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Your journey
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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
1
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