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

Phase 1

Completed

• Conditions: Mild Nephropathy; Moderate Nephropathy; Diabetes Mellitus
• Interventions: Drug: Technosphere Inhalation Powder

• Registration Number: NCT00626249
• Lead Sponsor: Mannkind Corporation

Brief 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

Detailed Description

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 .

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-02-21
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-02-29
• Primary Completion: 2008-09
• Study Completion: 2008-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-13
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T Inhalation powder in diabetic subjs w/ normal renal func	Technosphere Inhalation Powder	T inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units
T Inhalation powder diabetic subj w/mild or moderate nephrop	Technosphere Inhalation Powder	T Inhalation powder in diabetic subjects w/mild or moderate nephropathy - Single dose, 30 units

Primary Outcome Measures

Name	Time	Method
Differences in exposure to fumaryl diketopiperazine (FDKP)	14 days

Secondary Outcome Measures

Name	Time	Method
Additional safety parameters	14 days

Trial Locations

Locations (3)

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