Date: 2016-03-14
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 1 diabetes mellitus
Therapeutic area: Metabolic diseases
Country: Germany
Trial
details: This double-blind, randomised, controlled, two period crossover phase Ib trial is using an individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes mellitus to investigate postprandial blood glucose control with BioChaperone insulin lispro compared to Humalog®. The assessments will be conducted before and after a period of multiple daily dose administrations for 14 days. The meal tolerance test will be performed on day 1-3 and on day 14 of each period. Furthermore the study aims at investigating Post-prandial glucose (PPG) profiles with BioChaperone insulin lispro and Humalog® when injected at various injection meal intervals (-15min, 0 minutes, +15 minutes). Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-Biochaperone insulin lispro, and three different sequences of injection-meal intervals. A blinded to patient continuous monitoring of glucose (CGM) will be performed during the 14 day treatment periods. (NCT02528396)
Latest
news: * On March 14, 2016, Adocia and Eli Lilly announced positive topline results from a Phase 1b clinical trial under the Adocia-Lilly partnership evaluating BioChaperone Lispro. This study was the first outpatient 14-day study comparing 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 in 36 patients with type 1 diabetes. The study also investigated the effects of different timing of administration, with treatments being injected either at mealtime, 15 minutes before, or 15 minutes after the start of a solid meal. Whereas commercialized fast-acting insulin analogs are usually injected before the meal, an ultra-rapid insulin aims to allow injection at the time of the meal, or even after the start of a meal, while maintaining a reduction in the magnitude of glycemic excursions. * On August 27, 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 new study under the Adocia-Lilly partnership aims to compare the effect of BioChaperone Lispro, injected either at mealtime or 15 minutes after the meal, on post-meal glycemic control in type 1 diabetes patients to that of Humalog® (insulin lispro rDNA origin) over the same two-week period. Commercialized fast-acting insulin analogs are usually injected before the meal. An ultra-rapid insulin 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.
In this double-blind, randomized, crossover study, 36 patients with type 1 diabetes used individualized doses of either BioChaperone Lispro or Humalog as the short acting insulin in their multiple daily injection regimen, over two periods of 14 days. At the beginning and the end of each period, patients were subject to a meal tolerance test in the clinic to compare post-prandial blood glucose profiles after identical bolus injections immediately before the meal of either BioChaperone Lispro or Humalog relative to a solid standard meal. At the beginning of the study, when injected at the time of meal, BioChaperone Lispro demonstrated a statistically significant 31 percent reduction in blood glucose excursion over the first two hours compared to Humalog. After 14 days of treatment for each treatment, BioChaperone Lispro also demonstrated a statistically significant 42 percent reduction in blood glucose excursion over the first two hours compared to Humalog, when injected at the time of the meal. This last result demonstrates the robustness of the performance of BioChaperone Lispro on a two week period. Both BioChaperone Lispro and Humalog were similarly well tolerated throughout the 14 days. No new or unexpected safety findings were observed and no local reactions were seen on the site of administration for either treatment.
In this crossover, randomized, double-blind study, 36 type 1 diabetes patients will receive multiple daily doses of BioChaperone Lispro and Humalog over two periods of 14 days each. The main objective is to compare post-meal glucose profiles after identical bolus injections of either BioChaperone Lispro or Humalog relative to a solid meal stimulus. Additionally the study will document the safety and efficacy of an ultra-rapid insulin absorption profile in an outpatient setting. This study will be sponsored by Adocia, and performed by Profil Neuss in Germany. Additional Phase 1b clinical studies will be conducted this year in order to understand performance for additional diabetic patient needs.
