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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00968708
First received: August 28, 2009
Last updated: April 15, 2014
Last verified: April 2014
  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 patients 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:

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). ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    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.


Enrollment: 5380
Study Start Date: September 2009
Study Completion Date: June 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Placebo
Alogliptin placebo matching tablets
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.
Drug: Alogliptin
Alogliptin tablets
Other Names:
  • Nesina®
  • SYR-322
  • SYR110322

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.

  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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968708

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Locations
United States, Alabama
Birmingham, Alabama, United States
Dothan, Alabama, United States
Mobile, Alabama, United States
Muscle Shoals, Alabama, United States
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Cottonwood, Arizona, United States
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Chihuhua, Chihuhua, Mexico
Ciudad Obregon, Sonora, Mexico
Cuernavaca, Mexico
Cuernavaca, Morelos, Mexico
Culiacan, Mexico
Durango, Mexico
Guadalajara, Mexico
Guadalajara, Jalisco, Mexico
Merida, Yucatan, Mexico
Metepec, Mexico
Mexicali, Baja California, Mexico
Mexico, Mexico
Mexico City, Mexico
Mexico City, Mexico, Mexico
Monclova, Coahuila, Mexico
Monterrey, Mexico
Monterrey, NL, Mexico
Monterrey, Nuevo Le0n, Mexico
Monterrey, Nuevo Leon, Mexico
Morelia, Michoacan, Mexico
Pachuca, Mexico
Saltillo, Mexico
Saltillo, Coahuila, Mexico
San Luis Potosi, Mexico
San Luis Potosi.SLP, Mexico
Tijuana, Baja California Norte, Mexico
Tlalnepantla, Mexico
Tlalnepantla, Edo de Mexico, Mexico
Xalapa, Veracruz, Mexico
Zapopan, Mexico
New Zealand
Auckland, New Zealand
Christchurch, New Zealand
Otahuhu, New Zealand
Palmerston North, New Zealand
Takapuna, New Zealand
Tauranga, New Zealand
Peru
Arequipa, Peru
Bellavista, Peru
Callao, Peru
Cusco, Peru
Huacho, Peru
Ica, Peru
La Victoria, Lima, Peru
Lima, Peru
Lima San Isidro, Peru
Los Olivos, Peru
Miraflores, Lima, Peru
Piura, Peru
San Isidro, Lima, Peru
San Miguel, Lima, Peru
Trujillo, Peru
Trujillo, La Libertad, Peru
Philippines
Baguio, Philippines
Dasmarinas, Philippines
Davao City, Philippines
Iloilo City, Philippines
Laoag City, Philippines
Makati City, Philippines
Manila, Philippines
Marikina City, Philippines
Pasig City, Philippines
Quezon City, Philippines
Poland
Bialystok, Poland
Bydgoszcz, Poland
Czestochowa, Poland
Dabrowa Gornicza, Poland
Elblag, Poland
Gdansk, Poland
Gdynia, Poland
Grodzisk Mazowiecki, Poland
Inowroclaw, Poland
Katowice, Poland
Kielce, Poland
Krakow, Poland
Legnica, Poland
Lodz, Poland
Lubartow, Poland
Lublin, Poland
Plock, Poland
Pulawy, Poland
Radom, Poland
Ruda Slaska, Poland
Skierniewice, Poland
Slupsk, Poland
Szczecin, Poland
Torun, Poland
Warsaw, Poland
Warszawa, Poland
Wroclaw, Poland
Zabrze, Poland
Zgierz, Poland
Portugal
Coimbra, Portugal
Faro, Portugal
Lisboa, Portugal
Vila Real, Portugal
Puerto Rico
Aibonito, Puerto Rico
Carolina, Puerto Rico
Cidra, Puerto Rico
Halo Rey, Puerto Rico
Levittown, Puerto Rico
Manati, Puerto Rico
Mayaguez, Puerto Rico
Ponce, Puerto Rico
Salinas, Puerto Rico
San Juan, Puerto Rico
Santurce, Puerto Rico
Romania
Bacau, Romania
Baia Mare, Romania
Braila, Romania
Brasov, Romania
Bucharest, Romania
Bucuresti, Romania
Buzau, Romania
Galati, Romania
Iasi, Romania
Oradea, Romania
Ploiesti, Romania
Satu Mare, Romania
Targu Mures, Romania
Timisoara, Romania
Russian Federation
Arkhangelsk, Russian Federation
Barnaul, Russian Federation
Ivanovo, Russian Federation
Kazan, Russian Federation
Kemerovo, Russian Federation
Krasnodar, Russian Federation
Krasnoyarsk, Russian Federation
Kursk, Russian Federation
Moscow, Russian Federation
Nizhniy Novgorod, Russian Federation
Novosibirsk, Russian Federation
Rostov-on-Don, Russian Federation
Saratov, Russian Federation
St. Petersburg, Russian Federation
Ufa, Russian Federation
Volgograd, Russian Federation
Vsevolozhsk, Russian Federation
Serbia
Belgrade, Serbia
Beograd, Serbia
Nis, Serbia
Slovakia
Bardejov, Slovakia
Bratislava, Slovakia
Dolny Kubin, Slovakia
Komarno, Slovakia
Kosice, Slovakia
Kosice - Saca, Slovakia
Levice, Slovakia
Liptovsky Hradok, Slovakia
Nove Mesto nad Vahom, Slovakia
Nove Zamky, Slovakia
Povazska Bystrica, Slovakia
Rimavska Sobota, Slovakia
Ruzomberok, Slovakia
Svidnik, Slovakia
Zilina, Slovakia
South Africa
Port Elizabeth, Eastern Cape, South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Durban, Kwazulu-Natal, South Africa
Cape Town, Western Cape, South Africa
Paarl, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Tygerberg, Western Cape, South Africa
Worcester, Western Cape, South Africa
Durban, South Africa
Pretoria, South Africa
Spain
Zaragoza, Arag0n, Spain
Oviedo, Asturias, Spain
Cuenca, Castilla-La Mancha, Spain
Barcelona, Cataluna, Spain
Figueres, Cataluna, Spain
Torrevieja, Comunidad Valenciana, Spain
A Coruna, Galicia, Spain
Santiago de Compostela, Galicia, Spain
Bacarot, Spain
Merida, Spain
Palma de Mallorca, Spain
Sweden
Dalby, Sweden
Falkoping, Sweden
Goteborg, Sweden
Harnosand, Sweden
Kristianstad, Sweden
Malmo, Sweden
Motala, Sweden
Stockholm, Sweden
Taiwan
Kaohsiung, Taiwan
Taipei County, Taiwan
Taoyuan, Taiwan
Thailand
Amphure Muang, Thailand
Bangkojk, Thailand
Bangkok, Thailand
Chiang Rai, Thailand
Chiangmai, Thailand
Muang, Thailand
Nakhon Ratchasima, Thailand
Pathumwan, Thailand
Patumthani, Thailand
Phitsanulok, Thailand
Phrae, Thailand
Turkey
Ankara, Balgat, Turkey
Antalya, Turkey
Istanbul, Turkey
Kayseri, Turkey
Konya, Turkey
Ukraine
Donetsk, Ukraine
Ivano-Frankivsk, Ukraine
Kharkiv, Ukraine
Kyiv, Ukraine
Lviv, Ukraine
Odesa, Ukraine
Poltava, Ukraine
Simferopol, Ukraine
Vinnytsya, Ukraine
Zaporizhzhya, Ukraine
United Arab Emirates
Abu Dhabi, United Arab Emirates
United Kingdom
Barnsley, United Kingdom
Bath, United Kingdom
Birmingham, United Kingdom
Bournemouth, United Kingdom
Carshalton, United Kingdom
Chertsey, United Kingdom
Chichester, United Kingdom
Colchester, United Kingdom
Coventry, United Kingdom
Croydon, United Kingdom
Doncaster, United Kingdom
Glasgow, United Kingdom
Hull, United Kingdom
Inverness, United Kingdom
Kirkcaldy, United Kingdom
Liverpool, United Kingdom
Livingston, United Kingdom
London, United Kingdom
Nuneaton, United Kingdom
Stevenage, United Kingdom
Sunderland, United Kingdom
Torquay, United Kingdom
Wakefield, United Kingdom
West Midlands, United Kingdom
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda
  More Information

No publications provided by Takeda

Additional 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, 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
Results First Received: March 8, 2014
Last Updated: April 15, 2014
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: Federal Agency for Medicines and Health Products, FAMHP
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 Pública 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:
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 31, 2014