A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus

Phase 1

Terminated

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Combination Product: VC-01™ Combination Product

• Registration Number: NCT02239354
• Lead Sponsor: ViaCyte

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-12
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Disposition First Submitted: 2021-11-18
• Disposition First Submitted QC: 2021-11-29
• Disposition First Posted: 2021-12-06
• Results First Submitted: 2022-01-31
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-25
• Last Update Submitted: 2022-02-25
• Results First Posted: 2022-03-24
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• 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

Exclusion Criteria

• Advanced complications associated with diabetes
• Immunosuppressive therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	VC-01™ Combination Product	2 VC-01™ Combination Product implants
Cohort 2	VC-01™ Combination Product	4 or 6 VC-01™ Combination Product implants

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events Reported During the Study.	Thru the Month 24 Visit
Change in C-peptide	Baseline to the Month 6 Visit	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.

Trial Locations

Locations (2)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

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