Date: 2016-04-27
Type of information: Results
phase: 1b
Announcement: results
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: This double-blind, randomised, controlled, two-period crossover phase Ib trial is using an individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of multiple daily dose administrations for 14 days. Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-BioChaperone insulin lispro. Injections will take place immediately before an individualised standard meal in the morning of day 1, 2, 13, and 14. Insulin doses will be determined at the screening visit. During the outpatient phase the subjects will keep their basal insulin constant (except changes for safety reason). They will self-measure blood glucose at least 4 times daily (pre-prandial and at bedtime). In addition, on two days per outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial, 2 hours post-prandial and at bedtime). (NCT02562326)
Latest
news: * On April 27, 2016, Adocia and Eli Lilly announced positive topline results from a Phase 1b clinical trial
under the Adocia-Lilly partnership evaluating BioChaperone Lispro®, an ultra-rapid formulation of insulin lispro licensed to Lilly. This study was the first to evaluate BioChaperone Lispro® in people with type 2 diabetes, who
unlike people with type 1 diabetes, may show various degrees of disease progression, endogenous insulin production, and insulin resistance. The 14-day, outpatient study aimed to compare the effect of multiple daily injections of BioChaperone Lispro® and Humalog® (insulin lispro rDNA origin) on post-prandial glycemic control relative to solid standardized meals, when injected at the time of the meal, in 51 people with type 2 diabetes.
In this double-blind, randomized, crossover study, 51 subjects with type 2 diabetes used individualized doses of either BioChaperone Lispro® or Humalog® as the short acting insulin in their multiple daily injection regimen, injected at the time of the meal over two periods of 14 days. At the beginning (Days 1 and 2) and the end (Days 13 and 14) of each period, subjects were subject to a meal tolerance test in the clinic to compare post-prandial blood glucose profiles after identical bolus injections of either BioChaperone Lispro® or Humalog immediately before a solid standard meal. Based on a post-hoc analysis that include all four meal tolerance test for each treatment, BioChaperone Lispro® demonstrated a statistically significant 22 percent reduction in blood glucose excursion over the first two hours compared to Humalog®. The pharmacokinetic profile of BioChaperone Lispro U100 was consistent with that observed in previous studies in people with type 1 diabetes, demonstrating a statistically significant 83 percent increase in exposure to insulin lispro over the first 30 minutes compared to Humalog®.
Both BioChaperone Lispro® and Humalog® were similarly well tolerated throughout each 14-day period. No obvious differences in adverse events or injection site reactions and no differences in the overall incidence of hypoglycemia were seen. No new or unexpected safety findings were observed.
