Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine
Status:
Completed
Trial end date:
2019-01-12
Target enrollment:
Participant gender:
Summary
Primary Objective:
To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin
A1c (HbA1c) change from baseline to Week 26 in participants with type 1 or type 2 diabetes
mellitus (T1DM or T2DM) also using Lantus®.
Secondary Objectives:
- To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of
positive/negative status and anti-insulin antibody (AIA) titers during the course of the
study.
- To assess the relationship of AIAs with efficacy and safety.
- To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of
participants reaching HbA1c lesser than (<) 7.0% and change in HbA1c, fasting plasma
glucose (FPG), and self-measured plasma glucose (SMPG) profiles from baseline to Week 26
and Week 52 (only Week 52 for HbA1c).
- To assess safety of SAR341402 and NovoLog/NovoRapid.