Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler

Exclusion Criteria

• •Current or prior treatment with prandial or PreMix (70/30) insulin
• •History of insulin pump use within 6 weeks of Visit 1
• •Treatment with Glucagon-like Peptide (GLP-1) analog drugs within the preceding 12 weeks of Visit 1
• •History of chronic obstructive pulmonary disease (COPD), asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)
• •Any clinically significant radiological findings on screening chest x-ray
• •Use of medications for asthma, COPD, or any other chronic respiratory conditions
• •Evidence of serious complications of diabetes (eg, symptomatic autonomic neuropathy)
• •Significant cardiovascular dysfunction or history within 3 months of Visit 1 (eg, congestive heart failure \[New York Heart Association {NYHA} Class III or IV\])
• •Serious arrhythmia, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks, or any cerebrovascular accident
• •History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening (Visit 1)