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

• Status: Terminated
• Trial end date: 2008-03-05
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

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

Criteria

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