Zealand Pharma A/S said its experimental medicine dasiglucagon worked as well as an existing therapy in treating low glucose levels in children and adolescents with type 1 diabetes.
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The Danish biotechnology company was evaluating dasiglucagon in a late-stage trial as a rescue treatment for severe hypoglycemia in 42 patients. The condition causes one's glucose levels to drop, mainly because of injecting insulin multiple times daily.
The trial compared dasiglucagon against placebo and GlucaGen, a peptide-based medicine which is marketed specifically to target severe hypoglycemia.
Dasiglucagon shot up sugar levels in patients in 10 minutes, the same as GlucaGen and higher than the placebo's 30 minutes. "This study in children with diabetes keeps us on track for submitting the new drug application to the U.S. FDA in early 2020," Adam Steensberg, Zealand Pharma's chief medical and development officer and an executive vice president, said in a press note.
Dasiglucagon is being developed as HypoPal rescue pen, an auto-injector for easy, fast and effective treatment of severe hypoglycemia in people with diabetes.
This is the fourth consecutive phase 3 trial with positive results for dasiglucagon. Earlier this year, the company announced results from a late-stage study which showed dasiglucagon successfully increased blood sugar levels in adult diabetes patients within 10 minutes.
Meanwhile, previous immunogenicity and pivotal phase 3 trials established the drug's safety profile and fast onset of action when administered via a pre-filled syringe in adult patients with type 1 diabetes.

