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Trial · Interventional

CompletedPhase 2Registry data

Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass

NCTNCT03984370 (opens ClinicalTrials.gov in a new tab)Other idCKN-DASI-RYGBOther id2019-001915-22Other id2019
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
10 participants (actual)
Sponsor
University Hospital, Gentofte, Copenhagen · Other
Design
Randomized · Double masking
Countries
1 country

Denmark

Start
18 Sept 2019
Primary completion
26 Feb 2020
Completion
26 Feb 2020
First posted
13 Jun 2019
Last update posted
31 Mar 2020
Conditions
Hyperinsulinemic Hypoglycemia · Postprandial Hypoglycemia

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 2

    Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass

    NCT03984370

    18 Sept 2019 to 26 Feb 2020

Registry summary

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

The aim of this study is investigating the effect of a novel glucagon analogue administration in gastric bypass operated individuals, who are reactive hypoglycemic.

Interventions

  • ZP4207Drug
  • Placebo (saline)Other

Arms3

  • Experimental

    80 ug of sc dasiglucagon

    80 ug of dasiglucagon in a 0.4 mL fluid (saline) is injected abdominal subcutaneous postprandial prior to hypoglycemia.

  • Experimental

    200 ug of sc dasiglucagon

    200 ug of dasiglucagon in a 0.4 mL fluid (saline) is injected abdominal subcutaneous postprandial prior to hypoglycemia.

  • Placebo comparator

    0.4 mL of sc saline (placebo)

    0.4 mL fluid (saline/placebo) is injected abdominal subcutaneous postprandial prior to hypoglycemia.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Nadir plasma glucose concentration within two hundred forty minutes after MMT

    Time frame · Two hundred forty minutes

    Registry description

    Nadir plasma glucose concentration within two hundred forty minutes after MMT

Secondary outcomes(8)

  1. Time from dasiglucagon administration to recovery (first plasma glucose value above the fasting plasma glucose level

    Time frame · Two hundred forty minutes

    Registry description

    Time from dasiglucagon administration to recovery (first plasma glucose value above the fasting plasma glucose level

  2. Time in hypoglycaemia (plasma glucose concentration <3.9 mmol/l) from study drug administration until 240 minutes

    Time frame · Two hundred forty minutes

    Registry description

    Time in hypoglycaemia

  3. Time below fasting plasma glucose level from study drug administration until two hundred forty minutes

    Time frame · Two hundred forty minutes

    Registry description

    Time below fasting plasma glucose level

  4. Area 1: the area above the glucose curve and below the fasting level from the time of study drug administration until glucose values reach the fasting level.

    Time frame · Two hundred forty minutes

    Registry description

    Area 1

  5. Area 2: the area below the glucose curve and above the fasting level from the time glucose values reach the fasting level until 240 minutes.

    Time frame · Two hundred forty minutes

    Registry description

    Area 2

  6. Edinburgh Hypoglycaemia Symptom Scale (EHSS) responses of the Edinburgh Hypoglycaemia Symptom Scale (EHSS) and early dumping symptoms based on

    Time frame · t=zero to t=Two hundred forty minutes

    Registry description

    likert scale one (absent) to seven (severe)

  7. The Dumping Severity Score (DSS).

    Time frame · t=zero to t=Two hundred forty minutes

    Registry description

    likert scale, zero (absent) to three (severe)

  8. Frequency and severity of adverse events and serious adverse events recorded during the meal test

    Time frame · from t= minus thirty to t=Two hundred forty minutes

    Registry description

    Frequency

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.

Completed trials do not always post results.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

4 results

Dasiglucagon Effectively Mitigates Postbariatric Postprandial Hypoglycemia: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial.

Nielsen et al. 2022Diabetes carecited by 13

PMID 35320361DOI 10.2337/dc21-2252PUB-35320361

Rights unknown4 results
Source linkSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Documented postprandial hypoglycaemia (\<3.9 mmol/l) by 6-day CGM or during a MMT * Documented plasma glucose concentration excursions \>5.0 mmol/l by 6-day CGM or a MMT * Haemoglobin levels for women \>7.3 mmol/l and for men \>8.3 mmol/l * Ferritin \>10 μg/l * Cobalamin \>150 pmol/l * Fasting plasma glucose concentration within the range of 4.0-6.0 mmol/l CKN-DASI-RYGB protocol version 1.0 6 * Normal electrocardiogram (ECG) * Negative urine human chorionic gonadotropin (hCG) (for fertile women) Exclusion Criteria: * Treatment with medication(s) affecting insulin secretion or any antidiabetic drugs * Treatment with antipsychotics * Current participation in another clinical trial with administration of investigational drug. * Previous exposure to dasiglucagon (otherwise known as ZP4207) * History of liver disease that is expected to interfere with the anti-hypoglycaemic action of glucagon (e.g. liver failure or cirrhosis). * Pregnancy * Breastfeeding * Any factors that, in the opinion of the site principal investigator or clinical protocol chair, would interfere with the safe completion of the study, including medical conditions that may require hospitalization during the trial or allergy to the ingredients in the study drug.

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