Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Status:
Completed
Trial end date:
2020-07-08
Target enrollment:
Participant gender:
Summary
Primary Objective:
To demonstrate similarity in pharmacokinetics (PK) of SAR341402 and NovoLog after 4x4-week
periods of alternating administration of SAR341402 and NovoLog compared to 16-week continuous
use of NovoLog in participants with Type 1 diabetes mellitus also using insulin glargine.
Secondary Objectives:
- To compare the effects of alternating administration of SAR341402 and NovoLog with
continuous use of NovoLog on immunogenicity.
- To evaluate the safety of alternating administration of SAR341402 and NovoLog versus
continuous use of NovoLog.
- To compare other PK parameters between the two treatment arms (alternating
administration of SAR341402 and NovoLog and continuous use of NovoLog).