Action to Control Cardiovascular Risk in Diabetes (ACCORD)

NCT00000620 | Completed Phase 3 Results DMC

• 10 other identifiers: 123N01HC95178N01HC95179N01HC95180N01HC95181N01HC95182N01HC95183N01HC95184IAA#Y1HC9035IAA#Y1HC1010
• Study Type: interventional
• Target: 10,251
• Locations: 2 countries
• Sites: 7

Brief Summary

The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.

Conditions

Atherosclerosis; Cardiovascular Diseases; Hypercholesterolemia; Hypertension; Diabetes Mellitus, Type 2; Diabetes Mellitus; Coronary Disease

Keywords

Diabetes Mellitus, Non-Insulin-Dependent

Outcome Measures

Primary Outcomes (3)

• First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.

  Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial). In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion.

  4.9 years

• First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.

  Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial.

  4.7 years

• First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.

  Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants.

  4.7 years

Secondary Outcomes (3)

• Death From Any Cause in the Glycemia Trial.

  4.9 years

• Stroke in the Blood Pressure Trial.

  4.7 years

• First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.

  4.7 years

Study Arms (6)

Glycemia Trial: intensive control

EXPERIMENTAL

Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels \<6.0%.

Drug: Anti-hyperglycemic Agents

Glycemia Trial: standard control

ACTIVE COMPARATOR

Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 - 7.9%.

Drug: Anti-hyperglycemic Agents

BP Trial: intensive control

EXPERIMENTAL

Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to \<120 mmHg.

Drug: Anti-hypertensive Agents

BP Trial: standard control

ACTIVE COMPARATOR

Open label administration of multiple anti-hypertensive agents to maintain SBP level \<140 mm Hg.

Drug: Anti-hypertensive Agents

Lipid Trial: fenofibrate

EXPERIMENTAL

Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 or 54 mg/day in patients with eGFR \<50 mL/min/1.73m2 in combination with open label simvastatin.

Drug: Blinded fenofibrate or placebo plus simvastatin

Lipid Trial: placebo

PLACEBO COMPARATOR

Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR \<50 mL/min/1.73m2 in combination with open label simvastatin.

Drug: Blinded fenofibrate or placebo plus simvastatin

Interventions

Anti-hyperglycemic Agents DRUG

Multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals (intensive control \<6%; standard control 7.0-7.9%).

Also known as: glimepiride (Amaryl), metformin (Glucophage), repaglinide (Gluconorm, Prandin), rosiglitazone (Avandia), pioglitazone (Actos), human regular insulin (Novolin ge Toronto), human NPH (Novolin N), human mixed (Novolin 70/30), human isophane (Novolin ge NPH), human 30/70 (Novolin ge 30/70), insulin aspart (NovoRapid, NovoLog), insulin detemir (Levemir), human regular insulin (Novolin R), insulin glargine (Lantus), Acarbose

Glycemia Trial: intensive control; Glycemia Trial: standard control

Anti-hypertensive Agents DRUG

Multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals (intensive control \<120 mm Hg; standard control \<140 mm Hg).

Also known as: benazepril (Lotensin, Zestril, Altace), chlorthalidone (Thalitone), metoprolol (Toprol XL), diltiazem (Tiazac), plendil (Felodipine), terazosin (Hytrin), candesartan (Atacand), valsartan (Diovan), furosemide, reserpine, hydralazine, carvedilol (Coreg), triamterene / hydrochlorothiazide (Dyazide), metoprolol / hydrochlorothiazide(Lopressor HCT), benazepril / hydrochlorothiazide (Lotensin HCT), lisinopril / hydrochlorothiazide (Zestoretic), candesartan / hydrochlorothiazide (Atacand HCT), valsartan / hydrochlorothiazide (Diovan HCT), amlodipine / benazepril (Lotrel)

BP Trial: intensive control; BP Trial: standard control

Blinded fenofibrate or placebo plus simvastatin DRUG

Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 or 54 mg/day in patients with eGFR \<50 mL/min/1.73m2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day.

