Clinical Trials

Date: 2016-09-20

Type of information: Results

phase: 1b

Announcement: initiation of the trial

Company: Adocia (France)

Product: BioChaperone® Combo

Action mechanism: long-acting insulin analog/ultra-rapid-acting insulin analog. BioChaperone® Combo combines insulin glargine (Lantus®, Sanofi), to a fast-acting insulin analog, insulin lispro (Humalog®, Eli Lilly). People with type 2 diabetes who require insulin intensification over basal are either using twice-daily premix insulins, such as Humalog® Mix25TM, or multiple daily injections (MDI), consisting of up to three mealtime injections of a prandial insulin on top of their basal insulin. BioChaperone® Combo is designed to offer a simple and efficient alternative to these two options.

Disease: type 2 diabetes

Therapeutic area: Metabolic diseases

Country: Germany

Trial details:

Latest news:

• • On June 6, 2017, Adocia announced positive topline results from a Phase 1b clinical trial evaluating the post-meal effects of BioChaperone® Combo in people with type 2 diabetes. The goal of the current study was to compare the effects of BioChaperone Combo on post-meal glycemic control in participants with type 2 diabetes, to that of premixed insulin Humalog® Mix25™ (Eli Lilly) and that of the separate injections of Lantus (Sanofi) and Humalog (Eli Lilly), when each treatment was injected at mealtime. People with type 2 diabetes who require basal insulin treatment intensification are either using twice-daily premixed insulin, such as Humalog Mix25™, or multiple daily injections (MDI), consisting of up to three mealtime injections of a prandial insulin on top of their basal insulin. BioChaperone Combo is designed to offer a simple and efficient alternative to these two options. In this randomized, double-blind, double-dummy, three period cross-over study, 39 subjects with type 2 diabetes received three consecutive daily individualized doses of each treatment: BioChaperone Combo, Humalog Mix25™ and the simultaneous separate injections of Lantus and Humalog. The primary objective of this study was to compare the post-meal glycemic control obtained on day 2 and day 3 with BioChaperone Combo vs. Humalog Mix25™ when administered immediately before the meal. BioChaperone Combo resulted in a statistically significant glucose excursion reduction of 18% in the first two hours compared to Humalog Mix25™ (mean ?AUCBG0-2h: BC Combo 107 mg.h/dL vs. Humalog Mix25™ 129 mg.h/dL; p<0.001). Blood glucose concentrations at 1h were also statistically significantly reduced with BioChaperone Combo compared to Humalog Mix25 (mean BG1h: BC Combo 177 mg/dL vs. Humalog Mix25™ 192 mg/dL; p<0.001).
• In addition, BioChaperone Combo was associated with a statistically lower number of hypoglycemic events per subject (22 hypoglycemic events in 14 subjects with BC Combo vs. 43 events in 20 subjects with Humalog Mix25TM, p=0.003) and a significantly higher time in target range during meal tests (blood glucose interval: 72 – 162 mg/dL, BC Combo 202 min vs. Humalog Mix25™ 183 min; p=0.04) than the premix formulation in these subjects with type 2 diabetes.
• Compared to the separate simultaneous injections of Lantus and Humalog, BioChaperone Combo also significantly reduced blood glucose excursion in the first two hours by 10% (mean ?AUCBG0-2h: BC Combo 107 mg.h/dL vs. separate injections 119 mg.h/dL; p=0.045) and blood glucose concentrations at 1h (mean BG1h: BC Combo 177 mg/dL vs. separate injections 187 mg/dL; p=0.02).
• No significant difference in the number of hypoglycemic events per subject was observed between BioChaperone Combo and the separate injections (22 hypoglycemic events in 14 subjects with BC Combo vs. 28 events in 19 subjects with the separate injections, p=0.2523).
• All treatments were similarly well-tolerated. One serious adverse event during treatment with BioChaperone Combo and one non-serious adverse event during treatment with Humalog Mix25™, both unlikely related to treatment, led to subject discontinuations. No new or unexpected safety findings were observed. “This opens a new treatment dimension for people with type 2 diabetes, offering them a truly efficient, safe and easy-to-use 2-in-1 insulin combination. The next step will be to document dose-response, which is a regulatory requirement to prepare for Phase 3”commented Olivier Soula, Deputy General Manager and Director of R&D of Adocia. • On September 20, 2016, Adocia announced the initiation of a Phase 1b clinical trial evaluating BioChaperone® Combo, its proprietary formulation combining insulin analog glargine (Lantus®, Sanofi), the gold-standard of long acting insulin, and the fast-acting insulin analog, insulin lispro (Humalog®, Eli Lilly). This study aims to measure the effect of BioChaperone® Combo injected at mealtime on postmeal glycemic control in subjects with type 2 diabetes compared to that of premix insulin Humalog® Mix25™ (Eli Lilly) and the separate injection of Lantus® (Sanofi) and Humalog® (Eli Lilly). In this randomized, double-blind, double-dummy, three period cross-over study, 36 subjects with type 2 diabetes will receive three consecutive daily individualized doses of each treatment: BioChaperone® Combo, Humalog® Mix25™ and the simultaneous separate injections of Lantus® and Humalog®..

Is general: Yes