Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes

Summary

Primary objective to evaluate the effect of a 12-week treatment period with prandial administration of Technosphere Insulin on glucose control in subjects with T2 DM. Secondary objective is to Evaluate the safety and tolerability of a 12-week treatment period of Technosphere Insulin and Technosphere Placebo.

Timeline

Start

2003-12

Primary completion

2004-11

Completion

2005-12

Outcome

Met primary endpoint

paper A1C reduction from a mean baseline of 7.9% was greater with Technosphere insulin than with Technosphere powder (-0.72 vs. -0.30%; P = 0.003). PMID 18678610 ↗

Publications

• Rosenstock J, Bergenstal R, Defronzo RA, Hirsch IB, Klonoff D, Boss AH, Kramer D, Petrucci R, Yu W, Levy B; 0008 Study Group. Efficacy and safety of Technosphere inhaled insulin compared with Technosphere powder placebo in insulin-naive type 2 diabetes suboptimally controlled with oral agents. Diabetes Care. 2008 Nov;31(11):2177-82. doi: 10.2337/dc08-0315. Epub 2008 Aug 4.

Drugs

Indications