A review of newer treatment approaches for type-2 diabetes: Focusing safety and efficacy of incretin based therapy

Saudi Pharmaceutical Journal

Volumn 22, Issue 5, 2014, Pages 403-410

  George, Regin Elsa ^a   Joseph, Siby ^a  

^a AMRITA INSTITUTE OF MEDICAL SCIENCES   (India)

Author keywords

Dipetidyl peptidase inhibitors; Gliptins; Glucagon like peptide

Indexed keywords

CALCITONIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR; EXENDIN 4; GASTRIC INHIBITORY POLYPEPTIDE; GLIMEPIRIDE; GLIPIZIDE; GLUCAGON LIKE PEPTIDE 1; HEMOGLOBIN A1C; INCRETIN; INSULIN; LINAGLIPTIN; LIRAGLUTIDE; METFORMIN; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SITAGLIPTIN; SODIUM GLUCOSE COTRANSPORTER 2 INHIBITOR; SULFONYLUREA; VILDAGLIPTIN; VOGLIBOSE;

ACUTE PANCREATITIS; ANGIONEUROTIC EDEMA; BRONCHUS HYPERREACTIVITY; COMBINATION CHEMOTHERAPY; CONSTIPATION; COUGHING; DIABETES MELLITUS; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG MECHANISM; DRUG SAFETY; GLYCEMIC CONTROL; HEADACHE; HUMAN; HYPOGLYCEMIA; INJECTION SITE ERYTHEMA; INSULIN RELEASE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREATITIS; PRURITUS; RASH; REVIEW; RHINOPHARYNGITIS; SIDE EFFECT; SKIN MANIFESTATION; UPPER RESPIRATORY TRACT INFECTION; URTICARIA; VOMITING; WEIGHT GAIN;

EID: 84920190212     PISSN: 13190164     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jsps.2013.05.005     Document Type: Review

References (76)

