Non-safety related business decision to combine special population protocols

The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.

Inclusion Criteria:

• A clinical diagnosis of Step 1 to 3 asthma as per the NAEPP guidelines
• Clinical diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
• Current stable anti-diabetic regimen (insulin alone or in combination with oral anti-hyperglycemic agents)
• Subjects must exhibit <30% variability in PEF measurements during the 2 week run in period.
• Subjects must not meet any criteria for exacerbations of asthma during the 2 week run in period
• Body mass index (BMI) < 40kg/m2
• HbA1c >6.0% to <11.5%

Exclusion Criteria:

• Severe complications of diabetes in the opinion of the investigator
• Seizure disorder
• Significant cardiovascular dysfunction and/or history within 3 months of screening
• Hypertension with systolic blood pressure of !80 mm Hg and/or diastolic blood pressure >110 mm HG at screening despite pharmacologic therapy.
• Clinical nephrotic syndrome or renal dysfunction or disease
• Total daily insulin requirement of >1.4 U/kg body weight
• Clinical diagnosis of Step 4 asthma
• Use of >6 puffs/day of fast acting bronchodilator
• Currently using an insulin delivery pump
• Use of Pramlintide acetate or any incretins must be discontinued 8 weeks prior to screening
• Two or more severe hypoglycemic episodes within the past 6 months.
• Any hospitalization or emergency room visit due to poor diabetic control with 6 months of screening.
• Current use of systemic steroids
• Subjects who currently smoke tobacco or who have smoked within the past 6 months
• Urine cotinine test of > 100ng/ml
• Current drug or alcohol abuse
• Clinically significant abnormalities on screening laboratory evaluation
• Cancer within the past 5 years or any history of lung neoplasms
• History of active and/or cirrhotic hepatic disease and/or abnormal liver enzymes.
• Active infection or history of severe infection with 30 days of screening.
• Anemia
• History of anaphylaxis and/or angioneurotic edema
• Diagnosis of chronic obstructive pulmonary disease (COPE)
• Previous exposure to any inhaled insulin product