This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
618
Treat-to-target dose titration scheme, inhalation.
Injection s.c., 50% of daily dose.
Treat-to-target dose titration scheme, injection s.c.
Treatment difference in HbA1c
Time frame: After 52 weeks
Adverse events
Time frame: For the duration of the trial
Blood glucose
Time frame: After 52, 104 and 116 weeks of treatment
Body weight
Time frame: During treatment
Lung function
Time frame: After 52, 104 and 116 weeks of treatment
Hypoglycaemia
Time frame: From 12 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Treat-to-target dose titration scheme, injection s.c. After 2 years.
Novo Nordisk Investigational Site
Campinas, Brazil
Novo Nordisk Investigational Site
Higienópolis, Brazil
Novo Nordisk Investigational Site
Porto Alegre, Brazil
Novo Nordisk Investigational Site
São Paulo, Brazil
Novo Nordisk Investigational Site
Århus C, Denmark
Novo Nordisk Investigational Site
Hillerød, Denmark
Novo Nordisk Investigational Site
Hvidovre, Denmark
Novo Nordisk Investigational Site
Brest, France
Novo Nordisk Investigational Site
Grenoble, France
Novo Nordisk Investigational Site
La Rochelle, France
...and 63 more locations