1. Ahrén Bo Use of DPP-4 inhibitors in type 2 diabetes: focus on Sitagliptin. Diabetes Metab. Syndr. Obes.: Targets Ther. 2010, 3:31-41.
2. Ahren B., Gomis R., Standl E., et al. Twelve- and 52-week efficacy of the dipeptidyl peptidase IV inhibitor LAF237 in metformin-treated patients with type 2 diabetes. Diabetes Care 2004, 27:2874-2880.
3. Ahren B., Pacini G., Foley J.E., et al. Improved meal related beta cell function and insulin sensitivity by the dipeptidyl peptidase 4 inhibitor vildagliptin in Metformin treated patients with type 2 diabetes over 1year. Diabetes Care 2005, 28:1936-1940.
4. Arjona Ferreira J.C., Dobs A., Goldstein B.J., et al. Triple combination therapy with sitagliptin metformin and rosiglitazone improves glycaemic control in patients with type 2 diabetes. Diabetologia 2008, 51(Suppl. 1):S365.
5. Aroda V.R., DeYoung M.B. Clinical implications of exenatide as a twice-daily or once-weekly therapy for type 2 diabetes. Postgrad. Med. 2011, 123:228-238.
6. Aschner P., Kipnes M.S., Lunceford J.K., et al. 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.
7. Barzilai N., Mahoney E.M., Guo H., et al. Sitagliptin is well tolerated and leads to rapid improvement in blood glucose the first days of monotherapy in patients aged 65years and older with TDM. Diabetes 2009, (Suppl. 1):A158.
8. Bergenstal Richard M., Wysham Carol, MacConell Leigh, 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 2012, 376:431-439.
9. Bolli G., Dotta F., Rochotte E., et al. Efficacy and tolerability of vildagliptin vs. piogitazone when added to metformin: a 24-week, randomized, double-blind study. Diabetes Obes. Metab. 2008, 10:82-90.
10. Bosi E., Camisasca R.P., Collober C., et al. Effects of vildagliptin on glucose control over 24weeks in patients with type 2 diabetes inadequately controlled with metformin. Diabetes Care 2007, 30:890-895.
11. Buse John B., Henry Robert R., Han Jenny, et al. Effects of exenatide (exendin-4) on glycemic control over 30weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care 2004, 27:2628-2635.
12. 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 randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet 2009, 374:39-47.
13. Chan J.C.N., Scott R., Arjona Ferreira J.C., et al. Safety and efficacy of sitagliptin in patients with type 2 diabetes and chronic renal insufficiency. Diabetes Obes. Metab. 2008, 10:545-555.
14. Chang A.M., Jakobsen G., Sturis J., et al. The GLP-1 derivative NN2211 restores beta-cell sensitivity to glucose in type 2 diabetic patients after a single dose. Diabetes 2003, 52:1786-1791.
15. Charbonnel B., Karasik A., Liu J., et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care 2006, 29:2638-2643.
16. Chiniwala N., Jabbour S. Management of diabetes mellitus in the elderly. Curr. Opin. Endocrinol. Diabetes Obes. 2011, 18(2):148-152.
17. DeFronzo R.A., Ratner R.E., 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 2005, 28:1092-1100.
18. Degn K.B., Juhl C.B., Sturis J., et al. One week's treatment with the longacting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and alpha- and beta-cell function and reduce endogenous glucose release in patients with type 2 diabetes. Diabetes 2004, 53:1187-1194.
19. Dejager S., Razac S., Foley J.E., et al. Vildagliptin in drug-naive patients with type 2 diabetes: A 24-week, double-blind, randomized, placebo-controlled, multiple-dose study. Horm. Metab. Res. 2007, 39:218-223.
20. Del Prato S., Barnett A.H., Huisman H., et al. Effect of linagliptin monotherapy on glycaemic control and markers of beta-cell function in patients with inadequately controlled type 2 diabetes: a randomized controlled trial. Diabetes Obes. Metab. 2011, 13:258-267.
21. Dicker D. DPP-4 inhibitors: impact on glycemic control and cardiovascular risk factors. Diabetes Care 2011, 34:S276-S278.
22. Forst T., Uhlig-Laske B., Ring A., et al. Linagliptin (BI 1356), a potent and selective DPP-4 inhibitor, is safe and efficacious in combination with metformin in patients with inadequately controlled type 2 diabetes. Diabetes Med. 2010, 27:1409-1419.
23. Fujioka K. Pathophysiology of type 2 diabetes and the role of incretin hormones and beta-cell dysfunction. JAAPA 2007, 20(12):3-8.
24. Gallwitz B., Uhlig-Laske B., Bhattacharaya B. Linagliptin has similar efficacy to glimepiride but improved cardiovascular safety over 2years in patients with type 2 diabetes inadequately controlled on metformin. Diabetes 2011, 60(Suppl. 1). 39-LB.
25. Gallwitz B., Rosenstock J., Rauch J., et al. Two-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomized, double-blind, noninferiority trial. Lancet 2012, 380:475-483.
