Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease

Inclusion Criteria

• •Asthma
• •Physician diagnosis of asthma with history of any or all of the following: recurrent wheezing, recurrent chest tightness, recurrent difficulty breathing, or cough, particularly worse at nighttime
• •Never smoked or former smokers (= 6 months since cessation)
• •≥18 years of age
• •Prebronchodilator Forced Expiratory Volume in 1sec (FEV1) ≥ 60% Third National Health and Nutrition Examination Survey (NHANES III) predicted, prebronchodilator total lung capacity (TLC) ≥ 80% predicted Intermountain Thoracic Society (ITS), and prebronchodilator single breath carbon monoxide diffusing capacity of the lung (DLco) (unc) ≥70% predicted (Miller)
• •\< 30% day-to-day variability in daily morning Peak expiratory Volume (PEF) during the 2-week run-in period
• •Significant improvement in pre- to postbronchodilator spirometry (defined as an increase from baseline of ≥ 12% and ≥ 200 mL in FEV1 or Forced Vital Capacity \[FVC\]) at Screening/Visit 1 or documented significant improvement in pre- to postbronchodilator spirometry (as defined above) within past 12 months in subject's medical records or a documented positive methacholine challenge test within the past 12 months
• •COPD
• •Physician diagnosis of COPD (including emphysema and/or chronic bronchitis), history of dyspnea and/or intermittent or daily chronic cough with or without sputum production, not attributable to any other known cause
• •Former smoker (≥ 6 months since cessation) with smoking history of ≥ 10 pack years
• •≥40 years of age
• •Postbronchodilator FEV1/FVC ratio \< 70%
• •Postbronchodilator FEV1 ≥ 50% NHANES III predicted, total lung capacity (TLC) ≥ 80% predicted ITS, and DLco (unc) ≥ 50% predicted (Miller)
• •Both
• •Clinical diagnosis of Type1 or 2 diabetes mellitus for ≥ 12 months and no change in anti-diabetic regiment for at least 90-days prior to screening
• •BMI of, \< 39 kg/m2
• •Urine cotinine level ≤ 100ng/dL
• •Clinical diagnosis of obstructive lung disease
• •HbA1C \> 6.5% ≤ 11.5%