Overcoming challenges in Type 2 diabetes management to improve patient outcomes

Expert Review of Endocrinology and Metabolism

Volumn 5, Issue 5, 2010, Pages 741-751

  Brown, Marie T ^a   Leroith, Derek ^b  

^a RUSH UNIVERSITY MEDICAL CENTER   (United States)

^b MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

antihyperglycemic agents; biguanides; clinical inertia; dipeptidyl peptidase 4 inhibitors; glucose control; incretin based therapies; medication adherence; sulfonylureas; thiazolidinediones; Type 2 diabetes mellitus

Indexed keywords

ACARBOSE; ALOGLIPTIN; ALPHA GLUCOSIDASE; ALPHA GLUCOSIDASE INHIBITOR; BILE ACID SEQUESTRANT; COLESEVELAM; DIPEPTIDYL PEPTIDASE IV INHIBITOR; EXENDIN 4; GLIBENCLAMIDE; GLIMEPIRIDE; GLIPIZIDE; INSULIN; LIRAGLUTIDE; METFORMIN; PIOGLITAZONE; PRAMLINTIDE; ROSIGLITAZONE; SAXAGLIPTIN;

ABDOMINAL DISCOMFORT; ACUTE HEMORRHAGIC PANCREATITIS; BLOOD GLUCOSE MONITORING; CLINICAL ASSESSMENT; CONSTIPATION; DRUG SAFETY; FLATULENCE; FLUID RETENTION; GASTROINTESTINAL SYMPTOM; GLYCEMIC CONTROL; HEADACHE; HUMAN; HYPOGLYCEMIA; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PRIORITY JOURNAL; REVIEW; SIDE EFFECT; SOCIAL SUPPORT; STOMACH EMPTYING; WEIGHT GAIN;

EID: 77956842715     PISSN: 17446651     EISSN: None     Source Type: Journal    
DOI: 10.1586/eem.10.45     Document Type: Review

References (80)

