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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709577
• Other study ID #: 06-5
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 11, 2016
• Last updated: June 22, 2016
• Start date: January 2007
• Est. completion date: January 2009

Study information

• Verified date: March 2016
• Source: GI Dynamics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Age > 18 years and < 55 years - Male or Female

• Patients with type 2 diabetes, treated for 10 years or less

• HbA1c level = 7.0 and = 10.0%

• Fasting glucose = 240 mg/dl

• Patients taking metformin, sulfonylureas or thiazolidinediones (TZDs), either alone or in combination

• BMI > 30 and <50

• Patients willing to comply with study requirements

• Patients who have signed an informed consent form

• Women who are post-menopausal, surgically sterile, or on oral contraceptives for at least three months and who do not plan on becoming pregnant during the course of the study.

Exclusion Criteria:

• Patients taking oral medications to control their diabetes other than sulfonylureas, metformin or thiazolidinediones

• Patients diagnosed with type 1 diabetes mellitus or had a history of ketoacidosis

• Patients requiring insulin

• Patients with lab evidence of probable insulin production failure (fasting C peptide serum level < 1ng/ml)

• Patients with a weight loss of > 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
GI Dynamics	Hospital Dipreca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of HbA1c from baseline measurement		Baseline to 24 weeks or 52 weeks	No
Secondary	Absolute weight loss		24 weeks or 52 weeks	No