Type 1 Diabetes MellitusPhase 2NCT02204397
Study of Tolerability and Safety of Adding Ustekinumab to INGAP Peptide for 12 Weeks in Adult Patients With TD1 Melitis
A Phase 2 study testing INGAP Peptide, Ustekinumab in people with Type 1 Diabetes Mellitus, run by Jewish General Hospital at 1 site in Canada.
Trial summary
A proof-of-concept for safety and preliminary clinical efficacy of a combined regimen of INGAP-P for β-cell regeneration and ustekinumab for IL-12-23 autoimmune modulation in patients with established T1DM. Read more about this study
- Who is it for?
- Ages 19 to 40 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- INGAP Peptide, Ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to 8 Mar 2017
- Phase
- Phase 2
- 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 19 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients between the ages of 19 and 40 years old, inclusive, with a history of T1DM for >2 years and ≤20 years;
- Female patients will not be breast-feeding during the study or within at least seven days after the study is completed;
- Receiving multiple daily insulin injections or insulin pump therapy for >2 years;
- Body mass index (BMI) ≤32 kg/m2 and total body weight <100 kg;
- HbA1c ≤8.2%,
- Fasting C-peptide levels >0.1 ng/mL and <1.0 ng/mL;
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- CBC and platelet counts must be within normal limits, and specifically, the total absolute neutrophil count must not be <1500/μL;
- Willing to sign the study informed consent document;
- In good general health with no infections, active tuberculosis (TB), late severe complications, or concomitant medical conditions that would influence the outcome of the trial, at the discretion of the Investigator and the Sponsor;
- If treated with angiotensin-converting enzymes/angiotensin II receptor blockers (ACE/ARB), the doses should be unchanged for a month prior to enrollment;
- Females of child bearing potential must have a negative urine pregnancy test on Day 0 prior to dispensing drug and should additionally fulfill one of the following criteria:
- Willing to use oral, implantable, transdermal, or injectable contraceptives for 21 days prior to the first dose and until 28 days after the last dose; or,
- Willing to use another reliable means of contraception approved by the Investigator (intrauterine device, female condom, diaphragm with spermicide, cervical cap, use of condom by sexual partner, or a sterile sexual partner) from Screening until after the last blood sample (at Week 16).
Who cannot join
- Total daily insulin dosage exceeding 1.0 U/kg/day or a change in total daily insulin dose level of more than 50% (increase or decrease) within the past 3 months;
- Treatment with any diabetes medication other than insulin;
- A score of 4 or more restricted responses on the Clarke Hypoglycemia Awareness Survey;
- Systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively;
- Clinical worsening of retinopathy or neuropathy in the previous 3 months;
- Clinical worsening of nephropathy in the previous 3 months, or serum creatinine exceeding 2.0 mg/dL,;
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- History or presence of acute or chronic pancreatitis, including a serum amylase level >1.5 times the upper limit of normal (ULN) or a serum lipase level >2 times ULN;
- Active infections at screening and during the study;
- History of asthma;
- History of TB;
- Administration of bacille Calmette-Guérin (BCG) vaccine for TB during the one year before the Screening Visit or one year after the last dose of ustekinumab;
- A history or presence of any illness, disease, or condition (including cancer) that could impact patient safety or evaluability of drug effect, in the Investigator"s opinion;
- An episode of severe hypoglycemia (change in mental status requiring assistance) during the previous 30 days;
- An episode of acute glycemic decompensation with associated hyperosmolar non-ketotic state or diabetic ketoacidosis during the past 6 months;
- A serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin level >2 times ULN;
- Received any investigational product within 30 days of admission into this study or had any prior or existing exposure to INGAP-P, glucagon-like peptides (GLP-1, GLP-2, or analogs), ustekinumab, or TNF blocking agents (Patients that participated in the placebo group of previous INGAP-P study E-201 are not excluded from this study.);
- Known hypersensitivity to INGAP-P or any excipient used in the formulation;
- Known hypersensitivity to ustekinumab or any components of the product;
- Concurrent or planned participation in any other clinical study during the conduct of this study;
- Positive urine test for cocaine, opiates, amphetamines, or cannabinoids;
- Inability to fill out and maintain a daily diary during the screening period prior to dosing;
- Human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C seropositivity in blood sample taken during screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-Label, Exploratory Study to Assess the Tolerability and Safety of the Addition of Ustekinumab to INGAP Peptide for 12 Weeks in Adult Patients With Type 1 Diabetes Mellitus
A proof-of-concept for safety and preliminary clinical efficacy of a combined regimen of INGAP-P for β-cell regeneration and ustekinumab for IL-12-23 autoimmune modulation in patients with established T1DM.
Read the detailed description
The primary objective of this study is to assess the safety and tolerability of 12 weeks of subcutaneous (SC) daily administration of INGAP-P (600 mg SC once a day in three separate injection sites) with ustekinumab (two single injections of 45 mg SC, one as pretreatment two weeks before INGAP-P treatment begins and the second one after 2 weeks of INGAP-P treatment) in adult patients with established type 1 diabetes mellitus (T1DM). Safety will be evaluated by assessing local tolerability, recording incidence of hypoglycemia, performing safety laboratory measures at frequent intervals, and following subjects very closely for any adverse events (AEs).
Secondary objectives of this study are to generate preliminary data on the efficacy of INGAP-P and ustekinumab in adult patients with established T1DM, specifically by change from baseline to Week 12 in: 1) Maximal C-peptide (Cmax) during mixed meal test (MMT) and glucagon stimulated test (GST); 2) C-peptide release (AUC) during MMT and GST; 3) Fasting C-peptide; 4) Fasting glucose (before breakfast and after at least 8 hours of fasting); 5) Longer term glycemic control as reflected by glycosylated hemoglobin (HbA1c) and 1,5-anhydroglucitol (1,5-AG); and, 6) Total daily insulin dose relative to body weight.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- INGAP Peptide, Ustekinumab
- Keywords
- Type 1 Diabetes mellitus, INGAP, Ustekinumab
- 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.
INGAP Peptide, UstekinumabDrug
Also called INGAP Peptide, Ustekinumab (Stelara)
| Study group | Role | What they receive |
|---|---|---|
| INGAP Peptide, Ustekinumab | Experimental | INGAP Peptide, Ustekinumab subcutaneous Receives: Drug: INGAP Peptide, Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
The tolerability of injections and general safety will be assessed on the basis of patient recorded diaries, assessments of cutaneous injection sites during clinic visits, clinical observations, severity of AEs recorded by the Medical Dictionary for Regulatory Activities (MedDRA), measurement of vital signs, physical examinations, electrocardiograms (ECGs), and clinical laboratory evaluations.
Measured: 6 months
Secondary outcomes (1)
Composite C-Peptide efficacy according to specific parameters
Composite secondary objectives of this study are to generate preliminary data on the efficacy of INGAP-P and ustekinumab in adult patients with established T1DM, specifically by change from baseline to Week 12-13 in:
- Maximal C-peptide (Cmax) during mixed meal test (MMT) and glucagon stimulated test (GST);
- C-peptide release (AUC) during MMT and GST;
- Fasting C-peptide;
- Fasting glucose (before breakfast and after at least 8 hours of fasting);
- Longer term glycemic control as reflected by glycosylated hemoglobin (HbA1c)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startNov 2015
- Primary completion8 Mar 2017
- Study completion8 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Rosenberg, Jewish General Hospital
- Investigators
- George Tsoukas, MD, Principal investigator, Department of Endocrinology and Metabolism, Montreal General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204397
- Sponsor's protocol ID
- JewishGH
- Status last verified
- May 2017
- First submitted
- 28 Jul 2014
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: IPD sharing is still under review and will be determined at a later date
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-Label, Exploratory Study to Assess the Tolerability and Safety of the Addition of Ustekinumab to INGAP Peptide for 12 Weeks in Adult Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02204397
- Acronym / sponsor ID
- JewishGH
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes mellitus, INGAP, Ustekinumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 8 Mar 2017 (actual)
- First posted
- 30 Jul 2014 (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.
A proof-of-concept for safety and preliminary clinical efficacy of a combined regimen of INGAP-P for β-cell regeneration and ustekinumab for IL-12-23 autoimmune modulation in patients with established T1DM.
Detailed description
The primary objective of this study is to assess the safety and tolerability of 12 weeks of subcutaneous (SC) daily administration of INGAP-P (600 mg SC once a day in three separate injection sites) with ustekinumab (two single injections of 45 mg SC, one as pretreatment two weeks before INGAP-P treatment begins and the second one after 2 weeks of INGAP-P treatment) in adult patients with established type 1 diabetes mellitus (T1DM). Safety will be evaluated by assessing local tolerability, recording incidence of hypoglycemia, performing safety laboratory measures at frequent intervals, and following subjects very closely for any adverse events (AEs).
Secondary objectives of this study are to generate preliminary data on the efficacy of INGAP-P and ustekinumab in adult patients with established T1DM, specifically by change from baseline to Week 12 in: 1) Maximal C-peptide (Cmax) during mixed meal test (MMT) and glucagon stimulated test (GST); 2) C-peptide release (AUC) during MMT and GST; 3) Fasting C-peptide; 4) Fasting glucose (before breakfast and after at least 8 hours of fasting); 5) Longer term glycemic control as reflected by glycosylated hemoglobin (HbA1c) and 1,5-anhydroglucitol (1,5-AG); and, 6) Total daily insulin dose relative to body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INGAP Peptide, Ustekinumab | Experimental | Drug: INGAP Peptide, UstekinumabINGAP Peptide, Ustekinumab subcutaneous |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male and female patients between the ages of 19 and 40 years old, inclusive, with a history of T1DM for >2 years and ≤20 years;
- Female patients will not be breast-feeding during the study or within at least seven days after the study is completed;
- Receiving multiple daily insulin injections or insulin pump therapy for >2 years;
- Body mass index (BMI) ≤32 kg/m2 and total body weight <100 kg;
- HbA1c ≤8.2%,
Key exclusion criteria (22 listed)
- Total daily insulin dosage exceeding 1.0 U/kg/day or a change in total daily insulin dose level of more than 50% (increase or decrease) within the past 3 months;
- Treatment with any diabetes medication other than insulin;
- A score of 4 or more restricted responses on the Clarke Hypoglycemia Awareness Survey;
- Systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively;
- Clinical worsening of retinopathy or neuropathy in the previous 3 months;
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 |
|---|---|---|
| INGAP Peptide, UstekinumabAlso: INGAP Peptide, Ustekinumab (Stelara) | Drug | INGAP Peptide, Ustekinumab |
Primary outcome
Safety and tolerability
Time frame: 6 months
The tolerability of injections and general safety will be assessed on the basis of patient recorded diaries, assessments of cutaneous injection sites during clinic visits, clinical observations, severity of AEs recorded by the Medical Dictionary for Regulatory Activities (MedDRA), measurement of vital signs, physical examinations, electrocardiograms (ECGs), and clinical laboratory evaluations.
1 secondary outcome
Composite C-Peptide efficacy according to specific parameters
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Individual participant dataSharing planned: Undecided. IPD sharing is still under review and will be determined at a later date
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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.
George Tsoukas, MD principal investigator
Department of Endocrinology and Metabolism, Montreal General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INGAP Peptide, Ustekinumab in people with Type 1 Diabetes Mellitus, run by Jewish General Hospital 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 13 inclusion and 22 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: finished, as of the sponsor's last update on 30 May 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 6 months). 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 30 May 2017.