Mannkind Confirms Studies using Afrezza Insulin Threapy

More A Sweet Life Aug 12, 2011, 9:58 am

MannKind Corporation announced that it has confirmed with the U.S. Food and Drug Administration the design of two clinical studies that evaluate the efficacy and safety of AFREZZA (insulin human [rDNA origin]), an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind’s next-generation inhaler. The FDA had previously requested that MannKind conduct two clinical trials with the next-generation inhaler (one in patients with type 1 diabetes and one in patients with type 2 diabetes), with at least one trial including a treatment group using the previously studied MedTone inhaler in order to obtain a head-to-head comparison of the pulmonary safety data for the two devices.

Hakan Edstrom, President and Chief Operating Officer, reported that, “We held a successful meeting with the FDA yesterday, confirming the protocols for the type 1 and type 2 studies. We were also encouraged to proceed promptly with the initiation of both clinical trials.”

Study 171 is an open-label study in patients with type 1 diabetes. After a run-in period, during which all patients will be optimized on their basal insulin regimen, subjects will be randomized to one of three arms: a control arm, in which patients utilize injected rapid-acting insulin at mealtimes, or one of two AFREZZA arms, one each for the MedTone and next-generation device. After the mealtime insulin is titrated, there will be a 12-week observation period on stable doses of the mealtime insulin to assess HbA1c levels, which is the primary outcome parameter.

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  • Description: MannKind has confirmed with the U.S. FDA the design of two clinical studies to evaluate the efficacy and safety of AFREZZA, Inhaled ultra rapid-acting insulin therapy.