Two-year pulmonary safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 2 diabetes

Diabetes Care. 2008 Sep;31(9):1723-8. doi: 10.2337/dc08-0159. Epub 2008 Jun 5.

Abstract

Objective: The purpose of this study was to evaluate the 2-year pulmonary safety of inhaled human insulin (Exubera [EXU]) in 635 nonsmoking adults with type 2 diabetes.

Research design and methods: Patients were randomly assigned to receive prandial EXU or subcutaneous insulin (regular or short-acting) plus basal (intermediate- or long-acting) insulin. The primary end points were the annual rate of decline in forced expiratory volume in 1 s (FEV(1)) and carbon monoxide diffusing capacity (DL(CO)).

Results: Small differences in FEV(1) favoring subcutaneous insulin developed during the first 3 months but did not progress. Adjusted treatment group differences in FEV(1) annual rate of change were -0.007 l/year (90% CI -0.021 to 0.006) between months 0 and 24 and 0.000 l/year (-0.016 to 0.016) during months 3-24. Treatment group differences in DL(CO) annual rate of change were not significant. Both groups sustained similar reductions in A1C by month 24 (last observation carried forward) (EXU 7.7-7.3% vs. subcutaneous insulin 7.8-7.3%). Reductions in fasting plasma glucose (FPG) were greater with EXU than with subcutaneous insulin (adjusted mean treatment difference -12.4 mg/dl [90% CI -19.7 to -5.0]). Incidence of hypoglycemia was comparable in both groups. Weight increased less with EXU than with subcutaneous insulin (-1.3 kg [-1.9 to -0.7]). Adverse events were comparable, except for a higher incidence of mild cough and dyspnea with EXU.

Conclusions: Two-year prandial EXU therapy showed a small nonprogressive difference in FEV(1) and comparable sustained A1C improvement but lower FPG levels and less weight gain than seen in association with subcutaneous insulin in adults with type 2 diabetes.

Trial registration: ClinicalTrials.gov NCT00136916.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Inhalation
  • Blood Glucose / drug effects
  • Blood Glucose / metabolism
  • Carbon Monoxide / metabolism
  • Continental Population Groups
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diffusion
  • Female
  • Forced Expiratory Volume
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / therapeutic use
  • Injections, Subcutaneous
  • Insulin / administration & dosage
  • Insulin / therapeutic use*
  • Male
  • Respiratory Function Tests*
  • Safety
  • Treatment Outcome

Substances

  • Blood Glucose
  • Exubera
  • Hypoglycemic Agents
  • Insulin
  • Carbon Monoxide

Associated data

  • ClinicalTrials.gov/NCT00136916