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Phase III Trial Evaluates Novel Insulin Inhalation Powder for Type 2 Diabetes
Follow-up visits have been completed for patients enrolled in a phase III trial of Afrezza (MannKind Corporation), an investigational inhalation powder consisting of human insulin for the treatment of type 2 diabetes. The ultra rapid-acting mealtime insulin therapy is administered via an inhaler. Findings from the study are expected to be released later this summer.
The trial assessed Afrezza in patients with type 2 diabetes whose disease was inadequately controlled with metformin, with or without a second or third oral medication. After a run-in period, during which the patients remained on their oral medication, 353 patients were randomly assigned to receive additional treatment with Afrezza or a placebo inhalation powder. The study also included a titration period, followed by a 12-week evaluation period, to assess hemoglobin A1c levels.
Administered at the start of a meal, Afrezza dissolves immediately upon inhalation and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of meal-time insulin observed in healthy individuals. To date, the Afrezza clinical program has involved more than 5,600 adult patients.
Source: MannKind Corporation; June 17, 2013.