title: 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.
abstract: OBJECTIVE
  To compare the effectiveness and safety of add on therapy of bromocriptine with metformin in type 2 diabetes mellitus (DM) patients.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pharmacology, Nilratan Sircar Medical College, Kolkata, West Bengal, India.
authors.forename: Arijit
authors.initials: A
authors.lastname: Ghosh
authors.affiliation: Department of Endocrinology, Nilratan Sircar Medical College, Kolkata, West Bengal, India.
authors.forename: Nilanjan
authors.initials: N
authors.lastname: Sengupta
authors.affiliation: Department of Endocrinology, Nilratan Sircar Medical College, Kolkata, West Bengal, India.
authors.forename: Pranab
authors.initials: P
authors.lastname: Sahana
authors.affiliation: Department of Endocrinology, Nilratan Sircar Medical College, Kolkata, West Bengal, India.
authors.forename: Debasis
authors.initials: D
authors.lastname: Giri
authors.affiliation: Department of Pharmacology, Nilratan Sircar Medical College, Kolkata, West Bengal, India.
authors.forename: Parama
authors.initials: P
authors.lastname: Sengupta
authors.affiliation: Department of Pharmacology, Nilratan Sircar Medical College, Kolkata, West Bengal, India.
authors.forename: Nina
authors.initials: N
authors.lastname: Das
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D001835:Body Weight; D001971:Bromocriptine / Q000008:administration & dosage / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D001971:Bromocriptine; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; C517652:hemoglobin A1c protein, human
keywords: Bromocriptine; diabetes mellitus; metformin