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Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

Diabetes Clinical Trial

Official title:
Inhaled Mealtime Insulin With the AERx® iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Parallel Trial (Followed by a Twelve-Week Re-Randomised Extension) To Investigate Safety and Efficacy

Clinical Trial Summary

This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 Diabetes.

Clinical Trial Description

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00322257
Study type Interventional
Source Novo Nordisk A/S
Contact
Status Terminated
Phase Phase 3
Start date May 1, 2006
Completion date April 2, 2008
View Details
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