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 Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg in Asia Pacific Adults With Type 2 Diabetes (NCT01647542), a randomized phase 3 study. The primary outcome is Change From Baseline in HbA1c at Week 24.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01647542 |
| Phase | Phase 3 |
| Condition | Type 2 Diabetes Mellitus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 393 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Takeda |
| Results posted | Yes |
2. Clinical Question
Population
Adults in the Asia Pacific region with type 2 diabetes mellitus were the intended study population. The registry record describes a Full Analysis Set consisting of randomized participants who received at least 1 dose of double-blind study medication and had a baseline and at least 1 post-baseline measurement. More specific eligibility criteria, such as age limits or the countries represented, are not reported in the registry record.
Intervention
The active study arms received TAK-875 tablets orally once daily: one arm received 25 mg and another received 50 mg. Treatment was planned for up to 24 weeks. The registry record identifies TAK-875 as the study drug and gives these dose and schedule details.
Comparator
The comparator arm received placebo-matching tablets orally once daily for up to 24 weeks. The study is described as placebo-controlled, randomized, double-blind and quadruple-masked. The specific people or roles covered by the quadruple masking are not reported in the registry record.
Primary question
The primary endpoint asks how HbA1c changed from baseline to Week 24 in the study arms. The registry record names the endpoint as change from baseline in HbA1c at Week 24 and describes the planned summary as a least-squares mean. The question is whether the reported change differs between each TAK-875 dose and placebo, but the arm-level estimates and comparison results are not reported in the registry record. The endpoint description alone therefore does not establish the direction, size, or precision of any treatment contrast.
3. Trial Design
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The official title describes a 24-week comparison of daily oral TAK-875 at 25 mg and 50 mg with placebo in Asia Pacific subjects with type 2 diabetes. The registry record lists 393 participants as the enrollment. The status is terminated, with a study start of 2012-10 and primary completion of 2014-02. The reason for termination is not reported in the registry record.
The intervention descriptions specify oral tablets taken once daily for up to 24 weeks in each arm. The placebo tablets were described as matching TAK-875. Although the record says allocation was randomized, the randomization sequence method, allocation concealment process, and allocation ratio are not reported in the registry record. The record also does not specify how many study sites participated or which Asia Pacific countries were represented.
Quadruple masking is recorded, but the identities of the masked groups of people are not described. The record names the principal comparison as TAK-875 versus placebo and lists the active arms as TAK-875 25 mg and TAK-875 50 mg. Its safety-group labels use Fasiglifam 25 mg and Fasiglifam 50 mg. The relationship between those labels is not explained in the registry record, so the labels should be read as recorded rather than treated as an additional design detail.
The primary outcome is a continuous measure, change in HbA1c at Week 24. Secondary outcomes include the percentage of participants with HbA1c <7% at Week 24, change in fasting plasma glucose from baseline to Week 24, and change in 2-hour postprandial glucose after an oral glucose tolerance test at Week 24. The registry record does not describe the full statistical analysis plan or explain the study's termination.
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: Participants with a historical diagnosis of type 2 diabetes mellitus (T2DM) who were inadequately controlled when treated with only diet, exercise and any antidiabetic agent for less than or equal to (\<=) 7 days within 12 weeks prior to Screening, were enrolled in 1 of 3 treatment groups: placebo; fasiglifam 25 milligram (mg); fasiglifam 50 mg.
