Date: 2015-01-01
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Sanofi (France)
Product: SAR342434 (Humalog® biosimilar - insulin lispro)
Action
mechanism: biosimilar/insulin analog.
Disease: type 1 diabetes
Therapeutic area: Metabolic diseases
Country: France, Germany, Hungary, Japan, Poland, Russian Federation, Spain, USA
Trial
details: The SORELLA 1 study is a six-month, randomized, open-label, parallel-group comparison of SAR342434 to Humalog® in adult patients with type 1 diabetes mellitus also using insulin glargine, with a 6-month safety extension period. The primary objective of the study is to demonstrate non-inferiority of SAR342434 versus Humalog in HbA1c change in patients with type 1 diabetes mellitusalso using insulin glargine. The secondary objectives are 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 patients reaching target HbA1c (<7%) and on fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose and to assess safety of SAR342434 and Humalog. (NCT02273180)
Latest
news: This study is planned to be completed in June 2016.
