title: Comparison of thrice daily biphasic human insulin (30/70) versus basal detemir & bolus aspart in patients with poorly controlled type 2 diabetes mellitus - a pilot study.
abstract: OBJECTIVE
  Conventionally, biphasic human insulin (30/70, BHI) is used twice daily for the management of patients with diabetes. However, this regimen is suboptimal to control post-lunch and/or pre-dinner hyperglycaemia in some patients. This study was undertaken to compare the efficacy and safety of thrice-daily biphasic human insulin (30/70, BHI) versus basal detemir and bolus aspart (BB) in patients with poorly controlled type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  In this open labelled randomized pilot study, 50 patients with uncontrolled T2DM on twice-daily BHI and insulin sensitizers were randomized either to BHI thrice-daily or BB regimen. HbA1c, six point plasma glucose profile, increment in insulin dose, weight gain, hypoglycaemic episodes and cost were compared between the two treatment groups at the end of 12 wk.
  
  
  RESULTS
  Mean HbA l c (± SD) decreased from 9.0 ± 0.9 per cent at randomization to 7.9 ± 0.8 per cent in BHI (P<0.001) and from 9.4 ± 1.3 to 8.2 ± 1.0 per cent in BB regimen (P<0.001) after 12 wk of treatment. The mean (± SEM) weight gain in patients in the BHI regimen was 1.5 ± 0.33 kg compared to 1.4 ± 0.34 kg in the BB regimen. Insulin dose increment at 12 wk was significantly more in the BB regimen 0.46 ± 0.32 U/kg/day compared to 0.15 ± 0.21 U/kg/day in the BHI regimen (P<0.001). The incidence of major as well as minor hypoglycaemic episodes was not different in both the regimen. The BB regimen was more expensive than the BHI regimen (P<0.001).
  
  
  CONCLUSIONS
  The thrice daily biphasic human insulin regimen is non-inferior to the basal bolus insulin analogue regimen in terms efficacy and safety in patients with poorly controlled T2DM. However, these data require further substantiation in large long term prospective studies.
authors.affiliation: Department of Endocrinology, Postgraduate Institute of Medical Education & Research, Chandigarh, India.
authors.forename: G
authors.initials: G
authors.lastname: Shanmugasundar
authors.forename: Anil
authors.initials: A
authors.lastname: Bhansali
authors.forename: Rama
authors.initials: R
authors.lastname: Walia
authors.forename: Pinaki
authors.initials: P
authors.lastname: Dutta
authors.forename: Vimal
authors.initials: V
authors.lastname: Upreti
mesh_terms: D000328:Adult; D061265:Biphasic Insulins / Q000008:administration & dosage*; D001786:Blood Glucose; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000473:pathology; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D061267:Insulin Aspart / Q000008:administration & dosage*; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome; D015430:Weight Gain
chemical_list: D061265:Biphasic Insulins; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061267:Insulin Aspart; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting; C517652:hemoglobin A1c protein, human