Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

Stopped early · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT00322257

Run by

Novo Nordisk A/S

People needed

596

Starts

2006-05-01

Expected to finish

2008-04-02

Last updated by the study team

2018-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 diabetes
• HbA1c less than or equal to 11%
• Body mass index (BMI) less than or equal to 40.0 kg/m2

You may not qualify if…

• Total daily insulin dosage more than 100 IU or U/day.
• Current smoking or smoking within the last 6 months
• Impaired hepatic or renal function
• Cardiac problems
• Uncontrolled hypertension
• Current proliferative retinopathy or maculopathy requiring acute treatment

Where it is running

• Novo Nordisk Investigational Site — Tuscaloosa, Alabama, United States
• Novo Nordisk Investigational Site — Concord, California, United States
• Novo Nordisk Investigational Site — Encino, California, United States
• Novo Nordisk Investigational Site — Escondido, California, United States
• Novo Nordisk Investigational Site — Fresno, California, United States
• Novo Nordisk Investigational Site — Inglewood, California, United States
• Novo Nordisk Investigational Site — La Jolla, California, United States
• Novo Nordisk Investigational Site — Mission Viejo, California, United States
• Novo Nordisk Investigational Site — Poway, California, United States
• Novo Nordisk Investigational Site — San Mateo, California, United States
• Novo Nordisk Investigational Site — Santa Barbara, California, United States
• Novo Nordisk Investigational Site — Tustin, California, United States
• Novo Nordisk Investigational Site — Vista, California, United States
• Novo Nordisk Investigational Site — Walnut Creek, California, United States
• Novo Nordisk Investigational Site — Aurora, Colorado, United States
• Novo Nordisk Investigational Site — Colorado Springs, Colorado, United States
• Novo Nordisk Investigational Site — New Britain, Connecticut, United States
• Novo Nordisk Investigational Site — Norwalk, Connecticut, United States
• Novo Nordisk Investigational Site — Waterbury, Connecticut, United States
• Novo Nordisk Investigational Site — Boca Raton, Florida, United States
• Novo Nordisk Investigational Site — Hollywood, Florida, United States
• Novo Nordisk Investigational Site — Lake Mary, Florida, United States
• Novo Nordisk Investigational Site — Melbourne, Florida, United States
• Novo Nordisk Investigational Site — Merritt Island, Florida, United States
• Novo Nordisk Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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