Single Dose, Single Administration Study of Technosphere Inhalation Powder in Diabetic Subjects W… (NCT00626249) | Clinical Trial Compass
CompletedPhase 1
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
United States36 participantsStarted 2007-08
Plain-language 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differences in exposure to fumaryl diketopiperazine (FDKP)