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 Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients (NCT01219959), a randomized phase 3 study. The primary outcome is Change From the Baseline Value in HbA1c at Month 3 and 6.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01219959 |
| Phase | Phase 3 |
| Condition | End Stage Renal Disease (ESRD), Diabetes, CAPD |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 71 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Vantive Health LLC |
| Results posted | Yes |
2. Clinical Question
Population
Diabetic patients with end stage renal disease receiving continuous ambulatory peritoneal dialysis (CAPD). The brief summary includes patients with Type 1 and Type 2 diabetes. The primary efficacy population is described as randomized participants with a baseline HbA1c value and at least one peritoneal dialysis exchange using a study solution.
Intervention
A glucose-sparing prescription using Dianeal, Extraneal, and Nutrineal. The registry calls this the Glucose Sparing group.
Comparator
Dianeal only, described as the Non-glucose Sparing group.
Primary question
Does the change in HbA1c from baseline differ between the glucose-sparing prescription and Dianeal only at Month 3 and Month 6? The registry describes the primary objective as testing for improved metabolic control, but does not report the numerical group results or the estimated differences in the registry record.
The question is framed around a laboratory measure rather than a clinical event. HbA1c reflects glycemic exposure over time and is used as an indicator of metabolic control. For this trial, the registry specifies change from baseline at Month 3 and Month 6, with Month 6 identified as the end of study. The outcome is reported as percent change, and its summary statistic is the mean with standard deviation.
The comparison concerns treatment strategies in a specific clinical setting: diabetic patients receiving CAPD. It does not directly ask whether either prescription is better for all people with diabetes or for people receiving other forms of dialysis. The registry also lists secondary questions about medication use, severe hypoglycemic events requiring medical intervention, lipid and insulin-related measures, nutritional status, and quality of life. Those are separate outcomes and should not be substituted for the primary HbA1c question.
3. Trial Design
The registry describes a prospective, randomized, multicenter, parallel-group Phase 3 trial. Its title identifies a comparison of Dianeal, Extraneal, and Nutrineal against Dianeal only in diabetic CAPD patients. The allocation is randomized, while masking is listed as none. The record status is completed. Enrollment is reported as 71.
The two treatment strategies are named Glucose Sparing and Non-glucose Sparing. The Glucose Sparing arm used Dianeal, Extraneal, and Nutrineal; the Non-glucose Sparing arm used Dianeal only. Because masking is listed as none, the trial is described as open-label rather than blinded. The registry record does not report how randomization was generated or concealed, or whether any additional measures were used to reduce bias.
The study start is recorded as 2010-10, and primary completion as 2011-07. The primary endpoint is change from baseline in HbA1c at Month 3 and Month 6. The brief summary specifies that the objective was to compare metabolic control, and it lists further objectives involving medication requirements, severe hypoglycemic events, other metabolic measures, nutritional status, and quality of life.
The primary efficacy population is described as an intent-to-treat population, with eligibility for that analysis requiring randomization, a baseline HbA1c value, and at least one peritoneal dialysis exchange using a study solution. The primary outcome description also says that the result is a pooled analysis of three studies. The registry record does not explain how that pooled analysis relates to the enrollment of 71 or provide the underlying study-level participant flow. No sample-size justification, randomization details, or fuller protocol description is reported in the registry record.
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.
Overall Study
| Stage | Non-Glucose Sparing Prescriptions | Glucose Sparing Prescriptions |
|---|---|---|
| STARTED | 127 | 124 |
| COMPLETED | 120 | 101 |
| NOT COMPLETED | 7 | 23 |
Reasons for not completing this period:
| Reason | Non-Glucose Sparing Prescriptions | Glucose Sparing Prescriptions |
|---|---|---|
| Adverse Event | 6 | 14 |
| Physician Decision | 0 | 4 |
| Withdrawal by Subject | 0 | 2 |
| Renal Transplantation | 0 | 3 |
| Other | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Primary Efficacy Intent-to-Treat (ITT) population included all subjects randomized with a minimum of a baseline HbA1c value determined and one PD exchange using study solution performed. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489, NCT00567398, NCT01219959.
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.
