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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
Recruiting
To assess the safety of Afrezza in a pediatric population when compared to the usual standard of care insulin.
Male or Female
Up to 18 years old
Inclusion Criteria:
• 4 years to under 18 years old
• diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM)
• using insulin for at least 6 months for T1DM, or at least 3 months for T2DM
• treated with basal-bolus insulin therapy delivered by multiple daily injections for at least 2 weeks
• bolus insulins are restricted to the RAAs insulin lispro, insulin aspart or insulin glulisine, including biosimilar products
• basal insulins are restricted to insulin glargine, insulin degludec or insulin detemir, including biosimilar products
• HbA1c between 7.0% and 11%
• average prandial dose of insulin 2 or more units per meal
• used CGM for at least 70% of the time over a consecutive 14-day period before starting the study
• access to stable WiFi connection
Exclusion Criteria:
• history of recent blood transfusions (within previous 3 months)
• recent history of asthma (defined as using any medications to treat within the last year) or any other clinically important lung disease
• history of serious complications of diabetes
• any other illness that isn't stable (study staff will review)
• uncontrolled eating disorder (e.g., anorexia or bulimia nervosa)
• current drug or alcohol abuse or a history of drug or alcohol abuse
• smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) for the preceding 6 months
Diabetes & Endocrine
diabetes, insulin, type 1 diabetes, type 2 diabetes
Shannon Beasley - beasl103@umn.edu
Muna Sunni
PHASE3
SITE00001625
See this study on ClinicalTrials.gov