Diabetes Mellitus, Type 1Phase 1NCT02820558
Neuropeptide Therapy of Recent Onset Type 1 Diabetes
A Phase 1 study testing Substance P in people with Diabetes Mellitus, Type 1, run by Vanilloid Genetics Inc. at 1 site in Canada.
Trial summary
This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Substance P
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Catherine Pastor contact
Canada1 site, 1 recruiting
- Recruiting
Hospital for Sick Children
Toronto, Ontario
Holly Tschirhart, 416-813-7654 ext. 204517, holly.tschirhart@sickkids.ca
Catherine Pastor, 416-813-7654 ext. 204396, catherine.pastor@sickkids.ca
About this study
Official title: A Phase I Study of Safety and Pharmacological Activity of Substance P (sP) in the Reversal of Recent-Onset Type 1 Diabetes (T1D)
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
- Being tested
- Substance P
- Keywords
- Neuropeptide, Therapy, Onset
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Substance PDrug
| Study group | Role | What they receive |
|---|---|---|
| Substance P - 1nmol/kg | Experimental | Substance P 1nmol/kg intra-celiac artery, single treatment Receives: Drug: Substance P |
| Substance P - 5nmol/kg | Experimental | Substance P 5nmol/kg intra-celiac artery, single treatment Receives: Drug: Substance P |
| Substance P - 15nmol/kg | Experimental | Substance P 15nmol/kg intra-celiac artery, single treatment Receives: Drug: Substance P |
| Substance P - 45nmol/kg | Experimental | Substance P 45nmol/kg intra-celiac artery, single treatment Receives: Drug: Substance P |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Reported during the first 20-27 days following sP administration
Secondary outcomes (2)
C-Peptide Levels (small cohort)
To determine in an initial small cohort (n=12, toxicity and dose finding cohort) if one or more sP doses significantly increases the basal or stimulated c---Peptide levels at Day 20---27 post---injection using data from Mixed Meal Tolerance Test (MMTT).
Measured: Day 20-27 post sP injection
C-Peptide Levels (large cohort)
To assess in a larger cohort (n=40, continued safety and efficacy) whether sP dose, determined from the dose finding cohort, significantly increases basal or stimulated C-- peptide levels at Day 20---27 post sP---injection using MMTT data.
Measured: Day 20-27 post sP injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanilloid Genetics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Etienne Sochett, MD, Principal investigator, Hospital for Sick Children, Toronto Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820558
- Sponsor's protocol ID
- VanilloidGenetics-001-13
- Status last verified
- May 2020
- First submitted
- 19 May 2016
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Safety and Pharmacological Activity of Substance P (sP) in the Reversal of Recent-Onset Type 1 Diabetes (T1D)
- ClinicalTrials.gov ID
- NCT02820558
- Acronym / sponsor ID
- VanilloidGenetics-001-13
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Neuropeptide, Therapy, Onset
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Vanilloid Genetics Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Substance P - 1nmol/kg | Experimental | Drug: Substance PSubstance P 1nmol/kg intra-celiac artery, single treatment |
| Substance P - 5nmol/kg | Experimental | Drug: Substance PSubstance P 5nmol/kg intra-celiac artery, single treatment |
| Substance P - 15nmol/kg | Experimental | Drug: Substance PSubstance P 15nmol/kg intra-celiac artery, single treatment |
| Substance P - 45nmol/kg | Experimental | Drug: Substance PSubstance P 45nmol/kg intra-celiac artery, single treatment |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Substance P | Drug | Substance P - 15nmol/kg, Substance P - 1nmol/kg, Substance P - 45nmol/kg, Substance P - 5nmol/kg |
Primary outcome
Stage A Safety: Side effects reported for entire cohort
Time frame: Reported during the first 20-27 days following sP administration
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.
2 secondary outcomes
C-Peptide Levels (small cohort)
Time frame: Day 20-27 post sP injection
C-Peptide Levels (large cohort)
Time frame: Day 20-27 post sP injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- CDA 2013 guidelinesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Pastor contact
Etienne Sochett, MD principal investigator
Hospital for Sick Children, Toronto Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Substance P in people with Diabetes Mellitus, Type 1, run by Vanilloid Genetics Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Holly Tschirhart (416-813-7654 ext. 204517, holly.tschirhart@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage A Safety: Side effects reported for entire cohort (time frame: Reported during the first 20-27 days following sP administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.