Adocia and Eli Lilly have started a Phase Ib clinical trial evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly for the treatment of patients with type 2 diabetes.
BioChaperone Lispro uses Adocia’s technology, BioChaperone, to accelerate insulin absorption.
The trial is designed to measure the effect of BioChaperone Lispro injected at mealtime on post-meal glycemic control in these patients compared to that of Humalog (insulin lispro rDNA origin) over the same two-week period.
The company noted that commercialised fast-acting insulin analogs are usually injected before the meal and an ultra-rapid insulin aims to allow injection at the time of the meal, or even after the start of a meal, with an aim of reducing the magnitude of glycemic excursions.
The first clinical trial conducted by the companies showed that BioChaperone Lispro was associated with a 61% reduction in post-prandial glucose excursions over the first two hours post-meal compared to Humalog.
Adocia R&D director and deputy general manager Olivier Soula said: "This new clinical study is designed to document the potential benefit of BioChaperone Lispro in patients with type 2 diabetes, a population representing about 90% of people living with diabetes.
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"This study is similar in design to one we recently launched in people with type 1 diabetes."
The crossover, randomised, double-blind Phase Ib trial will include 50 subjects with type 2 diabetes, who will receive multiple daily doses of BioChaperone Lispro and multiple daily doses of Humalog over two periods of 14 days each.
The trial’s main objective is to compare the post-meal glycemic control obtained after the injection of either BioChaperone Lispro or Humalog immediately before the meal.
Sponsored by Adocia and carried out by Profil Neuss in Germany, the trial will also monitor pharmacokinetic profiles of both products.
Lilly Research Laboratories vice-president David Moller said: "Many patients with type 2 diabetes require mealtime insulin in order to adequately control their disease.
"It’s important that we continue to investigate new treatment options that could potentially help people better manage their diabetes."