Diabetes Mellitus, Type 1
Conditions
Keywords
Neuropeptide, Therapy, Onset
Brief summary
This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes.
Interventions
DRUGSubstance P
Sponsors
Vanilloid Genetics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Recent onset T1D (CDA 2013 guidelines: See link in links section * Age 10-18 years * Disease Duration 3-30 months * Fasting C-Peptide (measured at screening) greater than or equal to 33 pmol/L * Post honeymoon phase based on the following criteria: History of HbA1c values and insulin requirements from diagnosis indicating a honeymoon period followed by increased insulin requirements which at time of recruitment are \> 0.50 units/Kg together with an HbA1c value \> 7.2 %; Patients with diabetes duration \> 3 months who never experienced a honeymoon period as reflected by consistent HbA1c values \> 7.2 % from the time of diagnosis and at the time of recruitment are using an insulin dose \> 0.50 units/Kg. * The presence of one or more of the TRPV1 alleles similar to those found in patients currently enrolled in the TRPV1-North American - European Study. * Stimulated C-Peptide (measured at mixed meal tolerance at Stage A and Stage B of sP trial) ≥ 200 pmol/L and less than or equal to 1500 pmol/L.
Exclusion criteria
* Patients with known co-morbidities, including ACE-inhibitor treated hypertension as well as chromosomal abnormalities, involving one or more organ systems. * Type 2 Diabetes Mellitus * Patients with a known radiographic contrast allergy * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage A Safety: Side effects reported for entire cohort | Reported during the first 20-27 days following sP administration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-Peptide Levels (small cohort) | Day 20-27 post sP injection | 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). |
| C-Peptide Levels (large cohort) | Day 20-27 post sP injection | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| sP Longevity | 3 and 6 months | 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. |
Countries
Canada
Contacts
Primary ContactHolly Tschirhart
Backup ContactCatherine Pastor
Outcome results
None listed