title: Intensification of insulin therapy in patients with type 2 diabetes: a retrospective, non- interventional cohort study of patients treated with insulin glargine or biphasic human insulin in daily clinical practice.
abstract: BACKGROUND
  The aim of this study is to compare the efficacy of intensification of insulin treatment with insulin glargine and biphasic human insulin in patients with type 2 diabetes on concomitant therapy with oral antidiabetic drugs (OAD) in daily clinical practice.
  
  
  METHODS
  A retrospective multicentre parallel two-arm study included 301 patients with type 2 diabetes already on treatment with biphasic human insulin twice daily (bd) in combination with OAD. Data were collected retrospectively from 142 patients who had been switched from biphasic human insulin to insulin glargine in a period of 6-12 months prior to their inclusion (active group) and compared to data collected retrospectively from 159 patients who continued treatment with biphasic human insulin bd for the same time period (control group). Our primary objective was to examine the efficacy of the two treatments, assessed as change in HbA1c. Secondary objectives were to examine for changes in fasting blood glucose (FBG), body weight, treatment with OAD or fast-acting insulin and safety, by assessing the frequency and severity of hypoglycaemic episodes.
  
  
  RESULTS
  At the end of the study there was a significant reduction in HbA1c in both arms. The least squares (LS) mean [(95% confidence intervals (CI)] reduction in HbA1c was -1.13 (-0.96 to -1.30)% in the active and -0.59 (-0.41to -0.77)% in the control group [LS mean treatment difference 0.53 (0.31-0.76)%, p < 0.001]. Similarly, fasting blood glucose declined significantly in both arms. The LS mean decline in FBG was -47.02 (-37.89 to -56.14) mg/dl in the active and -19.73 (-11.57 to -27.89) mg/dl in the control group [LS mean treatment difference 27.85 (15.74-39.95) mg/dl, p < 0.001]. No significant difference in hypoglycaemic episodes and in body weight was found. In the active group, more patients received rapid-acting pre-meal insulin and used insulin secretagogues drugs.
  
  
  CONCLUSIONS
  Glargine alone or in combination with fast acting insulin is more effective in reducing glycaemia than biphasic human insulin alone or in combination with fast acting insulin in patients with type 2 diabetes without increase in hypoglycaemic episodes or body weight.
authors.affiliation: 1st Department of Propaedeutic and Internal Medicine, Athens University Medical School, Laiko General Hospital, 33 Lakonias Street, 115 23, Athens, Greece.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Tentolouris
authors.affiliation: Department of Internal Medicine, Division of Endocrinology and Diabetes, Patras University Medical School, University Hospital of Patras, Patras, Greece.
authors.forename: Venetsana
authors.initials: V
authors.lastname: Kyriazopoulou
authors.affiliation: Department of Internal Medicine, General Hospital of Ioannina Chatzikosta, Ioannina, Greece.
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Makrigiannis
authors.affiliation: sanofi - aventis, Athens, Greece.
authors.forename: Barbara
authors.initials: B
authors.lastname: Baroutsou
keywords: Biphasic human insulin; Body weight; Glycaemic control; Hypoglycaemia; Insulin glargine
references.citation: N Engl J Med. 1993 Sep 30;329(14):977-86
references.pmid: 8366922
references.citation: Diabetologia. 2009 Jan;52(1):17-30
references.pmid: 18941734
references.citation: Diabetes Care. 2005 Feb;28(2):254-9
references.pmid: 15677775
references.citation: Diabetes Care. 2009 Jan;32(1):193-203
references.pmid: 18945920
references.citation: Diabetologia. 2006 Nov;49(11):2564-71
references.pmid: 17001471
references.citation: Lancet. 1998 Sep 12;352(9131):837-53
references.pmid: 9742976
references.citation: Diabetes Care. 2005 Feb;28(2):260-5
references.pmid: 15677776
references.citation: Diabetes Care. 2012 Jun;35(6):1364-79
references.pmid: 22517736
references.citation: Diabetes Care. 2005 Jun;28(6):1282-8
references.pmid: 15920040
references.citation: Diabetes Care. 2003 Nov;26(11):3080-6
references.pmid: 14578243
references.citation: Diabetes Care. 2005 May;28(5):1245-9
references.pmid: 15855602
references.citation: Diabetologia. 2009 Oct;52(10):1990-2000
references.pmid: 19644668
references.citation: Diabetes Obes Metab. 2010 Feb;12(2):115-23
references.pmid: 20092584
references.citation: Diabetes Care. 2008 Feb;31 Suppl 2:S131-5
references.pmid: 18227473
references.citation: N Engl J Med. 2008 Jun 12;358(24):2545-59
references.pmid: 18539917
references.citation: Diabetes Care. 2005 Apr;28(4):950-5
references.pmid: 15793205
references.citation: Diabetes Care. 2002 Oct;25(10):1845-50
references.pmid: 12351489
references.citation: Lancet. 1998 Sep 12;352(9131):854-65
references.pmid: 9742977
references.citation: N Engl J Med. 2008 Jun 12;358(24):2560-72
references.pmid: 18539916
references.citation: N Engl J Med. 1995 Aug 31;333(9):541-9
references.pmid: 7623902
references.citation: N Engl J Med. 2007 Oct 25;357(17):1716-30
references.pmid: 17890232
references.citation: N Engl J Med. 2009 Oct 29;361(18):1736-47
references.pmid: 19850703