title: Effectiveness and safety of basal supported oral therapy with insulin glargine, in Japanese insulin-naive, type 2 diabetes patients, with or without microvascular complications: subanalysis of the observational, non-interventional, 24-week follow-up Add-on Lantus® to Oral Hypoglycemic Agents (ALOHA) study.
abstract: OBJECTIVE
  The aim of this study is to evaluate effectiveness and safety of basal supported oral therapy (BOT) using insulin glargine in insulin-naive Japanese patients, with and without microvascular complications.
  
  
  METHODS
  This sub-group analysis of observational, non-interventional ALOHA study, assessed changes in glycemic parameters and glargine dose, at 24weeks or at glargine discontinuation. Count of hypoglycemic episodes was based on physicians' documentation of patient reports. Patients were stratified according to presence/absence of microvascular complications, at baseline. Relationships between baseline patient characteristics and achievement of HbA1c <7% were examined by multivariate regression analysis.
  
  
  RESULTS
  A total of 3631 patients, included during 2007-2009, were stratified in sub-groups: no complications (n= 1889), retinopathy (n=318), neuropathy (n=297), nephropathy (n=356), retinopathy+neuropathy (n= 174), retinopathy+nephropathy (n=154), neuropathy+nephropathy (n=142), and retinopathy+neuropathy+nephropathy (n=301). Changes in HbA1c, fasting and postprandial plasma glucose, and glargine daily dose were similar among patients with and without complications. Response-rate for achieving HbA1c <7.0% was highest in patients without complications (19.1%). In multivariate analysis, patients without complications showed significantly higher odds of attaining HbA1c <7%, independent of diabetes duration and baseline HbA1c levels. Patients with retinopathy+nephropathy had the lowest response-rate (8.8%) and highest hypoglycemic-rate (3.2%).
  
  
  CONCLUSIONS
  Japanese insulin-naive patients without complications, on BOT with glargine, show higher chances of attaining HbA1c <7.0% than those with complications.
authors.affiliation: Department of Diabetology, Metabolism, and Endocrinology, Tokyo Medical University, 6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 160-0023, Japan. Electronic address: odawara@tokyo-med.ac.jp.
authors.forename: Masato
authors.initials: M
authors.lastname: Odawara
authors.affiliation: Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan. Electronic address: kadowaki-3im@h.u-tokyo.ac.jp.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kadowaki
authors.affiliation: Sanofi K.K., 3-20-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan. Electronic address: Yusuke.Naito@sanofi.com.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Naito
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000704:Analysis of Variance; D001786:Blood Glucose / Q000032:analysis; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000188:drug therapy*; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D000069036:Insulin Glargine / Q000008:administration & dosage*; D007564:Japan; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D061214:Patient Safety; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine
keywords: Hypoglycemia; Insulin glargine; Microvascular complications; Multivariate analysis; Type 2 diabetes