Evaluation of fixed dose combination of glimepiride and metformin in patients with type 2 diabetes. Results of Russian observational study
https://doi.org/10.14341/DM2015284-88
Abstract
Aim.
To investigate the efficacy and safety of combined glimepiride and metformin therapy in patients with type 2 diabetes mellitus (T2DM).
Materials and methods.
A multi-centre, open-label, prospective, observational study was conducted. A total of 1200 patients with T2DM inadequately controlled with metformin, glimepiride or combination of metformin + glimepiride were enrolled. Change in serum glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial blood glucose (PPG) levels; weight; waist circumference and hypoglycemic episodes were evaluated.
Results.
Baseline HbA1c levels (8.24% ? 0.42%) were significantly reduced after 12 weeks of treatment (7.48% ? 0.48%) and at the end of the study.
(6.88% ? 0.56%). Target HbA1c levels (?7%) were achieved in 65.1% of patients at the final visit at 24 weeks. FPG and PPG levels decreased by 1.45 ? 1.14 mmol/l and 2.17 ? 1.27 mmol/l respectively (p < 0.001). No severe hypoglycemic events were reported. Body mass index reduced by 0.85 ? 1.28 kg/m2 (p < 0.001).
Conclusion. .
Combined glimepiride and metformin therapy significantly improved long-term glycemic control in patients with T2DM during the period of 24 weeks.
without additional risk of hypoglycemic events or weight gain.
To investigate the efficacy and safety of combined glimepiride and metformin therapy in patients with type 2 diabetes mellitus (T2DM).
Materials and methods.
A multi-centre, open-label, prospective, observational study was conducted. A total of 1200 patients with T2DM inadequately controlled with metformin, glimepiride or combination of metformin + glimepiride were enrolled. Change in serum glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial blood glucose (PPG) levels; weight; waist circumference and hypoglycemic episodes were evaluated.
Results.
Baseline HbA1c levels (8.24% ? 0.42%) were significantly reduced after 12 weeks of treatment (7.48% ? 0.48%) and at the end of the study.
(6.88% ? 0.56%). Target HbA1c levels (?7%) were achieved in 65.1% of patients at the final visit at 24 weeks. FPG and PPG levels decreased by 1.45 ? 1.14 mmol/l and 2.17 ? 1.27 mmol/l respectively (p < 0.001). No severe hypoglycemic events were reported. Body mass index reduced by 0.85 ? 1.28 kg/m2 (p < 0.001).
Conclusion. .
Combined glimepiride and metformin therapy significantly improved long-term glycemic control in patients with T2DM during the period of 24 weeks.
without additional risk of hypoglycemic events or weight gain.
Supporting agencies: GLMET_L_06048
About the Authors
Natalya Vladislavovna Zaytseva
Endocrinology Research Centre, Moscow
Russian Federation
Competing Interests:
Russian Federation
MD, PhD, Senior research associate, Department of Diabetic Nephropathy and Haemodialysis
Competing Interests:
Авторы заявляют об отсутствии конфликта интересов при подготовке данной публикации.
Ivona Renata Jarek-Martynova
Endocrinology Research Centre, Moscow
Russian Federation
Competing Interests:
Russian Federation
MD, PhD, Leading research associate, Department of Diabetic Nephropathy and Haemodialysis
Competing Interests:
Авторы заявляют об отсутствии конфликта интересов при подготовке данной публикации.
References
1. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). The Lancet. 1998;352(9131):837-853. doi: 10.1016/S0140-6736(98)07019-6
2. Дедов И.И., Шестакова М.В. Сахарный диабет. Диагностика, лечение, профилактика. – Москва.: Медицинское информационное агентство; 2011. [Dedov I.I., Shestakova M.V. Diabetes mellitus. Diagnosis, treatment, prevention. – Moscow: Medical information Agency; 2011.]