Also known as: fenofibrate (Tricor)

Lipid Trial: fenofibrate; Lipid Trial: placebo

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes mellitus, as determined by the new American Diabetes Association guidelines, which include a fasting plasma glucose level greater than 126 mg/dl (7.0 mmol/l), or a 2-hour postload value in the oral glucose tolerance test of greater than 200 mg/dl, with confirmation by a retest
• For participants aged 40 years or older, history of CVD (heart attack, stroke, history of coronary revascularization, history of peripheral or carotid revascularization, or demonstrated angina)
• For participants aged 55 years or older, a history of CVD is not required, but participant must be considered to be at high risk for experiencing a CVD event due to existing CVD, subclinical disease, or 2+ CVD risk factors
• HbA1c 7.5%-9% (if on more drugs) or 7.5%-11% (if on fewer drugs)

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institute on Aging (NIA): collaborator
• National Eye Institute (NEI): collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (7)

Minneapolis Medical Research Foundation

Minneapolis, Minnesota, 55404, United States

Location

Columbia University

New York, New York, 10027, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27106, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Veterans Affairs

Memphis, Tennessee, 38104, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

McMaster University

Hamilton, Ontario, Canada

Location

Related Publications (120)

• Cushman WC, Grimm RH Jr, Cutler JA, Evans GW, Capes S, Corson MA, Sadler LS, Alderman MH, Peterson K, Bertoni A, Basile JN; ACCORD Study Group. Rationale and design for the blood pressure intervention of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):44i-55i. doi: 10.1016/j.amjcard.2007.03.005. Epub 2007 Apr 16.

  PMID: 17599425 BACKGROUND

• Williamson JD, Miller ME, Bryan RN, Lazar RM, Coker LH, Johnson J, Cukierman T, Horowitz KR, Murray A, Launer LJ; ACCORD Study Group. The Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Study (ACCORD-MIND): rationale, design, and methods. Am J Cardiol. 2007 Jun 18;99(12A):112i-122i. doi: 10.1016/j.amjcard.2007.03.029. Epub 2007 Apr 12.

  PMID: 17599421 BACKGROUND

• Sullivan MD, Anderson RT, Aron D, Atkinson HH, Bastien A, Chen GJ, Feeney P, Gafni A, Hwang W, Katz LA, Narayan KM, Nwachuku C, O'Connor PJ, Zhang P; ACCORD Study Group. Health-related quality of life and cost-effectiveness components of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: rationale and design. Am J Cardiol. 2007 Jun 18;99(12A):90i-102i. doi: 10.1016/j.amjcard.2007.03.027. Epub 2007 Apr 13.

  PMID: 17599429 BACKGROUND

• Bonds DE, Kurashige EM, Bergenstal R, Brillon D, Domanski M, Felicetta JV, Fonseca VA, Hall K, Hramiak I, Miller ME, Osei K, Simons-Morton DG; ACCORD Study Group. Severe hypoglycemia monitoring and risk management procedures in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):80i-89i. doi: 10.1016/j.amjcard.2007.03.026. Epub 2007 Apr 17.

  PMID: 17599428 BACKGROUND

• Kingry C, Bastien A, Booth G, Geraci TS, Kirpach BR, Lovato LC, Margolis KL, Rosenberg Y, Sperl-Hillen JM, Vargo L, Williamson JD, Probstfield JL; ACCORD Study Group. Recruitment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):68i-79i. doi: 10.1016/j.amjcard.2007.03.025. Epub 2007 Apr 12.

  PMID: 17599427 BACKGROUND

• Ginsberg HN, Bonds DE, Lovato LC, Crouse JR, Elam MB, Linz PE, O'connor PJ, Leiter LA, Weiss D, Lipkin E, Fleg JL; ACCORD Study Group. Evolution of the lipid trial protocol of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):56i-67i. doi: 10.1016/j.amjcard.2007.03.024. Epub 2007 Apr 12.

  PMID: 17599426 BACKGROUND

• Goff DC Jr, Gerstein HC, Ginsberg HN, Cushman WC, Margolis KL, Byington RP, Buse JB, Genuth S, Probstfield JL, Simons-Morton DG; ACCORD Study Group. Prevention of cardiovascular disease in persons with type 2 diabetes mellitus: current knowledge and rationale for the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):4i-20i. doi: 10.1016/j.amjcard.2007.03.002. Epub 2007 Apr 12.

  PMID: 17599424 BACKGROUND

• Gerstein HC, Riddle MC, Kendall DM, Cohen RM, Goland R, Feinglos MN, Kirk JK, Hamilton BP, Ismail-Beigi F, Feeney P; ACCORD Study Group. Glycemia treatment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):34i-43i. doi: 10.1016/j.amjcard.2007.03.004. Epub 2007 Apr 19.

