Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma (iINHALE 9)
|ClinicalTrials.gov Identifier: NCT00523042|
Recruitment Status : Terminated (See termination reason in detailed description)
First Posted : August 30, 2007
Last Update Posted : March 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Asthma||Drug: insulin aspart Drug: inhaled human insulin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 30, 2007|
|Actual Primary Completion Date :||February 28, 2008|
|Actual Study Completion Date :||February 28, 2008|
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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523042
Show 32 Study Locations
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|