Vol 10, No 4 (2021)
Research paper
Published online: 2021-06-23

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Real-world experience of treatment individualization based on fixed-dose combination of gliclazide extended release+ metformin extended release in type 2 diabetes mellitus

Sanjay Kalra1, Aravinda Jagadeesha2, Deepak Khandelwal3, Kirti Samudra4, Sharvil Gadve5, Supratik Bhattacharyya6
Clin Diabetol 2021;10(4):337-341.


Objective To evaluate efficacy of gliclazide extended release (XR) 60 mg + metformin XR 500 mg fixed-dose combination (FDC) with metformin as add-on (as needed) in real-world clinical practice. Methods This prospective observational study was performed in patients with type 2 diabetes mellitus uncontrolled on metformin (group M) or on conventional gliclazide XR 60 mg + metformin XR 500 mg (group GM); and newly diagnosed or untreated patients with HbA1c >9% (group U) at 6 out-patient diabetes care units. Patients received gliclazide XR 60 mg + metformin XR 500 mg FDC and metformin (as needed) at baseline for 30 days. Up-titration with gliclazide capped at 120 mg and metformin every 30 days till day-90. Proportion of patients achieving target FPG was primary endpoint. Results Of 455 patients (mean age:51.9±11.3 years; mean BMI 26.7±6.2 kg/m2), 261 patients had family history of diabetes and 161 patients had hypertension. Target FPG was achieved with 1 tablet each of gliclazide XR 60 mg + metformin XR 500 mg FDC and metformin by 73.09%, 74.26%, and 60.66% patients in groups M, GM, and U, respectively. Only 29.23% patients required up-titration to 1 tablet of FDC + 2 tablets each of metformin and FDC at days 60 and 90. Mean FPG, PPG and HbA1c significantly reduced at day-90 (P<0.001). Conclusions It can be concluded from this real-world primary-care practice study that the use of gliclazide XR 60 mg + metformin XR 500 mg FDC and metformin (as needed) was effective and well tolerated, and >3 out-of 5 patients achieved target glycemic control within 30 days in all groups.

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  1. International Diabetes Federation. IDF Diabetes Atlas 9th Edition. Brussels, Belgium: International Diabetes Federation 2019. http://www.diabetesatlas.org.
  2. International Diabetes Federation. Recommendations For Managing Type 2 Diabetes In Primary Care, 2017. www.idf.org/managing-type2-diabetes.
  3. Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm–2018 executive summary. Endocr Pract. 2018; 24(1): 91–120.
  4. Kalra S, Aamir AH, Raza A, et al. Place of sulfonylureas in the management of type 2 diabetes mellitus in South Asia: A consensus statement. Indian J Endocrinol Metab. 2015; 19(5): 577–596.
  5. Chan SP, Colagiuri S. Systematic review and meta-analysis of the efficacy and hypoglycemic safety of gliclazide versus other insulinotropic agents. Diabetes Res Clin Pract. 2015; 110(1): 75–81.
  6. Simpson S, Lee J, Choi S, et al. Mortality risk among sulfonylureas: a systematic review and network meta-analysis. The Lancet Diabetes & Endocrinology. 2015; 3(1): 43–51.
  7. Schernthaner G, Grimaldi A, Di Mario U, et al. GUIDE study: double-blind comparison of once-daily gliclazide MR and glimepiride in type 2 diabetic patients. Eur J Clin Invest. 2004; 34(8): 535–542.
  8. Schramm TK, Gislason GH, Vaag A, et al. Mortality and cardiovascular risk associated with different insulin secretagogues compared with metformin in type 2 diabetes, with or without a previous myocardial infarction: a nationwide study. Eur Heart J. 2011; 32(15): 1900–1908.
  9. Gæde P, Oellgaard J, Carstensen B, et al. Years of life gained by multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: 21 years follow-up on the Steno-2 randomised trial. Diabetologia. 2016; 59(11): 2298–2307.
  10. De Fa. Evidence-based benefits of a selective secretagogue: Diamicron MR 60 mg. Medicographia. 2016; 38: 77–87.
  11. Kalra S, Das AK. Epidemiologic Surveillance of Glycemic Response to a Scored, Breakable, Extended Release, Fixed Dose Combination of Gliclazide and Metformin in Persons with Type 2 Diabetes. J Assoc Physicians India. 2017; 65(6): 38–41.
  12. Mohan V, Chopra V, Sanyal D, et al. Treatment of Type 2 Diabetes with a Breakable Extended Release Gliclazide Formulation in Primary Care: The Xrise Study. J Assoc Physicians India. 2015; 63(12): 26–29.
  13. Lavernia F, Adkins SE, Shubrook JH. Use of oral combination therapy for type 2 diabetes in primary care: Meeting individualized patient goals. Postgrad Med. 2015; 127(8): 808–817.