A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2017-05-03

Summary

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.

• Phase: Phase 1

Details

• Lead Sponsor: Sanofi
• Treatments: Calcium heparin; Glucagon; Glucagon-Like Peptide 1; Heparin; Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin glulisine; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting; Isophane insulin, beef; Isophane Insulin, Human