Neuropeptide Therapy of Recent Onset Type 1 Diabetes

Vanilloid Genetics

Status and phase: Unknown; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Substance P

Study type: Interventional

Funder types: Industry

Identifiers

NCT02820558

VanilloidGenetics-001-13

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Substance P - 1nmol/kg

Experimental group

Description:

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

Treatment:

Drug: Substance P

Substance P - 5nmol/kg

Experimental group

Description:

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

Treatment:

Drug: Substance P

Substance P - 15nmol/kg

Experimental group

Description:

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

Treatment:

Drug: Substance P

Substance P - 45nmol/kg

Experimental group

Description:

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

Treatment:

Drug: Substance P