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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 Kalra, Aravinda Jagadeesha, Deepak Khandelwal, Kirti Samudra, Sharvil Gadve, Supratik Bhattacharyya
DOI: 10.5603/DK.a2021.0042

open access

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Published online: 2021-06-23

Abstract

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.

Abstract

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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Keywords

Gliclazide; Diabetes mellitus; Metformin; Glycemic control; Fixed dose combination

About this article
Title

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

Journal

Clinical Diabetology

Issue

Ahead of print

Article type

Research paper

Published online

2021-06-23

DOI

10.5603/DK.a2021.0042

Keywords

Gliclazide
Diabetes mellitus
Metformin
Glycemic control
Fixed dose combination

Authors

Sanjay Kalra
Aravinda Jagadeesha
Deepak Khandelwal
Kirti Samudra
Sharvil Gadve
Supratik Bhattacharyya

References (13)
  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.

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