Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Technosphere® Insulin; Technosphere Powder
Intervention description: Technosphere® Insulin Inhalation Powder; Placebo Comparator
Intervention MeSH terms: Insulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 353.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on
      either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or
      two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or
      Technosphere Powder (placebo) added to their oral antidiabetic drugs.
    

Eligibility criteria:

        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