title: Efficacy and safety of basal insulin glargine 12 and 24 weeks after initiation in persons with type 2 diabetes: a pooled analysis of data from treatment arms of 15 treat-to-target randomised controlled trials.
abstract: OBJECTIVE
  Evaluate early (0-12 weeks) and later (12-24 weeks) treatment outcomes in subjects with type 2 diabetes not achieving glycaemic control with oral antidiabetes drugs (OADs).
  
  
  METHODS
  Selected data were pooled from 15 randomised, controlled treat-to-target (fasting plasma glucose < 100mg/dL [< 5.6 mmol/L]) trials adding insulin glargine to metformin, a sulphonylurea, or both. Glycaemic and hypoglycaemia parameters, insulin dose, and body weight at weeks 12 and 24 were assessed using individualised subject-level data.
  
  
  RESULTS
  Data from 2837 subjects were analysed. HbA1c decreased from 8.8% (73 mmol/mol) at baseline by 1.4% (15 mmol/mol) at Week 12, and a further 0.2% (2 mmol/mol) at Week 24 in the pooled population. Similar reductions were observed across the different treatment groups. HbA1c < 7.0% (<53 mmol/mol) was reached by 34.8% of participants at Week 12 and an additional 24.3% by Week 24. Hypoglycaemia incidence and rates were similar during the early and continued treatment periods across all treatment combinations, but were markedly lower for insulin glargine plus metformin versus the other 2 regimens.
  
  
  CONCLUSIONS
  Early and sustained glycaemic benefits with a low-risk of hypoglycaemia are observed after initiation of insulin glargine in a pooled type 2 diabetes cohort previously uncontrolled on OADs.
authors.affiliation: Institute of Life Sciences, Swansea University, Swansea, UK. Electronic address: OwensDR@cardiff.ac.uk.
authors.forename: David R
authors.initials: DR
authors.lastname: Owens
authors.affiliation: Sanofi US, Inc., Bridgewater, NJ, USA.
authors.forename: Louise
authors.initials: L
authors.lastname: Traylor
authors.affiliation: Sanofi, Paris, France.
authors.forename: Marie-Paule
authors.initials: MP
authors.lastname: Dain
authors.affiliation: Sanofi, Frankfurt, Germany; Third Medical Department, University of Dresden, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Landgraf
mesh_terms: D001786:Blood Glucose / Q000032:analysis; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting / Q000008:administration & dosage* / Q000009:adverse effects*; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D013453:Sulfonylurea Compounds / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; D008687:Metformin; D013453:Sulfonylurea Compounds
keywords: Basal insulin initiation and maintenance; Glycaemic efficacy; Hypoglycaemia; Insulin glargine; Type 2 diabetes