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 Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study (NCT02489773), a registered phase not stated study. The primary outcome is Compare the Pearson Correlation of Glycated Albumin (GA) and Fructosamine Within All Subjects With the Performance Goal of 0.8.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02489773 |
| Phase | Phase not stated |
| Condition | Diabetes |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 150 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Asahi Kasei Therapeutics Corporation |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns patients with diabetes. The registry records an enrollment of 150. Group 1 is described as having HbA1c values ranging from 7.5% to 12% (or higher), while Group 2 is described as having HbA1c values <7.5%. The primary outcome is specified within all subjects.
Intervention
The clinical program evaluates Lucica ® Glycated Albumin-L. Its stated purpose is intermediate-term monitoring of glycemic control, described in the registry as preceding 2-3 weeks. The record does not report how the test was administered or how its results were used in care.
Comparator
The primary outcome compares the Pearson correlation of glycated albumin (GA) and fructosamine with a performance goal of 0.8. Group 1 and Group 2 are defined by HbA1c values, but the registry does not describe them as randomized treatment and control groups. Allocation is not stated, so they should not be treated as a like-for-like control comparison.
Primary question
From baseline to 6 months, what is the Pearson correlation coefficient for GA and fructosamine within all subjects, and how does it compare with the stated performance goal of 0.8? The coefficient and its uncertainty are not reported in the registry record, so the primary question cannot be answered from the available result information.
3. Trial Design
The registry identifies NCT02489773 as the Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study. It lists Asahi Kasei Therapeutics Corporation as the sponsor, Diabetes as the condition, an enrollment of 150, and a status of COMPLETED. The recorded start is 2015-06 and the primary completion is 2016-07. Those dates and the completed status describe the registry entry; they do not, on their own, establish that all planned analyses or results are available.
The stated study purpose is to confirm whether Lucica ® Glycated Albumin-L is useful for intermediate-term monitoring of glycemic control in patients with diabetes. The primary outcome concerns the Pearson correlation of GA and fructosamine within all subjects, with a performance goal of 0.8, over the timeframe from baseline to 6 months. Secondary outcomes are described as Spearman and Kendall correlation analyses of changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1.
The record defines Group 1 by HbA1c values ranging from 7.5% to 12% (or higher), and Group 2 by values <7.5%. It does not state how participants were allocated to these groups. The record specifically does not support interpreting them as randomized arms or as a like-for-like control comparison. It also does not report the recruitment process, eligibility criteria beyond the diabetes condition and group descriptions, test schedule, or a detailed analysis protocol. These details should not be inferred from the study title or its completed status.
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: A total of 165 patients were screened for the study, 150 patients were enrolled.
Overall Study
| Stage | HbA1c Values Ranged From ≥7.5% to 12% (or Higher) | HbA1c Values <7.5% |
|---|---|---|
| STARTED | 98 | 52 |
| COMPLETED | 91 | 50 |
| NOT COMPLETED | 7 | 2 |
Reasons for not completing this period:
| Reason | HbA1c Values Ranged From ≥7.5% to 12% (or Higher) | HbA1c Values <7.5% |
|---|---|---|
| Lost to Follow-up | 4 | 1 |
| Physician Decision | 1 | 0 |
| Withdrawal by Subject | 1 | 0 |
| Leave the country or the state | 1 | 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 | Group 1 | Group 2 | Total |
|---|---|---|---|---|
| Participants analysed | 98 | 52 | 150 | |
| Age, Continuous | years | 50.6 (SD 15.61) | 50.3 (SD 15.81) | 50.5 (SD 15.63) |
| Sex: Female, Male: Female | Participants | 53 | 27 | 80 |
| Sex: Female, Male: Male | Participants | 45 | 25 | 70 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 22 | 7 | 29 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 76 | 45 | 121 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 5 | 2 | 7 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 13 | 4 | 17 |
| Race (NIH/OMB): White | Participants | 80 | 46 | 126 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 98 | 52 | 150 |
6. Primary Endpoint
The registry lists the primary outcome as Compare the Pearson Correlation of Glycated Albumin (GA) and Fructosamine Within All Subjects With the Performance Goal of 0.8, measured over From baseline to 6 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Pearson correlation coefficient |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is a Pearson correlation coefficient for glycated albumin (GA) and fructosamine within all subjects. Its stated timeframe is from baseline to 6 months, and the result is intended to be compared with a performance goal of 0.8. The registry’s stated broader aim is to evaluate Lucica ® Glycated Albumin-L for intermediate-term monitoring of glycemic control, described as preceding 2-3 weeks.
