Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus
Status:
Completed
Trial end date:
2018-12-20
Target enrollment:
Participant gender:
Summary
Primary Objective:
To 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.
.
Secondary Objectives:
To compare HOE901-U300 and Lantus in terms of:
- Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG).
- To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events
of hyperglycemia with ketosis, and development of anti-insulin-antibodies.