EXEPUMP

UnknownPhase 2, PHASE3

Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes

Effects of EXEnatide on Glycemic Control and Weight Over 26 Weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients With Type 2 Diabetes : a Phase 2/3 Double Blind randoMized Placebo-controlled Trial.

Lead sponsor

University Hospital, Caen

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

110

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 2-5%

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 IDNCT01140893

Org study IDEudraCT N° 2009-016384-11

Timeline

Milestones

Study first posted2010-06-10estimated

Last update posted2016-08-23estimated

Study start2010-11 (month precision)

Primary completion2017-05estimated (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age35 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Men or women aged 35 to 70

•Type 2 diabetes diagnosed for at least 12 months, according the criteria of the American Diabetes Association :

–presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2-hour post-prandial or random glucose >200 mg/dL) or

–fasting plasma glucose elevation on more than 1 occasion > 125 mg/dL or

–patient currently undergoing pharmacological and/or non-pharmacological treatment for diabetes mellitus

•CSII treatment using a rapid analog for at least 6 month (CSII being initiated in patients with HbA1c > 8 % despite a well-conducted MDI trial using a 2 to 5 daily injection regimen)

•HbA1c ≥ 7,5% and ≤ 10 %

•BMI ≥ 25 and ≤ 45

•Stable body weight (≤10% variation) during the 3 last months

Exclusion criteria

•Type 1 diabetes assessed by positive anti-GAD65 or anti-insulin or anti-IA2 antibodies

•Monogenic diabetes (MODY, mitochondrial diabetes…)

•Current treatment with OHA (OHA ought to be interrupted at least two months prior to inclusion in the study)

•Current treatment specifically addressed for weight lost (orlistat, sibutramine, rimonabant may be interrupted at least 3 months prior to inclusion in the study)

•Use of corticosteroid therapy for more than 10 days within the 3-past months, or patient who ought to be treated by corticosteroid during the study period

•Clinically significant hepatic disease

•Documented gastroparesis, or current use of drugs that directly affect gastrointestinal motility, or any significant abdominal disease that may increase the risk of adverse gastrointestinal effects induced by exenatide

•Kidney failure (MDRD less than 50 ml/min)

•Pregnancy/breastfeeding

•Any social and/or mental condition rendering the subject unable to understand the scope and possible consequences of the study

•Concurrent enrolment in another clinical trial

•Geographically inaccessible for follow-up visits required by protocol

Endpoints (3)

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

Other (unclassified)

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change from baseline to 6 months of centrally measured HbA1c

Time frame:baseline to 6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline in mean blood glucose value

Time frame:baseline to 6 months

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change from baseline in weight, BMI, waist circumference, 6 points glucose profile, insulin doses, % of daily use of insulin as basal rate, % of daily use of insulin as bolus, quality of life questionnaire

Time frame:baseline to 6 months

descriptive

componentsBody weight, absolute change (kg), BMI, change, Waist circumference, change, Postprandial glucose, SF-36 total

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.