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

• Status: Terminated
• Trial end date: 2008-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin, Globin Zinc

Criteria

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