1. American Diabetes Association. Total Prevalence of Diabetes and Pre-Diabetes. American Diabetes Association, VA, USA (2009).
2. US Department of Health and Human Services. National Diabetes Statistics, 2007. National Diabetes Information Clearinghouse, MD, USA, NIH Publication No. 08-3892 (2008).
3. American Diabetes Association. Standards of medical care in diabetes - 2010. Diabetes Care. 33(Suppl. 1), S11-S61 (2010).
4. Schappert SM, Rechtsteiner EA. Ambulatory medical care utilization estimates for 2006. Natl Health Stat. Report 8(8), 1-29 (2008).
5. Katragadda S, Arora RR. Role of angiotensin-converting enzyme inhibitors in vascular modulation: beyond the hypertensive effects. Am. J. Ther. 17, e11-e23 (2010).
6. Saaddine JB, Cadwell B, Gregg EW et al. Improvements in diabetes processes of care and intermediate outcomes: United States, 1988-2002. Ann. Intern. Med. 144(7), 465-474 (2006).
7. Osterberg L, Blaschke T. Adherence to medication. N. Engl. J. Med. 353(5), 487-497 (2005).
8. Bailey CJ, Day C. Fixed-dose single tablet antidiabetic combinations. Diabetes Obes. Metab. 11(6), 527-533 (2009).
9. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin. Ther. 23(8), 1296-1310 (2001).
10. Rozenfeld Y, Hunt JS, Plauschinat C, Wong KS. Oral antidiabetic medication adherence and glycemic control in managed care. Am. J. Manag. Care 14(2), 71-75 (2008).
11. Nicolucci A, Rossi MC. Incretin-based therapies: a new potential treatment approach to overcome clinical inertia in type 2 diabetes. Acta Biomed. 79(3), 184-191 (2008).
12. Edelman SV, Henry RR. Diagnosis and Management of Type 2 Diabetes (8th Edition). Professional Communications, Inc., NY, USA 1-192 (2007).
13. 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 32(1), 193-203 (2009).
14. Grant R, Adams AS, Trinacty CM et al. Relationship between patient medication adherence and subsequent clinical inertia in Type 2 diabetes glycemic management. Diabetes Care 30(4), 807-812 (2007).
15. Brown JB, Conner C, Nichols GA. Secondary failure of metformin monotherapy in clinical practice. Diabetes Care 33(3), 501-506 (2010).
16. Rodondi N, Peng T, Karter AJ et al. Therapy modifications in response to poorly controlled hypertension, dyslipidemia, and diabetes mellitus. Ann. Intern. Med. 144(7), 475-484 (2006).
17. Woerle HJ, Neumann C, Zschau S et al. Impact of fasting and postprandial glycemia on overall glycemic control in Type 2 diabetes. Importance of postprandial glycemia to achieve target HbA1c levels. Diabetes Res. Clin. Pract. 77(2), 280-285 (2007).
18. Rodbard HW, Jellinger PS, Davidson JA et al. Statement by an American Association of Clinical Endocrinologists/ American College of Endocrinology consensus panel on Type 2 diabetes mellitus: an algorithm for glycemic control. Endocr. Pract. 15(6), 541-559 (2009).
19. De Ferrari GM, Klersy C, Ferrero P et al. Atrial fibrillation in heart failure patients: prevalence in daily practice and effect on the severity of symptoms. Data from the ALPHA study registry. Eur. J. Heart Fail. 9(5), 502-509 (2007).
20. Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCl improves glycemic control and reduces LDL-cholesterol in patients with Type 2 diabetes inadequately controlled on sulfonylurea-based therapy. Diabetes Care 31(8), 1479-1484 (2008).
21. Komajda M, McMurray JJ, Beck-Nielsen H et al. Heart failure events with rosiglitazone in type 2 diabetes: data from the RECORD clinical trial. Eur. Heart J. 31(7), 824-831 (2010).
22. Olansky L. Do incretin-based therapies cause acute pancreatitis? J. Diabetes Sci. Technol. 4(1), 228-229 (2010).
23. Kirby M, Yu DM, OConnor S, Gorrell M. Inhibitor selectivity in the clinical application of dipeptidyl peptidase-4 inhibition. Clin. Sci. (Lond.) 118(1), 31-41 (2009).
24. Kahn SE, Zinman B, Lachin JM et al. Rosiglitazone-associated fractures in Type 2 diabetes: an Analysis from A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care 31(5), 845-851 (2008).
25. Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in Type 2 diabetes: systematic review and meta-analysis. JAMA 298(2), 194-206 (2007).
26. Green DE. New therapies for diabetes. Clin. Cornerstone 8(2), 58-63 (2007).
27. [Glucotrol package insert]. Pfizer Inc.NY USA (2009).
28. [Victoza package insert]. Novo Nordisk A/S, NJ, USA (2010).
29. Salpeter SR, Buckley NS, Kahn JA, Salpeter EE. Meta-analysis: metformin treatment in persons at risk for diabetes mellitus. Am. J. Med. 121(2), 149-157 (2008).
