This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Rituximab in New Onset Type 1 Diabetes (NCT00279305), a randomized phase 2 study. The primary outcome is Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00279305 |
| Phase | Phase 2 |
| Condition | Type 1 Diabetes Mellitus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 87 |
| Arms in the primary outcome | 2 |
| Lead sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with new-onset type 1 diabetes mellitus. The title and outcome description identify this clinical setting, but detailed eligibility criteria and the characteristics of the enrolled participants are not reported in the registry record. The registry lists enrollment of 87 participants; the numbers contributing to the primary outcome are reported separately by arm.
Intervention
The intervention was intravenous rituximab, described as an anti-CD20 monoclonal antibody. The registry describes 4 administrations at weeks 0, 1, 2, and 3, at a dose of 375mg/m2. The rationale was to reduce B cells, which the study description proposes may help limit immune activity directed at insulin-producing beta cells.
Comparator
The comparator was placebo administered by intravenous infusion. The registry describes 4 administrations at weeks 0, 1, 2, and 3. The study was randomized and double masked, with a parallel-group model. Further details about the randomization procedure and how masking was maintained are not reported in the registry record.
Primary question
The primary question was whether the groups differed in the area under the stimulated C-peptide curve during the first 2 hours of a 4-hour mixed meal tolerance test at the 1-year visit. C-peptide is used as an indicator of endogenous insulin production. The posted registry analysis compares final values using ANCOVA and reports a mean difference with a 95% confidence interval and p-value. The result is a statistical comparison of this measure, not a direct measure of every aspect of diabetes progression.
3. Trial Design
This was a phase 2, randomized, double-masked, parallel-group trial sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases. The registry lists enrollment of 87 participants and identifies type 1 diabetes mellitus as the condition. The record gives a start date of 2005-08, primary completion in 2009-04, and completed status.
Participants were assigned to rituximab treatment or placebo. The rituximab arm received intravenous anti-CD20 treatment with 4 administrations at weeks 0, 1, 2, and 3, at a dose of 375mg/m2. The placebo arm received intravenous placebo at the same scheduled weeks. A parallel-group design means each participant belongs to one assigned study arm rather than crossing between treatments. The record identifies randomization and double masking but does not describe the sequence-generation method, allocation concealment, masking procedures, or whether masking was assessed.
The primary outcome was the area under the stimulated C-peptide curve, based on measurements from the first 2 hours of a 4-hour mixed meal tolerance test administered at the 1-year visit. The registry describes timed measurements at 0, 15, 30, 60, 90, and 120 minutes. Outcome summaries are reported for 49 participants in the rituximab group and 29 in the placebo group. These are the numbers associated with the posted primary outcome, and the registry does not explain how they relate to overall enrollment or give participant flow details.
The primary completion date indicates when the primary outcome collection was recorded as complete, not necessarily when all study activities ended. The registry does not report the full protocol, eligibility details, baseline characteristics, sample-size justification, planned interim analyses, or all analysis-population definitions. These omissions limit how fully the design and conduct can be assessed from the registry record alone.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 126 patients were assessed; 39 were excluded; 87 underwent randomization (57 were assigned to receive rituximab and 30 were assigned to receive placebo)
Overall Study
| Stage | Rituximab Treatment | Placebo |
|---|---|---|
| STARTED | 57 | 30 |
| COMPLETED | 49 | 29 |
| NOT COMPLETED | 8 | 1 |
Reasons for not completing this period:
| Reason | Rituximab Treatment | Placebo |
|---|---|---|
| Pregnancy | 1 | 0 |
| Withdrawal by Subject | 2 | 0 |
| Dificulting establishing IV | 1 | 0 |
| FDA Safety Alert | 4 | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Rituximab Treatment | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 57 | 30 | 87 | |
| Age, Continuous | years | 19.0 (SD 8.6) | 17.4 (SD 8.0) | 18.5 (SD 8.3) |
| Sex: Female, Male: Female | Participants | 21 | 12 | 33 |
| Sex: Female, Male: Male | Participants | 36 | 18 | 54 |
6. Primary Endpoint
The registry lists the primary outcome as Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year, measured over When all participants complete the 1 year visit.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | pmol per mL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the area under the stimulated C-peptide curve during the first 2 hours of a 4-hour mixed meal tolerance test at the 1-year visit. C-peptide is released when the body produces its own insulin, so a stimulated C-peptide measure is used to characterize remaining endogenous insulin production. A meal challenge provides a standardized stimulus, while timed blood measurements describe the response over the specified interval.
