Date: 2015-08-24
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Adocia (France) Eli Lilly (USA - IN)
Product: BioChaperone Lispro (new and more concentrated formulation)
Action
mechanism: insulin analogue. BioChaperone Lispro® is 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: type 1 diabetes mellitus
Therapeutic area: Metabolic diseases
Country: Germany
Trial details:
Latest
news: * On August 24, 2015, Adocia announced the initiation of a Phase I clinical trial evaluating a new and more concentrated formulation of BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Eli Lilly. It is a new formulation of insulin lispro, Humalog U200 (Lilly), bioequivalent product to Humalog U100. While commercialized rapid insulin analogs, e.g. Humalog U200, are injected 5 to 15 minutes before or immediately after a meal, an ultrarapid insulin may allow injection at the time of the
The rationale for this study is to file for registration of BioChaperone Lispro U200 based on BioChaperone Lispro U100’s dossier. The study aims to compare pharmacokinetic and pharmacodynamic parameters of the two formulations of BioChaperone Lispro, U100 and U200, to determine the potential for bioequivalence. In this double-blinded, randomized, four-period cross-over study, 24 male and female healthy volunteers under euglycemic clamp will be treated with two single doses of BioChaperone Lispro U200 and two single doses of BioChaperone Lispro U100. The primary objective includes establishing the intrasubject variability of key bioequivalence parameters. This study is performed by Profil Neuss in Germany.
