Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome (EXAMINE)
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| ClinicalTrials.gov Identifier: NCT00968708 |
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Recruitment Status :
Completed
First Posted : August 31, 2009
Results First Posted : April 15, 2014
Last Update Posted : May 2, 2014
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Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 Acute Coronary Syndrome | Drug: Alogliptin Drug: Placebo | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 5380 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | September 2009 |
| Actual Primary Completion Date : | April 2013 |
| Actual Study Completion Date : | June 2013 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Type 2 diabetes
Drug Information available for:
Alogliptin
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Placebo
Alogliptin placebo matching tablets |
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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.
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Drug: Alogliptin
Alogliptin tablets
Other Names:
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Primary Outcome Measures :
- 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). ]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 :
- 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). ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968708
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Sponsors and Collaborators
Takeda
Investigators
| Study Director: | Medical Director Clinical Science | Takeda |
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 ) |
| First Posted: | August 31, 2009 Key Record Dates |
| Results First Posted: | April 15, 2014 |
| Last Update Posted: | May 2, 2014 |
| Last Verified: | April 2014 |
Keywords provided by Takeda:
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Diabetes Mellitus - Type 2 Diabetes Mellitus cardiovascular outcomes heart attack stroke |
dipeptidyl-peptidase IV inhibitors metabolic disorders metabolic diseases glucose metabolism disorders |
Additional relevant MeSH terms:
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Acute Coronary Syndrome Diabetes Mellitus Diabetes Mellitus, Type 2 Syndrome Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Disease Pathologic Processes Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Alogliptin Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |