Clinical Trials Logo
  1. Home
  2. Type 1 Diabetes Mellitus
  3. NCT03162926
  4. Details
NCT03162926 Clinical Trial

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

Type 1 Diabetes Mellitus Clinical Trial

Official title:
An Open-Label Study Evaluating the Safety and Tolerability of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03162926
Other study ID # VC02-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 5, 2017
Est. completion date February 15, 2018

Study information
Verified date October 2018
Source ViaCyte
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 maintained safely for up to four (4) months.

Recruitment information / eligibility
Status Completed
Enrollment 3
Est. completion date February 15, 2018
Est. primary completion date February 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Men and non-pregnant women of non-childbearing potential

- Diagnosis of T1DM for a minimum of five (5) years

- 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.

- Two (2) 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

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• VC-02 Combination Product (aka PEC-Direct)
PEC-01 cells loaded into a Delivery Device

Locations
Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
ViaCyte

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of all adverse events reported for subjects Thru the Month 4 Visit]
See also
  Status Clinical Trial Phase
Completed NCT04476472 - Omnipod Horizon™ Automated Glucose Control System Preschool Cohort N/A
Completed NCT03635437 - Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes Phase 1/Phase 2
Completed NCT04909580 - Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes N/A
Active, not recruiting NCT00679042 - Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol Phase 3
Completed NCT03293082 - Preschool CGM Use and Glucose Variability in Type 1 Diabetes N/A
Completed NCT04016662 - Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D) Phase 4
Completed NCT02527265 - Afrezza Safety and Pharmacokinetics Study in Pediatric Patients Phase 2
Completed NCT03738865 - G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes Phase 3
Completed NCT03240432 - Wireless Innovation for Seniors With Diabetes Mellitus N/A
Completed NCT03168867 - Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms) N/A
Completed NCT03674281 - The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System N/A
Completed NCT03669770 - Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes
Recruiting NCT03682640 - Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes Phase 2
Recruiting NCT04096794 - Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
Completed NCT02882737 - The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus N/A
Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Withdrawn NCT02518022 - How to be Safe With Alcoholic Drinks in Diabetes N/A
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Completed NCT02558491 - Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM N/A
Completed NCT02596204 - Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring N/A