In general, Pearson correlation describes the strength and direction of a linear association between two measured quantities. It can indicate whether higher values of one measure tend to accompany higher values of another, but it does not establish that the measures agree numerically. Two measures can be strongly correlated while differing systematically in their values. Correlation also does not show that one measure causes changes in the other.
The record does not report the observed coefficient, a confidence interval, or a test result for comparison with the goal. Without those results, it is not possible to assess how close the observed association was to the goal or how precisely it was estimated. The endpoint title names GA and fructosamine, whereas the stated study aim refers to Lucica ® Glycated Albumin-L; the registry entry does not provide further detail about the measurement procedures or their relationship.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry sets out a correlation-based primary question rather than a treatment-effect comparison. It specifies Pearson correlation between GA and fructosamine within all subjects and names 0.8 as the performance goal. However, the observed coefficient and its uncertainty are not reported in the registry record. The available information therefore does not establish whether the observed result met, exceeded, or fell below that goal. It also does not establish whether any difference from the goal would be statistically distinguishable from random variation.
For correlation estimates, precision matters as well as the point estimate. In general, a confidence interval describes a range of values compatible with the data under the method used, and it helps show whether an estimate is precise or uncertain. No confidence interval or other uncertainty measure for the primary coefficient is reported. The record also gives no p-value for that endpoint. These absences prevent a fuller statistical interpretation; they are not evidence that the association was weak or strong.
The registry names Spearman and Kendall correlation analyses for changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1. The listed outcome descriptions identify planned or recorded analysis topics, but do not give the corresponding estimates. Results for those analyses are not reported in the registry record. No conclusion about the direction, size, or precision of these correlations can be drawn from the outcome names alone.
The group descriptions provide context about HbA1c strata, not evidence of a randomized contrast. Allocation is not stated, and the record says the arms are not a like-for-like control comparison. Any differences between the groups could not be interpreted as an effect of an intervention based on these registry entries alone. The record does not report adjusted comparisons between the groups.
The registry lists serious adverse events affecting 5 of 98 at risk in Group 1 and 3 of 52 at risk in Group 2, and reports 0 deaths in each group. It also lists other adverse events affecting 53 of 98 at risk in Group 1 and 28 of 52 at risk in Group 2. These are descriptive counts, not estimates of a causal effect or evidence that one group had greater risk. The record does not supply details on event timing, exposure, follow-up completeness, or statistical comparisons that would support those interpretations.
9. Statistical Methods Explained
The registry identifies Pearson correlation as the primary analysis and lists Spearman and Kendall correlation analyses among the secondary outcomes. These methods address association, but they do not answer identical statistical questions. The record does not report the actual estimates, the full analysis procedures, or uncertainty intervals. The explanations below describe the methods generally and do not imply that unreported checks or procedures were carried out in this study.
What does Pearson correlation describe?
In general, Pearson correlation quantifies the direction and strength of a linear association between two variables. A positive value means that higher values of one variable tend to occur with higher values of the other; a negative value indicates that higher values of one tend to accompany lower values of the other. Values nearer the endpoints of the correlation scale represent stronger linear association, while values nearer its center represent weaker linear association. The registry’s specified performance goal is 0.8, but the observed estimate is not reported.
