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A Randomized, 2X4 Week, Active-Controlled, Open-Label, 2-Treatment Arm, 2-Period Cross-Over Study Assessing the Safety of SAR342434 and Humalog Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)

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Trial Profile

A Randomized, 2X4 Week, Active-Controlled, Open-Label, 2-Treatment Arm, 2-Period Cross-Over Study Assessing the Safety of SAR342434 and Humalog Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Insulin lispro (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Adverse reactions
  • Sponsors Sanofi

Most Recent Events

  • 13 Jun 2017 Results assessing safety, presented at the 77th Annual Scientific Sessions of the American Diabetes Association.
  • 18 May 2017 According to a Sanofi media release, company has recieved Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of Insulin lispro to treat adults and children who have diabetes and need insulin to keep their blood sugar level controlled, including those patients whose diabetes has just been diagnosed. This recommendation is based on this and another phase 1 trial (CTP700250689), and two phase 3 trials (SORELLA 1 and SORELLA 2).
  • 18 May 2016 Status changed from recruiting to completed.

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