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

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.

Timeline

Start

2006-08

Primary completion

2008-06

Completion

2008-06

Outcome

Met primary endpoint

paper AIR produced 0.20% greater A1C decrease than IG (least-squares mean difference = -0.20%; 95% confidence interval [CI], -0.39, -0.02). PMID 19772451 ↗

paper AIR + IG had a 0.35% greater A1C decrease versus IG (95% CI, -0.57, -0.13). PMID 19772451 ↗

Publications

• Results Rosenstock J, Eliaschewitz FG, Heilmann CR, Muchmore DB, Hayes RP, Belin RM. Comparison of prandial AIR inhaled insulin alone to intensified insulin glargine alone and to AIR insulin plus intensified insulin glargine in patients with type 2 diabetes previously treated with once-daily insulin glargine. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S63-73. doi: 10.1089/dia.2009.0059.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	human insulin	Protein / enzyme biologic	—	Inhaled
Subject	insulin glargine	Protein / enzyme biologic	—	Other

Indications