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

February 16, 2023 updated by: Zealand Pharma

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence 1
Dasiglucagon high dose, followed by placebo, followed by dasiglucagon low dose
Drug: Dasiglucagon
dasiglucagon SC, low dose
Drug: Dasiglucagon
dasiglucagon SC, high dose
Drug: Placebo
placebo for dasiglucagon
Experimental: Sequence 2
Dasiglucagn low dose, followed by dasiglucagon high dose, followed by placebo
Drug: Dasiglucagon
dasiglucagon SC, low dose
Drug: Dasiglucagon
dasiglucagon SC, high dose
Drug: Placebo
placebo for dasiglucagon
Experimental: Sequence 3
Placebo, followed by dasiglucagon low dose, followed by dasiglucagon high dose
Drug: Dasiglucagon
dasiglucagon SC, low dose
Drug: Dasiglucagon
dasiglucagon SC, high dose
Drug: Placebo
placebo for dasiglucagon
Experimental: Sequence 4
Dasiglucagon high dose, followed by dasiglucagon low dose, followed by placebo
Drug: Dasiglucagon
dasiglucagon SC, low dose
Drug: Dasiglucagon
dasiglucagon SC, high dose
Drug: Placebo
placebo for dasiglucagon
Experimental: Sequence 5
Placebo, followed by dasiglucagon high dose, followed by dasiglucagn low dose
Drug: Dasiglucagon
dasiglucagon SC, low dose
Drug: Dasiglucagon
dasiglucagon SC, high dose
Drug: Placebo
placebo for dasiglucagon
Experimental: Sequence 6
Dasiglucagon low dose, followed by placebo, followed by dasiglucagon high dose
Drug: Dasiglucagon
dasiglucagon SC, low dose
Drug: Dasiglucagon
dasiglucagon SC, high dose
Drug: Placebo
placebo for dasiglucagon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Nadir plasma glucose concentration
Time Frame: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
From trial drug administration to 240 minutes after initiation of Mixed Meal Test

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent time spent in hypoglycemia
Time Frame: 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
From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Percent time spent in clinical significant hypoglycemia
Time Frame: 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
From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Percent time spent in target range
Time Frame: 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)
From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Percent time spent in hyperglycemia
Time Frame: 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)
From trial drug administration to 240 minutes after initiation of Mixed Meal Test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zealand Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZP4207-20123

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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