  PMID: 17599423 BACKGROUND

• ACCORD Study Group; Buse JB, Bigger JT, Byington RP, Cooper LS, Cushman WC, Friedewald WT, Genuth S, Gerstein HC, Ginsberg HN, Goff DC Jr, Grimm RH Jr, Margolis KL, Probstfield JL, Simons-Morton DG, Sullivan MD. Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. Am J Cardiol. 2007 Jun 18;99(12A):21i-33i. doi: 10.1016/j.amjcard.2007.03.003. Epub 2007 Apr 16.

  PMID: 17599422 BACKGROUND

• Chew EY, Ambrosius WT, Howard LT, Greven CM, Johnson S, Danis RP, Davis MD, Genuth S, Domanski M; ACCORD Study Group. Rationale, design, and methods of the Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE). Am J Cardiol. 2007 Jun 18;99(12A):103i-111i. doi: 10.1016/j.amjcard.2007.03.028. Epub 2007 Apr 13.

  PMID: 17599420 BACKGROUND

• Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.

  PMID: 18539917 RESULT

• Liu M, Pei J, Zeng C, Xin Y, Tang P, Tang L, Hu X. BRI shows stronger association than BMI for MACE in patients with T2DM: insights from the ACCORD study. Front Nutr. 2025 Dec 12;12:1720948. doi: 10.3389/fnut.2025.1720948. eCollection 2025.

  PMID: 41459091 DERIVED

• Liu M, Pei J, Zeng C, Xin Y, Tang P, Hu X. Associations and predictive value of weight-adjusted waist index for cardiovascular outcomes in type 2 diabetes: evidence from the ACCORD study. Nutr J. 2025 Dec 17;24(1):184. doi: 10.1186/s12937-025-01251-0.

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• Lavallee SK, Carew AS, Warren RA, Sapp JL, Levy AP, Andreou P, Herman CR, Rimm EB, Cahill LE. Haptoglobin Phenotype and Cardiovascular Risk: The ACCORD Blood Pressure RCT. Hypertension. 2026 Jan;83(1):189-198. doi: 10.1161/HYPERTENSIONAHA.125.25021. Epub 2025 Nov 11.

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• Sano Y, Jin R, Yoshioka H, Nakazato Y, Sato H, Hisaka A. Development of a Novel Machine Learning Method for Estimation of Life-Long Chronic Disease Progression and Its Application to Type 2 Diabetes. Clin Transl Sci. 2025 Oct;18(10):e70351. doi: 10.1111/cts.70351.

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• Wang Z, Wang J, He L, Jiang C, Wang Y, Shen T, Zhao M, Li E, Zhou N, Sang C, Du X, Dong J, Ma C. Intensive Blood Pressure Control in Patients With Diabetes and Previous Stroke: A Post-Hoc Analysis of ACCORD-BP Trial. J Clin Hypertens (Greenwich). 2025 Jul;27(7):e70095. doi: 10.1111/jch.70095.

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• Liu M, Pei J, Zeng C, Xin Y, Tang P, Hu X. Association and predictive value of the triglyceride glucose-weight adjusted waist index for cardiovascular outcomes in patients with type 2 diabetes. Sci Rep. 2025 Jul 8;15(1):24573. doi: 10.1038/s41598-025-08580-4.

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• Yang Y, Xing Z. Depressive Symptoms and Metabolic Dysregulation Control: A Closer Look at Control Challenges in T2DM Patients. Depress Anxiety. 2024 Sep 27;2024:7115559. doi: 10.1155/2024/7115559. eCollection 2024.

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• Cheng Y, Zhu XB, Xu YL, Zou J, Huang W, Tian J, Sheng CS. Time in target range of systolic blood pressure and eGFR slope in patients with type 2 diabetes. Hypertens Res. 2025 May;48(5):1787-1798. doi: 10.1038/s41440-025-02173-4. Epub 2025 Mar 10.

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• Li S, Lin L, Chen X, Liu S, Gao M, Cheng X, Li C. Association between body fat variation rate and risk of diabetic nephropathy - a posthoc analysis based on ACCORD database. BMC Public Health. 2024 Oct 14;24(1):2805. doi: 10.1186/s12889-024-20317-y.

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• Zhang W, Huang Y, Zhou Z, Xie P, Zhuang X, Jiang J, Liao X. Cardiac autonomic neuropathy modified the association between obesity and hypoglycemia in type 2 diabetes. Endocrine. 2024 Sep;85(3):1213-1221. doi: 10.1007/s12020-024-03728-0. Epub 2024 Jun 21.

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• Zhou Y, Chai X, Yang G, Sun X, Xing Z. Changes in body mass index and waist circumference and heart failure in type 2 diabetes mellitus. Front Endocrinol (Lausanne). 2023 Dec 21;14:1305839. doi: 10.3389/fendo.2023.1305839. eCollection 2023.

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• Cromer SJ, Thaweethai T, Wexler DJ. Racial/ethnic and socioeconomic disparities in achievement of treatment goals within a clinical trial: a secondary analysis of the ACCORD trial. Diabetologia. 2023 Dec;66(12):2261-2274. doi: 10.1007/s00125-023-05997-2. Epub 2023 Sep 16.

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• King JB, Berchie RO, Derington CG, Marcum ZA, Scharfstein DO, Greene TH, Herrick JS, Jacobs JA, Zheutlin AR, Bress AP, Cohen JB. New Users of Angiotensin II Receptor Blocker-Versus Angiotensin-Converting Enzyme Inhibitor-Based Antihypertensive Medication Regimens and Cardiovascular Disease Events: A Secondary Analysis of ACCORD-BP and SPRINT. J Am Heart Assoc. 2023 Sep 5;12(17):e030311. doi: 10.1161/JAHA.123.030311. Epub 2023 Aug 30.

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• Kloecker DE, Davies MJ, Pitocco D, Khunti K, Zaccardi F. Intensive glucose control and recurrent cardiovascular events: 14-year follow-up investigation of the ACCORDION study. Diabetes Metab Res Rev. 2023 Jul;39(5):e3634. doi: 10.1002/dmrr.3634. Epub 2023 Apr 4.

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• Fu L, Tai S, Sun J, Zhang N, Zhou Y, Xing Z, Wang Y, Zhou S. Remnant Cholesterol and Its Visit-to-Visit Variability Predict Cardiovascular Outcomes in Patients With Type 2 Diabetes: Findings From the ACCORD Cohort. Diabetes Care. 2022 Sep 1;45(9):2136-2143. doi: 10.2337/dc21-2511.

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• Hukportie DN, Li FR, Zhou R, Zheng JZ, Wu XX, Zou MC, Wu XB. Lipid variability and risk of microvascular complications in Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: A post hoc analysis. J Diabetes. 2022 Jun;14(6):365-376. doi: 10.1111/1753-0407.13273. Epub 2022 Jun 6.

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• Kaze AD, Jaar BG, Fonarow GC, Echouffo-Tcheugui JB. Diabetic kidney disease and risk of incident stroke among adults with type 2 diabetes. BMC Med. 2022 Mar 29;20(1):127. doi: 10.1186/s12916-022-02317-0.

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• Warren RA, Carew AS, Andreou P, Herman C, Levy AP, Ginsberg HN, Sapp J, Rimm EB, Kirkland S, Cahill LE. Haptoglobin Phenotype Modifies the Effect of Fenofibrate on Risk of Coronary Event: ACCORD Lipid Trial. Diabetes Care. 2022 Jan 1;45(1):241-250. doi: 10.2337/dc21-1429.

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• Hukportie DN, Li FR, Zhou R, Zou MC, Wu XX, Wu XB. Association of Predicted Lean Body Mass and Fat Mass With Incident Diabetic Nephropathy in Participants With Type 2 Diabetes Mellitus: A Post Hoc Analysis of ACCORD Trial. Front Endocrinol (Lausanne). 2021 Oct 27;12:719666. doi: 10.3389/fendo.2021.719666. eCollection 2021.

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• Ferreira JP, Ferrao D, Rossignol P, Zannad F, Sharma A, Vasques-Novoa F, Leite-Moreira A. Interplay between worsening kidney function and cardiovascular events in patients with type 2 diabetes: an analysis from the ACCORD trial. BMJ Open Diabetes Res Care. 2021 Jul;9(1):e002408. doi: 10.1136/bmjdrc-2021-002408.

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• Kloecker DE, Khunti K, Davies MJ, Pitocco D, Zaccardi F. Microvascular Disease and Risk of Cardiovascular Events and Death From Intensive Treatment in Type 2 Diabetes: The ACCORDION Study. Mayo Clin Proc. 2021 Jun;96(6):1458-1469. doi: 10.1016/j.mayocp.2020.08.047. Epub 2021 May 2.

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• Zhou JJ, Koska J, Bahn G, Reaven P. Fasting Glucose Variation Predicts Microvascular Risk in ACCORD and VADT. J Clin Endocrinol Metab. 2021 Mar 25;106(4):1150-1162. doi: 10.1210/clinem/dgaa941.

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• Tang Y, Shah H, Bueno Junior CR, Sun X, Mitri J, Sambataro M, Sambado L, Gerstein HC, Fonseca V, Doria A, Pop-Busui R. Intensive Risk Factor Management and Cardiovascular Autonomic Neuropathy in Type 2 Diabetes: The ACCORD Trial. Diabetes Care. 2021 Jan;44(1):164-173. doi: 10.2337/dc20-1842. Epub 2020 Nov 3.

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• Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.

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• Singleton MJ, Soliman EZ, Bertoni AG, Whalen SP, Bhave PD, Yeboah J. Effect of Intensive Glycemic and Blood Pressure Control on QT Prolongation in Diabetes: The ACCORD Trial. Diabetes. 2020 Oct;69(10):2186-2193. doi: 10.2337/db20-0401. Epub 2020 Jul 30.

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• Chen LY, Bigger JT, Hickey KT, Chen H, Lopez-Jimenez C, Banerji MA, Evans G, Fleg JL, Papademetriou V, Thomas A, Woo V, Seaquist ER, Soliman EZ. Effect of Intensive Blood Pressure Lowering on Incident Atrial Fibrillation and P-Wave Indices in the ACCORD Blood Pressure Trial. Am J Hypertens. 2016 Nov 1;29(11):1276-1282. doi: 10.1093/ajh/hpv172.

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• Siraj ES, Rubin DJ, Riddle MC, Miller ME, Hsu FC, Ismail-Beigi F, Chen SH, Ambrosius WT, Thomas A, Bestermann W, Buse JB, Genuth S, Joyce C, Kovacs CS, O'Connor PJ, Sigal RJ, Solomon S; ACCORD Investigators. Insulin Dose and Cardiovascular Mortality in the ACCORD Trial. Diabetes Care. 2015 Nov;38(11):2000-8. doi: 10.2337/dc15-0598. Epub 2015 Oct 13.

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• Chow LS, Chen H, Miller ME, Marcovina SM, Seaquist ER. Biomarkers associated with severe hypoglycaemia and death in ACCORD. Diabet Med. 2016 Aug;33(8):1076-83. doi: 10.1111/dme.12883. Epub 2015 Sep 6.

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• Espeland MA, Probstfield J, Hire D, Redmon JB, Evans GW, Coday M, Lewis CE, Johnson KC, Wilmoth S, Bahnson J, Dulin MF, Green JB, Knowler WC, Kitabchi A, Murillo AL, Osei K, Rehman SU, Cushman WC; Look AHEAD Research Group; ACCORD Study Group. Systolic Blood Pressure Control Among Individuals With Type 2 Diabetes: A Comparative Effectiveness Analysis of Three Interventions. Am J Hypertens. 2015 Aug;28(8):995-1009. doi: 10.1093/ajh/hpu292. Epub 2015 Feb 9.

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• Zhang Z, Lovato J, Battapady H, Davatzikos C, Gerstein HC, Ismail-Beigi F, Launer LJ, Murray A, Punthakee Z, Tirado AA, Williamson J, Bryan RN, Miller ME. Effect of hypoglycemia on brain structure in people with type 2 diabetes: epidemiological analysis of the ACCORD-MIND MRI trial. Diabetes Care. 2014 Dec;37(12):3279-85. doi: 10.2337/dc14-0973. Epub 2014 Sep 29.

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• Gerstein HC, Miller ME, Ismail-Beigi F, Largay J, McDonald C, Lochnan HA, Booth GL; ACCORD Study Group. Effects of intensive glycaemic control on ischaemic heart disease: analysis of data from the randomised, controlled ACCORD trial. Lancet. 2014 Nov 29;384(9958):1936-41. doi: 10.1016/S0140-6736(14)60611-5. Epub 2014 Jul 31.

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• Williamson JD, Launer LJ, Bryan RN, Coker LH, Lazar RM, Gerstein HC, Murray AM, Sullivan MD, Horowitz KR, Ding J, Marcovina S, Lovato L, Lovato J, Margolis KL, Davatzikos C, Barzilay J, Ginsberg HN, Linz PE, Miller ME; Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Investigators. Cognitive function and brain structure in persons with type 2 diabetes mellitus after intensive lowering of blood pressure and lipid levels: a randomized clinical trial. JAMA Intern Med. 2014 Mar;174(3):324-33. doi: 10.1001/jamainternmed.2013.13656.

