A Master Protocol to Evaluate the Safety, Tolerability, and Efficacy of Islet Cell Replacement Therapies in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia: A Phase 1/2/3 Study of VX-880 and a Phase 1/2 Study of VX-017

Trial ID: NCT04786262

Interventional - Phase 3 - Recruiting

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

Conditions

• Diabetes Mellitus, Type 1
• Impaired Hypoglycemic Awareness
• Severe Hypoglycemia

Interventions

• VX-880
• VX-017

Eligibility

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

Sponsor

Vertex Pharmaceuticals Incorporated

Source: ClinicalTrials.gov

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