The registry lists measurements at 0, 15, 30, 60, 90, and 120 minutes. It also explains that the reported concentration, referred to in the description as the AUC mean, is a weighted average of the six timed measurements and is expressed in pmol per mL. The record distinguishes this concentration summary from the area under the curve itself by describing the AUC mean as the area divided by 120 minutes. The posted endpoint is therefore a continuous summary of the stimulated response, not a single timed concentration.
This endpoint is relevant to the trial’s stated rationale because the study sought to examine preservation of insulin-producing beta-cell function after diagnosis. It captures one biological dimension of that question, but does not by itself describe glucose control, treatment burden, symptoms, or longer-term clinical outcomes. The endpoint was scheduled at the 1-year visit; the registry does not report additional primary time points.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
At the 1-year primary outcome, the mean stimulated C-peptide AUC mean was 0.58 pmol per mL in the rituximab group and 0.429 pmol per mL in the placebo group. The reported 95% confidence intervals were 0.476 to 0.691 and 0.289 to 0.585, respectively. These are arm-level summaries for 49 and 29 participants. The intervals describe uncertainty around each reported mean; they are not intervals for the between-group contrast.
The registry’s comparative analysis used ANCOVA and reported a mean difference in final values of 0.139, with a 95% confidence interval extending from a negative lower endpoint to 0.348, and p = 0.05. Because the interval reaches both sides of zero, it includes no difference as well as differences in either direction under the model. The confidence interval therefore indicates substantial uncertainty about the size and direction of the contrast. The p-value is at the conventional 0.05 boundary, but should be read alongside the confidence interval rather than as a complete account of the evidence.
The point estimate is positive for the reported contrast, but the registry’s analysis description does not specify the sign convention for the contrast. The comparison is reported for the rituximab and placebo groups in that order; readers should avoid assigning a direction beyond what the analysis definition establishes. The arm-level means are higher for rituximab, but the adjusted analysis and the difference between unadjusted arm means are not necessarily identical quantities.
The reported outcome summaries do not establish why the groups differed, and the registry record does not provide the ANCOVA covariates or details of missing-outcome handling. Nor does this single endpoint capture every aspect of the clinical course. The result should be understood as an estimate for a continuous laboratory-derived measure at the stated visit, with uncertainty represented by the confidence interval, rather than a definitive characterization of all treatment effects.
9. Statistical Methods Explained
What does the arm-level mean describe? The primary endpoint is continuous: each participant has a numerical stimulated C-peptide summary, and the arm-level result is reported as a mean. A mean gives a central summary of the measured values in that group. It does not show the full distribution of participant values, and it can be influenced by how values are spread around the center. The registry reports confidence intervals for both means but does not report a standard deviation or another direct measure of participant-level spread.
A 95% confidence interval communicates the statistical uncertainty associated with an estimated quantity under the assumptions of the analysis. It is not a range containing a fixed proportion of individual participant measurements. The arm-level intervals are 0.476 to 0.691 pmol per mL for rituximab and 0.289 to 0.585 pmol per mL for placebo. Their overlap is not a substitute for the reported between-group test: inference about a contrast should use the contrast estimate and its own uncertainty, rather than a visual comparison of separate arm intervals.
What does ANCOVA contribute? ANCOVA is a regression-based method that compares outcome values between groups while accounting for one or more covariates. In a randomized study, adjustment can be used to improve precision or account for prespecified baseline information. The registry reports ANCOVA for final values, but the covariates, model specification, and adjustment details are not reported in the registry record. Consequently, the posted adjusted contrast cannot be reconstructed from the arm-level means alone. In general, an adjusted estimate can differ from the simple difference between group means because it reflects the model and covariates used.
The registry reports a mean difference of 0.139, a 95% confidence interval with a negative lower endpoint and an upper endpoint of 0.348, and p = 0.05. The confidence interval is an important complement to the point estimate: it shows that the data are compatible with a range of contrasts, including values on both sides of zero. The p-value summarizes how unusual the data would be under a specified null model, subject to the analysis assumptions. It does not measure the probability that the null hypothesis is true, and it does not express the clinical importance of the estimate.
Why does dispersion matter for a continuous outcome?
Participants’ C-peptide responses can vary around the group mean. If the spread is large relative to the contrast, the estimate will generally be less precise than if participant values cluster more closely around their group mean. In some types of outcome data, variability may also be greater than a simple model assumes; this is called over-dispersion. Accounting for the actual variability matters because standard errors and confidence intervals depend on it. The registry does not report the participant-level distribution or enough detail to assess this issue directly.
How should the p-value and interval be read together?
The p-value and confidence interval address related but distinct features of the analysis. The interval gives a range of estimates compatible with the data and model at the stated confidence level. The p-value summarizes evidence against a null value under the test procedure. Here, the p-value is 0.05 and the reported interval extends across zero. This combination calls for attention to the imprecision and the analysis specification, rather than a binary conclusion based only on whether a threshold is reached. The registry’s reported numbers are rounded, and the exact relation between the p-value and interval may reflect rounding or features of the fitted model; further details are not reported in the registry record.
What does the endpoint’s timing mean? The primary measurement was taken at the 1-year visit, when all participants completed that visit according to the stated timeframe. The analysis is thus a comparison at a defined follow-up point, not an estimate of change at every time point. The registry does not report a primary longitudinal model or repeated-measures analysis. It also does not describe how an unavailable 1-year result was handled or whether the analysis included all randomized participants.
The endpoint description gives the timed sampling schedule and the weighted-average calculation used to express the C-peptide response. The distinction between the curve’s area and the AUC mean matters for interpretation because the latter is a concentration summary in pmol per mL. The posted group summaries are reported in this unit. Readers should interpret them as the registry’s described stimulated C-peptide measure, not as an unrelated raw glucose value or as a direct count of beta cells.
What can planning calculations say? Sample-size illustrations based on an observed effect are planning exercises: they explore the number of participants per arm that might be required under stated assumptions and for a chosen effect fraction. They are not observed power for the completed trial, and they do not show the probability that the study detected a true effect. The stated illustration assumptions include a two-sided significance level of 0.05, equal allocation, and a normal approximation. The registry does not report that these were the trial’s original design assumptions or provide a sample-size justification. No planning count should be treated as an observed outcome of the trial.
Finally, statistical interpretation depends on design and reporting details beyond the model label. The registry identifies randomization, masking, a parallel design, and ANCOVA, but does not report the full statistical analysis plan, interim-analysis approach, covariate set, missing-data procedures, or analysis population. These details would help evaluate how the reported inference relates to the trial’s prespecified objectives.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| ANCOVA | Mean Difference (Final Values) 0.139 | -0.0699 to 0.348 | 0.050 |
The registry reports the sponsor’s primary comparison as an ANCOVA of final values. It gives a mean difference of 0.139, a 95% confidence interval with a negative lower endpoint and an upper endpoint of 0.348, and p = 0.05. This is the analysis to use when describing the trial’s reported inferential result. The registry does not provide the adjustment covariates or model details needed to reproduce that ANCOVA from the posted arm-level means and confidence intervals.
The arm-level means are 0.58 pmol per mL for rituximab and 0.429 pmol per mL for placebo. These are descriptive summaries, whereas the ANCOVA contrast is a model-based comparison. A simple unadjusted re-calculation, when available, is not interchangeable with an adjusted sponsor analysis; differences can arise because the methods answer the comparison using different information or assumptions. The registry record does not report a recalculated contrast alongside the ANCOVA result, so no separate recalculated estimate or interval can be compared with the sponsor’s estimate.
The reported confidence interval crosses zero, indicating uncertainty around the comparative estimate. The p-value and interval should be read together, with the model specification and outcome handling in mind. Those additional details are not reported in the registry record, so the analysis can be described as posted but cannot be fully audited from the registry entry alone.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure and one reported analysis. It lists no secondary outcomes as posted. However, the registry record does not report whether other outcomes, time points, subgroups, or model variations were analyzed outside the posted result, nor whether a formal multiplicity strategy was planned. When several statistical questions are examined, the chance of a nominally unusual result can increase; procedures that account for multiple comparisons can address that issue. Without the broader analysis plan, it is not possible to determine whether multiplicity was relevant to the sponsor’s analysis or how it was handled.
The analysis population is not defined in the reported result. The registry lists 87 enrolled participants, while the primary endpoint summaries include 49 participants in the rituximab arm and 29 in the placebo arm. These counts should not be interpreted as proof that the remaining enrolled participants had missing outcomes, were excluded, or belonged to a specific analysis set: participant flow and reasons for any differences are not reported in the registry record. The safety denominators are also different from the primary endpoint counts, and the record does not explain the relationship between these populations.
Missing-data handling is not reported in the registry record. There is no stated method for handling participants without an observed 1-year outcome, no description of assumptions about why data might be missing, and no sensitivity analysis described. These details matter because an analysis based only on observed outcomes can be affected if outcome availability is related to treatment assignment or the outcome itself. The reported confidence interval accounts for uncertainty under its analysis model; it does not automatically resolve uncertainty from unreported missing-data processes.
The registry does not report the prespecified statistical analysis plan, sample-size justification, interim analyses, or any adjustment for multiple looks at the data. These omissions do not establish that such procedures were absent; they mean the registry record does not document them. As a result, the extent to which the posted analysis was prespecified, and whether its nominal inferential measures reflect all planned analyses, cannot be determined from the record.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Rituximab Treatment | 11 | 57 | 19.3% |
| Placebo | 9 | 30 | 30.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Rituximab Treatment | 56 of 57 |
| Placebo | 29 of 30 |
Most frequent serious adverse event terms
| Event term | Organ system | Rituximab Treatment | Placebo |
|---|---|---|---|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | 4 of 57 | 1 of 30 |
| Endocrine- other | Endocrine disorders | 2 of 57 | 2 of 30 |
| Infection Other | Infections and infestations | 0 of 57 | 2 of 30 |
| Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | 1 of 57 | 1 of 30 |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | 1 of 57 | 0 of 30 |
| Sudden Death | General disorders | 0 of 57 | 1 of 30 |
| Dermatology/Skin Other | Skin and subcutaneous tissue disorders | 1 of 57 | 0 of 30 |
| Pancreatic endocrine: glucose intolerance | Endocrine disorders | 0 of 57 | 1 of 30 |
| Gastrointestinal Other | Gastrointestinal disorders | 1 of 57 | 0 of 30 |
| Infection with unknown ANC- pneumonia | Infections and infestations | 0 of 57 | 1 of 30 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Rituximab Treatment | Placebo |
|---|---|---|---|
| Rash/desquamation | Skin and subcutaneous tissue disorders | 24 of 57 | 3 of 30 |
| Nausea | Gastrointestinal disorders | 25 of 57 | 2 of 30 |
| Upper Airway Infection with unknown ANC | Infections and infestations | 14 of 57 | 12 of 30 |
| Hypotension | Cardiac disorders | 18 of 57 | 5 of 30 |
| Fever | General disorders | 17 of 57 | 5 of 30 |
| Pruritus/itching | Skin and subcutaneous tissue disorders | 21 of 57 | 0 of 30 |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | 11 of 57 | 9 of 30 |
| Sinus Pain | General disorders | 13 of 57 | 7 of 30 |
| Vomiting | Gastrointestinal disorders | 16 of 57 | 3 of 30 |
| Musculoskeletal/Soft Tissue - Other | Musculoskeletal and connective tissue disorders | 12 of 57 | 7 of 30 |
Serious events with the highest arm-level rate: neutrophils/granulocytes (anc/agc) (7.0%), endocrine- other (6.7%), infection other (6.7%), sudden death (3.3%), pancreatic endocrine: glucose intolerance (3.3%).
