Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes

NCT01280682 | Completed Phase 4 Results DMC

• 1 other identifier: 2010-SR-021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; age; course of disease; autoantibodies; C-peptide levels

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change of Fasting C-peptide

  6 months after participants completed the injection

• Change of Peak C-peptide

  6 months after participants completed the injection

• HbA1c Levels

  6 months after participants completed the injection

Study Arms (2)

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

Drug: rituximab

parallel control

NO INTERVENTION

patients who had newly diagnosed type 1 diabetes only use insulin

Interventions

rituximab DRUG

anti-CD20 monoclonal antibody 125mg/m\^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)

Also known as: anti-CD20 monoclonal antibody

rituximab

Eligibility Criteria

• Age: 8 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of type 1 diabetes
• The age of subjects between 8 and 70 years old
• Course of disease within 12 months
• Presence of at least one type of detectable islet autoantibody \[zinc transporter 8 antibody(ZnT8A),glutamic acid decarboxylase antibody(GADA),protein tyrosine phosphatase-2 antibody(IA-2A),insulin autoantibody(IAA)\]
• Fasting C-peptide levels of at least 0.2 pmol/mL

You may not qualify if:

• Confirmed diagnosis of type 2 diabetes
• Severe chronic or acute complications of diabetes
• Severe infection or damage to the immune response
• Presence of chronic latent infection in vivo
• Viral hepatitis B patients whose hepatitis B virus(HBV)DNA \> log10\^5
• Liver and kidney dysfunction, alanine aminotransferase(ALT), aspartate aminotransferase(AST), and creatinine more than 2 times the upper limit of normal
• Hypotension, systolic blood pressure(SBP) ≤ 90mmHg, diastolic blood pressure(DBP) ≤ 60mmHg
• Patients with rheumatoid arthritis
• Allergic to any component of this drug
• Pregnancy, breast-feeding women
• Use of other immunosuppressive agents 3 months before selected

Sponsors & Collaborators

• Yang Tao: lead

Study Sites (1)

First Affiliated Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (2)

• 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.

  PMID: 39735417 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.

  PMID: 36879107 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Yang Tao
• Organization: Department of Endocrinology, First Affiliated Hospital of Nanjing Medical University

dryangtao@sina.com

+86-13851498409

Study Officials

• Tao Yang, MD/PhD

  First Affiliated Hospital, Nanjing Medical University, China

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Endocrinology & Metabolism

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: January 21, 2011
• Study Start: July 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2018
• Last Updated: December 11, 2023
• Results First Posted: December 11, 2023

Record last verified: 2023-03

Locations

CN (1)