BioChaperone® Combo has demonstrated a statistically significant reduction of 18% of the excursions of blood glucose on the first two hours after the meals compared to Humalog® Mix25TM
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The number of hypoglycemic episodes per patient was significantly lower with BioChaperone Combo with Humalog® Mix25TM
BioChaperone Combo has led to a control of the postprandial blood sugars at least as good as that obtained with separate injections, and simultaneous of Lantus® and Humalog® and a similar number of hypoglycemic episodes per patient
Lyon, France, on June 6, 2017 – 18h CET – Adocia (Euronext Paris: FR0011184241 – ADOC), a biopharmaceutical company specializing in the treatment of diabetes through innovative formulations of proteins approved, today announced the main results of a positive clinical study of Phase 1b assessment of the effect postprandial of BioChaperone® Combo in people with type 2 diabetes. BioChaperone Combo is a formulation owner of Adocia combining the insulin analog basal glargine (Lantus®, Sanofi) and insulin analogue prandial lispro (Humalog®, Eli Lilly and Company). The technology BioChaperone® allows this combination of solubilizing the insulin glargine at neutral pH, pH of compatibility with insulin analogues prandial.
“These clinical data on BioChaperone Combo demonstrate a statistically significant improvement compared to the premix, even in a limited number of subjects with type 2 diabetes, both excursions of postprandial glucose and number of hypoglycemic episodes,” says Dr. Steve Edelman, MD, clinical Professor of medicine at the University of California San Diego. “This new combination of insulins basal and prandial clearly responds to the limitations characteristic of the current options of insulins premix, which should allow wider use among people with type 2 diabetes.”
The objective of this study was to compare the effects of BioChaperone Combo on glycemic control postprandial in participants with type 2 diabetes to those of premix insulin, Humalog® Mix25TM, and separate injections of Lantus (Sanofi) and Humalog (Eli Lilly) when each treatment was administered immediately before the meal. People with type 2 diabetes, who require an intensification of their insulin treatment basal, using either a premix insulin twice a day, such as Humalog Mix25TM, either multiple daily injections that include up to three injections of prandial insulin at mealtimes in addition to the basal insulin. BioChaperone Combo has been designed to provide a simple and efficient alternative to these two options.
In this randomized, double-blind and double-placebo-controlled, cross-over three periods, 39 subjects with type 2 diabetes were given three daily doses individualized successive of each treatment : BioChaperone Combo, Humalog Mix25TM and separate injections and simultaneous Lantus and Humalog. The main objective of this study was to compare the glycemic control postprandial obtained on days 2 and 3 with BioChaperone Combo vs. Humalog Mix25TM when these treatments were administered immediately before the meal.
Treatment with BioChaperone Combo has resulted in a reduction of 18%, statistically significant, of the excursion of glucose during the first two hours compared to treatment with Humalog Mix25TM (∆AUCBG0-2h medium: BC Combo 107 mg.h/dL vs. Humalog Mix25TM 129 mg.h/dL; p