A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes (T1GER)
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|ClinicalTrials.gov Identifier: NCT02846545|
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Biological: Golimumab Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||SIMPONI® to Arrest β-cell Loss in Type 1 Diabetes|
|Actual Study Start Date :||August 26, 2016|
|Estimated Primary Completion Date :||February 25, 2019|
|Estimated Study Completion Date :||May 25, 2020|
Experimental: Group 1: Golimumab
Participants will receive subcutaneous (SC) golimumab intermittently for 52 weeks, where doses will be based on weight and/or body surface area.
Participants will receive subcutaneous golimumab intermittently for 52 weeks, where doses will be based on weight and/or body surface area.
Other Name: SIMPONI
Placebo Comparator: Group 2: Placebo
Participants will receive a matching placebo to golimumab.
Matching Placebo to golimumab
- C-peptide Area Under the Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) at Week 52 [ Time Frame: Baseline to Week 52 ]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.
- Change From Baseline in Insulin use in Units per Kilogram Body Weight per day [ Time Frame: Baseline to Weeks 26, 52 and 78 ]
- Change From Baseline in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Baseline to Weeks 26, 78 and 104 ]
- Hypoglycemic Event Rates [ Time Frame: Week 0 up to Week 52, Week 52 to Week 104 and Week 0 up to Week 104 ]Defined as Blood Glucose Levels(BG) of Less Than or Equal to(=<) 70 Milligram per Deciliter(mg/dL) or Clinical Sequelae in the Absence of a BG Reading
- C-peptide Area Under the Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time [ Time Frame: Baseline to Weeks 26, 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.
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to Week 52 and Week 104 ]
- Percentage of Participants With Severe Infections Through Weeks 52 and 104 [ Time Frame: Up to Week 52 and Week 104 ]
- Percentage of Participants With Study Agent Injection Site Reactions Through Week 52 [ Time Frame: Up to Week 52 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846545
|Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:||JNJ.CT@sylogent.com|
Show 42 Study Locations
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|