Trial Profile
A Phase 3, Randomized, Double-blind, Parallel Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in Rescue Treatment of Hypoglycemia in Subjects With Type 1 Diabetes Mellitus Compared to Placebo and With Reference to GlucaGen
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 29 Jun 2023
Price :
$35
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At a glance
- Drugs Dasiglucagon (Primary) ; Glucagon; Insulin glulisine
- Indications Hypoglycaemia; Type 1 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Sponsors Zealand Pharma
- 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.
- 29 Jun 2021 Results (n=253) of three randomized, placebo-controlled phase 3 trials (2 in adults and 1 in pediatric subjects), presented at the 81st Annual Scientific Sessions of the American Diabetes Association
- 03 May 2021 According to a Zealand Pharma media release, results from this trial were published in the Diabetes Care.