Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
This trial is conducted in Europe, Asia and South America. A one-year clinical trial to compare the safety of inhaled human insulin to subcutaneous insulin aspart in subjects with type 1 or type 2 diabetes and chronic obstructive pulmonary disease (COPD).
Detailed 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.
Interventions
Treat-to-target dose titration scheme, pre-prandial, inhalation.
DRUGinsulin aspart
Treat-to-target dose titration scheme, pre-prandial, injection s.c.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic Obstructive Pulmonary Disease * Type 1 or type 2 diabetes * HbA1c lower or equal to 11.0 % * Body Mass Index (BMI) lower or equal to 40.0 kg/m2
Exclusion criteria
* Recurrent severe hypoglycaemia * Current smoking or smoking within the last 6 months * Other pulmonary disease including asthma * Proliferative retinopathy or maculopathy requiring acute treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections | After one year |
Secondary
| Measure | Time frame |
|---|---|
| Patient Reported Outcomes | After one year |
| Diabetes control measured by change in HbA1c from baseline | After one year |
| Preprandial Insulin Doses | After one year |
Countries
Argentina, India, Romania, Slovakia, Taiwan, Thailand, Turkey (Türkiye)
Outcome results
None listed