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)
Lead SponsorVanilloid Genetics Inc.
Indication/ConditionDiabetes Mellitus, Type 1
Intervention/Treatmentsubstance p ...
This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes.
Substance P 1nmol/kg intra-celiac artery, single treatment
Substance P 5nmol/kg intra-celiac artery, single treatment
Substance P 15nmol/kg intra-celiac artery, single treatment
Substance P 45nmol/kg intra-celiac artery, single treatment
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.