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Delfa

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RecruitingPhase 3

Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes

Survey on the Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes and Interventional Study of GLP-1RA: a Multicenter, Prospective Study

Asset

Loxenatide / PEG-loxenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Estimated enrollment

1,000

Study population

Type 2 diabetes

Eligibility highlights

-

Primary endpoint

•Glucagon levels

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 IDNCT06825182
Org study IDKY20240514-11

Timeline

Milestones

Study start2024-11-07actual
Study first posted2025-02-13actual
Last update posted2025-02-13actual
Primary completion2025-08-01estimated
Study completion2025-12-31estimated

Assets

Investigational agents

Loxenatide / PEG-loxenatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Willing to participate voluntarily and able to sign the Informed Consent Form before the trial;
•Newly diagnosed patients with type 2 diabetes, aged 18 years or older, meeting the WHO 1999 diagnostic criteria;
•Subjects who are capable and willing to maintain a regular diet and exercise regimen.

Exclusion criteria

•Patients who are allergic to GLP-1RA or have a BMI less than 24 kg/m^2;
•History of using blood sugar-lowering medications;
•Estimated glomerular filtration rate (eGFR) less than 30 ml/(min*1.73 m^2);
•History of drug abuse or alcohol dependence within the past 5 years;
•Patients with poor compliance and irregular diet and exercise;
•History of diagnosed pancreatitis, pancreatic tumor, medullary thyroid carcinoma, or diabetic retinopathy stage IV or higher;
•Patients who have used systemic glucocorticoid therapy within the past 3 months;
•Presence of infection or stress within the past four weeks;
•Any other significant condition or comorbidity judged by the researcher, such as severe cardiopulmonary disease, endocrine disorders, neurological disorders, tumors, other pancreatic diseases, mental illness, history of alcohol or drug abuse.

Endpoints (1)

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.

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Glucagon levels

Time frame:19 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.