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Review

Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements

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Pages 315-325 | Published online: 20 Jul 2015

References

  • DormandyJACharbonnelBEcklandDJPROactive investigatorsSecondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trialLancet20053661279 128916214598
  • PatelAChalmersJPoulterNADVANCE: action in diabetes and vascular diseaseJ Hum Hypertens200519Suppl 1S27 S3216075030
  • PatelAADVANCE Collaborative GroupMacMahonSChalmersJEffects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trialLancet20073709590829 84017765963
  • VibertiGLachinJHolmanRADOPT Study GroupA Diabetes Outcome Progression Trial (ADOPT): baseline characteristics of type 2 diabetic patients in North America and EuropeDiabet Med200623121289 129417116177
  • DuckworthWAbrairaCMoritzTVADT InvestigatorsGlucose control and vascular complications in veterans with type 2 diabetesN Engl J Med20093602129 13919092145
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  • ACCORD Study GroupBuseJBBiggerJTAction to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methodsAm J Cardiol20079912A21i 33i
  • HomePDPocockSJBeck-NielsenHRECORD Study TeamRosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trialLancet200937396812125 213519501900
  • Bypass Angioplasty Revascularization Investigation 2 Diabetes Study GroupBaseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trialAm Heart J20081563528 53618760137
  • BARI 2D Study GroupFryeRLAugustPA randomized trial of therapies for type 2 diabetes and coronary artery diseaseN Engl J Med2009360242503 251519502645
  • WhiteWBBakrisGLBergenstalRMEXamination 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 syndromeAm Heart J20111624620 62621982652
  • WhiteWBCannonCPHellerSREXAMINE InvestigatorsAlogliptin after acute coronary syndrome in patients with type 2 diabetesN Engl J Med20133691327 133523992602
  • SciricaBMBhattDLBraunwaldESAVOR-TIMI 53 Steering Committee and InvestigatorsSaxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitusN Engl J Med2013369141317 132623992601
  • SciricaBMBhattDLBraunwaldEThe design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 studyAm Heart J20111625818 82522093196
  • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER)Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 DiabetesSilver SpringUS Food and Drug Administration2008

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  • National Diabetes Statistics Report, 2014: Estimates of Diabetes and Its Burden in the United StatesDivision of Diabetes Translation, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention2014 Available from: http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdfAccessed December 31, 2014
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  • PatelAChalmersJPoulterNADVANCE: action in diabetes and vascular diseaseJ Hum Hypertens200519Suppl 1S27 S3216075030
  • PatelAADVANCE Collaborative GroupMacMahonSChalmersJEffects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trialLancet20073709590829 84017765963
  • VibertiGLachinJHolmanRADOPT Study GroupA Diabetes Outcome Progression Trial (ADOPT): baseline characteristics of type 2 diabetic patients in North America and EuropeDiabet Med200623121289 129417116177
  • DuckworthWAbrairaCMoritzTVADT InvestigatorsGlucose control and vascular complications in veterans with type 2 diabetesN Engl J Med20093602129 13919092145
  • MeyersCDMcCarrenMWongNDAbrairaCDuckworthWCKashyapMLVADT InvestigatorsBaseline achievement of lipid goals and usage of lipid medications in patients with diabetes mellitus (from the Veterans Affairs Diabetes Trial)Am J Cardiol200698163 6516784922
  • ACCORD Study GroupBuseJBBiggerJTAction to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methodsAm J Cardiol20079912A21i 33i
  • HomePDPocockSJBeck-NielsenHRECORD Study TeamRosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trialLancet200937396812125 213519501900
  • Bypass Angioplasty Revascularization Investigation 2 Diabetes Study GroupBaseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trialAm Heart J20081563528 53618760137
  • BARI 2D Study GroupFryeRLAugustPA randomized trial of therapies for type 2 diabetes and coronary artery diseaseN Engl J Med2009360242503 251519502645
  • WhiteWBBakrisGLBergenstalRMEXamination 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 syndromeAm Heart J20111624620 62621982652
  • WhiteWBCannonCPHellerSREXAMINE InvestigatorsAlogliptin after acute coronary syndrome in patients with type 2 diabetesN Engl J Med20133691327 133523992602
  • SciricaBMBhattDLBraunwaldESAVOR-TIMI 53 Steering Committee and InvestigatorsSaxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitusN Engl J Med2013369141317 132623992601
  • SciricaBMBhattDLBraunwaldEThe design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 studyAm Heart J20111625818 82522093196
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