CompletedPhase EARLY_1

Determinants of Diabetes Remission After Gastric Bypass Surgery

Long Term Change of GLP-1 Insulinotropic Effect After GBP Surgery

Lead sponsor

Blandine Laferrere

Asset

Avexitide

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 35-55

Primary endpoint

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02287285

Org study IDAAAO1360

Secondary ID1F32DK113747-01A1

Secondary ID1R01DK098056-01A1

Timeline

Milestones

Study first posted2014-11-10estimated

Last update posted2020-04-24actual

Study start2014-10actual (month precision)

Primary completion2017-08actual (month precision)

Study completion2019-07actual (month precision)

Assets

Investigational agents

Avexitide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with a wide range of T2DM (duration, treatment modalities and control, in or not in remission) and scheduled for GBP surgery

•Blood pressure is under at least moderate control <160/100 mmHg

•Patients can be on dyslipidemia medications but need fasting triglyceride < 600 mg/dl

•Patients without recent (last 6 months) history of cardiovascular disease (CVD)

•BMI > 35 and < 55 kg/m2 prior to GBP surgery

Exclusion criteria

•Active cancer

•Unstable angina

•Recent stroke

•Current therapy that may affect glucose metabolism such as glucocorticoids, HIV medications, etc

•Active infection

•Kidney failure

•Severe liver dysfunction

•Severe respiratory or cardiac failure

•History of allergic reaction to exendin 9-39

•History of pancreatitis, history of cholelithiasis, history of alcoholism

•Presence of high triglyceride levels (>600 ng/dl)

•Pregnancy (a pregnancy test will be done prior to enrollment and prior to each procedure in all premenopausal women)

Endpoints (0)

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.

No endpoints recorded for this trial.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.