Trial · NCT01829477
Comparison of TAK-875 to Placebo as an Add-on to Glimepiride in Patients With Type 2 Diabetes
NCT01829477, Phase 3, Terminated, Takeda; results first posted 2016-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of TAK-875 to Placebo as an Add-on to Glimepiride in Patients With Type 2 Diabetes. Trials, record NCT01829477. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01829477
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of TAK-875 to Placebo as an Add-on to Glimepiride in Patients With Type 2 Diabetes
- NCT number
- NCT01829477
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 33 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- TAK-875, TAK-875 Placebo, Glimepiride
- First posted
- 2013-04-11
- Last updated
- 2016-06-01
- Other registries' IDs
- eudract:2013-000007-17
- Results first posted
- 2016-06-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Baseline and Week 24 | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 relative to baseline. |
| Secondary | Percentage of Participants With HbA1c <7 % at Week 24. | Week 24 | |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline and Week 24 | The change between the fasting plasma glucose value collected at week 24 or final visit relative to baseline. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Baseline and Week 24 | In accordance with the Statistical Analysis Plan (SAP), due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced. | ||
| SECONDARY | Percentage of Participants With HbA1c <7 % at Week 24. | Week 24 | In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced. | ||
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline and Week 24 | In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 17 | |
| Overall Study | STARTED | Fasiglifam 50 mg | 16 | |
| Overall Study | COMPLETED | Placebo | 1 | |
| Overall Study | COMPLETED | Fasiglifam 50 mg | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | Fasiglifam 50 mg | 15 |
Source ClinicalTrials.gov
Adverse events28
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 | Hypoesthesia | Nervous system disorders | Placebo | 1 | 17 | |
| other | Hypoesthesia | Nervous system disorders | Fasiglifam 50 mg | 1 | 16 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 17 | |
| other | Constipation | Gastrointestinal disorders | Fasiglifam 50 mg | 0 | 16 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 17 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Fasiglifam 50 mg | 1 | 16 | |
| other | Electrocardiogram (ECG) abnormal | Investigations | Placebo | 0 | 17 | |
| other | Electrocardiogram (ECG) abnormal | Investigations | Fasiglifam 50 mg | 1 | 16 | |
| other | Episcleritis | Eye disorders | Placebo | 1 | 17 | |
| other | Episcleritis | Eye disorders | Fasiglifam 50 mg | 0 | 16 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 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 | 5 | 17 |
| Total, other adverse events | Fasiglifam 50 mg | 3 | 16 |
| Total, serious adverse events | Placebo | 0 | 17 |
| Total, serious adverse events | Fasiglifam 50 mg | 0 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30880443 | DERIVED |
Source PubMed
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/NCT01829477
GET https://conductscience.org/api/trials/v1/NCT01829477/events?page=2