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randomization.\n* Less than 1 year on insulin treatment prior to screening visit.\n* Less than 6 months on basal plus mealtime insulin and self-monitoring of blood glucose prior to screening visit.\n* Participants using premix insulins in the last 3 months before screening visit or participants using human regular insulin as mealtime insulin in the last 3 months before screening visit.\n* Use of an insulin pump in the last 6 months before screening visit or plans to switch to pump within the next 6 months after screening visit.\n* Any contraindication to use of insulin glargine as defined in the national product label.\n* No willingness to inject insulin glargine (Lantus or HOE901-U300) once daily.\n* HbA1c \\\u003C7.5% or \\>11% at screening.\n* Initiation of any glucose-lowering medications in the last 3 months before screening visit.\n* Hospitalization or care in the emergency ward for diabetic ketoacidosis or history of severe hypoglycemia (as defined by need for glucagon or IV glucose) and accompanied by seizure and\u002For unconsciousness and\u002For coma in the last 3 months prior to screening visit.\n* Postmenarchal girls not protected by highly-effective method(s) of birth control and\u002For who were unwilling or unable to be tested for pregnancy. Abstinence from sexual intercourse was considered as an acceptable form of birth control.\n* Pregnant or breast-feeding adolescents, or adolescents who intended to become pregnant during the study period, or who were at risk of getting pregnant due to any psychosocial reason during the study period.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",false,"ALL","6 Years","17 Years",{"count":990,"type":991},463,"ACTUAL","INTERVENTIONAL",[994],"PHASE3","Primary Objective:\n\nTo compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus.\n\n.\n\nSecondary Objectives:\n\nTo compare HOE901-U300 and Lantus in terms of:\n\n* Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG).\n* To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.",[997],"Type 1 Diabetes Mellitus","COMPLETED","2022-03-15",{"date":1001,"type":991},"2022-03-25",{"date":1003,"type":991},"2016-04-14",{"date":1005,"type":991},"2018-12-20",{"name":5,"class":6},107]