Phase 2
Completed N=36
A Study of the GI Sleeve for the Treatment of Type 2 Diabetes
Source: ClinicalTrials.gov NCT02709577 ↗Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Dec 2016
Primary outcomePrimary: Change in HbA1c Values From Baseline Measurement — 2.4; 2.2; 0.8; 1.6 percentage of HbA1c
Summary
The purpose of the study was to evaluate the safety and efficacy of the EndoBarrier Gastrointestinal Liner compared to sham control in subjects with Type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c Values From Baseline Measurement |
2.4; 2.2; 0.8; 1.6 | — |
| SECONDARY Absolute Weight Change |
9.9; 11.3; 7.9; 5.4 | — |
Eligibility Criteria
Inclusion Criteria
- Age > 18 years and 30 and 10 lbs within the three months of screening
- Patients requiring prescription anticoagulation therapy
- Patients with iron deficiency and iron deficiency anemia
- Patients with a history of abnormal pathologies of the GI tract
- Patients with known gallstones or kidney stones prior to implant
- Known infection at the time of implant
- Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- Pregnant or has the intention of becoming pregnant in the next 12 months
- Patients with a history of active kidney stones
- Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial
- Previous GI surgery that could affect the ability to place the sleeve or the function of the implant
- Patients unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- H. pylori positive patients (Note: patients may be enrolled if they had a prior history and were successfully treated)
- Patients receiving weight loss medications such as Meridia and Xenical
- Family or patient history of a known diagnosis or pre-existing symptom of systemic lupus erythematous, scleroderma or other autoimmune connective tissue disorder
- Patients with Gastrointestinal Reflux Disease (GERD)
- Participating in another ongoing investigational clinical trial
- Patients taking corticosteroids or drugs known to affect gastrointestinal motility (such as reglan)
Data sourced from ClinicalTrials.gov (NCT02709577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.