Diabetes Mellitus, Type 1Phase 2STABLE-1NCT05454709
A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System
A Phase 2 study testing Dasiglucagon and GlucaGen in people with Diabetes Mellitus, Type 1, run by Inreda Diabetic B.V. at 1 site in Netherlands.
Trial summary
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®. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Dasiglucagon and GlucaGen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Dec 2023to 29 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System; a Feasibility Study
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.
Read the detailed description
Background of the study:
Inreda Diabetic B.V. (Goor, The Netherlands) developed a bi-hormonal reactive closed loop system to automate glucose regulation (artificial pancreas; AP) in patients with diabetes mellitus type 1. In the current CE-marked AP, GlucaGen® (Novo Nordisk, Denmark) is used as glucagon. This glucagon formulation is not stable and therefore fibrillation and infusion set occlusion could occur, resulting in reduced glucagon action with risk for hypoglycemia. Dasiglucagon (Zealand Pharma, Denmark) is a glucagon analog stable in aqueous solution and does therefore not suffer from fibrillation.
Objective of the study:
The main objective is to determine the feasibility of dasiglucagon in the Inreda AP-system. Secondary objectives are to assess safety parameters, differences in pharmacodynamics between dasiglucagon and GlucaGen® and differences in AP related outcomes.
Study design:
This study is a single-center, double-blinded, randomized, cross over trial which will be performed out-patient.
Study population:
The study population will comprise 12 subjects with diabetes type 1 using the AP system. Inclusion criteria are subjects from 18 years and older and treated with the Inreda AP system for a minimum of 1 month.
Intervention:
The intervention contains use of dasiglucagon administered by the Inreda AP-system. The subject will be randomized to receive either dasiglucagon or GlucaGen® during the first three days. After a wash-out period of four days, the subject will be switched to the alternate treatment. During both study periods subjects have to keep a diary, perform exercise, keep a WiFi access point with them, and have some eating restrictions.
Primary study parameters/outcome of the study:
Main parameter to express feasibility is the time in range (3.9 - 10.0 mmol/l), which will be compared between the dasiglucagon and reference glucagon.
Secondary study parameters/outcome of the study:
- Safety will be expressed as side effects of dasiglucagon compared to side effects of GlucaGen.
- The amount of extra food intakes to prevent/ combat hypoglycemia.
- Pharmacodynamics will be expressed in proportion of time spent in hypo-/hyperglycemia, median/mean glucose value, glycemic variability and PD curves, which will all be compared between the dasiglucagon and reference glucagon.
- AP related outcomes will be expressed in daily administered (maintenance) dosage of insulin/glucagon and the percentage of time that the closed loop algorithm is active.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Dasiglucagon, GlucaGen
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasiglucagonDrug
Use of dasiglucagon in the AP system.
GlucaGenDrug
Use of GlucaGen in the AP system.
| Study group | Role | What they receive |
|---|---|---|
| Dasiglucagon | Experimental | Dasiglucagon 1mg/ml solution for subcutaneous injection. Size and frequency of dosing will be determined by the AP algorithm. Duration: 3 days. Receives: Drug: Dasiglucagon |
| GlucaGen | Active comparator | Glucagon 1mg/ml solution for subcutaneous injection. Size and frequency of dosing will be determined by the AP algorithm. Duration: 3 days. Receives: Drug: GlucaGen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
Time of glucose concentration in the range 3.9-10.0 mmol/L in %
Measured: 3 days
Secondary outcomes (9)
Side effects
Side effects of dasiglucagon and GlucaGen
Measured: 3 days
Extra food intakes (food intake diary)
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.
