Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma
| Status: | Terminated |
|---|---|
| Conditions: | Asthma, Diabetes, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/7/2018 |
| Start Date: | August 30, 2007 |
| End Date: | February 28, 2008 |
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
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.
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.
The decision to discontinue the development of AERx® is not due to any safety concerns. An
analysis concluded that fast-acting inhaled insulin in the form it is known today, is
unlikely to offer significant clinical or convenience benefits over injections of modern
insulin with pen devices.
analysis concluded that fast-acting inhaled insulin in the form it is known today, is
unlikely to offer significant clinical or convenience benefits over injections of modern
insulin with pen devices.
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
We found this trial at
10
sites
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