N/A
Completed N=45
Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner
Source: ClinicalTrials.gov NCT01114438 ↗Enrolled (actual)
45
Serious AEs
28.9%
Results posted
Feb 2017
Primary outcomePrimary: HbA1c (%) Measured at Week 52 — 7.3 % glycated hemoglobin
Summary
The purpose of this study is to evaluate EndoBarrier Gastrointestinal Liner in the post marketing environment in subjects who are obese and have Type 2 Diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c (%) Measured at Week 52 |
7.3 | — |
| PRIMARY Total Weight Change From Baseline to Week 52 |
-12.1 | — |
| PRIMARY Changes in Diabetic Medications at Treatment Completion Compared to Baseline |
23; 4; 18 | — |
| PRIMARY Change From Baseline in SF 36v2 Quality of Life Assessment |
1.0; 1.0; 3.0; -0.5 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects Age > 18 years and ≤65 years - Male or Female
- Subjects with Type 2 Diabetes > 1 and ≤ 10 years in duration
- Subjects with an Hb A1c level > 7.5 and ≤ 10.0
- Subjects taking oral Type 2 Diabetes medications and/or insulin. Metformin is allowed, but not required.
- Subjects with a BMI > 30 and 150 units per day
- Subjects with probable insulin production failure (fasting C Peptide serum 180mmol/l)
- Subjects with poor dentition who can not adequately chew their food
Data sourced from ClinicalTrials.gov (NCT01114438). 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.