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 : Active, not recruiting
First Posted : July 27, 2016
Last Update Posted : January 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Biological: Golimumab Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 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 :||October 2016|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||May 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 ]
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
Show 33 Study Locations
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|