drugset / Trial / NCT00626249

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

NCT00626249 ↗

Phase 1 Completed 36 enrolled Mannkind Corporation
Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2007-08
Primary completion
2008-09
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Fumaryl Diketopiperazine Unknown 30 unknown Inhaled

Indications