A Randomized, Double-blind, Parallel-group Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Rescue Treatment of Hypoglycemia in Subjects With Type 1 Diabetes Mellitus (T1DM) Compared to Placebo
Latest Information Update: 04 Jun 2024
At a glance
- Drugs Dasiglucagon (Primary)
- Indications Hypoglycaemia; Type 1 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Sponsors Zealand Pharma
Most Recent Events
- 31 May 2024 According to a Zealand Pharma media release, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for dasiglucagon solution for injection in the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus based in the results of 3 phase3 pivotal trials in adults and children with diabetes.
- 26 Jun 2023 According to a Zealand Pharma media release, the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for dasiglucagon injection for the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus.
- 01 Oct 2021 Results assessing efficacy and safety of dasiglucagon when administered via an autoinjector device published in the Diabetes, Obesity and Metabolism