Trial Outcomes & Findings for Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes (NCT NCT01280682)
NCT ID: NCT01280682
Last Updated: 2023-12-11
Results Overview
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.
COMPLETED
PHASE4
120 participants
6 months after participants completed the injection
2023-12-11
Participant Flow
patients who had newly diagnosed type 1 diabetes
patients whose C-peptide were too low
Participant milestones
| Measure |
Paralelle Control Group
patients who had newly diagnosed type 1 diabetes only used insulin.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
90
|
|
Overall Study
COMPLETED
|
30
|
77
|
|
Overall Study
NOT COMPLETED
|
0
|
13
|
Reasons for withdrawal
| Measure |
Paralelle Control Group
patients who had newly diagnosed type 1 diabetes only used insulin.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
7
|
Baseline Characteristics
Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Rituximab
n=77 Participants
patients who had newly diagnosed type 1 diabetes are assigned to receive infusions of rituximab besides insulin
|
Parallel Control
n=30 Participants
patients who had newly diagnosed type 1 diabetes only used insulin
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
51 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
17.81 years
STANDARD_DEVIATION 8.76 • n=99 Participants
|
20.08 years
STANDARD_DEVIATION 7.40 • n=107 Participants
|
18.27 years
STANDARD_DEVIATION 8.51 • n=206 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
77 participants
n=99 Participants
|
30 participants
n=107 Participants
|
107 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 months after participants completed the injectionChange 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.
Outcome measures
| Measure |
Rituximab
n=77 Participants
patients who had newly diagnosed type 1 diabetes are assigned to receive infusions of rituximab besides insulin
|
Parallel Control
n=30 Participants
patients who had newly diagnosed type 1 diabetes only used insulin
|
|---|---|---|
|
Change of 3-hour Mean Area Under the Curve (AUC) of C-peptide
|
-0.01 pmol/L
Standard Error 0.03
|
-0.35 pmol/L
Standard Error 0.05
|
SECONDARY outcome
Timeframe: 6 months after participants completed the injectionThe 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.
Outcome measures
| Measure |
Rituximab
n=77 Participants
patients who had newly diagnosed type 1 diabetes are assigned to receive infusions of rituximab besides insulin
|
Parallel Control
n=30 Participants
patients who had newly diagnosed type 1 diabetes only used insulin
|
|---|---|---|
|
Change of Fasting C-peptide
|
-0.03 pmol/L
Standard Error 0.04
|
-0.34 pmol/L
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 6 months after participants completed the injectionThe 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.
Outcome measures
| Measure |
Rituximab
n=77 Participants
patients who had newly diagnosed type 1 diabetes are assigned to receive infusions of rituximab besides insulin
|
Parallel Control
n=30 Participants
patients who had newly diagnosed type 1 diabetes only used insulin
|
|---|---|---|
|
Change of Peak C-peptide
|
-0.01 pmol/L
Standard Error 0.03
|
-0.29 pmol/L
Standard Error 0.06
|
SECONDARY outcome
Timeframe: 6 months after participants completed the injectionGlycated hemoglobin (HbA1c) levels (%)
Outcome measures
| Measure |
Rituximab
n=77 Participants
patients who had newly diagnosed type 1 diabetes are assigned to receive infusions of rituximab besides insulin
|
Parallel Control
n=30 Participants
patients who had newly diagnosed type 1 diabetes only used insulin
|
|---|---|---|
|
HbA1c Levels
|
6.84 percentage of hemoglobin
Interval 6.5 to 7.17
|
9.35 percentage of hemoglobin
Interval 7.54 to 11.15
|
Adverse Events
Rituximab
Parallel Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rituximab
n=77 participants at risk
patients who had newly diagnosed type 1 diabetes are assigned to receive infusions of rituximab besides insulin
|
Parallel Control
n=30 participants at risk
patients who had newly diagnosed type 1 diabetes only used insulin
|
|---|---|---|
|
General disorders
Fever
|
10.4%
8/77
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
7/77
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
1.3%
1/77
|
0.00%
0/30
|
|
Cardiac disorders
Hypotension
|
2.6%
2/77
|
0.00%
0/30
|
|
Cardiac disorders
Hypertension
|
1.3%
1/77
|
0.00%
0/30
|
|
Cardiac disorders
Tachycardia
|
2.6%
2/77
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.5%
15/77
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
1/77
|
0.00%
0/30
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/77
|
0.00%
0/30
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/77
|
0.00%
0/30
|
|
General disorders
Other AE
|
9.1%
7/77
|
0.00%
0/30
|
Additional Information
Yang Tao
Department of Endocrinology, First Affiliated Hospital of Nanjing Medical University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place