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 Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus (NCT01387737), a randomized phase 3 study. The primary outcome is Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01387737 |
| Phase | Phase 3 |
| Condition | Type 2 Diabetes Mellitus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 1299 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Tanabe Pharma Corporation |
| Results posted | Yes |
2. Clinical Question
Population
Japanese patients with type 2 diabetes mellitus. The registry summary describes evaluating TA-7284 in patients receiving it alone or with another oral anti-hyperglycaemic agent. Detailed eligibility criteria, baseline characteristics, and the distribution of background therapies are not reported in the registry record.
Intervention
TA-7284, represented by the registry groups named TA-7284-Low and TA-7284-High. The arm descriptions are blank, so the doses and any other differences between these groups are not reported in the registry record.
Comparator
The posted groups are TA-7284-Low and TA-7284-High. The registry identifies randomized allocation and a parallel design, but it does not describe a placebo or untreated comparator. Further details of how participants were allocated are not reported in the registry record.
Primary question
The primary outcome is safety and tolerability, assessed by adverse events and hypoglycemic events as percentage of incidences over a timeframe of 54 weeks. The registry lists no single reduced comparison for this outcome, and a numerical primary-outcome result is not reported in the registry record.
In practical statistical terms, the study asks how safety and tolerability were recorded in the two TA-7284 groups during long-term administration, while the study summary also identifies efficacy as an objective. The secondary outcomes listed are change in HbA1c, fasting plasma glucose, body weight, and blood pressure. The record does not provide numerical results for those changes here, nor does it describe a specific dose contrast or a formal primary hypothesis.
The registry describes oral administration for 52 weeks in Japanese patients, while the primary endpoint entry gives a 54-week timeframe. The relationship between those time descriptions is not reported in the registry record. This matters when interpreting what period the primary safety assessment covers: the record identifies both durations but does not explain their timing or how measurements were scheduled.
3. Trial Design
This was a phase 3, randomized, open-label, multicenter, parallel study sponsored by Tanabe Pharma Corporation. Its title and summary describe a long-term evaluation of TA-7284 in patients with type 2 diabetes mellitus. The registry lists enrollment of 1299 and marks the study completed. The study start is recorded as 2011-05 and primary completion as 2012-11.
The two listed intervention groups are TA-7284-Low and TA-7284-High, both identified as drugs. The arm descriptions contain no further details. The specific doses, how treatment was administered beyond the summary’s reference to oral administration, and whether treatment differed in any other respect are not reported in the registry record. The summary says TA-7284 was evaluated as monotherapy or in combination with another oral anti-hyperglycaemic agent, but it does not specify which participants received which approach.
Randomization means that treatment assignment was intended to use a chance-based process, but the registry record does not describe the sequence-generation method, allocation concealment, or allocation ratio. Open-label means the study was not masked; who knew the assigned treatment and whether outcome assessors were masked are not reported in the registry record. The multicenter label indicates participation across centers, but the number and locations of centers are not reported.
The registry summary describes 52 weeks of oral administration, whereas the primary safety outcome is assigned a 54-week timeframe. It does not explain this difference, the visit schedule, treatment adherence procedures, or follow-up after treatment. These design details can affect the interpretation of safety and efficacy data, but should not be inferred from the study title alone.
The registry lists five outcome measures and identifies several secondary outcomes, but it reports zero analyses in the record. Accordingly, the design information establishes the broad comparison and study structure, not how each endpoint was analyzed or which analysis populations were used.
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 | TA-7284-Low | TA-7284-High |
|---|---|---|
| STARTED | 584 | 715 |
| COMPLETED | 532 | 641 |
| NOT COMPLETED | 52 | 74 |
Reasons for not completing this period:
| Reason | TA-7284-Low | TA-7284-High |
|---|---|---|
| Adverse Event | 20 | 30 |
| Lack of Efficacy | 1 | 0 |
| Physician Decision | 3 | 10 |
| Withdrawal by Subject | 27 | 31 |
| Clearly not eligible for the study | 1 | 3 |
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 | TA-7284-Low | TA-7284-High | Total |
|---|---|---|---|---|
| Participants analysed | 584 | 715 | 1299 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 436 | 520 | 956 |
| Age, Categorical: >=65 years | Participants | 148 | 195 | 343 |
| Sex: Female, Male: Female | Participants | 163 | 212 | 375 |
| Sex: Female, Male: Male | Participants | 421 | 503 | 924 |
6. Primary Endpoint
The registry lists the primary outcome as Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, measured over 54 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of incidences |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled “Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events.” Its unit is described as percentage of incidences, its parameter as number, and its timeframe as 54 weeks. The record does not give a fuller endpoint definition, including how events were classified, how recurrent events were counted, or how the percentage was calculated. A numerical result for the primary endpoint is not reported in the registry record.
