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 of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease (NCT01609582), a randomized phase 3 study. The primary outcome is Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01609582 |
| Phase | Phase 3 |
| Condition | Type 2 Diabetes, Cardiovascular Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 3207 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Takeda |
| Results posted | Yes |
2. Clinical Question
Population
Adults with type 2 diabetes and cardiovascular disease or multiple risk factors for cardiovascular events were eligible for the study described in the official title. The primary endpoint population was the Full Analysis Set, defined as randomized participants with a baseline assessment and at least one post-baseline assessment. The registry record does not report further eligibility details or the number meeting each eligibility criterion.
Intervention
The intervention was TAK-875 50 mg tablets, taken orally once daily for up to 6 years, in addition to standard of care. The registry lists the intervention name as TAK-875 and the treatment arm as Fasiglifam 50 mg. The registry record does not explain this naming difference.
Comparator
The comparator was placebo-matching tablets taken orally once daily for up to 6 years, in addition to standard of care. Participants were allocated to placebo or the active-treatment arm in a randomized, double-blind study. The registry does not report details of how the random sequence was generated or concealed.
Primary question
The primary question concerned time from randomization to the first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina, with or without revascularization. The study purpose was to demonstrate no excess risk of cardiovascular composite events with long-term TAK-875 treatment compared with placebo. The registry record does not report the primary comparison estimate or its confidence interval.
3. Trial Design
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The official title describes TAK-875 50 mg added to standard of care and evaluation of cardiovascular outcomes among adults with type 2 diabetes and cardiovascular disease or multiple cardiovascular risk factors. The registry lists an enrollment of 3207. That is the enrollment figure in the record; the primary endpoint results are not reported.
The treatment description specifies oral TAK-875 50 mg once daily and matching placebo once daily, each for up to 6 years. The intervention list names TAK-875, while the treatment arm is called Fasiglifam 50 mg. The record does not explain the difference in labels, so the naming is reported without assuming an explanation. The study status is terminated. Its start is recorded as 2012-06 and its primary completion as 2014-05. These dates do not establish why the study ended or whether the planned treatment duration was reached; that information is not reported in the registry record.
Randomization and masking help reduce bias in the allocation and assessment of outcomes. The record identifies masking as quadruple, but does not specify which roles were masked. It also does not provide details about the randomization procedure, treatment adherence, changes to treatment, or follow-up completeness.
The primary endpoint was a time-to-event measure analyzed using Kaplan-Meier analysis, according to its description. The endpoint timeframe is baseline to the end of study, stated as up to Day 588. The treatment descriptions separately state up to 6 years. The registry does not explain the relationship between these time descriptions. It reports no primary endpoint values or analyses with which to evaluate the treatment comparison.
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) and clinically-evident cardiovascular (CV) disease or multiple risk factors for CV events who were inadequately controlled while receiving the standard of care were enrolled in 1 of 2 treatment groups: placebo; fasiglifam 50 milligram (mg).
Overall Study
| Stage | Placebo | Fasiglifam 50 mg |
|---|---|---|
| STARTED | 1603 | 1604 |
| Treated | 1603 | 1601 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 1603 | 1604 |
Reasons for not completing this period:
| Reason | Placebo | Fasiglifam 50 mg |
|---|---|---|
| Adverse Event | 20 | 18 |
| Lost to Follow-up | 10 | 10 |
| Withdrawal by Subject | 21 | 15 |
| Study Terminated by Sponsor | 1543 | 1548 |
| Other | 9 | 10 |
| Randomized, but not treated | 0 | 3 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS) included all randomized participants who had baseline and at least 1 post-baseline assessment.
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 randomized participants.
| Characteristic | Unit | Placebo | Fasiglifam 50 mg | Total |
|---|---|---|---|---|
| Participants analysed | 1603 | 1604 | 3207 | |
| Age, Continuous | years | 63.9 (SD 9.03) | 63.4 (SD 9.20) | 63.7 (SD 9.12) |
| Age, Customized: Less than (<) 65 years | participants | 794 | 851 | 1645 |
| Age, Customized: Greater than or equal to (>=) 65 years | participants | 809 | 753 | 1562 |
| Sex: Female, Male: Female | Participants | 543 | 563 | 1106 |
| Sex: Female, Male: Male | Participants | 1060 | 1041 | 2101 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 150 | 119 | 269 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 446 | 477 | 923 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1007 | 1008 | 2015 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | participants | 47 | 41 | 88 |
| Race/Ethnicity, Customized: Asian | participants | 199 | 205 | 404 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | participants | 6 | 7 | 13 |
| Race/Ethnicity, Customized: Black or African American | participants | 79 | 95 | 174 |
| Race/Ethnicity, Customized: White | participants | 1265 | 1246 | 2511 |
| Race/Ethnicity, Customized: Multiracial/More than 1 race | participants | 7 | 10 | 17 |
| Height | centimeter (cm) | 168.1 (SD 9.84) | 167.6 (SD 10.54) | 167.8 (SD 10.20) |
| Weight | kilogram (kg) | 91.14 (SD 19.832) | 91.40 (SD 21.319) | 91.27 (SD 20.586) |
| Body Mass Index (BMI) | kilogram per square meter (kg/m^2) | 32.14 (SD 6.107) | 32.45 (SD 7.497) | 32.30 (SD 6.838) |
| Glycosylated Hemoglobin (HbA1c) Category: <8.5 percent (%) | participants | 988 | 936 | 1924 |
| Glycosylated Hemoglobin (HbA1c) Category: >=8.5% | participants | 615 | 668 | 1283 |
| Smoking Classification: Never smoked | participants | 667 | 668 | 1335 |
| Smoking Classification: Current smoker | participants | 330 | 328 | 658 |
| Smoking Classification: Ex-smoker | participants | 606 | 608 | 1214 |
| Duration of Diabetes | years | 13.583 (SD 8.409) | 13.333 (SD 8.321) | 13.458 (SD 8.365) |
| Region of Enrollment: Argentina | participants | 121 | 121 | 242 |
| Region of Enrollment: Australia | participants | 34 | 35 | 69 |
| Region of Enrollment: Bulgaria | participants | 21 | 22 | 43 |
| Region of Enrollment: Canada | participants | 104 | 107 | 211 |
| Region of Enrollment: Croatia | participants | 16 | 17 | 33 |
| Region of Enrollment: Czech Republic | participants | 56 | 56 | 112 |
| Region of Enrollment: Estonia | participants | 13 | 11 | 24 |
| Region of Enrollment: France | participants | 3 | 4 | 7 |
| Region of Enrollment: Germany | participants | 30 | 30 | 60 |
| Region of Enrollment: Hong Kong | participants | 29 | 29 | 58 |
6. Primary Endpoint
The registry lists the primary outcome as Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite, measured over Baseline up to end of study (up to Day 588).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | days |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint was time from randomization to the first occurrence of any component of the primary major adverse cardiovascular event composite. Its components were cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for unstable angina, with or without revascularization. The registry describes the endpoint as a median in days and specifies a 95% confidence interval. The analysis description says Kaplan-Meier methods were used.
A composite endpoint combines several defined outcomes into one measure. Time to first event focuses on how long it takes for a participant to experience any component, rather than counting every later event. This can be useful when the clinical question concerns the timing of an initial event across several related outcomes. However, a composite does not by itself show which component drives a result; component-level results are needed to assess that.
General statistical explanation: Kaplan-Meier methods estimate the event-free experience over time while accounting for participants whose event status is not observed through the full follow-up period. The median event time is the time at which the estimated event-free proportion reaches its median point, if that point can be estimated. A confidence interval describes uncertainty around an estimate under the analysis assumptions. The registry specifies these measures but does not report an estimable median time or confidence interval for either arm. The component event counts and treatment comparison are also not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record does not provide numerical results for the primary time-to-first-event endpoint. Both treatment arms have null values for the median and its confidence limits, and the record notes that values are missing or not estimable for a two-arm comparison of this median-time endpoint. It reports zero analyses. Consequently, no arm-level median, confidence interval, hazard ratio, or other primary comparison estimate can be interpreted from the registry record.
This absence is important because the study purpose was to assess whether TAK-875 had no excess risk of cardiovascular composite events compared with placebo. A study purpose is not a result. Without a reported estimate and its uncertainty, the registry entry does not establish the direction, size, or precision of the treatment comparison. It also does not establish whether the study met its objective. The status is terminated, but the record does not state the reason for termination or connect it to the primary endpoint findings.
The registry identifies 1603 participants in the placebo primary-outcome arm and 1604 in the Fasiglifam 50 mg arm. These arm counts do not supply the missing event-time estimates. In the safety record, the at-risk counts differ from the primary-outcome arm counts: 1603 for placebo and 1601 for Fasiglifam 50 mg. The registry does not explain the population or data-flow reasons for that difference, so the safety denominators should not be treated as interchangeable with the primary endpoint arm counts.
