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Trial · Interventional

WithdrawnPhase 2Registry data

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

NCTNCT04824872 (opens ClinicalTrials.gov in a new tab)Other idZP4207-20123
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 2
Enrollment
0 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Randomized · Quadruple masking
Countries
Not stated
Start
Feb 2023 (estimated)
Primary completion
Feb 2023 (estimated)
Completion
Feb 2023 (estimated)
First posted
1 Apr 2021
Last update posted
21 Feb 2023
Conditions
Hypoglycemia · Glucose Metabolism Disorders

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024
  1. Ph 2

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

    NCT04824872

    est. Feb 2023 to est. Feb 2023

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • DasiglucagonDrug
  • DasiglucagonDrug
  • PlaceboDrug

Arms6

  • Experimental

    Sequence 1

    Dasiglucagon high dose, followed by placebo, followed by dasiglucagon low dose

  • Experimental

    Sequence 2

    Dasiglucagn low dose, followed by dasiglucagon high dose, followed by placebo

  • Experimental

    Sequence 3

    Placebo, followed by dasiglucagon low dose, followed by dasiglucagon high dose

  • Experimental

    Sequence 4

    Dasiglucagon high dose, followed by dasiglucagon low dose, followed by placebo

  • Experimental

    Sequence 5

    Placebo, followed by dasiglucagon high dose, followed by dasiglucagn low dose

  • Experimental

    Sequence 6

    Dasiglucagon low dose, followed by placebo, followed by dasiglucagon high dose

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Nadir plasma glucose concentration

    Time frame · From trial drug administration to 240 minutes after initiation of Mixed Meal Test

Secondary outcomes(4)

  1. Percent time spent in hypoglycemia

    Time frame · From trial drug administration to 240 minutes after initiation of Mixed Meal Test

    Registry description

    Defined as time with a plasma glucose value of 70 mg/dL (3.9 mmol/L) or less

  2. Percent time spent in clinical significant hypoglycemia

    Time frame · From trial drug administration to 240 minutes after initiation of Mixed Meal Test

    Registry description

    Defined as time with a plasma glucose value of 54 mg/dL (3.0 mmol/L) or less

  3. Percent time spent in target range

    Time frame · From trial drug administration to 240 minutes after initiation of Mixed Meal Test

    Registry description

    Defined as time with a plasma glucose value of 70-180 mg/dL (3.9-10.0 mmol/L)

  4. Percent time spent in hyperglycemia

    Time frame · From trial drug administration to 240 minutes after initiation of Mixed Meal Test

    Registry description

    Defined as time with a plasma glucose value \>180 mg/dL (\>10 mmol/l)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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