Pearson correlation is sensitive to the pattern of the data. An unusual observation can have substantial influence, and a curved relationship may not be captured well by a single linear association measure. In general, a scatterplot and appropriate data checks help assess whether a linear summary is informative. The registry record does not report these diagnostics, so their use cannot be assumed.
Correlation is not the same as agreement. In general, agreement asks whether two measurements give sufficiently similar values, whereas correlation asks whether they vary together. A consistent offset or scale difference can coexist with a strong correlation. The primary endpoint therefore describes association between GA and fructosamine; it does not, by itself, establish that the two measurements are interchangeable or that either accurately reflects a clinical target.
Why are Spearman and Kendall correlations listed?
Spearman and Kendall methods are rank-based measures of association. In general, they assess whether observations tend to move in the same or opposite order, rather than measuring a specifically linear relationship in the original measurement units. They can be useful when the association is monotonic but not well described by a straight-line pattern, or when the data do not suit a Pearson summary. Each method has its own interpretation and assumptions; the registry does not state why these methods were selected for the secondary analyses.
The named secondary outcomes concern changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1. Naming a correlation method does not reveal the direction or strength of an association. The registry record does not report the corresponding estimates, uncertainty intervals, or details of how changes were defined.
How should the performance goal be read?
The goal of 0.8 is a benchmark stated in the primary outcome description. In general, comparing an estimate with a benchmark is most informative when the estimate and its uncertainty are available, along with a prespecified decision rule. A point estimate alone would not show how precisely the association was estimated. The registry record does not report a confidence interval, a formal test against the goal, or a decision rule for interpreting the comparison. It is therefore not possible to determine from the record whether the goal was met under a particular statistical criterion.
What do the planning assumptions mean?
The planning illustration is described as being computed from the observed effect, not as the trial’s own design. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect defined as a stated fraction of the observed effect. The description says that results for non-time-to-event outcomes are expressed as participants per arm. These assumptions explain the basis of a planning illustration; they do not establish that the original study was designed with those assumptions.
In general, a planning estimate depends on the chosen effect, variability, significance level, power target, and design assumptions. An illustration based on an observed effect is not observed power and does not show the probability that the completed study’s result is correct. No planning output or underlying observed primary effect is reported in the registry entries available for interpretation. The listed assumptions should therefore be kept separate from claims about the study’s original sample-size justification or statistical plan, which are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry records three outcome measures and four analyses, including the primary Pearson correlation outcome and secondary Spearman and Kendall correlation analyses. The record does not explain whether these analyses were prespecified in a protocol or whether additional analyses were conducted. It does not report a multiplicity adjustment, a hierarchy of outcomes, or a rule for deciding which analysis would support a primary conclusion. These details are not reported in the registry record, so the risk of selective emphasis across analyses cannot be assessed.
In general, conducting multiple statistical tests can increase the chance of at least one apparently notable result arising by chance. Adjustment procedures or a clearly defined hierarchy can help address that issue, but the appropriate approach depends on the intended claims and analysis plan. The registry’s listing of several analyses alone does not show whether multiplicity was controlled or how results were interpreted.
Missing-data methods and analysis populations are also not reported in the registry record. The entry does not say how missing measurements, withdrawals, or incomplete follow-up were handled, nor does it describe whether analyses used all enrolled participants or a defined subset. The outcome description says the primary analysis is within all subjects, but that wording does not explain how unavailable measurements were treated or how the analysis population was determined.
The registry does not report the statistical analysis plan, interim analyses, or a sample-size justification. Their absence from the entry should not be taken as proof that such plans or procedures did or did not exist. Without these details and the actual endpoint estimates, readers cannot assess whether all planned analyses are represented or how missing observations may have affected precision.