3. Дедов И.И., Шестакова М.В., Аметов А.С., и др. Консенсус совета экспертов Российской ассоциации эндокринологов по инициации и интенсификации сахароснижающей терапии у больных сахарным диабетом 2 типа. // Сахарный диабет. – 2011. - №4 – С.6–17. [Dedov II, Shestakova MV, Ametov AS, Antsiferov MB, Galstyan GR, Mayorov AY, et al. Russian Association of Endocrinologists expert consensus document on initiation and intensification of antyhyperglycaemic therapyin type 2 diabetes mellitus. Diabetes mellitus. 2011;14(4):6-17.] doi: 10.14341/2072-0351-5810
4. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. Под редакцией И.И. Дедова, М.В. Шестаковой (6-й выпуск). Сахарный диабет. 2013;(1s):1-121. [Dedov I, Shestakova M, Aleksandrov A, et al. Standards of specialized diabetes care. Edited by Dedov II, Shestakova MV (6th edition). Diabetes mellitus. 2013;(1S):1-120.] doi: 10.14341/DM20131S1-121
5. Inzucchi SE, Bergenstal RM, Buse JB, et al. 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(6):1364-1379. doi: 10.2337/dc12-0413
6. IDF Clinical Guidelines Task Force. Global Guideline for Type 2 Diabetes: recommendations for standard, comprehensive, and minimal care. Diabetic Medicine. 2006;23(6):579-593. doi: 10.1111/j.1464-5491.2006.01918.x
7. American Diabetes Association (ADA). Standards of Medical Care in Diabetes—2014. Diabetes care. 2014;37(Supplement 1):S14-S80. doi: 10.2337/dc14-S014
8. Результаты исследования ACCORD-EYE. // Сахарный диабет. – 2010. - №2. – С.132. [The ACCORD-EYE study results. Diabetes mellitus. 2010;13(2):132.] doi: 10.14341/2072-0351-5691
9. Müller G, Hartz D, Pünter J, et al. Differential interaction of glimepiride and glibenclamide with the β-cell sulfonylurea receptor I. Binding characteristics. Biochimica et Biophysica Acta (BBA) - Biomembranes. 1994;1191(2):267-277. doi: 10.1016/0005-2736(94)90177-5
10. Charpentier G, Fleury F, Kabir M, et al. Improved glycaemic control by addition of glimepiride to metformin monotherapy in Type 2 diabetic patients. Diabetic Medicine. 2001;18(10):828-834. doi: 10.1046/j.1464-5491.2001.00582.x
11. Pareek A, Chandurkar NB, Salkar HR, et al. Evaluation of Efficacy and Tolerability of Glimepiride and Metformin Combination: A Multicentric Study in Patients with Type-2 Diabetes Mellitus, Uncontrolled on Monotherapy with Sulfonylurea or Metformin. American Journal of Therapeutics. 2013;20(1):41-47. doi: 10.1097/MJT.0b013e3181ff7c63
12. Melikian C, White TJ, Vanderplas A, et al. Adherence to oral antidiabetic therapy in a managed care organization: A comparison of monotherapy, combination therapy, and fixed-dose combination therapy. Clinical Therapeutics. 2002;24(3):460-467. doi: http://dx.doi.org/10.1016/S0149-2918(02)85047-0
13. Penfornis A. Drug compliance in type 2 diabetes: role of drug treatment regimens and consequences of their benefits. Diabetes and Metabolism. Diabetes Metab. 2003;29(2 Pt 3):S31-37.
14. Donahue S, Turner K, Patel S. Pharmacokinetics and Pharmacodynamics of Glyburide/Metformin Tablets (Glucovance™) versus Equivalent Doses of Glyburide and Metformin in Patients with Type 2 Diabetes. Clin Pharmacokinet. 2002;41(15):1301-1309. doi: 10.2165/00003088-200241150-00004
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Zaytseva N.V., Jarek-Martynova I.R. Evaluation of fixed dose combination of glimepiride and metformin in patients with type 2 diabetes. Results of Russian observational study. Diabetes mellitus. 2015;18(2):84-88. (In Russ.) https://doi.org/10.14341/DM2015284-88
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