Clinical Trials

Date: 2017-06-07

Type of information: Initiation of the trial

phase: 1b

Announcement: initiation of the trial

Company: Adocia (France)

Product: BioChaperone® Combo 75/25

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: (NCT03180710)

Latest news:

• • On June 7, 2017, Adocia announced  the initiation of a Phase 1b clinical trial evaluating the dose-linearity of BioChaperone® Combo 75/25 at three different doses in people with type 2 diabetes. This study aims to document the dose exposure of BioChaperone Combo across three different doses in people with type 2 diabetes in order to assess dose-proportionality. In this double-blinded, randomized, four-period crossover trial, using automated 30-hour euglycemic clamp, 32 participants with type 2 diabetes mellitus will be randomly allocated to a sequence of four treatments, i.e. one of three single doses of BioChaperone Combo 75/25 (0.6 U/kg, 0.8 U/kg or 1.0 U/kg) or one single dose of Humalog® Mix25TM at 0.8 U/kg, on four separate dosing visits.
• The primary endpoint is assessment of dose-proportionality for the total insulin exposure across the three doses of BioChaperone Combo. Secondary endpoints include documentation of the dose-response relationship for the total metabolic effect of the three doses of BioChaperone Combo and the comparison of the pharmacodynamic and pharmacokinetic profiles of BioChaperone Combo (0.8 U/kg) with those of Humalog Mix25TM (0.8 U/kg).
• Objectives also include the assessment of safety and tolerability of both treatments in these participants. Study results are expected in Q4 2017.

Is general: Yes