STABLE-1

WithdrawnPhase 2

A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System

A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System; a Feasibility Study

Lead sponsor

Inreda Diabetic B.V.

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 1 diabetes

Eligibility highlights

•BMI ≤35

Primary endpoint

•Time in range

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05454709

Org study IDNL76691.100.22

Timeline

Milestones

Study first posted2022-07-12actual

Study start2023-12-29estimated

Primary completion2023-12-29estimated

Study completion2023-12-29estimated

Last update posted2024-01-03actual

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Type 1 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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;

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Time in range

Time frame:3 days

descriptive

Secondary/protocol endpoint

Pharmacodynamics - glucose value

Time frame:3 days

descriptive

Secondary/protocol endpoint

Pharmacodynamics - glycemic variability

Time frame:3 days

descriptive

Secondary/protocol endpoint

Pharmacodynamics - glycemic variability

Time frame:3 days

descriptive