In general, adverse-event endpoints are used to describe unwanted events observed during a study, while a hypoglycemic-event measure focuses on a specified safety event of particular relevance to the studied population and treatment context. Reporting these outcomes can help characterize the types and frequency of events recorded during follow-up. A percentage can communicate the share of a defined group with an event, but interpretation depends on the denominator, observation period, event definition, and analysis population.
Here, the registry’s adverse-event section supplies group counts at risk and counts affected for serious and other adverse-event categories. Those counts are useful descriptive safety information, but the record does not show how they map to the primary endpoint’s stated percentage of incidences or provide a separate hypoglycemic-event result. The secondary outcomes include change in HbA1c, fasting plasma glucose, body weight, and blood pressure. Their values and analysis details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety figures are descriptive counts for the TA-7284-Low and TA-7284-High groups. For serious adverse events, the registry lists 30 affected participants among 584 at risk in the low group and 32 among 715 at risk in the high group. For the registry’s other adverse-event category, it lists 371 affected among 584 at risk in the low group and 464 among 715 at risk in the high group. The accompanying tables and plots should be read as presentations of these posted data, not as a substitute for information about event definitions or analysis methods.
These figures do not, by themselves, establish whether the groups differ. The record does not provide a primary endpoint estimate, confidence interval, hypothesis test, adjustment for baseline factors, or account of follow-up time for the group comparison. The registry labels the primary outcome as a percentage of incidences, but does not report the numerical primary outcome result. The available counts therefore should not be treated as a complete analysis of that endpoint.
In general, a confidence interval describes the range of values compatible with a statistical estimate under the model used. It helps show the precision of an estimate, whereas a single count or point estimate does not convey that uncertainty. No confidence intervals for the primary outcome or these adverse-event counts are reported in the registry record. Similarly, the record supplies no inferential comparison from which to assess statistical uncertainty between groups.
The registry lists six serious adverse-event terms with percentages: Colonic polyp, 0.5%; Appendicitis, 0.3%; Large intestine carcinoma, 0.3%; Ankle fracture, 0.3%; Epiglottitis, 0.2%; and Gastroenteritis, 0.2%. These entries describe reported terms and percentages; the record does not provide the event counts, group-specific breakdowns, or denominator used for each percentage. The terms should not be interpreted as a complete account of all serious events.
The enrollment figure is 1299, while the adverse-event categories show group-specific numbers at risk. The record does not explain how those denominators relate to all enrolled participants, whether anyone was excluded from an analysis, or how missing follow-up was handled. Nor does it report deaths in these group entries; the death values are not populated. An unpopulated death field is not evidence that no deaths occurred.
The registry summary describes efficacy evaluation and lists secondary outcomes, but numerical efficacy results are not reported in the registry record. No conclusion about the size, precision, or direction of changes in HbA1c, fasting plasma glucose, body weight, or blood pressure can be drawn from the outcome names alone. The results are best understood as selected descriptive safety information within a trial whose full statistical analyses are not reported in the record.
9. Statistical Methods Explained
The registry identifies a randomized, parallel-group study. In general, randomization is intended to reduce systematic differences between treatment groups at the point of assignment. It does not guarantee identical groups, and it does not by itself ensure that later analyses are unbiased. The method used to generate the allocation sequence, conceal assignments, or implement randomization is not reported in the registry record. The allocation ratio is also not reported.
What does open-label mean for interpretation?
Open-label describes a study in which treatment assignment is not masked. In general, knowledge of assignment can affect participant behavior, clinical management, event reporting, and decisions about whether an observation qualifies as an outcome. These possibilities do not establish that bias occurred in this trial. The record does not state whether any outcome assessors or analysts were masked, nor does it describe procedures for adjudicating adverse events.
