DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT05284344

Completed

The Impact of Glucotoxicity on Gastric Emptying in Chinese Patients With Newly Diagnosed Type 2 Diabetes

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

—

Enrollment

78

actual

Study population

Healthy volunteers, Type 2 diabetes

Key I/E criterion

•HbA1c ≥7%

Primary endpoint

•Gastric-half emptying time of the 75 g glucose drink

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 IDNCT05284344
Org study IDKY20220214-08

Timeline

Milestones

Study start2021-01-24actual
Study first posted2022-03-17actual
Primary completion2023-12-31actual
Study completion2023-12-31actual
Last update posted2024-05-09actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Healthy volunteersType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted
Sampling methodNon probability sample

Study population text

Han Chinese patients newly diagnosed type 2 diabetes Han Chinese non-diabetic subjects

Inclusion criteria

1. Patients newly diagnosed of type 2 diabetes as defined by published Criteria of World Health Organization in 1999; with HbA1c ≥ 7%, age ≥ 18 years of age and ≤ 80 years old, and willing to receive anti-diabetic treatments,

2. Non-diabetic controls, with BMI and age matched to patients with type 2 diabetes

Exclusion criteria

1. Patients with a fasting blood glucose ≤ 3.9mmol/L;

2. Patients with insulin allergy;

3. Patients with severe gastrointestinal symptoms and diseases;

4. Patients with gastrointestinal surgery history;

5. Use of any medication that may influence gastrointestinal motor function, body weight or appetite (opiates, anticholinergics, levodopa, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, prucalopride, or erythromycin);

6. Patients with major cardiovascular disease event (e.g., stroke, symptomatic peripheral artery disease, myocardial infarction, percutaneous coronary or peripheral artery angioplasty or coronary artery bypass surgery) in the previous 6 months;

7. Patients with liver dysfunction (aspartate aminotransferase or alanine aminotransferase level of more than two times the upper limit of normal range) or renal dysfunction (creatinine > 150 μmol/L or GFR < 60 mL/min/1.73m2);

8. Patients with severe anemia and hemoglobin disorders (Hb < 60 g/L);

9. Patients with infected injection site or coagulation disorders;

10. Patients who are pregnant.

Endpoints (13)

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
5
Other (unclassified)
4
Cardiometabolic biomarkers
3
Other clinical outcomes
1

Glycemic / diabetes

5 endpoints
Secondary/protocol endpoint

The mean blood glucose level

Time frame:Baseline, 1 month and 3 months in the diabetic group

change from baseline, improvement

Secondary/protocol endpoint

The mean amplitude of glycemic excursion

Time frame:Baseline, 1 month and 3 months in the diabetic group

change from baseline, improvement

Secondary/protocol endpoint

The percentage of blood glucose levels within the target range

Time frame:Baseline, 1 month and 3 months in the diabetic group

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Serum insulin concentrations

Time frame:t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group

change from baseline, improvement

Secondary/protocol endpoint

Serum C-peptide concentrations

Time frame:t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group

C-peptide AUC

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Systolic blood pressure

Time frame:t = 0, 15, 30, 45, 60,75, 90, 105, 120, 135, 150, 165 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Diastolic blood pressure

Time frame:t = 0, 15, 30, 45, 60,75, 90, 105, 120, 135, 150, 165 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Heart rate

Time frame:t = 0, 15, 30, 45, 60,75, 90, 105, 120, 135, 150, 165 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group

Heart rate, change

change from baseline, improvement

Other clinical outcomes

1 endpoint
Primary/protocol endpoint/low confidence

Gastric-half emptying time of the 75 g glucose drink

Time frame:Baseline in both diabetic and non-diabetic group

descriptive

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

Change in Gastric-half emptying time of the 75 g glucose drink

Time frame:Baseline, 1 month and 3 months in diabetic group

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Serum total GLP-1 concentrations

Time frame:t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group

concentration, descriptive

Secondary/protocol endpoint/low confidence

Serum total GIP concentrations

Time frame:t = 0, 30, 60, 120 and 180 min (t = 0 is when 75 g glucose drink is given) on baseline, 1 month and 3 months in the diabetic group

descriptive

Secondary/protocol endpoint/low confidence

Serum bile acid concentrations

Time frame:Baseline, 1 month and 3 months in the diabetic group

change from baseline, descriptive

Publications (5)

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.