← Trials/Trial dossier/NCT05037045

CompletedPhase NA

Effect of Gene Polymorphisms on GLP-1 Receptor Agonists Response in Patients With T2DM

Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University

Asset

GLP-1 / incretin class catch-all

Subcutaneous

Listed sites

1

Recruiting sites

Enrollment

338

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI 20-35HbA1c 7-12%

Primary endpoints

HbA1c, changeFasting glucose, changePostprandial glucose

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 IDNCT05037045
Org study IDXYFY2018-KL085

Timeline

Milestones

Study start2019-01-10actual
Study first posted2021-09-08actual
Primary completion2023-10-01actual
Study completion2024-01-02actual
Last update posted2024-11-12actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age25 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. a diagnosis of T2DM;

2. a body mass index (BMI) of 20-35 kg/m2;

3. an HbA1c of 7.0%-12%, an age of 25-70 years;

4. required data available at baseline, 3 months, and 6 months after GLP-1 RA therapy.

Exclusion criteria

1. Patients with serious diseases such as acute myocardial infarction, cerebral vascular accident, trauma, kidney or liver diseases, severe gastrointestinal dysfunction, and history of pancreatitis;

2. patients receiving GLP-1 analogues, weight loss drugs, glucocorticoids, drugs affecting gastrointestinal peristalsis in the past 3 months;

3. those with missing data at the time points of baseline, 3 months, and 6 months after GLP-1 RA therapy.

Endpoints (15)

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

Glycemic / diabetes
9
Cardiometabolic biomarkers
3
Safety / tolerability / PK
3

Glycemic / diabetes

9 endpoints
Primary/protocol endpoint

Change from baseline HbA1c at 1 month

Time frame:1 month after GLP-1 RA treatment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Change from baseline FPG at 1 month

Time frame:1 month after GLP-1 RA treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Primary/protocol endpoint

Change from baseline PPG at 1 month

Time frame:1 month after GLP-1 RA treatment

Postprandial glucose

change from baseline, improvement

Primary/protocol endpoint

Change from baseline HbA1c at 3 month

Time frame:3 month after GLP-1 RA treatment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Change from baseline FPG at 3 month

Time frame:3 month after GLP-1 RA treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Primary/protocol endpoint

Change from baseline PPG at 3 month

Time frame:3 month after GLP-1 RA treatment

Postprandial glucose

change from baseline, improvement

Primary/protocol endpoint

Change from baseline HbA1c at 6 month

Time frame:6 month after GLP-1 RA treatment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Change from baseline FPG at 6 month

Time frame:6 month after GLP-1 RA treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Primary/protocol endpoint

Change from baseline PPG at 6 month

Time frame:6 month after GLP-1 RA treatment

Postprandial glucose

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Primary/protocol endpoint

Change from baseline serum lipids at 1 month

Time frame:1 month after GLP-1 RA treatment

change from baseline, improvement

Primary/protocol endpoint

Change from baseline serum lipids at 3 month

Time frame:3 month after GLP-1 RA treatment

change from baseline, improvement

Primary/protocol endpoint

Change from baseline serum lipids at 6 month

Time frame:6 month after GLP-1 RA treatment

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

incidence and severity of possible adverse reaction within 1 month after GLP-1 RA treatment

Time frame:1 month after GLP-1 RA treatment

Treatment-emergent AEs (any)

descriptive, event

Secondary/protocol endpoint

incidence and severity of possible adverse reaction within 3 month after GLP-1 RA treatment

Time frame:3 month after GLP-1 RA treatment

descriptive, event

componentsTreatment-emergent AEs (any), Nausea, Vomiting, Diarrhea, Documented hypoglycemia

Secondary/protocol endpoint

incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment

Time frame:6 month after GLP-1 RA treatment

descriptive, event

componentsNausea, Vomiting, Diarrhea, Documented hypoglycemia

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.