How should the adverse-event counts be read?
The safety data list, for each treatment group, a number at risk and a number affected in serious and other adverse-event categories. These are group-level counts, not a detailed event history. In general, a count of participants affected answers a different question from a count of all events: one participant may have more than one event, depending on the endpoint rules. The registry does not explain whether the figures count participants, event episodes, or another unit beyond the labels shown, and it does not define the “other” category in further detail.
The primary endpoint specifies percentage of incidences, but the record does not state the calculation denominator, whether recurrent events were included, or whether percentages were based on participants or event occurrences. The group counts should therefore be described as posted, without constructing an alternative percentage or assuming a specific event-counting rule. The registry also does not provide a time-to-event analysis or information about person-time.
Why can over-dispersion matter?
As a general statistical point, count outcomes can vary more than a simple model assumes, a condition often called over-dispersion. If present, it can make standard errors too small and confidence intervals too narrow when an analysis does not account for it. Repeated events within the same participant can also be statistically dependent. Whether these issues applied, and how the trial analysis addressed them, are not reported in the registry record. No model for the primary endpoint is specified.
What do the sample-size illustrations represent?
The sample-size section on the page gives planning illustrations based on fractions of the observed effect, using a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. These are planning examples, not the trial’s original design justification and not observed power. They do not show how many participants the trial actually needed under its protocol. The registry record does not report the original sample-size justification, the effect assumed at design, or the method used to determine enrollment.
In general, a sample-size calculation depends on the endpoint, the effect to detect, the variability or event rate, the chosen significance level, and the desired power. Changing those assumptions changes the planning result. A calculation made after results are available should not be read as evidence that the study had a particular probability of detecting the observed effect. The illustrations are distinct from the posted adverse-event counts and do not replace an analysis of those data.
What uncertainty and comparison information is missing?
The record reports zero analyses. It does not give a primary-outcome estimate, standard error, confidence interval, p-value, model specification, or adjusted comparison. Without such information, the descriptive figures cannot establish the precision of a group contrast. General statistical interpretation depends not only on the observed values but also on how uncertainty was quantified and what assumptions were used.
The record lists change in HbA1c, fasting plasma glucose, body weight, and blood pressure as secondary outcomes. It does not specify whether change was calculated from baseline, which follow-up measurement was selected, or how repeated measurements were handled. Nor does it state whether group comparisons were adjusted for baseline values or other covariates. Those analytic choices are not reported in the registry record.
Finally, the registry gives a 52-week administration period in its summary and a 54-week timeframe for the primary endpoint. The relationship between these periods, and the handling of observations outside or missing from the stated timeframe, is not reported. The endpoint results should therefore be interpreted within the limits of the outcome definitions and analysis details actually available.
10. Multiplicity, Missing Data and Analysis Populations
The record names a primary safety and tolerability outcome and lists secondary outcomes for HbA1c, fasting plasma glucose, body weight, and blood pressure. It also identifies hypoglycemic events within the primary outcome title and lists multiple serious adverse-event terms. When several outcomes or comparisons are examined, the chance of a false-positive finding can increase if each is tested separately. In general, multiplicity procedures may address this issue, but the registry record does not report whether any such procedure was planned or used.
The record does not state which endpoint was used to determine the study’s main conclusion, whether secondary outcomes were confirmatory or exploratory, or whether a hierarchy of testing was specified. With zero analyses listed, there are no posted statistical test results to assess for multiplicity adjustment. No adjustment should be assumed.
Missing-data methods and analysis populations are also not described. The record does not say whether analyses used all randomized participants, participants who received treatment, or another defined population. It does not report how incomplete follow-up, treatment discontinuation, missing measurements, or participants without evaluable outcome data were handled. The numbers at risk in the safety section do not establish the analysis population for the primary outcome or secondary outcomes.
These omissions limit interpretation of both the safety counts and any efficacy question. In general, different rules for including participants and handling missing observations can change an estimate and its uncertainty. The registry record does not allow readers to determine which rules applied in this study.
