Trial · NCT01647542

Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg in Asia Pacific Adults With Type 2 Diabetes

NCT01647542, Phase 3, Terminated, Takeda; results first posted 2015-08-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg in Asia Pacific Adults With Type 2 Diabetes. Trials, record NCT01647542. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01647542

On this page

Trial

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

Title: Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg in Asia Pacific Adults With Type 2 Diabetes
NCT number: NCT01647542
Status: Terminated
Phases: Phase 3
Enrollment: 393 participants, actual
Lead sponsor: Takeda
Conditions: Type 2 Diabetes Mellitus
Interventions: TAK-875, TAK-875 Placebo
First posted: 2012-07-23
Last updated: 2015-11-11
Results first posted: 2015-08-19

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 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 in Fasting Plasma Glucose From Baseline to Week 24	Baseline and Week 24	The change between the fasting plasma glucose value collected at Week 24 relative to baseline.
Secondary	Change From Baseline in 2-hour Postprandial Glucose (PPG) Following Oral Glucose Tolerance Test (OGTT) at Week 24	Baseline and Week 24	The change between the value of glucose after a meal, measured following OGTT collected at Week 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, and C-peptide through blood samples drawn at 0, 30, 60, 90, and 120 minutes following consumption of a 75 gram (g) glucose beverage.

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 HbA1c at Week 24	Baseline and Week 24	Full Analysis Set (FAS) included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post-baseline value were included.	Percentage of Glycosylated Hemoglobin	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With HbA1c <7% at Week 24	Week 24	FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only Participants with a baseline and at least 1 post baseline value were included.	Percentage of participants	NUMBER
SECONDARY	Change in Fasting Plasma Glucose From Baseline to Week 24	Baseline and Week 24	FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post baseline value were included	Milligram per deciliter (mg/dL)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 2-hour Postprandial Glucose (PPG) Following Oral Glucose Tolerance Test (OGTT) at Week 24	Baseline and Week 24	FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post-baseline value were included.	mg/dL	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group21

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= 120, 124, 131)	7.99	Standard Error 0.104	Percentage of Glycosylated Hemoglobin
Change From Baseline in HbA1c at Week 24	Fasiglifam 25 mg	Baseline (n= 120, 124, 131)	7.94	Standard Error 0.101	Percentage of Glycosylated Hemoglobin
Change From Baseline in HbA1c at Week 24	Fasiglifam 50 mg	Baseline (n= 120, 124, 131)	7.91	Standard Error 0.102	Percentage of Glycosylated Hemoglobin
Change From Baseline in HbA1c at Week 24	Placebo	Change at Week 24 (n= 52, 61, 59)	0.15	Standard Error 0.101	Percentage of Glycosylated Hemoglobin
Change From Baseline in HbA1c at Week 24	Fasiglifam 25 mg	Change at Week 24 (n= 52, 61, 59)	-0.67	Standard Error 0.097	Percentage of Glycosylated Hemoglobin
Change From Baseline in HbA1c at Week 24	Fasiglifam 50 mg	Change at Week 24 (n= 52, 61, 59)	-0.87	Standard Error 0.097	Percentage of Glycosylated Hemoglobin
Percentage of Participants With HbA1c <7% at Week 24	Placebo		20.0		Percentage of participants
Percentage of Participants With HbA1c <7% at Week 24	Fasiglifam 25 mg		42.7		Percentage of participants
Percentage of Participants With HbA1c <7% at Week 24	Fasiglifam 50 mg		52.7		Percentage of participants
Change in Fasting Plasma Glucose From Baseline to Week 24	Placebo	Baseline (n =129, 127, 129)	152.4	Standard Error 4.74	Milligram per deciliter (mg/dL)

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	131
Overall Study	STARTED	Fasiglifam 25 mg	131
Overall Study	STARTED	Fasiglifam 50 mg	131
Overall Study	COMPLETED	Placebo	55
Overall Study	COMPLETED	Fasiglifam 25 mg	58
Overall Study	COMPLETED	Fasiglifam 50 mg	59
Overall Study	NOT COMPLETED	Placebo	76
Overall Study	NOT COMPLETED	Fasiglifam 25 mg	73
Overall Study	NOT COMPLETED	Fasiglifam 50 mg	72

Source ClinicalTrials.gov

Adverse events111

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	Upper respiratory tract infection	Infections and infestations	Placebo	8	131
other	Upper respiratory tract infection	Infections and infestations	Fasiglifam 25 mg	6	131
other	Upper respiratory tract infection	Infections and infestations	Fasiglifam 50 mg	8	131
other	Nasopharyngitis	Infections and infestations	Placebo	5	131
other	Nasopharyngitis	Infections and infestations	Fasiglifam 25 mg	10	131
other	Nasopharyngitis	Infections and infestations	Fasiglifam 50 mg	6	131
other	Hyperuricaemia	Metabolism and nutrition disorders	Placebo	2	131
other	Hyperuricaemia	Metabolism and nutrition disorders	Fasiglifam 25 mg	2	131
other	Hyperuricaemia	Metabolism and nutrition disorders	Fasiglifam 50 mg	12	131
other	Dizziness	Nervous system disorders	Placebo	5	131

1 to 10 of 111Source ClinicalTrials.gov

See all 111 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
Total, all-cause mortality	Fasiglifam 50 mg
Total, other adverse events	Placebo	39	131
Total, other adverse events	Fasiglifam 25 mg	51	131
Total, other adverse events	Fasiglifam 50 mg	50	131
Total, serious adverse events	Placebo	5	131
Total, serious adverse events	Fasiglifam 25 mg	5	131
Total, serious adverse events	Fasiglifam 50 mg	8	131

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/NCT01647542

GET https://conductscience.org/api/trials/v1/NCT01647542/results?page=2

API reference For AI assistants