title: Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension.
abstract: OBJECTIVE
  To compare the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with insulin glargine 100 U/ml (Gla-100) over 12 months of treatment in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs (OADs).
  
  
  METHODS
  EDITION 2 (NCT01499095) was a randomized, 6-month, multicentre, open-label, two-arm, phase IIIa study investigating once-daily Gla-300 versus Gla-100, plus OADs (excluding sulphonylureas), with a 6-month safety extension.
  
  
  RESULTS
  Similar numbers of participants in each group completed 12 months of treatment [Gla-300, 315 participants (78%); Gla-100, 314 participants (77%)]. The reduction in glycated haemoglobin was maintained for 12 months with both treatments: least squares (LS) mean (standard error) change from baseline -0.55 (0.06)% for Gla-300 and -0.50 (0.06)% for Gla-100; LS mean difference -0.06 [95% confidence interval (CI) -0.22 to 0.10)%]. A significant relative reduction of 37% in the annualized rate of nocturnal confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemia was observed with Gla-300 compared with Gla-100: rate ratio 0.63 [(95% CI 0.42-0.96); p = 0.031], and fewer participants experienced ≥1 event [relative risk 0.84 (95% CI 0.71-0.99)]. Severe hypoglycaemia was infrequent. Weight gain was significantly lower with Gla-300 than Gla-100 [LS mean difference -0.7 (95% CI -1.3 to -0.2) kg; p = 0.009]. Both treatments were well tolerated with a similar pattern of adverse events (incidence of 69 and 60% in the Gla-300 and Gla-100 groups).
  
  
  CONCLUSIONS
  In people with type 2 diabetes treated with Gla-300 or Gla-100, and non-sulphonylurea OADs, glycaemic control was sustained over 12 months, with less nocturnal hypoglycaemia in the Gla-300 group.
authors.affiliation: Division of Diabetes, Faculty of Medicine, University of Helsinki, Helsinki University Central Hospital, Helsinki, Finland.|Minerva Foundation Institute for Medical Research, Helsinki, Finland.
authors.forename: H
authors.initials: H
authors.lastname: Yki-Järvinen
authors.affiliation: International Diabetes Center at Park Nicollet, Minneapolis, MN, USA.
authors.forename: R M
authors.initials: RM
authors.lastname: Bergenstal
authors.affiliation: Department of Medicine, University of Perugia, Perugia, Italy.
authors.forename: G B
authors.initials: GB
authors.lastname: Bolli
authors.affiliation: Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Ziemen
authors.affiliation: Sanofi, Warsaw, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Wardecki
authors.affiliation: Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
authors.forename: I
authors.initials: I
authors.lastname: Muehlen-Bartmer
authors.affiliation: Umanis, Levallois-Perret, France.
authors.forename: M
authors.initials: M
authors.lastname: Maroccia
authors.affiliation: Division of Endocrinology, Diabetes & Clinical Nutrition, Oregon Health & Science University, Portland, OR, USA.
authors.forename: M C
authors.initials: MC
authors.lastname: Riddle
mesh_terms: D000284:Administration, Oral; D015190:Blood Glucose Self-Monitoring; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004339:Drug Compounding; D004359:Drug Therapy, Combination; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D007003:Hypoglycemia / Q000453:epidemiology / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D015994:Incidence; D007279:Injections, Subcutaneous; D000069036:Insulin Glargine / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D057194:Intention to Treat Analysis; D000068880:Isophane Insulin, Human / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D010352:Patient Dropouts; D017060:Patient Satisfaction; D012306:Risk; D015430:Weight Gain / Q000187:drug effects
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; D000068880:Isophane Insulin, Human; C517652:hemoglobin A1c protein, human
keywords: basal insulin; insulin glargine; oral antihyperglycaemic drugs; type 2 diabetes