NCT02910518

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study duration per patient will be 18 to 62 days and will consist of a 4 to 28 days of screening period, a treatment period of 2 days, a washout between dosing occasions of 5-18 days, and follow up visit 7-14 days after last dosing.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin glulisine (U300)	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	Insulin glulisine	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	Insulin aspart	Pharmaceutical form: solution Route of administration: intravenous/subcutaneous
DRUG	NPH insulin	Pharmaceutical form: solution Route of administration: subcutaneous
DRUG	Glucagon	Pharmaceutical form: Powder and solvent for solution for injection Route of administration: subcutaneous
DRUG	Glucose	Pharmaceutical form: solution Route of administration: intravenous
DRUG	Heparin	Pharmaceutical form: solution Route of administration: intravenous

Timeline

• Start date: 2017-02-17
• Primary completion: 2017-05-03
• Completion: 2017-05-03
• First posted: 2016-09-22
• Last updated: 2022-04-25

Locations

1 site across 1 country: Germany