Overall Study
| Stage | Placebo | Fasiglifam 25 mg | Fasiglifam 50 mg |
|---|---|---|---|
| STARTED | 131 | 131 | 131 |
| COMPLETED | 55 | 58 | 59 |
| NOT COMPLETED | 76 | 73 | 72 |
Reasons for not completing this period:
| Reason | Placebo | Fasiglifam 25 mg | Fasiglifam 50 mg |
|---|---|---|---|
| Major Protocol Deviation | 1 | 0 | 0 |
| Adverse Event | 4 | 5 | 4 |
| Lost to Follow-up | 0 | 2 | 2 |
| Withdrawal by Subject | 6 | 4 | 0 |
| Study Termination | 64 | 61 | 65 |
| Lack of Efficacy | 1 | 1 | 0 |
| Death | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS) included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post-baseline value were included.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The randomized set included all participants who were randomized.
| Characteristic | Unit | Placebo | Fasiglifam 25 mg | Fasiglifam 50 mg | Total |
|---|---|---|---|---|---|
| Participants analysed | 131 | 131 | 131 | 393 | |
| Age, Continuous | years | 52.7 (SD 12.41) | 55.1 (SD 11.89) | 53.1 (SD 10.96) | 53.6 (SD 11.78) |
| Age, Customized: Less than (<) 65 years | Participants | 107 | 102 | 111 | 320 |
| Age, Customized: Greater than or equal to (>=) 65 years | Participants | 24 | 29 | 20 | 73 |
| Sex: Female, Male: Female | Participants | 64 | 61 | 44 | 169 |
| Sex: Female, Male: Male | Participants | 67 | 70 | 87 | 224 |
| Race/Ethnicity, Customized: Asian | Participants | 128 | 126 | 127 | 381 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 1 | 2 | 0 | 3 |
| Race/Ethnicity, Customized: White | Participants | 2 | 3 | 4 | 9 |
| Body Mass Index | Kilogram per square meter (kg/m^2) | 26.00 (SD 4.348) | 25.97 (SD 3.989) | 26.12 (SD 3.516) | 26.03 (SD 3.956) |
| Smoking Classification: Never smoked | Participants | 89 | 90 | 71 | 250 |
| Smoking Classification: Current smoker | Participants | 31 | 16 | 33 | 80 |
| Smoking Classification: Ex-smoker | Participants | 11 | 25 | 27 | 63 |
| Glycosylated Hemoglobin (HbA1c) Category: < 8.5 percent (%) | Participants | 98 | 99 | 107 | 304 |
| Glycosylated Hemoglobin (HbA1c) Category: >= 8.5% | Participants | 33 | 32 | 24 | 89 |
| Enrollment by Region: Australia | Participants | 6 | 5 | 6 | 17 |
| Enrollment by Region: China | Participants | 70 | 70 | 70 | 210 |
| Enrollment by Region: Korea, Republic of | Participants | 26 | 29 | 28 | 83 |
| Enrollment by Region: New Zealand | Participants | 1 | 2 | 1 | 4 |
| Enrollment by Region: Taiwan, Province of China | Participants | 28 | 25 | 26 | 79 |
| Duration of Diabetes | Years | 2.293 (SD 3.063) | 3.499 (SD 3.64) | 2.182 (SD 2.782) | 2.652 (SD 3.227) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in HbA1c at Week 24, measured over Baseline and Week 24.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | Standard Error |
| Unit | Percentage of Glycosylated Hemoglobin |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in HbA1c at Week 24, measured as a percentage of glycosylated hemoglobin. HbA1c represents glucose bound to hemoglobin; the endpoint description defines it as the concentration of glucose bound to hemoglobin relative to the absolute maximum that can be bound. The study therefore evaluates a change in a continuous laboratory measure over the treatment period.
In general, HbA1c is used in diabetes research because it provides an indicator related to glucose exposure over time, rather than a single glucose measurement at one moment. A baseline-to-follow-up change also allows the analysis to express how the measure shifted during the study. These are general features of the measure, not findings from this trial.
The registry record specifies a least-squares mean as the primary summary and a standard error as its dispersion measure. A least-squares mean is a model-based estimate; the specific model, covariates, and handling of repeated measurements are not reported in the registry record. The posted record does not give the arm-level changes, treatment contrasts, standard errors, confidence intervals, or p-values. Consequently, the endpoint definition clarifies what was intended to be assessed but not what the study found.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and its analysis population, but it does not report numerical results for change in HbA1c. There is no reported least-squares mean for any arm, no between-arm contrast, and no measure of uncertainty for the primary comparison. The available record therefore does not establish whether HbA1c changed, how the arms compared, or how precisely any contrast was estimated.
