A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System

Short name STABLE-1

NCTNCT05454709Other idNL76691.100.22

Open at ClinicalTrials.govAsk about this trial

This trial was withdrawn before it enrolled anyone.

Reason given at the registry: Study medication could not be delivered by manufacturer.

Overview

Status: Withdrawn
Phase: Phase 2
Enrollment: 0 participants (actual)
Sponsor: Inreda Diabetic B.V. · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
Netherlands
Start: 29 Dec 2023 (estimated)
Primary completion: 29 Dec 2023 (estimated)
Completion: 29 Dec 2023 (estimated)
First posted: 12 Jul 2022
Last update posted: 3 Jan 2024
Conditions: Diabetes Mellitus, Type 1

Timeline

1 trial · 1 stopped early

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

20232024

Ph 2
STABLE-1
NCT05454709
est. 29 Dec 2023 to est. 29 Dec 2023
Withdrawn
Withdrawn

Registry summary

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

The main objective is to determine the feasibility of dasiglucagon in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1. Safety parameters and pharmacodynamics are compared between Dasiglucagon and GlucaGen®. This study is a single-center, double-blinded, randomized, cross over trial in 12 subjects. The subjects will be randomized to receive either dasiglucagon or GlucaGen® for the first three day study period and switch to the alternate treatment after a wash-out treatment.

Interventions

DasiglucagonDrug
GlucaGenDrug

Arms2

Experimental
Dasiglucagon
Dasiglucagon 1mg/ml solution for subcutaneous injection. Size and frequency of dosing will be determined by the AP algorithm. Duration: 3 days.
Active comparator
GlucaGen
Glucagon 1mg/ml solution for subcutaneous injection. Size and frequency of dosing will be determined by the AP algorithm. Duration: 3 days.

Primary outcomes1

Outcomes the sponsor listed as primary.

Time in range
Time frame · 3 days
Registry description
Time of glucose concentration in the range 3.9-10.0 mmol/L in %

Secondary outcomes(9)

Side effects
Time frame · 3 days
Registry description
Side effects of dasiglucagon and GlucaGen
Extra food intakes (food intake diary)
Time frame · 3 days
Registry description
The participant is instructed to eat the same meals in the intervention and control period. Except extra food intakes when needed to prevent/combat hypoglycemia. Food intakes not present in the other period are extra food intakes.
Pharmacodynamics - hypo/hyper
Time frame · 3 days
Registry description
Time spent in hypo-/hyperglycemia in percent
Pharmacodynamics - glucose value
Time frame · 3 days
Registry description
Median glucose value in mmol/L
Pharmacodynamics - glycemic variability
Time frame · 3 days
Registry description
Coefficient of variation (Standard deviation divided by the mean) in percent
Pharmacodynamics - glycemic variability
Time frame · 3 days
Registry description
Inter quartile range in mmol/L
Pharmacodynamics - PD curves
Time frame · 3 days
Registry description
Pharmacodynamics curves
AP related parameters - doses
Time frame · 3 days
Registry description
Daily administered dose of insulin and glucagon in units
AP related parameters - algorithm
Time frame · 3 days
Registry description
Time that algorithm is active in percent

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.

A trial that is still running, or that stopped early, may post results later.

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: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Diagnosed with diabetes mellitus type 1; * Treated with the Inreda AP system for a minimum of 1 month; * Age between 18 and 75 years; * Adequate contraception is required (only applicable for female participants); * Willing and able to sign informed consent. Since subjects are treated with the Inreda AP, the following inclusion criteria will be met: * Treated with SAP or CSII for a minimum of 6 months; * HbA1c \< 97 mmol/mol; * BMI \< 35 kg/m2; * No use of acetaminophen, as this may influence the sensor glucose measurements. Exclusion Criteria: * Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire \[3\], \[4\]; * Pregnancy and/or breastfeeding; * Use of oral antidiabetic agents; * Pheochromocytoma; * Insulinoma; * Severe liver/heart/renal failure; * Alcohol abuse; * Hypersensitivity reactions to dasiglucagon, glucagon or any of the excipients;

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