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

MannKind

Status and phase: Completed; Phase 1

Conditions: Moderate Nephropathy; Mild Nephropathy; Diabetes Mellitus

Treatments: Drug: Technosphere Inhalation Powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT00626249

MKC-T-017

Details and patient eligibility

About

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

Full 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 .

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

T Inhalation powder in diabetic subjs w/ normal renal func

Experimental group

Description:

T inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units

Treatment:

Drug: Technosphere Inhalation Powder

T Inhalation powder diabetic subj w/mild or moderate nephrop

Experimental group

Description:

T Inhalation powder in diabetic subjects w/mild or moderate nephropathy - Single dose, 30 units

Treatment:

Drug: Technosphere Inhalation Powder