title: Safety and efficacy of AIR inhaled insulin compared with subcutaneous insulin in patients having diabetes and asthma: A 12-month, randomized, noninferiority trial.
abstract: BACKGROUND
  Long-term safety and efficacy of AIR((R)) inhaled insulin (Eli Lilly and Co., Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) in patients with diabetes and concomitant lung disease remain to be established.
  
  
  METHODS
  This 1-year, randomized, open-label, active comparator, two-arm, parallel study compared the safety and efficacy of AIR insulin to subcutaneous (SC) insulin in patients having type 1 or type 2 diabetes and asthma. Patients with type 2 diabetes continued taking their prestudy oral antihyperglycemic medication.
  
  
  RESULTS
  Change in hemoglobin A1C from baseline to end point was similar for the AIR insulin and SC insulin groups (-0.063 +/- 0.128% and -0.315 +/- 0.128% respectively, P = 0.105), but noninferiority failed to be achieved (the upper limit of the 95% confidence interval [-0.053, 0.555] was >0.4%). The total daily prandial dose increased more in the AIR insulin group than in the SC insulin group (0.150 U/kg and 0.044 U/kg, respectively, P = 0.002). Safety profiles were generally comparable between treatments. At end point, forced expiratory volume in 1 s (FEV(1))/forced vital capacity (FVC) postbronchodilator (-0.016 +/- 0.005 vs. 0.002 +/- 0.005, P = 0.006) and diffusing capacity of the lung for carbon monoxide (-1.214 +/- 0.325 mL/min/torr vs. -0.383 +/- 0.311 mL/min/torr, P = 0.028) both decreased more in the AIR insulin group than in the SC insulin group, but the differences were not present at follow-up. FEV(1) and FVC were similar between treatment groups at end point. Incidences of hypoglycemia were comparable between groups. Insulin antibody binding increased more in the AIR insulin group. Cough was the most common adverse event; however, there was no difference in incidence between the AIR insulin (15.3%) and SC insulin (12.4%) treatment groups (P = 0.572).
  
  
  CONCLUSIONS
  In patients who have diabetes and asthma, AIR insulin demonstrated glycemic efficacy similar to SC insulin. Additionally, the safety profile of AIR insulin in patients with and without asthma is consistent.
authors.affiliation: Cardinal Santos Medical Center, San Juan, Philippines.
authors.forename: Ernesto
authors.initials: E
authors.lastname: Ang
authors.forename: Mary K
authors.initials: MK
authors.lastname: Lawrence
authors.forename: Cory R
authors.initials: CR
authors.lastname: Heilmann
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Ferguson
authors.forename: Janet A
authors.initials: JA
authors.lastname: Tobian
authors.forename: David M
authors.initials: DM
authors.lastname: Webb
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Berclaz
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D017668:Age of Onset; D000368:Aged; D001249:Asthma / Q000150:complications*; D015992:Body Mass Index; D002248:Carbon Monoxide / Q000032:analysis; D048909:Diabetes Complications / Q000188:drug therapy*; D003920:Diabetes Mellitus / Q000097:blood / Q000188:drug therapy*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism*; D006801:Humans; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012907:Smoking; D014797:Vital Capacity / Q000187:drug effects
chemical_list: D002248:Carbon Monoxide; D006442:Glycated Hemoglobin; D007328:Insulin