Clarifying the role of incretin-based therapies in the treatment of type 2 diabetes mellitus

Clinical Therapeutics

Volumn 33, Issue 5, 2011, Pages 511-527

  Campbell, R Keith ^a  

^a WASHINGTON STATE UNIVERSITY   (United States)

Author keywords

Dipeptidyl peptidase 4; Exenatide; Glucagon like peptide 1 receptor agonist; Incretin; Type 2 diabetes mellitus; Weight

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ALBIGLUTIDE; ALOGLIPTIN; ANTIDIABETIC AGENT; DIPEPTIDYL PEPTIDASE IV; DIPEPTIDYL PEPTIDASE IV INHIBITOR; EXENDIN 4; GLIBENCLAMIDE; GLIPIZIDE; GLUCAGON LIKE PEPTIDE 1; GLUCAGON LIKE PEPTIDE 1 RECEPTOR; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; GLUCOSE; HEMOGLOBIN A1C; INCRETIN; INSULIN; INSULIN ASPART; INSULIN GLARGINE; LINAGLIPTIN; LIRAGLUTIDE; LIXISENATIDE; METFORMIN; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SAXAGLIPTIN; SITAGLIPTIN; SULFONYLUREA DERIVATIVE; TASPOGLUTIDE; UNCLASSIFIED DRUG; VILDAGLIPTIN;

ABDOMINAL PAIN; ACUTE PANCREATITIS; ARTHRALGIA; CARDIOVASCULAR DISEASE; COUGHING; DIABETIC DIET; DIABETIC PATIENT; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ERUPTION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DYSLIPIDEMIA; GASTROINTESTINAL SYMPTOM; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INFECTION; INJECTION SITE PRURITUS; INSULIN RELEASE; INSULIN TREATMENT; KINESIOTHERAPY; MONOTHERAPY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; OBESITY; PANCREAS ISLET BETA CELL; PANCREAS ISLET CELL FUNCTION; PANCREATITIS; PATIENT COMPLIANCE; PERIPHERAL EDEMA; REVIEW; RHINOPHARYNGITIS; SIDE EFFECT; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VOMITING; WEIGHT GAIN; WEIGHT REDUCTION;

DIABETES MELLITUS, TYPE 2; HUMANS; HYPOGLYCEMIC AGENTS; INCRETINS;

EID: 79958700336     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2011.04.015     Document Type: Review

References (96)

