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

Phase 2

Withdrawn

• Conditions: Hypoglycemia; Glucose Metabolism Disorders
• Interventions: Drug: Dasiglucagon; Drug: Placebo

• Registration Number: NCT04824872
• Lead Sponsor: Zealand Pharma

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Status Verified: 2023-02
• Study Start: 2023-02
• Primary Completion: 2023-02
• Study Completion: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 6	Placebo	Dasiglucagon low dose, followed by placebo, followed by dasiglucagon high dose
Sequence 1	Placebo	Dasiglucagon high dose, followed by placebo, followed by dasiglucagon low dose
Sequence 3	Placebo	Placebo, followed by dasiglucagon low dose, followed by dasiglucagon high dose
Sequence 5	Placebo	Placebo, followed by dasiglucagon high dose, followed by dasiglucagn low dose
Sequence 2	Placebo	Dasiglucagn low dose, followed by dasiglucagon high dose, followed by placebo
Sequence 4	Placebo	Dasiglucagon high dose, followed by dasiglucagon low dose, followed by placebo
Sequence 1	Dasiglucagon	Dasiglucagon high dose, followed by placebo, followed by dasiglucagon low dose
Sequence 4	Dasiglucagon	Dasiglucagon high dose, followed by dasiglucagon low dose, followed by placebo
Sequence 2	Dasiglucagon	Dasiglucagn low dose, followed by dasiglucagon high dose, followed by placebo
Sequence 3	Dasiglucagon	Placebo, followed by dasiglucagon low dose, followed by dasiglucagon high dose
Sequence 5	Dasiglucagon	Placebo, followed by dasiglucagon high dose, followed by dasiglucagn low dose
Sequence 6	Dasiglucagon	Dasiglucagon low dose, followed by placebo, followed by dasiglucagon high dose

Primary Outcome Measures

Name	Time	Method
Nadir plasma glucose concentration	From trial drug administration to 240 minutes after initiation of Mixed Meal Test

Secondary Outcome Measures

Name	Time	Method
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)