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Your journey
1What's a trial
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More info
You can access this
clinical trial
if you have
Type1 Diabetes Mellitus
and you are
between 18 and 64
years old
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

Primary Objective: To demonstrate bioequivalence between insulin glulisine given as 300 Units/mL test formulation and insulin glulisine 100 Units/mL reference formulation after a single subcutaneous (SC) dose. Secondary Objectives: - To assess the pharmacodynamic (PD) profiles and further pharmacokinetic (PK) characteristics of insulin glulisine U300 in comparison to insulin glulisine U100 after a single SC dose. - To assess safety and tolerability of the test and the reference formulation of insulin glulisine.

Provided treatments

  • Drug: Insulin glulisine (U300)
  • Drug: Insulin glulisine
  • Drug: Insulin aspart
  • Drug: NPH insulin
  • Drug: Glucagon
  • Drug: Glucose
  • Drug: Heparin

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02910518. The sponsor of the trial is Sanofi and it is looking for 44 volunteers for the current phase.
Official trial title:
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