Neuropeptide Therapy of Recent Onset Type 1 Diabetes

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

Sponsors

Lead Sponsor: Vanilloid Genetics Inc.

Source 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.

Overall Status Recruiting
Start Date May 2016
Completion Date December 2022
Primary Completion Date December 2022
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Stage A Safety: Side effects reported for entire cohort Reported during the first 20-27 days following sP administration
Secondary Outcome
Measure Time Frame
C-Peptide Levels (small cohort) Day 20-27 post sP injection
C-Peptide Levels (large cohort) Day 20-27 post sP injection
Enrollment 12
Condition
Intervention

Intervention Type: Drug

Intervention Name: Substance P

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 10 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Etienne Sochett, MD Principal Investigator Hospital for Sick Children, Toronto Ontario
Overall Contact

Last Name: Holly Tschirhart

Phone: 416-813-7654

Phone Ext.: 204517

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Hospital for Sick Children Holly Tschirhart 416-813-7654 204517 [email protected]
Location Countries

Canada

Verification Date

May 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Substance P - 1nmol/kg

Type: Experimental

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

Label: Substance P - 5nmol/kg

Type: Experimental

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

Label: Substance P - 15nmol/kg

Type: Experimental

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

Label: Substance P - 45nmol/kg

Type: Experimental

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

Patient Data Yes
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov