Trial · NCT01549964

Comparison of Fasiglifam (TAK-875) to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes

NCT01549964, Phase 3, Terminated, Takeda; results first posted 2016-06-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Fasiglifam (TAK-875) to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes. Trials, record NCT01549964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01549964

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Trial

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

Title: Comparison of Fasiglifam (TAK-875) to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes
NCT number: NCT01549964
Status: Terminated
Phases: Phase 3
Enrollment: 916 participants, actual
Lead sponsor: Takeda
Conditions: Glycemic Control
Interventions: Fasiglifam (TAK-875), Sitagliptin, Placebo
First posted: 2012-03-09
Last updated: 2016-06-02
Other registries' IDs: eudract:2011-001752-10
Results first posted: 2016-06-02

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 relative to Baseline. A Mixed Model Repeated Measures (MMRM) model was used for analysis with treatment, country, schedule, 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.
Secondary	Incidence of HbA1c <7%	24 Weeks	Incidence (percentage) of participants with glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than 7% at Week 24.
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG)	Baseline and Week 24	The change between FPG collected at week 24 relative to Baseline. A MMRM model was used for analysis with treatment, country, schedule, 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.

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	Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized. A participant was included in the analyses when there was both a Baseline and at least 1 Post-baseline value at Week 24.	Percent	LEAST_SQUARES_MEAN
SECONDARY	Incidence of HbA1c <7%	24 Weeks	Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Fasting Plasma Glucose (FPG)	Baseline and Week 24	Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized. A participant was included in the analyses when there was both a Baseline and at least 1 Post-baseline value at Week 24.	mg/dL	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	Value	Spread	Units
Change From Baseline in Glycosylated Hemoglobin (HbA1c)	Placebo	-0.19	Standard Error 0.098	Percent
Change From Baseline in Glycosylated Hemoglobin (HbA1c)	Sitagliptin 100 mg	-1.07	Standard Error 0.074	Percent
Change From Baseline in Glycosylated Hemoglobin (HbA1c)	Fasiglifam 25 mg	-0.75	Standard Error 0.073	Percent
Change From Baseline in Glycosylated Hemoglobin (HbA1c)	Fasiglifam 50 mg	-1.01	Standard Error 0.074	Percent
Incidence of HbA1c <7%	Placebo	14.9		percentage of participants
Incidence of HbA1c <7%	Sitagliptin 100 mg	42.8		percentage of participants
Incidence of HbA1c <7%	Fasiglifam 25 mg	24.3		percentage of participants
Incidence of HbA1c <7%	Fasiglifam 50 mg	37.0		percentage of participants
Change From Baseline in Fasting Plasma Glucose (FPG)	Placebo	-1.6	Standard Error 4.07	mg/dL
Change From Baseline in Fasting Plasma Glucose (FPG)	Sitagliptin 100 mg	-21.7	Standard Error 3.13	mg/dL

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow28

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

Period	Milestone	Group	Participants
24-Week Treatment Period	STARTED	Placebo	132
24-Week Treatment Period	STARTED	Sitagliptin 100 mg	260
24-Week Treatment Period	STARTED	Fasiglifam 25 mg	263
24-Week Treatment Period	STARTED	Fasiglifam 50 mg	261
24-Week Treatment Period	Safety Analysis Set=Received Treatment	Placebo	132
24-Week Treatment Period	Safety Analysis Set=Received Treatment	Sitagliptin 100 mg	260
24-Week Treatment Period	Safety Analysis Set=Received Treatment	Fasiglifam 25 mg	263
24-Week Treatment Period	Safety Analysis Set=Received Treatment	Fasiglifam 50 mg	260
24-Week Treatment Period	COMPLETED	Placebo	71
24-Week Treatment Period	COMPLETED	Sitagliptin 100 mg	149

1 to 10 of 28Source ClinicalTrials.gov

See all 28 participant flow

Adverse events156

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	Hyperglycaemia	Metabolism and nutrition disorders	Placebo	14	132
other	Hyperglycaemia	Metabolism and nutrition disorders	Sitagliptin 100 mg	9	260
other	Hyperglycaemia	Metabolism and nutrition disorders	Fasiglifam 25 mg	11	263
other	Hyperglycaemia	Metabolism and nutrition disorders	Fasiglifam 50 mg	7	260
other	Nasopharyngitis	Infections and infestations	Placebo	3	132
other	Nasopharyngitis	Infections and infestations	Sitagliptin 100 mg	8	260
other	Nasopharyngitis	Infections and infestations	Fasiglifam 25 mg	7	263
other	Nasopharyngitis	Infections and infestations	Fasiglifam 50 mg	14	260
serious	Anaemia	Blood and lymphatic system disorders	Placebo	0	132
serious	Anaemia	Blood and lymphatic system disorders	Sitagliptin 100 mg	0	260

1 to 10 of 156Source ClinicalTrials.gov

See all 156 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Sitagliptin 100 mg
Total, all-cause mortality	Fasiglifam 25 mg
Total, all-cause mortality	Fasiglifam 50 mg
Total, other adverse events	Placebo	17	132
Total, other adverse events	Sitagliptin 100 mg	16	260
Total, other adverse events	Fasiglifam 25 mg	18	263
Total, other adverse events	Fasiglifam 50 mg	20	260
Total, serious adverse events	Placebo	2	132
Total, serious adverse events	Sitagliptin 100 mg	10	260

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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

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