Comparison of vildagliptin as an add-on therapy and sulfonylurea dose-increasing therapy in patients with inadequately controlled type 2 diabetes using metformin and sulfonylurea (VISUAL study): A randomized trial

Diabetes Research and Clinical Practice

Volumn 109, Issue 1, 2015, Pages 141-148

  Hong, A Ram ^a,b   Lee, Jeun ^b,c   Ku, Eu Jeong ^a,b   Hwangbo, Yul ^b,c   Kim, Kyoung Min ^a,b   Moon, Jae Hoon ^a,b   Choi, Sung Hee ^a,b   Jang, Hak Chul ^a,b   Lim, Soo ^a,b  

^a Seoul National University Bundang Hospital   (South Korea)

^b Seoul National University College of Medicine   (South Korea)

^c Seoul National University Hospital   (South Korea)

Author keywords

Clinical trial; Hypoglycemia; Sulfonylurea; Vildagliptin

Indexed keywords

ALANINE AMINOTRANSFERASE; ANGIOTENSIN 2 RECEPTOR ANTAGONIST; ASPARTATE AMINOTRANSFERASE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; GLICLAZIDE PLUS METFORMIN; GLIMEPIRIDE PLUS METFORMIN; HEMOGLOBIN A1C; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; SULFONYLUREA; SULFONYLUREA DERIVATIVE; UNCLASSIFIED DRUG; VILDAGLIPTIN; ADAMANTANE; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; METFORMIN; NITRILE; PYRROLIDINE DERIVATIVE;

AGED; ARTICLE; BODY WEIGHT; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DRINKING BEHAVIOR; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INCIDENCE; INSULIN RELEASE; LIFESTYLE; LIPID ANALYSIS; MAJOR CLINICAL STUDY; MALE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PHYSICAL ACTIVITY; POSTPRANDIAL STATE; RANDOMIZED CONTROLLED TRIAL; SMOKING; SYSTOLIC BLOOD PRESSURE; VOMITING; WEIGHT GAIN; ANALOGS AND DERIVATIVES; BLOOD; CHEMICALLY INDUCED; DIABETES MELLITUS, TYPE 2; DOSE RESPONSE; DRUG COMBINATION; DRUG EFFECTS; GLUCOSE BLOOD LEVEL; METABOLISM; MIDDLE AGED;

ADAMANTANE; AGED; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; MALE; METFORMIN; MIDDLE AGED; NITRILES; PYRROLIDINES; SULFONYLUREA COMPOUNDS;

EID: 84930821066     PISSN: 01688227     EISSN: 18728227     Source Type: Journal    
DOI: 10.1016/j.diabres.2015.04.019     Document Type: Article

References (42)

1. American Diabetes Association Standards of medical care in diabetes-2014. Diabetes Care 2014, 37(Suppl 1):S14-S80.
2. Inzucchi S.E., Bergenstal R.M., Buse J.B., Diamant M., Ferrannini E., Nauck M., et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012, 35:1364-1379.
3. Cook M.N., Girman C.J., Stein P.P., Alexander C.M., Holman R.R. Glycemic control continues to deteriorate after sulfonylureas are added to metformin among patients with type 2 diabetes. Diabetes Care 2005, 28:995-1000.
4. Nathan D.M., Buse J.B., Davidson M.B., Ferrannini E., Holman R.R., Sherwin R., 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.
5. Balas B., Baig M.R., Watson C., Dunning B.E., Ligueros-Saylan M., Wang Y., et al. The dipeptidyl peptidase IV inhibitor vildagliptin suppresses endogenous glucose production and enhances islet function after single-dose administration in type 2 diabetic patients. J Clin Endocrinol Metab 2007, 92:1249-1255.
6. Mari A., Sallas W.M., He Y.L., Watson C., Ligueros-Saylan M., Dunning B.E., et al. Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed beta-cell function in patients with type 2 diabetes. J Clin Endocrinol Metab 2005, 90:4888-4894.
7. Migoya E.M., Bergeron R., Miller J.L., Snyder R.N., Tanen M., Hilliard D., et al. Dipeptidyl peptidase-4 inhibitors administered in combination with metformin result in an additive increase in the plasma concentration of active GLP-1. Clin Pharmacol Ther 2010, 88:801-808.
8. Mathieu C. The scientific evidence: vildagliptin and the benefits of islet enhancement. Diabetes Obes Metab 2009, 11(Suppl 2):9-17.
9. Lukashevich V., Prato S.D., Araga M., Kothny W. Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. Diabetes Obes Metab 2014, 16:403-409.
10. Hermansen K., Kipnes M., Luo E., Fanurik D., Khatami H., Stein P. 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.
11. Owens D.R., Swallow R., Dugi K.A., Woerle H.J. Efficacy and safety of linagliptin in persons with type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: a 24-week randomized study. Diabetes Med 2011, 28:1352-1361.
12. Garber A.J., Foley J.E., Banerji M.A., Ebeling P., Gudbjornsdottir S., Camisasca R.P., et al. Effects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea. Diabetes Obes Metab 2008, 10:1047-1056.
13. Kikuchi M., Haneda M., Koya D., Tobe K., Onishi Y., Couturier A., et al. Efficacy and tolerability of vildagliptin as an add-on to glimepiride in Japanese patients with Type 2 diabetes mellitus. Diabetes Res Clin Pract 2010, 89:216-223.
14. Matthews D.R., Hosker J.P., Rudenski A.S., Naylor B.A., Treacher D.F., Turner R.C. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 1985, 28:412-419.
15. Hong E.S., Khang A.R., Yoon J.W., Kang S.M., Choi S.H., Park K.S., et al. Comparison between sitagliptin as add-on therapy to insulin and insulin dose-increase therapy in uncontrolled Korean type 2 diabetes: CSI study. Diabetes Obes Metab 2012, 14:795-802.
16. Lavalle-Gonzalez F.J., Januszewicz A., Davidson J., Tong C., Qiu R., Canovatchel W., et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia 2013, 56:2582-2592.
17. Keating G.M. Vildagliptin: a review of its use in type 2 diabetes mellitus. Drugs 2014, 74:587-610.
18. Herman G.A., Bergman A., Stevens C., Kotey P., Yi B., Zhao P., et al. Effect of single oral doses of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on incretin and plasma glucose levels after an oral glucose tolerance test in patients with type 2 diabetes. J Clin Endocrinol Metab 2006, 91:4612-4619.
19. Foley J.E., Bunck M.C., Moller-Goede D.L., Poelma M., Nijpels G., Eekhoff E.M., et al. Beta cell function following 1 year vildagliptin or placebo treatment and after 12 week washout in drug-naive patients with type 2 diabetes and mild hyperglycaemia: a randomised controlled trial. Diabetologia 2011, 54:1985-1991.
20. Guerci B., Monnier L., Serusclat P., Petit C., Valensi P., Huet D., et al. Continuous glucose profiles with vildagliptin versus sitagliptin in add-on to metformin: results from the randomized Optima study. Diabetes Metab 2012, 38:359-366.
21. Bosi E., Dotta F., Jia Y., Goodman M. Vildagliptin plus metformin combination therapy provides superior glycaemic control to individual monotherapy in treatment-naive patients with type 2 diabetes mellitus. Diabetes Obes Metab 2009, 11:506-515.
22. Ahren B., Schweizer A., Dejager S., Villhauer E.B., Dunning B.E., Foley J.E. Mechanisms of action of the dipeptidyl peptidase-4 inhibitor vildagliptin in humans. Diabetes Obes Metab 2011, 13:775-783.
23. Ahren B., Schweizer A., Dejager S., Dunning B.E., Nilsson P.M., Persson M., et al. Vildagliptin enhances islet responsiveness to both hyper- and hypoglycemia in patients with type 2 diabetes. J Clin Endocrinol Metab 2009, 94:1236-1243.
24. Marfella R., Barbieri M., Grella R., Rizzo M.R., Nicoletti G.F., Paolisso G. Effects of vildagliptin twice daily vs. sitagliptin once daily on 24-hour acute glucose fluctuations. J Diabetes Complications 2010, 24:79-83.
25. Rizzo M.R., Barbieri M., Marfella R., Paolisso G. Reduction of oxidative stress and inflammation by blunting daily acute glucose fluctuations in patients with type 2 diabetes: role of dipeptidyl peptidase-IV inhibition. Diabetes Care 2012, 35:2076-2082.
26. Iwamoto Y., Kashiwagi A., Yamada N., Terao S., Mimori N., Suzuki M., 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, 12:700-708.
27. Goke B., Gallwitz B., Eriksson J.G., Hellqvist A., Gause-Nilsson I. Saxagliptin vs. glipizide as add-on therapy in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: long-term (52-week) extension of a 52-week randomised controlled trial. Int J Clin Pract 2013, 67:307-316.
28. Jabbour S.A., Hardy E., Sugg J., Parikh S. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care 2014, 37:740-750.
29. Kahn S.E., Haffner S.M., Heise M.A., Herman W.H., Holman R.R., Jones N.P., et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006, 355:2427-2443.
30. Dormandy J.A., Charbonnel B., Eckland D.J., Erdmann E., Massi-Benedetti M., Moules I.K., et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet 2005, 366:1279-1289.
31. Lewis J.D., Ferrara A., Peng T., Hedderson M., Bilker W.B., Quesenberry C.P., et al. Risk of bladder cancer among diabetic patients treated with pioglitazone: interim report of a longitudinal cohort study. Diabetes Care 2011, 34:916-922.
32. Monami M., Dicembrini I., Mannucci E. Dipeptidyl peptidase-4 inhibitors and pancreatitis risk: a meta-analysis of randomized clinical trials. Diabetes Obes Metab 2014, 16:48-56.
33. Scirica B.M., Bhatt D.L., Braunwald E., Steg P.G., Davidson J., Hirshberg B., et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med 2013, 369:1317-1326.
34. White W.B., Cannon C.P., Heller S.R., Nissen S.E., Bergenstal R.M., Bakris G.L., et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med 2013, 369:1327-1335.
35. Scheen A.J. Pharmacokinetics of dipeptidylpeptidase-4 inhibitors. Diabetes Obes Metab 2010, 12:648-658.
36. Zoungas S., Patel A., Chalmers J., de Galan B.E., Li Q., Billot L., et al. Severe hypoglycemia and risks of vascular events and death. New Engl J Med 2010, 363:1410-1418.
37. Kelly T.N., Bazzano L.A., Fonseca V.A., Thethi T.K., Reynolds K., He J. Systematic review: glucose control and cardiovascular disease in type 2 diabetes. Ann Intern Med 2009, 151:394-403.
38. Matthews D.R., Dejager S., Ahren B., Fonseca V., Ferrannini E., Couturier A., et al. Vildagliptin add-on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: results from a 2-year study. Diabetes Obes Metab 2010, 12:780-789.
39. Ferrannini E., Fonseca V., Zinman B., Matthews D., Ahren B., Byiers S., et al. Fifty-two-week efficacy and safety of vildagliptin vs. glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy. Diabetes Obes Metab 2009, 11:157-166.
40. Charbonnel B., Karasik A., Liu J., Wu M., Meininger G. 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.
41. Foley J.E., Jordan J. Weight neutrality with the DPP-4 inhibitor, vildagliptin: mechanistic basis and clinical experience. Vasc Health Risk Manage 2010, 6:541-548.
42. Goke B., Hershon K., Kerr D., Calle Pascual A., Schweizer A., Foley J., et al. Efficacy and safety of vildagliptin monotherapy during 2-year treatment of drug-naive patients with type 2 diabetes: comparison with metformin. Horm Metab Res 2008, 40:892-895.