An analysis of the impact of FDA's guidelines for addressing cardiovascular risk of drugs for type 2 diabetes on clinical development

Contemporary Clinical Trials

Volumn 32, Issue 3, 2011, Pages 324-332

  Viereck, Christopher ^a   Boudes, Pol ^b  

^a Quadratum Consulting Services LLC   (United States)

^b Endocrinology and Metabolic Diseases   (United States)

Author keywords

Alogliptin; Exenatide; Insulin inhalation powder; Saxagliptin and liraglutide; Sitagliptin; Vildagliptin

Indexed keywords

AFREZZA; ALOGLIPTIN; ANTIDIABETIC AGENT; BROMOCRIPTINE MESILATE; BYDUREON; COLESEVELAM; DIPEPTIDYL PEPTIDASE IV INHIBITOR; EXENDIN 4; GLAVUS; GLITAZONE DERIVATIVE; GLUCAGON LIKE PEPTIDE 1 DERIVATIVE; HEMOGLOBIN A1C; INCRETIN; INSULIN; LIRAGLUTIDE; METFORMIN; PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR GAMMA AGONIST; PIOGLITAZONE; ROSIGLITAZONE; SAXAGLIPTIN; SITAGLIPTIN; SULFONYLUREA; UNCLASSIFIED DRUG; VILDAGLIPTIN;

ACROMEGALY; ADD ON THERAPY; ADJUVANT THERAPY; ANALYSIS OF COVARIANCE; ANALYSIS OF VARIANCE; ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CLINICAL PRACTICE; DIET; DISEASE DURATION; DRUG APPROVAL; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG FORMULATION; DRUG INDICATION; DRUG MECHANISM; DRUG SAFETY; EXERCISE; FOOD AND DRUG ADMINISTRATION; GLYCEMIC CONTROL; HUMAN; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPERPROLACTINEMIA; MONOTHERAPY; MORNING DOSAGE; NON INSULIN DEPENDENT DIABETES MELLITUS; PARKINSON DISEASE; PHASE 3 CLINICAL TRIAL (TOPIC); POWDER; PRACTICE GUIDELINE; PROLACTINOMA; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; RISK ASSESSMENT; STATISTICAL ANALYSIS; TREATMENT OUTCOME;

ADAMANTANE; ALLYLAMINE; CARDIOVASCULAR DISEASES; DIABETES MELLITUS, TYPE 2; DIPEPTIDES; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; GLUCAGON-LIKE PEPTIDE 1; HUMANS; HYPOGLYCEMIC AGENTS; INCRETINS; INSULIN; INVESTIGATIONAL NEW DRUG APPLICATION; NITRILES; PEPTIDES; PIPERIDINES; PRACTICE GUIDELINES AS TOPIC; PYRAZINES; PYRROLIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIME FACTORS; TRIAZOLES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; URACIL; VENOMS;

EID: 79953038214     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2011.01.009     Document Type: Article

References (44)

