Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes

This trial is conducted in Asia, Europe and Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects)

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 2 diabetes
• Treated with OAD(s) for more than or equal to 2 months
• Body mass index (BMI) less than or equal to 40.0 kg/m2
• HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy
• HbA1c greater than or equal to 7.5 % and less than or equal to 10.0 % for subjects on OAD combination therapy

Exclusion Criteria:

• Recurrent major hypoglycaemia
• Current smoking or smoking within the last 6 months
• Impaired hepatic or renal function
• Cardiac problems
• Uncontrolled hypertension
• Proliferative retinopathy or maculopathy