title: Efficacy and safety of biphasic insulin aspart 30/70 in type 2 diabetes suboptimally controlled on oral antidiabetic therapy in Korea: a multicenter, open-label, single-arm study.
abstract: BACKGROUND
  The purpose of this study was to evaluate change in glycosylated hemoglobin (HbA1c), side effects, and quality of life (QOL) after a 16-week treatment period with Biphasic insulin aspart 30/70 (BIasp30) in patients with type 2 diabetes mellitus (T2DM) who had been suboptimally controlled with oral antidiabetic drugs (OADs).
  
  
  METHODS
  The study consisted of a 4-week titration period when concurrent OAD(s) were replaced with BIasp30 and followed by a 12-week maintenance period. All patients completed the Diabetes Treatment Satisfaction Questionnaire at the beginning and the end of the trial. Hypoglycemic episodes were recorded by the patient throughout the trial.
  
  
  RESULTS
  Sixty patients were included, of whom 55 patients (92%) completed the full 16-week treatment period. Seven-point blood glucose was significantly improved as compared with the baseline, except for the postlunch blood glucose level. HbA1c at the end of period was significantly improved from 9.2% to 8.2% (P<0.001). Eleven percent (n=6) of patients achieved HbA1c values ≤6.5% and 22% (n=12) of patients achieved <7.0%. There were 3.4 episodes/patients-year of minor hypoglycemia and 0.05 episodes/patients-year of major hypoglycemia. QOL showed significant changes only in the acceptability of high blood glucose category (P=0.003).
  
  
  CONCLUSIONS
  Treatment with once or twice daily BIasp30 may be an option for the patients with T2DM suboptimally controlled with OADs in Korea. However, considering the low number of patients achieving the HbA1c target and the high postlunch blood glucose levels, additional management with another modality may be required for optimal control.
authors: Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
authors: Kee-Ho
authors: KH
authors: Song
authors: Jung Min
authors: JM
authors: Kim
authors: Jung-Hyun
authors: JH
authors: Noh
authors: Yongsoo
authors: Y
authors: Park
authors: Hyun-Shik
authors: HS
authors: Son
authors: Kyong Wan
authors: KW
authors: Min
authors: Kyung Soo
authors: KS
authors: Ko
keywords: Diabetes mellitus, type 2; Glycemic control; Insulin aspart, insulin aspart protamine drug combination 30:70
references: Lancet. 2008 Mar 29;371(9618):1073-84
references: 18374840
references: Diabetologia. 2009 Jan;52(1):17-30
references: 18941734
references: Diabetes Care. 2009 Jan;32(1):193-203
references: 18945920
references: Drugs. 2006;66(1):31-49
references: 16398567
references: Diabetes Care. 2006 Feb;29(2):379-84
references: 16443891
references: Diabet Med. 1990 Jun;7(5):445-51
references: 2142043
references: Diabetes Care. 2003 Mar;26(3):688-96
references: 12610023
references: BMJ. 2009 Nov 09;339:b4324
references: 19900993
references: Ann Intern Med. 2008 Oct 21;149(8):549-59
references: 18794553
references: Diabetes Care. 2009 Nov;32 Suppl 2:S253-9
references: 19875560
references: Diabetes Educ. 2006 Jan-Feb;32(1 Suppl):19S-28S
references: 16439486
references: Diabetes Care. 2005 Feb;28(2):260-5
references: 15677776
references: Curr Med Res Opin. 2008 Jan;24(1):11-20
references: 18021495
references: Diabetes Obes Metab. 2006 Jan;8(1):58-66
references: 16367883
references: Diabetes Care. 2002 Oct;25(10):1845-50
references: 12351489
references: Diabetes Care. 2002 Feb;25(2):275-8
references: 11815495
references: Diabetes Res Clin Pract. 2009 Oct;86(1):31-6
references: 19692134
references: Diabetes Res Clin Pract. 2009 Jul;85(1):47-52
references: 19427051
references: Diabetes. 2009 Apr;58(4):773-95
references: 19336687
references: Diabet Med. 2005 Apr;22(4):374-81
references: 15787659
references: Diabetes Care. 2005 Jun;28(6):1282-8
references: 15920040
references: JAMA. 2009 May 27;301(20):2129-40
references: 19470990
references: N Engl J Med. 2007 Oct 25;357(17):1716-30
references: 17890232
references: J Nutr. 2002 Sep;132(9):2574-9
references: 12221211
references: N Engl J Med. 2009 Oct 29;361(18):1736-47
references: 19850703
references: Endocr Pract. 2009 Sep-Oct;15(6):540-59
references: 19858063