678
Participants
Start Date
December 10, 2024
Primary Completion Date
September 18, 2026
Study Completion Date
September 18, 2026
iGlarLixi (insulin glargine/lixisenatide)
"iGlarLixi will be supplied as a sterile aqueous solution in a pen-injector.~There will be 2 pen-injectors with different insulin glargine/lixisenatide fixed ratios which allow insulin glargine titration from 5 U/day to 40 U/day while limiting lixisenatide dose to a maximum of 20 μg/day:~\- iGlarLixi must not be mixed with other insulins nor diluted."
Gla-100 (insulin glargine)
Gla-100 will be supplied as a 3 mL sterile aqueous solution for SC injection in a pre-filled disposable Gla-100 SoloStar® pen containing 300 U insulin glargine (100 U/mL). Doses could be set in the range of 5 to 80 U in increments of 1 unit.
RECRUITING
Investigational Site Number: 1560001, Beijing
Lead Sponsor
Sanofi
INDUSTRY