Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma (iINHALE 9)
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.
|Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Asthma||Drug: insulin aspart Drug: inhaled human insulin||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Inhaled Preprandial Human Insulin With the AERx® iMS Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Asthma: A 52-week, Open-label, Multinational, Randomised, Parallel Trial to Investigate Long-term Safety|
- Changes in lung function, chest X-rays, or asthma exacerbation frequency [ Time Frame: after 52 weeks of treatment ]
- Diabetes control measured by change in HbA1c [ Time Frame: from baseline to end of treatment ]
- Laboratory assessments (biochemistry, insulin antibodies, blood count) [ Time Frame: from baseline to end of treatment ]
- Preprandial insulin doses [ Time Frame: for the duration of the trial ]
|Actual Study Start Date:||August 30, 2007|
|Study Completion Date:||February 28, 2008|
|Primary Completion Date:||February 28, 2008 (Final data collection date for primary outcome measure)|
Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
|Active Comparator: B||
Drug: insulin aspart
Treat-to-target dose titration scheme, injection s.c.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523042
Show 32 Study Locations
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|