Clinical trial NCT00968708: Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Acute Coronary Syndrome
Keywords: Diabetes Mellitus - Type 2
Diabetes Mellitus
cardiovascular outcomes
heart attack
stroke
dipeptidyl-peptidase IV inhibitors
metabolic disorders
metabolic diseases
glucose metabolism disorders
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-08-31
Enrollment: 5380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)
timeFrame: From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).
Secondary outcomes:
measure: Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)
timeFrame: From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).
Other outcomes:
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city: Cuernavaca, Morelos
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city: Cuernavaca
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city: Culiacan
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city: Durango
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city: Guadalajara
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city: Metepec
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city: Saltillo
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state: Cataluna
city: Figueres
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state: Comunidad Valenciana
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state: Galicia
city: Bacarot
country: Spain
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country: Spain
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city: Falkoping
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city: Goteborg
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city: Harnosand
country: Sweden
city: Kristianstad
country: Sweden
city: Malmo
country: Sweden
city: Motala
country: Sweden
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country: Sweden
city: Kaohsiung
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city: Taoyuan
country: Taiwan
city: Amphure Muang
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city: Bangkojk
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Rai
country: Thailand
city: Chiangmai
country: Thailand
city: Muang
country: Thailand
city: Nakhon Ratchasima
country: Thailand
city: Pathumwan
country: Thailand
city: Patumthani
country: Thailand
city: Phitsanulok
country: Thailand
city: Phrae
country: Thailand
city: Ankara, Balgat
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city: Antalya
country: Turkey
city: Istanbul
country: Turkey
city: Kayseri
country: Turkey
city: Konya
country: Turkey
city: Donetsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Odesa
country: Ukraine
city: Poltava
country: Ukraine
city: Simferopol
country: Ukraine
city: Vinnytsya
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Abu Dhabi
country: United Arab Emirates
city: Barnsley
country: United Kingdom
city: Bath
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Bournemouth
country: United Kingdom
city: Carshalton
country: United Kingdom
city: Chertsey
country: United Kingdom
city: Chichester
country: United Kingdom
city: Colchester
country: United Kingdom
city: Coventry
country: United Kingdom
city: Croydon
country: United Kingdom
city: Doncaster
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Hull
country: United Kingdom
city: Inverness
country: United Kingdom
city: Kirkcaldy
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Livingston
country: United Kingdom
city: London
country: United Kingdom
city: Nuneaton
country: United Kingdom
city: Stevenage
country: United Kingdom
city: Sunderland
country: United Kingdom
city: Torquay
country: United Kingdom
city: Wakefield
country: United Kingdom
city: West Midlands
country: United Kingdom
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References:
citation: Ferreira JP, Rossignol P, Bakris G, Mehta C, White WB, Zannad F. Blood and Urine Biomarkers Predicting Worsening Kidney Function in Patients with Type 2 Diabetes Post-Acute Coronary Syndrome: An Analysis from the EXAMINE Trial. Am J Nephrol. 2021;52(12):969-976. doi: 10.1159/000519436. Epub 2021 Dec 6.
citation: Ferreira JP, Mehta C, Sharma A, Nissen SE, Rossignol P, Zannad F. Alogliptin after acute coronary syndrome in patients with type 2 diabetes: a renal function stratified analysis of the EXAMINE trial. BMC Med. 2020 Jun 4;18(1):165. doi: 10.1186/s12916-020-01616-8.
citation: Sharma A, Vaduganathan M, Ferreira JP, Liu Y, Bakris GL, Cannon CP, White WB, Zannad F. Clinical and Biomarker Predictors of Expanded Heart Failure Outcomes in Patients With Type 2 Diabetes Mellitus After a Recent Acute Coronary Syndrome: Insights From the EXAMINE Trial. J Am Heart Assoc. 2020 Jan 7;9(1):e012797. doi: 10.1161/JAHA.119.012797. Epub 2020 Jan 4.
citation: White WB, Jalil F, Cushman WC, Bakris GL, Bergenstal R, Heller SR, Liu Y, Mehta C, Zannad F, Cannon CP. Average Clinician-Measured Blood Pressures and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Ischemic Heart Disease in the EXAMINE Trial. J Am Heart Assoc. 2018 Oct 16;7(20):e009114. doi: 10.1161/JAHA.118.009114.
