Enrollment Goal of INHALE-1 Ped Diabetes Trial
Feb 15, 2024 7:43:46 GMT -5
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Post by kite on Feb 15, 2024 7:43:46 GMT -5
investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-enrollment-goal-completion-inhale-1-pediatric?_gl=1*mrzq7d*_ga*MTY5NjI0MzcxMi4xNzA2ODExNzg3*_ga_4PG70PBDQW*MTcwNzk5NjMwNi4xOC4xLjE3MDc5OTYzMTEuNTUuMC4w&_ga=2.184854889.1728357004.1707759947-1696243712.1706811787
02/15/24
Reached enrollment goal of 305 patients living with Type 1 or Type 2 diabetes
Primary endpoint analysis expected in 4Q 2024
Data dissemination and FDA submission expected in 2025
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that it has fully enrolled 305 patients living with type 1 or type 2 diabetes in its INHALE-1 study assessing efficacy and safety of inhaled insulin in the pediatric population.
As reported by pediatric study investigator Lori Laffel, MD, MPH, “There remains a need for innovative insulin preparations to help manage glucose levels at mealtimes in children and adolescents living with diabetes.” Dr. Laffel is Chief of the Pediatric, Adolescent and Young Adult Section at Joslin Diabetes Center and Professor of Pediatrics at Harvard Medical School. Dr. Laffel goes on to note that “It is especially important that young people have as many treatment options as their adult counterparts with diabetes, and this trial has the potential to expand the treatment choices for children and adolescents living with diabetes.”
INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension. The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events. The multi-center study evaluated Afrezza in combination with basal insulin vs. multiple daily injections (MDI) of insulin in children and adolescents aged 4-17 who are living with type 1 or type 2 diabetes.
“We are excited to reach this milestone in exploring the potential of Afrezza for a younger generation living with diabetes,” said Dr. Kevin Kaiserman, Senior Vice President, Clinical Development and Medical Affairs for MannKind Corporation. “We expect to complete a primary endpoint analysis in the fourth quarter.”
More information on the study details is available at: www.clinicaltrials.gov/study/NCT04974528
02/15/24
Reached enrollment goal of 305 patients living with Type 1 or Type 2 diabetes
Primary endpoint analysis expected in 4Q 2024
Data dissemination and FDA submission expected in 2025
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that it has fully enrolled 305 patients living with type 1 or type 2 diabetes in its INHALE-1 study assessing efficacy and safety of inhaled insulin in the pediatric population.
As reported by pediatric study investigator Lori Laffel, MD, MPH, “There remains a need for innovative insulin preparations to help manage glucose levels at mealtimes in children and adolescents living with diabetes.” Dr. Laffel is Chief of the Pediatric, Adolescent and Young Adult Section at Joslin Diabetes Center and Professor of Pediatrics at Harvard Medical School. Dr. Laffel goes on to note that “It is especially important that young people have as many treatment options as their adult counterparts with diabetes, and this trial has the potential to expand the treatment choices for children and adolescents living with diabetes.”
INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension. The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events. The multi-center study evaluated Afrezza in combination with basal insulin vs. multiple daily injections (MDI) of insulin in children and adolescents aged 4-17 who are living with type 1 or type 2 diabetes.
“We are excited to reach this milestone in exploring the potential of Afrezza for a younger generation living with diabetes,” said Dr. Kevin Kaiserman, Senior Vice President, Clinical Development and Medical Affairs for MannKind Corporation. “We expect to complete a primary endpoint analysis in the fourth quarter.”
More information on the study details is available at: www.clinicaltrials.gov/study/NCT04974528