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
L
Linda DiMeglio, MD
Primary Investigator
Not Recruiting
4 years - 18 years
All
Phase
3
5 Locations
Brief description of study
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)
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: diabetes
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Age: 4 years - 18 years
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Gender: All
Updated on
01 Aug 2024.
Study ID: PENDO-MANNKIND-INHALE-1, 12681, TX11423