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 |
|---|---|---|---|
| Group 1 | 5 | 98 | 5.1% |
| Group 2 | 3 | 52 | 5.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Group 1 | 0 of 98 |
| Group 2 | 0 of 52 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Group 1 | 53 of 98 |
| Group 2 | 28 of 52 |
Most frequent serious adverse event terms
| Event term | Organ system | Group 1 | Group 2 |
|---|---|---|---|
| A loss of consciousness | Nervous system disorders | 1 of 98 | 0 of 52 |
| Paraesthesia | Nervous system disorders | 1 of 98 | 0 of 52 |
| Atrial fibrillation | Cardiac disorders | 1 of 98 | 0 of 52 |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | 1 of 98 | 0 of 52 |
| Femur fracture | Injury, poisoning and procedural complications | 1 of 98 | 0 of 52 |
| Sepsis | Infections and infestations | 1 of 98 | 0 of 52 |
| Acute myocardial infarction | Cardiac disorders | 1 of 98 | 0 of 52 |
| Pneumonia | Infections and infestations | 1 of 98 | 0 of 52 |
| Gastroenteritis | Infections and infestations | 1 of 98 | 0 of 52 |
| Cellulitis | Infections and infestations | 1 of 98 | 0 of 52 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Group 1 | Group 2 |
|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | 8 of 98 | 8 of 52 |
| Upper respiratory tract infection | Infections and infestations | 12 of 98 | 3 of 52 |
| Nasopharyngitis | Infections and infestations | 5 of 98 | 3 of 52 |
| Gastroenteritis | Infections and infestations | 7 of 98 | 0 of 52 |
| Sinusitis | Infections and infestations | 5 of 98 | 0 of 52 |
| Back pain | Musculoskeletal and connective tissue disorders | 4 of 98 | 1 of 52 |
| Nausea | Gastrointestinal disorders | 4 of 98 | 0 of 52 |
| Urinary tract infection | Infections and infestations | 2 of 98 | 2 of 52 |
| Headache | Nervous system disorders | 4 of 98 | 0 of 52 |
| Bronchitis | Infections and infestations | 3 of 98 | 0 of 52 |
Serious events with the highest arm-level rate: cholecystitis (1.9%), appendicitis (1.9%), hypoglycaemia (1.9%), a loss of consciousness (1.0%), paraesthesia (1.0%).
The registry lists serious adverse events for Group 1 as affecting 5 participants among 98 at risk, and for Group 2 as affecting 3 among 52 at risk. It reports 0 deaths in each group. For other adverse events, the listed counts are 53 among 98 at risk in Group 1 and 28 among 52 at risk in Group 2. These are the record’s reported counts; they should not be read as evidence of a treatment effect.
The record also lists Cholecystitis, Appendicitis, and Hypoglycaemia at 1.9% each, and A loss of consciousness, Paraesthesia, and Atrial fibrillation at 1.0% each, among the top serious terms. The entry does not clarify in this information how these terms were assigned to groups or the denominator used for the percentages. The terms and percentages should therefore be read as registry listings, not as group-specific comparisons.
In general, adverse-event counts describe events recorded under a study’s reporting procedures. They do not alone explain severity, timing, duration, relatedness to a product, or whether the same participant experienced more than one event. The registry does not report those details. Nor does it provide a statistical comparison for these safety figures. The counts are descriptive and do not establish relative safety or causation.
12. What the Result Does, and Does Not, Mean
The study’s stated aim is to evaluate Lucica ® Glycated Albumin-L for intermediate-term monitoring of glycemic control in patients with diabetes. Its primary endpoint is a Pearson correlation between GA and fructosamine within all subjects, compared with a performance goal of 0.8 over the timeframe from baseline to 6 months. The registry also names secondary rank-correlation analyses involving changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in Group 1.
The central limitation for interpreting the efficacy-related statistical question is that the primary coefficient and its uncertainty are not reported in the registry record. As a result, the record does not show how large the estimated association was, how precise it was, or whether it met the stated goal. The secondary analysis descriptions likewise do not include estimates or uncertainty. A completed study status does not supply those missing numerical results.
Even if a correlation estimate were available, correlation would establish association rather than agreement, causation, or clinical usefulness on its own. The record does not provide a decision rule defining how a correlation result would confirm the stated monitoring purpose. It also does not report how the test was used in clinical decisions or what patient outcomes were assessed. The study aim should therefore be distinguished from evidence demonstrating clinical benefit.
