Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus (NCT01826370), a registered phase not stated study. The primary outcome is Frequency of Adverse Events and Serious Adverse Events.

2. Clinical Question

This is a descriptive safety question, not a test of whether linagliptin performs better than another treatment or than no treatment. Without a suitable comparison group, the recorded event frequency cannot by itself establish how much of the observed experience is attributable to the drug rather than to patients’ underlying conditions, other care, or circumstances of follow-up. The study description also names tolerability and efficacy as aims, and lists change in HbA1c and fasting blood sugar from baseline to Week 24 as secondary outcomes. However, analyses of those outcomes are not reported in the registry record. The evidence available therefore addresses the posted safety counts, not the full range of aims in the study description.

3. Trial Design

The registry describes a prospective, non-interventional, open-label, multicenter, post-marketing surveillance study of linagliptin among Filipino patients with type 2 diabetes mellitus. Its stated study duration was 24 weeks, and the primary outcome timeframe is Week 24. Enrollment is listed as 678. The study status is terminated; start and primary-completion dates are recorded as 2012-05 and 2013-10, respectively. Boehringer Ingelheim is listed as sponsor.

Non-interventional means the study description does not present treatment assignment as a randomized trial procedure. Open-label means the study is described as not masked. These features make the results observational and descriptive: the posted event counts do not constitute a randomized comparison. The registry record does not state an allocation method, and it does not present a like-for-like control arm. An arm description beyond the listed linagliptin intervention is not reported in the registry record.

The primary safety outcome is defined for a safety analysis set consisting of patients who took at least one dose and participated in the follow-up visit, with both baseline and end-point evaluation. The adverse-event figures use 660 as the number at risk for the listed linagliptin group. This is not the same population definition as enrollment; the registry does not report a participant flow explaining the difference. Reasons for non-inclusion in the safety analysis set are not reported in the registry record.

The registry lists change from baseline to Week 24 in HbA1c and fasting blood sugar as secondary outcomes. Detailed methods for these measures, including their analysis populations and statistical procedures, are not reported in the registry record. The study is terminated, but the reason for termination is not reported in the registry record. The record does not state whether termination changed follow-up or outcome collection.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Safety analysis set which consisted of all patients who have taken at least one dose of linagliptin and participated in the follow-up visit, thus, having a baseline and end-point evaluation.

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: Safety analysis set which consisted of all patients who have taken at least one dose of linagliptin and participated in the follow-up visit, thus, having a baseline and end-point evaluation.

6. Primary Endpoint

The registry lists the primary outcome as Frequency of Adverse Events and Serious Adverse Events, measured over Week 24.

The primary endpoint is the frequency of adverse events and serious adverse events by Week 24, expressed as a percentage of participants. Its description specifies events in an actual clinical setting and includes hypoglycemic events. The endpoint is intended to describe safety experience during the observation period; it is not a measure of comparative efficacy.

In general, an event frequency places event counts in the context of the participants assessed. A denominator matters because a count alone does not show how many people were observed. The registry identifies the safety analysis set and records 660 at risk for the linagliptin group. It reports zero serious adverse events and zero other adverse events for that group. No percentage should be inferred from those counts unless an explicitly reported percentage is available; an independently calculated value would not be a posted result.

In general, safety outcomes are useful in surveillance because they describe events recorded during exposure and follow-up, including events that may be uncommon or clinically important. However, interpretation depends on how events were defined, sought, classified, and followed. Those operational details are not reported in the registry record. The endpoint also depends on attendance and the availability of baseline and end-point evaluations, because those are part of the safety-set definition. It therefore describes the defined analysis population, not necessarily every person enrolled.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record describes a prospective observational surveillance study and reports an event-frequency outcome. That design and outcome call for descriptive interpretation. The reported counts summarize events in the defined safety analysis set; they do not estimate a randomized treatment contrast. No analysis methods or analysis results are listed in the registry record.

What does an event frequency describe?

In general, a participant-level event frequency relates the number of participants with an event to the number assessed. It differs from a count of all event episodes if one participant can experience more than one event. The primary outcome is described as a percentage of participants, while the adverse-event record reports counts of zero for serious events and zero for other events, with 660 at risk. The record does not explain whether repeated episodes were tabulated separately or how event terms were coded, so the counts should not be expanded into assumptions about event-level details.

When an event is not recorded in an observed group, the result describes that dataset. It does not establish that the underlying event probability is exactly zero. General statistical inference would express uncertainty around an estimate, often with a confidence interval. Such an interval is not reported in the registry record. Its absence means that the posted results do not directly show how wide the range of values compatible with the observations might be.

Why does the analysis population matter?

The safety population includes patients who took at least one dose and attended follow-up with baseline and end-point evaluations. This definition is important because the event counts apply to people meeting those criteria, not automatically to all enrolled patients. In general, restricting an analysis to participants with observed follow-up can create selection concerns if inclusion is related to outcome experience. The registry does not report the reasons for missing follow-up or an assessment of how missingness might affect the results.

The record lists 678 enrolled and 660 at risk for the safety outcome. Those figures refer to different roles in the study record. They should not be treated as interchangeable denominators, and the record does not give a participant-flow account that explains the difference. The safety outcome denominator is the relevant one for interpreting the adverse-event counts as recorded.

What can an observational design establish?

In general, prospective observation can document events as participants are followed in clinical practice. It can help characterize what was recorded in the setting studied. But without a randomized, comparable control group, differences from an external expectation or another population may reflect differences in patient characteristics, coexisting conditions, care, event detection, or follow-up. Here, the registry does not describe a like-for-like control comparison. Consequently, the posted counts are not a comparative estimate and do not identify a causal effect of treatment.

Open-label status means that the study is described as not masked. In general, knowledge of treatment can influence reporting, follow-up, or attribution of events. The record does not describe specific safeguards or event-adjudication procedures, so their presence or absence cannot be determined.

How should planning calculations be understood?

The stated planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial itself used that design. The study record describes surveillance rather than a randomized two-arm comparison, so the assumptions do not turn its safety counts into a controlled trial result. Sample-size planning values are illustrations rather than observed power. The registry does not report a protocol sample-size justification, and that justification is not reported in the registry record.

More generally, power is a design-stage probability under specified assumptions about an effect, variability, allocation, and analysis. It is not a measure of the probability that a reported result is true. A post hoc calculation based on observed results does not show that a study was adequately planned. The record does not report an interim-analysis plan or a statistical analysis plan.

What analysis details are absent?

The registry record lists no analyses. It does not report confidence intervals, hypothesis tests, covariate adjustment, subgroup analyses, or procedures for handling repeated measurements. It also does not report detailed definitions or ascertainment rules for adverse events. These omissions limit assessment of reproducibility and precision. General statistical principles can clarify what such methods would mean, but they cannot substitute for methods or results that are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary safety outcome and two secondary measures: change from baseline to Week 24 in HbA1c and change from baseline to Week 24 in fasting blood sugar. Considering several outcomes can raise multiplicity concerns. In general, the more separate hypotheses assessed, the greater the chance that at least one appears notable by chance if each is tested without adjustment. Whether an adjustment is needed depends on the intended inferential goals and analysis plan. A multiplicity strategy is not reported in the registry record.

The record does not report analyses for the secondary measures. Their results, estimates, uncertainty intervals, and analysis populations are therefore not reported in the registry record. The number of listed outcome measures does not establish that every outcome was measured or analyzed for every enrolled participant.

The primary safety population requires at least one dose, a follow-up visit, and baseline and end-point evaluation. This definition excludes people without the required assessments from that particular analysis. In general, missing outcomes can affect a result when the probability of being observed is related to a participant’s health or event experience. Statistical methods can address some missing-data situations, but the choice depends on why data are missing and what assumptions are defensible. The registry does not report missing-data methods, the extent or reasons for missing outcome data, or a sensitivity analysis.

It is also not reported in the registry record whether all prespecified outcomes and analyses were retained through termination. The reason for termination and any effect on assessment completion are not reported in the registry record. These gaps prevent a full evaluation of selective outcome availability or the robustness of the posted findings.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The registry reports zero serious adverse events and zero other adverse events for the linagliptin group, with 660 participants at risk. These are the reported counts; the record does not provide a percentage or an uncertainty interval for them. The primary outcome timeframe is Week 24, and the stated safety population requires at least one dose and a follow-up visit with baseline and end-point evaluation.

A zero count means that the registry reports no events in the relevant category for the participants included in that analysis. It should not be interpreted as proof that such events are impossible or that no events could occur outside the observed follow-up. In general, event detection depends on how participants are monitored and how events are defined and recorded. Detailed ascertainment and classification procedures are not reported in the registry record.

The registry’s death field does not report a count. The record therefore does not establish a death count for interpretation. In addition, because the study is non-interventional and has no like-for-like control comparison, the counts cannot be used to estimate a comparative safety effect or attribute events causally. They describe the recorded experience in the specified analysis set only.

12. What the Result Does, and Does Not, Mean

The posted primary outcome describes safety-event counts during the stated Week 24 timeframe among the defined safety analysis set. The registry records zero serious adverse events and zero other adverse events for the linagliptin group, with 660 participants at risk. The result is descriptive: it tells readers what counts are recorded for that population and follow-up, not what would have happened under an alternative treatment.

It does not establish that serious or other adverse events cannot occur. A result with no recorded events can still leave uncertainty about the event frequency in a wider population, particularly when precision intervals and details of event ascertainment are not reported. The registry does not provide a confidence interval, a comparative estimate, or analyses that adjust for differences between treatment groups.

