Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | August 2006 |
| End Date: | May 2008 |
A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus
A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin
Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable
insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with
type 1 diabetes mellitus.
This study is designed also to examine insulin antibody levels in AIR Insulin -treated
patients compared with injectable insulin-treated patients with type 1 diabetes.
The present study is intended to determine if preprandial AIR Insulin is non-inferior to
preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from
baseline to endpoint at 6 months in patients with type 1 diabetes.
Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable
insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with
type 1 diabetes mellitus.
This study is designed also to examine insulin antibody levels in AIR Insulin -treated
patients compared with injectable insulin-treated patients with type 1 diabetes.
The present study is intended to determine if preprandial AIR Insulin is non-inferior to
preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from
baseline to endpoint at 6 months in patients with type 1 diabetes.
Inclusion Criteria:
- Type 1 diabetes for at least 24 months
- Have an HbA1c less than or equal to 11%
- Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day
for at least 2 months
- Non-smoker
Exclusion Criteria:
- Require a daily total insulin dosage greater than 150 U at screening
- Patients who have a current or past history of asthma, chronic obstructive pulmonary
disease, other clinically relevant pulmonary disease
- Systemic glucocorticoid therapy
- Clinical signs or symptoms of liver disease, acute or chronic hepatitis
- History of lung transplantation and/or lung cancer
- Diagnosed with pneumonia in the 3 months prior to screening
- History of renal transplantation
- Active or untreated malignancy
We found this trial at
15
sites
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