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

Sponsor

Zealand Pharma (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04824872

Collaborator

(none)

Enrollment

Arms

10.1

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hypoglycemia Glucose Metabolism Disorders	Drug: Dasiglucagon Drug: Dasiglucagon Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Nadir plasma glucose concentration [From trial drug administration to 240 minutes after initiation of Mixed Meal Test]

Secondary Outcome Measures

Percent time spent in hypoglycemia [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
Percent time spent in clinical significant hypoglycemia [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
Percent time spent in target range [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)
Percent time spent in hyperglycemia [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Zealand Pharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zealand Pharma

ClinicalTrials.gov Identifier:

NCT04824872

Other Study ID Numbers:

ZP4207-20123

First Posted:

Apr 1, 2021

Last Update Posted:

Apr 1, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Hypoglycemia

Metabolic Diseases

Glucose Metabolism Disorders

Study Results

No Results Posted as of Apr 1, 2021