First clinical study directly comparing the two formulations “ultra – rapid” insulin in subjects with type 1 diabetes
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The trial is designed to compare the pharmacodynamic and pharmacokinetic profiles of BioChaperone® Lispro with those of Fiasp® and Novolog® after single-dose administration through an insulin pump
The main results are expected before the end of the year
Lyon, France, June 1, 2017 – 18: 00 CET – Adocia (Euronext Paris : FR0011184241 – ADOC), a biopharmaceutical company specializing in the treatment of diabetes with innovative formulations of proteins approved, today announced the launch of a clinical study comparing BioChaperone® Lispro, a formulation of “ultra-fast” insulin lispro in Fiasp® (insulin aspart compared to accelerated action, Novo Nordisk), the only formulation of “ultra-fast” insulin recently approved by the EMA (Europe) and the Health Canada and Novolog® (insulin aspart, Novo Nordisk), an insulin analogue with fast action, after administration of each treatment by an insulin pump. BioChaperone Lispro is using BioChaperone®, the proprietary technology of Adocia designed for accelerating the absorption of insulin. BioChaperone Lispro showed a profile of accelerated action across multiple trials phase 1/2 in people with type 1 diabetes or type 2, when it is administered by a syringe or by a pump. BioChaperone Lispro is now ready to enter in clinical studies of phase 3. This clinical study of phase 2 will be the first to directly compare the two formulations “ultra-fast” insulin.
“The advent of this new class of insulin is an integral and exciting part, because insulin action accelerated the potential to respond to the urgent need to improve the glycemic control in people with diabetes.” commented Dr. Bruce Bode, MD, FACE. “These insulins may also play a crucial role in the development of the artificial pancreas, improving the overall performance of such systems. ”
The study was designed to compare pharmacokinetic and pharmacodynamic profiles of BioChaperone Lispro U100 to those of Fiasp and Novolog in participants with type 1 diabetes placed under clamp euglycemic clamp.
“This is the first study conducted independently by Adocia on BioChaperone Lispro since the interruption of the collaboration with Eli Lilly in January 2017. We are looking forward to evaluate the performance in pumps of BioChaperone Lispro compared Fiasp, the only insulin approved for this class. “commented Olivier Soula, deputy General Manager and R&D Director of Adocia. “We hope to be able to publish preliminary results before the end of the year and we believe that this study should enable to consolidate the demonstration of the value of BioChaperone Lispro in the major segment and in the growth of the insulin administered by pump. ”
In this randomized, double-blind, cross-over three times, 42 participants with type 1 diabetes placed under clamp euglycemic will receive single doses (0,15 IU/kg) of BioChaperone Lispro U100, Fiasp and Novolog, which are administered by an insulin pump (Medtronic MiniMed Paradigm® Veo) during three separate visits.
The objectives of the study include the comparison of the response glucodynamique during the first hour after administration of BioChaperone Lispro U100 to those obtained after administration of Fiasp and Novolog and the evaluation of pharmacokinetic profiles of BioChaperone Lispro U100, Fiasp and Novolog. The objectives also include an assessment of the safety and tolerance of three treatments among the participants.
Adocia is the sponsor of this study, which will be conducted by Profile Neuss in Germany.
This study is registered and will appear on clinicaltrials.gov.
Adocia is a biotechnology company clinical stage specialized in the development of innovative formulations of proteins already approved. The portfolio of injectable products of Adocia for the treatment of diabetes, which includes four products in clinical phase and six products in the preclinical phase, is one of the widest and most differentiated in the industry.
The platform’s proprietary technology BioChaperone® aims to improve the effectiveness and/or safety of therapeutic proteins and facilitate their use by patients. Adocia customizes BioChaperone to each protein for a given application, in order to meet the specific needs of patients.
The clinical pipeline of Adocia includes four innovative formulations of insulin for the treatment of diabetes: two formulations, ultra-fast insulin analog (BioChaperone Lispro U100 and U200), a formulation of rapid-acting insulin human (HinsBet U100), and a combination of slow insulin glargine and rapid-acting insulin lispro (BioChaperone Combo). Adocia is also developing an aqueous formulation of glucagon, human (BioChaperone Human Glucagon), two combinations of insulin glargine with GLP-1 (BioChaperone Glargine Dulaglutide and BioChaperone Glargine Liraglutide), two combinations of insulin lispro with hormones prandial synergistic (BioChaperone Lispro Pramlintide and BioChaperone Lispro Exenatide) and a concentrated formulation is fast-acting insulin human (HinsBet U500), all in preclinical development.
Adocia aims to deliver “innovative medicines for everyone, everywhere.”
To learn more about Adocia, please visit us on www.adocia.com
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