DelfaGLP-1 Atlas

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SPPS

UnknownPhase 2

The Safety,Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus

The Safety, Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese T2DM

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

36

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-13%

Primary endpoint

•HbA1c, change

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 IDNCT01342042
Org study IDCSPC/PRO-rE4/IIa-04

Timeline

Milestones

Study first posted2011-04-26estimated
Last update posted2011-04-26estimated
Study start2011-03 (month precision)
Primary completion2011-12estimated (month precision)
Study completion2011-12estimated (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. 18 ~ 75 years with T2DM in China;

2. HbA1c of 7% to 13%;

3. negative pregnancy test in females, all subjects have no family planning during the test and after the end within 3 months.

Exclusion criteria

1. HBsAg, HCV, HIV and syphilis test was positive;

2. any time FBG <6.1 or> 14.0 mmol / L in the morning;

3. Renal function: eGFR <60 mL / min ;

4. TG> 5mmol / L;

5. Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases;

6. Ischemic heart disease, heart failure, stroke or peripheral vascular disease;

7. Pregnancy and breast-feeding women;

8. Patients requiring insulin treatment;

9. Have medical history of hypoglycemia;

10. Have a clear history of allergic patients;

11. Patients addicted to alcohol and tobacco.

Endpoints (5)

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
4
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

To compare treatment arms in terms of change from baseline to endpoint in body weight

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

To compare treatment arms in terms of change from baseline to endpoint in HbA1c

Time frame:12 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

To compare treatment arms in terms of change from baseline to endpoint in GA

Time frame:12 Weeks

change from baseline, improvement

Secondary/protocol endpoint

To compare treatment arms in terms of change from baseline to endpoint in fasting serum glucose

Time frame:12 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

To compare treatment arms in terms of change from baseline to endpoint in postprandial blood glucose 2-hour

Time frame:12 weeks

Postprandial glucose

change from baseline, improvement

Publications (1)

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.