title: The impact of initiating biphasic human insulin 30 therapy in type 2 diabetes patients after failure of oral antidiabetes drugs.
abstract: BACKGROUND
  The present study evaluated the efficacy of biphasic human insulin 30 (BHI 30) in type 2 diabetes patients who had failed in therapy with two or more oral antidiabetes drugs (OADs).
  
  
  METHODS
  This open-label, nonrandomized, 4-month, multicenter, clinical observational study was conducted in Shanghai, China. A total of 660 insulin-naive type 2 diabetes patients with poor glycemic control (glycosylated hemoglobin [HbA1c] ≥7.5%), despite treatment with two or more OADs for more than 6 months, were recruited and received BHI 30 monotherapy or BHI 30 plus OAD(s) (metformin only, α-glucosidase inhibitor only, or both).
  
  
  RESULTS
  Among the 660 subjects, 644 completed the 4-month study. At the end of the study, the median level of HbA1c decreased by 2.0% (from 9.1% to 7.0%) in the BHI 30 monotherapy group and also 2.0% (from 9.5% to 7.3%) in the BHI 30 plus OAD group. More patients achieved the HbA1c <7.0% target in the BHI 30 monotherapy group than in the BHI 30 plus OAD(s) group (47.9% vs. 35.3%, P=0.002). Compared with the expenses of the prior treatment strategy, the median daily cost decreased by 39.8% (4.5 yuan, Chinese RMB) at the end point in the BHI 30 monotherapy group but increased by 20.0% (2.2 yuan) in the BHI 30 plus OAD(s) group (P<0.0001). Moreover, patients in the BHI 30 plus OAD(s) group had fewer minor hypoglycemic episodes than in the BHI 30 monotherapy group (mean of 1.06 vs. 2.77 per patient per year, P<0.0001).
  
  
  CONCLUSIONS
  Short-term BHI 30 therapy can improve glycemic control in insulin-naive type 2 diabetes patients after failure of two or more OADs. With higher baseline glucose level, the BHI 30 plus OAD(s) group had lower pharmacoeconomic efficacy than the BHI 30 monotherapy group despite having fewer hypoglycemia events.
authors: Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.
authors: Yunjuan
authors: Y
authors: Gu
authors: Xuhong
authors: X
authors: Hou
authors: Lei
authors: L
authors: Zhang
authors: Jiemin
authors: J
authors: Pan
authors: Qingxia
authors: Q
authors: Cai
authors: Yuqian
authors: Y
authors: Bao
authors: Weiping
authors: W
authors: Jia
mesh_terms: D000368:Aged; D061265:Biphasic Insulins / Q000008:administration & dosage* / Q000191:economics; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D002681:China / Q000453:epidemiology; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000191:economics / Q000453:epidemiology; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000191:economics; D008297:Male; D008687:Metformin / Q000008:administration & dosage* / Q000191:economics; D008875:Middle Aged; D017678:Sex Distribution; D017211:Treatment Failure; D015430:Weight Gain / Q000187:drug effects
chemical_list: D061265:Biphasic Insulins; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; C517652:hemoglobin A1c protein, human