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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00968708
Recruitment Status : Completed
First Posted : August 31, 2009
Results First Posted : April 15, 2014
Last Update Posted : May 2, 2014
Information provided by (Responsible Party):

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

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 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

Drug Information available for: Alogliptin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

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 identifier (NCT number): NCT00968708

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Metepec, Mexico
Mexicali, Baja California, Mexico
Mexico City, Mexico, Mexico
Mexico City, Mexico
Mexico, Mexico
Monclova, Coahuila, Mexico
Monterrey, NL, Mexico
Monterrey, Nuevo Le0n, Mexico
Monterrey, Nuevo Leon, Mexico
Monterrey, Mexico
Morelia, Michoacan, Mexico
Pachuca, Mexico
Saltillo, Coahuila, Mexico
Saltillo, Mexico
San Luis Potosi.SLP, Mexico
San Luis Potosi, Mexico
Tijuana, Baja California Norte, Mexico
Tlalnepantla, Edo de Mexico, Mexico
Tlalnepantla, 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
Arequipa, Peru
Bellavista, Peru
Callao, Peru
Cusco, Peru
Huacho, Peru
Ica, Peru
La Victoria, Lima, Peru
Lima San Isidro, Peru
Lima, Peru
Los Olivos, Peru
Miraflores, Lima, Peru
Piura, Peru
San Isidro, Lima, Peru
San Miguel, Lima, Peru
Trujillo, La Libertad, Peru
Trujillo, Peru
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
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
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
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
Belgrade, Serbia
Beograd, Serbia
Nis, Serbia
Bardejov, Slovakia
Bratislava, Slovakia
Dolny Kubin, Slovakia
Komarno, Slovakia
Kosice - Saca, Slovakia
Kosice, 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
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
Dalby, Sweden
Falkoping, Sweden
Goteborg, Sweden
Harnosand, Sweden
Kristianstad, Sweden
Malmo, Sweden
Motala, Sweden
Stockholm, Sweden
Kaohsiung, Taiwan
Taipei County, Taiwan
Taoyuan, Taiwan
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
Ankara, Balgat, Turkey
Antalya, Turkey
Istanbul, Turkey
Kayseri, Turkey
Konya, Turkey
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
Study Director: Medical Director Clinical Science Takeda

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Takeda 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:
Diabetes Mellitus - Type 2
Diabetes Mellitus
cardiovascular outcomes
heart attack
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
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action