BRIGHTComparaison de l'efficacité et de la sécurité de Toujeo® et de Tresiba® chez des patients atteints de diabète de type 2 non traités par insuline

Date de début de l'étude : 19 mai 2016

Inclusion criteria : * Adult participants with type 2 diabetes mellitus (T2DM) inadequately controlled with OADs therapy with/without GLP-1 receptor agonist at stable dose for at least 3 months. * Signed written informed consent. Exclusion criteria: * Age \<18 years. * HbA1c \<7.5% or \>10.5% (at screening visit). Body mass index (BMI) \<25 kg/m\^2 or \>40 kg/m\^2. * History of T2DM for less than 1 year before screening. * Less than 6 months before screening on OADs treatment and GLP-1 receptor agonist (if taken). * Current or previous insulin use except for a maximum of 8 consecutive days or totally 15 days (eg, acute illness, surgery) during the last year prior to screening. * Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit. * Participant receiving only noninsulin antihyperglycemic drugs not approved for combination with insulin according to local labelling/local treatment guideline. * History of hypoglycemia unawareness or repeated episodes of severe hypoglycemia or metabolic acidosis, including hospitalization for diabetic ketoacidosis during the last 12 months prior to screening. * Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period. * End stage renal disease. * Any acute or chronic condition that in the opinion of Investigator would affect the safety of participant, compliance, or study results. * Any contraindication to use of Toujeo® or Tresiba® as defined in the national product label, hypersensitivity to Toujeo® or Tresiba® active ingredients or one of the excipients. * Pregnant or breast-feeding women. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.