A 4-6 Months Open Labelled, Multicentric, Non-comparative Study For Evaluation Of Efficacy, Safety And Tolerability Of Glizid-

Glizid-M is the fixed dose combination of Gliclazide (80mg) and Metformin (500mg) indicated for the treatment of non-insulin dependent diabetes mellitus; type 2 diabetes with or without obesity in adults. The present post marketing surveillan ce evaluated the efficacy, safety and tolerability of Glizid-M in 497 patients with type 2 diabetes. It was an open labelled, non-comparative, multi centric study; which involved 26 investigators across the country. The total duration of protocol therapy was 4 weeks, whereas duration of study was 4-6 months. Assessment of the blood glucose levels was performed at the baseline, at 2nd week and at the end of the therapy (4th week). Safety parameters were assessed at week 2 and at the end of the therapy. Results There was a significant decrease in mean fasting blood glucose (from base line of 182.16mg/dl to 148.32mg/dl at week 2 and 124.9mg/dl at week 4) and post prandial blood glucose (from baseline of 262.19 mg/dl to 200.81mg/dl at week 2 and 168.24mg/dl at week 4). Moreover, 64.2% patients were able to achieve the target of blood glucose level defined by American Diabetes Association (ADA 2004) for good glycemic control, i.e. fasting blood glucose of ≤ 130mg/dl and 2-hour post parandial blood glucose of ≤ 180 mg/dl. The combination was well tolerated in general except few suspected episodes of hypoglycaemia. Conclusion The fixed dose combination of Gliclazide and Metformin showed statistically significant efficacy in improving the glycemic control in type 2 diabetics. Good safety and tolerability profile of the combination was also demonstrated in the clinical trial. (The Ind. Pract. 2005; 58(5):283-291)