (U300)
Title: A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin
Acronym: REGAIN 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, 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, Month 12|Percentage of patients whose HbA1c decreased at least 0.5%, At Month 6 and Month 12|Percentage of patients whose HbA1c decreased at least 0.5%, 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, From baseline to Month 6 and Month 12
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 609
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-12-21
Completion Date: 2017-10-20
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 076-001, Curitiba, 80810-140, Brazil|Investigational Site Number 076008, Fortaleza, 60115-282, Brazil|Investigational Site Number 076004, Fortaleza, Brazil|Investigational Site Number 076009, Rio de Janeiro, 202110340, Brazil|Investigational Site Number 076-003, Sao Paulo, 01244-030, Brazil|Investigational Site Number 076011, São José dos Campos, 12243-280, Brazil|Investigational Site Number 076006, São paulo, 01223-001, Brazil|Investigational Site Number 076005, São Paulo, 04024-002, Brazil|Investigational Site Number 076010, Taguatinga, 72155000, Brazil|Investigational Site Number 246008, Helsinki, 00100, Finland|Investigational Site Number 246007, Muurame, 40930, Finland|Investigational Site Number 246002, Oulu, 90100, Finland|Investigational Site Number 246001, Oulu, 90220, Finland|Investigational Site Number 246009, Pori, 28100, Finland|Investigational Site Number 246004, Rauma, 26100, Finland|Investigational Site Number 250008, Amiens Cedex 1, 80054, France|Investigational Site Number 250011, Bordeaux, 33000, France|Investigational Site Number 250009, Caen, 14000, France|Investigational Site Number 250001, Corbeil Essonnes, 91100, France|Investigational Site Number 250005, Eaubonne, France|Investigational Site Number 250026, La Rochelle Cedex 1, 17019, France|Investigational Site Number 250020, Montpellier, 34059, France|Investigational Site Number 250015, Mulhouse, France|Investigational Site Number 250003, Paris, 75018, France|Investigational Site Number 250010, Pierre-Bénite, 69310, France|Investigational Site Number 250014, Pierre-Bénite, 69310, France|Investigational Site Number 250025, POITIERS Cedex, 86021, France|Investigational Site Number 250002, Valenciennes, 59322, France|Investigational Site Number 250013, Vandoeuvre Les Nancy Cedex, 54511, France|Investigational Site Number 300002, Athens, 18454, Greece|Investigational Site Number 300003, Kalamata, Greece|Investigational Site Number 300001, Lamia, 35100, Greece|Investigational Site Number 300004, Thessaloniki, 56429, Greece|Investigational Site Number 372003, Dublin 4, Ireland|Investigational Site Number 372002, Dublin 7, Ireland|Investigational Site Number 380033, Arzignano (VI), 36071, Italy|Investigational Site Number 380016, Catania, 95122, Italy|Investigational Site Number 380004, Catania, Italy|Investigational Site Number 380006, Catanzaro, Italy|Investigational Site Number 380031, Eboli, 84025, Italy|Investigational Site Number 380007, Forlì, Italy|Investigational Site Number 380018, Genova, 16132, Italy|Investigational Site Number 380020, Iglesias (CI), 09016, Italy|Investigational Site Number 380015, Milano, 20132, Italy|Investigational Site Number 380001, Milano, 20162, Italy|Investigational Site Number 380012, Milano, Italy|Investigational Site Number 380011, Orbassano (TO), 10043, Italy|Investigational Site Number 380026, Padova, Italy|Investigational Site Number 380021, Palermo, 90127, Italy|Investigational Site Number 380014, Partinico, 90047, Italy|Investigational Site Number 380032, Roma, 00133, Italy|Investigational Site Number 380002, Roma, 00161, Italy|Investigational Site Number 380023, Roma, Italy|Investigational