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Study of Comparison the Treatment Effect Between Gastric Bypass and Exenatide in Type 2 Diabetes
Lead sponsor
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 ≥35•HbA1c ≥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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Glycemic / diabetes
2 endpointsBlood testing
Time frame:1 year
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Blood testing
Time frame:1 year
descriptive, improvement
LOINC 4548-4
Cardiometabolic biomarkers
4 endpointsechocardiography
Time frame:1 year
change from baseline, improvement
Blood testing
Time frame:1 year
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Blood testing
Time frame:1 year
Adiponectin, change
change from baseline, improvement
Blood pressure monitoring
Time frame:1 month
descriptive, improvement
Safety / tolerability / PK
1 endpointClinical events
Time frame:1 year
descriptive
componentsStroke (any), Myocardial infarction (any), Custom renal composite, All-cause death, Treatment-emergent AEs (any)
Other (unclassified)
1 endpointechocardiography
Time frame:1 year
descriptive
Provenance
Sources
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.