General statistical explanation: an estimate and its confidence interval are both needed for a useful reading of a treatment comparison. The estimate conveys the observed contrast, while the interval indicates how uncertain that estimate is under the analysis. A null or unavailable estimate cannot be treated as evidence of equivalence, noninferiority, or absence of excess risk. Those interpretations require an appropriate prespecified margin and an analysis that can be evaluated; the margin and analysis result are not reported in the registry record.
The record does describe a secondary endpoint: time to first occurrence of any component of a secondary MACE composite. It does not provide a secondary result. The count of posted outcome measures is 2, but no analyses are reported. The available record therefore supports description of the design and endpoint, not a conclusion about comparative cardiovascular outcomes.
9. Statistical Methods Explained
What does a time-to-event analysis measure?
The primary endpoint concerns the interval from randomization to a first qualifying event. This differs from an endpoint that simply records whether an event occurred by a fixed visit: it uses the timing of the event as well as whether it occurred during observed follow-up. The event definition combines cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for unstable angina, with or without revascularization. The record does not report component-specific event results.
General explanation: time-to-event analyses can include participants who have not had an event by their last observed follow-up. Their data are censored at that point rather than treated as if an event occurred. Valid interpretation depends on appropriate follow-up information and assumptions about censoring. Details of censoring rules and follow-up completeness are not reported in the registry record.
What does Kaplan-Meier analysis contribute?
The registry says the primary endpoint was evaluated using Kaplan-Meier analysis. General explanation: the Kaplan-Meier estimator describes the probability of remaining free of the event over time, accounting for censored observations. An estimated median event time can be derived when the estimated event-free curve reaches the relevant midpoint. If too few events occur, or follow-up does not extend far enough, the median may not be estimable. The record states that values are missing or not estimable for a two-arm comparison of the median-time endpoint, but does not explain the specific reason.
The primary measure is described as a median in days with a 95% confidence interval. A confidence interval expresses uncertainty around an estimate under the statistical method and assumptions; it is not a range containing a fixed proportion of individual participant event times. Since the registry gives no median or interval values, no precision assessment can be made for either arm.
Why might a hazard ratio be used?
General explanation: a hazard ratio compares event rates over time between groups, conditional on the analysis model and assumptions. It is not the same as a ratio of the final event proportions, and it does not directly state how many days longer or shorter participants remained event-free. Interpretation typically considers the estimated hazard ratio and its confidence interval together. The registry record reports no hazard ratio or sponsor analysis for this endpoint; therefore, no such comparison can be described.
General explanation: a proportional-hazards model is often used to estimate a hazard ratio, and its interpretation depends on whether the relative hazards are sufficiently stable over time. The registry does not state whether that model was used, whether its assumptions were assessed, or whether an alternative model was planned. No model details should be inferred from the endpoint description alone.
How should the composite be understood?
A composite endpoint can capture several clinically relevant outcomes in one time-to-first-event measure. Its interpretation depends on the chosen components and on the distribution of events across them. If a common or less severe component contributes most of the events, the overall composite may not represent the same pattern as its most serious component. This is a general consideration, not a claim about the event distribution in this study. The registry does not report component counts or estimates, so it is not possible to determine which components contributed to the endpoint.
The primary composite includes hospitalization for unstable angina, with or without revascularization, as well as cardiovascular death and nonfatal events. The endpoint description gives this definition, but does not provide adjudication details or explain how event status was determined. Those details are not reported in the registry record.
What can planning calculations say?
General explanation: sample-size planning calculations estimate the number of participants or events needed to detect a chosen effect under stated assumptions. They are not the same as observed evidence and do not establish that a study had a particular probability of success after results are known. The planning illustration associated with the record is based on an observed effect and uses a two-sided significance level of 0.05, equal allocation, and a normal approximation; time-to-event planning is expressed in total events. The record says these are planning illustrations, not the trial's own design. No resulting planning values are reported in the registry record, and they should not be read as observed power.
The registry provides an enrollment figure and arm counts, but the primary comparison is missing. Enrollment alone does not show how much information was available for the endpoint: event frequency, follow-up, and censoring also matter in a time-to-event analysis. Since the registry does not report endpoint event counts or follow-up detail, the adequacy or precision of the primary analysis cannot be assessed from the entry.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary time-to-first-occurrence composite and one secondary outcome, time to first occurrence of any component of a secondary MACE composite. It reports 2 outcome measures and zero analyses. No endpoint results are reported for either outcome. The registry does not describe a hierarchy of hypotheses, adjustment for multiple comparisons, or another multiplicity strategy. These methods are not reported in the registry record, so it is not possible to assess how the risk of false-positive findings across outcomes was handled.
The primary endpoint population is described as the Full Analysis Set, including all randomized participants who had a baseline and at least one post-baseline assessment. This definition is not identical to a description of all randomized participants, because it includes an assessment requirement. The record does not explain how participants without those assessments were handled or provide a participant-flow account for the primary analysis.
Missing-data methods, censoring rules, and the handling of incomplete outcome information are not reported in the registry record. This matters for a time-to-event analysis because follow-up ending before an event is observed is treated differently from a known event, and the validity of estimates depends on how incomplete follow-up is addressed. The registry does not report reasons for missing observations, follow-up completeness, or sensitivity analyses. It also does not report interim analyses, a statistical analysis plan, or the sample-size justification for the trial. None of those details can be inferred from the study status or endpoint description.
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 | 197 | 1603 | 12.3% |
| Fasiglifam 50 mg | 201 | 1601 | 12.6% |
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 | 427 of 1603 |
| Fasiglifam 50 mg | 415 of 1601 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | Fasiglifam 50 mg |
|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | 9 of 1603 | 12 of 1601 |
| Cardiac failure congestive | Cardiac disorders | 7 of 1603 | 12 of 1601 |
| Renal failure acute | Renal and urinary disorders | 6 of 1603 | 11 of 1601 |
| Angina pectoris | Cardiac disorders | 7 of 1603 | 9 of 1601 |
| Chest pain | General disorders | 6 of 1603 | 8 of 1601 |
| Coronary artery disease | Cardiac disorders | 7 of 1603 | 6 of 1601 |
| Angina unstable | Cardiac disorders | 5 of 1603 | 7 of 1601 |
| Pneumonia | Infections and infestations | 5 of 1603 | 7 of 1601 |
| Renal failure | Renal and urinary disorders | 4 of 1603 | 6 of 1601 |
| Myocardial infarction | Cardiac disorders | 5 of 1603 | 4 of 1601 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Fasiglifam 50 mg |
|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 87 of 1603 | 75 of 1601 |
| Nasopharyngitis | Infections and infestations | 55 of 1603 | 61 of 1601 |
| Bronchitis | Infections and infestations | 45 of 1603 | 49 of 1601 |
| Diarrhoea | Gastrointestinal disorders | 48 of 1603 | 44 of 1601 |
| Hypertension | Vascular disorders | 40 of 1603 | 42 of 1601 |
| Urinary tract infection | Infections and infestations | 43 of 1603 | 35 of 1601 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 36 of 1603 | 41 of 1601 |
| Headache | Nervous system disorders | 32 of 1603 | 41 of 1601 |
| Influenza | Infections and infestations | 37 of 1603 | 34 of 1601 |
| Cough | Respiratory, thoracic and mediastinal disorders | 30 of 1603 | 40 of 1601 |
Serious events with the highest arm-level rate: cardiac failure congestive (0.7%), acute myocardial infarction (0.7%), renal failure acute (0.7%), angina pectoris (0.6%), chest pain (0.5%).
The registry reports serious adverse event counts for the safety groups: 197 affected participants among 1603 at risk in the placebo group and 201 among 1601 at risk in the Fasiglifam 50 mg group. It also reports other adverse event counts of 427 among 1603 at risk for placebo and 415 among 1601 at risk for Fasiglifam 50 mg. These are group-specific counts and denominators as recorded; no percentages have been calculated. The registry does not report deaths in these safety fields.
The listed serious adverse event terms and percentages are congestive cardiac failure, 0.7%; acute myocardial infarction, 0.7%; acute renal failure, 0.7%; angina pectoris, 0.6%; chest pain, 0.5%; and unstable angina, 0.4%. The registry does not give additional detail in this list about event timing, recurrence, severity grading, or the denominator underlying each percentage.
General explanation: adverse-event counts describe events recorded during the specified safety observation, and are not automatically evidence that treatment caused them. Comparing safety groups requires consistent definitions, observation periods, and analysis populations. The record does not provide enough detail to establish those features or to support a causal interpretation. The safety at-risk counts also differ from the primary endpoint arm counts; the reason is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was designed to compare TAK-875 50 mg with placebo, both added to standard of care, for cardiovascular outcomes in adults with type 2 diabetes and cardiovascular disease or cardiovascular risk factors. It identifies a randomized, double-blind, parallel-group Phase 3 design and defines the primary composite endpoint. These design details describe the question the trial set out to address.
