Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

Hypoglycemia Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Cross-over Trial, Evaluating Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04824872
• Other study ID #: ZP4207-20123
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2023
• Est. completion date: February 2023

Study information

• Verified date: February 2023
• Source: Zealand Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß-blocker therapy
• Clinically significant ECG abnormalities at screening

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Hypoglycemia
• Metabolic Diseases

Intervention

Drug:
• Dasiglucagon
dasiglucagon SC, low dose
• Dasiglucagon
dasiglucagon SC, high dose
• Placebo
placebo for dasiglucagon

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zealand Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nadir plasma glucose concentration		From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Secondary	Percent time spent in hypoglycemia	Defined as time with a plasma glucose value of 70 mg/dL (3.9 mmol/L) or less	From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Secondary	Percent time spent in clinical significant hypoglycemia	Defined as time with a plasma glucose value of 54 mg/dL (3.0 mmol/L) or less	From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Secondary	Percent time spent in target range	Defined as time with a plasma glucose value of 70-180 mg/dL (3.9-10.0 mmol/L)	From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Secondary	Percent time spent in hyperglycemia	Defined as time with a plasma glucose value >180 mg/dL (>10 mmol/l)	From trial drug administration to 240 minutes after initiation of Mixed Meal Test