30. ® Metformin Hydrochloride. Manufacturers standard 500 mg and 850 mg tablets. Oral Antihyperglycemic Agent (Version 4.0). sanofi-aventis Canada Inc. Submission Control No.: 128147. Revised 29 October (2009).
31. Salpeter S, Greyber E, Pasternak G, Salpeter E. Risk of fatal and nonfatal lactic acidosis with metformin use in Type 2 diabetes mellitus. Cochrane Database Syst. Rev. (1), CD002967 (2006).
32. [Glucophage package insert]. Bristol-Myers Squibb Co.NJ USA. (2008).
33. Tzoulaki I, Molokhia M, Curcin V et al. Risk of cardiovascular disease and all cause mortality among patients with Type 2 diabetes prescribed oral antidiabetes drugs: retrospective cohort study using UK general practice research database. BMJ 3(39), b4731 (2009).
34. Kahn SE, Haffner SM, Heise MA et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N. Engl. J. Med. 355(23), 2427-2443 (2006).
35. Nissen SE, Nicholls SJ, Wolski K et al. Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with Type 2 diabetes: the PERISCOPE randomized controlled trial. JAMA 299(13), 1561-1573 (2008). (Pubitemid 351482795)
36. Tenzer-Iglesias P, Brunton S. Managing postprandial glucose levels in patients with diabetes. J. Fam. Pract. 57(1 Suppl.), S17-S24 (2008).
37. Dagenais GR, Gerstein HC, Holman R et al. Effects of ramipril and rosiglitazone on cardiovascular and renal outcomes in people with impaired glucose tolerance or impaired fasting glucose: results of the Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial. Diabetes Care 31(5), 1007-1014 (2008).
38. Diabetes Prevention Program Research Group. Prevention of Type 2 diabetes with troglitazone in the Diabetes Prevention Program. Diabetes 54(4), 1150-1156 (2005).
39. DeFronzo RA. ACTos NOW for the prevention of diabetes (ACT NOW) study. Late-breaking oral presentation at: 68th Scientific Sessions of the American Diabetes Association. CA, USA 6-10 June 2008.
40. Mazzone T, Meyer PM, Feinstein SB et al. Effect of pioglitazone compared with glimepiride on carotid intima-media thickness in Type 2 diabetes: a randomized trial. JAMA 296(21), 2572-2581 (2006).
41. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N. Engl. J. Med. 356(24), 2457-2471 (2007).
42. [Actos package insert]. Takeda Pharmaceuticals America Inc.IL USA (2008).
43. Avandia package insert]. GlaxoSmithKline, NC, USA (2009).
44. Gautier JF, Choukem SP, Girard J. Physiology of incretins (GIP and GLP-1) and abnormalities in Type 2 diabetes. Diabetes Metab. 34(Suppl. 2), S65-S72 (2008).
45. Zarowitz BJ, Conner C. The intersection of safety and adherence: new incretin-based therapies in patients with Type 2 diabetes mellitus. Pharmacotherapy 29(12 Pt 2), 55S-67S (2009).
46. Verspohl EJ. Novel therapeutics for Type 2 diabetes: incretin hormone mimetics (glucagon-like peptide-1 receptor agonists) and dipeptidyl peptidase inhibitors. Pharmacol. Ther. 124(1), 113-138 (2009).
47. Klonoff DC, Buse JB, Nielsen LL et al. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with Type 2 diabetes treated for at least 3 years. Curr. Med. Res. Opin. 24(1), 275-286 (2008).
48. Byetta package insert]. Amylin Pharmaceuticals, Inc, CA, USA (2009).
49. Drucker DJ. Dipeptidyl peptidase-4 inhibition and the treatment of Type 2 diabetes: preclinical biology and mechanisms of action. Diabetes Care 30(6), 1335-1343 (2007).
50. Augeri DJ, Robl JA, Betebenner DA et al. Discovery and preclinical profile of Saxagliptin (BMS-477118): a highly potent, long-acting, orally active dipeptidyl peptidase IV inhibitor for the treatment of Type 2 diabetes. J. Med. Chem. 48(15), 5025-5037 (2005).
51. Gallwitz B. Sitagliptin: profile of a novel DPP-4 inhibitor for the treatment of Type 2 diabetes. Drugs Today (Barc.). 43(11), 801-814 (2007).
52. Rosenstock J, Aguilar-Salinas C, Klein E et al. Effect of saxagliptin monotherapy in treatment-naive patients with Type 2 diabetes. Curr. Med. Res. Opin 25(10), 2401-2411 (2009).
53. DeFronzo RA, Hissa M, Garber AJ et al. The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled Type 2 diabetes on metformin alone. Diabetes Care 32(9), 1649-1655 (2009).
54. PfÜtzner A, Paz-Pacheco E, Berglind N et al. Saxagliptin initial combination with metformin provides sustained glycemic control and is well tolerated in patients with Type 2 diabetes: 76-week results. Diabetes 59(Suppl. 1), A17 (2010) (Abstract 64-OR).
55. Ravichandran S, DeFronzo R, Garber AJ et al. Once-daily saxagliptin added to metformin provides sustained glycemic control and is well tolerated over 102 weeks in patients with type 2 diabetes. Diabetologia 52(Suppl. 1), S60 (2009) (Abstract 132).
