According to an announcement by the MannKind Corporation, the FDA has validated the design of two clinical studies for the company. These trials are meant to assess the safety and efficacy of insulin, AFREZZA(R), administered using MannKind’s next-generation inhaler. AFREZZA(R) is an experimental, ultra rapid-acting mealtime insulin therapy of human rDNA origin. The company was previously asked by the FDA to perform two clinical studies using the next-generation inhaler: one in patients with type 1 diabetes and the other in patients with type 2 diabetes. Of the two trials, at least one was expected to involve the MedTone inhaler treatment group to facilitate an equal comparison of the pulmonary safety data for both devices.
President and Chief Operating Officer Hakan Edstrom said, “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.
The study involves a run-in period wherein all patients will be optimized on their basal insulin schedule; subsequently, they will be assigned one of three treatment arms: a control arm, in which patients utilize injected rapid-acting insulin at mealtimes, or one of two AFREZZA arms, MedTone arm, and next-generation device arm.
The mealtime insulin is titrated. The primary endpoint, i.e., HbA1c levels, will be determined after an observation period of 12 weeks on stable doses of the mealtime insulin.
The evaluation of AFREZZA will be performed through Study 174 using the next-generation inhaler in patients whose type 2 diabetes is ineffectually controlled on metformin with or without a second or third oral medication. Patients will be randomized either to the AFREZZA treatment group or placebo arm. HbA1c levels will be evaluated after the study titration phase followed by a 12-week observation period.
Chairperson and Chief Executive Officer Alfred Mann added, “We are very encouraged and pleased with this outcome. Our attention now turns to the execution of these trials. 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.”