Evaluation of Efficacy and Tolerability of Gliclazide and Metformin Combination: A Multicentric Study in Patients With Type 2 Diabetes Mellitus Uncontrolled on Monotherapy With Sulfonylurea or Metformin

Abstract

The objective of this study was to compare the effects of gliclazide/metformin on glycemic control in patients with Type 2 diabetes mellitus uncontrolled on monotherapy with sulfonylurea or metformin. This was a prospective, open-labeled, multicentric study over 12 weeks. Patients who were diagnosed of Type 2 diabetes and were uncontrolled on monotherapy with oral hypoglycemic agents, including gliclazide and metformin, characterized by HbA1c 7% or greater and 10% or less and fasting plasma glucose (FPG) 140 mg/dL or greater were enrolled in this study. The treatment regimen was started at 80 mg gliclazide plus 500 mg metformin once a day and was titrated to the next dose level depending on the clinician's judgment, not exceeding a total daily dose of 320 mg gliclazide and 2000 mg metformin. Changes from baseline HbA1c, FPG, and postprandial glucose were examined. After 12-weeks treatment, the gliclazide + metformin combination showed improvement in metabolic control as assessed by changes in HbA1c, FPG, and postprandial glucose. The primary efficacy parameter, HbA1c, was significantly reduced to 7.35 ± 1.10 at the end of treatment from the baseline value (8.51 ± 0.77) (P < 0.001). A total of 84.35% of patients showed a 0.5% or greater reduction in HbA1c and 37.39% of patients reported less than 7% HbA1c at the end of therapy. FPG and postprandial glucose were significantly reduced at the end of therapy as compared with baseline values (P < 0.001). Moreover, the lipid profile was also improved during the treatment period. The addition of gliclazide to metformin is an effective treatment for patients inadequately controlled on sulfonylurea or metformin alone. A combination of gliclazide with metformin achieves good glycemic control and improves lipid levels with better tolerability profile.

Comparison of efficacy and safety of metformin and vildagliptin versus metformin and glimepiride in patients of Type 2 diabetes mellitus

“…This coincides with a study conducted by Charpentier et al, Wang et al, and Pareek et al, [13][14][15] who showed a significant reduction in FBS and PPBS (P < 0.001) from baseline than either glimepiride or metformin alone. The results of the present study coincide with these studies where FBS and PPBS decreased significantly (P < 0.01) from baseline to 12 weeks (P < 0.001).…”

Evaluation of fixed dose combination of glimepiride and metformin in patients with type 2 diabetes. Results of Russian observational study

“…Эффективность комбинации глимепирида и метформина была доказана в исследовании с участием пациентов с СД2 без адекватного контроля на фоне монотерапии метформи-ном. Двенадцатинедельная терапия продемонстрировала эффективность комбинации в плане улучшения (сниже- [11].…”

Severe hypoglycaemia in elderly patients with type 2 diabetes and coexistence of cardiovascular history

“…According to current recommendations of the European Association for the Study of Diabetes (EASD), the American Diabetes Association (ADA), and the PTD, metformin is the first drug of choice in all patients with newly diagnosed type 2 diabetes (after exclusion of contraindications). An important advantage of metformin treatment is low risk of hypoglycaemia, at the level of the placebo [20]. Among other oral antidiabetic agents with a good safety profile, it is worth mentioning acarbose -an inhibitor of intestinal alpha-glucosidase (alone does not cause hypoglycaemia) [21], gliflozins -inhibitors of type 2 sodium-glucose cotransporter (SGLT2) [22], and inhibitors of dipeptidyl peptidase (DPP-4) [23].…”