Simple pharmacometric tools for oral anti-diabetic drug development: Competitive landscape for oral non-insulin therapies in type 2 diabetes

Biopharmaceutics and Drug Disposition

Volumn 31, Issue 2-3, 2010, Pages 162-177

  Samtani, Mahesh N ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Clinical trial; Meta analysis; Pharmacometrics; PK PD; Type 2 diabetes

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ACARBOSE; ALPHA GLUCOSIDASE INHIBITOR; GLIBENCLAMIDE; GLIMEPIRIDE; GLUCOSE; HEMOGLOBIN A1C; METFORMIN; MIGLITOL; MITIGLINIDE; NATEGLINIDE; ORAL ANTIDIABETIC AGENT; PIOGLITAZONE; PLACEBO; REPAGLINIDE; ROSIGLITAZONE; SITAGLIPTIN; SULFONYLUREA DERIVATIVE;

ARTICLE; CLINICAL TRIAL; COMPARTMENT MODEL; DIARRHEA; DIET RESTRICTION; DIET THERAPY; DISEASE COURSE; DRUG COST; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INFORMATION; DRUG RESEARCH; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; FLATULENCE; FOOD AND DRUG ADMINISTRATION; FRACTURE; GASTROINTESTINAL DISEASE; GLUCOSE BLOOD LEVEL; HEART DISEASE; HUMAN; HYPOGLYCEMIA; LACTIC ACIDOSIS; MEDICAL LITERATURE; NON INSULIN DEPENDENT DIABETES MELLITUS; PREDICTION; SIDE EFFECT; TREATMENT RESPONSE; WEIGHT GAIN;

ADMINISTRATION, ORAL; BLOOD GLUCOSE; CLINICAL TRIALS, PHASE III AS TOPIC; COST OF ILLNESS; DIABETES MELLITUS, TYPE 2; DISEASE PROGRESSION; DRUG ADMINISTRATION SCHEDULE; DRUG DELIVERY SYSTEMS; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; PATIENT COMPLIANCE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 77951063464     PISSN: 01422782     EISSN: 1099081X     Source Type: Journal    
DOI: 10.1002/bdd.700     Document Type: Article

References (40)

