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

Completed · Phase 1

Conditions studied: Mild Nephropathy, Moderate Nephropathy, Diabetes Mellitus

In brief

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

Key facts

Study ID: NCT00626249
Run by: Mannkind Corporation
People needed: 36
Starts: 2007-08-01
Expected to finish: 2008-10-01
Last updated by the study team: 2013-12-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Davita Clinical Research — Minneapolis, Minnesota, United States
Qualia Clinical Research — Omaha, Nebraska, United States
Diabetes & Glandular Disease Research Assoc PA — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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