Site for INHALE-1: A 26-week Primary Treatment Phase with 26-week Extension Open-label Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza Versus Rapid-acting Insulin Analog Injections Both in Combination with a Basal Insulin in Pediatric Subjects with Type 1 or Type 2 Diabetes Mellitus

Brief description of study

Site for MKC-TI-155 Part 2 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart or insulin lispro in combination with a basal insulin (i.e., the RAA injection group) in pediatric subjects with T1DM or T2DM. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), subjects will enter a treatment extension where they will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza.


Clinical Study Identifier: s22-00359
ClinicalTrials.gov Identifier: NCT04974528
Principal Investigator: Mary Patricia Gallagher.


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