Date: 2015-09-30
Type of information: Initiation of the trial
phase: 1b
Announcement: initiation of the trial
Company: Adocia (France) Eli Lilly (USA - IN)
Product: BioChaperone Lispro
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 2 diabetes
Therapeutic area: Metabolic diseases
Country: Germany
Trial details:
Latest
news: * On September 30, 2015, Adocia and Eli Lilly announced the initiation of a Phase 1b clinical trial evaluating BioChaperone Lispro®, an ultra-rapid formulation of insulin lispro licensed to Lilly. This study, under the Adocia-Lilly partnership, aims to measure the effect of BioChaperone Lispro® injected at mealtime on post-meal glycemic control in type 2 diabetes patients compared to that of Humalog® (insulin lispro rDNA origin) over the same two-week period. Commercialized fast-acting insulin analogs are usually injected before the meal. An ultra-rapid insulin aims to allow injection at the time of the meal, or even after the start of a meal, with the goal of reducing the magnitude of glycemic excursions. The first clinical study conducted by the two companies demonstrated that BioChaperone Lispro® was associated with a 61 percent reduction in post-prandial glucose excursions over the first two hours post-meal compared to Humalog®. In this crossover, randomized, double-blind study, 50 subjects with type 2 diabetes will receive multiple daily doses of BioChaperone Lispro® and multiple daily doses of Humalog® over two periods of 14 days each. The main objective of this study is to compare the post-meal glycemic control obtained after the injection of either BioChaperone Lispro® or Humalog® immediately before the meal. The pharmacokinetic profiles of both products will also be monitored. This study will be sponsored by Adocia, and performed by Profil Neuss in Germany. This trial (EudraCT 2015-00-1865-17) is registered.
