Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake
Condition: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
MeSH terms: Respiratory Aspiration; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Intervention: TI Inhalation Powder and Humalog (Amendment 1); TI Inhalation Powder (original protocol)
Intervention description: Subcutaneous (sc) rapid acting analog to be administered at one half of the meal challenge visits 15 minutes before a meal. Only the last 5 - 10 patients (Type 2) will be undergoing this amendment to the protocol.; Inhaled insulin technology to be administered immediately before a meal (prandially) for glucose control in Type 1 or Type 2 diabetics
Intervention MeSH terms: Insulin Lispro
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder
      is established for either a type 1 or 2 patient, based on a average diabetic meal, the
      patient's favorable dose can be used safely, regardless of change in meal carbohydrate
      content. Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150%
      or 200%). The 100% carbohydrate load was determined based upon their standard insulin dose
      for their normal meal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnoses of type 1 or type 2 diabetes mellitus

          -  Fasting Plasma Glucose (FPG) 80, 140 mg/dL and glycated hemoglobin (A1C) > 6.5% and <
             or = 10.0%.

          -  Body mass index (BMI) of < or = 40 kg/m2

          -  Non-smokers (never smoked or former smokers [= 6 months since cessation]) and a urine
             cotinine level < or = 100 ng/dL

          -  Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition
             Examination Survey (NHANES III) Predicted; pre-bronchodilator FEV1 as a percentage of
             forced vital capacity (FEV1/Forced vital capacity(FVC)) = 70%

          -  For subjects with type 2 diabetes mellitus: Currently receiving oral diabetic
             treatment or basal insulin +/- oral diabetic treatment

        Exclusion Criteria:

          -  History of chronic obstructive pulmonary disease (COPD), clinically proven asthma,
             and/or any other clinically important pulmonary disease confirmed by pulmonary
             function test (PFT) and/or radiologic findings

          -  Elevated liver function test (alanine aminotransferase [ALT] or aspartate
             aminotransferase [AST] > 3 times the normal reference range or bilirubin > 1.5 times
             the reference range)

          -  Previous use of Exubera; use of Symlin (pramlintide acetate) and/or Byetta (exenatide)
             within the past 12 weeks

          -  Unstable diabetes control and evidence of severe complications of diabetes mellitus
             (ie, autonomic neuropathy)

          -  Exposure to any investigational product(s) in the past 12 weeks

          -  For subjects with type 2 diabetes mellitus: In subjects taking metformin, serum
             creatinine > 1.4 mg/dL in female subjects and > 1.5 mg/dL in male subjects