Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (EXAMINE)
This study is ongoing, but not recruiting participants.
Sponsor:
Takeda Global Research & Development Center, Inc.
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00968708
First received: August 28, 2009
Last updated: March 9, 2013
Last verified: March 2013
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Purpose
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 subjects with type 2 diabetes mellitus and acute coronary syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 Acute Coronary Syndrome |
Drug: Alogliptin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Takeda Global Research & Development Center, Inc.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 5400 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Alogliptin QD |
Drug: Alogliptin
Alogliptin 25 mg, tablets, orally, once daily for up to 4.75 years for patients with normal or mildly impaired renal function as defined by estimated glomerular filtration rate. Alogliptin 12.5 mg, tablets, orally, once daily for up to 4.75 years for patients with moderately impaired renal function as defined by estimated glomerular filtration rate. Alogliptin 6.25 mg, tablets, orally, once daily for up to 4.75 years for patients with severely impaired renal function or end stage renal disease defined by estimated glomerular filtration rate. Other Names:
|
| Placebo Comparator: Placebo QD |
Drug: Placebo
Alogliptin placebo matching tablets, orally, once daily for up to 4.75 years.
|
Detailed Description:
Alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor currently being developed by Takeda for use in patients with type 2 diabetes mellitus. Results from five phase 3 double-blind, placebo-controlled, 26-week studies have demonstrated that alogliptin is effective in reducing glycosylated hemoglobin as monotherapy and when added to commonly used antidiabetic agents, including sulfonylureas, metformin, thiazolidinediones, and insulin. Alogliptin is well-tolerated and associated with few adverse events.
Cardiovascular outcomes is of special interest in the type 2 diabetes mellitus population, particularly in type 2 diabetes mellitus subjects 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 subjects with type 2 diabetes mellitus and acute coronary syndrome.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of type 2 diabetes mellitus
- Subject 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 subject'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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968708
Show 918 Study Locations
Show 918 Study LocationsSponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
| Study Director: | Medical Director Clinical Science | Takeda Global Research & Development Center, Inc. |
More Information
No publications provided by Takeda Global Research & Development Center, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00968708 History of Changes |
| Other Study ID Numbers: | 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 |
| Study First Received: | August 28, 2009 |
| Last Updated: | March 9, 2013 |
| Health Authority: | United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Argentina: Human Research Bioethics Committee Austria: Agency for Health and Food Safety Austria: Ethikkommission Austria: Federal Ministry for Health and Women Austria: Federal Office for Safety in Health Care Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee Australia: National Health and Medical Research Council Belgium: Directorate general for the protection of Public health: Medicines Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board Belgium: Ministry of Social Affairs, Public Health and the Environment Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Brazil: Ministry of Health Brazil: National Committee of Ethics in Research Brazil: National Health Surveillance Agency Bulgaria: Bulgarian Drug Agency Bulgaria: Ministry of Health Canada: Canadian Institutes of Health Research Canada: Ethics Review Committee Canada: Health Canada Canada: Ministry of Health & Long Term Care, Ontario Chile: Comisión Nacional de Investigación Científica y Tecnológica Chile: Instituto de Salud Publica de Chile Costa Rica: Ministry of Health Costa Rica Czech Republic: Ethics Committee Czech Republic: State Institute for Drug Control Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Denmark: Ethics Committee Denmark: National Board of Health Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: The Ministry of the Interior and Health Denmark: The Regional Committee on Biomedical Research Ethics European Union: European Medicines Agency Finland: Ethics Committee Finland: Ministry of Social Affairs and Health Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Direction Générale de la Santé France: French Data Protection Authority France: Institutional Ethical Committee France: Ministry of Health France: National Consultative Ethics Committee for Health and Life Sciences Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices Germany: Federal Ministry of Education and Research Germany: Federal Ministry of Food, Agriculture and Consumer Protection Germany: German Institute of Medical Documentation and Information Germany: Ministry of Health Germany: Paul-Ehrlich-Institut Guatemala: Ministry of Public Health and Social Assistance Hong Kong: Department of Health Hong Kong: Ethics Committee Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee Hungary: National Institute of Pharmacy India: Central Drugs Standard Control Organization India: Department of Atomic Energy India: Drugs Controller General of India India: Indian Council of Medical Research India: Institutional Review Board India: Ministry of Health India: Ministry of Science and Technology India: Science and Engineering Research Council Israel: The Israel National Institute for Health Policy Research and Health Services Research Israel: Ethics Commission Israel: Israeli Health Ministry Pharmaceutical Administration Israel: Ministry of Health Italy: Ethics Committee Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Korea: Food and Drug Administration Latvia: State Agency of Medicines Lithuania: Bioethics Committee Lithuania: State Medicine Control Agency - Ministry of Health Malaysia: Ministry of Health Mexico: Ethics Committee Mexico: Federal Commission for Protection Against Health Risks Mexico: Federal Commission for Sanitary Risks Protection Mexico: Ministry of Health Mexico: National Council of Science and Technology Mexico: National Institute of Public Health, Health Secretariat Netherlands: Dutch Health Care Inspectorate Netherlands: Medical Ethics Review Committee (METC) Netherlands: Medicines Evaluation Board (MEB) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) New Zealand: Food Safety Authority New Zealand: Health Research Council New Zealand: Health and Disability Ethics Committees New Zealand: Institutional Review Board New Zealand: Medsafe Peru: Ethics Committee Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Peru: Ministry of Health Philippines: Department of Health Philippines: Bureau of Food and Drugs Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland: Ministry of Health Poland: Ministry of Science and Higher Education Portugal: Ethics Committee for Clinical Research Portugal: Health Ethic Committee Portugal: National Pharmacy and Medicines Institute Romania: Ministry of Public Health Romania: National Medicines Agency Romania: State Institute for Drug Control Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Russia: Pharmacological Committee, Ministry of Health Serbia: Ethics Committee Slovakia: State Institute for Drug Control South Africa: Department of Health South Africa: Medicines Control Council South Africa: National Health Research Ethics Council South Korea: Institutional Review Board South Korea: Korea Food and Drug Administration (KFDA) Spain: Comité Ético de Investigación Clínica Spain: Ethics Committee Spain: Ministry of Health Spain: Ministry of Health and Consumption Spain: Spanish Agency of Medicines Sweden: Institutional Review Board Sweden: Medical Products Agency Sweden: Regional Ethical Review Board Sweden: Swedish National Council on Medical Ethics Sweden: Swedish Research Council Sweden: The National Board of Health and Welfare Thailand: Ethical Committee Thailand: Food and Drug Administration Thailand: Khon Kaen University Ethics Committee for Human Research Thailand: Ministry of Public Health Turkey: Ethics Committee Turkey: Ministry of Health Ukraine: Ministry of Health Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Department of Health United Kingdom: Food Standards Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Health Service United Kingdom: Research Ethics Committee United States: Federal Government United States: Institutional Review Board |
Keywords provided by Takeda Global Research & Development Center, Inc.:
|
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:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Acute Coronary Syndrome Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases |
Chest Pain Pain Signs and Symptoms Dipeptidyl-Peptidase IV Inhibitors Alogliptin Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013