citation: Jarolim P, White WB, Cannon CP, Gao Q, Morrow DA. Serial Measurement of Natriuretic Peptides and Cardiovascular Outcomes in Patients With Type 2 Diabetes in the EXAMINE Trial. Diabetes Care. 2018 Jul;41(7):1510-1515. doi: 10.2337/dc18-0109. Epub 2018 May 30.
citation: Sharma A, Cannon CP, White WB, Liu Y, Bakris GL, Cushman WC, Zannad F. Early and Chronic Dipeptidyl-Peptidase-IV Inhibition and Cardiovascular Events in Patients With Type 2 Diabetes Mellitus After an Acute Coronary Syndrome: A Landmark Analysis of the EXAMINE Trial. J Am Heart Assoc. 2018 May 16;7(11):e007649. doi: 10.1161/JAHA.117.007649.
citation: White WB, Heller SR, Cannon CP, Howitt H, Khunti K, Bergenstal RM; EXAMINE Investigators. Alogliptin in Patients with Type 2 Diabetes Receiving Metformin and Sulfonylurea Therapies in the EXAMINE Trial. Am J Med. 2018 Jul;131(7):813-819.e5. doi: 10.1016/j.amjmed.2018.02.023. Epub 2018 Mar 23.
citation: Hwang YC, Morrow DA, Cannon CP, Liu Y, Bergenstal R, Heller S, Mehta C, Cushman W, Bakris GL, Zannad F, White WB. High-sensitivity C-reactive protein, low-density lipoprotein cholesterol and cardiovascular outcomes in patients with type 2 diabetes in the EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial. Diabetes Obes Metab. 2018 Mar;20(3):654-659. doi: 10.1111/dom.13136. Epub 2017 Nov 21.
citation: Kay S, Strickson A, Puelles J, Selby R, Benson E, Tolley K. Comparative Effectiveness of Adding Alogliptin to Metformin Plus Sulfonylurea with Other DPP-4 Inhibitors in Type 2 Diabetes: A Systematic Review and Network Meta-Analysis. Diabetes Ther. 2017 Apr;8(2):251-273. doi: 10.1007/s13300-017-0245-8. Epub 2017 Mar 8.
citation: Cavender MA, White WB, Jarolim P, Bakris GL, Cushman WC, Kupfer S, Gao Q, Mehta CR, Zannad F, Cannon CP, Morrow DA. Serial Measurement of High-Sensitivity Troponin I and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus in the EXAMINE Trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care). Circulation. 2017 May 16;135(20):1911-1921. doi: 10.1161/CIRCULATIONAHA.116.024632. Epub 2017 Feb 28.
citation: White WB, Kupfer S, Zannad F, Mehta CR, Wilson CA, Lei L, Bakris GL, Nissen SE, Cushman WC, Heller SR, Bergenstal RM, Fleck PR, Cannon CP; EXAMINE Investigators. Cardiovascular Mortality in Patients With Type 2 Diabetes and Recent Acute Coronary Syndromes From the EXAMINE Trial. Diabetes Care. 2016 Jul;39(7):1267-73. doi: 10.2337/dc16-0303. Epub 2016 Jun 11.
citation: Zannad F, Cannon CP, Cushman WC, Bakris GL, Menon V, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Lam H, White WB; EXAMINE Investigators. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet. 2015 May 23;385(9982):2067-76. doi: 10.1016/S0140-6736(14)62225-X. Epub 2015 Mar 10.
citation: White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Cushman WC, Zannad F; EXAMINE Investigators. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013 Oct 3;369(14):1327-35. doi: 10.1056/NEJMoa1305889. Epub 2013 Sep 2.
citation: White WB, Bakris GL, Bergenstal RM, Cannon CP, Cushman WC, Fleck P, Heller S, Mehta C, Nissen SE, Perez A, Wilson C, Zannad F. EXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome. Am Heart J. 2011 Oct;162(4):620-626.e1. doi: 10.1016/j.ahj.2011.08.004. Epub 2011 Sep 14.