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Category: Volume 10 Issue 03 March 2022
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Title: Efficacy and Safety of Empagliflozin in Patients with Type 2 Diabetes Mellitus in Adequately Controlled on Triple Drug Therapy

Authors: Dr Sachin, Dr P.K Agrawal (Prof. & HOD), Dr Faiyaz Alam (Asst. Prof), Dr Saad Bin Saif (SR), Dr Rakesh Raushan

 DOI: https://dx.doi.org/10.18535/jmscr/v10i3.19

Abstract

Objective: Empagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, has been associated with HbA1c reduction and weight loss in a broad range of patients with type 2 diabetes mellitus (T2DM). This analysis evaluated changes in HbA1c and body weight in patients who were inadequately responding to maximum dose of three oral hypoglycemic agents and reluctant to take insulin therapy.

Methods: In this open label interventional single arm study, patients aged 18 to 65 years (N=100) received Empagliflozin 10mg for in addition to an ongoing triple drug oral hypoglycemic agents (OHA) regimen for a period of 12 weeks.

The said population was inadequately responding to maximum dose of three oral hypoglycemic agents and was reluctant to take insulin therapy. Percent change from baseline in HbA1c and body weight was evaluated in the study.

Results: Empagliflozin 10mg additional dose above a triple OH provided significant HbA1c reduction by 1.4% and weight reduction by 1.5  kg over 12 weeks from baseline. Empagliflozin was generally well tolerated, with 2.54% of the patient population reporting Urinary tract infection (UTI) who were withdrawn

from study and given appropriate treatment.

Conclusions: Empagliflozin 10 mg (One tablet) administered to patients in addition to the inadequately controlled triple drug OHs who were reluctant for an insulin therapy provided a significant reduction in HbAlc and body weight over 12 weeks. Empagliflozin a SGLT 2 inhibitor is a promising new drug in patients with T2DM in patients who are inadequately controlled on triple therapy and are reluctant to insulin therapy.

References

  1. Melmed, Shlomo; Polonsky, Kenneth S.; Larsen, P. Reed; Kronenberg, Henry M., eds. (2019). Williams textbook of endocrinology(12th ed.). Philadelphia: Elsevier/Saunders. pp. 1371–1435.
  2. Vos T, Allen C, Arora M, Barber RM, Bhutta ZA, Brown A, et al. (GBD 2015 Disease and Injury Incidence and Prevalence Collaborators) (October 2016).
  3. Gardner, David G.; Shoback, Dolores, eds. "Pancreatic hormones & diabetes mellitus". Greenspan's basic & clinical endocrinology(9th ed.). New York: McGraw-Hill Medical. 2011;17.
  4. National Institute of Diabetes and Digestive and Kidney Diseases. June 2014. Archived from the original on 2 February 2016. Retrieved 10 February 2016.
  5. "Diabetes Fact sheet N°312". World Health Organization. August 2011. Archived from the original on 26 August 2013. Retrieved 2012-01-09.
  6. Ripsin CM, Kang H, Urban RJ (January 2009). "Management of blood glucose in type 2 diabetes mellitus". American Family Physician. 79(1): 29–36.
  7. Inzucchi SE, Bergenstal RM, Buse JB, et al,.; American Diabetes Association (ADA), ; European Association for the Study of Diabetes (EASD). 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.
  8. 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.
  9. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008;359:1577–1589.
  10. Medivizor “Is empagliflozin better than glimepiride?”  in Diabetes mellitus  on Aug 5, 2018.
  11. S. Dabhi, N.R. Bhatt, M.J. Shah Voglibose: An Alpha Glucosidase Inhibitor J. Clin. Diagn. Res., 7 (2013), pp. 3023-3027.
  12. Therapy in Type 2 Diabetes, Diabetes. Care. 39 (2016) S137–S145.
  13. Diabetes and vascular disease research 2016 vol.13(2) 119-126
  14. Diabetes, obesity and metabolism 18. 812-819 2016.
  15. J Clin med research 2019 11(4) 267-274
  16. Giorgino et al. cardiovascular diabetology 2020,19:196

Corresponding Author

Dr Sachin