drugset / Trial / NCT00322257

Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

NCT00322257

Phase 3 Terminated 596 enrolled Novo Nordisk A/S
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-05-01
Primary completion
2008-04-02
Completion
2008-04-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic Inhaled
Comparator insulin aspart Protein / enzyme biologic Subcutaneous
Background insulin detemir Protein / enzyme biologic 50 % Subcutaneous