Trial · NCT01387737

Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

NCT01387737, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2014-04-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus. Trials, record NCT01387737. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01387737

On this page

Trial

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

Title: Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus
NCT number: NCT01387737
Status: Completed
Phases: Phase 3
Enrollment: 1,299 participants, actual
Lead sponsor: Tanabe Pharma Corporation
Conditions: Type 2 Diabetes Mellitus
Interventions: TA-7284-Low, TA-7284-High
First posted: 2011-07-06
Last updated: 2026-01-08
Results first posted: 2014-04-28

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events	54 weeks
Secondary	Change in HbA1c	Week 52
Secondary	Change in Fasting Plasma Glucose	Week 52
Secondary	Change in Body Weight	Week 52
Secondary	Change in Blood Pressure	Week 52

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events	54 weeks	percentage of incidences	NUMBER
SECONDARY	Change in HbA1c	Week 52
SECONDARY	Change in Fasting Plasma Glucose	Week 52
SECONDARY	Change in Body Weight	Week 52
SECONDARY	Change in Blood Pressure	Week 52

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	Units
Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events	TA-7284-Low	adverse events	81.8	percentage of incidences
Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events	TA-7284-High	adverse events	82.8	percentage of incidences
Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events	TA-7284-Low	hypoglycemia	14.9	percentage of incidences
Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events	TA-7284-High	hypoglycemia	13.3	percentage of incidences

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	TA-7284-Low	584
Overall Study	STARTED	TA-7284-High	715
Overall Study	COMPLETED	TA-7284-Low	532
Overall Study	COMPLETED	TA-7284-High	641
Overall Study	NOT COMPLETED	TA-7284-Low	52
Overall Study	NOT COMPLETED	TA-7284-High	74

Source ClinicalTrials.gov

Adverse events158

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	Bronchitis	Infections and infestations	TA-7284-Low	23	584
other	Bronchitis	Infections and infestations	TA-7284-High	29	715
other	Cystitis	Infections and infestations	TA-7284-Low	15	584
other	Cystitis	Infections and infestations	TA-7284-High	13	715
other	Gastroenteritis	Infections and infestations	TA-7284-Low	14	584
other	Gastroenteritis	Infections and infestations	TA-7284-High	22	715
other	Influenza	Infections and infestations	TA-7284-Low	13	584
other	Influenza	Infections and infestations	TA-7284-High	10	715
other	Nasopharyngitis	Infections and infestations	TA-7284-Low	176	584
other	Nasopharyngitis	Infections and infestations	TA-7284-High	223	715

1 to 10 of 158Source ClinicalTrials.gov

See all 158 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TA-7284-Low
Total, all-cause mortality	TA-7284-High
Total, other adverse events	TA-7284-Low	371	584
Total, other adverse events	TA-7284-High	464	715
Total, serious adverse events	TA-7284-Low	30	584
Total, serious adverse events	TA-7284-High	32	715

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25802729	DERIVED	PubMed
26530268	DERIVED	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
TA-7284-Low vs TA-7284-High: 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.

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/NCT01387737

GET https://conductscience.org/api/trials/v1/NCT01387737/events?page=2

API reference For AI assistants