This distinction is important for reading a randomized trial. Random allocation is a design feature intended to support a fair comparison, but the design description is not itself evidence about the observed outcome. Interpretation of an efficacy comparison requires the results for the groups and an estimate of the contrast, together with information about its uncertainty. Those results are not reported in the registry record. No conclusion about the size or direction of an effect can be drawn from the endpoint title or treatment assignments alone.
The registry lists secondary outcomes concerning HbA1c below 7% at Week 24, fasting plasma glucose change, and 2-hour postprandial glucose change. Their names indicate what was measured, not their results. Numerical estimates for these outcomes are not reported in the registry record. The listed count of outcome measures and analyses does not substitute for arm-level estimates or explain how the analyses were conducted.
In general, a confidence interval describes the range of values reasonably compatible with the data under the analysis assumptions. It can show both the estimated direction and the uncertainty around an estimate. No confidence interval for the primary comparison is reported in the registry record. A p-value, when available, addresses compatibility of the data with a specified statistical null model; it does not by itself quantify the size or clinical importance of a difference. No primary p-value is reported in the registry record either.
The record states that the study was terminated, but the reason and any consequences for data collection or analysis are not reported in the registry record. Termination status alone does not reveal whether the study ended early, whether all planned assessments were completed, or why it ended. The record's stated completion timing cannot resolve those questions. Accordingly, the most defensible interpretation is descriptive: the trial was designed to compare two doses with placebo on HbA1c and other glucose measures, but the posted record does not provide the primary outcome results needed to interpret efficacy.
9. Statistical Methods Explained
What does a least-squares mean represent?
The primary outcome is summarized as a least-squares mean. In general, this is an estimated group mean from a statistical model rather than necessarily the raw arithmetic average of all observed values. A model can account for specified features of the design or data, but the result depends on the model and the terms included in it. The particular model, adjustment variables, and assumptions used for this trial are not reported in the registry record. The least-squares mean label therefore identifies the intended type of summary, but it is not enough to reproduce or fully assess the analysis.
For a treatment comparison, the contrast between group estimates is often central. A group mean describes an outcome within one arm; a contrast describes how estimates differ between arms under the chosen analysis. The registry record does not report the least-squares means or the contrasts for the primary endpoint. Thus, neither the magnitude nor direction of the primary comparison can be assessed from the posted outcome description.
What does the standard error describe?
The registry names the standard error as the dispersion measure for the primary outcome. In general, a standard error describes the sampling uncertainty of an estimated quantity, such as a mean. It is not the same as the spread of individual participants' measurements. Individual variability is commonly described using a measure such as a standard deviation, whereas a standard error concerns the uncertainty in an estimate. The record does not provide the numerical standard errors for the primary outcome.
A standard error can contribute to constructing a confidence interval when the relevant estimation details are available. Such an interval helps readers understand the precision of an estimate, not merely its point value. The registry record does not report confidence intervals for the primary outcome, and it does not identify a method for constructing them. No precision judgment about the primary comparison is therefore possible from the endpoint description alone.
Why is the outcome treated as continuous?
HbA1c is recorded as a quantitative percentage, and the primary endpoint is its change from baseline. In general, a continuous outcome retains more information about the range of measurements than converting it into a threshold category. The registry separately lists the percentage of participants with HbA1c <7% at Week 24 as a secondary outcome. A threshold outcome answers a different question from a mean change: it describes how many participants fall on one side of a specified cutoff, while a continuous change summary describes shifts in measured values.
The record does not report values for either type of outcome. It also does not state how the continuous measure was checked for model assumptions or how participants with missing Week 24 observations were handled. Those details matter because they can affect which observations contribute to an estimate and how much uncertainty is represented.
What does the analysis population mean?