1. Bolen S, Feldman L, Vassy J, et al. Systematic review: comparative effectiveness and safety of oral medications for type 2 diabetes mellitus. Ann Intern Med 2007; 147: 386-399. (Pubitemid 351664540)
2. Electronic Orange Book Approved Drug Products. Food and Drug Administration. http://www.fda.gov/cder/ob/ [25 September 2009].
3. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356: 2457-2471. DOI: 10.1056/NEJMoa072761. (Pubitemid 46919772)
4. Kahn SE, Haffner SM, Heise MA, et al.; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006; 355: 2427-2443. DOI: 10.1056/NEJMoa066224.
5. Rosenstock J, Hassman DR, Madder RD, et al.; Repaglinide Versus Nateglinide Comparison Study Group. Repaglinide versus nateglinide monotherapy: a randomized, multicenter study. Diabetes Care 2004; 27: 1265-1270. DOI: 10.2337/diacare.27.6.1265.
6. Jovanovic L, Dailey III G, Huang WC, Strange P, Goldstein BJ. Repaglinide in type 2 diabetes: a 24-week, fixed-dose efficacy and safety study. J Clin Pharmacol 2000; 40: 49-57.
7. Tan MH, Baksi A, Krahulec B, et al.; GLAL Study Group. Comparison of pioglitazone and gliclazide in sustaining glycemic control over 2 years in patients with type 2 diabetes. Diabetes Care 2005; 28: 544-550. DOI: 10.2337/diacare.28.3.544.
8. Aronoff S, Rosenblatt S, Braithwaite S, Egan JW, Mathisen AL, Schneider RL. Pioglitazone hydrochloride monotherapy improves glycemic control in the treatment of patients with type 2 diabetes: a 6-month randomized placebo-controlled dose-response study. The Pioglitazone 001 Study Group. Diabetes Care 2000; 23: 1605-1611. DOI: 10.2337/diacare.23.11.1605.
9. Scherbaum WA, Göke B; German Pioglitazone Study Group. Metabolic efficacy and safety of once-daily pioglitazone monotherapy in patients with type 2 diabetes: a double-blind, placebo-controlled study. Horm Metab Res 2002; 34: 589-595. DOI: 10.1055/s-2002-35421.
10. Schernthaner G, Matthews DR, Charbonnel B, Hanefeld M, Brunetti P; Quartet Study Group. Efficacy and safety of pioglitazone versus metformin in patients with type 2 diabetes mellitus: a double-blind, randomized trial. J Clin Endocrinol Metab 2004; 89: 6068-6076. DOI: 10.1210/jc.2003-030861. (Pubitemid 39628416)
11. Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care 2006; 29: 2632-2637. DOI: 10.2337/dc06-0703.
12. Avandia (Rosiglitazone Maleate) tablets. NDA 21-071: Statistical Review Study 011, pages 9-13. www.accessdata.fda.gov/drugsatfda-docs/nda/99/21071- Avandia-statr.pdf [25 September 2009].
13. Avandia (Rosiglitazone Maleate) tablets. NDA 21-071: Statistical Review Study 024, pages 14-18. www.accessdata.fda.gov/drugsatfda-docs/nda/99/21071- Avandia-statr.pdf [25 September 2009].
14. Rosenstock J, Rood J, Cobitz A, Biswas N, Chou H, Garber A. Initial treatment with rosiglitazone/metformin fixed-dose combination therapy compared with monotherapy with either rosiglitazone or metformin in patients with uncontrolled type 2 diabetes. Diabetes Obes Metab 2006; 8: 650-660. DOI: 10.1111/j.1463-1326.2006.00659.x. (Pubitemid 44515562)
15. Schade DS, Jovanovic L, Schneider J. A placebo-controlled, randomized study of glimepiride in patients with type 2 diabetes mellitus for whom diet therapy is unsuccessful. J Clin Pharmacol 1998; 38: 636-641. (Pubitemid 28354902)
16. Graph Digitizer®, Version 2.0. http://www.geocities.com/ graphdigitizer/index2.htm [25 September 2009].
17. Burnett RW, D'Orazio P, Fogh-Andersen N, et al. Scientific Division, Working Group on Selective Electrodes. IFCC recommendation on reporting results for blood glucose. Clin Chim Acta 2001; 307: 205-209. DOI: 10.1016/S0009- 8981(01)00431-4.
18. Yao Z, Krzyzanski W, Jusko WJ. Assessment of basic indirect pharmacodynamic response models with physiological limits. J Pharmacokinet Pharmacodyn 2006; 33: 167-193. DOI: 10.1007/s10928-006-9003-7. (Pubitemid 44819258)
19. Sun YN, Jusko WJ. Transit compartments versus gamma distribution function to model signal transduction processes in pharmacodynamics. J Pharm Sci 1998; 87: 732-737. DOI: 10.1021/js970414z.
20. Struys MM, Coppens MJ, De Neve N, et al. Influence of administration rate on propofol plasma-effect site equilibration. Anesthesiology 2007; 107: 386-396. DOI: 10.1097/01.anes.0000278902.15505.f8. (Pubitemid 47329536)