It also does not answer the study’s listed glycemic questions. HbA1c and fasting blood sugar changes from baseline to Week 24 appear as secondary outcomes, but their analyses are not reported in the registry record. The record therefore does not support a conclusion about change in either measure. The study description names efficacy and tolerability, but the available results do not establish findings for those broader aims.

The observational, open-label design can describe clinical-setting experience but cannot isolate treatment effects in the way a suitable randomized comparison is intended to do. The safety-set definition further means the counts pertain to people with the required follow-up and assessments, rather than necessarily everyone enrolled. The reason for the difference between enrollment and the safety-set denominator is not reported.

The study’s terminated status is relevant context, but the reason for termination and its effect on data collection are not reported in the registry record. Without that information, the completeness of follow-up and analyses cannot be assessed. The most defensible interpretation is therefore narrow: the record posts zero counts for the specified adverse-event categories in the stated safety population, while leaving comparative effects, precision, missing-data implications, and secondary outcome results unresolved.

13. Why This Trial Matters Statistically

This study matters statistically because safety surveillance and treatment-effect evaluation answer different questions. A prospective, non-interventional study can document events recorded during clinical use, and the registry specifies a Week 24 safety outcome that includes hypoglycemic events. Such descriptive evidence can add context about observed experience in the population and setting under study.

At the same time, the design places clear limits on inference. The record does not describe a like-for-like control comparison, so the event counts do not estimate a relative effect. They cannot distinguish events related to treatment from events arising from underlying illness, other care, or other circumstances. A precise description of the observed counts is useful, but it should not be mistaken for causal evidence.

The analysis population is another important statistical feature. The safety set requires treatment exposure and completed baseline and end-point evaluation at follow-up. The reported counts therefore depend on who met that definition. Since the registry does not explain why the safety denominator differs from enrollment, readers cannot assess whether inclusion in the analysis might be associated with outcomes.

The study also lists two glycemic secondary outcomes, but analyses of them are not reported. This illustrates why a registry’s stated objectives and its posted results must be distinguished: an outcome listed as planned does not itself supply evidence about that outcome. The record does not report a statistical analysis plan, multiplicity approach, or confidence intervals, making it harder to assess inferential precision and the handling of multiple outcomes.

Finally, terminated status and absent details about the reason for termination underscore the importance of transparent reporting. They do not invalidate the recorded counts, but they limit evaluation of completeness and context. The statistical value of the record lies in what it explicitly documents, alongside clear recognition of what it does not establish.

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.

Several trial-specific limitations constrain interpretation. The study is described as non-interventional, open-label, and without a like-for-like control comparison. The record does not state an allocation method. Accordingly, the primary safety counts are not a randomized comparison and cannot establish a causal treatment effect.

The safety analysis set is defined by exposure and follow-up completion, including baseline and end-point evaluation. The registry lists enrollment of 678 and 660 at risk for the safety outcome, but does not provide a participant-flow explanation for the difference. Reasons for missing follow-up, the characteristics of people excluded from the safety set, and methods for handling missing data are not reported in the registry record.

For the primary outcome, the registry reports counts but does not report a confidence interval or a comparative estimate. Detailed adverse-event definitions, ascertainment procedures, and classification methods are also not reported in the registry record. The death count is not reported. These gaps prevent fuller assessment of precision, completeness, and event recording.

Although HbA1c and fasting blood sugar changes from baseline to Week 24 are listed as secondary outcomes, their analyses are not reported. A statistical analysis plan, multiplicity handling, and interim-analysis information are not reported in the registry record. The stated sample-size assumptions are planning illustrations and do not establish the study’s design rationale or observed power.

The study is marked terminated, but the reason and implications for follow-up or outcome collection are not reported in the registry record. Dose details and a fuller intervention description are also not reported. These limitations do not change the posted event counts, but they restrict the conclusions that can reasonably be drawn from them.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus — NCT01826370.
• Registry record last updated 2014-09-18; status last verified 2014-09.
• Results first posted 2014-09-18.
• 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.

18. Record Summary

The registry describes NCT01826370, “Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus,” as a prospective, non-interventional, open-label, multicenter post-marketing surveillance study. Boehringer Ingelheim is listed as sponsor. The study is marked terminated; enrollment is 678, with start and primary-completion dates recorded as 2012-05 and 2013-10.

The primary outcome is the frequency of adverse events and serious adverse events, including hypoglycemic events, at Week 24. In the defined safety analysis set, the registry lists 660 at risk and reports zero serious adverse events and zero other adverse events. A like-for-like control comparison is not described.

Change from baseline to Week 24 in HbA1c and fasting blood sugar are listed as secondary outcomes, but their analyses are not reported in the registry record. The reason for termination, detailed event-ascertainment procedures, missing-data methods, and an analysis plan are also not reported.