1. Wild S., Roglic G., Green A., et al. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004, 27:1047-1053.
2. Diabetes and impaired glucose tolerance. Global burden: prevalence and projections, 2010 and 2030 International Diabetes Federation-Diabetes Atlas, Accessed March 12, 2010. http://www.diabetesatlas.org/content/diabetes-and-impaired-glucose-tolerance.
3. Huang E.S., Basu A., O'Grady M., Capretta J.C. Projecting the future diabetes population size and related costs for the US. Diabetes Care 2009, 32:2225-2229.
4. National diabetes statistics, 2007 National Diabetes Information Clearinghouse, Updated June 2008. Accessed March 12, 2010. http://diabetes.niddk.nih.gov/dm/pubs/statistics.
5. Diagnosis and classification of diabetes mellitus. Diabetes Care 2010, 33(Suppl 1):S62-S69. American Diabetes Association.
6. Prevalence of overweight and obesity among adults: United States, 2003-2004 Centers for Disease Control and Prevention, Updated April 2006. Accessed March 12, 2010. http://www.cdc.gov/nchs/fastats/overwt.htm.
7. National diabetes fact sheet, 2007 Centers for Disease Control and Prevention, Updated 2008. Accessed March 12, 2010. http://apps.nccd.cdc.gov/DDTSTRS/FactSheet.aspx.
8. Cheung B.M., Ong K.L., Cherny S.S., et al. Diabetes prevalence and therapeutic target achievement in the United States, 1999 to 2006. Am J Med 2009, 122:443-453.
9. Mulnier H.E., Seaman H.E., Raleigh V.S., et al. Mortality in people with type 2 diabetes in the UK. Diabet Med 2006, 23:516-521.
10. Ong K.L., Cheung B.M., Wong L.Y., et al. Prevalence, treatment, and control of diagnosed diabetes in the U.S. National Health and Nutrition Examination Survey 1999-2004. Ann Epidemiol 2008, 18:222-229.
11. Suadicani P., Hein H.O., von Eyben F.E., Gyntelberg F. Metabolic and lifestyle predictors of ischemic heart disease and all-cause mortality among normal weight, overweight, and obese men: a 16-year follow-up in the Copenhagen Male Study. Metab Syndr Relat Disord 2009, 7:97-104.
12. Lloyd A., Sawyer W., Hopkinson P. Impact of long-term complications on quality of life in patients with type 2 diabetes not using insulin. Value Health 2001, 4:392-400.
13. Spencer M.S., Kieffer E.C., Sinco B.R., et al. Diabetes-specific emotional distress among African Americans and Hispanics with type 2 diabetes. J Health Care Poor Underserved 2006, 17(Suppl 2):88-105.
14. Edgar K.A., Skinner T.C. Illness representations and coping as predictors of emotional well-being in adolescents with type 1 diabetes. J Pediatr Psychol 2003, 28:485-493.
15. Campbell R.K., Bennett J.A. Assessing diabetes patients' healthcare needs. Diabetes Educ 2002, 28:40-44. 49-50.
16. Campbell R.K., White J. Counseling patients with type 2 diabetes and insulin resistance in the outpatient setting. Diabetes Educ 2002, 28:938-943. 947-950;952-954.
17. Duke S.A., Colagiuri S., Colagiuri R. Individual patient education for people with type 2 diabetes mellitus. Cochrane Database Syst Rev 2009, 1. CD005268.
18. Brandle M., Zhou H., Smith B.R., et al. The direct medical cost of type 2 diabetes. Diabetes Care 2003, 26:2300-2304.
19. Economic costs of diabetes in the United States-2007. Diabetes Care 2008, 31:596-615. American Diabetes Association.
20. Nathan D.M., Buse J.B., Davidson M.B., 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. American Diabetes Association; European Association for the Study of Diabetes.
21. Alexander G.C., Sehgal N.L., Moloney R.M., Stafford R.S. National trends in treatment of type 2 diabetes mellitus, 1994-2007. Arch Intern Med 2008, 168:2088-2094.
22. Rodbard H.W., Jellinger P.S., Davidson J.A., et al. AACE/ACE consensus statement: 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 2009, 15:540-559.
23. Saydah S.H., Fradkin J., Cowie C.C. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA 2004, 291:335-342.
24. Campbell R.K., White J.R. More choices than ever before: emerging therapies for type 2 diabetes. Diabetes Educ 2008, 34:518-534.
