Trial · NCT01829464

TAK-875 (Fasiglifam) in Combination With Sitagliptin in Adults With Type 2 Diabetes

NCT01829464, Phase 3, Terminated, Takeda; results first posted 2016-06-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. TAK-875 (Fasiglifam) in Combination With Sitagliptin in Adults With Type 2 Diabetes. Trials, record NCT01829464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01829464

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: TAK-875 (Fasiglifam) in Combination With Sitagliptin in Adults With Type 2 Diabetes
NCT number: NCT01829464
Status: Terminated
Phases: Phase 3
Enrollment: 90 participants, actual
Lead sponsor: Takeda
Conditions: Diabetes
Interventions: Placebo, TAK-875, TAK-875
First posted: 2013-04-11
Last updated: 2016-06-01
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 HbA1c at Week 24	Baseline and Week 24	The change in the value of HbA1c (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%	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 values collected at Week 24 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 HbA1c at Week 24	Baseline and Week 24	Full analysis set (FAS) included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.	Percentage of glycosylated haemoglobin	MEAN
SECONDARY	Percentage of Participants With HbA1c <7%	Week 24	Due to the relatively limited enrollment and follow-up at the time of study termination, the analysis of percentage of participants with HbA1c \<7% at Week 24 was not performed.
SECONDARY	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Baseline and Week 24	FAS included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.	milligram per deciliter (mg/dL)	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 HbA1c at Week 24	Placebo	Baseline (n= 26, 31, 27)	8.39	Standard Deviation 0.766	Percentage of glycosylated haemoglobin
Change From Baseline in HbA1c at Week 24	Fasiglifam 25 mg QD	Baseline (n= 26, 31, 27)	8.46	Standard Deviation 0.932	Percentage of glycosylated haemoglobin
Change From Baseline in HbA1c at Week 24	Fasiglifam 50 mg QD	Baseline (n= 26, 31, 27)	8.52	Standard Deviation 0.956	Percentage of glycosylated haemoglobin
Change From Baseline in HbA1c at Week 24	Placebo	Change at Week 24 (n= 2, 4, 2)	0.25	Standard Deviation 0.495	Percentage of glycosylated haemoglobin
Change From Baseline in HbA1c at Week 24	Fasiglifam 25 mg QD	Change at Week 24 (n= 2, 4, 2)	-0.80	Standard Deviation 0.883	Percentage of glycosylated haemoglobin
Change From Baseline in HbA1c at Week 24	Fasiglifam 50 mg QD	Change at Week 24 (n= 2, 4, 2)	-1.85	Standard Deviation 0.495	Percentage of glycosylated haemoglobin
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Placebo	Baseline (n= 29, 31, 28)	193.76	Standard Deviation 50.090	milligram per deciliter (mg/dL)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Fasiglifam 25 mg QD	Baseline (n= 29, 31, 28)	184.52	Standard Deviation 45.126	milligram per deciliter (mg/dL)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Fasiglifam 50 mg QD	Baseline (n= 29, 31, 28)	185.96	Standard Deviation 53.767	milligram per deciliter (mg/dL)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Placebo	Change at Week 24 (n= 2, 2, 2)	30.50	Standard Deviation 55.861	milligram per deciliter (mg/dL)

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	30
Overall Study	STARTED	Fasiglifam 25 mg QD	31
Overall Study	STARTED	Fasiglifam 50 mg QD	29
Overall Study	COMPLETED	Placebo	2
Overall Study	COMPLETED	Fasiglifam 25 mg QD	2
Overall Study	COMPLETED	Fasiglifam 50 mg QD	3
Overall Study	NOT COMPLETED	Placebo	28
Overall Study	NOT COMPLETED	Fasiglifam 25 mg QD	29
Overall Study	NOT COMPLETED	Fasiglifam 50 mg QD	26

Source ClinicalTrials.gov

Adverse events39

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
other	Influenza like illness	General disorders	Placebo	0	30
other	Influenza like illness	General disorders	Fasiglifam 25 mg QD	0	31
other	Influenza like illness	General disorders	Fasiglifam 50 mg QD	2	29
other	Hyperglycaemia	Metabolism and nutrition disorders	Placebo	0	30
other	Hyperglycaemia	Metabolism and nutrition disorders	Fasiglifam 25 mg QD	0	31
other	Hyperglycaemia	Metabolism and nutrition disorders	Fasiglifam 50 mg QD	2	29
other	Dyspepsia	Gastrointestinal disorders	Placebo	0	30
other	Dyspepsia	Gastrointestinal disorders	Fasiglifam 25 mg QD	2	31
other	Dyspepsia	Gastrointestinal disorders	Fasiglifam 50 mg QD	0	29
other	Sinusitis	Infections and infestations	Placebo	1	30

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse 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 QD
Total, all-cause mortality	Fasiglifam 50 mg QD
Total, other adverse events	Placebo	8	30
Total, other adverse events	Fasiglifam 25 mg QD	10	31
Total, other adverse events	Fasiglifam 50 mg QD	15	29
Total, serious adverse events	Placebo	0	30
Total, serious adverse events	Fasiglifam 25 mg QD	1	31
Total, serious adverse events	Fasiglifam 50 mg QD	0	29

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01829464

GET https://conductscience.org/api/trials/v1/NCT01829464/events?page=2

API reference For AI assistants