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

Takeda

Status and phase: Completed; Phase 3

Conditions: Acute Coronary Syndrome; Diabetes Mellitus, Type 2

Treatments: Drug: Alogliptin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00968708

JapicCTI-101246 (Registry Identifier)

CTRI/2010/091/000046 (Registry Identifier)

09/H0709/63 (Registry Identifier)

2009-011222-34 (Registry Identifier)

SYR-322_402

NMRR-09-872-4471 (Registry Identifier)

DOH-27-0310-3047 (Registry Identifier)

U1111-1111-6825 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,380 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5,380 participants in 2 patient groups

Placebo

Experimental group

Description:

Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.

Treatment:

Drug: Placebo

Alogliptin

Experimental group

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.

Treatment:

Drug: Alogliptin