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news.MannKind has finalized the design for two clinical trials to investigate its Afrezza (insulin human [rDNA origin]).
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Earlier, the FDA had requested the company to organize two clinical trials – in patients with type 1 diabetes and type 2 diabetes, with the company’s next-generation inhaler.
According to the criteria asked by the agency, at least one of the trials should include 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.
The first trial namely, Study 171 will evaluate Afrezza in patients suffering from type 1 diabetes, however the second trial will evaluate Afrezza using the next-generation inhaler in patients with type 2 diabetes who are inadequately controlled on metformin with or without a second or third oral medication.
MannKind chairman and CEO Alfred Mann said the protocol for Study 171 has already been sent to Institutional Review Boards and the protocol for Study 174 is being finalized and will be distributed to our sites shortly.