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Six-Month, Randomized, Open-Label, Parallel-group Comparison of SAR342434 to Humalog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period

Trial Profile

Six-Month, Randomized, Open-Label, Parallel-group Comparison of SAR342434 to Humalog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jan 2018

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At a glance

  • Drugs Insulin lispro (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms SORELLA1
  • Sponsors Sanofi
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 11 Dec 2017 The U.S. Food and Drug Administration has approved Admelog (insulin lispro injection), indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus, as reported in a US FDA media release.
    • 13 Jun 2017 Results presented at the 77th Annual Scientific Sessions of the American Diabetes Association
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