Adocia/Lilly successfully complete insulin pump study

Adocia and Eli Lilly have completed an insulin pump study under the Adocia-Lilly partnership evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly.

This formulation uses Adocia’s proprietary technology BioChaperone, designed to accelerate insulin absorption.

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.

“We are pleased to confirm that BioChaperone Lispro consistently delivered ultra-rapid insulin absorption compared to Humalog in the two insulin pumps tested. This increased early insulin exposure translated into improved post-prandial glucose control.” said Simon Bruce, MD, Adocia’s Chief Medical Officer. “Thus, BioChaperone Lispro has demonstrated a consistent absorption profile across multiple studies, different populations, and, now, different delivery modes.”

Companies explained that 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 controlled clinical 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 non-significant 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)).

Companies said that 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.