PMID- 19772447
OWN - NLM
STAT- MEDLINE
DCOM- 20100108
LR  - 20221207
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Linking)
VI  - 11 Suppl 2
DP  - 2009 Sep
TI  - Safety and efficacy of AIR inhaled insulin compared with subcutaneous insulin in 
      patients having diabetes and asthma: A 12-month, randomized, noninferiority 
      trial.
PG  - S35-44
LID - 10.1089/dia.2009.0054 [doi]
AB  - 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.
FAU - Ang, Ernesto
AU  - Ang E
AD  - Cardinal Santos Medical Center, San Juan, Philippines.
FAU - Lawrence, Mary K
AU  - Lawrence MK
FAU - Heilmann, Cory R
AU  - Heilmann CR
FAU - Ferguson, Jeffrey A
AU  - Ferguson JA
FAU - Tobian, Janet A
AU  - Tobian JA
FAU - Webb, David M
AU  - Webb DM
FAU - Berclaz, Pierre-Yves
AU  - Berclaz PY
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Insulin)
RN  - 7U1EE4V452 (Carbon Monoxide)
SB  - IM
MH  - *Administration, Inhalation
MH  - Adult
MH  - Age of Onset
MH  - Aged
MH  - Asthma/*complications
MH  - Body Mass Index
MH  - Carbon Monoxide/analysis
MH  - Diabetes Complications/*drug therapy
MH  - Diabetes Mellitus/blood/*drug therapy
MH  - Diabetes Mellitus, Type 1/blood/drug therapy
MH  - Diabetes Mellitus, Type 2/blood/drug therapy
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Glycated Hemoglobin/drug effects/*metabolism
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Insulin/*administration & dosage/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Smoking
MH  - Vital Capacity/drug effects
EDAT- 2009/09/30 06:00
MHDA- 2010/01/09 06:00
CRDT- 2009/09/24 06:00
PHST- 2009/09/24 06:00 [entrez]
PHST- 2009/09/30 06:00 [pubmed]
PHST- 2010/01/09 06:00 [medline]
AID - 10.1089/dia.2009.0054 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S35-44. doi: 10.1089/dia.2009.0054.