Comparative Evaluation of BGR-34 and Sitagliptin in Diabetic Subjects - Open Labelled Randomised Parallel Clinical Study

This article is mainly concerned with the simultaneous open model clinical study of the drug named sitagliptin, a potent hyperglycaemic drug against a novel entity of the natural origin BGR- 34 in diabetic subjects. This was a 3-month randomized, parallel, comparative study. One hundred subjects were planned to be included in the study. The patients were randomly divided into two groups and according to the appropriate sample size analysis, both groups consisted of 100 patients, following the inclusion and exclusion criteria. A total of 90 patients (both male and female) of the mean patient age 30-65 years with the type 2 diabetes were enrolled in the phase 4 of this study and then the data were analyzed on the basis of the different test which included HbA1c (glycated haemoglobin), RBS (random blood sugar), FBS (fasting blood sugar) and PPG (postprandial glucose) values. After completion of the data calibration, the results were analyzed and as a result 10-20% decreased values of HBA1C values accompanied with the RBS, FBS and PPG values were seen in the patients undergoing a 12-week course with BGR-34. Based on the results obtained in the present study, it can be concluded that BGR-34 is effective in reducing high blood sugar levels and this reflects that the BGR-34 therapy is more effective drug in the treatment of diabetes suggesting that it is better in efficacy, and reliability with little or no adverse effects.