to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

Inclusion Criteria:

• Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months
• Stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
• Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria
• HbA1c >or= to 7.5% and < or= to 11.0%
• BMI < or = to 40kg/m2.
• FEV1> or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70%

Exclusion Criteria:

• Treatment with any type of anti-diabetic therapy, other than metformin & secretagogues within the preceding 12 weeks
• Serum creatinine > 1.4mg/dL in female subjects and >1.5mg/dL in male subjects
• History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
• Evidence of serious complications of diabetes (e.g. autonomic neuropathy)

MannKind has right to 1st joint multicenter publication. After 1st publication PI may publish data only if PI submits proposed publication to MNKD for review 60 days prior to publication date. MNKD may remove any confidential information. If a multicenter publication is not submitted 12 months after conclusion, abandonment, or termination of the Study at all sites, or if MNKD confirms there will be no multicenter Study publication, PI may publish the Study results subject to MNKD rights herein.