Trial · NCT01834274
Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes
NCT01834274, Phase 3, Terminated, Takeda; results first posted 2015-09-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes. Trials, record NCT01834274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01834274
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes
- NCT number
- NCT01834274
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 96 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Fasiglifam (TAK-875), Fasiglifam (TAK-875) Placebo, Sitagliptin, Sitagliptin Placebo, Metformin
- First posted
- 2013-04-17
- Last updated
- 2015-09-28
- Other registries' IDs
- eudract:2013-000542-19
- Results first posted
- 2015-09-28
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) | 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 or final visit relative to Baseline. A negative change from Baseline indicated improvement. |
| Secondary | Percentage of Participants With HbA1c <7% at Week 24 | Week 24 | The percentage of participants with glycosylated hemoglobin less than 7% after 24 weeks of treatment. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline and Week 24 | The change between FPG collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement. |
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) | Baseline and Week 24 | All randomized participants with data available for analysis. | Percent | MEAN |
| SECONDARY | Percentage of Participants With HbA1c <7% at Week 24 | Week 24 | As pre-defined in the SAP, no summary is provided for the secondary efficacy endpoint incidence of HbA1c \<7% at Week 24 due to the limited enrollment and study duration at the time of study termination. | ||
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline and Week 24 | All randomized participants with data available for analysis. | mmol/L | MEAN |
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 |
|---|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Fasiglifam 50 mg | -0.63 | Standard Deviation 0.340 | Percent | |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Sitagliptin 100 mg | -0.43 | Standard Deviation 0.208 | Percent | |
| Change From Baseline in Fasting Plasma Glucose (FPG) | Fasiglifam 50 mg | -0.22 | Standard Deviation 1.971 | mmol/L | |
| Change From Baseline in Fasting Plasma Glucose (FPG) | Sitagliptin 100 mg | 1.54 | Standard Deviation 5.087 | mmol/L |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fasiglifam 50 mg | 50 | |
| Overall Study | STARTED | Sitagliptin 100 mg | 46 | |
| Overall Study | COMPLETED | Fasiglifam 50 mg | 3 | |
| Overall Study | COMPLETED | Sitagliptin 100 mg | 5 | |
| Overall Study | NOT COMPLETED | Fasiglifam 50 mg | 47 | |
| Overall Study | NOT COMPLETED | Sitagliptin 100 mg | 41 |
Source ClinicalTrials.gov
Adverse events10
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 | Diarrhoea | Gastrointestinal disorders | Fasiglifam 50 mg | 1 | 50 | |
| other | Diarrhoea | Gastrointestinal disorders | Sitagliptin 100 mg | 3 | 46 | |
| other | Constipation | Gastrointestinal disorders | Fasiglifam 50 mg | 0 | 50 | |
| other | Constipation | Gastrointestinal disorders | Sitagliptin 100 mg | 3 | 46 | |
| other | Sinusitis | Infections and infestations | Fasiglifam 50 mg | 2 | 50 | |
| other | Sinusitis | Infections and infestations | Sitagliptin 100 mg | 1 | 46 | |
| other | Headache | Nervous system disorders | Fasiglifam 50 mg | 2 | 50 | |
| other | Headache | Nervous system disorders | Sitagliptin 100 mg | 0 | 46 | |
| serious | Chest pain | General disorders | Fasiglifam 50 mg | 1 | 50 | |
| serious | Chest pain | General disorders | Sitagliptin 100 mg | 0 | 46 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fasiglifam 50 mg | ||
| Total, all-cause mortality | Sitagliptin 100 mg | ||
| Total, other adverse events | Fasiglifam 50 mg | 4 | 50 |
| Total, other adverse events | Sitagliptin 100 mg | 5 | 46 |
| Total, serious adverse events | Fasiglifam 50 mg | 1 | 50 |
| Total, serious adverse events | Sitagliptin 100 mg | 0 | 46 |
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 Sitagliptin 100 mg: 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/NCT01834274
GET https://conductscience.org/api/trials/v1/NCT01834274/registered