Original ArticleEvaluation 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 MetforminPareek, Anil MD1*; Chandurkar, Nitin MPharm2; Zawar, Shyamsundar MD3; Agrawal, Navneet MD4Author Information 1Medical Affairs & Clinical Research; 2Clinical Research & Development, Ipca Laboratories Limited, Mumbai, India; 3Department of Medicine, Indira Gandhi Government Medical College & Mayo Hospital, Nagpur, India; and 4Department of Medicine, G. R. Medical College & J.A. Group of Hospitals, Gwalior, India. This study was sponsored by Ipca Laboratories Limited, Mumbai, India. *Address for correspondence: Medical Affairs and Clinical Research, Ipca Laboratories Ltd., 142 AB, Kandivli Industrial Estate, Kandivli (West), Mumbai 400067, India. E-mail: [email protected] American Journal of Therapeutics: November 2010 - Volume 17 - Issue 6 - p 559-565 doi: 10.1097/MJT.0b013e3181c6c0f9 Buy Metrics 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. © 2010 Lippincott Williams & Wilkins, Inc.