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Adocia Announces Initiation of a Clinical Trial on its Combination of Glargine and Lispro

Published: Monday, November 18, 2013
Last Updated: Monday, November 18, 2013
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This phase I/II clinical trial on Type I diabetics seeks to compare the performance of this Combo based on insulin Glargine with HumalogMix®.

Adocia has announced that it has launched the first clinical trial of its innovative formulation combining insulin Glargine (Lantus®, Sanofi), the gold-standard of long acting insulin, with a fast-acting insulin analog, insulin Lispro (Humalog®, Eli Lilly). This unique combination is made possible thanks to the BioChaperone® technology developed by Adocia, which makes insulin Glargine compatible with fast-acting insulin analogs.

This clinical trial aims to demonstrate that the combination could offer diabetic patients improved glycemic control compared to a Premix of insulin analog such as HumalogMix, based on insulin Lispro (Eli Lilly), or NovoMix®, based on insulin Aspart (Novo Nordisk).

Hence, pharmacodynamic and pharmacokinetic profiles of the combination BioChaperone Glargine/Lispro will be compared to the pharmacodynamic and pharmacokinetic profiles of HumalogMix in a cross-over design on 20 Type I diabetic patients under a euglycemic clamp. The first patients of this double-blind study conducted in Germany have already been treated.

Today, Type I and Type II diabetic patients requiring intensive insulin therapy have two treatment options: either a Premix, which is a formulation of a single insulin with both fast and long actions, or an association of two products, a long-acting insulin and a fast-acting insulin. The current gold-standard of long-acting insulin is Lantus, which generated USD 6.5 billion in 2012.

Premix products, NovoMix (Novo Nordisk) and HumalogMix (Eli Lilly), ease everyday life for diabetics, who can manage their glycaemia using only one product injected twice daily. These Premix have been commercialized for more than ten years and generate annual revenues of more than USD 2.3 billion, with significant growth in emerging markets. However, these products put patients at higher risk of hypoglycemia compared to separate injections of Lantus and a fast-acting analog insulin.

“There is a real need to provide patients using Lantus and a fast-acting insulin with the simplicity afforded by Premix products, as well as to offer Premix-using patients the greater medical efficacy obtained with Lantus, a real gold-standard,” said Gerard Soula, Adocia’s CEO. This combination could therefore extend Glargine’s market potential towards the Premix market. This Combo based on insulin Glargine, an insulin off-patent in 2015, has been internationally patented in 2012.”

“Adocia’s BioChaperone proprietary technology allows for a clear and stable solution of insulin Glargine and a fast-acting analog insulin, two products that are not compatible under natural conditions,” said Olivier Soula, deputy general director and R&D director at Adocia. “In this clinical trial, we are testing one of the potential combinations but alternative combinations, namely with insulin Glulisine (Apidra®, Sanofi) and insulin Aspart (NovoLog®, Novo Nordisk) have also been validated in preclinics.”

Results from this study are expected during the first quarter of 2014.

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