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

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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.

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.

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
Pittsburgh, Pennsylvania 15224
2119
mi
from 91732
Pittsburgh, PA
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Broadmeadow, New South Wales
?
mi
from 91732
Broadmeadow,
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Columbus, Ohio 43205
1960
mi
from 91732
Columbus, OH
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Fresno, California 93702
209
mi
from 91732
Fresno, CA
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Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Kansas City, Missouri 64106
1341
mi
from 91732
Kansas City, MO
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New Orleans, Louisiana 70112
1655
mi
from 91732
New Orleans, LA
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590
mi
from 91732
Ogden, UT
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Philadelphia, Pennsylvania 19104
2373
mi
from 91732
Philadelphia, PA
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Spokane, Washington 99202
939
mi
from 91732
Spokane, WA
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