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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
Study ID: STU-2022-0667
Summary
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. Pediatric subjects >=4 and <18 years of age will be enrolled in this study. Subjects will be randomly assigned in a 1:1 ratio to either the Afrezza group or the RAA injection group. The study is composed of (Figure S1): -Up to 4-week screening/run-in period -26-week randomized treatment period -26-week treatment extension -4-week follow-up period
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- PERRIN C WHITE
MANNKIND CORPORATION
Primary Objective: -To demonstrate that the efficacy of Afrezza is noninferior to rapid-acting insulin analog (RAA) injections, when both are in combination with a basal insulin, as measured by the change in glycated hemoglobin (HbA1c) from baseline to Week 26 in pediatric subjects ≥4 and <18 years of age with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) Secondary Objectives: Key Efficacy Objectives -To demonstrate that the efficacy of Afrezza is superior to RAA injections, when both are in combination with a basal insulin, as measured by change in fasting plasma glucose (FPG) from baseline to Week 26 -To demonstrate that the efficacy of Afrezza is superior to RAA injections, when both are in combination with a basal insulin, as measured by change in HbA1c from baseline to Week 26 -To demonstrate that the efficacy of Afrezza is superior to RAA injections, when both are in combination with a basal insulin, as measured by a lower event rate of pooled level 2 and level 3 hypoglycemia (SMBG <54 mg/dL and/or severe hypoglycemic events reported on the adverse event CRF) during the 26-week randomized treatment period
