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Transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease immune-mediated destruction of beta cells and result in preserved beta-cell function in patients with type 1 diabetes of recent onset.
Although the presence of autoantibodies is a diagnostic criterion, the immunopathogenesis of beta-cell destruction in type 1 diabetes is typically associated with T-lymphocyte autoimmunity.
Many T-lymphocyte-mediated diseases include a B-lymphocyte component. B lymphocytes can play a crucial role as antigen-presenting cells, expressing high levels of class II major-histocompatibility-complex antigens and generating cryptic peptides to which T lymphocytes are not tolerant.
B lymphocytes can be selectively depleted with the anti-CD20 monoclonal antibody. We will test the hypothesis that transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease immune-mediated destruction of beta cells and result in preserved beta-cell function in patients with type 1 diabetes of recent onset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rituximab | Experimental | patients who had newly diagnosed type 1 diabetes are assigned to receive infusions of rituximab of 125mg/m^2 day1 day8 day15 day22 repeat after six months (only day1 and day8) besides insulin |
|
| parallel control | No Intervention | patients who had newly diagnosed type 1 diabetes only use insulin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Drug | anti-CD20 monoclonal antibody 125mg/m^2 day1 day8 day15 day22 repeat after six months (only day1 and day8) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of 3-hour Mean Area Under the Curve (AUC) of C-peptide | Change of 3-hour mean area under the curve (AUC) of C-peptide at 6 months from baseline. AUC was calculated from C-peptide timing measurements during the 3-hour mixed meal tolerance test with the trapezoidal rule. The mean AUC for C-peptide is equal to the calculated AUC divided by the 3 h interval (i.e., AUC/180). All mean C-peptide AUC data were transformed as log (mean AUC) for analysis. | 6 months after participants completed the injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Fasting C-peptide | The change of fasting level of C-peptide during the 3-hour of a mixed meal tolerance test at 6 months from baseline. All fasting C-peptide data were transformed as log (fasting C-peptide) for analysis. | 6 months after participants completed the injection |
| Change of Peak C-peptide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tao Yang, MD/PhD | First Affiliated Hospital, Nanjing Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39735417 | Derived | Ajmal N, Bogart MC, Khan P, Max-Harry IM, Healy AM, Nunemaker CS. Identifying Promising Immunomodulators for Type 1 Diabetes (T1D) and Islet Transplantation. J Diabetes Res. 2024 Dec 20;2024:5151171. doi: 10.1155/jdr/5151171. eCollection 2024. | |
| 36879107 | Derived | Su Z, Ma C, Zhao R, Jiang Y, Cai Y, Yong G, Yang T, Xu X. Heterogeneity of circulating CXCR5-PD-1hiTph cells in patients of type 2 and type 1 diabetes in Chinese population. Acta Diabetol. 2023 Jun;60(6):767-776. doi: 10.1007/s00592-023-02055-6. Epub 2023 Mar 6. |
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patients whose C-peptide were too low
patients who had newly diagnosed type 1 diabetes
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| ID | Title | Description |
|---|---|---|
| FG000 | Paralelle Control Group | patients who had newly diagnosed type 1 diabetes only used insulin. |
| FG001 | Rituximab Group | besides insulin, patients who had newly diagnosed type 1 diabetes are assigned to receive infusions of rituximab (125 mg per square meter of body-surface area) in a solution (pH 6.5) with 9 mg of sodium chloride per milliliter on days 1, 8, 15, and 22 of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab | patients who had newly diagnosed type 1 diabetes are assigned to receive infusions of rituximab besides insulin |
| BG001 | Parallel Control | patients who had newly diagnosed type 1 diabetes only used insulin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of 3-hour Mean Area Under the Curve (AUC) of C-peptide | Change of 3-hour mean area under the curve (AUC) of C-peptide at 6 months from baseline. AUC was calculated from C-peptide timing measurements during the 3-hour mixed meal tolerance test with the trapezoidal rule. The mean AUC for C-peptide is equal to the calculated AUC divided by the 3 h interval (i.e., AUC/180). All mean C-peptide AUC data were transformed as log (mean AUC) for analysis. | Posted | Mean | Standard Error | pmol/L | 6 months after participants completed the injection |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab | patients who had newly diagnosed type 1 diabetes are assigned to receive infusions of rituximab besides insulin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yang Tao | Department of Endocrinology, First Affiliated Hospital of Nanjing Medical University | +86-13851498409 | dryangtao@sina.com |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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The change of peak level of C-peptide during the 3-hour of a mixed meal tolerance test at 6 months from baseline. All peak C-peptide data were transformed as log (peak C-peptide) for analysis. |
| 6 months after participants completed the injection |
| HbA1c Levels | Glycated hemoglobin (HbA1c) levels (%) | 6 months after participants completed the injection |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
patients who had newly diagnosed type 1 diabetes only used insulin
|
|
| Secondary | Change of Fasting C-peptide | The change of fasting level of C-peptide during the 3-hour of a mixed meal tolerance test at 6 months from baseline. All fasting C-peptide data were transformed as log (fasting C-peptide) for analysis. | Posted | Mean | Standard Error | pmol/L | 6 months after participants completed the injection |
|
|
|
| Secondary | Change of Peak C-peptide | The change of peak level of C-peptide during the 3-hour of a mixed meal tolerance test at 6 months from baseline. All peak C-peptide data were transformed as log (peak C-peptide) for analysis. | Posted | Mean | Standard Error | pmol/L | 6 months after participants completed the injection |
|
|
|
| Secondary | HbA1c Levels | Glycated hemoglobin (HbA1c) levels (%) | Posted | Mean | 95% Confidence Interval | percentage of hemoglobin | 6 months after participants completed the injection |
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| 44 |
| 77 |
| EG001 | Parallel Control | patients who had newly diagnosed type 1 diabetes only used insulin | 0 | 30 | 0 | 30 | 0 | 30 |
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Other AE | General disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |