Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus (NCT02916706), a registered phase 3 study. The primary outcome is Change in HbA1c From Baseline to Week 24.

2. Clinical Question

3. Trial Design

The registry record describes a prospective, multi-centre, parallel-group, double-blind, placebo-controlled phase 3 study of teneligliptin, also identified in the brief summary as MP-513. Its title identifies the population as Chinese patients with type 2 diabetes mellitus. The record gives an enrollment of 254 and a completed status. It lists a start date of 2016-09 and a primary completion date of 2018-08-14.

The two listed regimens were teneligliptin 20mg once daily for 24 weeks and placebo for 24 weeks. The design field identifies a parallel model, meaning the listed treatment groups are considered separately rather than describing a crossover. The masking field says quadruple. Which people or roles were masked is not reported in the registry record, so the masking label alone does not establish the practical details of concealment or the success of masking.

There is an important qualification when interpreting the comparison. The brief study description calls the study randomized, but allocation is not stated in the comparison information, and that information cautions that the arms are not a like-for-like control comparison. The registry record does not explain this inconsistency. Consequently, the design description can be reported, but the basis for treating the posted arms as a randomized causal comparison is not clear from the record.

The primary endpoint is change in HbA1c from baseline to Week 24. Fasting plasma glucose change at Week 24 is listed as a secondary outcome. The registry lists two outcome measures but reports no analyses. The analysis methods, actual analysis populations beyond the primary endpoint definition, and numerical efficacy findings are not 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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period and have at least one post-baseline efficacy observation. Subjects who were not diagnosed with type 2 diabetes mellitus were excluded.

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: FAS: All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period and have at least one post-baseline efficacy observation. Subjects who were not diagnosed with type 2 diabetes mellitus were excluded.

6. Primary Endpoint

The registry lists the primary outcome as Change in HbA1c From Baseline to Week 24, measured over at Day 1(baseline) and Week 24.

The primary endpoint is change in HbA1c from baseline to Week 24, expressed as a percentage of HbA1c. It represents a within-participant change over the stated follow-up period, summarized for each treatment group using a least-squares mean. The endpoint description says the comparison was performed on the full analysis set, defined as randomized participants who received at least one dose of study medication during the double-blind period and had at least one post-baseline efficacy observation; participants without a diagnosis of type 2 diabetes mellitus were excluded.

HbA1c is used in clinical research as a measure of longer-term glycaemia. In general, measuring change from a baseline value can describe how an outcome shifts during follow-up while accounting for where participants started. A between-group comparison of changes can help distinguish the pattern in one assigned group from change over the same period in a comparator group. The registry record does not explain the specific rationale for choosing this endpoint or the model used to calculate the least-squares means.

Least-squares means are model-based group summaries; their interpretation depends on the model and any included terms. Those details, the estimated changes, their standard errors, the between-group contrast, and its confidence interval are not reported in the registry record. The endpoint is therefore defined, but its numerical result and precision cannot be described from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a continuous outcome: change in HbA1c from baseline to Week 24. The registry identifies the summary as a least-squares mean and the dispersion measure as a standard error. Those labels describe the intended form of the result, but the numerical results are not reported in the registry record. The model specification, covariates, and exact calculation procedure are also not reported.

What does a least-squares mean represent?

In general, a least-squares mean is a model-based estimate of a group mean. It can differ from a simple arithmetic average when the analysis model includes other terms, such as baseline values or design factors. The estimate is interpreted in light of the model used to obtain it. Since the registry record does not identify the model terms or report the estimates, it is not possible to determine what adjustment was made or to compare the model-based result with a raw group average.

What does a standard error describe?

In general, a standard error describes the sampling precision of an estimated quantity. It is not the same as the variability of individual participants’ measurements. A standard error can help characterize uncertainty around an estimated mean, and it can contribute to a confidence interval when the relevant method and assumptions are specified. The standard errors for the primary endpoint are not reported in the registry record, so the precision of the estimated changes cannot be assessed.

How should a between-group result be read?

For a two-group endpoint, the central comparison is the estimated contrast between the groups, alongside its uncertainty. A difference in group means is not, by itself, enough to describe how precisely that difference is estimated. In general, the contrast and its confidence interval are more informative than considering each group estimate in isolation. The registry record does not report the contrast or its uncertainty, so no direction, magnitude, or precision can be stated. It also does not report a primary-outcome test result.

What does the endpoint population mean?

The endpoint description specifies a full analysis set comprising randomized participants who received at least one dose during the double-blind treatment period and had at least one post-baseline efficacy observation. It also excludes participants who were not diagnosed with type 2 diabetes mellitus. This definition identifies eligibility for the stated endpoint analysis, but does not give the number of participants included or explain how observations were handled after treatment discontinuation or missed visits.

In general, analysis populations matter because conclusions refer to the participants represented in the analyzed data. Different inclusion rules can affect both the estimate and its uncertainty. The registry does not report whether other analysis populations were used, whether the primary analysis followed an intention-to-treat principle, or whether a per-protocol or safety population was used for efficacy analyses.

Why do allocation and masking details matter?

The brief description calls the study randomized and double-blind, while the comparison information says allocation is not stated and the arms are not a like-for-like control comparison. The discrepancy is not explained in the registry record. Random allocation, when present and properly implemented, is generally intended to reduce systematic differences between groups at baseline. Masking is generally intended to reduce the influence of knowledge about assigned treatment on conduct or assessment. The record’s quadruple-masking label does not identify who was masked or provide details about implementation. These design terms therefore give context, but do not resolve the caution about comparing the arms.

What can planning calculations establish?

General sample-size planning calculations describe hypothetical requirements under specified assumptions. They do not show how much power the completed trial actually achieved, and they are not observed results. The planning assumptions associated with this record specify a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect defined as a stated fraction of the observed effect. The numerical planning illustrations are based on the observed effect, but the primary numerical effect is not reported in the registry record. Such illustrations should therefore be understood as planning scenarios, not evidence that the trial did or did not detect an effect. They are not a substitute for the estimate and uncertainty from the primary analysis.

Over-dispersion is a general concern when count data vary more than a statistical model expects; it can make standard errors and tests based on an overly restrictive model unreliable. The primary endpoint is continuous, and no over-dispersion analysis is reported in the registry record. No further model checks, assumptions, or sensitivity analyses are described.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Teneligliptin 20mg", "Placebo")
n   <- c(125, 126)
m   <- c(-0.95, -0.14)
sp  <- c(0.06, 0.06)
sd  <- sp * sqrt(n)      # standard errors converted to SDs
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Teneligliptin 20mg  125  -0.950  0.671  -1.069  -0.831
CARM  Placebo  126  -0.140  0.673  -0.259  -0.021

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists a primary endpoint of change in HbA1c from baseline to Week 24 and a secondary outcome of change in fasting plasma glucose at Week 24. It lists two outcome measures and zero analyses. Numerical results for either outcome are not reported in the registry record.

Multiplicity arises in general when several outcomes, time points, subgroups, or statistical comparisons are tested. Testing multiple questions can increase the chance of obtaining at least one apparently unusual result by chance if the tests are treated as independent opportunities for a finding. Researchers may address this through a prespecified hierarchy, adjustment, or another strategy. The registry record does not report a multiplicity procedure, a testing hierarchy, or whether the listed secondary outcome was part of a confirmatory testing plan. It is therefore not possible to determine how the primary and secondary questions were intended to relate statistically.

Missing-data handling is also not reported in the registry record. The primary endpoint population requires at least one post-baseline efficacy observation, but this eligibility rule does not explain how missing Week 24 measurements were handled, whether any values were imputed, or which assumptions underlay the analysis. The number of participants with missing endpoint data and the reasons for missingness are not reported.

The registry defines the full analysis set, but the size of that set is not given. Enrollment of 254 should not be treated as the number included in the primary endpoint analysis. No sensitivity analyses or alternative analysis-population results are reported. These omissions limit assessment of how robust the primary result might be to missing observations, analysis choices, or multiple testing; in this case, the primary result itself is not reported either.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: angina pectoris (0.8%), coronary artery disease (0.8%), gastritis (0.8%), appendicitis (0.8%), splenic rupture (0.8%).

The safety figures list 127 participants at risk in each group for serious adverse events. Serious adverse events are recorded for 6 participants in the teneligliptin 20mg group and 4 participants in the placebo group. Deaths are listed as 0 in both groups. These are descriptive counts; the registry record does not report a statistical comparison, confidence interval, or assessment of whether the group difference could be due to chance.

The record also lists 69 participants affected by other adverse events in the teneligliptin group and 50 in the placebo group, with 127 at risk in each group. These figures are not a substitute for details about the type, timing, severity, or relationship of events to study treatment. The most frequent serious-event terms are each listed at 0.8%: angina pectoris, coronary artery disease, gastritis, appendicitis, splenic rupture, and blood glucose increased. The registry record does not provide further event-level context in these entries.

In general, safety counts describe what was recorded during the specified study period; they do not by themselves establish causation. Interpretation also depends on how events were defined, collected, and classified. Those details, and any formal safety analysis, are not reported in the registry record.

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

The registry record identifies a clinical question and describes how the primary endpoint was defined: change in HbA1c from baseline to Week 24, summarized using a least-squares mean in a specified full analysis set. It also describes the intervention and comparator regimens and lists safety counts. This is useful for understanding what the study was intended to assess and what information the record makes available.

