NCT02239354

Brief Summary

The purpose of this trial is to test if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2014

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

March 24, 2022

Completed
Last Updated

March 24, 2022

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

September 9, 2014

Results QC Date

January 31, 2022

Last Update Submit

February 25, 2022

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Number of Adverse Events Reported During the Study.

    Thru the Month 24 Visit

  • Change in C-peptide

    The Full Analysis Set (FAS) is the intent-to-treat (ITT) set of subjects. This set is defined as all T1DM subjects who were enrolled into the study and received implantation of at least one VC-01-250 or sentinel unit on Study Day 1. The FAS (Cohort 2 T1DM subjects who meet the FAS criteria) will be used to analyze the primary efficacy endpoint.

    Baseline to the Month 6 Visit

Study Arms (2)

Cohort 1

EXPERIMENTAL

2 VC-01™ Combination Product implants

Combination Product: VC-01™ Combination Product

Cohort 2

EXPERIMENTAL

4 or 6 VC-01™ Combination Product implants

Combination Product: VC-01™ Combination Product

Interventions

VC-01™ Combination ProductCOMBINATION_PRODUCT

Biologic and Device

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women (non-pregnant and non-childbearing potential)
  • Diagnosis of type 1 diabetes mellitus for at least 3 years
  • Stable diabetic treatment
  • Willingness to use a continuous glucose meter
  • Acceptable candidate for implantation

You may not qualify if:

  • Advanced complications associated with diabetes
  • Immunosuppressive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California at San Diego

San Diego, California, United States

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (3)

  • Satin LS, Soleimanpour SA, Walker EM. New Aspects of Diabetes Research and Therapeutic Development. Pharmacol Rev. 2021 Jul;73(3):1001-1015. doi: 10.1124/pharmrev.120.000160.

    PMID: 34193595DERIVED

  • Saber N, Bruin JE, O'Dwyer S, Schuster H, Rezania A, Kieffer TJ. Sex Differences in Maturation of Human Embryonic Stem Cell-Derived beta Cells in Mice. Endocrinology. 2018 Apr 1;159(4):1827-1841. doi: 10.1210/en.2018-00048.

    PMID: 29420708DERIVED

  • Pase C, Mathias AD, Garcia CD, Garcia Rodrigues C. Using Social Media for the Promotion of Education and Consultation in Adolescents Who Have Undergone Kidney Transplant: Protocol for a Randomized Control Trial. JMIR Res Protoc. 2018 Jan 9;7(1):e3. doi: 10.2196/resprot.8065.

    PMID: 29317381DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

Study did not proceed to Cohort 2 to evaluate efficacy.

Results Point of Contact

Title
Corporate Communications
Organization
ViaCyte
info@viacyte.com
858-207-0500

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 12, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 24, 2022

Results First Posted

March 24, 2022

Record last verified: 2022-02

Locations

US(1)CA(1)