Adocia and Tonghua Dongbao Report Positive Results for Ultra-Rapid Insulin
Adocia and Tonghua Dongbao have announced positive topline results from a Phase 3 clinical trial of BioChaperone® Lispro (THDB0206 injection), an ultra-rapid insulin formulation, in adults with type 1 diabetes.
Conducted in China with approval from the Chinese regulatory authorities, the study compared THDB0206 injection against the standard of care, Humalog, in adults whose glycaemic control remained inadequate despite therapy.
Over a 26-week treatment period, 550 adults using multiple daily insulin injections were enrolled and randomised. The trial met its primary endpoint, demonstrating non-inferior reduction in HbA1c with THDB0206 versus Humalog – confirming that the investigational ultra-rapid insulin delivers overall glycaemic control on par with the established comparator.
Beyond the headline result, the drug also cleared its key secondary endpoint: participants receiving THDB0206 experienced a statistically significant lower rise in blood glucose after a standardised meal compared with those on Humalog.
Additional analyses reinforced this postprandial advantage, showing improved blood glucose levels two hours after meals and a consistent reduction one hour after each meal, as captured by 10-point self-monitoring blood glucose (SMBG) profiles.
Company leaders welcomed the outcome. Tonghua Dongbao’s President said the team was delighted with the Phase 3 results, noting they confirm the benefits of THDB0206 injection in improving blood glucose control for adults with type 1 diabetes, and reaffirmed the company’s commitment to innovation in diabetes and obesity care.
Adocia’s CEO and Co-Founder added that the organisation is extremely proud of Phase 3 results achieved across both type 1 and type 2 diabetes, highlighting that in both populations THDB0206 improved post-meal control versus standard therapy.
According to Adocia, BioChaperone Lispro is the only one of the three ultra-fast insulins to show this level of performance across all meals of the day.
What’s more, safety findings were favourable. Most adverse events were mild or moderate in severity and were comparable to those observed with Humalog, supporting the tolerability of THDB0206 in a real-world-like, multiple-daily-injection setting.
Conclusion
With non-inferior HbA1c reduction and superior post-meal glucose control versus Humalog, coupled with a favourable safety profile, BioChaperone Lispro (THDB0206 injection) has cleared a major late-stage milestone in type 1 diabetes.
For clinicians and people living with diabetes, these data strengthen the case for an ultra-rapid insulin that not only matches overall glycaemic outcomes but better tames the critical spikes after eating – an area that remains central to daily quality of life and long-term outcomes.
News Credits: Ultra-rapid insulin shows promise in phase 3 trial for type 1 diabetes
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