Phase 2b Study Will Present New Insulin Trial Data
Researchers will share findings on a potential new insulin therapy for adults living with type 1 diabetes.
Updated on Sept. 21, 2026 in Diabetes
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Diasome Pharmaceuticals will present data from its 25-week OPTI-2 trial involving 226 adults with type 1 diabetes. The findings will be shared at upcoming international and national medical conferences in late 2026.
Why it matters
This study evaluates whether the investigational therapy HDV-insulin lispro can help maintain glycemic control while potentially reducing episodes of hypoglycemia. These results offer insight into emerging options for managing insulin delivery in the type 1 diabetes population.
The OPTI-2 study is a 25-week Phase 2b trial that randomized 226 adults across 27 U.S. sites. Participants were assigned 1:1 to either the investigational HDV-insulin lispro or standard insulin lispro, with results pending formal presentation.
The players
Diasome Pharmaceuticals
A developer of novel hepatic-directed insulin therapies for diabetes management.
Dexcom
A medical device company specializing in continuous glucose monitoring technology for diabetes care.
Breakthrough T1D
A non-profit organization focused on funding and accelerating type 1 diabetes research.
The details
Participants in the study received mealtime HDV-insulin lispro or standard insulin lispro alongside once-daily insulin degludec. The trial structure included a 12-week dose-optimization period, which utilized weekly CGM-guided titration to adjust dosages, followed by a 13-week maintenance phase. Researchers monitored participant glucose levels throughout the process using Dexcom G7 continuous glucose monitoring devices.
Timeline
September 28, 2026: The EASD Annual Meeting begins in Milan, Italy.
October 2, 2026: Presentation of OPTI-2 study findings occurs at EASD.
October 9, 2026: The Breakthrough T1D Clinical & Research Congress begins.
October 10, 2026: Presentation of new EAIR analyses occurs in Philadelphia.
Health Landscape
The development of novel insulin formulations aims to refine the standard of care for type 1 diabetes by improving glucose stability. This research reflects a broader clinical trend toward enhancing the precision of insulin delivery to better mimic natural physiological processes.
As HDV-insulin lispro is an investigational therapy that is not currently approved by the FDA, it is not available for clinical use. If you have questions about how new insulin technologies might fit into your long-term management plan, it is worth discussing these developments with your endocrinologist.
The takeaway
Clinical trial data helps illustrate potential advancements in how we treat type 1 diabetes and manage hypoglycemia risks. Patients should continue to monitor their blood glucose using their existing prescribed methods and consult their healthcare team regarding any new, approved treatment options.
Further reading
For more information on the latest approaches to glucose management, visit our Diabetes section.
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