Date: 2015-10-06
Type of information: Initiation of the trial
phase: 1b
Announcement: initiation of the trial
Company: Adocia (France) Eli Lilly (USA - IN)
Product: BioChaperone Lispro® U100
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: patients with type 1 diabetes using insulin pump therapy
Therapeutic area: Metabolic diseases
Country: Germany
Trial
details: This trial evaluates a new test formulation of insulin lispro, delivered by an insulin pump continuously under the skin. The study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes the new test formulation and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks, including screening, lead-in and follow up. Screening is required within 28 days prior to entering the study. (EudraCT 2015-002808-81/NCT02623478)
Latest
news: * On October 6, 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 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.
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.
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.
