A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes
T1GER
SIMPONI® to Arrest β-cell Loss in Type 1 Diabetes
3 other identifiers
interventional
84
1 country
33
Brief Summary
The primary purpose of this study is to determine if golimumab can preserve beta-cell function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2016
Typical duration for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 27, 2016
CompletedStudy Start
First participant enrolled
August 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2021
CompletedResults Posted
Study results publicly available
July 14, 2022
CompletedFebruary 4, 2025
January 1, 2025
2.7 years
July 22, 2016
May 18, 2022
January 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) at Week 52
MMTT-Stimulated 4-Hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 4-hour period divided by the duration after a mixed-meal tolerance test.
Week 52
Secondary Outcomes (11)
Active Treatment Period: Change From Baseline in Insulin Use in Units Per Kilogram Body Weight Per Day
Baseline and Week 52
Active Treatment Period: Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 52
Baseline and Week 52
Hypoglycemic Event Rates
Up to Week 52
Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time
Baseline, Weeks 12, 26, 38, 52, 78 and 104
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)
- +6 more secondary outcomes
Study Arms (2)
Group 1: Golimumab
EXPERIMENTALParticipants will receive subcutaneous (SC) golimumab intermittently for 52 weeks in double-blind period, where doses will be based on weight and/or body surface area. Participants meeting response criteria at Week 52, may enter in an open-label (OL) extension period to receive golimumab SC for 50 weeks (doses will be based on weight and/or body surface area).
Group 2: Placebo
PLACEBO COMPARATORParticipants will receive a matching placebo to golimumab.
Interventions
Participants will receive subcutaneous golimumab intermittently for 52 weeks in double-blind period, where doses will be based on weight and/or body surface area. Participants meeting response criteria at Week 52, may receive golimumab SC for 50 weeks (doses will be based on weight and/or body surface area) in an OL extension period.
Eligibility Criteria
You may qualify if:
- Double-blind Period:
- Be positive for at least 1 of the following diabetes-related autoantibodies obtained at study screening: Glutamic acid decarboxylase (GAD-65), islet antigen 2 (IA-2), zinc transporter 8 (ZnT8), Islet Cell Cytoplasmic Autoantibodies (ICA), or Insulin (if obtained within 10 days of the onset of exogenous insulin therapy)
- Have a peak stimulated C-peptide level greater than or equal to (\>=) 0.2 picomole per milliliter (pmol/mL) following a 4-hour Mixed-meal Tolerance Test (MMTT) obtained at study screening
- Be medically stable on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population
- Females of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) test at screening and a negative urine pregnancy test at the Week 0 visit
- Participants (or their legally acceptable representatives) are willing and able to adhere to requirements, prohibitions, and restrictions specified in this protocol
- Open-Label Extension Period:
- \- Participants must meet the responder criteria based on C-peptide area under the concentration-time curve (AUC) and insulin dose-adjusted HbA1c (IDAAC) remission score
You may not qualify if:
- Double-blind Period:
- Has a history of significant renal, vascular, pulmonary, gastrointestinal, neurologic, hematologic, rheumatologic, or psychiatric disease or immune suppression or immune deficiency.
- Has significant cardiovascular disease, including history of myocardial infarction, congestive heart failure, angina, abnormal electrocardiogram or abnormal stress test
- Has active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, chronic renal infection, chronic chest infection (example \[eg.\], bronchiectasis), sinusitis, recurrent urinary tract infection (eg., recurrent pyelonephritis, chronic cystitis), Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing skin wound or ulcer
- Has a clinically active infection with Epstein-Barr virus (EBV) or an EBV viral load \>=10,000 copies per milliliter (mL) of plasma obtained at study screening. Has a clinically active infection with cytomegalovirus (CMV) or a CMV viral load \>= 10,000 copies per milliliter (mL) of plasma obtained at study screening
- Current or prior (within 30 days of screening) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including high-dose inhaled, extensive topical, or systemic glucocorticoids
- Has another autoimmune disease (eg, rheumatoid arthritis \[RA\], polyarticular juvenile idiopathic arthritis \[pJIA\], psoriatic arthritis \[PsA\], ankylosing spondylitis \[AS\], multiple sclerosis \[MS\], systemic lupus erythematosus \[SLE\], celiac disease \[clinically symptomatic and antibody positive, that is, tissue transglutaminase Immunoglobulin A \[IgA\]) excluding clinically stable autoimmune thyroiditis whether treated or untreated
- Has any of the following tuberculosis \[TB\] screening criteria: A history of latent or active TB prior to screening (including but not limited to a positive QuantiFERON®-TB Gold test), signs or symptoms suggestive of active TB upon medical history and/or physical examination, recent close contact with a person with known or suspected active TB
- Has known allergies, intolerance and/or hypersensitivity to human immunoglobulin proteins, golimumab or any of its components or its excipients
- Open-Label Extension Period:
- Participants having reported clinically significant AEs or serious adverse events (SAEs) deemed to be related to the study agent during the double blind period (for example. severe infections or hypersensitivity reactions), precluding renewed exposure to golimumab
- Participants who discontinued study agent administration prior to Week 52 or who have completed the Week 104 visit of the double-blind period or discontinued early from study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Newport Beach, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Doral, Florida, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Columbus, Georgia, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Baton Rouge, Louisiana, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Morristown, New Jersey, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
The Bronx, New York, United States
Unknown Facility
Mentor, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Sioux Falls, South Dakota, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Schertz, Texas, United States
Unknown Facility
Webster, Texas, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Tacoma, Washington, United States
Related Publications (1)
Quattrin T, Haller MJ, Steck AK, Felner EI, Li Y, Xia Y, Leu JH, Zoka R, Hedrick JA, Rigby MR, Vercruysse F; T1GER Study Investigators. Golimumab and Beta-Cell Function in Youth with New-Onset Type 1 Diabetes. N Engl J Med. 2020 Nov 19;383(21):2007-2017. doi: 10.1056/NEJMoa2006136.
PMID: 33207093DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clinical Development
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2016
First Posted
July 27, 2016
Study Start
August 26, 2016
Primary Completion
May 21, 2019
Study Completion
January 5, 2021
Last Updated
February 4, 2025
Results First Posted
July 14, 2022
Record last verified: 2025-01