Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 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: | June 2008 |
A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients With Type 2 Diabetes Treated With Once-Daily Insulin Glargine
A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder [also known as
AIR® Inhaled Insulin][AIR® is a registered trademark of Alkermes,Inc.] in patients with Type
2 diabetes who are currently being treated with once daily insulin glargine injections. The
present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily
insulin glargine injections.
AIR® Inhaled Insulin][AIR® is a registered trademark of Alkermes,Inc.] in patients with Type
2 diabetes who are currently being treated with once daily insulin glargine injections. The
present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily
insulin glargine injections.
Inclusion Criteria:
- type 2 diabetes mellitus
- one or more oral antihyperglycemic medications
- once-daily insulin glargine
- HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
- Non-smoker
Exclusion Criteria:
- taking a TZD dose greater than what is indicated
- more than two episodes of severe hypoglycemia during the 6 months prior
- Have had a lower respiratory infection in the 3 months prior
- systemic glucocorticoid therapy
- clinical signs or symptoms of liver disease, acute or chronic hepatitis
- history of renal transplantation
- Have an active or untreated malignancy
- Require more than 150 U/day of insulin glargine
We found this trial at
25
sites
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