Population: The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.
| Characteristic | Unit | Non-Glucose Sparing Prescriptions | Glucose Sparing Prescriptions | Total |
|---|---|---|---|---|
| Participants analysed | 127 | 124 | 251 | |
| Age, Continuous | years | 58 (SD 12.8) | 57.3 (SD 12) | 57.65 (SD 12.4) |
| Sex: Female, Male: Female | Participants | 59 | 64 | 123 |
| Sex: Female, Male: Male | Participants | 68 | 60 | 128 |
| Race/Ethnicity, Customized: Baseline – Asian | Participants | 41 | 42 | 83 |
| Race/Ethnicity, Customized: Baseline – Black | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Baseline – Caucasian | Participants | 41 | 41 | 82 |
| Race/Ethnicity, Customized: Baseline – Hispanic | Participants | 32 | 31 | 63 |
| Race/Ethnicity, Customized: Baseline – Other | Participants | 12 | 10 | 22 |
6. Primary Endpoint
The registry lists the primary outcome as Change From the Baseline Value in HbA1c at Month 3 and 6, measured over Baseline, Month 3, Month 6 (End of Study).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Percent Change |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in HbA1c at Month 3 and Month 6, with Month 6 identified as the end of study. HbA1c is a glycohemoglobin formed when glucose attaches to hemoglobin. The registry describes use of a Tina-quant immunological assay suitable for samples from patients with end stage renal disease and with icodextrin metabolites, or an equivalent assay. The endpoint is expressed as percent change, and the summary measure is the mean with standard deviation.
HbA1c is used as an indicator of glycemic control because it reflects glucose exposure over time, rather than a single measurement at one moment. In this trial, the central statistical question is whether average change differs between the glucose-sparing prescription and Dianeal only at the specified visits. The registry says that the analysis estimates least-squares differences between treatment groups by visit and uses an analysis of covariance approach to test whether the differences equal zero.
That endpoint captures one aspect of metabolic control; it is not itself a direct measure of symptoms, severe hypoglycemic events, nutritional status, or quality of life. The registry lists those domains among the secondary objectives. The numerical HbA1c changes, the group estimates, their uncertainty intervals, and the p-values are not reported in the registry record, so the direction and precision of the primary comparison cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clear primary outcome and a planned comparison: change in HbA1c from baseline at Month 3 and Month 6. However, it does not report numerical results for that outcome in the registry record. There are no posted group means or changes, estimated treatment differences, confidence intervals, or p-values in the record. Consequently, the record does not establish the direction, magnitude, or statistical precision of the primary comparison.
The statistical description says that least-squares estimates compare treatment groups by visit and that an analysis of covariance tests whether the differences equal zero. Those statements describe an analysis approach, not its result. Without the estimates and their uncertainty, it is not possible to judge whether the observed comparison was close to zero or more pronounced, nor how compatible the data are with a range of possible effects. A test description alone cannot answer whether the groups differed.
The study is randomized, which supports a treatment-group comparison, but the registry lists no masking. An open-label design can matter for outcomes or decisions that may be influenced by awareness of assigned treatment. HbA1c is a laboratory endpoint, but the registry does not provide enough detail about conduct, measurement, or analysis to assess the potential effect of lack of masking on the reported endpoint.
The primary efficacy population is not described as every randomized participant without qualification. It includes randomized participants with a baseline HbA1c value and at least one study-solution exchange. The registry does not report how many participants met that definition, how many contributed observations at each visit, or how missing measurements were handled. The enrollment figure alone therefore cannot be used to infer the analysis denominator at either visit.
The primary outcome description says it is a pooled analysis of three studies, while the general trial record reports enrollment of 71. The registry does not explain the relation between the pooled analysis and that enrollment figure. That leaves the scope of the primary result unclear from the registry record. It is important not to treat the adverse-event group denominators as primary endpoint sample sizes: they are reported separately and the registry does not explain their relationship to the enrollment figure or pooled efficacy population.
The secondary outcomes cover several domains and visits. Their presence makes it important to distinguish the primary HbA1c question from other analyses. The registry lists 22 outcome measures and 73 analyses, but does not report a multiplicity strategy. Multiple analyses can increase the chance of finding apparently notable results by chance if each is treated as a separate confirmatory test. The record does not say whether such results were adjusted or interpreted as exploratory.
Overall, the registry provides design information and an outline of the intended primary analysis, but not the numerical primary results needed for a result-focused interpretation. It also leaves important questions about the pooled population, missing data, and multiplicity unanswered. These gaps limit conclusions about both the estimated HbA1c contrast and its precision.
9. Statistical Methods Explained
The registry describes the primary outcome as a continuous measure summarized by a mean and standard deviation. A mean represents the average value in a group, while a standard deviation describes how spread out individual values are around that average. These summaries are useful for describing a continuous outcome, but a treatment comparison also needs an estimate of the difference between groups and an indication of its uncertainty. The numerical summaries and uncertainty estimates for HbA1c are not reported in the registry record.
