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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2024

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At a glance

  • Drugs Insulin aspart (Primary) ; Insulin glargine
  • Indications Type 1 diabetes mellitus
  • Focus Pharmacokinetics; Registrational
  • Acronyms GEMELLI X
  • Sponsors Sanofi

    • Most Recent Events

    • 01 Feb 2024 Results published in the Diabetes, Obesity and Metabolism
    • 28 Jun 2023 Time frame changed to 0 hour (hr)(Pre-dose), 10, 20, 30, 40 & 50 minutes (min), 1hr, 1hr-10, 20, 30, 40 & 50min, 2hr, 2hr-15, 30 & 45min, 3hr, 3hr-15, 30 & 45min, 4hr, 4hr-20 & 40min, 5hr, 5hr-20 & 40min, 6hr, 6hr-30min, 7hr, 7hr-30min & 8hr post-dose on Day 112.
    • 15 Jul 2020 Status changed from active, no longer recruiting to completed.

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