The HbA1c-defined groups are not described as randomized arms, and allocation is not stated. The registry cautions that they are not a like-for-like control comparison. Their adverse-event counts should consequently be treated as descriptive rather than as evidence that one group caused more or fewer events.
The appropriate reading is narrow: the record documents a completed clinical program with a stated correlation goal, named secondary analyses, group definitions, and reported safety counts. It does not report enough primary outcome information to determine whether the correlation goal was achieved, nor enough design and analysis detail to support broader causal or clinical conclusions.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of why the endpoint definition and the available result must be considered together. The primary question is expressed as a Pearson correlation of GA and fructosamine, with a performance goal of 0.8. That is a specific association question. It is not automatically a test of agreement, a causal comparison, or a direct measure of clinical usefulness. Keeping these concepts separate helps avoid claims that go beyond what a correlation endpoint can show.
The registry also makes clear that the HbA1c-defined groups are not a like-for-like control comparison and that allocation is not stated. This matters because group labels can look like trial arms even when the record does not support a randomized contrast. Without a suitable comparison design and relevant adjustment information, differences between groups cannot be attributed to the test or to a treatment effect.
The entry illustrates the importance of reporting estimates with uncertainty. A performance goal gives readers a benchmark, but without the observed correlation and a measure of its precision, the benchmark cannot be evaluated from the record. Named secondary methods similarly do not substitute for their estimates. Statistical interpretation depends on the reported results as well as the methods identified.
Finally, the safety counts are useful descriptive information but do not provide a causal comparison. The registry does not report the event context needed to interpret timing, relatedness, or group differences. The value of the record is therefore in clarifying the study’s intended question and some of its recorded safety information, while also showing where reporting gaps constrain inference.
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 primary endpoint result is not reported in the registry record. The observed Pearson correlation, its confidence interval, and a test or decision rule for comparison with the goal of 0.8 are unavailable. This prevents assessment of the magnitude and precision of the primary result. The secondary Spearman and Kendall outcomes are listed without estimates or uncertainty measures as well.
Design details are limited. Although the registry describes Group 1 and Group 2 by HbA1c values, allocation is not stated and the groups are not a like-for-like control comparison. The record does not report the recruitment process, complete eligibility criteria, measurement procedures, or detailed follow-up schedule. The primary timeframe is from baseline to 6 months, while the broader aim refers to monitoring preceding 2-3 weeks; the registry does not explain how those timeframes relate in the analysis.
The analysis plan is not reported in sufficient detail to assess missing-data handling, analysis populations, multiplicity control, or whether interim analyses occurred. The record also does not report a sample-size justification. Planning assumptions describe an illustration based on an observed effect, but do not establish the original study design or its rationale.
Safety information is limited to listed counts and selected serious-event terms. The record does not provide event timing, relatedness, participant-level overlap, follow-up completeness, or a statistical comparison. These limitations mean that neither the group counts nor the listed terms support a causal safety conclusion. The completed registry status does not resolve these omissions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study — NCT02489773.
- Registry record last updated 2019-11-21; status last verified 2019-11.
- Results first posted 2019-11-21.
- 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
NCT02489773 is listed as the completed Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study, sponsored by Asahi Kasei Therapeutics Corporation. The condition is Diabetes, enrollment is 150, the recorded start is 2015-06, and primary completion is 2016-07.
The stated purpose is intermediate-term monitoring of glycemic control, described as preceding 2-3 weeks. The primary outcome is the Pearson correlation of GA and fructosamine within all subjects, compared with a performance goal of 0.8, from baseline to 6 months. Secondary outcome descriptions name Spearman and Kendall analyses of changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1.
The primary coefficient and uncertainty are not reported in the registry record. The group definitions are based on HbA1c values, allocation is not stated, and the groups are not a like-for-like control comparison. Serious and other adverse-event counts are recorded, but they do not establish causal differences between groups.