← Trials/Trial dossier/NCT01435980

UnknownPhase 4

Study of Comparison the Treatment Effect Between Gastric Bypass and Exenatide in Type 2 Diabetes

Lead sponsor

Wu Qinan

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

60

estimated

Study population

Bariatric Surgery Candidate, Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥35HbA1c ≥7%

Primary endpoint

Clinical events (Stroke (any), Myocardial infarction (any), Custom renal composite, All-cause death)

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 IDNCT01435980
Org study IDthe south west Hospital2

Timeline

Milestones

Study first posted2011-09-19estimated
Last update posted2015-03-27estimated
Study start2008-02 (month precision)
Primary completion2016-01estimated (month precision)
Study completion2016-02estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Bariatric Surgery CandidateObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. BMI ≥ 35kg/m2, With Type 2 Diabetes;

2. BMI32-34.9kg/m2, With Type 2 Diabetes, Insulin Therapy in Combination With Oral Administration of Drugs for 6 Months and HbA1c ≥ 7%;

3. Between the Ages of 18-60 Years;

4. Course of Type 2 Diabetes ≤ 5 Years;

5. ICA, IAA, GAD Are Negative , C-peptide Level is Not Less Than 0.3mg / L;

Exclusion criteria

1. non-diabetic patients , type 1 diabetes (serum insulin antibodies (ICA) or glutamic acid decarboxylase antibodies (GADA)-positive autoimmune diabetes), special type of diabetes, gestational diabetes;

2. patients who had liver or renal failure

3. severe infections in patients and patients who had cerebrovascular disease

4. patients who had heart failure

5. fasting serum insulin or 2-hour postprandial serum insulin were lower than normal (<20mmol / L)

6. course of diabetes> 5 years or age> 60 years or age <18 years

Endpoints (8)

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

Cardiometabolic biomarkers
4
Glycemic / diabetes
2
Safety / tolerability / PK
1
Other (unclassified)
1

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Blood testing

Time frame:1 year

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Blood testing

Time frame:1 year

descriptive, improvement

LOINC 4548-4

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

echocardiography

Time frame:1 year

change from baseline, improvement

Secondary/protocol endpoint

Blood testing

Time frame:1 year

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Blood testing

Time frame:1 year

Adiponectin, change

change from baseline, improvement

Secondary/protocol endpoint

Blood pressure monitoring

Time frame:1 month

descriptive, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint/low confidence

Clinical events

Time frame:1 year

descriptive

componentsStroke (any), Myocardial infarction (any), Custom renal composite, All-cause death, Treatment-emergent AEs (any)

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

echocardiography

Time frame:1 year

descriptive

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.