At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Open Label, Parallel-group Study Comparing the Pharmacokinetics and Immunogenicity of Alternating Use of SAR341402 and NovoLog® Versus Continuous Use of NovoLog in Participants With Type 1 Diabetes Mellitus Also Using Insulin Glargine
In Brief
A Phase 3 clinical trial evaluating Insulin Aspart SAR341402, Insulin Aspart, and 1 other intervention for Type 1 Diabetes Mellitus. Completed, enrolled 210 participants across 33 sites.
Detailed 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 (T1DM) 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).
Study Details
Timeline
Interventions
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous