Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD)

Inhaled Pre-prandial Human Insulin Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Chronic Obstructive Pulmonary Disease: A 52-week Open Label, Multicentre, Randomized, Parallel Trial to Investigate Long-term Safety

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).

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:

• 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