24 diabetics with mild & moderate renal disease and 12 diabetics without renal disease. One screening, one dosing & one follow-up visit with Technosphere® Inhalation Powder given at Visit 2 via MedTone® Inhaler and PK testing at 26 designated time points

This Phase 1, single-dose trial is being conducted to determine if nephropathy affects the way the kidneys eliminate the byproducts of Technosphere® Inhalation Powder as compared to kidneys free of disease. This trial will test the safety, tolerability and pharmacokinetics of the study medication. The trial consists of a screening, dosing and a follow-up visit. Single dose administration of Technosphere® Inhalation Powder occurs at the dosing visit. (V2) with serum and urine PK testing .

Inclusion Criteria:

• Non-smoking males and females, = 18 and = 80 years with a BMI of = 37 kg/m2
• Type 1 or type 2 diabetic
• Subjects with mild or moderate DNP and subjects with normal renal function, based on GFR rate and albuminuria
• Normal pulmonary function and performance based on PFTs

Exclusion Criteria:

• No history of COPD, asthma, or active respiratory infection; must be able to perform PFTs
• No dose and/or formulation changes within the preceding 6 weeks for any concomitant medications
• No clinically significant major organ/systemic disease
• No previous or current chemotherapy or radiation therapy that may result in pulmonary toxicity
• No clinically significant abnormalities on screening laboratory evaluation, except abnormal laboratory renal parameters in subjects with DNP