Trial · NCT01263509

Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan

NCT01263509, Phase 2, Phase 3, Completed, Takeda; results first posted 2011-08-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan. Trials, record NCT01263509. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01263509

On this page

Trial

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

Title: Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan
NCT number: NCT01263509
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 179 participants, actual
Lead sponsor: Takeda
Conditions: Type 2 Diabetes Mellitus
Interventions: Alogliptin and voglibose, Alogliptin and voglibose
First posted: 2010-12-20
Last updated: 2012-02-03
Results first posted: 2011-08-29

Source ClinicalTrials.gov

Registered outcomes60

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 8).	Baseline and Week 8.	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 8 and glycosylated hemoglobin collected at baseline.
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.

1 to 10 of 60Source ClinicalTrials.gov

See all 60 registered outcomes

Outcomes60

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 8).	Baseline and Week 8.	Values are Summary Statistics.	percentage of Glycosylated Hemoglobin	MEAN
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

1 to 10 of 60Source ClinicalTrials.gov

See all 60 outcomes

Results by group124

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Adverse Events.	Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Serious Adverse Event	6		participants
Number of Participants With Adverse Events.	Alogliptin 25 mg QD and Voglibose 0.2 mg TID	Serious Adverse Event	7		participants
Number of Participants With Adverse Events.	Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Serious Adverse Event Related to Study Drug	0		participants
Number of Participants With Adverse Events.	Alogliptin 25 mg QD and Voglibose 0.2 mg TID	Serious Adverse Event Related to Study Drug	1		participants
Number of Participants With Adverse Events.	Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Other Adverse Events (Incidence ≥3%)	85		participants
Number of Participants With Adverse Events.	Alogliptin 25 mg QD and Voglibose 0.2 mg TID	Other Adverse Events (Incidence ≥3%)	73		participants
Change From Baseline in Glycosylated Hemoglobin (Week 8).	Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID		-0.69	Standard Deviation 0.479	percentage of Glycosylated Hemoglobin
Change From Baseline in Glycosylated Hemoglobin (Week 8).	Alogliptin 25 mg QD and Voglibose 0.2 mg TID		-0.79	Standard Deviation 0.417	percentage of Glycosylated Hemoglobin
Change From Baseline in Glycosylated Hemoglobin (Week 12).	Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID		-0.89	Standard Deviation 0.589	percentage of Glycosylated Hemoglobin
Change From Baseline in Glycosylated Hemoglobin (Week 12).	Alogliptin 25 mg QD and Voglibose 0.2 mg TID		-0.96	Standard Deviation 0.486	percentage of Glycosylated Hemoglobin

1 to 10 of 124Source ClinicalTrials.gov

See all 124 results by group

Participant flow24

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

Period	Milestone	Group	Participants
Enrolled - Long-Term Extension Study	STARTED	12.5 mg Combination Dose Group* → 12.5 mg Combination Group	61
Enrolled - Long-Term Extension Study	STARTED	25 mg Combination Dose Group* → 25 mg Combination Dose Group	60
Enrolled - Long-Term Extension Study	STARTED	α-glucosidase Monotherapy Group* → 12.5 mg Combination Group	32
Enrolled - Long-Term Extension Study	STARTED	α-glucosidase Monotherapy Group*→ 25 mg Combination Group	26
Enrolled - Long-Term Extension Study	COMPLETED	12.5 mg Combination Dose Group* → 12.5 mg Combination Group	61
Enrolled - Long-Term Extension Study	COMPLETED	25 mg Combination Dose Group* → 25 mg Combination Dose Group	60
Enrolled - Long-Term Extension Study	COMPLETED	α-glucosidase Monotherapy Group* → 12.5 mg Combination Group	32
Enrolled - Long-Term Extension Study	COMPLETED	α-glucosidase Monotherapy Group*→ 25 mg Combination Group	26
Enrolled - Long-Term Extension Study	NOT COMPLETED	12.5 mg Combination Dose Group* → 12.5 mg Combination Group	0
Enrolled - Long-Term Extension Study	NOT COMPLETED	25 mg Combination Dose Group* → 25 mg Combination Dose Group	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events60

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 12.5 mg QD and Voglibose 0.2 mg TID	38	108
other	Nasopharyngitis	Infections and infestations	Alogliptin 25 mg QD and Voglibose 0.2 mg TID	30	105
other	Bronchitis	Infections and infestations	Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	6	108
other	Bronchitis	Infections and infestations	Alogliptin 25 mg QD and Voglibose 0.2 mg TID	3	105
other	Cystitis	Infections and infestations	Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	4	108
other	Cystitis	Infections and infestations	Alogliptin 25 mg QD and Voglibose 0.2 mg TID	2	105
other	Pharyngitis	Infections and infestations	Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	1	108
other	Pharyngitis	Infections and infestations	Alogliptin 25 mg QD and Voglibose 0.2 mg TID	4	105
other	Seasonal allergy	Immune system disorders	Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	6	108
other	Seasonal allergy	Immune system disorders	Alogliptin 25 mg QD and Voglibose 0.2 mg TID	1	105

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
Total, all-cause mortality	Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Total, other adverse events	Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	85	108
Total, other adverse events	Alogliptin 25 mg QD and Voglibose 0.2 mg TID	73	105
Total, serious adverse events	Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	6	108
Total, serious adverse events	Alogliptin 25 mg QD and Voglibose 0.2 mg TID	7	105

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22106975	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID vs Alogliptin 25 mg QD and Voglibose 0.2 mg TID: 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/NCT01263509

GET https://conductscience.org/api/trials/v1/NCT01263509/registered?page=2

API reference For AI assistants