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 |
|---|---|---|---|
| TA-7284-Low | 30 | 584 | 5.1% |
| TA-7284-High | 32 | 715 | 4.5% |
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 |
|---|---|
| TA-7284-Low | 371 of 584 |
| TA-7284-High | 464 of 715 |
Most frequent serious adverse event terms
| Event term | Organ system | TA-7284-Low | TA-7284-High |
|---|---|---|---|
| Colonic polyp | Gastrointestinal disorders | 3 of 584 | 1 of 715 |
| Appendicitis | Infections and infestations | 1 of 584 | 2 of 715 |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 584 | 1 of 715 |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 584 | 1 of 715 |
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 584 | 2 of 715 |
| Acute myocardial infarction | Cardiac disorders | 1 of 584 | 1 of 715 |
| Myocardial ischaemia | Cardiac disorders | 1 of 584 | 1 of 715 |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | 1 of 584 | 1 of 715 |
| Ankle fracture | Injury, poisoning and procedural complications | 0 of 584 | 2 of 715 |
| Meniscus lesion | Injury, poisoning and procedural complications | 1 of 584 | 1 of 715 |
Most frequent non-serious adverse event terms
| Event term | Organ system | TA-7284-Low | TA-7284-High |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 176 of 584 | 223 of 715 |
| Hypoglycaemia unawareness | Metabolism and nutrition disorders | 54 of 584 | 66 of 715 |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | 44 of 584 | 59 of 715 |
| Hypoglycaemia | Metabolism and nutrition disorders | 44 of 584 | 44 of 715 |
| Constipation | Gastrointestinal disorders | 28 of 584 | 40 of 715 |
| Pharyngitis | Infections and infestations | 30 of 584 | 37 of 715 |
| Eczema | Skin and subcutaneous tissue disorders | 29 of 584 | 24 of 715 |
| Pollakiuria | Renal and urinary disorders | 24 of 584 | 29 of 715 |
| Bronchitis | Infections and infestations | 23 of 584 | 29 of 715 |
| Back pain | Musculoskeletal and connective tissue disorders | 16 of 584 | 33 of 715 |
Serious events with the highest arm-level rate: colonic polyp (0.5%), appendicitis (0.3%), large intestine carcinoma (0.3%), ankle fracture (0.3%), epiglottitis (0.2%).
The registry lists 30 serious-adverse-event-affected participants among 584 at risk in TA-7284-Low, and 32 among 715 at risk in TA-7284-High. For the “other” adverse-event category, it lists 371 affected among 584 at risk in the low group and 464 among 715 at risk in the high group. These are the posted group counts; they are not a complete statistical comparison between treatments.
In general, safety counts need to be interpreted alongside event definitions, exposure duration, follow-up, and the population used for analysis. The registry record does not describe these details for the displayed categories, nor does it provide confidence intervals or a test comparing groups. The counts should not be converted into additional rates or used to infer a treatment difference without the relevant analysis information.
The listed serious-event terms and percentages are Colonic polyp, 0.5%; Appendicitis, 0.3%; Large intestine carcinoma, 0.3%; Ankle fracture, 0.3%; Epiglottitis, 0.2%; and Gastroenteritis, 0.2%. Group-specific counts and the denominator for these term percentages are not reported in the registry record. Death values are not populated in the group entries, which does not establish that no deaths occurred.
12. What the Result Does, and Does Not, Mean
The posted record establishes that this was a randomized, open-label, parallel phase 3 study of TA-7284 in Japanese patients with type 2 diabetes mellitus. It identifies two treatment groups and provides selected descriptive safety counts. It also lists a primary outcome focused on adverse events and hypoglycemic events, with a 54-week timeframe, and names several secondary measures. These features describe the study’s intended scope, but they are not themselves evidence of a comparative treatment effect.
The serious and other adverse-event counts describe how many participants were listed as affected in each group and how many were at risk. The listed serious-event terms give additional descriptions of reported events. However, the record does not provide a numerical result for the primary endpoint as defined, a statistical comparison, or uncertainty estimates. It also does not provide numerical results for the secondary outcomes. Readers therefore cannot use this record alone to determine the magnitude or precision of differences between groups.
In general, a statistically interpretable comparison requires a defined outcome, a clearly described analysis population, an estimate of the contrast, and a measure of uncertainty. For safety data, event definitions and follow-up also matter. The registry record does not report these analysis details. The absence of a reported analysis is not evidence that no analysis was conducted elsewhere; it means that the analysis is not available in this registry record.
