Trial · NCT00968708

Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome

NCT00968708, Phase 3, Completed, Takeda; results first posted 2014-04-15

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome. Trials, record NCT00968708. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00968708

On this page

Trial

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

Title: Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome
NCT number: NCT00968708
Status: Completed
Phases: Phase 3
Enrollment: 5,380 participants, actual
Lead sponsor: Takeda
Conditions: Diabetes Mellitus, Type 2, Acute Coronary Syndrome
Interventions: Alogliptin, Placebo
First posted: 2009-08-31
Last updated: 2014-05-02
Other registries' IDs: eudract:2009-011222-34
Results first posted: 2014-04-15

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)	From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).	Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.
Secondary	Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)	From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).	Secondary MACE composite consisted of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina; these events were adjudicated by an independent cardiovascular endpoint committee.

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	Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)	From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).	Full analysis set (all randomized participants)	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)	From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).	Full analysis set	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)	Placebo	11.8	percentage of participants
Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)	Alogliptin	11.3	percentage of participants
Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)	Placebo	13.4	percentage of participants
Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)	Alogliptin	12.7	percentage of participants

Source ClinicalTrials.gov

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	2,679
Overall Study	STARTED	Alogliptin	2,701
Overall Study	Treated	Placebo	2,676
Overall Study	Treated	Alogliptin	2,698
Overall Study	COMPLETED	Placebo	2,361
Overall Study	COMPLETED	Alogliptin	2,403
Overall Study	NOT COMPLETED	Placebo	318
Overall Study	NOT COMPLETED	Alogliptin	298

Source ClinicalTrials.gov

Adverse events1,464

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	Anaemia	Blood and lymphatic system disorders	Placebo	96	2,679
other	Anaemia	Blood and lymphatic system disorders	Alogliptin	130	2,701
other	Angina pectoris	Cardiac disorders	Placebo	133	2,679
other	Angina pectoris	Cardiac disorders	Alogliptin	122	2,701
other	Diarrhoea	Gastrointestinal disorders	Placebo	99	2,679
other	Diarrhoea	Gastrointestinal disorders	Alogliptin	122	2,701
other	Constipation	Gastrointestinal disorders	Placebo	66	2,679
other	Constipation	Gastrointestinal disorders	Alogliptin	70	2,701
other	Nausea	Gastrointestinal disorders	Placebo	53	2,679
other	Nausea	Gastrointestinal disorders	Alogliptin	56	2,701

1 to 10 of 1,464Source ClinicalTrials.gov

See all 1,464 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Alogliptin
Total, other adverse events	Placebo	1,493	2,679
Total, other adverse events	Alogliptin	1,523	2,701
Total, serious adverse events	Placebo	952	2,679
Total, serious adverse events	Alogliptin	907	2,701

Source ClinicalTrials.gov

Papers14

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21982652	DERIVED	PubMed
23992602	DERIVED	PubMed
25765696	DERIVED	PubMed
27289121	DERIVED	PubMed
28246236	DERIVED	PubMed
28275958	DERIVED	PubMed
29064626	DERIVED	PubMed
29581078	DERIVED	PubMed
29769203	DERIVED	PubMed
29848776	DERIVED	PubMed

1 to 10 of 14

See all 14 papers

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 vs Placebo: 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.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone 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/NCT00968708

GET https://conductscience.org/api/trials/v1/NCT00968708/events?page=2

API reference For AI assistants