Postprandial hyperinsulinemic hypoglycaemia MedDRA version: 20.1 Level: LLT Classification code 10079748 Term: Reactive hypoglycaemia System Organ Class: 100000004861
Conditions
Interventions
Product Name: Dasiglucagon (4 mg/mL)
Product Code: ZP4207
Pharmaceutical Form: Injection
INN or Proposed INN: Dasiglucagon
CAS Number: 1544300-84-6
Concentration unit: mg/ml milligram(s)/millilitre
Co
Sponsors
Center for Clinical Metabolic Research at Herlev-Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Documented postprandial hypoglycaemia (IG 7.3 mmol/l and for men >8.3 mmol/l - Ferritin >10 µg/l - Cobalamin >150 pmol/l - Fasting plasma glucose concentration within the range of 4.0–6.0 mmol/l - Normal electrocardiogram (ECG) - Negative urine human chorionic gonadotropin (hCG) (for fertile women) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Treatment with medication(s) affecting insulin secretion, glucose metabolism or any antidiabetic drugs - Treatment with antipsychotics - Current participation in another clinical trial with administration of investigational drug - Previous exposure to dasiglucagon (also known as ZP4207) within the last 30 days prior screening - History of liver disease that is expected to interfere with the anti-hypoglycaemic action of glucagon (e.g. liver failure or cirrhosis) - Pregnancy - Breastfeeding - Major surgery within 30 days before screening - Alcohol abuse (per investigator assessment) - Any factors that, in the opinion of the site principal investigator or clinical protocol chair, would interfere with the safe completion of the study, including medical conditions that may require hospitalization during the trial - History of pheochromocytoma or insulinoma - History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients - Known or suspected allergies to glucagon or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the study is to compare the effects of self-administered 120 µg dasiglucagon versus placebo (during postprandial hypoglycaemia) on CGM-assessed time spent in hypoglycaemia in RYGB-operated individuals in an out-patient setting.;Primary end point(s): The primary endpoint is the percentage of time in hypoglycaemia (IG <3.9 mmol/l) assessed by CGM during the out-patient part. ;Timepoint(s) of evaluation of this end point: After all patients have completed the study and samples are analysed.;Secondary Objective: Secondary aims are to evaluate the effects of self-administered 120 µg dasiglucagon versus placebo on CGM-assessed incidences of serious hypoglycaemia (<3.0 mmol/l), blood glucose (BG) recovery, symptomatic recovery, glucose peak and nadir concentrations and glycaemic variability compared to placebo treatment. Moreover, we aim to examine the effects of dasiglucagon treatment on hypoglycaemic symptoms, fear of hypoglycaemia and quality of life (QoL) using standardised questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints during out-patient part: • Recovery of BG 15 minutes after administration (as measured by finger prick (BG >3.9 mmol/l)) • Change in QoL as assed by EORTC-QLQ-PAN26 • Change in hypoglycaemic symptoms will be evaluated after dosing by Edinburgh Hypoglycaemia Symptom Scale (EHSS) • Change in fear of hypoglycaemia as assessed by Hypoglycaemia Fear Scale • Change in administration frequency (as measured by percentage) All the following in-patient part endpoints refers to the difference between placebo- and treatment arm (dasiglucagon 120 µg). Secondary endpoints from the in-patient part of the study are: • The key secondary endpoint of the in-patient part is the mean nadir plasma glucose compromised three concurrently glucose measurements during the 240-minute MMT • Recovery of BG 15 minutes after administration (as measured by finger prick (BG >3.9 mmol/l)) • Time spent in level 1 and level 2 hypoglycaemia (7.8 mmol/l, respectively) from study drug administration until 240 minutes • Peak plasma glucose concentration after study drug administration • Changes in plasma / serum concentrations of insulin, C-peptide, glucagon, glucagon-like peptide 1, glucagon-like peptide 2, glucose-dependent insulinotropic polypeptide, epinephrine, norepinephrine, growth hormone and cortisol measured as area under the curve (AUC) and / or incremental (iAUC) as appropriate, peak values and values at nadir plasma glucose concentration • Changes in heart rate and blood pressure Safety endpoints include: • Frequency and severity of adverse events (AE)s and serious adverse events (SAE)s during the in-patient part MMTs and the out-patient part • Percentage (%) of subjects with treatment-induced or treatment-boosted anti-dasiglucagon antibodies Device endpoint: • Device failures/ malfunctions occurring during the trial. ;Timepoint(s) of evaluation of this end point: After all patients have completed the study and samples are analysed. | — |
Countries
Denmark
Contacts
Public ContactHerlev-Gentofte Hospital
Center for Clinical Metabolic Research at Gentofte Hospital
Outcome results
None listed