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

Completed

Phase 3 Results

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Alogliptin placebo matching tablets
    ARM 1: Kind: Experimental
    Label: Placebo QD
    ARM 2: Kind: Experimental
    Label: Placebo
    Description: Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
  • Alogliptin Drug
    Other Names: Nesina®; SYR-322; SYR110322
    Intervention Desc: Alogliptin tablets
    ARM 1: Kind: Experimental
    Label: Alogliptin QD
    ARM 2: Kind: Experimental
    Label: Alogliptin
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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. At first occurrence (up to 4.75 years). No
Secondary 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. At first occurrence (up to 4.75 years). No
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). No
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). No

Sponsors