The record does not report the numerical primary endpoint results. It therefore does not establish the observed direction or size of the HbA1c contrast, how precise that contrast was, or whether it met any statistical criterion. The secondary fasting plasma glucose result is likewise not reported. Without the estimates and uncertainty measures, the data cannot support a statistical conclusion about the comparative efficacy outcome.

Even when an estimate is available, a statistical result is not identical to a clinical judgment. In general, an estimate describes a measured contrast, while a confidence interval describes uncertainty under the analysis assumptions. Decisions about clinical importance require context that the registry result alone may not provide. No medical advice or treatment recommendation follows from the information in this record.

The design description requires care as well. The brief summary calls the study randomized, but allocation is not stated in the comparison information, which cautions that the arms are not a like-for-like control comparison. The registry record does not explain the inconsistency. Thus, the listed groups and their outcomes should not automatically be interpreted as a clean randomized treatment contrast.

The safety entries show counts of serious and other adverse events and zero recorded deaths in each group. These figures are descriptive and do not, on their own, establish whether an event was caused by treatment or whether a difference between groups is statistically reliable. Overall, the record permits a description of the planned question, endpoint, regimen, and posted safety counts, but does not provide the efficacy results needed to characterize the primary comparison.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of the distinction between a registered research question and a reported analysis result. The record specifies a phase 3, parallel-group study, its two regimens, a 24-week treatment period, and a primary outcome. It also gives a population definition for that outcome. Those details clarify what comparison was intended, but they do not supply the estimate needed to answer the primary statistical question.

For a continuous endpoint such as change in HbA1c, a useful report ordinarily includes the group estimates, the between-group contrast, and a measure of uncertainty. Each contributes different information: group summaries describe observed outcomes, the contrast describes the comparative estimate, and uncertainty measures characterize its precision. The registry record does not report those numerical results, so the listed endpoint cannot be interpreted for direction, size, or precision.

The record also illustrates why design labels need to be read alongside allocation information. Its brief description calls the trial randomized, while the comparison information says allocation is not stated and the arms are not a like-for-like control comparison. Since the record does not resolve this discrepancy, the strength of a causal interpretation cannot be assumed solely from the general design description.

Finally, planning calculations and observed results answer different questions. General sample-size planning describes what might be needed under assumptions; it does not establish the precision of a completed trial or its observed power. A numerical result and its uncertainty remain necessary for interpretation. The main statistical lesson is that endpoint definitions, design descriptions, analysis populations, and safety counts are valuable context, but cannot replace the missing efficacy estimates.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary limitation for interpreting efficacy is that the registry record does not report the primary endpoint estimate, between-group contrast, standard errors, confidence interval, or p-value. The listed secondary outcome, fasting plasma glucose change at Week 24, also has no reported result. Although the record lists two outcome measures, it reports zero analyses. Thus, the magnitude and precision of the principal efficacy comparison cannot be assessed.

The trial description and comparison information are not fully aligned. The brief summary describes a randomized study, while the comparison information says allocation is not stated and that the arms are not a like-for-like control comparison. The reason for this caution is not reported in the registry record. This prevents an unqualified interpretation of differences between the listed groups as the effect of randomized assignment.

The number enrolled is 254, but the number included in the primary analysis is not reported. The full analysis set definition requires at least one dose and at least one post-baseline efficacy observation; the record does not give the number meeting these criteria. It also does not report the extent or handling of missing Week 24 observations, model details, covariates, sensitivity analyses, or methods for multiplicity.

The safety figures are limited to counts and selected serious-event terms. Formal comparisons, confidence intervals, event definitions, and further details on collection or attribution are not reported in the registry record. These limitations mean the posted information supports a description of the study and its recorded counts, but not a complete assessment of efficacy, uncertainty, or comparative safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus — NCT02916706.
• Registry record last updated 2026-01-06; status last verified 2025-12.
• Results first posted 2022-01-28.
• 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.

19. Record Summary

The record describes a completed phase 3, parallel-group study of teneligliptin 20mg once daily versus placebo for 24 weeks in patients with type 2 diabetes mellitus. It lists enrollment of 254, a quadruple-masking label, a start date of 2016-09, and a primary completion date of 2018-08-14.

The primary endpoint is change in HbA1c from baseline to Week 24, summarized as a least-squares mean in a defined full analysis set. Fasting plasma glucose change at Week 24 is listed as a secondary outcome. Numerical efficacy analyses are not reported in the registry record. The record’s randomized-study description is qualified by comparison information stating that allocation is not stated and the arms are not a like-for-like control comparison.

Safety entries list serious adverse events for 6 of 127 participants in the teneligliptin group and 4 of 127 in the placebo group, with 0 deaths in each group. These counts are descriptive and do not replace a formal comparative analysis.