A comparative study of efficacy and safety of vildagliptin against metformin in newly diagnosed patients of type 2 diabetes mellitus
DOI:
https://doi.org/10.18203/2320-6012.ijrms20164539Keywords:
Metformin, HbA1c, Obesity, T2DM, VildagliptinAbstract
Background: Diabetes mellitus is a progressive disease characterised by declining β-cell function. Cornerstone of effective management of T2DM is maintaining strict glycaemic control through agency of various oral hypo-glycaemic agents (OHAs). Metformin (a biguanide) currently forms the preferred treatment in newly diagnosed patients of T2DM. Vildagliptin is a potent, orally administered, competitive and reversible inhibitor of DPP-4, which was launched in 2006 and is now approved in more than 70 countries worldwide.
Methods: The study was a single blinded study conducted in a district level tertiary care hospital attached to a medical teaching institute. Newly diagnosed patients were screened and randomised in two groups. Group 1 received metformin (500 mg) twice daily and group 2 received vildagliptin (50 mg) twice daily. FPG, PPPG, HbA1c and Weight were assessed on week 0 and week 12.
Results: At the end of 12 weeks, ∆FPG was 39.33±4.72mg/dL and 37.84±6.58mg/dL with metformin and vildagliptin respectively. ∆PPPG was 73.88±13.80 mg/dL and 65.08±13.00mg/dL with metformin and vildagliptin. ∆HbA1c was 1.12±0.46 and 0.95±0.32 with metformin and vildagliptin. ∆Weight was 1.02±0.90 Kg with metformin and 0.69±1.33 Kg.
Conclusions: Vildagliptin offers an alternative mode of therapy for newly diagnosed, obese patients of type 2 DM, especially those with impaired fasting plasma glucose.Metrics
References
Scheen AJ. Pathophysiology of type 2 diabetes. Acta Clin Belg. 2003;58(6):335-41.
U.K. prospective diabetes study 16. Overview of 6 years’ therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group. Diabetes. 1995.
Joshi SR, Parikh RM. India - Diabetes capital of the world: Now heading towards hypertension. J Assoc Physicians India. 2007;55:323-4.
Kumar A, Goel MK, Jain RB, Khanna P, Chaudhary V. India towards diabetes control: Key issues. Australas Med J. 2013;6(10):524-31.
Mohan V, Sandeep S, Deepa R, Shah B, Varghese C. Epidemiology of type 2 diabetes: Indian scenario. Indian J Med Res. 2007;125(3):217-30.
Powers AC, Dalessio D. Endocrine Pancreas and Pharmacotherapy of Diabetes Mellitus and Hypoglycemia. In: Burton LL, editor. Goodman and Gilman’s Pharrmacological Basis of Therapeutics. 12th edition. New York: McGraw Hill Education; 2011;1237-74.
Kirpichnikov D, McFarlane SI SJ. Metformin: an update. Ann Intern Med. 2002;137:25-33.
Ting RZ, Szeto CC, Chan MH, Ma KK, Chow KM. Risk factors of vitamin B (12) deficiency in patients receiving metformin. Arch Intern Med. 2006;166(18):1975-9.
Han J, Kim S, Hong S, Kim S. Metformin-associated Lactic Acidosis: Predisposing Factors and Outcome. Endocrinol Metab. 2014;30:78-83.
Drucker DJ. Enhancing incretin action for the treatment of type 2 diabetes. Diabetes Care. 2003;26(10):2929-40.
Drucker DJ, Nauck MA. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet. 2006;368(9548):1696-705.
Ahrén B, Foley JE. The islet enhancer vildagliptin: Mechanisms of improved glucose metabolism. Int J Clin Pract. 2008;62(SUPPL. 159):8-14.
Masur K, Thâevenod F, Zèanker KS. Diabetes and cancer: epidemiological evidence and molecular links. 1st ed. Masur K, Thévenod F, S ZK, editors. Basel: S. Karger Ag (switzerland); 2008;8:148.
Kalra S. Emerging role of dipeptidyl peptidase-IV (DPP-4) inhibitor vildagliptin in the management of Type 2 diabetes. J Assoc Physicians India. 2011;59(4):237-45.
Dejager S, Razac S, Foley JE SA. Vildagliptin in Drug-naïve Patients with Type 2 Diabetes: A 24-Week, Double-blind, Randomized, Placebo-controlled, Multiple-dose Study. Horm Metab Res. 2007;39(3):218-23.
He YL, Ligueros-Saylan M, Sunkara G, Sabo R, Zhao C, Wang Y, et al. Vildagliptin, a novel dipeptidyl peptidase IV inhibitor, has no pharmacokinetic interactions with the antihypertensive agents amlodipine, valsartan, and ramipril in healthy subjects. J Clin Pharmacol. Blackwell Publishing Ltd. 2008;48(1):85-95.
Patel B, Shah J. Safety And Efficacy Of Vildagliptin: Dipeptidyl Peptidase-4 Inhibitor. Int J Pharm Res BIO-SCIENCE. 2012;1(2):35-51.
Ahrén B, Gomis R, Standl E, Mills D, Schweizer A. Twelve- and 52-week efficacy of the dipeptidyl peptidase IV inhibitor LAF237 in metformin-treated patients with type 2 diabetes. Diabetes Care. 2004;27(12):2874-80.
Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Horm Metab Res. Germany. 2009;41(5):368-73.
Filozof C, Schwartz S, Foley JE. Effect of vildagliptin as add-on therapy to a low-dose metformin. World journal of diabetes. 2010:19-26.
De Luise M. Diabetes mellitus. In: Longo DL, Kasper DL Jameson JL, Fausi AS, Hauser SL LJ, editor. The Medical journal of Australia. 18th ed. New York: McGraw Hill Education; 1993:537-40.
Aronoff SL, Berkowitz K, Shreiner B, Want L. Glucose Metabolism and Regulation: Beyond Insulin and Glucagon. Diabetes Spectr. 2004;17(3):183-90.
Schweizer A, Couturier A, Foley JE, Dejager S. Comparison between vildagliptin and metformin to sustain reductions in HbA1c over 1 year in drug-naive patients with Type 2 diabetes. Diabet Med. England. 2007;24(9):955-61.
Göke 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-naïve patients with type 2 diabetes: Comparison with metformin. Horm Metab Res. Germany. 2008;40(12):892-5.
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(8):700-8.
Schweizer A, Dejager S, Bosi E. Comparison of vildagliptin and metformin monotherapy in elderly patients with type 2 diabetes: A 24-week, double-blind, randomized trial. Diabetes, Obes Metab. England. 2009;11(8):804-12.
Pan C, Yang W, Barona JP, Wang Y, Niggli M, Mohideen P, et al. Comparison of vildagliptin and acarbose monotherapy in patients with type 2 diabetes: A 24-week, double-blind, randomized trial. Diabet Med. England. 2008;25(4):435-41.
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. England. 2009;11(5):506-15.