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A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes

ConditionsDiabetes Mellitus, Type 1Impaired Hypoglycemic AwarenessSevere Hypoglycemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVertex Pharmaceuticals Incorporated

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • VX-880

    Biological/Vaccine

    Infused into the hepatic portal vein.

  • VX-017

    Biological/Vaccine

    Infused into the hepatic portal vein.

Treatment groups

57 Participants
are divided into 2 treatment groups
Group A: VX-880Experimental treatment 1 intervention
Group B: VX-017Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)

Time frame
From VX-880 infusion to end of study (at least 5 years)
2

Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs)

Time frame
1 year after achieving insulin independence (following VX-880 infusion)
3

Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)

Time frame
From VX-017 infusion to end of study (at least 5 years)

Secondary outcomes

1

Parts B and C: Proportion of Participants who are Insulin Independent

Time frame
At 1 year after VX-880 infusion
2

Parts B and C: Proportion of Participants Free from SHEs with a Glycated Hemoglobin (HbA1c) less than (<) 7.0%

Time frame
SHEs: from Day 90 through 1 year (inclusive) after VX-880 infusion; HbA1c < 7% at 1 year after VX-880 infusion
3

Parts B and C: Change From Baseline in Glycated Hemoglobin (HbA1c)

Time frame
At 1 year after VX-880 infusion
4

Parts B and C: Proportion of Participants Who Maintain Insulin Independence for at least 1 year

Time frame
From VX-880 infusion to end of study (at least 5 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vertex Pharmaceuticals Incorporated

Lead sponsor

Source ClinicalTrials.gov
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