The registry lists serious adverse events for 57 participants at risk in the rituximab group, of whom 11 were affected, and for 30 participants at risk in the placebo group, of whom 9 were affected. For other adverse events, it lists 56 affected among 57 at risk in the rituximab group and 29 affected among 30 at risk in the placebo group. These counts describe the registry’s event reporting and denominators; they are not the primary efficacy outcome and should not be combined with the C-peptide analysis.
The listed serious-event terms include Neutrophils/granulocytes (ANC/AGC) at 7.0%, Endocrine- other at 6.7%, Infection Other at 6.7%, Sudden Death at 3.3%, Pancreatic endocrine: glucose intolerance at 3.3%, and Infection with unknown ANC- pneumonia at 3.3%. The registry does not provide group attribution for this list in the reported information, so these percentages should not be assigned to a specific arm. The deaths field is not reported in the registry record; a missing entry should not be read as zero deaths.
Safety counts depend on the definitions, observation period, and participants included in each denominator. The record does not describe those details or provide further context for individual events. These figures should therefore be read as registry-reported counts, not as a complete comparative safety analysis or as proof about the cause of an event.
13. What the Result Does, and Does Not, Mean
The posted result describes a comparison of stimulated C-peptide at the 1-year visit. The arm-level mean was 0.58 pmol per mL for rituximab and 0.429 pmol per mL for placebo. The registry’s ANCOVA analysis reported a mean difference of 0.139, with a 95% confidence interval that extends from a negative lower endpoint to 0.348, and p = 0.05. This conveys a positive point estimate alongside uncertainty that includes values on both sides of zero.
The result does not, by itself, establish the size of a clinically important effect. The registry does not report a threshold for clinical importance, nor does the C-peptide endpoint summarize all outcomes relevant to type 1 diabetes. It is a measure of stimulated endogenous insulin production as described in the endpoint definition. It is not a direct measurement of beta-cell count, a measure of every feature of glucose control, or a statement about an individual participant’s likely outcome.
The reported group means are not the same thing as a causal explanation for any difference. Randomization supports a comparative design, but the registry entry does not include enough detail about participant flow, missing outcomes, covariate adjustment, and analysis populations to assess all assumptions behind the reported estimate. The uncertainty interval also matters: it allows a range of contrasts rather than identifying one exact effect.
The trial’s findings should be limited to the reported population, treatment schedule, comparator, endpoint, and follow-up. The registry title refers to new-onset type 1 diabetes, but detailed eligibility criteria and participant characteristics are not reported in the registry record. The result cannot automatically be extended to other populations, treatment schedules, outcomes, or follow-up periods. It also does not establish what would happen beyond the stated visit.
In short, the registry reports an ANCOVA comparison with p = 0.05 and an interval spanning zero. That is a statistical description of the posted endpoint and its uncertainty, not a medical recommendation and not a complete account of benefit, harm, or long-term clinical outcomes.
14. Why This Trial Matters Statistically
This trial is statistically instructive because it pairs a continuous biological outcome with an adjusted between-group analysis. The arm means give an accessible description of the measured C-peptide response, while the ANCOVA result is the registry’s formal comparative estimate. Keeping those summaries distinct helps prevent readers from treating a descriptive difference as though it were necessarily the adjusted analysis result.
