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 2 diabetes
Therapeutic area: Metabolic diseases
Country: Argentina, Chile, Colombia, Germany, Hungary, Italy, Korea, Republic of, Romania, Russian Federation, Spain, Turkey, USA
Trial
details: The SORELLA 2 study is a six-month, randomized, open-label, parallel-group comparison of SAR342434 to Humalog® in adult patients with type 2 diabetes mellitus also using insulin glargine. The primary objective of the study is to demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus (T2DM) also using insulin glargine. 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. To assess the efficacy of SAR342434 and Humalog on: proportion of patients reaching target HbA1c <7.0% and ?6.5%, fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin dose. To assess safety of SAR342434 and Humalog. (NCT02294474)
Latest
news: This study is planned to be completed in February 2016.
