- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Positive topline results from a Phase Ib study of BioChaperone Lispro
28 April 2016 • Author: Victoria White, Digital Content Producer
This formulation uses Adocia’s proprietary technology BioChaperone, designed to accelerate insulin absorption.
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 glycaemic control relative to solid standardised meals, when injected at the time of the meal, in 51 people with type 2 diabetes.
A 22% reduction in blood glucose excursion
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.
Commenting on the results, Thomas Hardy, M.D., Senior Medical Director, Endocrinology, Eli Lilly and Company, said: “We are encouraged by the results of this trial. In addition, we are pleased with the expeditious progress of our joint programme with Adocia.”
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 hypoglycaemia were seen. No new or unexpected safety findings were observed.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics