MannKind Corporation has announced the initiation of the INHALE-1 study of its Afrezza insulin DPI in type 1 and type 2 diabetes patients aged 4-17. The initial 26-week trial will evaluate Afrezza plus basal insulin versus multiple injections of insulin daily and is expected to enroll approximately 260 patients. Following that portion of the trial, all of the subjects will be treated with Afrezza in a 26-week extension.
Afrezza was approved by the FDA for the treatment of Type 1 and Type 2 diabetes in adults in 2014. The dry powder insulin has also been approved in Brazil since 2019 and is sold there by Biomm.
MannKind VP, Medical Affairs and Safety, Kevin Kaiserman said, “We are pleased to announce enrollment has begun for the INHALE-1 Phase 3 study, which is designed to assess the safety and efficacy of Afrezza in young people living with type 1 or type 2 diabetes. MannKind is pleased to sponsor this study with the goal of bringing Afrezza to a younger generation.”
Read the MannKind Corporation press release.
