After enduring challenges earlier this year that left most companies running for the exits, the inhaled insulin market showed some lingering signs of life last month when MannKind Corp., virtually the only company now left in the game, released preliminary results from the first of three pivotal, Phase III clinical trials of its Technosphere Insulin System. (See "Inhaled Insulin’s Death Knell?," Medtech Insight, May 2008 Also see "Market & Industry Briefs" - Medtech Insight, 1 May, 2008..) The study, comparing the safety and effectiveness of prandial Technosphere inhaled insulin versus prandial subcutaneous insulin injections, found that A1C levels decreased comparatively in the two treatment groups over a 52-week follow-up period. The between-group difference of -0.24% (95% confidence interval: -0.09% to -0.40%) did not exceed the predetermined threshold of 0.40%, thus the study met its noninferiority endpoint.
The 565-patient study, conducted in the US, Europe, and Latin America, randomized 293 patients with type 1 diabetes to prandial Technosphere Insulin (TI) and 272 patients to prandial insulin aspart...
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