Trial · NCT01263496

Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan

NCT01263496, Phase 2, Completed, Takeda; results first posted 2011-07-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan. Trials, record NCT01263496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01263496

On this page

Trial

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

Title: Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan
NCT number: NCT01263496
Status: Completed
Phases: Phase 2
Enrollment: 438 participants, actual
Lead sponsor: Takeda
Conditions: Type 2 Diabetes Mellitus
Interventions: Alogliptin, Alogliptin, Alogliptin, Alogliptin, Voglibose
First posted: 2010-12-20
Last updated: 2012-02-03
Results first posted: 2011-07-07

Source ClinicalTrials.gov

Registered outcomes57

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events.	52 Weeks.	A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date \>30) will be listed, but not included in the summary tables below.
Secondary	Change From Baseline in Glycosylated Hemoglobin (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 and glycosylated hemoglobin collected at baseline.
Secondary	Change From Baseline in Glycosylated Hemoglobin (Week 16).	Baseline and Week 16.	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 16 and glycosylated hemoglobin collected at baseline.
Secondary	Change From Baseline in Glycosylated Hemoglobin (Week 20).	Baseline and Week 20.	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 20 and glycosylated hemoglobin collected at baseline.
Secondary	Change From Baseline in Glycosylated Hemoglobin (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 and glycosylated hemoglobin collected at baseline.
Secondary	Change From Baseline in Glycosylated Hemoglobin (Week 28).	Baseline and Week 28.	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 28 and glycosylated hemoglobin collected at baseline.
Secondary	Change From Baseline in Glycosylated Hemoglobin (Week 32).	Baseline and Week 32.	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 32 and glycosylated hemoglobin collected at baseline.
Secondary	Change From Baseline in Glycosylated Hemoglobin (Week 36).	Baseline and Week 36.	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 36 and glycosylated hemoglobin collected at baseline.
Secondary	Change From Baseline in Glycosylated Hemoglobin (Week 40).	Baseline and Week 40.	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 40 and glycosylated hemoglobin collected at baseline.
Secondary	Change From Baseline in Glycosylated Hemoglobin (Week 44).	Baseline and Week 44.	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 44 and glycosylated hemoglobin collected at baseline.

1 to 10 of 57Source ClinicalTrials.gov

See all 57 registered outcomes

Outcomes57

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events.	52 Weeks.	Adverse Event Profile in the Safety Analysis Set	participants	NUMBER
SECONDARY	Change From Baseline in Glycosylated Hemoglobin (Week 12).	Baseline and Week 12.	Values are Summary Statistics.	percentage of Glycosylated Hemoglobin	MEAN
SECONDARY	Change From Baseline in Glycosylated Hemoglobin (Week 16).	Baseline and Week 16.	Values are Summary Statistics.	percentage of Glycosylated Hemoglobin	MEAN
SECONDARY	Change From Baseline in Glycosylated Hemoglobin (Week 20).	Baseline and Week 20.	Values are Summary Statistics.	percentage of Glycosylated Hemoglobin	MEAN
SECONDARY	Change From Baseline in Glycosylated Hemoglobin (Week 24).	Baseline and Week 24.	Values are Summary Statistics.	percentage of Glycosylated Hemoglobin	MEAN
SECONDARY	Change From Baseline in Glycosylated Hemoglobin (Week 28).	Baseline and Week 28.	Values are Summary Statistics.	percentage of Glycosylated Hemoglobin	MEAN
SECONDARY	Change From Baseline in Glycosylated Hemoglobin (Week 32).	Baseline and Week 32.	Values are Summary Statistics.	percentage of Glycosylated Hemoglobin	MEAN
SECONDARY	Change From Baseline in Glycosylated Hemoglobin (Week 36).	Baseline and Week 36.	Values are Summary Statistics.	percentage of Glycosylated Hemoglobin	MEAN
SECONDARY	Change From Baseline in Glycosylated Hemoglobin (Week 40).	Baseline and Week 40.	Values are Summary Statistics.	percentage of Glycosylated Hemoglobin	MEAN
SECONDARY	Change From Baseline in Glycosylated Hemoglobin (Week 44).	Baseline and Week 44.	Values are Summary Statistics.	percentage of Glycosylated Hemoglobin	MEAN

1 to 10 of 57Source ClinicalTrials.gov

See all 57 outcomes

Results by group295

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

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Events.	Alogliptin 6.25 mg QD	Serious Adverse Event	1	participants
Number of Participants With Adverse Events.	Alogliptin 12.5 mg QD	Serious Adverse Event	5	participants
Number of Participants With Adverse Events.	Alogliptin 25 mg QD	Serious Adverse Event	8	participants
Number of Participants With Adverse Events.	Alogliptin 50 mg QD	Serious Adverse Event	5	participants
Number of Participants With Adverse Events.	Voglibose 0.2 mg TID	Serious Adverse Event	4	participants
Number of Participants With Adverse Events.	Alogliptin 6.25 mg QD	Serious Adverse Event Related to Study Drug	1	participants
Number of Participants With Adverse Events.	Alogliptin 12.5 mg QD	Serious Adverse Event Related to Study Drug	2	participants
Number of Participants With Adverse Events.	Alogliptin 25 mg QD	Serious Adverse Event Related to Study Drug	2	participants
Number of Participants With Adverse Events.	Alogliptin 50 mg QD	Serious Adverse Event Related to Study Drug	2	participants
Number of Participants With Adverse Events.	Voglibose 0.2 mg TID	Serious Adverse Event Related to Study Drug	0	participants

1 to 10 of 295Source ClinicalTrials.gov

See all 295 results by group

Participant flow54

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

Period	Milestone	Group	Participants
Enrolled - Long-Term Extension Study	STARTED	Alogliptin 6.25 mg Dose Group* → Alogliptin 6.25 mg Dose Group	72
Enrolled - Long-Term Extension Study	STARTED	Alogliptin 12.5 mg Dose Group* → Alogliptin 12.5 mg Dose Group	75
Enrolled - Long-Term Extension Study	STARTED	Alogliptin 25 mg Dose Group* → Alogliptin 25 mg Dose Group	72
Enrolled - Long-Term Extension Study	STARTED	Alogliptin 50 mg Dose Group* → Alogliptin 50 mg Dose Group	75
Enrolled - Long-Term Extension Study	STARTED	Voglibose 0.2 mg Dose Group* → Voglibose 0.2 mg Dose Group	74
Enrolled - Long-Term Extension Study	STARTED	Placebo Dose Group* → Alogliptin 6.25 mg Dose Group	17
Enrolled - Long-Term Extension Study	STARTED	Placebo Dose Group* → Alogliptin 12.5 mg Dose Group	17
Enrolled - Long-Term Extension Study	STARTED	Placebo Dose Group* → Alogliptin 25 mg Dose Group	18
Enrolled - Long-Term Extension Study	STARTED	Placebo Dose Group* → Alogliptin 50 mg Dose Group	18
Enrolled - Long-Term Extension Study	COMPLETED	Alogliptin 6.25 mg Dose Group* → Alogliptin 6.25 mg Dose Group	71

1 to 10 of 54Source ClinicalTrials.gov

See all 54 participant flow

Adverse events380

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	Nasopharyngitis	Infections and infestations	Alogliptin 6.25 mg QD	29	96
other	Nasopharyngitis	Infections and infestations	Alogliptin 12.5 mg QD	29	101
other	Nasopharyngitis	Infections and infestations	Alogliptin 25 mg QD	32	97
other	Nasopharyngitis	Infections and infestations	Alogliptin 50 mg QD	34	97
other	Nasopharyngitis	Infections and infestations	Voglibose 0.2 mg TID	21	83
other	Bronchitis	Infections and infestations	Alogliptin 6.25 mg QD	4	96
other	Bronchitis	Infections and infestations	Alogliptin 12.5 mg QD	6	101
other	Bronchitis	Infections and infestations	Alogliptin 25 mg QD	1	97
other	Bronchitis	Infections and infestations	Alogliptin 50 mg QD	4	97
other	Bronchitis	Infections and infestations	Voglibose 0.2 mg TID	1	83

1 to 10 of 380Source ClinicalTrials.gov

See all 380 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Alogliptin 6.25 mg QD
Total, all-cause mortality	Alogliptin 12.5 mg QD
Total, all-cause mortality	Alogliptin 25 mg QD
Total, all-cause mortality	Alogliptin 50 mg QD
Total, all-cause mortality	Voglibose 0.2 mg TID
Total, other adverse events	Alogliptin 6.25 mg QD	78	96
Total, other adverse events	Alogliptin 12.5 mg QD	81	101
Total, other adverse events	Alogliptin 25 mg QD	81	97
Total, other adverse events	Alogliptin 50 mg QD	88	97
Total, other adverse events	Voglibose 0.2 mg TID	74	83

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

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/NCT01263496

GET https://conductscience.org/api/trials/v1/NCT01263496/registered?page=2

API reference For AI assistants