Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus

Inclusion Criteria: * HbA1c \> or = to 7.5% and \< or = to 10.0% * Body mass index (BMI) \< or = to 45 kg/m2 * Non smoker for at least 6 months before Screening * Clinical diagnosis of type 2 diabetes mellitus for more than 12 months * Currently receiving as diabetes treatment only metformin or 2 or more OADs and on stable doses for at least 3 months before enrollment * Subjects receiving metformin must be on at least 1.5gm daily, or up to the maximum tolerated dose * Subjects treated with a sulfonylurea must be on at least 50% of the total maximum approved dose for a given agent * Subjects receiving a DPP-4 inhibitor must receive the maximum approved dose specific for that agent * Metiglinide and alpha-glucoside inhibitors must be taken at the highest tolerated dose within the approved dose range * No previous or current treatment with insulin, except during an acute illness, gestational diabetes, or at time of initial diagnosis of diabetes * Forced expiratory volume in one second (FEV1) \> or = to 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted * Forced vital capacity (FVC) \> or = to 70% NHANES III predicted * Forced expiratory volume in one second as a percentage of forced vital capacity (FEV1/FVC) \> or = to NHANES III lower limit of normal (LLN) Exclusion Criteria: * History of chronic obstructive pulmonary disease (COPD), clinically proven 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 (proliferative retinopathy, autonomic neuropathy with symptoms of gastroparesis or cardiac arrhythmia; sensory neuropathy that makes manipulation of the Gen2C inhaler difficult) * Renal disease or renal dysfunction * Significant cardiovascular dysfunction or history thereof within 12 months of screening; serious arrhythmia, treatment with medications to control/treat arrhythmias; myocardial infarction; cardiac surgery; history of valvular heart disease * Previous or current use of amiodarone * Treatment with glucagon-like peptide-1 (GLP-1) analogs, thiazolidinediones (TZD), or weight loss drugs (eg, sibutramine, orlistat) within 3 months of screening * History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening * History of recent blood transfusion (within previous 3 months) or diagnosis of hemoglobinopathies that may affect HbA1c measurements