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