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A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes (T1GER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02846545
Recruitment Status : Completed
First Posted : July 27, 2016
Results First Posted : July 14, 2022
Last Update Posted : July 14, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Biological: Golimumab Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: SIMPONI® to Arrest β-cell Loss in Type 1 Diabetes
Actual Study Start Date : August 26, 2016
Actual Primary Completion Date : May 21, 2019
Actual Study Completion Date : January 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Golimumab

Arm Intervention/treatment
Experimental: Group 1: Golimumab
Participants 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).
Biological: Golimumab
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.
Other Name: SIMPONI

Placebo Comparator: Group 2: Placebo
Participants will receive a matching placebo to golimumab.
Biological: Placebo
Matching Placebo to golimumab.




Primary Outcome Measures :
  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 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Active Treatment Period: Change From Baseline in Insulin Use in Units Per Kilogram Body Weight Per Day [ Time Frame: Baseline and Week 52 ]
    Change from baseline in daily insulin use at Week 52 was reported.

  2. Active Treatment Period: Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 52 [ Time Frame: Baseline and Week 52 ]
    Change from baseline in glycosylated HbA1c at Week 52 was reported.

  3. Hypoglycemic Event Rates [ Time Frame: Up to Week 52 ]
    A hypoglycemic event was defined as either a biochemically confirmed hypoglycemic episode or a severe hypoglycemic event. The hypoglycemia event rate (number of hypoglycemia episodes per patient-year) was defined as blood glucose levels of less than and equal to (<=) 70, 55, and 35 mg/dL or clinical sequelae consistent with severe hypoglycemia in the absence of a BG reading.

  4. Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time [ Time Frame: Baseline, Weeks 12, 26, 38, 52, 78 and 104 ]
    MMTT-Stimulated 4-Hour C-peptide AUC is 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.

  5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability [ Time Frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period) ]
    An adverse event (AE) was defined as any untoward medical occurrence in clinical study subject administered medicinal product. It could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Treatment emergent AEs were defined as AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline.

  6. Percentage of Participants With Serious Adverse Events [ Time Frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period) ]
    An AE was defined as any untoward medical occurrence in clinical study participant administered medicinal product. It could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. A serious AE was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious treatment via medicinal product and was medically important.

  7. Percentage of Participants With Severe Infections Through Week 52 and Week 104 [ Time Frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period) ]
    Participants having 1 or more severe infections were evaluated and reported.

  8. Active Treatment Period: Percentage of Participants With Study Agent Injection Site Reactions Up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with study agent injection site reactions up to Week 52 were reported.

  9. Serum Golimumab Concentrations [ Time Frame: Preinjection: Week 0, Week 2, Week 4, Week 8, Week 12, and Week 26, Week 33, Week 38 (preinjection),Week 45 and Week 52 (preinjection), for active treatment period; Weeks 78 and 104 for Off-therapy follow-up period ]
    Serum samples were collected for the measurement of golimumab concentrations.

  10. Number of Participants With Antibodies to Golimumab [ Time Frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period) ]
    Number of participants with antibodies to golimumab were reported.

  11. Titers of Antibodies to Golimumab [ Time Frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period) ]
    Titers of antibodies to golimumab were evaluated.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846545


Locations
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United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Newport Beach, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
Walnut Creek, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Florida
Doral, Florida, United States
Gainesville, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Columbus, Georgia, United States
United States, Idaho
Boise, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kentucky
Lexington, Kentucky, United States
Louisville, Kentucky, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
United States, New Jersey
Morristown, New Jersey, United States
United States, New York
Bronx, New York, United States
Buffalo, New York, United States
United States, Ohio
Mentor, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
United States, Texas
Dallas, Texas, United States
San Antonio, Texas, United States
Schertz, Texas, United States
Webster, Texas, United States
United States, Washington
Seattle, Washington, United States
Tacoma, Washington, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:
Study Protocol  [PDF] August 23, 2019
Statistical Analysis Plan  [PDF] June 25, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02846545    
Other Study ID Numbers: CR108187
CNTO148DML2001 ( Other Identifier: Janssen Research & Development, LLC )
2021-000189-13 ( EudraCT Number )
First Posted: July 27, 2016    Key Record Dates
Results First Posted: July 14, 2022
Last Update Posted: July 14, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Golimumab
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs