A Randomized, Double-blind, Single-dose, 2-Treatment, 2-Period, 2-Sequence Crossover Bioequivalence Study Comparing Two Formulations of Insulin Glulisine (Insulin Glulisine 300 Units/mL Versus Insulin Glulisine 100 Units/mL Marketed as Apidra® 100 Units/mL) Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus

Trial Profile

A Randomized, Double-blind, Single-dose, 2-Treatment, 2-Period, 2-Sequence Crossover Bioequivalence Study Comparing Two Formulations of Insulin Glulisine (Insulin Glulisine 300 Units/mL Versus Insulin Glulisine 100 Units/mL Marketed as Apidra® 100 Units/mL) Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus

Completed
Phase of Trial: Phase I

Latest Information Update: 14 Jun 2017

At a glance

  • Drugs Insulin glulisine (Primary) ; Glucagon; Glucose; Heparin; Insulin aspart; Insulin aspart; Insulin suspension isophane
  • Indications Type 1 diabetes mellitus
  • Focus Pharmacokinetics
  • Sponsors Sanofi
  • Most Recent Events

    • 09 Jun 2017 Status changed from recruiting to completed.
    • 19 Apr 2017 Planned End Date changed from 19 Apr 2017 to 3 May 2017.
    • 19 Apr 2017 Planned primary completion date changed from 19 Apr 2017 to 3 May 2017.
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