Six-month, Randomized, Open-label, Parallel-group Comparison of the Insulin Analog SAR342434 to Humalog® in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine
Six-month, Randomized, Open-label, Parallel-group Comparison of the Insulin Analog SAR342434 to Humalog® in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine
Primary Objective:
To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 2 diabetes mellitus (T2DM) 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. To assess the efficacy of SAR342434 and Humalog on: proportion of participants 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.
The study will consist of a: up to 2 weeks screening period, 26-week treatment period, and 1-day follow-up period.
The maximum study duration will then be 28 weeks per participant and a 1-day safety follow-up.
Inclusion criteria:
Exclusion criteria:
Caba, C1425AGC, Argentina
Capital Federal, C1056ABJ, Argentina
Capital Federal, C1179AAB, Argentina
Ciudad Autonoma de Buenos Aire, Argentina