21. Mandema JW, Hermann D, Wang W, et al. Model-based development of gemcabene, a new lipid-altering agent. AAPS J 2005; 7: E513-E522. DOI: 10.1208/aapsj070352. (Pubitemid 41631737)
22. Bonate PL. Nonlinear Mixed Effects Models: Theory. In Pharmacokinetic- Pharmacodynamic Modeling and Simulation, Bonate PL (ed.). Springer Science and Business Media: New York, 2005; 205-265.
23. Inzucchi SE. Oral antihyperglycemic therapy for type 2 diabetes: Scientific Review. JAMA 2002; 287: 360-372. DOI: 10.1001/jama.287.3.360. (Pubitemid 34256388)
24. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009; 32: 193-203. DOI: 10.2337/dc08-9025.
25. Wang Y, Bhattaram AV, Jadhav PR, et al. Lever-aging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006. J Clin Pharmacol 2008; 48: 146-156. DOI: 10.1177/0091270007311111.
26. US Food and Drug Administration. Drugs@FDA. http://www.accessdata.fda. gov/scripts/cder/drugsatfda [25 September 2009].
27. Wallace TM, Matthews DR. Coefficient of failure: a methodology for examining longitudinal beta-cell function in Type 2 diabetes. Diabet Med 2002; 19: 465-469. DOI: 10.1046/j.1464-5491.2002.00718.x.
28. UK Prospective Diabetes Study Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type II diabetes (UKPDS 34). Lancet 1998; 352: 854-865. DOI: 10.1016/S0140-6736(98) 07037-8.
29. US Food and Drug Administration. Label for GLUCOPHAGE metformin hydrochloride tablets. www.accessdata.fda.gov/drugsatfda-docs/label/2006/ 020357s030,021202s015lbl.pdf [25 September 2009].
30. Fischer S, Hanefeld M, Spengler M, Boehme K, Temelkova-Kurktschiev T. European study on dose-response relationship of acarbose as a first-line drug in non-insulin-dependent diabetes mellitus: efficacy and safety of low and high doses. Acta Diabetol 1998; 35: 34-40. DOI: 10.1007/s005920050098.
31. US Food and Drug Administration. Label for STARLIX nateglinide tablets. www.accessdata. fda.gov/drugsatfda-docs/label/2008/021204s011lbl.pdf [25 September 2009].
32. Horton ES, Clinkingbeard C, Gatlin M, Foley J, Mallows S, Shen S. Nateglinide alone and in combination with metformin improves glycemic control by reducing mealtime glucose levels in type 2 diabetes. Diabetes Care 2000; 23: 1660-1665. DOI: 10.2337/diacare.23.11.1660.
33. Drent ML, Tollefsen AT, van Heusden FH, Hoenderdos EB, Jonker JJ, van der Veen EA. Dose-dependent efficacy of miglitol, an alpha-glucosidase inhibitor, in type 2 diabetic patients on diet alone: results of a 24-week double-blind placebo-controlled study. Diabetes Nutr Metab 2002; 15: 152-159.
34. Segal P, Feig PU, Schernthaner G, et al. The efficacy and safety of miglitol therapy compared with glibenclamide in patients with NIDDM inadequately controlled by diet alone. Diabetes Care 1997; 20: 687-691. DOI: 10.2337/diacare.20.5.687. (Pubitemid 27202513)
35. Shojania KG, Ranji SR, McDonald KM, et al. Effects of quality improvement strategies for Type 2 diabetes on glycemic control. JAMA 2006; 296: 427-440. DOI: 10.1001/jama.296.4.427
36. de Winter W, DeJongh J, Post T, et al. A mechanism-based disease progression model for comparison of long-term effects of pioglitazone, metformin and gliclazide on disease processes underlying type 2 diabetes mellitus. J Pharmacokinet Pharmacodyn 2006; 33: 313-343. DOI: 10.1007/s10928-006-9008-2. (Pubitemid 44020384)
37. Benincosa L, Jusko WJ. Novel method of treatment. Geneva: World Intellectual Property Organization, 1999. Publ. no. W0/2000/027341.
38. Landersdorfer CB, Jusko WJ. Pharmacokinetic/pharmacodynamic modelling in diabetes mellitus. Clin Pharmacokinet 2008; 47: 417-448. DOI: 10.2165/00003088-200847070-00001.
39. Rohlfing CL, Wiedmeyer HM, Little RR, England JD, Tennill A, Goldstein DE. Defining the relationship between plasma glucose and HbA(1c): analysis of glucose profiles and HbA(1c) in the Diabetes Control and Complications Trial. Diabetes Care 2002; 25: 275-278. DOI: 10.2337/diacare.25.2.275. (Pubitemid 41079621)
40. Ashiya M, Smith RET. Non-insulin therapies for type 2 diabetes. Nat Rev Drug Discov 2007; 6: 777-778. DOI: 10.1038/nrd2420.