A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Adults With Type 1 Diabetes and Impaired Hypoglycemic Awareness

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of VX-880 infusion in people with Type 1 diabetes (T1D) who have impaired awareness of hypoglycemia (IAH) and experience severe hypoglycemia. This study is a Phase 3 clinical trial sponsored by Vertex Pharmaceuticals Incorporated, focusing on participants with a history of T1D and severe low blood sugar episodes. The study involves infusing VX-880, a biological treatment, directly into the hepatic portal vein. There are multiple parts to the study, with primary outcomes including monitoring adverse events up to 5 years and assessing the proportion of participants who become insulin independent without severe hypoglycemic events one year after treatment. Secondary outcomes include changes in blood sugar control measured by HbA1c and long-term maintenance of insulin independence. Participants will be followed from the time they receive the VX-880 infusion and throughout the study period, which can last up to 5 years. Researchers will track safety through adverse event reports, use continuous glucose monitoring throughout the study, and assess outcomes like insulin independence, absence of severe hypoglycemia, and blood sugar control with HbA1c. The study includes careful monitoring and follow-up visits to evaluate these measures over time.

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes