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

Diabetes, Metabolic Syndrome and Obesity

Volumn 8, Issue , 2015, Pages 315-324

  Yang, Fred ^a   Stewart, Murray ^b   Ye, June ^b   Demets, David ^c  

^a ASTRAZENECA   (United Kingdom)

^b GLAXOSMITHKLINE   (United States)

^c UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

Author keywords

Cardiac event; Cardiovascular outcome; CV risk; Major adverse; Noninferiority; Superiority; T2DM

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ALOGLIPTIN; BIOLOGICAL MARKER; DULAGLUTIDE; EXENDIN 4; GLIMEPIRIDE; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; HEMOGLOBIN A1C; INSULIN; LINAGLIPTIN; LIPID; LIRAGLUTIDE; LIXISENATIDE; METFORMIN; ORAL ANTIDIABETIC AGENT; PIOGLITAZONE; PLACEBO; SAXAGLIPTIN; SITAGLIPTIN;

ACUTE CORONARY SYNDROME; AGE; ARTICLE; BLOOD PRESSURE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; DRUG SAFETY; DRUG TOLERABILITY; GLYCEMIC CONTROL; HEART DEATH; HEART DISEASE; HEART INFARCTION; HUMAN; HYPERGLYCEMIA; KIDNEY FAILURE; NON INSULIN DEPENDENT DIABETES MELLITUS; NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PROGRAM DEVELOPMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT; RISK BENEFIT ANALYSIS; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; TREATMENT OUTCOME;

EID: 84938387826     PISSN: None     EISSN: 11787007     Source Type: Journal    
DOI: 10.2147/DMSO.S84005     Document Type: Article

References (32)

1. Danaei G, Finucane MM, Lu Y, et al; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Blood Glucose). National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2-7 million participants. Lancet. 2011;378(9785):31-40.
2. Definition and Diagnosis of Diabetes Mellitus and Intermediate Hyperglycemia: Report of a WHO/IDF Consultation. World Health Organization; International Diabetes Federation; 2006. Available from: http://whqlibdoc.who.int/publications/2006/9241594934_eng.pdf?ua=1. Accessed January 31, 2015.
3. National Diabetes Statistics Report, 2014: Estimates of Diabetes and Its Burden in the United States. Division of Diabetes Translation, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention; 2014. Available from: http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed December 31, 2014.
4. Brass EP. The Food and Drug Administration and the future of drug development for the treatment of diabetes. Diabetes Spectr. 2014;27(2):75-77.
5. Fleming TR. Identifying and addressing safety signals in clinical trials: some issues and challenges. In: Fleming TR, Weir BS, editors. Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials. New York, NY: Springer; 2013:137-156.
6. Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2008. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf. Accessed January 31, 2012.
7. Dormandy JA, Charbonnel B, Eckland DJ, et al; PROactive investigators. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005;366:1279-1289.
8. Patel A, Chalmers J, Poulter N. ADVANCE: action in diabetes and vascular disease. J Hum Hypertens. 2005;19 Suppl 1:S27-S32.
9. Patel A; ADVANCE Collaborative Group, MacMahon S, Chalmers J, et al. Effects 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 trial. Lancet. 2007;370(9590):829-840.
10. Viberti G, Lachin J, Holman R, et al; ADOPT Study Group. A Diabetes Outcome Progression Trial (ADOPT): baseline characteristics of type 2 diabetic patients in North America and Europe. Diabet Med. 2006;23(12):1289-1294.
11. Duckworth W, Abraira C, Moritz T, et al; VADT Investigators. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009;360(2):129-139.
12. Meyers CD, McCarren M, Wong ND, Abraira C, Duckworth WC, Kashyap ML; VADT Investigators. Baseline achievement of lipid goals and usage of lipid medications in patients with diabetes mellitus (from the Veterans Affairs Diabetes Trial). Am J Cardiol. 2006; 98(1):63-65.
13. ACCORD Study Group, Buse JB, Bigger JT, et al. Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. Am J Cardiol. 2007;99(12A):21i-33i.
14. Home PD, Pocock SJ, Beck-Nielsen H, et al; RECORD Study Team. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet. 2009;373(9681):2125-2135.
15. Bypass Angioplasty Revascularization Investigation 2 Diabetes Study Group. Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Am Heart J. 2008;156(3):528-536.
16. BARI 2D Study Group, Frye RL, August P, et al. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med. 2009;360(24):2503-2515.
17. White WB, Bakris GL, Bergenstal RM, et al. 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;162(4):620-626.
18. White WB, Cannon CP, Heller SR, et al; EXAMINE Investigators. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013;369:1327-1335.
19. Scirica BM, Bhatt DL, Braunwald E, et al; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369(14):1317-1326.
20. Scirica BM, Bhatt DL, Braunwald E, et al. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J. 2011;162(5):818-825.
21. Eli Lilly and Company. Researching cardiovascular events with a weekly incretin in diabetes (REWIND). Available from: http://www.clinicaltrials.gov/ct2/show/NCT01394952. NLM identifier: NCT01394952. Accessed June 30, 2014.
22. AstraZeneca. Exenatide study of cardiovascular event lowering trial (EXSCEL): a trial to evaluate cardiovascular outcomes after treatment with exenatide once weekly in patients with type 2 diabetes mellitus. Available from: https://clinicaltrials.gov/ct2/show/NCT01144338. NLM identifier: NCT01144338. Accessed October 24, 2011.
23. Boehringer Ingelheim. CAROLINA: cardiovascular outcome study of linagliptin versus glimepiride in patients with type 2 diabetes. Available from: http://www.clinicaltrials.gov/ct2/show/NCT01243424. NLM identifier: NCT01243424. Accessed June 30, 2014.
24. Boehringer Ingelheim. Cardiovascular and renal microvascular outcome study with linagliptin in patients with type 2 diabetes mellitus (CARMELINA). Available from: http://www.clinicaltrials.gov/ct2/show/NCT01897532. NLM identifier: NCT01897532. Accessed June 30, 2014.
25. Novo Nordisk A/S. Liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results - a long term evaluation (LEADER®). Available from: http://www.clinicaltrials.gov/ct2/show/NCT01179048?term=NCT01179048&rank=1. NLM identifier: NCT01179048. Accessed October 25, 2011.
26. Sanofi. Evaluation of cardiovascular outcomes in patients with type 2 diabetes after acute coronary syndrome during treatment with AVE0010 (lixisenatide) (ELIXA). Available from: http://www.clinicaltrials.gov/ct2/show/NCT01147250. NLM identifier: NCT01147250. Accessed June 30, 2014.
27. Merck Sharp & Dohme Corp. Sitagliptin cardiovascular outcome study (MK-0431-082) (TECOS). Available from: http://www.clinicaltrials.gov/ct2/show/NCT00790205. NLM identifier: NCT00790205. Accessed June 30, 2014.
28. Badimon L, Hernández Vera R, Vilahur G. Determinants of cardiovascular risk in diabetes beyond hyperglycemia. J Cardiovasc Dis. 2013;1(2):53-62.
29. Baron JA, Sandler RS, Bresalier RS, et al. Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial. Lancet. 2008;372(9651):1756-1764.
30. Bresalier RS, Sandler RS, Quan H, et al; Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med. 2005;352(11):1092-1102.
31. Akl EA, Briel M, You JJ, et al. Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review. BMJ. 2012;344:e2809.
32. Hung HM, Wang SJ. Some controversial multiple testing problems in regulatory applications. J Biopharm Stat. 2009;19(1):1-11.