A Phase 1/2 interventional study of VC-01™ Combination Product in Type 1 Diabetes Mellitus, sponsored by ViaCyte. Terminated at 2 sites in 2 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-03-24.
Sponsored by ViaCyte (part of Vertex Pharmaceuticals Incorporated) · Phase 1/2, Interventional, and Other
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 19 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →ViaCyte is the lead sponsor of 5 studies on the registry; none are open to participants now.
First submitted before ViaCyte became part of Vertex Pharmaceuticals Incorporated.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
2 VC-01™ Combination Product implants
Combination Product: VC-01™ Combination Product
4 or 6 VC-01™ Combination Product implants
Combination Product: VC-01™ Combination Product
Biologic and Device
Number of Adverse Events Reported During the Study.
Time frame: 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.
Time frame: Baseline to the Month 6 Visit
| Milestone | Cohort 1 | Cohort 2 |
|---|---|---|
| Started | 19 | 0 |
| Completed | 9 | 0 |
| Not completed | 10 | 0 |
| events | Cohort 1 |
|---|---|
| Number of Adverse Events Reported During the Study. | 114 |
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.
No measurements were reported for this outcome.
Collected over AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 0/19 (0%) | 2/19 (10.5%) | 18/19 (94.7%) |
| Cohort 2 | — | — | — |
| Event | Cohort 1 | Cohort 2 |
|---|---|---|
| CellulitisInfections and infestations | 1/19 | — |
| Right middle lobe pneumoniaInfections and infestations | 1/19 | — |
| Event | Cohort 1 | Cohort 2 |
|---|---|---|
| Procedural painInjury, poisoning and procedural complications | 14/19 | — |
| Device dislocationGeneral disorders | 7/19 | — |
| Device breakageGeneral disorders | 5/19 | — |
| Implant site extravasationGeneral disorders | 5/19 | — |
| NauseaGastrointestinal disorders | 3/19 | — |
| ContusionInjury, poisoning and procedural complications | 2/19 | — |
| Incision site haematomaInjury, poisoning and procedural complications | 2/19 | — |
| Post procedural haematomaInjury, poisoning and procedural complications | 2/19 | — |
| Implant site haemorrhageGeneral disorders | 2/19 | — |
| Implant site hypoaesthesiaGeneral disorders | 2/19 | — |
Cohort 2 enrollment was never initiated and is therefore 'zero'.
| Age, Continuous(years) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Median | 29.0 ± 11.92 | — | 29.0 ± 11.92 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Female | 1 | — | 1 |
| Male | 18 | — | 18 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | — | 1 |
| Not Hispanic or Latino | 18 | — | 18 |
| Unknown or Not Reported | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 |
| Black or African American | 0 | — | 0 |
| White | 19 | — | 19 |
| More than one race | 0 | — | 0 |
| Unknown or Not Reported | 0 | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Ran from Sep 2014 to primary completion in Dec 2017, 39 months.
Results were first posted in Mar 2022, 4 years 3 months after primary completion. A results delay was requested in Nov 2021.
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This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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