Lyon and Indianapolis, October 6, 2015 - Adocia (Euronext Paris: ADOC) and Eli Lilly and Company (NYSE: LLY) today announced the initiation of a Phase 1b clinical trial evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly. This formulation uses Adocia's proprietary technology BioChaperone, which is designed to accelerate insulin absorption.
This two-week study, under the Adocia-Lilly partnership, aims to compare the effects of BioChaperone Lispro and Humalog® (insulin lispro rDNA origin) on post-meal glycemic control in type 1 diabetes patients using insulin pump therapy.
Insulin pump therapy, also known as continuous subcutaneous insulin therapy (CSII), is an alternative to multiple daily injections from insulin syringes or pens. The insulin pump provides a steady stream of rapid-acting insulin to the patient's body, thus replacing basal insulin injections, and also provides bolus infusions in response to food intake. Using an ultra-rapid insulin in a pump could provide a significant impact around mealtimes, since the rapid onset would better match the quick rise in blood sugar that follows a meal.
"The number of diabetes patients using pumps is increasing for practical and medical reasons. Outpatient data using CSII are an important part of further documenting BioChaperone Lispro's benefits for type 1 diabetes patients," says Olivier Soula, Adocia's R&D Director and Deputy General Manager.
In this crossover, randomized, double-blind study, 36 type 1 diabetes patients will receive continuous subcutaneous insulin injection of BioChaperone Lispro U100 and Humalog U100 in an outpatient setting over the course of two, 14-day periods. The main objective of this study is to compare post-meal glycemic control obtained after the bolus injection of either BioChaperone Lispro or Humalog relative to a solid meal stimulus. The pharmacokinetic profiles of both products will also be monitored. Continuous glucose monitoring will be performed throughout the period. This study will be sponsored by Adocia, and performed by Profil Neuss in Germany.
"Lilly's foundation is built on innovation and discovery in the diabetes space," says David Moller, Vice President, Lilly Research Laboratories. "The study of this new rapid insulin formulation in the context of an insulin pump is an important step in the ongoing BioChaperone Lispro development program."
Additional clinical studies will be conducted this year in order to further document BioChaperone Lispro's performance in other patient populations and prepare the product for Phase III testing.
This trial (EudraCT 2015-002808-81) is registered and appears on clinicaltrials.gov.
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This two-week study, under the Adocia-Lilly partnership, aims to compare the effects of BioChaperone Lispro and Humalog® (insulin lispro rDNA origin) on post-meal glycemic control in type 1 diabetes patients using insulin pump therapy.
Insulin pump therapy, also known as continuous subcutaneous insulin therapy (CSII), is an alternative to multiple daily injections from insulin syringes or pens. The insulin pump provides a steady stream of rapid-acting insulin to the patient's body, thus replacing basal insulin injections, and also provides bolus infusions in response to food intake. Using an ultra-rapid insulin in a pump could provide a significant impact around mealtimes, since the rapid onset would better match the quick rise in blood sugar that follows a meal.
"The number of diabetes patients using pumps is increasing for practical and medical reasons. Outpatient data using CSII are an important part of further documenting BioChaperone Lispro's benefits for type 1 diabetes patients," says Olivier Soula, Adocia's R&D Director and Deputy General Manager.
In this crossover, randomized, double-blind study, 36 type 1 diabetes patients will receive continuous subcutaneous insulin injection of BioChaperone Lispro U100 and Humalog U100 in an outpatient setting over the course of two, 14-day periods. The main objective of this study is to compare post-meal glycemic control obtained after the bolus injection of either BioChaperone Lispro or Humalog relative to a solid meal stimulus. The pharmacokinetic profiles of both products will also be monitored. Continuous glucose monitoring will be performed throughout the period. This study will be sponsored by Adocia, and performed by Profil Neuss in Germany.
"Lilly's foundation is built on innovation and discovery in the diabetes space," says David Moller, Vice President, Lilly Research Laboratories. "The study of this new rapid insulin formulation in the context of an insulin pump is an important step in the ongoing BioChaperone Lispro development program."
Additional clinical studies will be conducted this year in order to further document BioChaperone Lispro's performance in other patient populations and prepare the product for Phase III testing.
This trial (EudraCT 2015-002808-81) is registered and appears on clinicaltrials.gov.
Help employers find you! Check out all the jobs and post your resume.