The confidence interval is especially important for interpreting the estimate. A point estimate alone can appear precise in meaning even when the underlying data allow a range of plausible contrasts. Here, the reported interval extends across zero, so the posted estimate should be read with its uncertainty rather than reduced to a simple positive-versus-negative label. The p-value of 0.05 adds information about the test, but does not replace the estimate, interval, endpoint context, or model assumptions.
The registry also illustrates the limits of a short outcome record. It identifies randomization, double masking, the treatment schedule, endpoint, and method, but leaves covariate selection, missing-data handling, analysis population, and multiplicity procedures undocumented. Those details are central to reproducibility and to understanding how an adjusted result was obtained. A named method alone does not reveal the full analysis.
Finally, the distinctions among enrollment, endpoint denominators, and safety denominators matter. The record lists different counts for these purposes but does not explain participant flow. Careful reading avoids treating the counts as interchangeable or inferring reasons for their differences. Together, these issues show why statistical interpretation requires more than a point estimate or a thresholded p-value: it depends on the estimand, uncertainty, design, analysis choices, and completeness of reporting.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record gives only a limited account of the trial methods. Although it identifies the study as randomized, double masked, and parallel group, it does not describe how the randomization sequence was generated, how allocation was concealed, or how masking was implemented. These details are not reported in the registry record, so the safeguards against selection or measurement bias cannot be assessed from this entry.
The primary endpoint is described in detail, but the registry does not report baseline C-peptide values, participant characteristics, the ANCOVA covariates, model diagnostics, or a full statistical analysis plan. Without those elements, the adjusted comparison cannot be reproduced or assessed for sensitivity to modeling choices. The report also does not state how missing 1-year observations were handled or identify the analysis population. Enrollment and outcome denominators differ, but participant flow and reasons are not reported in the registry record.
The registry lists only one outcome measure and one analysis, with no secondary outcomes posted. This limits the available view of the broader trial results and does not establish whether additional outcomes or analyses were conducted. Multiplicity procedures, interim analyses, and the study’s original sample-size justification are not reported in the registry record. The planning illustrations based on the observed effect should not be mistaken for the original design rationale or for observed power.
The safety information is also limited. Counts and a list of serious-event terms are posted, but the relationship between event terms, treatment groups, and denominators is not fully described in the reported information. Deaths are not reported in the registry record. Adverse-event counts alone do not establish causality or provide a complete comparative assessment.
Finally, the endpoint is a measure of stimulated C-peptide at the 1-year visit. The record does not report additional primary follow-up points or provide detailed eligibility and baseline information needed to judge how broadly the results apply. The statistical and clinical interpretation should therefore remain tied to this measure, the posted analysis, and the information actually documented in the registry.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Rituximab in New Onset Type 1 Diabetes — NCT00279305.
- Registry record last updated 2020-05-06; status last verified 2020-04.
- Results first posted 2016-08-18.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
The registry describes a completed phase 2 randomized, double-masked, parallel-group trial of intravenous rituximab versus intravenous placebo in new-onset type 1 diabetes. Enrollment was 87. Rituximab was administered at weeks 0, 1, 2, and 3 at a dose of 375mg/m2, and placebo was given on the same schedule.
The primary outcome was stimulated C-peptide AUC mean during the first 2 hours of a 4-hour mixed meal tolerance test at the 1-year visit. The arm-level means were 0.58 pmol per mL for rituximab and 0.429 pmol per mL for placebo. The registry reports an ANCOVA mean difference of 0.139, a 95% confidence interval spanning a negative lower endpoint to 0.348, and p = 0.05.
Important analysis details, including covariates, missing-data handling, participant flow, and multiplicity procedures, are not reported in the registry record. Serious adverse event counts are listed, while deaths are not reported in the registry record.