drugset / Trial / NCT01459133

Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere Inhalation System

NCT01459133 ↗

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this program is to allow patients with diabetes and with specific medical needs which require them to use this investigational inhaled insulin product in order to adequately manage their diabetes. Treatment use of this investigational product is only anticipated when exceptional need is identified by a treating physician on a per patient case by case review.

Timeline

Start
2013-05
Primary completion
2014-10
Completion
2014-10

Outcome

Outcome not reported

Stopped: “Unable to register Treatment IND with the US Food And Drug Administration's new process of establishing TLS encryption for email correspondence.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic 10 unknown Inhaled
Subject Insulin Protein / enzyme biologic 20 unknown Inhaled

Indications