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

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus With Hypoglycemia
• Interventions: Combination Product: VC-02 Combination Product

• Registration Number: NCT03163511
• Lead Sponsor: ViaCyte

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-23
• Study Start: 2017-07-06
• Primary Completion: 2023-10-13
• Study Completion: 2023-10-19
• Results First Submitted: 2024-10-12
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-07
• Last Update Submitted: 2024-11-07
• Results First Posted: 2024-12-03
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 2	VC-02 Combination Product	VC-02 Combination Product; Up to twelve units implanted of which up to ten (10) are VC-02-300 implants and the rest are VC-02-20 implants.
Cohort 1	VC-02 Combination Product	VC-02 Combination Product; Up to six (6) VC-02-20 implants and up to two (2) VC-02-300 implants

Primary Outcome Measures

Name	Time	Method
Incidence of All AEs in Cohort 1 Participants	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.
Change in C-peptide for Cohort 2 Subjects	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.

Trial Locations

Locations (10)

University Hospital Brussels; 🇧🇪 Brussel, Belgium

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

UC Davis - Alpha Stem Cell Clinic; 🇺🇸 Sacramento, California, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

UCLA-UCI Alpha Stem Cell Clinic; 🇺🇸 Irvine, California, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States