25. Burant C.F. Medical Management of Type 2 Diabetes 2008, American Diabetes Association, Inc, Alexandria, VA. 6th ed.
26. DeFronzo R.A. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes 2009, 58:773-795.
27. Wajchenberg B.L. Beta-cell failure in diabetes and preservation by clinical treatment. Endocr Rev 2007, 28:187-218.
28. Elrick H., Stimmler L., Hlad C.J., Arai Y. Plasma insulin response to oral and intravenous glucose administration. J Clin Endocrinol Metab 1964, 24:1076-1082.
29. Drucker D.J., Nauck M.A. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet 2006, 368:1696-1705.
30. Vilsbøll T., Holst J.J. Incretins, insulin secretion and type 2 diabetes mellitus. Diabetologia 2004, 47:357-366.
31. Toft-Nielsen M.B., Damholt M.B., Madsbad S., et al. Determinants of the impaired secretion of glucagon-like peptide-1 in type 2 diabetic patients. J Clin Endocrinol 2001, 86:3717-3723.
32. Toft-Nielsen M.B., Madsbad S., Holst J.J. Determinants of the effectiveness of glucagon-like peptide-1 in type 2 diabetes. J Clin Endocrinol 2001, 86:3853-3860.
33. Mayo K.E., Miller L.J., Bataille D., et al. International Union of Pharmacology. XXXV. The glucagon receptor family. Pharmacol Rev 2003, 55:167-194.
34. Ban K., Noyan-Ashraf M.H., Hoefer J., et al. Cardioprotective and vasodilatory actions of glucagon-like peptide 1 receptor are mediated through both glucagon-like peptide 1 receptor-dependent and independent pathways. Circulation 2008, 117:2340-2350.
35. Holst J.J., Vilsbøll T., Deacon C.F. The incretin system and its role in type 2 diabetes mellitus. Mol Cell Endocrinol 2009, 297:127-136.
36. Muscelli E., Mari A., Casolaro A., et al. Separate impact of obesity and glucose tolerance on the incretin effect in normal subjects and type 2 diabetic patients. Diabetes 2008, 57:1340-1348.
37. Kieffer T.J., McIntosh C.H., Pederson R.A. Degradation of glucose-dependent insulinotropic polypeptide and truncated glucagon-like peptide 1 in vitro and in vivo by dipeptidyl peptidase IV. Endocrinology 1995, 136:3585-3596.
38. Ahrén B. DPP-4 inhibitors. Best Pract Res Clin Endocrinol Metab 2007, 21:517-533.
39. Morimoto C., Schlossman S.F. The structure and function of CD26 in the T-cell immune response. Immunol Rev 1998, 161:55-70.
40. Amori R.E., Lau J., Pittas A.G. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA 2007, 298:194-206.
41. Eng J., Kleinman W.A., Singh L., et al. Isolation and characterization of exendin-4, an exendin-3 analogue, from Heloderma suspectum venom. J Biol Chem 1992, 267:7402-7405.
42. Young A.A., Gedulin B.R., Bhavsar S., et al. Glucose-lowering and insulin-sensitizing actions of exendin-4: studies in obese diabetic (ob/ob, db/db) mice, diabetic fatty Zucker rats, and diabetic rhesus monkeys (Macaca mulatta). Diabetes 1999, 48:1026-1034.
43. Byetta (exenatide) 2009, [package insert], Amylin Pharmaceuticals, Inc, San Diego, CA.
44. Bunck M.C., Diamant M., Cornér A., et al. One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial. Diabetes Care 2009, 32:762-768.
45. Kolterman O.G., Kim D.D., Shen L., et al. Pharmacokinetics, pharmacodynamics, and safety of exenatide in patients with type 2 diabetes mellitus. Am J Health Syst Pharm 2005, 62:173-181.
46. Tourrel C., Bailbe D., Lacorne M., et al. Persistent improvement of type 2 diabetes in the Goto-Kakizaki rat model by expansion of the beta-cell mass during the prediabetic period with glucagon-like peptide-1 or exendin-4. Diabetes 2002, 51:1443-1452.
47. Klonoff D.C., Buse J.B., Nielsen L.L., 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 2008, 24:275-286.
48. Barnett A.H., Burger J., Johns D., et al. Tolerability and efficacy of exenatide and titrated insulin glargine in adult patients with type 2 diabetes previously uncontrolled with metformin or a sulfonylurea: a multinational, randomized, open-label, two-period, crossover noninferiority trial. Clin Ther 2007, 29:2333-2348.
49. Nauck M.A., Duran S., Kim D., et al. A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a non-inferiority study. Diabetologia 2007, 50:259-267.
