Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus

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.

Timeline

Start

2016-04-14

Primary completion

2018-05-31

Completion

2018-12-20

Outcome

Met primary endpoint

paper LS mean between-group difference of 0.004% (95% CI -0.17 to 0.18), confirming noninferiority at the prespecified 0.3% (3.3 mmol/mol) margin. PMID 32430458 ↗

release “This study met its primary and secondary endpoints. Positive results from the EDITION JUNIOR phase 3 trial, evaluating Toujeo ® in children” sanofi.com ↗

Publications

• Danne T, Tamborlane WV, Malievsky OA, Franco DR, Kawamura T, Demissie M, Niemoeller E, Goyeau H, Wardecki M, Battelino T. Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6-17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial. Diabetes Care. 2020 Jul;43(7):1512-1519. doi: 10.2337/dc19-1926. Epub 2020 May 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin glargine	Protein / enzyme biologic	100 iu	Subcutaneous
Subject	insulin glargine	Protein / enzyme biologic	300 iu	Subcutaneous

Indications