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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Withdrawn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

Placebo

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

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

NCT ID

NCT04824872

First Posted

March 29, 2021

Last Updated

February 16, 2023

Sponsor

Zealand Pharma

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

Product Manufactured in and Exported from the U.S.

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

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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