The primary endpoint description identifies a Full Analysis Set consisting of randomized participants who received at least 1 dose of double-blind study medication and had a baseline and at least 1 post-baseline value. This definition makes clear that inclusion in the stated population depended on both treatment receipt and availability of outcome measurements. The number of participants meeting this definition, the number analyzed in each arm, and reasons for missing measurements are not reported in the registry record.
In general, analyzing participants according to their randomized assignment preserves the benefits of randomization, but the stated population definition also includes post-randomization conditions. The registry record does not explain whether other analysis populations were used, how participants were assigned in the analysis, or how protocol deviations were addressed. It does not describe a sensitivity analysis to test whether conclusions depended on the analysis population or missing-data assumptions.
What can planning assumptions tell readers?
The planning illustration is described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It is described as detecting a stated fraction of the observed effect. Such calculations are planning illustrations rather than evidence about what the trial observed. In particular, they are not observed power and do not establish the probability that a treatment effect is real. The registry record does not report the study's original sample-size justification or say whether those illustration assumptions were used to design the trial.
In general, sample-size calculations depend on assumptions about the effect to detect and the variability of the outcome, among other design choices. If those assumptions differ from the study's actual data, planning estimates may not describe the precision achieved. The calculations should not be interpreted as a substitute for the actual outcome estimates and their uncertainty. Numerical planning outputs are not reported in the registry record.
Which analysis choices remain unclear?
The registry identifies the primary measure, a summary type, a dispersion type, and an analysis population. It does not report the precise statistical model, the primary contrast specification, the method for handling missing data, or any interim analysis plan. It also does not report whether analyses were adjusted for multiple comparisons. General statistical practice can explain why these choices matter, but it cannot establish which choices were made in this trial. Interpretations beyond the stated design and outcome definitions would therefore require information not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several outcomes, including the primary HbA1c change and secondary measures of HbA1c threshold status, fasting plasma glucose, and postprandial glucose. It also records 4 outcome measures and 8 analyses. When a trial examines multiple outcomes, time points, or treatment comparisons, the chance of obtaining at least one apparently notable result can increase. In general, multiplicity procedures address this issue by controlling how evidence is evaluated across a defined family of tests. Whether any such procedure was used for this study is not reported in the registry record.
The posted record does not state the planned testing hierarchy, which comparisons were designated confirmatory, or whether secondary outcomes were adjusted for multiple testing. Because the primary numerical results are also not reported, the record does not permit an assessment of how multiplicity affected the interpretation of findings.
The Full Analysis Set definition requires a baseline and at least 1 post-baseline value. The number of participants excluded from this population, the pattern of missing measurements, and the reasons for missingness are not reported in the registry record. The record does not describe imputation, a likelihood-based approach, or sensitivity analyses for missing data. In general, missing-data methods rely on assumptions about why measurements are absent; different assumptions can yield different estimates. The record does not allow readers to judge those assumptions or their impact.
Randomized enrollment and analysis-population counts are distinct concepts. Although enrollment is recorded as 393, arm-level counts for the primary analysis population are not reported in the registry record. The stated population criteria alone do not show how many participants contributed to each endpoint analysis.
