Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes
| Status: | Terminated |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/7/2018 |
| Start Date: | May 1, 2006 |
| End Date: | April 2, 2008 |
Inhaled Mealtime Insulin With the AERx® iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Parallel Trial (Followed by a Twelve-Week Re-Randomised Extension) To Investigate Safety and Efficacy
This trial is conducted in the United States of America (USA) and Canada. The aim of this
research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary
safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous
insulin aspart both in combination with insulin determir in Type 1 Diabetes.
research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary
safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous
insulin aspart both in combination with insulin determir in Type 1 Diabetes.
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 diabetes
- HbA1c less than or equal to 11%
- Body mass index (BMI) less than or equal to 40.0 kg/m2
Exclusion Criteria:
- Total daily insulin dosage more than 100 IU or U/day.
- Current smoking or smoking within the last 6 months
- Impaired hepatic or renal function
- Cardiac problems
- Uncontrolled hypertension
- Current proliferative retinopathy or maculopathy requiring acute treatment
We found this trial at
82
sites
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