Measured: 3 days
Pharmacodynamics - hypo/hyper
Time spent in hypo-/hyperglycemia in percent
Measured: 3 days
Pharmacodynamics - glucose value
Median glucose value in mmol/L
Measured: 3 days
Pharmacodynamics - glycemic variability
Coefficient of variation (Standard deviation divided by the mean) in percent
Measured: 3 days
Pharmacodynamics - glycemic variability
Inter quartile range in mmol/L
Measured: 3 days
Pharmacodynamics - PD curves
Pharmacodynamics curves
Measured: 3 days
AP related parameters - doses
Daily administered dose of insulin and glucagon in units
Measured: 3 days
AP related parameters - algorithm
Time that algorithm is active in percent
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start29 Dec 2023 (estimated)
- Primary completion29 Dec 2023 (estimated)
- Study completion29 Dec 2023 (estimated)
Why it stopped: Study medication could not be delivered by manufacturer.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three days treatment A, four days wash out period (standard treatment), three days treatment B.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inreda Diabetic B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- G Laverman, MD, Principal investigator, ZGT hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454709
- Sponsor's protocol ID
- NL76691.100.22
- Acronym
- STABLE-1
- Status last verified
- Dec 2023
- First submitted
- 6 May 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System; a Feasibility Study
- ClinicalTrials.gov ID
- NCT05454709
- Acronym / sponsor ID
- STABLE-1 / NL76691.100.22
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study medication could not be delivered by manufacturer.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Inreda Diabetic B.V.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2023 (estimated)
- Primary completion
- 29 Dec 2023 (estimated)
- Study completion
- 29 Dec 2023 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background of the study:
Inreda Diabetic B.V. (Goor, The Netherlands) developed a bi-hormonal reactive closed loop system to automate glucose regulation (artificial pancreas; AP) in patients with diabetes mellitus type 1. In the current CE-marked AP, GlucaGen® (Novo Nordisk, Denmark) is used as glucagon. This glucagon formulation is not stable and therefore fibrillation and infusion set occlusion could occur, resulting in reduced glucagon action with risk for hypoglycemia. Dasiglucagon (Zealand Pharma, Denmark) is a glucagon analog stable in aqueous solution and does therefore not suffer from fibrillation.
Objective of the study:
The main objective is to determine the feasibility of dasiglucagon in the Inreda AP-system. Secondary objectives are to assess safety parameters, differences in pharmacodynamics between dasiglucagon and GlucaGen® and differences in AP related outcomes.
Study design:
This study is a single-center, double-blinded, randomized, cross over trial which will be performed out-patient.
Study population:
The study population will comprise 12 subjects with diabetes type 1 using the AP system. Inclusion criteria are subjects from 18 years and older and treated with the Inreda AP system for a minimum of 1 month.
Intervention:
The intervention contains use of dasiglucagon administered by the Inreda AP-system. The subject will be randomized to receive either dasiglucagon or GlucaGen® during the first three days. After a wash-out period of four days, the subject will be switched to the alternate treatment. During both study periods subjects have to keep a diary, perform exercise, keep a WiFi access point with them, and have some eating restrictions.
Primary study parameters/outcome of the study:
Main parameter to express feasibility is the time in range (3.9 - 10.0 mmol/l), which will be compared between the dasiglucagon and reference glucagon.
Secondary study parameters/outcome of the study:
- Safety will be expressed as side effects of dasiglucagon compared to side effects of GlucaGen.
- The amount of extra food intakes to prevent/ combat hypoglycemia.
- Pharmacodynamics will be expressed in proportion of time spent in hypo-/hyperglycemia, median/mean glucose value, glycemic variability and PD curves, which will all be compared between the dasiglucagon and reference glucagon.
- AP related outcomes will be expressed in daily administered (maintenance) dosage of insulin/glucagon and the percentage of time that the closed loop algorithm is active.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Three days treatment A, four days wash out period (standard treatment), three days treatment B.
| Arm | Type | Receives |
|---|---|---|
| Dasiglucagon | Experimental | Drug: DasiglucagonDasiglucagon 1mg/ml solution for subcutaneous injection. Size and frequency of dosing will be determined by the AP algorithm. Duration: 3 days. |
| GlucaGen | Active comparator | Drug: GlucaGenGlucagon 1mg/ml solution for subcutaneous injection. Size and frequency of dosing will be determined by the AP algorithm. Duration: 3 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosed with diabetes mellitus type 1;
- 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;
Key exclusion criteria (8 listed)
- Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire [3], [4];
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasiglucagonUse of dasiglucagon in the AP system. | Drug | Dasiglucagon |
| GlucaGenUse of GlucaGen in the AP system. | Drug | GlucaGen |
Primary outcome
Time in range
Time frame: 3 days
Time of glucose concentration in the range 3.9-10.0 mmol/L in %
9 secondary outcomes
Side effects
Time frame: 3 days
Extra food intakes (food intake diary)
Time frame: 3 days
Pharmacodynamics - hypo/hyper
Time frame: 3 days
Pharmacodynamics - glucose value
Time frame: 3 days
Pharmacodynamics - glycemic variability
Time frame: 3 days
Pharmacodynamics - glycemic variability
Time frame: 3 days
Pharmacodynamics - PD curves
Time frame: 3 days
AP related parameters - doses
Time frame: 3 days
AP related parameters - algorithm
Time frame: 3 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G Laverman, MD principal investigator
ZGT hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasiglucagon and GlucaGen in people with Diabetes Mellitus, Type 1, run by Inreda Diabetic B.V. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.