Trial · NCT01982253

Fasiglifam 25 mg BID vs 50 mg QD

NCT01982253, Phase 2, Terminated, Takeda; results first posted 2016-10-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Fasiglifam 25 mg BID vs 50 mg QD. Trials, record NCT01982253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01982253

On this page

Trial

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

Title: Fasiglifam 25 mg BID vs 50 mg QD
NCT number: NCT01982253
Status: Terminated
Phases: Phase 2
Enrollment: 10 participants, actual
Lead sponsor: Takeda
Conditions: Type 2 Diabetes Mellitus
Interventions: Fasiglifam, Placebo to fasiglifam
First posted: 2013-11-13
Last updated: 2016-10-07
Other registries' IDs: eudract:2013-000886-35
Results first posted: 2016-10-07

Source ClinicalTrials.gov

Registered outcomes2

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 12.	Baseline and Week 12	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 12 or final visit relative to baseline.
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12	Baseline and Week 12	The change between the FPG value collected at week 12 or final visit relative to baseline.

Source ClinicalTrials.gov

Outcomes2

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 12.	Baseline and Week 12	In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.
SECONDARY	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12	Baseline and Week 12	In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.

Source ClinicalTrials.gov

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	2
Overall Study	STARTED	Fasiglifam 25 mg BID	4
Overall Study	STARTED	Fasiglifam 50 mg QD	4
Overall Study	COMPLETED	Placebo	0
Overall Study	COMPLETED	Fasiglifam 25 mg BID	0
Overall Study	COMPLETED	Fasiglifam 50 mg QD	0
Overall Study	NOT COMPLETED	Placebo	2
Overall Study	NOT COMPLETED	Fasiglifam 25 mg BID	4
Overall Study	NOT COMPLETED	Fasiglifam 50 mg QD	4

Source ClinicalTrials.gov

Adverse events21

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	Abdominal distension	Gastrointestinal disorders	Placebo	1	2
other	Abdominal distension	Gastrointestinal disorders	Fasiglifam 25 mg BID	0	4
other	Abdominal distension	Gastrointestinal disorders	Fasiglifam 50 mg QD	0	4
other	Abdominal hernia	Gastrointestinal disorders	Placebo	0	2
other	Abdominal hernia	Gastrointestinal disorders	Fasiglifam 25 mg BID	0	4
other	Abdominal hernia	Gastrointestinal disorders	Fasiglifam 50 mg QD	1	4
other	Bronchitis	Infections and infestations	Placebo	0	2
other	Bronchitis	Infections and infestations	Fasiglifam 25 mg BID	1	4
other	Bronchitis	Infections and infestations	Fasiglifam 50 mg QD	0	4
other	Constipation	Gastrointestinal disorders	Placebo	1	2

1 to 10 of 21Source ClinicalTrials.gov

See all 21 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 BID
Total, all-cause mortality	Fasiglifam 50 mg QD
Total, other adverse events	Placebo	1	2
Total, other adverse events	Fasiglifam 25 mg BID	1	4
Total, other adverse events	Fasiglifam 50 mg QD	2	4
Total, serious adverse events	Placebo	0	2
Total, serious adverse events	Fasiglifam 25 mg BID	0	4
Total, serious adverse events	Fasiglifam 50 mg QD	0	4

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT01982253

GET https://conductscience.org/api/trials/v1/NCT01982253/events?page=2

API reference For AI assistants