Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine

Summary

Primary Objective: To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) also using insulin glargine. Secondary Objectives: To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study. To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension. To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants reaching target HbA1c (\<7%), Fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose. To assess safety of SAR342434 and Humalog.

Timeline

Start

2014-10

Primary completion

2015-12

Completion

2016-07

Publications

• Background Garg SK, Wernicke-Panten K, Rojeski M, Pierre S, Kirchhein Y, Jedynasty K. Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine-SORELLA 1 Study. Diabetes Technol Ther. 2017 Sep;19(9):516-526. doi: 10.1089/dia.2017.0117. Epub 2017 Aug 30.

Drugs

Indications