A Phase 1 interventional study of Substance P in Diabetes Mellitus, Type 1, sponsored by Vanilloid Genetics Inc.. Status unknown at 1 site in Canada. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-05-21.
Sponsored by Vanilloid Genetics Inc. · Phase 1, Interventional, and Treatment
This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 12 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →This is the only study on the registry with Vanilloid Genetics Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Substance P 1nmol/kg intra-celiac artery, single treatment
Drug: Substance P
Substance P 5nmol/kg intra-celiac artery, single treatment
Drug: Substance P
Substance P 15nmol/kg intra-celiac artery, single treatment
Drug: Substance P
Substance P 45nmol/kg intra-celiac artery, single treatment
Drug: Substance P
Stage A Safety: Side effects reported for entire cohort
To determine if there are unexpected adverse events with intra arterial delivery of sP into the celiac artery in individuals with Type 1 Diabetes, and evidence of residual beta cell function as reflected by a peak C---peptide levels of \> 200 pmol/L. Multiple measurements per patient will be aggregated to arrive at one reported value: Number of participants with abnormal laboratory values, adverse events and/or peak C-peptide levels \>200pmol/L that are related to treatment.
Time frame: Reported during the first 20-27 days following sP administration
C-Peptide Levels (small cohort)
To determine in an initial small cohort (n=12, toxicity and dose finding cohort) if one or more sP doses significantly increases the basal or stimulated c---Peptide levels at Day 20---27 post---injection using data from Mixed Meal Tolerance Test (MMTT).
Time frame: Day 20-27 post sP injection
C-Peptide Levels (large cohort)
To assess in a larger cohort (n=40, continued safety and efficacy) whether sP dose, determined from the dose finding cohort, significantly increases basal or stimulated C-- peptide levels at Day 20---27 post sP---injection using MMTT data.
Time frame: Day 20-27 post sP injection
sP Longevity
To determine an estimate of sP longevity in the entire cohort of patients, by monitoring HbA1c values, exogenous insulin requirement, daily recorded blood sugar levels and adverse event recording at 3 and 6 months post injection of sP. Multiple measurements per patient will be aggregated to arrive at one reported value for the aforementioned outcome measures.
Time frame: 3 and 6 months
Plan to share: Yes
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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