They do not answer that question. The primary median times and confidence intervals are not reported, the record states that values are missing or not estimable for a two-arm comparison, and no analyses are reported. There is no registry result from which to judge the direction or magnitude of the primary treatment comparison, its precision, or the contribution of individual endpoint components. No conclusion about excess risk, noninferiority, equivalence, or benefit follows from the design description alone.
The study is marked terminated, but termination status does not explain why the trial ended or what the results were. The registry record does not report a reason for termination, a final analysis, or the outcome of the stated study objective. The treatment descriptions say dosing was for up to 6 years, while the primary endpoint timeframe is baseline to end of study up to Day 588. The record does not reconcile these descriptions or show actual follow-up duration.
The safety counts offer descriptive information about adverse events recorded in the two safety groups, but do not by themselves establish whether treatment caused an event or whether one group had greater risk. The record lacks additional details needed to interpret the percentages and safety observation process. In short, the posted information can support a careful account of the planned comparison and some safety counts, but not a determination of the comparative cardiovascular outcome.
13. Why This Trial Matters Statistically
This study is statistically notable for asking a cardiovascular safety question using a time-to-first-event composite rather than a single short-term measurement. The endpoint joins cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for unstable angina. Such a design makes the definition of the composite, timing of events, and follow-up process central to interpretation. The record clearly describes the endpoint components and the intended Kaplan-Meier approach.
It also illustrates why a trial's objective and design should be separated from its reported evidence. The stated purpose was to demonstrate no excess risk relative to placebo, but the registry entry does not report the primary estimate, confidence interval, or analysis. A design aimed at assessing a safety question does not itself resolve that question. Without an estimate and uncertainty measure, readers cannot judge how compatible the observed data are with different treatment effects.
Another statistical issue is the relation between the composite and its components. A combined time-to-first-event result, if reported, would need interpretation alongside component-level information to show what events contributed. Those results are absent from the registry record. The entry also lists a secondary MACE outcome but does not report results or a multiplicity strategy, leaving the planned inferential relationship among outcomes unclear.
Finally, the record shows why the analysis population and safety denominators matter. It defines a Full Analysis Set with baseline and post-baseline assessment requirements and gives separate at-risk counts for safety outcomes. These details should not be silently treated as one common population. The record does not explain the differences or provide participant flow, reinforcing that clear population accounting is necessary for interpreting trial estimates.
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 main limitation is the lack of reported efficacy analyses. The median-time values and confidence intervals are null, the registry notes missing or non-estimable values for a two-arm comparison, and the number of analyses is recorded as 0. No primary estimate, hazard ratio, or component event results are available in the registry record. As a result, this entry cannot support a quantitative assessment of the primary treatment comparison.
The registry does not explain why the median comparison was not estimable or why the study was terminated. It does not report the statistical analysis plan, sample-size justification, interim analyses, missing-data methods, censoring rules, or follow-up completeness. The stated endpoint timeframe of up to Day 588 and the treatment description of up to 6 years are both recorded, but their relationship and actual follow-up are not explained.
There is limited information about the analysis population and event ascertainment. The Full Analysis Set requires baseline and at least one post-baseline assessment, while the registry does not provide participant flow or explain exclusions. Safety at-risk counts differ from the primary outcome arm counts, with no explanation. Event adjudication details and component-level endpoint results are not reported.
The record also uses TAK-875 in the intervention description and Fasiglifam 50 mg as the active arm title, without explaining the naming difference. This is a documentation limitation, not a basis for inferring that the arm labels represent different treatments. The registry gives descriptive safety counts and selected event terms, but not enough information about observation periods or event-level detail to support a causal safety comparison. These limitations constrain interpretation to the design and recorded counts rather than comparative clinical conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease — NCT01609582.
- Registry record last updated 2015-10-19; status last verified 2015-10.
- Results first posted 2015-08-21.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a terminated, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study of TAK-875 50 mg added to standard of care in adults with type 2 diabetes and cardiovascular disease or cardiovascular risk factors. The recorded enrollment is 3207. The primary endpoint was time to first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina, analyzed using Kaplan-Meier methods.
The primary median values and confidence intervals are not reported, and the registry states that values are missing or not estimable for a two-arm comparison. No analyses are reported. The record includes descriptive safety counts and one secondary outcome but no comparative outcome results. It does not report the termination reason, missing-data methods, or the statistical analysis plan. The available information describes the trial design and selected safety data, but does not establish the primary treatment comparison.