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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
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.
Matching Placebo to golimumab.
Unnamed facility
Little Rock, Arkansas, United States
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.
Time frame: Week 52
Active Treatment Period: Change From Baseline in Insulin Use in Units Per Kilogram Body Weight Per Day
Change from baseline in daily insulin use at Week 52 was reported.
Time frame: Baseline and Week 52
Active Treatment Period: Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 52
Change from baseline in glycosylated HbA1c at Week 52 was reported.
Time frame: Baseline and Week 52
Hypoglycemic Event Rates
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.
Time frame: 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
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.
Time frame: 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
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Unnamed facility
Newport Beach, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Walnut Creek, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
New Haven, Connecticut, United States
Unnamed facility
Doral, Florida, United States
Unnamed facility
Gainesville, Florida, United States
...and 23 more locations
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.
Time frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)
Percentage of Participants With Serious Adverse Events
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.
Time frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)
Percentage of Participants With Severe Infections Through Week 52 and Week 104
Participants having 1 or more severe infections were evaluated and reported.
Time frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)
Active Treatment Period: Percentage of Participants With Study Agent Injection Site Reactions Up to Week 52
Percentage of participants with study agent injection site reactions up to Week 52 were reported.
Time frame: Up to Week 52
Serum Golimumab Concentrations
Serum samples were collected for the measurement of 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
Number of Participants With Antibodies to Golimumab
Number of participants with antibodies to golimumab were reported.
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
Titers of antibodies to golimumab were evaluated.
Time frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)