Date: 2016-12-16
Type of information: Completion of the trial
phase: 1
Announcement: completion of the trial
Company: Adocia (France) Eli Lilly (USA - IN)
Product: BioChaperone Lispro®
Action
mechanism: insulin analogue. BioChaperone Lispro® is an ultra-fast acting formulation of insulin Lispro - Humalog® licensed to Lilly. This formulation uses Adocia’s proprietary technology BioChaperone, which is designed to accelerate insulin absorption.
Disease: type 1 diabetes mellitus
Therapeutic area: Metabolic diseases
Country: Germany
Trial
details: This study is constituted of 2 parts: Part A: A total of 36 patients will be enrolled in part A. Each eligible subject will participate in two 14-day treatment periods with Continuous Subcutaneous Insulin Infusion (CSII) of BioChaperone insulin lispro and insulin lispro (Humalog®, Eli Lilly and Company). Each treatment period consists of 10 treatment days under free living conditions (e.g. home / workplace) and under standardised conditions at the clinic. Various assessments for pharmacodynamics, pharmacokinetics, pump compatibility, short-term efficacy and safety are performed on selected days, including: - Mixed Meal Test (MMT), Day 1, Day 3, Day 12 and Day 14, that will assess the post-prandial glucose response for 6 hours after individualized standard meal (fixed nutrient ratio) ingestion and bolus administration via CSII. - Continuous Glucose Monitoring (CGM), (Day 1 - 14) that will be used in blinded mode (i.e. neither subjects nor the investigators are aware of the sensor glucose values). - Pump compatibility (Day 1 - 14): Subjects will continue CSII treatment with the Investigational Medicinal Products (IMP) during the outpatient periods. Part B: A total of 44 patients will be enrolled. Subjects will be randomized to a 4-period cross-over study aiming at comparing the performance of BC Lispro and Humalog after a prandial bolus administration with two different CSII systems (Roche Accu-Chek® Spirit and Medtronic Paradigm® Veo™) or with a syringe. Pharmacodynamics, pharmacokinetics, pump compatibility and safety will be analyzed. Each period will include a mixed meal tolerance test with a CSII device and a mixed meal tolerance test with the same dose of insulin administered with a syringe. (NCT02562313)
Latest
news: * On December 16, 2016, Adocia announced successful completion of an insulin pump study under the Adocia-Lilly partnership evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly.
This study was the first to compare, in people with type 1 diabetes, the post-prandial glycaemia and pharmacokinetic response to an individualized mixed meal after a bolus of BioChaperone Lispro and Humalog® (insulin lispro rDNA origin), administered with two different Continuous Subcutaneous Insulin Infusion (CSII) systems (Roche Accu-Chek® Spirit and Medtronic Paradigm® Veo™) immediately before a meal. The study also investigated the effects of both agents administered subcutaneously with a syringe.
This was a two-part study. The first part comparing the products in the Roche Accu-Chek® Spirit pump did not clearly demonstrate an advantage for BioChaperone Lispro. The second part involved more subjects and included three devices: Roche Accu-Chek® Spirit pump, Medtronic Paradigm® Veo™ pump and insulin syringe. In this latter part 44 subjects were enrolled in a randomized, double-blind, 2-treatment, 4-period cross-over, active controlledclinical trial to investigate BioChaperone Lispro compared to Humalog in CSII. During the treatment period, patients made four, 2-day visits to the clinic interspersed with wash-out periods. On the day of each visit, patients were subjected to a meal-tolerance test (MTT) after receiving one of the two treatments immediately prior to the meal using one of the two pumps (Day 1), or the same treatment using a syringe (Day 2) on top of basal delivery.
One primary objective of the second part of the study was to compare the absorption profile of BioChaperone Lispro vs. Humalog, when administered immediately before an individualized mixed meal, with the selected pump models and syringes. BioChaperone Lispro U100 demonstrated a statistically significant increase in insulin exposure over the first 30 minutes compared to Humalog in the two pumps tested: early exposure was increased by 33% in the Roche pump (primary endpoint, p=0.0007) and by 54% in the Medtronic pump (p<0.0001). This was consistent with a comparable increase of early insulin exposure for BioChaperone Lispro vs. Humalog using syringes on top of basal administration with a Roche pump (+71%, p<0.0001) and with a Medtronic pump (+83%, p<0.0001).
BioChaperone Lispro was associated with a consistent pattern of improved response to mixed meal testing compared to Humalog. In the Roche pump a statistically significant 83% reduction (p=0.0018) in the 2hr blood glucose excursion has been shown while a nonsignificant 12% reduction in the 2hr blood glucose excursion has been observed with the Medtronic pump. When delivered as a bolus from syringes, on top of basal delivery with an insulin pump, BioChaperone Lispro was also associated with significant reductions in the 2hr blood glucose excursion vs. Humalog (-56% with the Roche pump (p=0.0008) and -61% with the Medtronic pump (p<0.0001)).
Both BioChaperone Lispro and Humalog were similarly well tolerated. No new or unexpected safety findings were observed and no local reactions were seen on the site of administration for either treatment.
