Phase 4
N=120
Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01280682 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Change of 3-hour Mean Area Under the Curve (AUC) of C-peptide — -0.01; -0.35 pmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- rituximab (Drug)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Yang Tao
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of 3-hour Mean Area Under the Curve (AUC) of C-peptide |
-0.01; -0.35 | — |
| SECONDARY Change of Fasting C-peptide |
-0.03; -0.34 | — |
| SECONDARY Change of Peak C-peptide |
-0.01; -0.29 | — |
| SECONDARY HbA1c Levels |
6.84; 9.35 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01280682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.