NCT02709577

A Study of the GI Sleeve for the Treatment of Type 2 Diabetes

A Pilot Feasibility Sham Controlled Study of the GI Sleeve for the Treatment of Type 2 Diabetes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Morphic Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study was designed as a randomized, single blind, sham controlled, pilot efficacy study of subjects with Type 2 diabetes enrolled at 2 centers in Santiago, Chile. Subjects were enrolled at a 2:1 ratio (EndoBarrier to sham). Following implantation or sham procedure, subjects were treated for 24 weeks or 52 weeks. Following explant, subjects were followed for an additional 8-12 weeks. Subject evaluations included measurements of HbA1c, glucose, insulin, weight, changes in diabetic medications, and meal tolerance tests. Safety was monitored through the collection of clinical labs, physical assessments, endoscopy and adverse events.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	EndoBarrier Gastrointestinal Liner	The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum.
OTHER	Sham: endoscopy and standard of care	Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2016-03-16
• Last updated: 2016-12-28
• Results posted: 2016-12-28