50. Moretto T.J., Milton D.R., Ridge T.D., et al. Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther 2008, 30:1448-1460.
51. Heine R.J., Van Gaal L.F., Johns D., et al. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med 2005, 143:559-569.
52. Fabunmi R., Nielsen L.L., Quimbo R., et al. Patient characteristics, drug adherence patterns, and hypoglycemia costs for patients with type 2 diabetes mellitus newly initiated on exenatide or insulin glargine. Curr Med Res Opin 2009, 25:777-786.
53. Chia C.W., Egan J.W. Incretin-based therapies in type 2 diabetes mellitus. J Clin Endocrin Metab 2008, 93:3703-3716.
54. Dore D.D., Seeger J.D., Arnold Chan K. Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide. Curr Med Res Opin 2009, 25:1019-1027.
55. Noel R.A., Braun D.K., Patterson R.E., Bloomgren G. Increased risk of acute pancreatitis and biliary disease observed in patients with type 2 diabetes: a retrospective, cohort study. Diabetes Care 2009, 32:834-838.
56. Drucker D.J., Buse J.B., Taylor K., et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet 2008, 372:1240-1250. DURATION-1 Study Group.
57. Delamater A.M. Improving patient adherence. Clin Diabetes 2006, 24:71-77.
58. Ingersoll K.S., Cohen J. The impact of medication regimen factors on adherence to chronic treatment: a review of the literature. J Behav Med 2008, 31:213-224.
59. Bergenstal R.M., Kim T., Trautmann M., et al. Exenatide once weekly elicited improvements in blood pressure and lipid profile over 52 weeks in patients with type 2 diabetes (abstract no. 1239). Circulation 2008, 118(Suppl 1):1086.
60. Kim D., MacConell L., Zhuang D., et al. Effects of once-weekly dosing of a long-acting release formulation of exenatide on glucose control and body weight in subjects with type 2 diabetes. Diabetes Care 2007, 30:1487-1493.
61. Victoza (liraglutide) 2010, [package insert], Novo Nordisk Inc, Princeton, NJ.
62. Russell-Jones D. Molecular, pharmacological and clinical aspects of liraglutide, a once-daily human GLP-1 analogue. Mol Cell Endocrinol 2009, 297:137-140.
63. Marre M., Shaw J., Brändle M., et al. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with type 2 diabetes (LEAD-1 SU). Diabet Med 2009, 26:268-278. LEAD-1 SU Study Group.
64. Madsbad S. Liraglutide effect and action in diabetes (LEAD) trial. Expert Rev Endocrinol Metab 2009, 4:119-129.
65. Zinman B., Gerich J., Buse J.B., et al. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care 2009, 32:1224-1230. LEAD-4 Study Investigators.
66. Buse J.B., Rosenstock J., Sesti G., et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomized, parallel-group, open-label trial (LEAD-6). Lancet 2009, 374:39-47. LEAD-6 Study Group.
67. Garber A., Henry R., Ratner R., et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet 2009, 373:473-481. LEAD-3 Mono Study Group.
68. Nauck M., Frid A., Hermansen K., et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (Liraglutide Effect and Action in Diabetes)-2 study. Diabetes Care 2009, 32:84-90. LEAD-2 Study Group.
69. Liraglutide (injection) for the treatment of patients with type 2 diabetes: Briefing Document (NDA 22-341). Endocrine and Metabolic Drug Advisory Committee US Food and Drug Administration, Accessed March 12, 2010. http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4422b2-02-NovoNordisk.pdf.
70. FDA Briefing Materials-Liraglutide Center for Drug Evaluation and Research US Food and Drug Administration, Accessed March 12, 2010. http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4422b2-01-FDA.pdf.
71. De Block C.E., Van Gaal L.F. GLP-1 receptor agonists for type 2 diabetes. Lancet 2009, 374:4-6.
72. Drucker D.J. Development of glucagon-like peptide-1-based pharmaceuticals as therapeutic agents for the treatment of diabetes. Curr Pharm Des 2001, 7:1399-1412.
73. Nauck M.A., Ratner R.E., Kapitza C., et al. Treatment with the human once-weekly GLP-1 analogue taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes mellitus inadequately controlled with metformin alone: a double-blind placebo-controlled study. Diabetes Care 2009, 32:1237-1243.
