Date: 2017-06-01
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Adocia (France)
Product: BioChaperone® Lispro U100 with Fiasp® (faster-acting insulin aspart) and Novolog®(insulin aspart)
Action
mechanism:
Disease: type 1 diabetes
Therapeutic area: Metabolic diseases
Country: Germany
Trial details:
Latest news: • On June 1, 2017, Adocia announced the initiation of a clinical study evaluating BioChaperone® Lispro, an “ultra-rapid” formulation of insulin lispro, compared to Fiasp® (faster-acting insulin aspart, Novo Nordisk) and Novolog® (insulin aspart, Novo Nordisk), when administered using an insulin pump. The present Phase 2 study will be the first to compare two “ultra-rapid” insulin formulations head-to-head. The study aims to compare the pharmacokinetic and pharmacodynamic profiles of BioChaperone Lispro U100 to those of Fiasp and Novolog in participants with type 1 diabetes under a euglycemic clamp procedure. Adocia expects to publish the topline clinical results before year end. In this double-blind, randomized, three-period crossover study, 42 participants with type 1 diabetes under a euglycemic clamp procedure will receive single doses (0.15 U/kg) of BioChaperone Lispro U100, Fiasp and Novolog, administered by an insulin pump (Medtronic MiniMed Paradigm® Veo) on three separate dosing visits. Objectives of the study include the comparison of the glucose response obtained during the first hour after administration of BioChaperone Lispro U100 to those obtained after administration of Fiasp and Novolog and the evaluation of the pharmacokinetic profiles of BioChaperone Lispro U100, Fiasp and Novolog. Objectives also include the assessment of safety and tolerability of the three treatments in these participants. This study will be sponsored by Adocia and performed by Profil Neuss in Germany.
