DelfaGLP-1 Atlas

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UnknownPhase NA

Efficacy Comparison of Polyethylene Glycol Loxenatide and Gliclazide on the Brain Function in T2DM Patients

Efficacy Comparison of Polyethylene Glycol Loxenatide and Gliclazide on the Brain Function in T2DM Patients: a Randomized, Parallel Controlled Clinical Trial

Asset

Loxenatide / PEG-loxenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

58

estimated

Study population

Alzheimer's / cognition, Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

Primary endpoint

•Olfactory brain activation by fMRI

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06217887
Org study IDz-2017-26-1902

Timeline

Milestones

Study start2020-05-10actual
Study first posted2024-01-23actual
Last update posted2024-01-23actual
Primary completion2024-02estimated (month precision)
Study completion2024-06estimated (month precision)

Assets

Investigational agents

Loxenatide / PEG-loxenatide

Study populations

Who this study enrolls

Alzheimer's / cognitionType 2 diabetes

Eligibility

Who can enroll

Minimum age40 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•patients with type 2 diabetes mellitus ;
•Aged:40 -75 years ;
•Cognitive function assessment suggests normal status or mild cognitive impairment;
•a stable dose of metformin monotherapy (≥1,500 mg daily) for at least 90 days,
•HbA1c 7 - 10%;
•≥6 years of education;
•Right-handed.

Exclusion criteria

•patients unable to complete brain MRI scanning;
•nasal disease that affected olfactory function;
•hepatic dysfunction with liver transaminases > 2.5 times upper normal limits and renal impairment with an estimated glomerular filtration rate < 60ml/min/1.73m2 ;
•acute cardio/cerebrovascular disease, psychiatric disorders, pancreatitis, acute infection, malignant tumor,thyroid disease and homorne drug use;
•a history of related drug allergy;
•alcohol or drug misuse;
•pregnant, breast-feeding or intending to become pregnant.

Endpoints (3)

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)

3 endpoints
Primary/protocol endpoint/low confidence

Change of olfactory brain activation by fMRI

Time frame:from baseline to 4-month follow-up

descriptive

Secondary/protocol endpoint/low confidence

Change of cognitive function

Time frame:from baseline to 4-month follow-up

descriptive

Secondary/protocol endpoint/low confidence

Change of metabolism

Time frame:from baseline to 4-month follow-up

descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.