The sample-size illustrations elsewhere on the page are planning examples based on an observed effect, not the original design rationale and not observed power. They cannot establish whether the trial was adequately planned or whether an effect was detected. Likewise, the registry’s completed status does not by itself establish that all outcomes were reported.
The appropriate reading is therefore limited: the record documents the broad design, the stated safety focus, and selected event counts, while leaving key outcome and analysis information unavailable. It does not support a clinical recommendation or a conclusion that one group was better or worse.
13. Why This Trial Matters Statistically
This study illustrates an important distinction in registry interpretation: a trial may have a clearly named primary outcome and substantial enrollment while the available record still provides limited inferential results. The registry identifies safety and tolerability as the primary focus and lists group-level adverse-event counts, but the numerical primary endpoint result and analysis are not reported. Statistical interpretation should reflect that gap rather than treating descriptive counts as a formal comparison.
The trial also highlights why endpoint definitions matter. “Percentage of incidences” is stated as the unit, but the registry does not specify the denominator or event-counting rules. In general, percentage summaries can mean different things depending on whether they describe participants with events or event occurrences. Transparent definitions are necessary for readers to understand and reproduce a safety analysis.
Another useful lesson is that a registry’s broad design labels are not a full statistical methods section. Randomized, open-label, multicenter, and parallel describe important features, but do not reveal allocation procedures, masking of assessors, analysis populations, missing-data rules, or multiplicity handling. Those details can influence how confidently results are interpreted.
Finally, planning illustrations should be separated from a trial’s original design and from its observed results. The sample-size section uses stated assumptions for illustration; it is not evidence of the protocol’s justification or of observed power. Distinguishing design, analysis, and descriptive reporting helps prevent conclusions that go beyond what the record documents.
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 leaves important design details unresolved. Although the study is described as randomized and open-label, the allocation method, allocation ratio, concealment procedures, and any masking of assessors are not reported. The arm descriptions are blank, so the doses and treatment distinctions represented by TA-7284-Low and TA-7284-High are not specified. The summary mentions monotherapy or combination therapy with another oral anti-hyperglycaemic agent, but does not show how those approaches were distributed across groups.
The primary outcome is described as safety and tolerability assessed by adverse events and hypoglycemic events, expressed as percentage of incidences over 54 weeks. The event definitions and calculation rules are not reported. The summary describes 52 weeks of oral administration, and the registry does not explain how that period relates to the endpoint timeframe. The record also does not report a numerical primary-outcome result, a hypoglycemic-event result, or numerical results for the listed secondary outcomes.
The safety data include group counts at risk and affected, but the record does not define the “other” adverse-event category or explain the analysis population and follow-up behind these counts. The serious-event terms are accompanied by percentages without term-specific counts or denominators. Death entries are not populated, so their status cannot be determined from these fields.
There are zero analyses listed in the record. Statistical models, uncertainty estimates, missing-data methods, analysis populations, multiplicity procedures, and the original sample-size justification are not reported. The enrollment figure and completed status do not resolve these limitations. Together, these gaps constrain interpretation of the displayed counts and prevent a full assessment of comparative efficacy or safety from this record alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus — NCT01387737.
- Registry record last updated 2026-01-08; status last verified 2025-12.
- Results first posted 2014-04-28.
- 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 describes NCT01387737 as a completed phase 3 randomized, open-label, multicenter, parallel study sponsored by Tanabe Pharma Corporation. It lists enrollment of 1299, a study start of 2011-05, and primary completion in 2012-11. The population was Japanese patients with type 2 diabetes mellitus, and the listed groups were TA-7284-Low and TA-7284-High.
The primary outcome concerns safety and tolerability assessed by adverse events and hypoglycemic events, with a stated timeframe of 54 weeks. The study summary describes 52 weeks of oral administration and evaluation as monotherapy or combination therapy. Secondary outcomes include changes in HbA1c, fasting plasma glucose, body weight, and blood pressure.
The record reports selected adverse-event counts and serious-event terms, but lists zero analyses. Numerical primary and secondary outcome results, detailed endpoint definitions, and key statistical methods are not reported in the registry record. The accompanying tables, plots, and planning illustrations should be read with these limits in mind.