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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2023-02-28

Brief Summary

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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

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Detailed Description

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Conditions

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Hypoglycemia Glucose Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sequence 1

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

Group Type EXPERIMENTAL

Dasiglucagon

Intervention Type DRUG

dasiglucagon SC, low dose

Dasiglucagon

Intervention Type DRUG

dasiglucagon SC, high dose

Placebo

Intervention Type DRUG

placebo for dasiglucagon

Sequence 2

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

Group Type EXPERIMENTAL

Dasiglucagon

Intervention Type DRUG

dasiglucagon SC, low dose

Dasiglucagon

Intervention Type DRUG

dasiglucagon SC, high dose

Placebo

Intervention Type DRUG

placebo for dasiglucagon

Sequence 3

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

Group Type EXPERIMENTAL

Dasiglucagon

Intervention Type DRUG

dasiglucagon SC, low dose

Dasiglucagon

Intervention Type DRUG

dasiglucagon SC, high dose

Placebo

Intervention Type DRUG

placebo for dasiglucagon

Sequence 4

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

Group Type EXPERIMENTAL

Dasiglucagon

Intervention Type DRUG

dasiglucagon SC, low dose

Dasiglucagon

Intervention Type DRUG

dasiglucagon SC, high dose

Placebo

Intervention Type DRUG

placebo for dasiglucagon

Sequence 5

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

Group Type EXPERIMENTAL

Dasiglucagon

Intervention Type DRUG

dasiglucagon SC, low dose

Dasiglucagon

Intervention Type DRUG

dasiglucagon SC, high dose

Placebo

Intervention Type DRUG

placebo for dasiglucagon

Sequence 6

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

Group Type EXPERIMENTAL

Dasiglucagon

Intervention Type DRUG

dasiglucagon SC, low dose

Dasiglucagon

Intervention Type DRUG

dasiglucagon SC, high dose

Placebo

Intervention Type DRUG

placebo for dasiglucagon

Interventions

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Dasiglucagon

dasiglucagon SC, low dose

Intervention Type DRUG

Dasiglucagon

dasiglucagon SC, high dose

Intervention Type DRUG

Placebo

placebo for dasiglucagon

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No