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

August 28, 2009
April 15, 2014
September 2009
April 2013   (final data collection date for primary outcome measure)
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). ] [ Designated as safety issue: No ]
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.
Time from randomization to the occurrence of the Primary Major Adverse Cardiac Events, defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke. [ Time Frame: At first occurrence (up to 4.75 years). ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00968708 on ClinicalTrials.gov Archive Site
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). ] [ Designated as safety issue: No ]
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.
Time from randomization to the occurrence of the Secondary Major Adverse Cardiac Events defined as a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke and urgent revascularization due to unstable angina. [ Time Frame: At first occurrence (up to 4.75 years). ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome

The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.

Alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor developed by Takeda for use in patients with type 2 diabetes mellitus.

Cardiovascular outcomes is of special interest in the type 2 diabetes mellitus population, particularly in type 2 diabetes mellitus patients who have cardiovascular disease and are at high risk for major adverse cardiac events, such as those patients who have had recent acute coronary syndrome.

This study has been designed to evaluate the cardiovascular safety of alogliptin versus placebo in addition to Standard of Care in adults with type 2 diabetes mellitus and acute coronary syndrome.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Acute Coronary Syndrome
  • Drug: Alogliptin
    Alogliptin tablets
    Other Names:
    • Nesina®
    • SYR-322
    • SYR110322
  • Drug: Placebo
    Alogliptin placebo matching tablets
  • Experimental: Placebo
    Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
    Intervention: Drug: Placebo
  • Experimental: 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.
    Intervention: Drug: Alogliptin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5380
June 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus
  • Is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 11.0%, inclusive, if the participant's antidiabetic regimen includes insulin)
  • Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization.

Exclusion Criteria:

  • Signs of type 1 diabetes mellitus
  • Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening
  • Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Czech Republic,   Denmark,   Egypt,   Finland,   France,   Germany,   Greece,   Guatemala,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Kuwait,   Latvia,   Lithuania,   Malaysia,   Mexico,   New Zealand,   Peru,   Philippines,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Arab Emirates
 
NCT00968708
SYR-322_402, U1111-1111-6825, 2009-011222-34, JapicCTI-101246, DOH-27-0310-3047, 09/H0709/63, CTRI/2010/091/000046, 2009-011222-34, 2009-011222-34, NMRR-09-872-4471
Yes
Takeda
Takeda
Not Provided
Study Director: Medical Director Clinical Science Takeda
Takeda
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP