Trial | NCT02820558  Report issue

Title

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)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    12
This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes.
Study Started
May 31
2016
Primary Completion
Dec 31
2022
Anticipated
Study Completion
Dec 31
2022
Anticipated
Last Update
May 21
2020

Drug Substance P

Substance P - 1nmol/kg Experimental

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

Substance P - 5nmol/kg Experimental

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

Substance P - 15nmol/kg Experimental

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

Substance P - 45nmol/kg Experimental

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

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.
No Results Posted