1. Nissen S.E., Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007, 356:2457-2471.
2. FDA Final Guidance for Industry: "Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes". December, 2008, Accessed April 15, 2010. http://tinyurl.com/lkwfp5.
3. REMS for Rosiglitazone. Accessed September 23, 2010. http://tinyurl.com/27n4m3y.
4. Takeda Press Release (June 26, 2009) "Takeda Receives FDA Complete Response Letter for Alogliptin, An Investigational Treatment for Type 2 Diabetes". Accessed April 15, 2010. http://tinyurl.com/y7uf7f4.
5. Vildagliptin EU Marketing Authorization. 26 September 2007. Accessed September 20, 2010. http://tinyurl.com/2537a6t.
6. Vildagliptin Resubmission in the US Not Planned. Accessed June 16, 2010. http://tinyurl.com/6avz4d.
7. Insulin Inhalation Powder (Afrezza): FDA Complete Response Letter. Accessed September 22, 2010. http://www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1402294&highlight.
8. New PDUFA date for ExenatideLAR. May 19, 2010. http://tinyurl.com/2czkwb9.
9. Exenatide. First NDA Approval letter. Accessed September 20, 2010. http://tinyurl.com/24r9kwx.
10. Liraglutide. First NDA Approval letter. Accessed September 20, 2010. http://tinyurl.com/272s5zz.
11. Sitagliptin. First NDA Approval letter. Accessed May 10, 2010. http://tinyurl.com/22trsj5.
12. Saxagliptin. First NDA Approval letter. Accessed May 10, 2010. http://tinyurl.com/27m2q6f.
13. Exenatide Prescribing Information; 2005; Accessed April 15, 2010. http://tinyurl.com/y6mam5d.
14. Liraglutide Prescribing Information; 2010; Accessed April 15, 2010. http://tinyurl.com/yynbfl7.
15. Saxagliptin Prescribing Information; 2009; Accessed April 15, 2010. http://tinyurl.com/y5jv2f6.
16. Sitagliptin Prescribing Information; 2006 Accessed April 15, 2010. http://tinyurl.com/y5ah4ph.
17. Exenatide Approval for Monotherapy (10/30/2009): (accessed April 20, 2010). http://tinyurl.com/y4m8erj.
18. Colesevelam. FDA approval letter, Accessed September 20, 2010. http://tinyurl.com/2f89aa8.
19. Bromocryptine mesylate. FDA approval letter, Accessed September 20, 2010. http://tinyurl.com/2ac94ur.
20. FDA Advisory Panel for bromocriptine NDA. Accessed September 20, 2010. http://tinyurl.com/23zslbe.
21. Colesevelam Prescribing Information. Accessed September 22, 2010. http://www.welchol.com/pdf/Welchol_PI.pdf.
22. Bromocryptine mesylate Prescribing Information. Accessed September 22, 2010. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020866lbl.pdf.
23. Alogliptin NDA Submission. Accessed June 16 2010. http://tinyurl.com/232a82p.
24. Exenatide LAR NDA Submission. Accessed April 20, 2010. http://tinyurl.com/2d2l7jy.
25. Vildagliptin FDA Submission and Approvable letter. Accessed September 22, 2010. http://tinyurl.com/2d42bp5.
26. Alogliptin Complete FDA Response Letter. Accessed April 16, 2010. http://tinyurl.com/y7uf7f4.
27. Alogliptin (NCT00968708); Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (EXAMINE); Clinicaltrials.gov Accessed September 20, 2010. http://tinyurl.com/24d8q23.
28. New PDUFA date: Insulin Inhalation Powder (Afrezza): Accessed September 22, 2010. http://tinyurl.com/25vq8dc.
29. Exenatide: FDA Summary Review. Accessed April 15, 2010. http://tinyurl.com/ye83c53.
30. Saxagliptin: FDA Summary Review. Accessed April 15, 2010. http://tinyurl.com/y2sjyxs.
31. Saxagliptin: FDA Cross Discipline Team Leader Review. Accessed April 15, 2010. http://tinyurl.com/ycckepa.
32. Sitagliptin: FDA Summary Review. Accessed April 15, 2010. http://tinyurl.com/y3mbqoo.
33. Liraglutide: FDA Summary Review. cm Accessed April 15, 2010. http://tinyurl.com/688.
34. Colesevelam: FDA Summary Review. Accessed June 22, 2010. http://tinyurl.com/2wjuyck.
35. Bromocryptine Mesylate. FDA Summary Review. Accessed June 22, 2010. http://tinyurl.com/2ba32t8.
36. Cincotta A.H., Meier A.H., Cincotta M. Bromocriptine improves glycaemic control and serum lipid profile in obese type 2 diabetic subjects: a new approach in the treatment of diabetes. Expert Opin Investig Drugs 1999, 8(10):1683-1707.
37. Vildagliptin EMEA Dossier. Accessed June 18, 2010. http://tinyurl.com/2eswlb8.
38. Number of Phase 3 Trials (Alogliptin): Accessed June 17, 2010. http://tinyurl.com/2cs864o.
39. Number of Phase 3 Trials: Insulin Inhalation Powder. Accessed June 22, 2010. http://tinyurl.com/24zk6bn.
40. Number of Phase 3 Trials: Exenatide LAR Accessed June 22, 2010. http://tinyurl.com/3yhhycy.
41. Bromocryptine Safety Trial (NCT00377676): Accessed September 20, 2010. http://tinyurl.com/29t8ue2.
42. Liraglutide EU Marketing Authorization. Accessed September 23, 2010. http://tinyurl.com/2e5slwo.
43. A drug's journey from idea to reality. Boston Globe. Accessed June 7, 2010. http://tinyurl.com/c7ev9m.
44. Guidance for Industry. Non-inferiority Clinical Trials. March 2010. Accessed September 24, 2010. http://tinyurl.com/yehram2.