title: Efficacy and safety of insulin lispro in geriatric patients with type 2 diabetes: a retrospective analysis of seven randomized controlled clinical trials.
abstract: OBJECTIVE
  Glycemic control in geriatric patients with type 2 diabetes (T2DM) remains clinically challenging. The objective of this study was to compare the safety and efficacy of insulin lispro in patients C65 years (geriatric) to those\65 years (non-geriatric), using a metaanalysis of randomized controlled clinical trials (RCT).
  
  
  METHODS
  This is a retrospective analysis of predefined endpoints from an integrated database of seven RCTs of T2DM patients treated with insulin lispro. The primary efficacy measure tested the non-inferiority of insulin lispro (geriatric vs. non-geriatric; non-inferiority margin 0.4 %) in terms of hemoglobin A1c (HbA1c) change from baseline to Month 3 (N = 1,525), with change from baseline to Month 6 as a supportive analysis (N = 885). Changes in HbA1c from baseline were evaluated with an analysis of covariance model. Secondary measures included incidence and rate of hypoglycemia, and incidence of cardiovascular events.
  
  
  RESULTS
  Mean change in HbA1c from baseline to Month 3 was similar for geriatric (-0.97 %) and non-geriatric patients (-1.05 %); least-square (LS) mean difference (95 % CI) was 0.02 % (-0.11, 0.15 %; p = 0.756). Similar results were observed in patients treated up to Month 6; LS mean difference (95 % CI) was 0.07 % (-0.12, 0.26 %; p = 0.490). Decrease in HbA1c from baseline to Months 3 and 6 was non-inferior in geriatric compared with non-geriatric patients. There were no significant differences in the incidence and the rate of hypoglycemia, incidence of cardiovascular events, or other serious adverse events including malignancy, post-baseline between the two cohorts.
  
  
  CONCLUSIONS
  Key measures of efficacy and safety in geriatric patients with T2DM were not significantly different from non-geriatric patients when utilizing insulin lispro. Insulin lispro may be considered a safe and efficacious therapeutic option for the management of T2DM in geriatric patients.
authors: Bradley H
authors: BH
authors: Curtis
authors: Tina M
authors: TM
authors: Rees
authors: Kim A
authors: KA
authors: Gaskins
authors: Justo
authors: J
authors: Sierra-Johnson
authors: Rong
authors: R
authors: Liu
authors: Honghua H
authors: HH
authors: Jiang
authors: John H
authors: JH
authors: Holcombe
mesh_terms: D000367:Age Factors; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D061268:Insulin Lispro / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061268:Insulin Lispro
references: Diabetes Care. 2009 Mar;32(3):381-6
references: 19246588
references: J Am Geriatr Soc. 2011 Apr;59(4):666-72
references: 21480838
references: Am J Geriatr Pharmacother. 2009 Dec;7(6):324-42
references: 20129254
references: Hosp Pract (1995). 2011 Feb;39(1):7-21
references: 21441754
references: Endocr Pract. 2010 May-Jun;16(3):371-5
references: 20551007
references: Arch Intern Med. 2011 Feb 28;171(4):362-4
references: 21357814
references: Diabetes Metab. 2011 Apr;37(2):152-61
references: 21435929
references: Clin Ther. 2006 Oct;28(10):1569-81
references: 17157113
references: Diabet Med. 2010 Feb;27(2):181-8
references: 20546262
references: Diabetes Metab. 2005 Dec;31 Spec No 2:5S58-5S61
references: 16415766
references: Diabetes Care. 2012 Jan;35 Suppl 1:S11-63
references: 22187469
references: Clin Ther. 1997 Jan-Feb;19(1):62-72
references: 9083709
references: Diabetes Obes Metab. 2000 Jan;2(1):39-46
references: 11220353
references: JAMA. 2003 May 7;289(17):2254-64
references: 12734137
references: Diabet Med. 1999 Jul;16(7):586-90
references: 10445835
references: Arch Intern Med. 1997 Jun 9;157(11):1249-55
references: 9183237
references: Mayo Clin Proc. 2010 Dec;85(12 Suppl):S15-26
references: 21106867
references: Clin Ther. 1999 Oct;21(10):1703-14
references: 10566566
references: J Gerontol Nurs. 2011 Apr;37(4):10-5
references: 21539006
references: Acta Diabetol. 2013 Feb;50(1):33-7
references: 21547506
references: Diabet Med. 2010 May;27(5):563-9
references: 20536953
references: Rev Invest Clin. 2010 Jul-Aug;62(4):366-74
references: 21222316
references: N Engl J Med. 2005 Jan 13;352(2):174-83
references: 15647580
references: Clin Interv Aging. 2006;1(2):107-13
references: 18044107
references: J Am Geriatr Soc. 2003 May;51(5 Suppl Guidelines):S265-80
references: 12694461
references: J Diabetes Complications. 2007 Jan-Feb;21(1):20-7
references: 17189870
references: Am J Health Syst Pharm. 2011 Mar 15;68(6):500-9
references: 21378298
references: Drugs. 2007;67(3):407-34
references: 17335298
references: Am J Geriatr Pharmacother. 2011 Feb;9(1):24-36
references: 21459306
references: Exp Clin Endocrinol Diabetes. 2010 Apr;118(4):215-9
references: 20072965