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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Withdrawn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
Zealand Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoglycemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 29, 2021
    Last Updated
    February 16, 2023
    Sponsor
    Zealand Pharma
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    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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