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Completed

NCT Number: NCT03163511

A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness

VC02-101 will evaluate an experimental cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes and Hypoglycemia Unawareness.

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Key information

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital Brussels, Brussels, Belgium

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About this study

The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained safely for up to two years. It will also test if VC-02 is an effective treatment for these subjects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and non-pregnant women
  • Diagnosis of T1DM for a minimum of five (5) years
  • Hypoglycemia unawareness or significant glycemic lability
  • Stable diabetic treatment
  • Willingness to use a continuous glucose meter
  • Acceptable candidate for implantation

Exclusion criteria

  • History of islet cell, kidney, and/or pancreas transplant.
  • Six (6) or more severe, unexplained hypoglycemic events within six (6) months of enrollment
  • Uncontrolled or untreated thyroid disease or adrenal insufficiency
  • Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy
  • Non-compliance with current anti-diabetic regimen
  • Detectable stimulated serum C-peptide during screening period assessment.

Treatment and study plan

VC-02 Combination Product

Combination Product

PEC-01 cells loaded into a Delivery Device

Other names: PEC-Direct

Primary outcomes

  1. Incidence of All AEs in Cohort 1 Participants

    Time frame: Enrollment (Visit 3, Day 1) through the Month 4 Visit

    Incidence of all AEs and evaluation of causality related to VC-02 combination product, the surgical procedures, and the immunosuppressive drug regimen.

  2. Change in C-peptide for Cohort 2 Subjects

    Time frame: Baseline to Week 26 Visit

    Change from baseline to Week 26 in C-peptide area under the curve from 0 to 4 hours following a mixed meal tolerance test.

Sponsors and collaborators

Lead sponsor

ViaCyte

Industry

Collaborators

  • California Institute for Regenerative Medicine (CIRM)
  • Horizon 2020 - European Commission
  • Vertex Pharmaceuticals Incorporated

Registry information

Official study title

An Open-Label, First-In-Human Study Evaluating the Safety, Tolerability, and Efficacy of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
May 23, 2017
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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