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 |
|---|---|---|---|
| Placebo | 5 | 131 | 3.8% |
| Fasiglifam 25 mg | 5 | 131 | 3.8% |
| Fasiglifam 50 mg | 8 | 131 | 6.1% |
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 |
|---|---|
| Placebo | 39 of 131 |
| Fasiglifam 25 mg | 51 of 131 |
| Fasiglifam 50 mg | 50 of 131 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | Fasiglifam 25 mg | Fasiglifam 50 mg |
|---|---|---|---|---|
| Liver function test abnormal | Investigations | 0 of 131 | 1 of 131 | 1 of 131 |
| Hypertensive heart disease | Cardiac disorders | 0 of 131 | 0 of 131 | 1 of 131 |
| Acute coronary syndrome | Cardiac disorders | 0 of 131 | 1 of 131 | 0 of 131 |
| Gastritis erosive | Gastrointestinal disorders | 1 of 131 | 0 of 131 | 0 of 131 |
| Intestinal obstruction | Gastrointestinal disorders | 0 of 131 | 1 of 131 | 0 of 131 |
| Pancreatitis acute | Gastrointestinal disorders | 0 of 131 | 0 of 131 | 1 of 131 |
| Cholecystitis | Hepatobiliary disorders | 0 of 131 | 0 of 131 | 1 of 131 |
| Hepatitis acute | Hepatobiliary disorders | 0 of 131 | 0 of 131 | 1 of 131 |
| Gastroenteritis | Infections and infestations | 1 of 131 | 0 of 131 | 0 of 131 |
| Pneumonia | Infections and infestations | 0 of 131 | 1 of 131 | 0 of 131 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Fasiglifam 25 mg | Fasiglifam 50 mg |
|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 8 of 131 | 6 of 131 | 8 of 131 |
| Nasopharyngitis | Infections and infestations | 5 of 131 | 10 of 131 | 6 of 131 |
| Hyperuricaemia | Metabolism and nutrition disorders | 2 of 131 | 2 of 131 | 12 of 131 |
| Dizziness | Nervous system disorders | 5 of 131 | 7 of 131 | 2 of 131 |
| Proteinuria | Renal and urinary disorders | 3 of 131 | 5 of 131 | 5 of 131 |
| Dyslipidaemia | Metabolism and nutrition disorders | 3 of 131 | 4 of 131 | 5 of 131 |
| Hyperlipidaemia | Metabolism and nutrition disorders | 4 of 131 | 6 of 131 | 2 of 131 |
| Blood creatine phosphokinase increased | Investigations | 3 of 131 | 5 of 131 | 3 of 131 |
| Headache | Nervous system disorders | 2 of 131 | 4 of 131 | 3 of 131 |
| Hypertension | Vascular disorders | 1 of 131 | 4 of 131 | 3 of 131 |
Serious events with the highest arm-level rate: hypertensive heart disease (0.8%), acute coronary syndrome (0.8%), gastritis erosive (0.8%), intestinal obstruction (0.8%), pancreatitis acute (0.8%).
The safety record lists 131 participants at risk in each of the Placebo, Fasiglifam 25 mg, and Fasiglifam 50 mg groups. Serious adverse events affected 5 participants in the Placebo group, 5 in the Fasiglifam 25 mg group, and 8 in the Fasiglifam 50 mg group. Other adverse events affected 39, 51, and 50 participants in those groups, respectively. These are participant counts, not measures of event severity beyond the record's serious-versus-other grouping.
The record lists six serious adverse-event terms at 0.8% each: hypertensive heart disease, acute coronary syndrome, erosive gastritis, intestinal obstruction, acute pancreatitis, and cholecystitis. The group attribution for these terms is not reported in the registry record. Death counts are not reported in the registry record.
In general, adverse-event counts describe events recorded during a study and do not, by themselves, establish that a study treatment caused an event. A comparison of safety also depends on how events were defined, collected, and followed, as well as on the duration of observation and participant exposure. Those additional details are not reported in the registry record. The listed counts should therefore be read as descriptive safety information, not as proof of a causal difference between groups.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this randomized study was designed to compare daily oral TAK-875 at 25 mg and 50 mg with placebo in adults with type 2 diabetes in the Asia Pacific region. It also identifies change in HbA1c at Week 24 as the primary endpoint and describes the analysis population and summary type. These details clarify the intended clinical and statistical question.
They do not reveal the answer to that question. The primary estimates, treatment contrasts, uncertainty intervals, and p-values are not reported in the registry record. The secondary outcome names also do not provide findings. It is therefore not possible to state from this record whether the groups differed, how large any difference was, or whether the estimates were precise.
