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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00968708
First received: August 28, 2009
Last updated: April 15, 2014
Last verified: April 2014
Results First Received: March 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus, Type 2
Acute Coronary Syndrome
Interventions: Drug: Alogliptin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 898 investigative sites worldwide from 24 September 2009 to 18 June 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a diagnosis of type 2 diabetes mellitus and acute coronary syndrome were enrolled equally in 1 of 2 treatment groups, once a day placebo or alogliptin, in addition to receiving standard of care for cardiovascular disease and diabetes.

Reporting Groups
  Description
Placebo Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
Alogliptin Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.

Participant Flow:   Overall Study
    Placebo   Alogliptin
STARTED   2679   2701 
Treated   2676   2698 
COMPLETED   2361   2403 
NOT COMPLETED   318   298 
Adverse Event                169                150 
Major Protocol Deviation                0                1 
Lost to Follow-up                19                11 
Voluntary Withdrawal                104                101 
Investigator Discretion                0                1 
Other                26                34 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)   [ Time Frame: From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months). ]

2.  Secondary:   Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)   [ Time Frame: From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00968708     History of Changes
Other Study ID Numbers: SYR-322_402
U1111-1111-6825 ( Registry Identifier: WHO )
2009-011222-34 ( Registry Identifier: EudraCT )
JapicCTI-101246 ( Registry Identifier: JapicCTI )
DOH-27-0310-3047 ( Registry Identifier: SANCTR )
09/H0709/63 ( Registry Identifier: NRES )
CTRI/2010/091/000046 ( Registry Identifier: CTRI )
2009-011222-34 ( Registry Identifier: REPEC )
2009-011222-34 ( Registry Identifier: OsSC )
NMRR-09-872-4471 ( Registry Identifier: NMRR )
Study First Received: August 28, 2009
Results First Received: March 8, 2014
Last Updated: April 15, 2014