A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia

Type 1 Diabetes Mellitus with Impaired Hypoglycemic Awareness and Severe Hypoglycemia

Part A - Safety and tolerability based on treatment-emergent adverse events (TEAEs; including incidence and severity of adverse events [AEs] and serious adverse events [SAEs]), clinical laboratory values, vital signs, standard 12-lead ECGs, and imaging findings, Part B and C - The following endpoints apply to the analysis of all infused subjects who intended to receive 0.8 × 10E9 total SC-islet cells with 1 infusion: •Proportion of subjects who are insulin independent at Day 365 after VX-880 infusion

Part B and C: Secondary Endpoints - Proportion of subjects free of SHEs from Day 90 through Day 365 (inclusive) and HbA1c <7.0% at Day 365 after VX 880 infusion, Part B and C: Secondary Endpoints - Change from baseline in HbA1c at Day 365 after VX-880 infusion, Part B and C: Secondary Endpoints- Proportion of subjects who achieve insulin independence and are insulin independent 12 months later, with absence of SHEs, Part B and C: Secondary Endpoints- Proportion of subjects who maintain insulin independence for at least 1 year, Part B and C: afety and tolerability based on TEAEs (including incidence and severity of AEs and SAEs), clinical laboratory values, vital signs, standard 12-lead ECGs, and imaging findings

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