A Randomized, Double-Blind, Controlled, Single-Dose, 3-Treatment, 3-Period, 6-Sequence Crossover Study to Compare Exposure and Activity of SAR342434 to Humalog® Using the Euglycemic Clamp Technique, in Subjects With Type 1 Diabetes Mellitus

Trial Profile

A Randomized, Double-Blind, Controlled, Single-Dose, 3-Treatment, 3-Period, 6-Sequence Crossover Study to Compare Exposure and Activity of SAR342434 to Humalog® Using the Euglycemic Clamp Technique, in Subjects With Type 1 Diabetes Mellitus

Completed
Phase of Trial: Phase I

Latest Information Update: 18 May 2017

At a glance

  • Drugs Insulin lispro (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Sanofi
  • Most Recent Events

    • 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 (CTP700263201), and two phase 3 trials (SORELLA 1 and SORELLA 2).
    • 09 Jun 2015 Results presented at the 75th Annual Scientific Sessions of the American Diabetes Association.
    • 28 Oct 2014 New trial record
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