Neuropeptide Therapy of Recent Onset Type 1 Diabetes

NCT02820558 | Unknown Phase 1 DMC

• 1 other identifier: VanilloidGenetics-001-13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Neuropeptide; Therapy; Onset

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• C-Peptide Levels (small cohort)

  Day 20-27 post sP injection

• C-Peptide Levels (large cohort)

  Day 20-27 post sP injection

Other Outcomes (1)

• sP Longevity

  3 and 6 months

Study Arms (4)

Substance P - 1nmol/kg

EXPERIMENTAL

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

Drug: Substance P

Substance P - 5nmol/kg

EXPERIMENTAL

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

Drug: Substance P

Substance P - 15nmol/kg

EXPERIMENTAL

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

Drug: Substance P

Substance P - 45nmol/kg

EXPERIMENTAL

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

Drug: Substance P

Interventions

Substance P DRUG

Substance P - 15nmol/kg; Substance P - 1nmol/kg; Substance P - 45nmol/kg; Substance P - 5nmol/kg

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanilloid Genetics Inc.: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

Related Links

• CDA 2013 guidelines

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Substance P

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tachykinins; Kinins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Neuropeptides; Oligopeptides; Proteins; Nerve Tissue Proteins; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Etienne Sochett, MD

  Hospital for Sick Children, Toronto Ontario

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Tschirhart

CONTACT

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

Catherine Pastor

CONTACT

416-813-7654

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: July 1, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)