title: The DURAbility of Basal versus Lispro mix 75/25 insulin Efficacy (DURABLE) trial: comparing the durability of lispro mix 75/25 and glargine.
abstract: OBJECTIVE
  This study compared the durability of glycemic control of twice-daily insulin lispro mix 75/25 (LM75/25: 75% insulin lispro protamine suspension/25% lispro) and once-daily insulin glargine, added to oral antihyperglycemic drugs in type 2 diabetes patients.
  
  
  METHODS
  During the initiation phase, patients were randomized to LM75/25 or glargine. After 6 months, patients with A1C ≤ 7.0% advanced to the maintenance phase for ≤ 24 months. The primary objective was the between-group comparison of duration of maintaining the A1C goal.
  
  
  RESULTS
  Of 900 patients receiving LM75/25 and 918 patients receiving glargine who completed initiation, 473 and 419, respectively, had A1C ≤ 7.0% and continued into maintenance. Baseline characteristics except age were similar in this group. Median time of maintaining the A1C goal was 16.8 months for LM75/25 (95% CI 14.0-19.7) and 14.4 months for glargine (95% CI 13.4-16.8; P = 0.040). A1C goal was maintained in 202 LM75/25-treated patients (43%) and in 147 glargine-treated patients (35%; P = 0.006). No differences were observed in overall, nocturnal, or severe hypoglycemia. LM75/25 patients had higher total daily insulin dose (0.45 ± 0.21 vs. 0.37 ± 0.21 units/kg/day) and more weight gain (5.4 ± 5.8 vs. 3.7 ± 5.6 kg) from baseline. Patients taking LM75/25 and glargine with lower baseline A1C levels were more likely to maintain the A1C goal (P = 0.043 and P < 0.001, respectively).
  
  
  CONCLUSIONS
  A modestly longer durability of glycemic control was achieved with LM75/25 compared with glargine. Patients with lower baseline A1C levels were more likely to maintain the goal, supporting the concept of earlier insulin initiation.
authors.affiliation: University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA. jbuse@med.unc.edu
authors.forename: John B
authors.initials: JB
authors.lastname: Buse
authors.forename: Bruce H R
authors.initials: BH
authors.lastname: Wolffenbuttel
authors.forename: William H
authors.initials: WH
authors.lastname: Herman
authors.forename: Stephen
authors.initials: S
authors.lastname: Hippler
authors.forename: Sherry A
authors.initials: SA
authors.lastname: Martin
authors.forename: Honghua H
authors.initials: HH
authors.lastname: Jiang
authors.forename: Sylvia K
authors.initials: SK
authors.lastname: Shenouda
authors.forename: Jessie L
authors.initials: JL
authors.lastname: Fahrbach
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D038321:Glycemic Index / Q000187:drug effects*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000069036:Insulin Glargine; D061268:Insulin Lispro; D049528:Insulin, Long-Acting; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D000069036:Insulin Glargine; D061268:Insulin Lispro; D049528:Insulin, Long-Acting; C517652:hemoglobin A1c protein, human