In general, a statistically detectable difference and a clinically important difference are not identical concepts. Statistical evidence concerns the compatibility of observed data with a model and specified hypotheses; clinical importance concerns the meaning of the size of a difference in context. The registry record does not provide the numerical results needed to discuss either dimension for this trial. No treatment-effect claim follows from randomization, study completion timing, or the endpoint definition alone.
The safety information supplies counts of participants affected by serious and other adverse events, along with several serious-event terms. These counts are useful descriptions of what the record lists, but the record does not supply the detail needed to establish causality or make a comprehensive safety comparison. The reason the trial was terminated is also not reported. The appropriate reading is therefore limited: the design and some safety counts are recorded, while the primary efficacy results and several details needed for fuller interpretation are absent.
13. Why This Trial Matters Statistically
This trial illustrates why a clear design description and a complete results record serve different purposes. Randomization, masking, a placebo comparison, and a prespecified continuous endpoint describe how investigators intended to compare groups. They help readers understand the structure of the evidence, but they cannot replace the estimated outcomes. Without the numerical HbA1c results and their uncertainty, the central comparison cannot be evaluated.
The study also makes the analysis population important. The stated Full Analysis Set requires treatment exposure and both baseline and post-baseline information. Those criteria can affect which participants contribute to the endpoint analysis. Without analysis counts by arm, missing-data methods, or sensitivity analyses, readers cannot assess how the analyzed participants relate to the randomized group.
Several outcome measures and analyses are recorded, making the prespecified testing strategy relevant to interpretation. In general, a transparent analysis plan helps readers distinguish the main confirmatory question from secondary or exploratory questions and understand how multiple comparisons were handled. That plan is not reported in the registry record.
Finally, the terminated status and the safety counts are part of the record but do not explain the outcome of the primary comparison or the reason for termination. Statistically, the key lesson is that design information, endpoint definitions, and safety summaries are not substitutes for effect estimates, uncertainty, and transparent account of missing data and analysis decisions. Those details are needed to judge what the observed data support.
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 most important limitation for interpretation is that the registry record does not report the primary HbA1c results. It names the endpoint and analysis summary but gives no group estimates, contrast, standard errors, confidence intervals, or p-values. Without these, the main efficacy comparison cannot be quantified or assessed for precision.
The record does not provide the reason the study was terminated or describe whether termination affected follow-up, endpoint collection, or the analysis plan. It also does not report participant flow by arm, the number meeting the Full Analysis Set definition, or the number contributing data at Week 24. These omissions limit assessment of completeness and attrition.
Several analysis details are not reported in the registry record, including the statistical model, covariate adjustment, missing-data method, sensitivity analyses, and multiplicity procedure. The randomization method, allocation ratio, site count, and countries represented are also not specified. The masking level is recorded as quadruple, but the masked roles are not identified.
The listed safety counts lack the event-collection details needed for a full comparative safety interpretation. The registry does not report death counts, and the listed serious-event terms are not attributed to a group. The record's different names for intervention arms and safety groups are not reconciled. These limitations do not demonstrate that any particular bias or harm occurred; they describe what cannot be evaluated from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg in Asia Pacific Adults With Type 2 Diabetes — NCT01647542.
- Registry record last updated 2015-11-11; status last verified 2015-10.
- Results first posted 2015-08-19.
- 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
NCT01647542 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in adults with type 2 diabetes in the Asia Pacific region. It compared daily oral TAK-875 at 25 mg and 50 mg with matching placebo for up to 24 weeks. The registry record lists enrollment of 393, a start of 2012-10, primary completion of 2014-02, and status as terminated.
The primary endpoint was change from baseline in HbA1c at Week 24, summarized as a least-squares mean with standard error. The record describes the Full Analysis Set criteria and lists secondary glucose-related outcomes. It also records participant counts for serious and other adverse events. The reason for termination and the numerical primary efficacy results are not reported in the registry record. The record therefore describes the design and selected safety information, but does not support an interpretation of the primary treatment comparison.