Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
Primary Purpose
Hypoglycemia, Glucose Metabolism Disorders
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dasiglucagon
Dasiglucagon
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypoglycemia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Sequence 1
Sequence 2
Sequence 3
Sequence 4
Sequence 5
Sequence 6
Arm Description
Dasiglucagon high dose, followed by placebo, followed by dasiglucagon low dose
Dasiglucagn low dose, followed by dasiglucagon high dose, followed by placebo
Placebo, followed by dasiglucagon low dose, followed by dasiglucagon high dose
Dasiglucagon high dose, followed by dasiglucagon low dose, followed by placebo
Placebo, followed by dasiglucagon high dose, followed by dasiglucagn low dose
Dasiglucagon low dose, followed by placebo, followed by dasiglucagon high dose
Outcomes
Primary Outcome Measures
Nadir plasma glucose concentration
Secondary Outcome Measures
Percent time spent in hypoglycemia
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
Defined as time with a plasma glucose value of 54 mg/dL (3.0 mmol/L) or less
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)
Percent time spent in hyperglycemia
Defined as time with a plasma glucose value >180 mg/dL (>10 mmol/l)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04824872
Brief Title
Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Never started
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia, Glucose Metabolism Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Dasiglucagon high dose, followed by placebo, followed by dasiglucagon low dose
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Dasiglucagn low dose, followed by dasiglucagon high dose, followed by placebo
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
Placebo, followed by dasiglucagon low dose, followed by dasiglucagon high dose
Arm Title
Sequence 4
Arm Type
Experimental
Arm Description
Dasiglucagon high dose, followed by dasiglucagon low dose, followed by placebo
Arm Title
Sequence 5
Arm Type
Experimental
Arm Description
Placebo, followed by dasiglucagon high dose, followed by dasiglucagn low dose
Arm Title
Sequence 6
Arm Type
Experimental
Arm Description
Dasiglucagon low dose, followed by placebo, followed by dasiglucagon high dose
Intervention Type
Drug
Intervention Name(s)
Dasiglucagon
Intervention Description
dasiglucagon SC, low dose
Intervention Type
Drug
Intervention Name(s)
Dasiglucagon
Intervention Description
dasiglucagon SC, high dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo for dasiglucagon
Primary Outcome Measure Information:
Title
Nadir plasma glucose concentration
Time Frame
From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Secondary Outcome Measure Information:
Title
Percent time spent in hypoglycemia
Description
Defined as time with a plasma glucose value of 70 mg/dL (3.9 mmol/L) or less
Time Frame
From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Title
Percent time spent in clinical significant hypoglycemia
Description
Defined as time with a plasma glucose value of 54 mg/dL (3.0 mmol/L) or less
Time Frame
From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Title
Percent time spent in target range
Description
Defined as time with a plasma glucose value of 70-180 mg/dL (3.9-10.0 mmol/L)
Time Frame
From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Title
Percent time spent in hyperglycemia
Description
Defined as time with a plasma glucose value >180 mg/dL (>10 mmol/l)
Time Frame
From trial drug administration to 240 minutes after initiation of Mixed Meal Test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
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