Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine
Summary
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.
Timeline
- Start
- 2015-01
- Primary completion
- 2016-02
- Completion
- 2016-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin Lispro | Protein / enzyme biologic | 1 iu | Subcutaneous |
| Comparator | Insulin Lispro | Protein / enzyme biologic | 60 iu | Subcutaneous |
| Subject | SAR342434 | Protein / enzyme biologic | 1 iu | Subcutaneous |
| Subject | SAR342434 | Protein / enzyme biologic | 80 iu | Subcutaneous |
| Background | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |