Clinical Trials

Date: 2015-11-04

Type of information: Results

phase: 1b

Announcement: results

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 fastacting 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.

Disease: type 1 diabetes, type 2 diabetes

Therapeutic area: Metabolic diseases

Country: Germany

Trial details:

Latest news:

• • On November 4, 2015, Adocia announced positive topline results from a Phase Ib randomized double-blind crossover trial of BioChaperone Combo® in 28 subjects with type 1 diabetes. The study, comparing the effect on post-meal glycemic control of individualized doses of BioChaperone Combo and Humalog® Mix75/25™ (Eli Lilly) injected at the beginning of standardized meals, met its primary endpoint, demonstrating superiority of BioChaperone Combo® in the reduction of post-meal blood glucose over the first two hours (Delta-AUC-BG(0-2h)) compared to Humalog® Mix75/25™. In this study, BioChaperone Combo® has been demonstrated to be superior to Humalog® Mix75/25™ on these two criteria, consistent with tighter blood glucose control:
• - BioChaperone Combo® was associated with significantly lower blood glucose excursions in the first two hours vs. Humalog® Mix75/25™ (primary endpoint, Delta-AUC-BG(0-2h)= 89.2 ± 48.6 mg*h/dL vs 117.7 ± 47.6 mg*h/dL, p=0.0078). This result is confirmed by a reduction of the maximum blood glucose level of 23 mg/dL (BGmax: ratio = 0.9; p=0.0003).
• - The minimum blood glucose level observed during the period with BioChaperone Combo® was also significantly better controlled than with Humalog® Mix75/25™ (BGmin: ratio = 1.3; p=0.0030). While this study was not designed to measure differences in hypoglycaemia between both treated groups, a lower number of hypoglycaemic events was observed with Biochaperone Combo® vs. Humalog® Mix75/25™.
• No new or unexpected safety findings for BioChaperone Combo® and Humalog® Mix75/25 were observed in the study. No local reactions were seen on the site of administration for either treatment.
• Additional clinical studies are planned in 2016 to further establish the medical benefit of BioChaperone Combo®. A Phase Ib clinical trial is also ongoing in type 2 diabetes patients, to compare the pharmacodynamic profiles of BioChaperone Combo® to those of Humalog® Mix™ and of the basal-bolus injection of Lantus® and d'Humalog®. Results for this study are expected before year end. Detailed results of the present trial, conducted by Profil GmbH in Germany, will be submitted for publication at the American Diabetes Association's 76th Scientific Sessions in June 2016.
• • On July 10, 2015, Adocia announced the initiation of two Phase Ib clinical trials evaluating its formulation combining insulin glargine (Lantus®, Sanofi), to a fastacting insulin analog, insulin lispro (Humalog®, Eli Lilly and company). The first study aims to measure the effect of BioChaperone Combo, injected at the time of a standardized meal, on post-meal glycemic control in type 1 diabetes patients and compare this effect to that of HumalogMix, based on insulin lispro (Lilly). In this double-blind, randomized crossover study, 28 subjects with type 1 diabetes will receive one individualized dose of BioChaperone Combo and one individualized dose of HumalogMix at the beginning of a standardized mixed meal.
• The second clinical trial is an euglycemic clamp study in type 2 diabetes patients to compare the pharmacodynamic profile of BioChaperone Combo to that of HumalogMix and of the double injection of Lantus and Humalog. In this double-blind, randomized crossover study, 24 subjects with type 2 diabetes will receive one dose of BioChaperone Combo (0.8 IU/kg), versus one dose of HumalogMix (0.8 IU/kg), versus simultaneous doses of Lantus (0.6 IU/kg) and Humalog (0.2 IU/kg) injected at the same time. These two clinical studies are performed by Profil GmbH in Germany.

Is general: Yes