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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Acute Coronary Syndrome
• Interventions: Drug: Placebo; Drug: Alogliptin

• Registration Number: NCT00968708
• Lead Sponsor: Takeda

Brief Summary

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.

Study Timeline

• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Study Start: 2009-09
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Results First Submitted: 2014-03-08
• Results First Submitted QC: 2014-03-08
• Status Verified: 2014-04
• Results First Posted: 2014-04-15
• Last Update Submitted: 2014-04-15
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5380

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.