Trial · NCT01609582
Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease
NCT01609582, Phase 3, Terminated, Takeda; results first posted 2015-08-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease. Trials, record NCT01609582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01609582
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease
- NCT number
- NCT01609582
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 3,207 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Type 2 Diabetes, Cardiovascular Disease
- Interventions
- TAK-875, TAK-875 Placebo
- First posted
- 2012-06-01
- Last updated
- 2015-10-19
- Other registries' IDs
- eudract:2011-001732-37
- Results first posted
- 2015-08-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite | Baseline up to end of study (up to Day 588) | The time from randomization to the first occurrences of any event in the primary MACE composite was evaluated using Kaplan-Meier analysis. The primary MACE composite comprised cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization). |
| Secondary | Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite | Baseline up to end of study (up to Day 588) | The time from randomization to the first occurrences of any event in the secondary MACE composite was evaluated using Kaplan-Meier analysis. The secondary MACE composite comprised CV death, nonfatal MI, and nonfatal stroke. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite | Baseline up to end of study (up to Day 588) | Full Analysis Set (FAS) included all randomized participants who had baseline and at least 1 post-baseline assessment. | days | MEDIAN |
| SECONDARY | Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite | Baseline up to end of study (up to Day 588) | Full Analysis Set (FAS) included all randomized participants who had baseline and at least 1 post-baseline assessment. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite | Placebo | NA | 95% Confidence Interval NA to NA | days | |
| Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite | Fasiglifam 50 mg | NA | 95% Confidence Interval NA to NA | days | |
| Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite | Placebo | NA | 95% Confidence Interval NA to NA | days | |
| Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite | Fasiglifam 50 mg | NA | 95% Confidence Interval NA to NA | days |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 1,603 | |
| Overall Study | STARTED | Fasiglifam 50 mg | 1,604 | |
| Overall Study | Treated | Placebo | 1,603 | |
| Overall Study | Treated | Fasiglifam 50 mg | 1,601 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | COMPLETED | Fasiglifam 50 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1,603 | |
| Overall Study | NOT COMPLETED | Fasiglifam 50 mg | 1,604 |
Source ClinicalTrials.gov
Adverse events510
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 87 | 1,603 | |
| other | Upper respiratory tract infection | Infections and infestations | Fasiglifam 50 mg | 75 | 1,601 | |
| other | Bronchitis | Infections and infestations | Placebo | 45 | 1,603 | |
| other | Bronchitis | Infections and infestations | Fasiglifam 50 mg | 49 | 1,601 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 48 | 1,603 | |
| other | Diarrhoea | Gastrointestinal disorders | Fasiglifam 50 mg | 44 | 1,601 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 43 | 1,603 | |
| other | Urinary tract infection | Infections and infestations | Fasiglifam 50 mg | 35 | 1,601 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 55 | 1,603 | |
| other | Nasopharyngitis | Infections and infestations | Fasiglifam 50 mg | 61 | 1,601 |
1 to 10 of 510Source ClinicalTrials.gov
See all 510 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Fasiglifam 50 mg | ||
| Total, other adverse events | Placebo | 427 | 1,603 |
| Total, other adverse events | Fasiglifam 50 mg | 415 | 1,601 |
| Total, serious adverse events | Placebo | 197 | 1,603 |
| Total, serious adverse events | Fasiglifam 50 mg | 201 | 1,601 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fasiglifam 50 mg vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01609582
GET https://conductscience.org/api/trials/v1/NCT01609582/events?page=2