Efficacy And Safety Of Add On Therapy Of Bromocriptine With Metformin In Indian Patients With Type 2 Diabetes Mellitus: A Randomized Open Labeled Phase Iv Clinical Trial

Objective: To compare the effectiveness and safety of add on therapy of bromocriptine with metformin in type 2 diabetes mellitus (DM) patients. Material and Methods: Adult type 2 DM patients fulfilling the inclusion criteria were randomized in three groups. Group A received metformin (1000 mg/ day), while group B patients were treated with metformin (1000 mg/day) plus bromocriptine (0.8 mg/day) and group C received metformin (1000 mg/day) plus bromocriptine (1.6 mg/day) for 12 weeks. Fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), and body weight were measured at week 4, 8, and 12 visits and glycosylated hemoglobin (HbA 1C ) at week 12 visit. Results: Metformin alone and in combination with bromocriptine in escalating dose (0.8 mg/day and 1.6 mg/day) significantly (P < 0.05) decreased FPG and PPPG levels at weeks 4, 8, and 12 compared with pretreatment values. HbA 1C level in all three treatment groups significantly (P < 0.05) decreased at week 12 as compared with pretreatment baseline value. HbA 1C level in groups B and C significantly (P < 0.05) decreased as compared with group A at week 12 . Addition of bromocriptine to metformin also significantly (P < 0.05) decreased FPG and PPPG levels in a dose-dependent manner as compared with metformin alone. Intergroup analysis did not show any statistically significant change in weight of study subjects at different intervals. Conclusion: The combination of bromocriptine with metformin significantly decreased FPG, PPPG, and HbA 1C compared with metformin alone in type 2 DM patients in a dose-dependent manner.