Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Alkermes, Inc.
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

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