Neuropeptide Therapy of Recent Onset Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Phase I Study of Safety and Pharmacological Activity of Substance P (sP) in the Reversal of Recent-Onset Type 1 Diabetes (T1D)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02820558
• Other study ID #: VanilloidGenetics-001-13
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2016
• Est. completion date: December 2022

Study information

• Verified date: May 2020
• Source: Vanilloid Genetics Inc.
• Contact: Holly Tschirhart
• Phone: 416-813-7654
• Email: holly.tschirhart[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Substance P

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Vanilloid Genetics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	3 and 6 months
Primary	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.	Reported during the first 20-27 days following sP administration
Secondary	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).	Day 20-27 post sP injection
Secondary	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.	Day 20-27 post sP injection

External Links

•   CDA 2013 guidelines