Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes
| Status: | Terminated |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/7/2018 |
| Start Date: | November 29, 2006 |
| End Date: | March 18, 2008 |
Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes
This trial is conducted in the United States of America (USA). This trial will compare the
changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy
versus pioglitazone treatment alone.
changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy
versus pioglitazone treatment alone.
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 2 diabetes
- Current treatment with oral antidiabetes drugs (OADs) for at least 2 months
- HbA1c between 7.0-11.0% if on OAD monotherapy
- HbA1c between 7.0-10.0% if on OAD combination therapy
- BMI less than or equal to 40 kg/m2
Exclusion Criteria:
- Current regular smoking or regular smoking within the last 6 months
- Current acute or chronic pulmonary disease (except for asthma)
- Proliferative retinopathy requiring treatment
- Clinically significant disease history including kidney or liver disease, or heart
disease which limits physical activity or results in discomfort with physical activity
- Pregnancy
We found this trial at
103
sites
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