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Clinical Trial Details

Trial ID: L5758
Source ID: NCT02967237
Associated Drug: Insulin Glargine (U300)
Title: Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment
Acronym: Transition II
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: insulin glargine (U300)
Outcome Measures: Primary: Mean change from baseline in HbA1c, Baseline, Week 24 | Secondary: Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL), At Weeks 12 and 24|Percentage of patients with HbA1c <7%, <7.5%, and <8%, At Week 24|Mean change from baseline in HbA1c across HbA1c subgroups category (≤8%, >8 to 9%, and >9%), Baseline to Week 12 and Week 24|Mean change from baseline in fasting plasma glucose, Baseline to Week 12 and Week 24|Assessment of patient reported outcomes (satisfaction on treatment and perception of hypoglycemia/hyperglycemia) based on the Diabetes Treatment Satisfaction Questionnaire (DTSQ), Baseline to Week 24|Change in Diabetes Treatment Satisfaction Questionnaire score, Week 24|Number of hypoglycemic events, From inclusion up to Week 24|Number of adverse events, From inclusion up to Week 24
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 136
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-01-04
Completion Date: 2017-07-24
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 250017, Alencon Cedex, 61014, France|Investigational Site Number 250073, Ales, 30100, France|Investigational Site Number 250047, Amiens Cedex 1, 80054, France|Investigational Site Number 250028, Amilly, France|Investigational Site Number 250062, Bagnols-sur-Cèze, France|Investigational Site Number 250093, Bar le Duc, France|Investigational Site Number 250020, Besancon, 25030, France|Investigational Site Number 250081, BETHUNE Cedex, 62408, France|Investigational Site Number 250034, Bondy, 93143, France|Investigational Site Number 250070, Brest Cedex, 29610, France|Investigational Site Number 250022, Brest, 29000, France|Investigational Site Number 250060, CAHORS Cedex 9, 46005, France|Investigational Site Number 250096, Cannes, 06401, France|Investigational Site Number 250037, CHALONS EN CHAMPAGNE Cedex, 51005, France|Investigational Site Number 250072, Chambery, 73000, France|Investigational Site Number 250018, Cholet, 49300, France|Investigational Site Number 250068, Clermont Ferrand, 63000, France|Investigational Site Number 250098, Cognac, 16112, France|Investigational Site Number 250048, Colmar, 68024, France|Investigational Site Number 250088, Contamines Sur Arve, 74130, France|Investigational Site Number 250054, Coudray, 28630, France|Investigational Site Number 250063, Dijon, 21000, France|Investigational Site Number 250013, Eaubonne, France|Investigational Site Number 250095, Etampes, France|Investigational Site Number 250104, Grenoble, 38043, France|Investigational Site Number 250004, La Roche Sur Yon, 85025, France|Investigational Site Number 250002, La Rochelle Cedex 1, 17019, France|Investigational Site Number 250019, La Seyne sur Mer, France|Investigational Site Number 250030, Lamagistere, 82360, France|Investigational Site Number 250103, LE CHESNAY Cedex, 78157, France|Investigational Site Number 250053, Le Creusot, 71200, France|Investigational Site Number 250044, Le Mans Cedex 9, 72037, France|Investigational Site Number 250056, Lens, France|Investigational Site Number 250051, Lourdes, 65000, France|Investigational Site Number 250071, Mantes La Jolie, France|Investigational Site Number 250092, Marseille, 13006, France|Investigational Site Number 250064, Marseille, 13008, France|Investigational Site Number 250089, Maubeuge, 59600, France|Investigational Site Number 250083, Merignac, 33700, France|Investigational Site Number 250035, Montpellier, 34000, France|Investigational Site Number 250061, Montpellier, 34059, France|Investigational Site Number 250010, Montpellier, 34295, France|Investigational Site Number 250008, Montpellier, France|Investigational Site Number 250032, Mulhouse, France|Investigational Site Number 250043, Nancy, France|Investigational Site Number 250005, NARBONNE Cedex, 11018, France|Investigational Site Number 250069, Nevers, 58000, France|Investigational Site Number 250052, Nimes, 30029, France|Investigational Site Number 250059, Noisy Le Grand, France|Investigational Site Number 250058, Orleans, 45100, France|Investigational Site Number 250031, Paris, 75008, France|Investigational Site Number 250105, Paris, 75012, France|Investigational Site Number 250086, Paris, 75014, France|Investigational Site Number 250026, Paris, 75020, France|Investigational Site Number 250084, PERIGUEUX Cedex, 24019, France|Investigational Site Number 250101, Pessac Cedex, 33604, France|Investigational Site Number 250107, Pointe À Pitre, 97159, France|Investigational Site Number 250067, Pontoise, 95300, France|Investigational Site Number 250078, PRINGY Cedex, 74374, France|Investigational Site Number 250042, Reims Cedex, 51092, France|Investigational Site Number 250012, Roubaix, 59100, France|Investigational Site Number 250055, Roubaix, 59100, France|Investigational Site Number 250102, Saint Brieuc, France|Investigational Site Number 250108, Saint Pierre, 97448, France|Investigational Site Number 250065, Saint-Denis, 93200, France|Investigational Site Number 250029, Saint-Mandé, 94160, France|Investigational Site Number 250087, Seclin, 59113, France|Investigational Site Number 250090, Sete, 34200, France|Investigational Site Number 250024, Strasbourg Cedex 2, 67098, France|Investigational Site Number 250006, Strasbourg, 67000, France|Investigational Site Number 250033, Suresnes, 92150, France|Investigational Site Number 250057, Tarbes, 65013, France|Investigational Site Number 250082, Toulouse Cedex 3, 31076, France|Investigational Site Number 250001, Toulouse, 31000, France|Investigational Site Number 250076, Toulouse, 31027, France|Investigational Site Number 250050, Toulouse, 31100, France|Investigational Site Number 250027, Tours, 37000, France|Investigational Site Number 250075, Tours, 37000, France|Investigational Site Number 250041, Valenciennes, 59322, France|Investigational Site Number 250021, Vandoeuvre Les Nancy Cedex, 54511, France|Investigational Site Number 250023, Venissieux, 69200, France|Investigational Site Number 250046, VICHY Cedex, 03201, France|Investigational Site Number 250039, Vichy, 03200, France|Investigational Site Number 250100, Villeneuve sur Lot, 47300, France|Investigational Site Number 250007, Warloy Baillon, 80300, France
URL: https://clinicaltrials.gov/show/NCT02967237

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress