A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
This study tests a new treatment called VX-880 that is given as an infusion to help people with type 1 diabetes, particularly those who have trouble recognizing when their blood sugar is too low (impaired awareness of hypoglycemia) or who experience severe low blood sugar episodes. The research will examine whether VX-880 is safe, well-tolerated, and effective at improving blood sugar control and reducing dangerous low blood sugar events.
Key Objective: VX-880 aims to reduce dangerous low blood sugar episodes and improve the ability to recognize when blood sugar is dropping in people with type 1 diabetes.
Who to Consider: People with type 1 diabetes who experience impaired awareness of hypoglycemia or frequent severe low blood sugar episodes despite standard treatment should consider enrolling.
Trial Parameters
Brief Summary
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
Eligibility Criteria
Key Inclusion Criteria: * Clinical history of T1D with \> 5 years of duration of insulin dependence * At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment * Stable diabetic treatment * Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study Key Exclusion Criteria: -Prior islet cell transplant, organ transplant, or cell therapy Other protocol defined Inclusion/Exclusion criteria may apply