A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes
Status:
Completed
Trial end date:
2019-08-19
Target enrollment:
Participant gender:
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