What does change from baseline represent?
Change from baseline compares a participant's follow-up measurement with their own starting measurement. The registry specifies measurements at baseline, Month 3, and Month 6, with Month 6 as the end of study. Comparing changes can account for starting values in a direct way, although the registry's stated analysis also describes an analysis of covariance rather than simply comparing raw change scores. The record does not provide the underlying data or clarify all details of the model.
What is an analysis of covariance?
Analysis of covariance is a method for comparing groups while accounting for one or more measured variables included in the model. In a randomized trial, it is commonly used to adjust a follow-up comparison for baseline values of the outcome. This can improve precision when baseline measurements are related to follow-up measurements. The registry says the primary analysis estimates least-squares differences between groups by visit and uses analysis of covariance to test whether the differences equal zero. It does not state the full model specification, the variables included, or the assumptions checked.
Least-squares estimates are model-based group estimates. A least-squares difference represents the fitted contrast between treatment groups under the model, rather than necessarily being the simple difference between two unadjusted group means. Interpretation depends on the model and its included terms. Because the numerical estimates are not reported, there is no treatment contrast or precision estimate available to interpret from the registry record.
How should a confidence interval be read?
In general, a confidence interval gives a range of values compatible with the data and the statistical model at a stated confidence level. It communicates estimation uncertainty and is more informative than a point estimate alone. A narrow interval indicates more precise estimation than a wide interval, while an interval spanning values on both sides of no difference may leave the direction of the effect uncertain. These are general principles; the registry record does not report confidence intervals for the primary endpoint.
What does a p-value test?
The registry describes testing whether the between-group differences equal zero. In general, a p-value measures how unusual the observed data, or data more extreme, would be under a specified null hypothesis and statistical model. It does not measure the probability that the null hypothesis is true, nor does it quantify the size or clinical importance of a difference. No primary p-value is reported in the registry record, so the analysis description cannot be read as evidence for either a difference or no difference.
Why do visits and multiple outcomes matter?
The primary endpoint is evaluated at Month 3 and Month 6, and the registry lists numerous secondary outcomes. When many outcomes or time points are examined, the opportunity for chance findings increases if each test is considered on its own. A multiplicity plan may control the overall false-positive risk or specify which analyses are confirmatory. The registry record does not report such a plan. It also does not say whether one visit had priority over the other in testing or interpretation.
What does the planning illustration mean?
In general, sample-size calculations estimate how many participants may be needed under chosen assumptions to detect an effect with a chosen power. Such calculations are planning illustrations, not observed power and not evidence that a study did or did not detect an effect. The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and an effect defined as a fraction of the observed effect. The registry record does not report the trial's own sample-size justification. Any illustration based on an observed effect also depends on that estimate and should not be treated as the trial's prespecified design rationale.
The registry specifies an intent-to-treat label for the primary efficacy population, but its description includes a baseline HbA1c requirement and at least one exchange using study solution. The exact analysis population therefore needs to be understood from the stated eligibility definition rather than inferred from the label alone. The record does not report participant counts at each endpoint visit, missing-data methods, or sensitivity analyses. Those omissions prevent assessment of how incomplete follow-up may affect the estimated contrast.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is measured at Month 3 and Month 6, and the registry also lists a broad set of secondary outcomes. These include medication use, severe hypoglycemic events requiring medical intervention, lipid and lipoprotein measures, insulin-related measures, subjective global assessment, albumin, and total protein. The record lists 22 outcome measures and 73 analyses. With many outcomes, visits, or comparisons, chance findings become more likely when each test is read in isolation. In general, a prespecified multiplicity strategy can help distinguish confirmatory analyses from exploratory ones and address the overall risk of false-positive findings. Such a strategy is not reported in the registry record.
The record describes the primary efficacy population as randomized participants who had a baseline HbA1c measurement and completed at least one peritoneal dialysis exchange using a study solution. It does not report how many participants met this definition, how many had HbA1c data at each visit, or whether the analysis included all eligible observations. Missing-data handling, assumptions about missingness, and sensitivity analyses are not reported in the registry record.
The intent-to-treat label and the eligibility definition should be read together. The record does not explain how participants who lacked a baseline measure or did not receive a study-solution exchange were handled, or whether other analysis populations were used. It also does not report whether the analysis accounted for the pooled nature of the primary outcome, which is described as combining three studies. These omissions limit assessment of the population represented by the estimates and the robustness of any result.
