NCT03903016

A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes

A Randomized, Double-blind, Single-dose, 2-treatment, 2-period, 2-sequence Crossover Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single subcutaneous (SC) dose Secondary Objectives: * To assess the pharmacodynamic profiles and further pharmacokinetic characteristics of the test formulation (T) in comparison to the reference formulation (R) after a single SC dose * To assess the safety and tolerability of the test and the reference formulation of insulin lispro

Detailed description

Study duration per participant is approximately 62 days including a screening period up to 28 days before first dose, 2 periods of 2 days, a wash out period of 5 to 18 days (preferred7 days) and an end of study visit 7 to 14 days after the last dose

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Insulin Lispro SAR342434	Pharmaceutical form:solution for injection Route of administration: subcutaneous
DRUG	Insulin Lispro SAR342434	Pharmaceutical form:solution for injection Route of administration: subcutaneous

Timeline

• Start date: 2019-03-26
• Primary completion: 2019-08-19
• Completion: 2019-08-19
• First posted: 2019-04-04
• Last updated: 2025-09-24

Locations

1 site across 1 country: Germany