Neuropeptide Therapy of Recent Onset Type 1 Diabetes

Phase 1

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Substance P

• Registration Number: NCT02820558
• Lead Sponsor: Vanilloid Genetics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-07-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Substance P - 1nmol/kg	Substance P	Substance P 1nmol/kg intra-celiac artery, single treatment
Substance P - 5nmol/kg	Substance P	Substance P 5nmol/kg intra-celiac artery, single treatment
Substance P - 15nmol/kg	Substance P	Substance P 15nmol/kg intra-celiac artery, single treatment
Substance P - 45nmol/kg	Substance P	Substance P 45nmol/kg intra-celiac artery, single treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).

Trial Locations

Locations (1)

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada