Date: 2015-06-26
Type of information: Completion of the trial
phase: 1b
Announcement: completion 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. Last September, Adocia announced positive preliminary results from a Phase IIa dose-response clinical trial evaluating its ultra-fast formulation of insulin lispro (BioChaperone Lispro U100) tested at three doses, relative to Eli Lilly’s Humalog® commercial insulin (insulin lispro U100).
Disease: type 1 diabetes
Therapeutic area: Metabolic diseases
Country: Germany
Trial
details: The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection. This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus. This double-blinded, randomized, controlled, two-period crossover phase Ib trial compares the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg. (NCT02344992)
Latest
news: * On June 26, 2015, Adocia and Eli Lilly announced the completion of a Phase 1b clinical trial evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly. This completed study aimed to compare the effects of BioChaperone Lispro and Humalog® (insulin lispro rDNA origin) when injected at mealtime on post-prandial glycemic control in type 1 diabetes patients. While commercialized fastacting insulin analogs are injected five to 15 minutes before or immediately after a meal, an ultra-rapid insulin may allow injection at the time of the meal, or even after the start of a meal while improving post-prandial glycemic control. In this crossover, randomized, double-blind meal study, 38 people with type 1 diabetes received a 0.2 U/kg dose of either BioChaperone Lispro or Humalog just prior to a standardized meal. The primary endpoint was a comparison of the post-meal glycemic excursions over the first two hours (Delta-AUC-BG(0-2h)). BioChaperone Lispro was associated with a 61 percent reduction in post-prandial glucose excursion over the first two hours compared to Humalog (Delta-AUC-BG(0-2h) ratio = 0.39; 95%-CI 0.28 to 0.52; p<0.0001). In this crossover, randomized, double-blind study, 36 type 1 diabetes patients will receive one dose of BioChaperone Lispro and one dose of Humalog when taking a standardized meal. The main objective of this study is to compare post-meal glycemic control obtained after the injection of either BioChaperone Lispro or Humalog. The pharmacokinetic profiles of both products will also be monitored.
The study also provides confirmation of the ultra-rapid pharmacokinetic profile of BioChaperone Lispro. These results are consistent with previous clinical findings demonstrating BioChaperone Lispro has a significantly faster rate of insulin lispro absorption than Humalog with an increase in the early insulin exposure of 168 percent at the same dose (AUClispro_0-30min ratio = 2.68; 95%-CI 2.18 to 3.30; p<0.0001). In terms of safety, BioChaperone Lispro and Humalog led to similar numbers of hypoglycemia episodes. No local reactions were seen on the site of administration for either treatment. Additional clinical studies will be conducted this year in order to prepare the Phase 3 clinical plan.
* On January 20, 2015, Adocia announced the initiation of a Phase Ib clinical trial evaluation for BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Eli Lilly. This formulation uses Adocia's proprietary technology BioChaperone, which is believed to enable the acceleration of insulin absorption. This is the first study to be initiated as part of the Adocia-Lilly partnership. The study aims to measure the effect of BioChaperone Lispro, injected at the time of a standardized meal, on post-meal glycemic control in type 1 diabetes patients and compare this effect to that of Humalog®(insulin lispro rDNA origin). Commercialized fast-acting insulin analogs are usually injected before the meal. An ultra-rapid insulin, meanwhile, 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. This study will be sponsored by Adocia, and performed by Profil in Germany.