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• Linz PE, Lovato LC, Byington RP, O'Connor PJ, Leiter LA, Weiss D, Force RW, Crouse JR, Ismail-Beigi F, Simmons DL, Papademetriou V, Ginsberg HN, Elam MB. Paradoxical reduction in HDL-C with fenofibrate and thiazolidinedione therapy in type 2 diabetes: the ACCORD Lipid Trial. Diabetes Care. 2014;37(3):686-93. doi: 10.2337/dc13-0790. Epub 2013 Dec 2.

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• Barzilay JI, Lovato JF, Murray AM, Williamson J, Ismail-Beigi F, Karl D, Papademetriou V, Launer LJ. Albuminuria and cognitive decline in people with diabetes and normal renal function. Clin J Am Soc Nephrol. 2013 Nov;8(11):1907-14. doi: 10.2215/CJN.11321112. Epub 2013 Aug 29.

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• Fonseca V, McDuffie R, Calles J, Cohen RM, Feeney P, Feinglos M, Gerstein HC, Ismail-Beigi F, Morgan TM, Pop-Busui R, Riddle MC; ACCORD Study Group. Determinants of weight gain in the action to control cardiovascular risk in diabetes trial. Diabetes Care. 2013 Aug;36(8):2162-8. doi: 10.2337/dc12-1391. Epub 2013 Feb 14.

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• Gerstein HC, Ambrosius WT, Danis R, Ismail-Beigi F, Cushman W, Calles J, Banerji M, Schubart U, Chew EY; ACCORD Study Group. Diabetic retinopathy, its progression, and incident cardiovascular events in the ACCORD trial. Diabetes Care. 2013 May;36(5):1266-71. doi: 10.2337/dc12-1311. Epub 2012 Dec 13.

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• Reyes-Soffer G, Ngai CI, Lovato L, Karmally W, Ramakrishnan R, Holleran S, Ginsberg HN. Effect of combination therapy with fenofibrate and simvastatin on postprandial lipemia in the ACCORD lipid trial. Diabetes Care. 2013 Feb;36(2):422-8. doi: 10.2337/dc11-2556. Epub 2012 Oct 1.

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• Barzilay JI, Howard AG, Evans GW, Fleg JL, Cohen RM, Booth GL, Kimel AR, Pedley CF, Cushman WC. Intensive blood pressure treatment does not improve cardiovascular outcomes in centrally obese hypertensive individuals with diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial. Diabetes Care. 2012 Jul;35(7):1401-5. doi: 10.2337/dc11-1827.

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• Bonds DE, Miller ME, Dudl J, Feinglos M, Ismail-Beigi F, Malozowski S, Seaquist E, Simmons DL, Sood A. Severe hypoglycemia symptoms, antecedent behaviors, immediate consequences and association with glycemia medication usage: Secondary analysis of the ACCORD clinical trial data. BMC Endocr Disord. 2012 May 30;12:5. doi: 10.1186/1472-6823-12-5.

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• Sullivan MD, O'Connor P, Feeney P, Hire D, Simmons DL, Raisch DW, Fine LJ, Narayan KM, Ali MK, Katon WJ. Depression predicts all-cause mortality: epidemiological evaluation from the ACCORD HRQL substudy. Diabetes Care. 2012 Aug;35(8):1708-15. doi: 10.2337/dc11-1791. Epub 2012 May 22.

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• Raisch DW, Feeney P, Goff DC Jr, Narayan KM, O'Connor PJ, Zhang P, Hire DG, Sullivan MD. Baseline comparison of three health utility measures and the feeling thermometer among participants in the Action to Control Cardiovascular Risk in Diabetes trial. Cardiovasc Diabetol. 2012 Jul 11;11:35. doi: 10.1186/1475-2840-11-35.

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• Bonds DE, Craven TE, Buse J, Crouse JR, Cuddihy R, Elam M, Ginsberg HN, Kirchner K, Marcovina S, Mychaleckyj JC, O'Connor PJ, Sperl-Hillen JA. Fenofibrate-associated changes in renal function and relationship to clinical outcomes among individuals with type 2 diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) experience. Diabetologia. 2012 Jun;55(6):1641-50. doi: 10.1007/s00125-012-2524-2. Epub 2012 Mar 27.

