Adocia (ADOC) Study result summary

Event overview

• Key opinion leader event and ADA 86th Scientific Sessions presented phase III results for BioChaperone Lispro (BC Lispro/BCLIS) in over 1,000 Chinese adults with type 2 diabetes.

• Presentations covered company background, BioChaperone technology, clinical data, commercialization plans, and included Q&A with analysts.

Study objectives and design

• Phase 3, 26-week, multicenter, randomized, open-label trial compared BC Lispro/BCLIS to insulin lispro (Humalog) in 1,038 adults with type 2 diabetes, both with basal insulin glargine and metformin.

• Primary endpoint: change in HbA1c at 26 weeks; key secondary endpoints: 1- and 2-hour postprandial glucose excursions.

• Inclusion: adults 18–75 years, T2D ≥6 months, stable insulin regimen, HbA1c 7–11%, BMI 18–35 kg/m².

• High treatment completion rates: 92.96% for BCLIS, 95.42% for LIS.

Key efficacy and safety results

• BC Lispro/BCLIS demonstrated non-inferior HbA1c reduction compared to insulin lispro/Humalog at 26 weeks (ETD -0.07% [95% CI: -0.18; 0.003]).

• Superior HbA1c improvements in subgroups using metformin or with baseline HbA1c <8.5%.

• Significantly more participants achieved HbA1c <7% with BCLIS.

• Superior postprandial and daily glucose control throughout the day and after each meal (1h ETD -0.91 mmol/L, 2h ETD -0.69 mmol/L, mean daily reduction -0.44 mmol/L).

• Safety profile similar to comparator, with low rates of hypoglycemia and injection site reactions (0.8% BCLIS vs. 0.48% LIS).