Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c. Insulin Aspart Both Combined With NPH in Subjects With Type 1 Diabetes

A 24-month Multicentre, Open-label, Randomised, Parallel Group, Long Term Safety Trial Comparing Intensive Treatment of Pulmonary Inhaled Human Insulin With Insulin Aspart Administered s.c., Both in Combination With NPH, in Subjects With Type 1 Diabetes

This trial is conducted in Oceania.

The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.

Inclusion Criteria:

• Type 1 diabetes
• Current treatment with any insulin in any regimen
• Body mass index (BMI) below 38.0 kg/m2
• HbA1c below or equal to 13.0%

Exclusion Criteria:

• Total daily insulin dosage more than 100 IU/day
• Current acute or chronic pulmonary disease (excluding asthma)
• Recurrent major hypoglycaemia
• Proliferative retinopathy or maculopathy requiring acute treatment
• Smoker
• Chest X-ray with clinically significant abnormalities