11. 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 |
|---|---|---|---|
| Non-Glucose Sparing Prescriptions | 41 | 127 | 32.3% |
| Glucose Sparing Prescriptions | 58 | 124 | 46.8% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Non-Glucose Sparing Prescriptions | 101 of 127 |
| Glucose Sparing Prescriptions | 98 of 124 |
Most frequent serious adverse event terms
| Event term | Organ system | Non-Glucose Sparing Prescriptions | Glucose Sparing Prescriptions |
|---|---|---|---|
| Peritonitis Bacterial | Infections and infestations | 5 of 127 | 8 of 124 |
| Fluid Overload | Metabolism and nutrition disorders | 3 of 127 | 5 of 124 |
| Peritonitis | Gastrointestinal disorders | 2 of 127 | 3 of 124 |
| Anaemia | Blood and lymphatic system disorders | 2 of 127 | 2 of 124 |
| Cellulitis | Infections and infestations | 1 of 127 | 3 of 124 |
| Gastroenteritis | Infections and infestations | 2 of 127 | 2 of 124 |
| Pneumonia | Infections and infestations | 2 of 127 | 2 of 124 |
| Hypertensive Crisis | Vascular disorders | 1 of 127 | 3 of 124 |
| Cardiac Failure Acute | Cardiac disorders | 1 of 127 | 2 of 124 |
| Catheter Related Complication | General disorders | 2 of 127 | 1 of 124 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Non-Glucose Sparing Prescriptions | Glucose Sparing Prescriptions |
|---|---|---|---|
| Peritonitis | Gastrointestinal disorders | 10 of 127 | 10 of 124 |
| Hypertension | Vascular disorders | 10 of 127 | 6 of 124 |
| Peritonitis Bacterial | Infections and infestations | 7 of 127 | 8 of 124 |
| Fluid Overload | Metabolism and nutrition disorders | 6 of 127 | 8 of 124 |
| Anaemia | Blood and lymphatic system disorders | 6 of 127 | 7 of 124 |
| Vomiting | Gastrointestinal disorders | 4 of 127 | 9 of 124 |
| Constipation | Gastrointestinal disorders | 4 of 127 | 8 of 124 |
| Oedema Peripheral | General disorders | 10 of 127 | 2 of 124 |
| Hypoglycaemia | Metabolism and nutrition disorders | 1 of 127 | 10 of 124 |
| Nausea | Gastrointestinal disorders | 6 of 127 | 4 of 124 |
Serious events with the highest arm-level rate: peritonitis bacterial (6.5%), fluid overload (4.0%), peritonitis (2.4%), cellulitis (2.4%), hypertensive crisis (2.4%).
The registry reports serious adverse event figures for Non-Glucose Sparing Prescriptions and Glucose Sparing Prescriptions. For serious adverse events, it lists 41 affected among 127 at risk in the Non-Glucose Sparing group and 58 affected among 124 at risk in the Glucose Sparing group. For other adverse events, it lists 101 affected among 127 at risk and 98 affected among 124 at risk, respectively. These are descriptive counts as recorded; the registry does not provide a comparative statistical analysis or uncertainty estimates for them.
The serious-event terms most frequently listed include Peritonitis Bacterial at 6.5%, Fluid Overload at 4.0%, and Peritonitis, Cellulitis, Hypertensive Crisis, and Urinary Tract Infection at 2.4% each. The record does not give enough information to interpret these term percentages as risks for an individual participant, and it does not specify in the listed terms whether events could be counted more than once per participant.
The safety denominators do not match the overall enrollment figure of 71. The registry record does not explain the relationship between those figures, including whether they reflect pooled data or another safety population. Deaths are not reported in the registry record. The counts should therefore be read as the reported safety summaries, not as a direct substitute for the primary efficacy results or a complete account of comparative safety.
12. What the Result Does, and Does Not, Mean
This trial asks whether a glucose-sparing CAPD prescription is associated with a different change in HbA1c than Dianeal only in diabetic patients receiving CAPD. The registry gives the treatment groups, the primary outcome, measurement visits, and a description of the planned group comparison. It also identifies secondary questions covering medication use, severe hypoglycemic events, other metabolic measures, nutritional status, and quality of life.
What the registry record does not provide is the numerical primary outcome result. Without the group changes, estimated differences, uncertainty intervals, or p-values, it is not possible to describe whether HbA1c increased or decreased in either group, whether the groups were separated, or how precise the estimated comparison was. The analysis plan cannot stand in for observed results. No conclusion that either prescription improves or fails to improve metabolic control follows from the information reported in the registry record.