56. Seck T, Nauck M, Sheng D et al. Safety and efficacy of treatment with sitagliptin or glipizide in patients with Type 2 diabetes inadequately controlled on metformin: a 2-year study. Int. J. Clin. Pract. 64(5), 562-576 (2010).
57. Williams-Herman D, Johnson J, Teng R et al. Efficacy and safety of sitagliptin and metformin as initial combination therapy and as monotherapy over 2 years in patients with Type 2 diabetes. Diabetes Obes. Metab. 12(5), 442-451 (2010).
58. Nauck MA, Heimesaat MM, Behle K et al. Effects of glucagon-like peptide 1 on counterregulatory hormone responses, cognitive functions, and insulin secretion during hyperinsulinemic, stepped hypoglycemic clamp experiments in healthy volunteers. J. Clin. Endocrinol. Metab. 87(3), 1239-1246 (2002).
59. Buteau J. GLP-1 receptor signaling: effects on pancreatic b-cell proliferation and survival. Diabetes Metab. 34(Suppl. 2), S73-S77 (2008).
60. Khoo J, Rayner CK, Jones KL, Horowitz M. Incretin-based therapies: new treatments for Type 2 diabetes in the new millennium. Ther. Clin. Risk Manag. 5(3), 683-698 (2009).
61. [Apidra package insert]. Sanofi-Aventis US LLC NJ USA. (2009).
62. [NovoLog package insert]. Novo Nordisk A/S, NJ, USA (2002-2009).
63. [Levemir package insert]. Novo Nordisk A/S, NJ, USA (2005-2009).
64. [Lantus Package Insert]. Sanofi-Aventis US LLC NJ USA. (2007).
65. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in Type 2 diabetes. N. Engl. J. Med. 359(15), 1577-1589 (2008).
66. Horvath K, Jeitler K, Berghold A et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for Type 2 diabetes mellitus. Cochrane Database Syst. Rev. 2, CD005613 (2007).
67. DeFronzo RA, Ratner RE, Han J et al. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with Type 2 diabetes. Diabetes Care 28(5), 1092-1100 (2005).
68. Gerstein HC, Miller ME, Byington RP et al. Effects of intensive glucose lowering in Type 2 diabetes. N. Engl. J. Med. 358(24), 2545-2559 (2008).
69. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with Type 2 diabetes (UKPDS 33). Lancet. 352(9131), 837-853 (1998).
70. Zoungas S, De Galan BE, Ninomiya T et al. Combined effects of routine blood pressure lowering and intensive glucose control on macrovascular and microvascular outcomes in patients with Type 2 diabetes. Diabetes Care 32(11), 2068-2074 (2009).
71. Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in Type 2 diabetes. N. Engl. J. Med. 358(6), 580-591 (2008).
72. Jadzinsky M, PfÜtzner A, Paz-Pacheco E et al. Saxagliptin given in combination with metformin as initial therapy improves glycemic control in patients with Type 2 diabetes compared with either monotherapy: a randomized controlled trial. Diabetes Obes. Metab. 11(6), 611-622 (2009).
73. Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with Type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int. J. Clin. Pract. 63(1), 46-55 (2009).
74. Chacra AR, Tan GH, Apanovitch A et al. Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with Type 2 diabetes: a randomised controlled trial. Int. J. Clin. Pract. 63(9), 1395-1406 (2009).
75. Hollander P, Li J, Allen E, Chen R; for the CV181-013 investigators. Saxagliptin added to a thiazolidinedione improves glycemic control in patients with Type 2 diabetes and inadequate control on thiazolidinedione alone. J. Clin. Endocrinol. Metab. 94(12), 4810-4819 (2009).
76. Qi DS, Teng R, Jiang M. Two-year treatment with sitagliptin and initial combination therapy of sitagliptin and metformin provides substantial and durable glycaemic control in patients with Type 2 diabetes. Presented at: 44th Annual Meeting of the European Association for the Study of Diabetes. Rome, Italy, 7-11 September 2008.
77. DeFronzo R, Hissa MN, Garber AJ et al. Once-daily saxagliptin added to metformin provides sustained glycemic control and is well tolerated over 102 weeks in patients with Type 2 diabetes. Diabetes 58(Suppl. 1), 547-P (2009).
78. United States Federal Government. Electronic Code of Federal Regulations (eCFR) 410.141: outpatient diabetes self-management training http://ecfr.gpoaccess.gov/cgi/t/text/text-id x?c=ecfr&sid= 8b34df4c408fab632985506 48b65f0a8&rgn=div8&view=text&node= 42:2.0.1.2.10.8.35.2&idno=42 (Accessed 12 March 2010)
79. United States National Institutes of Health. ClinicalTrials.gov. ACTNOW study design: NCT00220961 www.clinicaltrials.gov (Accessed 12 March 2010)
80. Eli Lilly and Company Press Release. Exenatide once weekly new drug application review extended by FDA due to weather-related closure http://newsroom.lilly.com/releasedetail. cfm?releaseid=447138 (Accessed 12 March 2010)