Single Dose, Single Administration Study of Technosphere Inhalation Powder in Diabetic Subjects With Mild or Moderate Kidney Disease Compared to Diabetic Subjects With Normal Kidney Function

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mannkind Corporation

Criteria

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