74. Baggio L.L., Drucker D.J., Lamont B.J., Maida A. ADA 2008: incretin-based therapeutics Updated July 31, 2008. Accessed March 12, 2010. http://cme.medscape.com/viewprogram/15786.
75. Matthews J.E., Stewart M.W., De Boever E.H., et al. Pharmacodynamics, pharmacokinetics, safety, and tolerability of albiglutide, a long-acting glucagon-like peptide-1 mimetic, in patients with type 2 diabetes. J Clin Endocrinol Metab 2008, 93:4810-4817. Albiglutide Study Group.
76. Herman G.A., Stevens C., Van Dyck K., et al. Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses. Clin Pharmacol Ther 2005, 78:675-688.
77. Triplitt C.L., McGill J.B., Porte D., Conner C.S. The changing landscape of type 2 diabetes: the role of incretin-based therapies in managed care outcomes. J Manag Care Pharm 2007, 13(Suppl 2):S2-S16.
78. Rosenstock J., Brazg R., Andryuk P.J., et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther 2006, 28:1556-1568.
79. McGill J.B. Impact of incretin therapy on islet dysfunction: an underlying defect in the pathophysiology of type 2 diabetes. Postgrad Med 2009, 121:46-58.
80. Williams-Herman D., Engel S.S., Round E., et al. Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes. BMC Endocr Disord 2010, 10:7.
81. Rosenstock J., Sankoh S., List J.F. Glucose-lowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naive patients with type 2 diabetes. Diabetes Obes Metab 2008, 10:376-386.
82. DeFronzo R.A., Fleck P.R., Wilson C.A., Mekki Q. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. Diabetes Care 2008, 31:2315-2317. Alogliptin Study 010 Group.
83. Matteucci E., Giampietro O. Dipeptidyl peptidase-4 (CD26). Knowing the function before inhibiting the enzyme. Curr Med Chem 2009, 16:2943-2951.
84. Januvia (sitagliptin) 2007, [package insert], Merck & Co., Inc, Whitehouse Station, NJ.
85. Nauck M.A., Vilsbøll T., Gallwitz B., et al. Incretin-based therapies. Viewpoints on the way to consensus. Diabetes Care 2009, 32:S223-S231.
86. Drucker D.J., Sherman S.I., Gorelick F.S., et al. Incretin-based therapies for the treatment of type 2 diabetes: evaluation of the risks and benefits. Diabetes Care 2010, 33:428-433.
87. Gedulin B., Tatarkiewicz K., Smith P., et al. Contrasting actions of sitagliptin and exenatide on food intake, body weight, glucose stimulated insulin secretion and gastric emptying in rodents (abstract no. 0576). Diabetologia 2007, 50(Suppl 1):S239.
88. Lamont B.J., Drucker D.J. Differential antidiabetic efficacy of incretin agonists versus DPP-4 inhibition in high fat fed mice. Diabetes 2008, 57:190-198.
89. Garber A.J., Spann S.J. An overview of incretin clinical trials. J Fam Pract 2008, 57(9 Suppl):S10-S18.
90. Bergenstal R.M., Wysham C., Macconell L., et al. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet 2010, 376:431-439. DURATION-2 Study Group.
91. Pratley R.E., Nauck M., Bailey T., et al. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycemic control with metformin: a 26-week, randomized, parallel-group, open-label trial. Lancet 2010, 375:1447-1456. 1860-LIRA-DPP-4 Study Group.
92. DeFronzo R.A., Okerson T., Viswanathan P., et al. Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: a randomized, cross-over study. Curr Med Res Opin 2008, 24:2943-2952.
93. Eeg-Oloffson K., Cederholm J., Nilsson P.M., et al. Risk of cardiovascular disease and mortality in overweight and obese patients with type 2 diabetes: an observational study in 13,087 patients. Diabetologia 2009, 52:65-73.
94. Guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract 2007, 13(Suppl 1):S3-S68. American Association of Clinical Endocrinologists.
95. Mistry G.C., Maes A.L., Lasseter K.C., et al. Effect of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on blood pressure in nondiabetic patients with mild to moderate hypertension. J Clin Pharmacol 2008, 48:592-598.
96. Onglyza (saxagliptin) 2009, [package insert], Bristol-Myers Squibb Company, Princeton, NJ.