Combining Therapy of Vildagliptin with Metformin Improves Glycemic Control than Using Metformin Alone in The Treatment of Type 2 Diabetes Mellitus
Abstract
The purpose of the trial was to determine whether combination medication for type 2 diabetes mellitus offers better glycemic control than monotherapy. Subjects whose ages were more than 18 years and with glycated hemoglobin levels higher than 7.5% were enrolled. Among the 664 patients enrolled, 332 received monotherapy, while 332 were treated with combination therapy. The treatment groups received either vildagliptin + metformin combination therapy or metformin monotherapy. Vildagliptin, as an adjunct to metformin treatment, was to be evaluated for its safety and efficacy in reducing HbA1c levels from baseline. The study included individuals with a history of T2DM for 3 to 4 years who had been treated with either combination therapy or monotherapy for at least three months. Statistical analysis was done using SPSS software. As per the findings, it indicated that combination therapy led to a considerably greater reduction in glycated hemoglobin levels compared to monotherapy. Adverse events were also observed to vary significantly between the two treatment cohorts. Outcomes suggest that combination medication should be started earlier than monotherapy for superior glycemic control. Additionally, it was thought that the combo therapy had a positive safety profile.
Keywords:
Primary combination therapy, Metformin, Type 2 diabetes mellitus, Vildagliptin, DPP-4 inhibitorDOI
https://doi.org/10.25004/IJPSDR.2024.160317References
Zinman B. Initial Combination Therapy for Type 2 Diabetes Mellitus: Is It Ready for Prime Time? 2011 Jan 1;124(1):S19–34. Available from: doi.org 10.1016/j.amjmed.2010.11.003
Saeedi P, Petersohn I, Salpea P, et al. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: results from the international diabetes federation diabetes atlas, 9th edition. Diabetes Res Clin Pract. 2019;157:107843. diabres.2019.107843 Available from: doi.org 10.1016/j.
ATLAS I. 2017: http://www. diabetesatlas. org. Accessed on Feb 10th. 2019.
Cahn A, Cefalu WT. Clinical Considerations for Use of Initial Combination Therapy in Type 2 Diabetes. Diabetes Care. 2016 Jul 19;39(Supplement 2):S137–45. Available from: doi.org 10.2337/dcS15-3007
Phung OJ, Sobieraj DM, Engel SS, Rajpathak SN. Early combination therapy for the treatment of type 2 diabetes mellitus: systematic review and meta-analysis. Diabetes, Obesity and Metabolism. 2013 Dec 16;16(5):410–7. Available from: doi.org 10.1111/dom.12233
Kirpichnikov D, McFarlane SI, Sowers JR. Metformin: an update. Ann Intern Med. 2002; 137:25–33. Available from: doi.org 10.7326/0003-4819-137-1-200207020-00009
Riddle M. Combining sulfonylureas and other oral agents. The American Journal of Medicine [Internet]. 2000 Apr 17 [cited 2023 Jan 8];108 Suppl 6a:15S22S. Available from: doi.org 10.1016/s0002-9343(00)00338-7
Warren RE. The stepwise approach to the management of type 2 diabetes. Diabetes Research and Clinical Practice. 2004 Sep;65:S3–8. Available from: doi.org 10.1016/j.diabres.2004.07.002
Foley. Weight neutrality with the DPP-4 inhibitor, vildagliptin: Mechanistic basis and clinical experience. Vascular Health and Risk Management. 2010 Jul;541. Available from: doi.org 10.2147/vhrm.s10952
Mathieu C, Kozlovski P, Paldánius PM, Foley JE, Modgill V, Evans M, et al. Clinical Safety and Tolerability of Vildagliptin – Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance. European Endocrinology. 2017;13(02):68. Available from: doi.org 10.17925/EE.2017.13.02.68
Chawla M, Tae Ho Kim, Mirasol RC, Faruque P, Cooke K, Hours-Zesiger P, et al. Initial combination therapy with vildagliptin plus metformin in drug-naïve patients with T2DM: a 24-week real-life study from Asia. Current medical research and opinion. 2018 Jun 12;34(9):1605–11. Available from: doi.org 10.1080/03007995.2018.1476333
Matthews DR, Paldánius PM, Proot P, Chiang Y, Stumvoll M, Del Prato S. Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicentre, randomised, double-blind trial. The Lancet. 2019 Oct; 394(10208):1519–29. Available from: doi.org 10.1016/S0140-6736(19)32131-2
Matthews DR, Paldánius PM, Proot P, Foley JE, Stumvoll M, Del Prato S. Baseline characteristics in the VERIFY study: a randomized trial assessing the durability of glycaemic control with early vildagliptin‐metformin combination in newly diagnosed Type 2 diabetes. Diabetic Medicine. 2019 Feb 12;36(4):505-13. Available from: doi.org 10.1111/dme.13886
Matthews D, Del Prato S, Mohan V, Mathieu C, Vencio S, Chan JCN, et al. Insights from VERIFY: Early Combination Therapy Provides Better Glycaemic Durability Than a Stepwise Approach in Newly Diagnosed Type 2 Diabetes. Diabetes Therapy. 2020 Sep 25;11(11):2465–76. Available from: doi.org 10.1007/s13300-020-00926-7
Kalra S, Das AK, Priya G, et al. Fixed-dose combination in manage- ment of type 2 diabetes mellitus: expert opinion from an international panel. J Family Med Prim Care. 2020;9(11):5450–5457. doi:10.4103/ jfmpc.jfmpc_843_20. Available from: doi.org 10.4103/jfmpc.jfmpc_843_20
Cahn A, Cefalu WT. Clinical considerations for use of initial combination therapy in type 2 diabetes. Diabetes Care. 2016 Aug 1;39(Supplement_2):S137-45. Available from: doi.org 10.2337/dcS15-3007
Chawla M, Kim TH, Mirasol RC, Faruque P, Cooke K, Hours-Zesiger P, Shete A. Initial combination therapy with vildagliptin plus metformin in drug-naïve patients with T2DM: a 24-week real-life study from Asia. Current Medical Research and Opinion. 2018 Sep 2;34(9):1605-11. Available from: doi.org 10.1080/03007995.2018.1476333
Xie X, Wu C, Hao Y, Wang T, Yang Y, Cai P, Zhang Y, Huang J, Deng K, Yan D, Lin H. Benefits and risks of drug combination therapy for diabetes mellitus and its complications: a comprehensive review. Frontiers in Endocrinology. 2023 Dec 19;14:1301093. Available from: doi.org 10.3389/fendo.2023.1301093
Mohan V, Zargar A, Chawla M, Joshi A, Ayyagari U, Sethi B, Gaurav K, Patted UR, Bhagat SV, Mane AI. Efficacy of a combination of metformin and vildagliptin in comparison to metformin alone in type 2 diabetes mellitus: a multicentre, retrospective, real-world evidence study. Diabetes, Metabolic Syndrome and Obesity. 2021 Jun 29:2925-33. Available from: doi.org 10.2147/DMSO.S315227
Goodyear MDE, Krleza-Jeric K, Lemmens T. The Declaration of Helsinki. BMJ : British Medical Journal [Internet]. 2007 Sep 29;335(7621):624–5. Available from: doi.org 10.1136/bmj.39339.610000.BE
Naoum SG. Dissertation research and writing for construction students. Routledge; 2012 Nov 12. ISBN 10: 0415538440
Lawshe CH. A quantitative approach to content validity. Personnel psychology. 1975 Dec 1;28(4):563-75. Available from: doi.org 10.1111/j.1744-6570.1975.tb01393.x
Lynn MR. Determination and quantification of content validity. Nursing research. 1986 Nov 1;35(6):382-6.
Mohan V, Zargar A, Chawla M, Joshi A, Ayyagari U, Sethi B, et al. Efficacy of a Combination of Metformin and Vildagliptin in Comparison to Metformin Alone in Type 2 Diabetes Mellitus: A Multicentre, Retrospective, Real-World Evidence Study. Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy. 2021 Jun;Volume 14:2925–33. Available from: doi.org 10.2147/DMSO.S315227
Su Y, Su YL, Lv LF, Wang LM, Li QZ, Zhao ZG. A randomized controlled clinical trial of vildagliptin plus metformin combination therapy in patients with type II diabetes mellitus. Experimental and Therapeutic Medicine. 2014 Apr 1;7(4):799-803. Available from: doi.org 10.3892/etm.2014.1545
Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. 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 Spectrum. 2012 Aug 1;25(3):154-71. Available from: doi.org 10.2337/dc14-2441
Rodbard HW, Jellinger PS, Davidson JA, Einhorn D, Garber AJ, Grunberger G, Handelsman Y, Horton ES, Lebovitz H, Levy P, Moghissi ES. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology consensus panel on type 2 diabetes mellitus: an algorithm for glycemic control. Endocrine practice. 2009 Sep 1;15(6):540-59. Available from: doi.org 10.4158/CS-2019-0472
Engel SS, Seck TL, Golm GT, Meehan AG, Kaufman KD, Goldstein BJ. Assessment of AACE/ACE recommendations for initial dual antihyperglycemic therapy using the fixed-dose combination of sitagliptin and metformin versus metformin. Endocrine Practice. 2013 Sep 1;19(5):751-7. Available from: doi.org 10.4158/EP12436.OR
Cook MN, Girman CJ, Stein PP, Alexander CM. Initial monotherapy with either metformin or sulphonylureas often fails to achieve or maintain current glycaemic goals in patients with Type 2 diabetes in UK primary care. Diabetic medicine. 2007 Apr;24(4):350-8. Available from: doi.org 10.1111/j.1464-5491.2007.02078.x
Dailey G, Kim MS, Lian JF. Patient compliance and persistence with antihyperglycemic drug regimens: evaluation of a medicaid patient population with type 2 diabetes mellitus. Clinical therapeutics. 2001 Aug 1;23(8):1311-20. Available from: doi.org 10.1016/s0149-2918(01)80110-7
Hutchins V, Zhang B, Fleurence RL, Krishnarajah G, Graham J. A systematic review of adherence, treatment satisfaction and costs, in fixed-dose combination regimens in type 2 diabetes. Current medical research and opinion. 2011 Jun 1;27(6):1157-68. Available from: doi.org 10.1185/03007995.2011.570745
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