Even if a numerical difference were available, its interpretation would require attention to its size and uncertainty, the analysis population, missing measurements, and the relationship between the pooled analysis and the general trial enrollment. Statistical evidence about a difference is also distinct from whether a difference matters clinically. The registry record does not provide a clinical threshold for a meaningful HbA1c change.
The safety summaries describe serious and other adverse events in separate at-risk groups, but they do not provide adjusted comparisons or uncertainty measures. Their denominators also differ from the enrollment figure, and the registry does not explain that relationship. These reports should not be treated as proof of a safety advantage or disadvantage.
The most defensible reading is therefore limited: the record outlines a randomized, open-label comparison and specifies HbA1c change at Month 3 and Month 6 as the primary endpoint, but it does not report the numerical primary results required to assess the treatment contrast. The record also leaves analysis-population, multiplicity, and missing-data details unresolved.
13. Why This Trial Matters Statistically
This study raises several statistical issues that are important when interpreting clinical trial records. First, it distinguishes an endpoint description from an endpoint result. The registry specifies HbA1c change, the measurement visits, and an analysis approach, but does not report the group estimates or their uncertainty. Statistical methods are essential for understanding how a comparison was intended to be made, yet they cannot reveal the direction or size of a result when the result itself is absent.
Second, the primary efficacy population is defined by more than randomization: participants must also have a baseline HbA1c value and at least one study-solution exchange. Clear population definitions matter because analysis denominators affect the interpretation of estimates. The registry does not report how many participants contributed data at each visit, which makes it difficult to connect the stated enrollment with the primary analysis.
Third, the record describes a pooled analysis of three studies but does not explain how that analysis relates to the trial enrollment figure. Pooling can affect the population represented and the structure of an analysis; the methods used to account for study differences are not reported in the registry record. This uncertainty is relevant to both generalizability and precision.
Finally, there are multiple outcomes and visits, with 22 outcome measures and 73 analyses listed. Without a reported multiplicity plan, readers cannot tell which analyses were intended to be confirmatory or how the risk of chance findings was addressed. Together, these points show why interpretation depends not only on the treatment comparison but also on reporting of the estimand, analysis population, missing data, and multiplicity.
14. 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 does not report the numerical HbA1c results, including group summaries, between-group estimates, confidence intervals, or p-values. This is the most direct limitation for interpreting the primary question: neither the direction nor the precision of the comparison can be assessed from the record.
The primary outcome is described as a pooled analysis of three studies, but the record does not explain the pooled dataset's relationship to the enrollment of 71. It does not provide study-specific contributions, participant flow, or details of any model terms accounting for study. The primary efficacy population is described using baseline measurement and treatment-exposure criteria, but visit-specific denominators are not reported.
The trial is listed as randomized and open-label. The registry does not describe sequence generation, allocation concealment, or other safeguards against bias. It also does not provide enough analysis detail to assess the model assumptions, the handling of repeated visits, or whether departures from the planned approach occurred. Missing-data methods and sensitivity analyses are not reported in the registry record.
The record lists many outcomes and analyses but does not report a multiplicity strategy or distinguish confirmatory from exploratory analyses. Its adverse-event denominators differ from the overall enrollment, without an explanation of the relevant safety population or the relationship to pooled data. Deaths are not reported in the registry record. These reporting gaps limit interpretation of both the efficacy and safety information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients — NCT01219959.
- Registry record last updated 2025-07-24; status last verified 2025-07.
- Results first posted 2019-06-03.
- 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.
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18. Record Summary
The registry record describes a completed, randomized, open-label, parallel-group Phase 3 trial in diabetic patients receiving CAPD. It compares Dianeal, Extraneal, and Nutrineal with Dianeal only. Enrollment is listed as 71, with study start recorded as 2010-10 and primary completion as 2011-07.
The primary outcome is change from baseline in HbA1c at Month 3 and Month 6. The record describes least-squares comparisons by visit using analysis of covariance, but numerical primary results are not reported in the registry record. The primary efficacy population has a stated baseline-measurement and study-exchange requirement, and the outcome description identifies a pooled analysis of three studies. Their relationship to the enrollment figure is not explained.
The registry lists multiple secondary outcomes and reports adverse-event counts, but does not report a multiplicity plan, missing-data methods, or deaths. These omissions limit assessment of the efficacy comparison, precision, and safety summaries.