Main Article Content
Objective: To assess the safety and efficacy of Vildagliptin with metformin and Glimepiride with metformin among Type 2 Diabetes Mellitus (T2DM) patients with inadequate glycemic control using Metformin mono-therapy.
Methodology: This comparative, interventional study was conducted at the Medicine and Endocrinology Department, Lady Reading Hospital, Peshawar. A total of 180 T2DM patients were divided into two groups (Glimepiride-Metformin group and Vildagliptin-Metformin group), with 90 patients in each group. Glycosylated hemoglobin (HbA1c), Fasting Plasma Glucose (FPG), Postprandial Glucose (PPG) were assessed with hypoglycemic incidences, weight gain, other adverse drug reactions were also monitored. The 1st follow-up visit was planned after 12-weeks of receiving the treatment and the 2nd after 24-weeks. Recorded data was analyzed through SPSS v.22.0.
Results: The mean decrease in the FPG level after 24-weeks of treatment was -42.93±13.46 mg/dl in Vildagliptin-Metformin group, while it was. -46.76±11.04 mg/dl in the Glimepiride-Metformin group. Similarly, both drugs, Vildagliptin-Metformin vs Glimepiride-Metformin decreased mean PPG and HbA1c level i.e., -42.93 mg/dl vs. -46.76 mg/dl and -3.12% vs. -2.39% respectively (p<0.05). Mild adverse effects, like hypoglycemic incidences (10%) and weight gain (73.31±13.94 kg at 2nd visit) was more prominent among the Glimepiride-Metformin group.
Conclusion: In terms of safety and efficacy, the Vildagliptin-Metformin combination showed a considerably healthier response in achieving the HbA1c level among T2DM patients, with no weight gain and decreased risk of hypoglycemia as compared to Glimepiride.
Work published in JPMI is licensed under a
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.
International Diabetes Federation. Diabetes Atlas Ninth edition 2019. [cited 2020 Oct 17] Available from: URL: https:// www.diabetesatlas.org/upload/resources/material/20200302_133351_ID¬FATLAS9e-finalweb.pdf
Aamir AH, Ul-Haq Z, Mahar SA, Qureshi FM, Ahmad I, Jawa A, et al. Diabetes Prevalence Survey of Pakistan (DPS-PAK): prevalence of type 2 diabetes mellitus and prediabetes using HbA1c: a population-based survey from Pakistan. BMJ open. 2019; 9(2):e025300.
Holman RR, Paul SK, Bethel MA, Mathews DR, Neil HA. 10- year follow-up of intensive glucose control in type 2 diabetes. NEJM. 2008; 359:1577-1589.
Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycaemia 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). Diabetologia. 2012; 55(6):1577-1596.
Rhee SY, Kim HJ, Ko SH, Hur KY, Kim NH, Moon MK, et al. Monotherapy in patients with type 2 diabetes mellitus. Diabetes Metab. 2017; 41(5):349-356.
Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centred approach. Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 2015; 58(3):429-442.
Ko SH, Hur KY, Rhee SY, Kim NH, Moon MK, Park SO, et al. Antihyperglycemic agent therapy for adult patients with type 2 diabetes mellitus 2017: a position statement of the Korean Diabetes Association. Diabetes Metab. 2017; 41(5):337-348.
Cahn A, Cefalu WT. Clinical considerations for use of initial combination therapy in type 2 diabetes. Diabetes Care. 2016; 39(Suppl 2): S137–145.
Kwon CS, Seoane-Vazquez E, Rodriguez-Monguio R. Cost-effectiveness analysis of metformin+dipeptidyl peptidase-4 inhibitors compared to metformin+ sulfonylureas for treatment of type 2 diabetes. BMC Health Serv Res. 2018; 18(1):1-2.
Wu Y, Ding Y, Tanaka Y, Zhang W. Risk factors contributing to type 2 diabetes and recent advances in the treatment and prevention. Int J Med Sci. 2014; 11(11):1185-1200.
Rosenstock J, Rendell MS, Gross JL, Fleck PR, Wilson CA, Mekki Q. Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA1c without causing weight gain or increased hypoglycaemia. Diabetes Obesi Metab. 2009; 11(12):1145-1152.
Lwanga SK, Lemeshow S. Sample size determination in health studies: a practical manual. World Health Organization [Online] 1991. [Cited 2019 Dec 10]. Available from: URL: https://apps.who. int/iris/handle/10665/40062
Jeon HJ, Oh TK. Comparison of vildagliptin-metformin and glimepiride-metformin treatments in type 2 dia¬betic patients. Diabetes Metab J. 2011; 35(5):529-535.
Harris SB. The power of two: an update on fixed-dose combinations for type 2 diabetes. Expert Rev Clin Pharmacol. 2016;9(11):1453–1462.
Matthews DR, Paldanius PM, Proot P, Chiang Y, Stumvoll M, Del Prato S, et al. 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. Lancet. 2019; 394(10208):1519-1529.
Matthews DR, Dejager S, Ahren B, Fonseca V, Ferrannini E, Couturier A, Foley JE, Zinman B. 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(9):780-789.
Gullapalli H, Desai S. Comparison of efficacy and safety of Metformin and vildagliptin versus Metformin and Glimepiride in patients of Type 2 diabetes mellitus. Natl J Physiol Pharm Pharmacol. 2018; 8(4):521-525.
Trerattanavong K, Tadi P. Glimepiride. InStatPearls [Internet] 2020 Feb 26. Treasure Island (FL): StatPearls Publishing.
Palalau AI, Tahrani AA, Piya MK, Barnett AH. DPP-4 inhibitors in clinical practice. J Postgrad Med. 2009; 121(6):70-100.
Rosenstock J, Fitchet M. Vildagliptin: clinical trials programme in monotherapy and combination therapy for type 2 diabetes. Int J ClinPract Suppl. 2008;(159):15-23.
Mokta JK, Sahai AK, Kaundal PK, Mokta K. Comparison of Safety and Efficacy of Glimepiride-Metformin and Vildagliptin-Metformin Treatment in Newly Diagnosed Type 2 Diabetic Patients. J Assoc Physicians India. 2018; 66(8):30-35.
Zoungas S, Patel A, Chalmers J, De Galan BE, Li Q, Billot L, et al. Severe hypoglycemia and risks of vascular events and death. N Engl J Med. 2010; 363(15):1410-1418.
Bekiari E, Rizava C, Athanasiadou E, Papatheodorou K, Liakos A, Karagiannis T, et al. Systematic review and meta-analysis of vildagliptin for treatment of type 2 diabetes. Endocrine. 2016; 52:458–480.
Khazrai YM, Buzzetti R, Del Prato S, Cahn A, Raz I, Pozzilli P. The addition of E (Empowerment and Economics) to the ABCD algorithm in diabetes care. J Diabetes Complications. 2015;29(4):599-