Trials / Terminated
TerminatedNCT01728116
Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese
A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 325 (actual)
- Sponsor
- Morphic Medical Inc. · Industry
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes
Detailed description
This is a randomized, double blinded, prospective study. Subjects will be evaluated and randomized to either the device or sham treatment group if they qualify for the study. A comparison of glycemic control between the two groups will be assessed as the primary outcome measurement as well as the safety profile of the device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EndoBarrier | Endoscopically-delivered and removable device comprised of an anchor that is placed in the duodenal bulb and a 60 cm long impermeable liner that passes distal from the anchor point |
| PROCEDURE | Sham Procedure | Endoscopic evaluation but no device placement |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2016-02-01
- Completion
- 2016-02-01
- First posted
- 2012-11-16
- Last updated
- 2017-02-01
- Results posted
- 2016-12-02
Locations
25 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01728116. Inclusion in this directory is not an endorsement.