Last updated on November 2019

Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine


Brief description of study

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).

Detailed Study Description

The study duration per participant will be less than 19 weeks (for participants who do not require the run-in period) and less than 31 weeks (for participants who require the run-in period).

Clinical Study Identifier: NCT03874715

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Investigational Site Number 8400035

Rocky Mount, NC United States
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