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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03163511
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : January 30, 2020
Sponsor:
Collaborator:
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
ViaCyte

Tracking Information
First Submitted Date  ICMJE May 19, 2017
First Posted Date  ICMJE May 23, 2017
Last Update Posted Date January 30, 2020
Actual Study Start Date  ICMJE July 6, 2017
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2017)
  • Incidence of all adverse events reported for Cohort 1 subjects [ Time Frame: Thru the Month 4 Visit ]
  • Change in C-peptide for Cohort 2 subjects [ Time Frame: Baseline to the Month 6 Visit ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
There are two Cohorts in this study design. Cohort 1 enrolls up to 15 subjects total. After Cohort 1 enrollment is completed, Cohort 2 enrollment then occurs with up to an additional 60 subjects.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Type 1 Diabetes Mellitus With Hypoglycemia
Intervention  ICMJE Combination Product: VC-02 Combination Product
PEC-01 cells loaded into a Delivery Device
Other Name: PEC-Direct
Study Arms  ICMJE
  • Experimental: Cohort 1
    VC-02 Combination Product; Up to six (6) VC-02-20 implants and up to two (2) VC-02-300 implants
    Intervention: Combination Product: VC-02 Combination Product
  • Experimental: Cohort 2
    VC-02 Combination Product; Up to ten units implanted of which up to six (6) are VC-02-300 implants and the rest are VC-02-20 implants.
    Intervention: Combination Product: VC-02 Combination Product
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2020)
75
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2017)
55
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03163511
Other Study ID Numbers  ICMJE VC02-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ViaCyte
Study Sponsor  ICMJE ViaCyte
Collaborators  ICMJE California Institute for Regenerative Medicine (CIRM)
Investigators  ICMJE Not Provided
PRS Account ViaCyte
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP