Study of Tolerability and Safety of Adding Ustekinumab to INGAP Peptide for 12 Weeks in Adult Patients With TD1 Melitis

NCT02204397 | Completed Phase 2

• 1 other identifier: JewishGH
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes mellitus; INGAP; Ustekinumab

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Composite C-Peptide efficacy according to specific parameters

  6 months

Study Arms (1)

INGAP Peptide, Ustekinumab

EXPERIMENTAL

INGAP Peptide, Ustekinumab subcutaneous

Drug: INGAP Peptide, Ustekinumab

Interventions

INGAP Peptide, Ustekinumab DRUG

Also known as: INGAP Peptide, Ustekinumab (Stelara)

INGAP Peptide, Ustekinumab

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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).

You may not qualify if:

• 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,;
• 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;

Sponsors & Collaborators

• Jewish General Hospital: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

INGAP peptide; Ustekinumab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• George Tsoukas, MD

  Department of Endocrinology and Metabolism, Montreal General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: November 1, 2015
• Primary Completion: March 8, 2017
• Study Completion: March 8, 2017
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

CA (1)