Treatment of Post-bariatric Hypoglycaemia

Short name SHERRY

NCTNCT04836273Other idCKN-DASI120-RYGBOther id2020-005241-16

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 24 participants (actual)
Sponsor: Filip Krag Knop · Other
Design: Randomized · Double masking
Countries: 1 country
Denmark
Start: 20 Aug 2021
Primary completion: 15 May 2022
Completion: 15 Dec 2022
First posted: 8 Apr 2021
Last update posted: 2 Feb 2023
Conditions: Hyperinsulinemic Hypoglycemia · Postprandial Hypoglycemia

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202120222023

Ph 2
SHERRY
NCT04836273
20 Aug 2021 to 15 Dec 2022

Registry summary

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

This is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, single-centre phase II study aiming to evaluate the efficacy, safety and tolerability of self-administered subcutaneous 120 µg dasiglucagon with an investigational trial device (i.e. a multi-dose reusable pen) for the treatment of postprandial hypoglycaemia after Roux-en-Y gastric bypass (RYGB) surgery. The study is divided into an in-patient and out-patient part. The primary aim of the study is to compare the effects of self-administered 120 µg dasiglucagon versus placebo on continuous glucose monitoring (CGM)-assessed time spent in hypoglycaemia in RYGB-operated individuals in an out-patient setting.

Interventions

DasiglucagonDrug
HyoPenDevice
PlaceboDrug

Arms2

Experimental
120 µg dasiglucagon
Subcutaneous 120 µg dasiglucagon self-administration
Placebo comparator
Placebo
Subcutaneous placebo self-administration

Primary outcomes1

Outcomes the sponsor listed as primary.

Time spent in hypoglycaemia (IG < 3.9 mmol)
Time frame · During the four weeks of placebo and dasiglucagon treatment.
Registry description
The primary endpoint is the percentage of time in hypoglycaemia (IG \<3.9 mmol/l) assessed by CGM during the out-patient part.

Secondary outcomes(20)

Time (percent or minutes) spent in serious hypoglycaemia (IG <3.0 mmol/l)
Time frame · During the four weeks of placebo and dasiglucagon treatment.
Frequency of hypoglycaemic events (IG <3.9 mmol/l and <3.0 mmol/l, respectively)
Time frame · During the four weeks of placebo and dasiglucagon treatment.
Glycaemic time in range defined as: 1) hypoglycaemia (<3.9 mmol/l), 2) normoglycaemia (3.9-10.0 mmol/l), and 3) hyperglycaemia (>10.0 mmol/l)
Time frame · During the four weeks of placebo and dasiglucagon treatment.
Frequency of hyperglycaemic events (IG >7.8 mmol/l and >10.0 mmol/l, respectively)
Time frame · During the four weeks of placebo and dasiglucagon treatment.
Glycaemic variability assessed as coefficient of variance (CV)
Time frame · During the four weeks of placebo and dasiglucagon treatment.
Glycaemic variability assessed as standard deviation (SD)
Time frame · During the four weeks of placebo and dasiglucagon treatment.
Recovery of BG 15 minutes after trial drug administration (as measured by finger prick (BG >3.9 mmol/l))
Time frame · During the four weeks of placebo and dasiglucagon treatment.
Change in QoL as assessed by the World Health Organization's quality of life assessment (WHOQOL-BREF)
Time frame · During the four weeks of placebo and dasiglucagon treatment.
Registry description
likert scale, zero (very poor) to five (very good)
Change in hypoglycaemic symptoms will be evaluated by Edinburgh Hypoglycaemia Symptom Scale (EHSS)
Time frame · During the four weeks of placebo and dasiglucagon treatment.
Registry description
likert scale, zero (not a all) to seven (a lot)
Change in fear of hypoglycaemia as assessed by Hypoglycaemia Fear Scale (HFS-II)
Time frame · During the four weeks of placebo and dasiglucagon treatment.
Registry description
likert scale, zero (never) to four (always)
Change in administration frequency (as measured by percentage)
Time frame · During the four weeks of placebo and dasiglucagon treatment.
Nadir plasma glucose as assessed both as 1) absolute lowest value, and 2) a mean of three consecutive glucose measurements during the 240-minute MMT
Time frame · Two hundred forty minutes of mixed meal test
Registry description
Nadir plasma glucose after the postprandial peak during the MMT in the in-patient part
Recovery of BG 15 minutes after administration (as measured by finger prick (BG >3.9 mmol/l))
Time frame · Two hundred forty minutes of mixed meal test
Registry description
After the postprandial peak during the MMT in the in-patient part
Time spent in level 1 and level 2 hypoglycaemia (<3.9 and <3.0 mmol/l, respectively) from study drug administration until 240 minutes
Time frame · Two hundred forty minutes of mixed meal test
Registry description
After the postprandial peak during the MMT in the in-patient part
Glycaemic rescue intervention due to critically low plasma glucose concentration (<1.8 mmol/l)
Time frame · Two hundred forty minutes of mixed meal test
Registry description
During the MMT in the in-patient part
Time spent in hyperglycaemia (>7.8 mmol/l) from study drug administration until 240 minutes
Time frame · Two hundred forty minutes of mixed meal test
Registry description
During the MMT in the in-patient part
Peak plasma glucose concentration after study drug administration
Time frame · Two hundred forty minutes of mixed meal test
Registry description
During the MMT in the in-patient part
Counter-regulatory hormonal response
Time frame · Two hundred forty minutes of mixed meal test
Registry description
Measured as area under the curve (AUC) and / or incremental (iAUC) as appropriate, peak values and values at nadir plasma glucose concentration during the MMT in the in-patient part. glucagon-like peptide 1 (GLP-1), glucagon-like peptide 2 (GLP-2), glucose-dependent insulinotropic polypeptide (GIP)
Changes in blood pressure
Time frame · Two hundred forty minutes of mixed meal test
Registry description
During the MMT in the in-patient part
Changes in heart rate
Time frame · Two hundred forty minutes of mixed meal test
Registry description
During the MMT in the in-patient part

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

Studies0

Studies that cite this trial.

No study cites this trial.

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 (IG \<3.9 mmol/l, ≥3 times/week) assessed by 14-days of blinded CGM recording * 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 * Normal electrocardiogram (ECG) * Negative urine human chorionic gonadotropin (hCG) (for fertile women) Exclusion Criteria: * Treatment with medication(s) affecting insulin secretion, glucose metabolism or any antidiabetic drugs * Treatment with antipsychotics * Current participation in another clinical trial with administration of investigational drug * Previous exposure to dasiglucagon (also known as ZP4207) within the last 30 days prior screening * History of liver disease that is expected to interfere with the anti-hypoglycaemic action of glucagon (e.g. liver failure or cirrhosis) * Pregnancy * Breastfeeding * Major surgery within 30 days before screening * Alcohol abuse (per investigator assessment) * 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 * History of pheochromocytoma or insulinoma * History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients * Known or suspected allergies to glucagon or related products

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