ZP4207-17109 Phase 3- Studie bei angeborenem Hyperinsulinismus)

This is a 2-period, open-label study to evaluate the efficacy and safety of dasiglucagon in children between the ages of 3 months and 12 years. Patients are to have undergone near-total pancreatectomy and have a documented HbA1c = 7% or be diagnosed with diffuse CHI treated with a non-surgical approach. To qualify for participation, patients are to experience 3 or more events of hypoglycaemia per week (plasma glucose < 70 mg/dL) and have an absolute need for supplementary gastric glucose infusions despite standard of care (SOC) medications.

The purpose of this trial is to evaluate whether dasiglucagon can reduce the number and severity of hypoglycaemic episodes. To use a minimally invasive yet objective method of assessing the frequency of hypoglycaemia, patients will be required to wear a continuous glucose monitoring (CGM) device from enrollment (Day 0) through the end of treatment (Week 8). During both treatment periods, patients will have CGM performed and results will be masked. Patients will furthermore be asked to wear the CGM for 2-4 weeks in the screening period. This is done to establish a solid baseline for hypo rates and correct for variation between patients.