26. Gallwitz Baptist, Guzman Juan, Dotta Francesco, et al. Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure (EUREXA): an open-label, randomised controlled trial. Lancet 2012, 379:2270-2278.
27. Garber A.J., Schweizer A., Baron M.A., et al. Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidedione monotherapy: a placebo-controlled study. Diabetes Obes. Metab. 2007, 9:166-174.
28. Garber A.J., Foley J.E., Banerji M.A., et al. Efficacy of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea. Diabetes Obes. Metab. 2008, 10(11):1047-1056.
29. 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.
30. Garber A., Henry R.R., Ratner R., et al. Liraglutide, a once-daily human glucagon-like peptide 1 analogue, provides sustained improvements in glycaemic control and weight for 2years as monotherapy compared with glimepiride in patients with type 2 diabetes. Diabetes Obes. Metab. 2011, 13:348-356.
31. Goldstein B.J., Feinglos M.N., Lunceford J.K., et al. Sitagliptin 036 study group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care 2007, 30:1979-1987.
32. Gomis R., Espadero R.M., Jones R., et al. Efficacy and safety of initial combination therapy with linagliptin and pioglitazone in patients with inadequately controlled type 2 diabetes: a randomized double-blind placebo-controlled study. Diabetes Obes. Metab. 2011, 13:653-661.
33. Graefe-Mody U., Friedrich C., Port A., et al. Effect of renal impairment on the pharmacokinetics of the dipeptidyl peptidase-4 inhibitor linagliptin. Diab. Obes. Metab. 2011, 13:939-946.
34. Grempler R., Thomas L., Eckhardt M., et al. Empagliflozin, a novel selective sodium glucose cotransporter-2 (SGLT-2) inhibitor: characterisation and comparison with other SGLT-2 inhibitors. Diabetes Obes. Metab. 2012, 14(1):83-90.
35. Hanefeld M., Herman G.A., Wu M., et al. Once-daily sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of patients with type 2 diabetes. Curr. Med. Res. Opin. 2007, 23:1329-1339.
36. Hermansen K., Kipnes M., Luo E., et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes. Metab. 2007, 9:733-745.
37. Isaji M. Sodium glucose cotransporter inhibitors for diabetes. Curr. Opin. Investig. Drugs 2007, 8:285-292.
38. Iwamato Y., Kashiwagi A., Yamada N., et al. Efficacy and safety of vildagliptin and voglibose in Japanese patients with type 2 diabetes: a 12-week, randomized, double-blind, active-controlled study. Diabetes Obes. Metab. 2010, 12(8):700-708.
39. Jones David Russel, Cuddihy Robert M., Hanefeld Markolf, et al. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4). A 26-week double-blind study. Diabetes Care 2012, 35:252-258.
40. Juhl C.B., Hollingdal M., Sturis J., et al. Bedtime administration of NN2211, a long-acting GLP-1 derivative, substantially reduces fasting and postprandial glycemia in type 2 diabetes. Diabetes 2002, 51:424-429.
41. Kaku K., Rasmussen M.F., Clauson P., et al. Improved glycaemic control with minimal hypoglycaemia and no weight change with the once-daily human GLP-1 analogue liraglutide as add-on to sulfonylurea in Japanese patients with type 2 diabetes. Diab. Obes. Metab. 2010, 12:341-347.
42. Kalra Sanjay Emerging role of dipeptidyl peptidase-IV (DPP-4). Inhibitor vildagliptin in the management of type 2 diabetes. JAPI 2011, 59:237-245.
43. Kawamori R., Inagaki, Araki E., et al. Linagliptin monotherapy improves glycemic control in Japanese patients with T2DM over 12weeks. Diabetes 2011, 59(Suppl. 1):696. Abstract.
44. Kawamori R., Inagaki N., Araki E., et al. Linagliptin monotherapy provides superior glycaemic control versus placebo or voglibose with comparable safety in Japanese patients with type 2 diabetes: a randomized, placebo and active comparator-controlled, double-blind study. Diabetes Obes. Metab. 2012, 14:348-357.
45. Kendall David M., Riddle Matthew C., Rosenstock Julio, et al. Effects of exenatide (exendin-4) on glycemic control over 30weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care 2005, 28:1083-1091.
46. Kikuchi M., Abe N., Kato M., et al. Vildagliptin dose-dependently improves glycemic control in Japanese patients with type 2 diabetes mellitus. Diabetes Res. Clin. Pract. 2009, 83:233-240.
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 3years. Curr. Med. Res. Opin. 2008, 24:275-286.
48. Kothny, W., Schweizer, A., Dickinson, S. et al., 2009. Hepatic safety profile of vildagliptin a new DPP-4 inhibitor for the treatment of type 2 diabetes. 45th Annual Meeting of the European Association for the Study of Diabetes, abstr. 764.
49. Lewin A.J., Arvay L., Liu D., et al. Safety and efficacy of linagliptin as add-on therapy to a sulphonylurea in inadequately controlled type 2 diabetes. Diabetologia 2010, 53(Suppl. 1):S326.
50. Marre M., Shaw J., Brandle 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). Diabetes Med. 2009, 26:268-278.
51. McIntosh C.H., Demuth H.U., Pospisilik J.A., et al. Dipeptidyl peptidase IV inhibitors: how do they work as new antidiabetic agents?. Regul. Pept. 2005, 128:159-165.
52. Nauck M.A., Meininger G., Sheng D., et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes. Metab. 2007, 9:194-205.
53. 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.
54. Owens D.R., Swallow R., Dugi K.A., et al. Efficacy and safety of linagliptin in persons with type 2 diabetes inadequately controlled by a combination of metformin and sulfonylurea: a 24-week randomized study. Diabetes Med. 2011, 28:1352-1361.
55. Pi-Sunyer F.X., Schweizer A., Mills D., et al. Efficacy and tolerability of vildagliptin monotherapy in drug-naive patients with type 2 diabetes. Diabetes Res. Clin. Pract. 2007, 76:132-138.
56. Pratley R.E., Salsali A. Inhibition of DPP-4: a new therapeutic approach for the treatment of type 2 diabetes. Curr. Med. Res. Opin. 2007, 23(4):919-931.
57. Pratley R.E., Jauffret-Kamel S., Galbreath E., et al. Twelve-week monotherapy with the DPP-4 inhibitor vildagliptin improves glycemic control in subjects with type 2 diabetes. Horm. Metab. Res. 2006, 38:423-428.
58. Pratley R.E., Nauck M., Bailey T., et al. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet 2010, 375:1447-1456.
59. Prins Johannes B. Incretin mimetics and enhancers: mechanisms of action. Aust. Prescr. 2008, 31:102-104.
60. Raz I., Hanefeld M., Xu L., et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia 2006, 49:2564-2571.
61. Rosenstock J., Baron M.A., Dejager S., et al. Comparison of vildagliptin and Rosiglitazone monotherapy in patients with type 2 diabetes: a 24-week, double-blind, randomized trial. Diabetes Care 2007, 30(2):217-223.
62. Rosenstock J., Baron M.A., Camisasca R.P., et al. Efficacy and tolerability of initial combination therapy with vildagliptin and pioglitazone compared with component monotherapy in patients with type 2 diabetes. Diabetes Obes. Metab. 2007, 9:175-185.
63. Rosenstock Julio., Brazg Ronald., Andryuk Paula.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.
64. Russell-Jones D., Vaag A., Schmitz O., et al. Liraglutide vs. insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia 2009, 52:2046-2055.
65. Scherbaum W.A., Schweizer A., Mari A., et al. Efficacy and tolerability of vildagliptin in drug naïve patients with type 2 diabetes and mild hyperglycaemia. Diabetes Obes. Metab. 2008, 10:675-682.
66. Schweizer A., Couturier A., Foley J.E., et al. Comparison between vildagliptin and metformin to sustain reductions in HbA(1c) over 1year in drug-naïve patients with Type 2 diabetes. Diabetes Med. 2007, 24:955-961.
67. Scott R., Wu L., Sanchez M., et al. Efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy over 12weeks in patients with type 2 diabetes. Int. J. Clin. Pract. 2007, 61:171-180.
68. Scott R., Loeys T., Davies M.J., et al. Efficacy and safety of Sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes. Metab. 2008, 10:959-969.
69. Seino Y., Rasmussen M.F., Nishida T., et al. Efficacy and Safety of the once-daily human GLP-1 analogue, liraglutide, vs. glibenclamide monotherapy in Japanese patients with type 2 diabetes. Curr. Med. Res. Opin. 2010, 26:1013-1022.
70. Sloan L., Newman J., Sauce C., et al. Safety and efficacy of linagliptin in type 2 diabetes patients with severe renal impairment. Diabetes 2011, 60(Suppl. 1):24-28.
71. Stonehouse A.H., Darsow T., Maggs D.G. Incretin-based therapies. J. Diabetes 2012, 4(1):55-67.
72. Taskinen M.R., Rosenstock J., Tamminen I., et al. Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebocontrolled study. Diabetes Obes. Metab. 2011, 13:65-74.
73. Tradjenta (linagliptin) [package insert]. Ridgefield, Conn: Boehringer Ingelheim Pharmaceuticals, Inc.; 2011.
74. Vilsboll Tina, Zdravkovic Milan, Le-Thi Tu Liraglutide, a long acting human Glucagon-Like Peptide-1 Analog, Given as Monotherapy Significantly Improves Glycemic Control and Lowers Body Weight Without Risk of Hypoglycemia in Patients With Type 2 Diabetes. Diabetes Care 2007, 30:1608-1610.
75. Vilsboll T., Rosenstock J.M., Yki-Järvinen H., et al. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes. Metab. 2010, 12:167-177.
76. 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.