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• Mychaleckyj JC, Craven T, Nayak U, Buse J, Crouse JR, Elam M, Kirchner K, Lorber D, Marcovina S, Sivitz W, Sperl-Hillen J, Bonds DE, Ginsberg HN. Reversibility of fenofibrate therapy-induced renal function impairment in ACCORD type 2 diabetic participants. Diabetes Care. 2012 May;35(5):1008-14. doi: 10.2337/dc11-1811. Epub 2012 Mar 19.

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• Punthakee Z, Miller ME, Launer LJ, Williamson JD, Lazar RM, Cukierman-Yaffee T, Seaquist ER, Ismail-Beigi F, Sullivan MD, Lovato LC, Bergenstal RM, Gerstein HC; ACCORD Group of Investigators; ACCORD-MIND Investigators. Poor cognitive function and risk of severe hypoglycemia in type 2 diabetes: post hoc epidemiologic analysis of the ACCORD trial. Diabetes Care. 2012 Apr;35(4):787-93. doi: 10.2337/dc11-1855. Epub 2012 Feb 28.

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• Seaquist ER, Miller ME, Bonds DE, Feinglos M, Goff DC Jr, Peterson K, Senior P; ACCORD Investigators. The impact of frequent and unrecognized hypoglycemia on mortality in the ACCORD study. Diabetes Care. 2012 Feb;35(2):409-14. doi: 10.2337/dc11-0996. Epub 2011 Dec 16.

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• Genuth S, Ismail-Beigi F. Clinical implications of the ACCORD trial. J Clin Endocrinol Metab. 2012 Jan;97(1):41-8. doi: 10.1210/jc.2011-1679. Epub 2011 Nov 2.

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• Launer LJ, Miller ME, Williamson JD, Lazar RM, Gerstein HC, Murray AM, Sullivan M, Horowitz KR, Ding J, Marcovina S, Lovato LC, Lovato J, Margolis KL, O'Connor P, Lipkin EW, Hirsch J, Coker L, Maldjian J, Sunshine JL, Truwit C, Davatzikos C, Bryan RN; ACCORD MIND investigators. Effects of intensive glucose lowering on brain structure and function in people with type 2 diabetes (ACCORD MIND): a randomised open-label substudy. Lancet Neurol. 2011 Nov;10(11):969-77. doi: 10.1016/S1474-4422(11)70188-0. Epub 2011 Sep 28.

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• Mychaleckyj JC, Farber EA, Chmielewski J, Artale J, Light LS, Bowden DW, Hou X, Marcovina SM. Buffy coat specimens remain viable as a DNA source for highly multiplexed genome-wide genetic tests after long term storage. J Transl Med. 2011 Jun 10;9:91. doi: 10.1186/1479-5876-9-91.

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• ACCORD Study Group; Gerstein HC, Miller ME, Genuth S, Ismail-Beigi F, Buse JB, Goff DC Jr, Probstfield JL, Cushman WC, Ginsberg HN, Bigger JT, Grimm RH Jr, Byington RP, Rosenberg YD, Friedewald WT. Long-term effects of intensive glucose lowering on cardiovascular outcomes. N Engl J Med. 2011 Mar 3;364(9):818-28. doi: 10.1056/NEJMoa1006524.

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• ACCORD Study Group; ACCORD Eye Study Group; Chew EY, Ambrosius WT, Davis MD, Danis RP, Gangaputra S, Greven CM, Hubbard L, Esser BA, Lovato JF, Perdue LH, Goff DC Jr, Cushman WC, Ginsberg HN, Elam MB, Genuth S, Gerstein HC, Schubart U, Fine LJ. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med. 2010 Jul 15;363(3):233-44. doi: 10.1056/NEJMoa1001288. Epub 2010 Jun 29.

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• Strylewicz G, Doctor J. Evaluation of an automated method to assist with error detection in the ACCORD central laboratory. Clin Trials. 2010 Aug;7(4):380-9. doi: 10.1177/1740774510372779. Epub 2010 Jun 22.

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• Riddle MC, Ambrosius WT, Brillon DJ, Buse JB, Byington RP, Cohen RM, Goff DC Jr, Malozowski S, Margolis KL, Probstfield JL, Schnall A, Seaquist ER; Action to Control Cardiovascular Risk in Diabetes Investigators. Epidemiologic relationships between A1C and all-cause mortality during a median 3.4-year follow-up of glycemic treatment in the ACCORD trial. Diabetes Care. 2010 May;33(5):983-90. doi: 10.2337/dc09-1278.

