Recruiting
Phase 1

Neuropeptide Therapy

Sponsor:

Vanilloid Genetics Inc.

Code:

NCT02820558

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

Substance P

Study Details

Brief summary:

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

Conditions

Diabetes Mellitus, Type 1

Study ID

NCT02820558

Start date

May, 2016

Status verified date

May, 2020

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

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

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Substance P - 1nmol/kg

Substance P 1nmol/kg intra-celiac artery, single treatment

experimental: Substance P - 5nmol/kg

Substance P 5nmol/kg intra-celiac artery, single treatment

experimental: Substance P - 15nmol/kg

Substance P 15nmol/kg intra-celiac artery, single treatment

experimental: Substance P - 45nmol/kg

Substance P 45nmol/kg intra-celiac artery, single treatment

Interventions

Substance P

Primary outcome measure

  • Stage A Safety: Side effects reported for entire cohort [ Time Frame: Reported during the first 20-27 days following sP administration ]

Central Contacts and Locations

Central contacts

Holly Tschirhart

416-813-7654holly.tschirhart@sickkids.ca

Catherine Pastor

416-813-7654

Locations

Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada

Contacts

Holly Tschirhart

416-813-7654holly.tschirhart@sickkids.ca

Catherine Pastor

416-813-7654catherine.pastor@sickkids.ca

More Information

Sponsor

Vanilloid Genetics Inc.

Last update posted

May 21, 2020

Last verified

May, 2020

Keywords

  • Neuropeptide
  • Therapy
  • Onset

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanilloid Genetics Inc. on 2020-05-21.