Site Number 380036, San Benedetto del Tronto, 63074, Italy|Investigational Site Number 380024, Sarzana, Italy|Investigational Site Number 380013, Savigliano (CN), 12038, Italy|Investigational Site Number 380017, Sesto S. Giovanni, 20099, Italy|Investigational Site Number 380025, Torino, 10128, Italy|Investigational Site Number 642008, Arad, Romania|Investigational Site Number 642005, Baia MAre, Romania|Investigational Site Number 642002, Brasov, 500326, Romania|Investigational Site Number 642006, Brasov, 500326, Romania|Investigational Site Number 642003, Cluj-Napoca, 400006, Romania|Investigational Site Number 642007, Cluj-Napoca, 400006, Romania|Investigational Site Number 642004, Targu-Mures, 540015, Romania|Investigational Site Number 642001, Timisoara, 300125, Romania|Investigational Site Number 724002, Barcelona, 08003, Spain|Investigational Site Number 724019, Barcelona, 08035, Spain|Investigational Site Number 724012, Barcelona, 08036, Spain|Investigational Site Number 724011, Barcelona, Spain|Investigational Site Number 724027, Castellón, 12004, Spain|Investigational Site Number 724028, Córdoba, 14004, Spain|Investigational Site Number 724008, Galdakao (Bilbao), 48960, Spain|Investigational Site Number 724010, León, 24071, Spain|Investigational Site Number 724001, LLeida, Spain|Investigational Site Number 724013, Madrid, 28007, Spain|Investigational Site Number 724018, Madrid, Spain|Investigational Site Number 724020, Málaga, 29010, Spain|Investigational Site Number 724025, Móstoles, 28933, Spain|Investigational Site Number 724006, Palma de Mallorca, 07010, Spain|Investigational Site Number 724007, Palma de Mallorca, 07010, Spain|Investigational Site Number 724024, Pontevedra, 36071, Spain|Investigational Site Number 724017, Sabadell, 08208, Spain|Investigational Site Number 724022, San Cristóbal De La Laguna - Santa Cruz De Tenerife, 38320, Spain|Investigational Site Number 724003, San Juan de Alicante, 3550, Spain|Investigational Site Number 724030, Sant Joan Despí, 08970, Spain|Investigational Site Number 724023, Santa Cruz de Tenerife, 38010, Spain|Investigational Site Number 724014, Santiago de Compostela, 15706, Spain|Investigational Site Number 724005, Sevilla, 41003, Spain|Investigational Site Number 724016, Sevilla, 41010, Spain|Investigational Site Number 724004, Sevilla, 41071, Spain|Investigational Site Number 724021, Valencia, 46010, Spain|Investigational Site Number 724009, Valladolid, 47011, Spain|Investigational Site Number 724029, Vigo, 36200, Spain|Investigational Site Number 756003, Bern, 3010, Switzerland|Investigational Site Number 756002, St. Gallen, 9007, Switzerland|Investigational Site Number 826033, Atherstone, CV91EU, United Kingdom|Investigational Site Number 826016, Ayr, KA66DX, United Kingdom|Investigational Site Number 826039, Blackburn, BB21AX, United Kingdom|Investigational Site Number 826008, Bradford on Avon, BA151DQ, United Kingdom|Investigational Site Number 826004, Chertsey, KT160PZ, United Kingdom|Investigational Site Number 826038, Cornwall, PL143XA, United Kingdom|Investigational Site Number 826031, Coventry, CV22DX, United Kingdom|Investigational Site Number 826024, Darlington, DL36HX, United Kingdom|Investigational Site Number 826035, Dudley, DY1 2HQ, United Kingdom|Investigational Site Number 826017, Glasgow, G213UW, United Kingdom|Investigational Site Number 826025, Huntingdon, PE296JN, 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 826037, Manchester, M86RB, United Kingdom|Investigational Site Number 826023, Norwich, nr34dg, 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|Investigational Site Number 826007, Welwyn Garden City, AL74HQ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02967211

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress