Date: 2015-12-11
Type of information: Results
phase: 1b
Announcement: results
Company: Adocia (France) Eli Lilly (USA - IN)
Product: BioChaperone Lispro® U200
Action
mechanism: insulin analogue. BioChaperone Lispro® U200 is concentrated formulation of BioChaperone Lispro®, an ultra-fast acting formulation of insulin Lispro - Humalog® licensed to Lilly. This formulation uses Adocia’s proprietary technology BioChaperone, which is designed to accelerate insulin absorption.
Disease: diabetes
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: * On December 11, 2015, Adocia and Eli Lilly announced the successful completion of a preliminary Phase 1 clinical trial evaluating BioChaperone Lispro® U200. This completed pilot study aimed to determine the potential for bioequivalence of BioChaperone Lispro® U200 to BioChaperone Lispro® U100 in healthy volunteers. Recently, Lilly’s Humalog® 200 units per mL (U-200), the first concentrated mealtime insulin analog and a new formulation of insulin lispro, was approved and launched in Europe and in the United States. Humalog® U200 was established bioequivalent to Humalog 100 units per mL (U-100) in healthy volunteers. However, an ultrarapid version of concentrated insulin may better mimic the physiological timing of prandial insulin action. In this four-period crossover, randomized, double-blind study, 26 male and female healthy volunteers under euglycemic clamp received two alternate 0.2 U/kg doses of both BioChaperone Lispro® U100 and BioChaperone Lispro® U200. The primary objective was a comparison of BioChaperone Lispro® U200 to BioChaperone Lispro® U100 with respect to two standard bioequivalence parameters, Cmax and AUClispro(0-infinity), and two supporting ultra-rapid properties, AUClispro (0-1h) and early t50% Cmax lispro. Based on pre-defined criteria, the results show that BioChaperone Lispro® U200 retained the ultra-rapid profile of BioChaperone U100. These positive feasibility results support the development of BioChaperone Lispro® U200 based on demonstration of bioequivalence.
