Assessment of safety and efficacy of bromocriptine in comparison with teneligliptin in newly diagnosed type 2 diabetes mellitus

Abstract

The objective was to evaluate the safety and efficacy of Bromocriptine in comparison with Teneligliptin in patients with newly diagnosed type 2 diabetes mellitus with the following outcome measurements, FBS (Fasting blood sugar), PPBS (Post prandial blood sugar-2 hours after breakfast), HbA1c (Glycosylated hemoglobin), BMI (Body mass index) and Adverse events and tolerability. The study was a prospective, open labelled randomized controlled, clinical evaluation done in 50 newly diagnosed type 2 diabetic patients. The study participants were randomly divided into two groups, Bromocriptine group (25 patients) and Teneligliptin group (25 patients). Bromocriptine was administered at the dose of 0.8 mg in the morning with food which was increased to 1.6 mg from 15th day and was maintained at 1.6 mg till the completion of the study (3 months). Teneligliptin was administered at a dose of 20 mg, once a day in the morning after food, throughout the study (3 months). FBS, PPBS, HbA1c and BMI were assessed at baseline and at the end of 1st, 2nd and 3rd months. Statistical analysis was done using one-way ANOVA (Analysis of variance) between the groups and repeated measures ANOVA within the groups.Bromocriptine and Teneligliptin significantly reduced FBS, PPBS, HbA1c and BMI values (p value < 0.0001). However, Teneligliptin was found to be superior to Bromocriptine in the reduction of FBS, PPBS and HbA1c levels whereas Bromocriptine was found to be superior in reducing BMI levels at the end of 3 months. Teneligliptin was well tolerated by all the patients with no adverse events reported, whereas, 5 patients taking Bromocriptine were found to have nausea as adverse effect. Hence it is concluded that, Teneligliptin and Bromocriptine significantly reduced FBS, PPBS, HbA1c and BMI at the end of 3 months in newly diagnosed type 2 diabetic patients. But Teneligliptin was superior to Bromocriptine in overall efficacy and safety.