Trial · NCT01456195
Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes
NCT01456195, Phase 3, Completed, Takeda; results first posted 2016-04-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes. Trials, record NCT01456195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01456195
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes
- NCT number
- NCT01456195
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 421 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Placebo, Fasiglifam
- First posted
- 2011-10-20
- Last updated
- 2016-04-05
- Other registries' IDs
- eudract:2011-002741-35
- Results first posted
- 2016-04-05
Source ClinicalTrials.gov
Registered outcomes4
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) | 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. A mixed model repeated measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis. |
| Secondary | Incidence of HbA1c <7% | Week 24 | The incidence (percentage of participants with) HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of less than seven percent for target glycemic control at Week 24. |
| Secondary | Change From Baseline in Fasting Plasma Glucose | Baseline and Week 24 | The change between the fasting plasma glucose value collected at Week 24 relative to Baseline measured in milligrams per deciliter (mg/dL). A MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis. |
| Secondary | Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT) | Baseline and Week 24 | The change between the value of glucose after a meal, measured by the meal tolerance test collected at Week 24 relative to Baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal measured in millimoles per liter (mmol/L). An Analysis of Covariance (ANCOVA) model with treatment and country as fixed factors and Baseline value as covariate was used for analysis. |
Source ClinicalTrials.gov
Outcomes4
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) | Baseline and Week 24 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included. | percent | LEAST_SQUARES_MEAN |
| SECONDARY | Incidence of HbA1c <7% | Week 24 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included. Last Observation Carried Forward. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose | Baseline and Week 24 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT) | Baseline and Week 24 | Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included. MTT were only done at sites that had MTT capabilities. | mmol/L | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Placebo | -0.17 | Standard Error 0.090 | percent | |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Fasiglifam 25 mg | -0.65 | Standard Error 0.087 | percent | |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Fasiglifam 50 mg | -0.93 | Standard Error 0.087 | percent | |
| Incidence of HbA1c <7% | Placebo | 24.1 | percentage of participants | ||
| Incidence of HbA1c <7% | Fasiglifam 25 mg | 36.0 | percentage of participants | ||
| Incidence of HbA1c <7% | Fasiglifam 50 mg | 50.4 | percentage of participants | ||
| Change From Baseline in Fasting Plasma Glucose | Placebo | 1.4 | Standard Error 3.45 | mg/dL | |
| Change From Baseline in Fasting Plasma Glucose | Fasiglifam 25 mg | -12.3 | Standard Error 3.29 | mg/dL | |
| Change From Baseline in Fasting Plasma Glucose | Fasiglifam 50 mg | -20.9 | Standard Error 3.26 | mg/dL | |
| Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT) | Placebo | -0.6 | Standard Error 12.47 | mmol/L |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 143 | |
| Overall Study | STARTED | Fasiglifam 25 mg | 137 | |
| Overall Study | STARTED | Fasiglifam 50 mg | 141 | |
| Overall Study | COMPLETED | Placebo | 132 | |
| Overall Study | COMPLETED | Fasiglifam 25 mg | 127 | |
| Overall Study | COMPLETED | Fasiglifam 50 mg | 127 | |
| Overall Study | NOT COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | Fasiglifam 25 mg | 10 | |
| Overall Study | NOT COMPLETED | Fasiglifam 50 mg | 14 |
Source ClinicalTrials.gov
Adverse events30
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 | Nasopharyngitis | Infections and infestations | Placebo | 9 | 143 | |
| other | Nasopharyngitis | Infections and infestations | Fasiglifam 25 mg | 6 | 137 | |
| other | Nasopharyngitis | Infections and infestations | Fasiglifam 50 mg | 7 | 141 | |
| serious | Cardio-respiratory arrest | Cardiac disorders | Placebo | 0 | 143 | |
| serious | Cardio-respiratory arrest | Cardiac disorders | Fasiglifam 25 mg | 0 | 137 | |
| serious | Cardio-respiratory arrest | Cardiac disorders | Fasiglifam 50 mg | 1 | 141 | |
| serious | Abdominal hernia | Gastrointestinal disorders | Placebo | 0 | 143 | |
| serious | Abdominal hernia | Gastrointestinal disorders | Fasiglifam 25 mg | 1 | 137 | |
| serious | Abdominal hernia | Gastrointestinal disorders | Fasiglifam 50 mg | 0 | 141 | |
| serious | Anal fistula | Gastrointestinal disorders | Placebo | 0 | 143 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Fasiglifam 25 mg | ||
| Total, all-cause mortality | Fasiglifam 50 mg | ||
| Total, other adverse events | Placebo | 9 | 143 |
| Total, other adverse events | Fasiglifam 25 mg | 6 | 137 |
| Total, other adverse events | Fasiglifam 50 mg | 7 | 141 |
| Total, serious adverse events | Placebo | 3 | 143 |
| Total, serious adverse events | Fasiglifam 25 mg | 3 | 137 |
| Total, serious adverse events | Fasiglifam 50 mg | 3 | 141 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01456195
GET https://conductscience.org/api/trials/v1/NCT01456195/events?page=2