Date: 2016-10-27
Type of information: Results
phase: 1-2a
Announcement: results
Company: Adocia (France)
Product: HinsBet® U100
Action
mechanism: rapid-acting insulin. Adocia has developed its fast-acting insulin HinsBet® using its BioChaperone library of polysaccharides modified with naturally occurring molecules. BioChaperone is designed to form a reversible molecular complex with therapeutic proteins in order to solubilize and stabilize these proteins and to control their delivery.
Disease: type 1 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial
details: The Phase 1b trial is a randomized, double-blind, three-treatment, three-period cross-over trial in 36 patients with type 1 diabetes. Subjects enrolled in the trial will receive individualized single doses of rapid-acting human insulin (HinsBet), insulin lispro (Humalog) and regular human insulin (Humulin) immediately prior to ingesting a standardized mixed meal. The main objective of this study is to compare post-meal glycemic control obtained with HinsBet or Humulin relative to a standardized meal. Secondary objectives include the comparison of post-meal glycemic control obtained after administering an injection of HinsBet or Humalog, as well as comparisons between the post-meal pharmacokinetic profiles of the three products and the assessment of their safety and tolerability.
Latest
news: * On October 27 , 2016, Adocia announced positive topline results from a Phase 1b clinical trial evaluating the post-meal effects of HinsBet® U100 in subjects with type 1 diabetes. The goal of the current study was to compare the effects of HinsBet, Humulin® (regular human insulin; Eli Lilly and Co), and Humalog® (insulin lispro; Eli Lilly and Co) when injected at the start of a standardized mixed meal, on post-meal glycemic control in patients with type 1 diabetes. * On April 11 , 2016, Adocia announced the initiation of a Phase 1b clinical trial to evaluate the post meal effects of HinsBet® U100 in subjects with type 1 diabetes. The trial aims to assess the effect of HinsBet® U100, injected at the start of a standardized mixed meal, on post-meal glycemic control in patients with type 1 diabetes in comparison with the effect exhibited by Humalog® (insulin lispro, Lilly) and Humulin® (regular human insulin, Lilly). Prandial insulins aim to control blood glucose during and after the meal. Whereas regular human insulin is recommended to be injected 30 minutes before a meal to achieve optimal control, prandial insulin analogs have an accelerated profile allowing for injection just 15 minutes before the meal. This difference is important to reduce post-meal hyperglycemia, a primary cause of the long term complications of diabetes. HinsBet is designed to act as rapidly as a prandial insulin analog while taking advantage of the lower cost of human insulin to facilitate easy access for patients worldwide.
The randomized, double-blind, three-treatment, three-period cross-over Phase 1b trial enrolled 36 people with type 1 diabetes. Subjects received individualized single doses of rapidacting human insulin (HinsBet), regular human insulin (Humulin) and rapid-acting analog insulin lispro (Humalog) immediately before ingesting a standardized mixed meal. The primary endpoint of this study was to compare the effect of HinsBet and Humulin on the postmeal glycemic control one hour after the meal. This study successfully met its primary endpoint, as HinsBet treatment resulted in lower blood glucose one hour after the meal compared to Humulin treatment (BG1h=228 mg/dL with HinsBet vs. 253 mg/dL with Humulin, LSM ratio 0.9, 95% CI, p=0.0002).
Secondary endpoints included the comparison of post-meal glycemic control over the first hour after the meal obtained with HinsBet and Humalog, as well as comparisons between the post-meal pharmacokinetic profiles of the three products and the assessment of their safety and tolerability. There was no significant difference found between HinsBet and Humalog on their effect on postprandial glucose excursion over the first hour after the meal (AUCBG0- 1h=174 h*mg/dL with HinsBet vs. 172 h*mg/dL with Humalog, LSM ratio 1.0, 90% CI, p=0.5373). Conversely, HinsBet significantly reduced postprandial glucose excursion over the first hour compared to Humulin (AUCBG0-1h=174 h*mg/dL with HinsBet vs. 192 h*mg/dL with Humulin, LSM ratio 0.9, 95% CI, p=0.0002). HinsBet, Humulin and Humalog were similarly well tolerated. No new or unexpected safety findings were observed.
Adocia intends to submit these results for presentation at a major diabetes-related conference. Until such time, detailed results for this trial will remain under embargo.
