Hypoglycemia, Glucose Metabolism Disorders
Conditions
Brief summary
The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects
Interventions
DRUGDasiglucagon
dasiglucagon SC, low dose
DRUGPlacebo
placebo for dasiglucagon
Sponsors
Zealand Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Previously undergone Roux-en-Y gastric bypass (RYGB) surgery at least 6 months prior to screening * Previous diagnosis of post-bariatric hypoglycemia (PBH), requiring intake of oral carbohydrates. * Body mass index (BMI) ≤ 40 kg/m2 * Fasting plasma glucose between 72-106 mg/dL (4.0-6.0 mmol/l)
Exclusion criteria
* History of hypersensitivity reactions to glucagon or dasiglucagon or any of the excipients * History of insulinoma, pheochromocytoma, MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease. * Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m2 or end-stage renal disease at screening * Hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase ≥ 2.5 times the upper limit of normal (ULN) * Active malignancy, except for basal or squamous cell skin cancers * History of a cerebrovascular accident within 6 months prior to screening * History of myocardial infarction, unstable angina, or revascularization within 6 months prior to screening. * Congestive heart failure, New York Heart Association Class III or IV * Concurrent administration of β-blocker therapy * Clinically significant ECG abnormalities at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nadir plasma glucose concentration | From trial drug administration to 240 minutes after initiation of Mixed Meal Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent time spent in hyperglycemia | From trial drug administration to 240 minutes after initiation of Mixed Meal Test | Defined as time with a plasma glucose value \>180 mg/dL (\>10 mmol/l) |
| Percent time spent in hypoglycemia | From trial drug administration to 240 minutes after initiation of Mixed Meal Test | Defined as time with a plasma glucose value of 70 mg/dL (3.9 mmol/L) or less |
| Percent time spent in clinical significant hypoglycemia | From trial drug administration to 240 minutes after initiation of Mixed Meal Test | Defined as time with a plasma glucose value of 54 mg/dL (3.0 mmol/L) or less |
| Percent time spent in target range | From trial drug administration to 240 minutes after initiation of Mixed Meal Test | Defined as time with a plasma glucose value of 70-180 mg/dL (3.9-10.0 mmol/L) |
Outcome results
None listed