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• ACCORD Study Group; Ginsberg HN, Elam MB, Lovato LC, Crouse JR 3rd, Leiter LA, Linz P, Friedewald WT, Buse JB, Gerstein HC, Probstfield J, Grimm RH, Ismail-Beigi F, Bigger JT, Goff DC Jr, Cushman WC, Simons-Morton DG, Byington RP. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1563-74. doi: 10.1056/NEJMoa1001282. Epub 2010 Mar 14.

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• ACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.

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• Pop-Busui R, Evans GW, Gerstein HC, Fonseca V, Fleg JL, Hoogwerf BJ, Genuth S, Grimm RH, Corson MA, Prineas R; Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of cardiac autonomic dysfunction on mortality risk in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Diabetes Care. 2010 Jul;33(7):1578-84. doi: 10.2337/dc10-0125. Epub 2010 Mar 9.

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• Miller ME, Bonds DE, Gerstein HC, Seaquist ER, Bergenstal RM, Calles-Escandon J, Childress RD, Craven TE, Cuddihy RM, Dailey G, Feinglos MN, Ismail-Beigi F, Largay JF, O'Connor PJ, Paul T, Savage PJ, Schubart UK, Sood A, Genuth S; ACCORD Investigators. The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. BMJ. 2010 Jan 8;340:b5444. doi: 10.1136/bmj.b5444.

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• Bonds DE, Miller ME, Bergenstal RM, Buse JB, Byington RP, Cutler JA, Dudl RJ, Ismail-Beigi F, Kimel AR, Hoogwerf B, Horowitz KR, Savage PJ, Seaquist ER, Simmons DL, Sivitz WI, Speril-Hillen JM, Sweeney ME. The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study. BMJ. 2010 Jan 8;340:b4909. doi: 10.1136/bmj.b4909.

  PMID: 20061358 DERIVED

• Meier M, Hummel M. Cardiovascular disease and intensive glucose control in type 2 diabetes mellitus: moving practice toward evidence-based strategies. Vasc Health Risk Manag. 2009;5:859-71. doi: 10.2147/vhrm.s4808. Epub 2009 Nov 2.

  PMID: 19898642 DERIVED

Related Links

• Click here for the ACCORD trial web site

MeSH Terms

Conditions

Atherosclerosis; Cardiovascular Diseases; Hypercholesterolemia; Hypertension; Diabetes Mellitus, Type 2; Diabetes Mellitus; Coronary Disease

Interventions

glimepiride; Metformin; repaglinide; Rosiglitazone; Pioglitazone; Insulin; Isophane Insulin, Human; Insulin Aspart; Insulin Detemir; Insulin Glargine; Acarbose; Antihypertensive Agents; benazepril; Lisinopril; Ramipril; Chlorthalidone; Metoprolol; Diltiazem; Felodipine; Terazosin; candesartan; candesartan cilexetil; Valsartan; Furosemide; Reserpine; Hydralazine; Carvedilol; Triamterene; Hydrochlorothiazide; hydrochlorothiazide-triamterene; hydrochlorothiazide, lisinopril drug combination; Amlodipine; Simvastatin; Fenofibrate

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Isophane; Insulin, Long-Acting; Insulin, Regular, Human; Insulin, Short-Acting; Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Dipeptides; Oligopeptides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Isoindoles; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Benzazepines; Dihydropyridines; Pyridines; Tetrazoles; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Essential; Sulfanilamides; Aniline Compounds; Yohimbine; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Phthalazines; Pyridazines; Carbazoles; Heterocyclic Compounds, 3-Ring; Pteridines; Chlorothiazide; Benzothiadiazines; Thiazides; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Phenyl Ethers; Ethers; Phenols

Results Point of Contact

• Title: Tim Craven / Senior Biostatistician
• Organization: Wake Forest School of Medicine

tcraven@wakehealth.edu

336-716-6109

Study Officials

• Denise Simons-Morton, MD, PhD

  National Heart, Lung, and Blood Institute (NHLBI)

  STUDY DIRECTOR

• William Friedewald, MD

  Columbia University, New York, NY

  STUDY CHAIR

• Robert Byington, PhD

  Wake Forest University, Winston-Salem, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: September 1, 1999
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2012
• Last Updated: November 22, 2016
• Results First Posted: September 15, 2014

Record last verified: 2014-11

Locations

US (6); CA (1)