Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma

Inhaled Preprandial Human Insulin With the AERx® iMS Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Asthma: A 52-week, Open-label, Multinational, Randomised, Parallel Trial to Investigate Long-term Safety

This trial is conducted in Europe, Asia, Oceania and the United States of America (USA).

This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.

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.

Inclusion Criteria:

• Type 1 or type 2 diabetes
• Treatment with insulin and/or oral anti-diabetic drugs
• Asthma for at least 6 months
• Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years
• HbA1C less than or equal to 11.0 %
• Body Mass Index (BMI) less than or equal to 40.0 kg/m2

Exclusion Criteria:

• Current smoking or smoking within the last 6 months
• Other current acute or chronic pulmonary disease excluding asthma
• Recurrent severe hypoglycaemia
• Proliferative retinopathy or maculopathy