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.
Author(s): Ghosh A(1), Sengupta N(2), Sahana P(2), Giri D(2), Sengupta P(1), Das N(1).
Affiliation(s): Author information:
(1)Department of Pharmacology, Nilratan Sircar Medical College, Kolkata, West
Bengal, India.
(2)Department of Endocrinology, Nilratan Sircar Medical College, Kolkata, West
Bengal, India.
Publication date & source: 2014, Indian J Pharmacol. , 46(1):24-8
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. HbA1C 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 HbA1C compared with metformin alone in type 2 DM
patients in a dose-dependent manner.
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